Federal Register / Vol. 87, No. 42 / Thursday, March 3, 2022 / Rules and Regulations 11965 

N.J.A.C. 7:27–22.30. Renewals 

N.J.A.C. 7:27–22.31. Fees 

N.J.A.C. 7:27–22.32. Hearings and appeals 

N.J.A.C. 7:27–22.33. Preconstruction review 

N.J.A.C. 7:27–22.34. Early reduction of HAP 

emissions 

N.J.A.C. 7:27–22.35. Advances in the art of 

air pollution 

Appendix 

Table A 

Chapter 27B Subchapter 1—Sampling and 

Analytical Procedures for Determining 

Emissions of Particles From Manufacturing 

Processes and From Combustion of Fuels 

(Effective 6/21/1976) 

N.J.A.C. 7:27B–1.1. Definitions 

N.J.A.C. 7:27B–1.2. Acceptable test methods 

N.J.A.C. 7:27B–1.3. Operating conditions 

during the test 

N.J.A.C. 7:27B–1.4. Sampling facilities to be 

provided by the person responsible for 

emissions 

N.J.A.C. 7:27B–1.5. Sampling train 

N.J.A.C. 7:27B–1.6. Performance test 

principle 

N.J.A.C. 7:27B–1.7. General testing 

requirements 

N.J.A.C. 7:27B–1.8. Required test data 

N.J.A.C. 7:27B–1.9. Preparation for sampling 

N.J.A.C. 7:27B–1.10. Sampling 

N.J.A.C. 7:27B–1.11. Sample recovery 

N.J.A.C. 7:27B–1.12. Analysis 

N.J.A.C. 7:27B–1.13. Calculations 

N.J.A.C. 7:27B–1.14. Validation of test 

Chapter 27B Subchapter 2—Procedures for 

Visual Determination of the Opacity 

(Percent) and Shade or Appearance 

(Ringelmann Number) of Emissions From 

Sources (Effective 6/21/1976) 

N.J.A.C. 7:27B–2.1. Definitions 

N.J.A.C. 7:27B–2.2. Acceptable observation 

methods 

N.J.A.C. 7:27B–2.3. Observation principle 

N.J.A.C. 7:27B–2.4. General observation 

requirements 

N.J.A.C. 7:27B–2.5. Required observation 

data 

N.J.A.C. 7:27B–2.6. Certification 

References 

Appendix 

Chapter 27B Subchapter 3—Air Test Method 

3: Sampling and Analytical Procedures for 

the Determination of Volatile Organic 

Compounds From Source Operations 

(Effective 12/1/2008) 

N.J.A.C. 7:27B–3.1. Definitions 

N.J.A.C. 7:27B–3.2. Sampling and analytical 

protocol: Acceptable test methods 

N.J.A.C. 7:27B–3.3. Operating conditions 

during the test 

N.J.A.C. 7:27B–3.4. Sampling facilities 

N.J.A.C. 7:27B–3.5. Source operations and 

applicable test methods 

N.J.A.C. 7:27B–3.6. Procedures for the 

determinations of vapor pressures of a 

single known VOC or mixtures of known 

and/or unknown VOC 

N.J.A.C. 7:27B–3.7. Procedures for the direct 

measurement of volatile organic 

compounds using a flame ionization 

detector (FID), a photoionization detector 

(PID) or a non-dispersive infrared 

analyzer (NDIR) 

N.J.A.C. 7:27B–3.8. Procedures for the direct 

measurement of volatile organic 

compounds using a gas chromatograph 

(GC) with a flame ionization detector 

(FID) or other suitable detector 

N.J.A.C. 7:27B–3.9. Procedures for the 

sampling and remote analysis of known 

volatile organic compounds using a gas 

chromatograph (GC) with a flame 

ionization detector (FID) or other 

suitable detector 

N.J.A.C. 7:27B–3.10. Procedures for the 

determination of volatile organic 

compounds in surface coating 

formulations 

N.J.A.C. 7:27B–3.11. Procedures for the 

determination of volatile organic 

compounds emitted from transfer 

operations using a flame ionization 

detector (FID) or non-dispersive infrared 

analyzer (NDIR) 

N.J.A.C. 7:27B–3.12. Procedures for the 

determination of volatile organic 

compounds in cutback and emulsified 

asphalts 

N.J.A.C. 7:27B–3.13. Procedures for the 

determination of leak tightness of 

gasoline delivery vessels 

N.J.A.C. 7:27B–3.14. Procedures for the direct 

detection of fugitive volatile organic 

compound leaks 

N.J.A.C. 7:27B–3.15. Procedures for the direct 

detection of fugitive volatile organic 

compound leaks from gasoline tank 

trucks and vapor collection systems 

using a combustible gas detector 

N.J.A.C. 7:27B–3.18. Test methods and 

sources incorporated by reference. 

* * * * * 

[FR Doc. 2022–04271 Filed 3–2–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2021–0292; FRL–9420–01– 

OCSPP] 

Polyammonium Bisulfate; Exemption 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of Polyammonium 

bisulfate (PABS) (CAS Reg. No. 10043– 

02–4), herein referred to as PABS, when 

used as an inert ingredient (carrier, 

adjuvant, buffer and stabilizer) in/on 

growing crops and raw agricultural 

commodities pre- and post-harvest, 

limited to 40% in pesticide nonresidential formulations and 5% in 

pesticide formulations for residential 

use. An exemption is also established 

for its use in antimicrobial formulations 

applied to food-contact surfaces in 

public eating places, dairy-processing 

equipment, food-processing equipment 

and utensils, limited to 250 parts per 

million (ppm). Spring Regulatory 

Sciences on behalf of Earth Science 

Laboratories, Inc., submitted a petition 

to EPA under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), requesting 

the establishment of exemptions from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of PABS. 

DATES: This regulation is effective 

March 3, 2022. Objections and requests 

for hearings must be received on or 

before May 2, 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–2021–0292, is 

available at https://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 

open to visitors by appointment only. 

For the latest status information on 

EPA/DC services and access, visit 

https://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echevarria, 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: 


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• 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 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–2021–0292 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 May 2, 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– 

2021–0292, 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. Petition for Exemption 

In the Federal Register of June 1, 2021 

(86 FR 29229) (FRL–10023–95), EPA 

issued a document pursuant to FFDCA 

section 408, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP IN– 

11410) by the Spring Regulatory 

Sciences (6620 Cypresswood Dr., Suite 

250 Spring, TX 77379) on behalf of 

Earth Science Laboratories, Inc., (113 SE 

22nd Street, Suite 1, Bentonville, AR 

72712). The petition requested that 40 

CFR 180.910 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of PABS (CAS Reg. No. 10043–02–4) 

when used as an inert ingredient 

(carrier, adjuvant, buffer and as a 

stabilizer) in pesticide formulations 

applied in/on growing crops pre- and 

post-harvest, and in antimicrobial 

formulations applied to food-contact 

surfaces in public eating places, dairyprocessing equipment, food-processing 

equipment and utensils under 40 CFR 

180.940(a). That document referenced a 

summary of the petition prepared by 

Spring Regulatory Sciences on behalf of 

Earth Science Laboratories, Inc., the 

petitioner, 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, EPA has limited 

the maximum concentration of PABS to 

not more than 40% in pesticide 

formulations for non-residential use and 

not more than 5% in pesticide 

formulations for residential use under 

40 CFR 180.910 and limited the 

maximum concentration of PABS to 250 

ppm under 40 CFR 180.940(a). These 

limitations are based on the Agency’s 

risk assessment which can be found at 

https://www.regulations.gov in 

document ‘‘Polyammonium Bisulfate; 

Human Health Risk Assessment and 

Ecological Effects Assessment to 

Support Proposed Amendment to the 

Tolerance Exemption When Used as an 

Inert Ingredient in Pesticide 

Formulations’’ in docket ID number 

EPA–HQ–OPP–2021–0292. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for 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 . . .’’ and specifies 

factors EPA is to consider in 

establishing an exemption. 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 


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Consistent with FFDCA section 

408(c)(2)(A), and the factors specified in 

FFDCA section 408(c)(2)(B), 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 PABS including 

exposure resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with PABS follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by PABS as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies are 

discussed in this unit. 

Acute toxicity studies were conducted 

with ET–3000, a mixture containing 

PABS. According to these studies acute 

oral toxicity is low, as the lethal dose 

(LD50) is 1,750 milligrams/kilogram (mg/ 

kg) in rats, and the acute dermal toxicity 

in rats is also low, the LD50 is greater 

than 5,000 mg/kg. PABS is also not toxic 

via acute inhalation exposure, as the 

lethal concentration (LC50) is greater 

than 2.09 mg/L in rats. PABS is, 

however, corrosive to rabbit skin and 

the results were equivocal in a dermal 

sensitization study in mice. 

Based on the available data on 

surrogate chemicals, PABS is expected 

to cause anemia and diarrhea at doses 

greater than 1,000 mg/kg/day following 

subchronic exposure in rats. In a 

chronic and multigeneration toxicity 

study in which carcinogenicity was also 

evaluated, hyperplasia of the glandular 

stomach and occult blood in the feces 

were observed at 144 mg/kg/day in rats. 

No reproduction toxicity or fetal 

susceptibility was observed in this 

study. In another chronic/ 

carcinogenicity toxicity study in rats, 

chronic nephropathy was observed at 

approximately 564 mg/kg/day. No 

evidence of carcinogenicity was 

observed in either study. 

No mutagenicity, genotoxicity, or 

chromosomal aberrations were seen in a 

battery of mutagenicity tests with the 

surrogate chemicals except in the case 

of sodium metabisulfite. Sodium 

metabisulfite was negative in the Ames 

test and a mammalian bone marrow 

chromosome aberration test. However, 

positive results were observed in a 

mammalian cell chromosome aberration 

assay and sister chromatid exchange 

assays in human lymphoctyes, and a 

questionably positive result was 

observed in an in vivo mammalian cell 

chromosome aberration assay. The 

mutagenicity results are equivocal for 

sodium metabisulfite. 

Neurotoxicity and immunotoxicity 

toxicity studies are not available for 

review. However, no evidence of 

neurotoxicity or immunotoxicity was 

seen in the available studies. 

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/pesticides/factsheets/ 

riskassess.htm. 

No acute endpoint was identified; 

therefore, an acute assessment is not 

necessary. The combined chronic 

toxicity/carcinogenicity study in rats 

was selected for chronic dietary 

exposure as well as all other exposure 

scenarios (incidental oral, dermal and 

inhalation). In this study, the NOAEL is 

72 mg/kg/day, and the LOAEL is 144 

mg/kg/day based on hyperplasia of the 

glandular stomachs and occult blood in 

the feces. This represents the lowest 

NOAEL in the database in the most 

sensitive species. The standard 

uncertainty factors (UFs) were applied 

to account for interspecies (10x) and 

intraspecies (10x) variations. The 

default value of 100% was used for the 

dermal and inhalation absorption 

factors. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to PABS, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance. 

EPA assessed dietary exposures from 

PABS in food as follows: 

In conducting the chronic dietary 

exposure assessment using the Dietary 

Exposure Evaluation Model DEEM– 

FCIDTM, Version 3.16, EPA used food 

consumption information from the U.S. 

Department of Agriculture’s (USDA’s) 

2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, no residue data 

were submitted for PABS. In the 

absence of specific residue data, EPA 

has developed an approach which uses 

surrogate information to derive upper 

bound exposure estimates for the 

subject inert ingredient. Upper bound 

exposure estimates are based on the 

highest tolerance for a given commodity 

from a list of high use insecticides, 

herbicides, and fungicides. A complete 

description of the general approach 

taken to assess inert ingredient risks in 

the absence of residue data is contained 

in the memorandum entitled ‘‘Alkyl 

Amines Polyalkoxylates (Cluster 4): 

Acute and Chronic Aggregate (Food and 

Drinking Water) Dietary Exposure and 

Risk Assessments for the Inerts,’’ 

(D361707, S. Piper, 2/25/09) and can be 

found at https://www.regulations.gov in 

docket ID number EPA–HQ–OPP–2008– 

0738. 

In the dietary exposure assessment, 

the Agency assumed that the residue 

level of the inert ingredient would be no 

higher than the highest tolerance for a 

given commodity. Implicit in this 

assumption is that there would be 

similar rates of degradation (if any) 

between the active and inert ingredient 

and that the concentration of inert 

ingredient in the scenarios leading to 

these highest levels of tolerances would 

be no higher than the concentration of 

the active ingredient. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentrations 


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11968 Federal Register / Vol. 87, No. 42 / Thursday, March 3, 2022 / Rules and Regulations 

of active ingredient in agricultural 

products are generally at least 50 

percent of the product and often can be 

much higher. However, due to dietary 

risk concerns in assessing this petition 

request, the Agency assumed that a 

product consisted of 40 percent PABS 

instead of 50 percent, as mentioned 

above. Further, pesticide products rarely 

have a single inert ingredient; rather, 

there is generally a combination of 

different inert ingredients used, which 

additionally reduces the concentration 

of any single inert ingredient in the 

pesticide product in relation to that of 

the active ingredient. 

Second, the conservatism of this 

methodology is compounded by EPA’s 

decision to assume that, for each 

commodity, the Agency considers the 

active ingredient with the highest 

tolerance level for that commodity as 

the guide to assess the total potential 

level of inert ingredient residues on that 

commodity. This assumption overstates 

residue values because it would be 

highly unlikely, given the high number 

of inert ingredients, that a single inert 

ingredient or class of ingredients would 

be present at the level of the active 

ingredient in the highest tolerance for 

every commodity. 

Finally, a third compounding 

conservative assumption is EPA’s 

assumption that all foods contain the 

inert ingredient at the highest tolerance 

level. In other words, EPA assumed 100 

percent of all foods are treated with the 

inert ingredient at 40% in the pesticide 

product at the rate and manner 

necessary to produce the highest residue 

legally possible for an active ingredient. 

In summary, EPA chose a very 

conservative method for estimating 

what level of inert residue could be on 

food, then used this methodology to 

choose the highest possible residue that 

could be found on food and assumed 

that all food contained this residue. No 

consideration was given to potential 

degradation between harvest and 

consumption even though monitoring 

data shows that tolerance level residues 

are typically one to two orders of 

magnitude higher than actual residues 

in food when distributed in commerce. 

Accordingly, although sufficient 

information to quantify actual residue 

levels in food is not available, the 

compounding of these conservative 

assumptions will lead to a significant 

exaggeration of actual exposures. EPA 

does not believe that this approach 

underestimates exposure in the absence 

of residue data. EPA did assume that 

PABS will be limited to 40% in 

pesticide non-residential formulations 

that will be applied to crops and raw 

agricultural commodities pre- and postharvest. 

To assess dietary exposure to PABS 

due to its use in antimicrobial products, 

the EPA calculated the daily dietary 

dose (DDD) and the estimated daily 

intake (EDI) as described in the Food 

and Drug Administration (FDA) model. 

The assessment considered: Application 

rates (limited to 250 ppm), residual 

solution or quantity of solution 

remaining on the treated surface 

without rinsing with potable water, 

surface area of the treated surface which 

comes into contact with food, pesticide 

migration fraction, and body weight. 

These assumptions are based on FDA 

Food Contact Surface Sanitizing 

Solution Dietary Exposure Assessment 

Model (2003). 

2. Dietary exposure from drinking 

water. For the purpose of the screening 

level dietary risk assessment to support 

this request for an exemption from the 

requirement of a tolerance for PABS, a 

conservative drinking water 

concentration value of 100 ppb based on 

screening level modeling was used to 

assess the contribution to drinking 

water for the chronic dietary risk 

assessments for parent compound. 

These values were directly entered into 

the dietary exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). PABS may be used as an inert 

ingredient in pesticide products that are 

registered for specific uses that may 

result in residential exposure, 

specifically in antimicrobial 

formulations applied to food-contact 

surfaces and utensils. Adult residential 

exposure combines high end dermal and 

inhalation handler exposure from 

liquids/trigger sprayer/home garden 

with a high-end post application dermal 

exposure from contact with treated 

lawns. Children’s residential exposure 

includes total exposures associated with 

contact with treated lawns (dermal and 

hand-to-mouth exposures). A 

conservative residential exposure and 

risk assessments was completed for 

pesticide products containing PABS as 

an inert ingredient. Due to risks of 

concern resulting from aggregate 

exposure to PABS, the petitioner 

requested a limitation of 5% in products 

for residential use. Therefore, the 

Agency conducted an assessment to 

represent conservative residential 

exposure by assessing PABS (outdoor 

scenarios) and in disinfectant-type uses 

(indoor scenarios) at no more than 5% 

in the final formulation. The Agency 

assessed pesticide products containing 

PABS using exposure scenarios used by 

OPP’s Antimicrobials Division to 

represent conservative residential 

handler exposure. Further details of this 

residential exposure and risk analysis 

can be found at https://

www.regulations.gov in the 

memorandum entitled: ‘‘JITF Inert 

Ingredients. Residential and 

Occupational Exposure Assessment 

Algorithms and Assumptions Appendix 

for the Human Health Risk Assessments 

to Support Proposed Exemption from 

the Requirement of a Tolerance When 

Used as Inert Ingredients in Pesticide 

Formulations,’’ (D364751, 5/7/09, 

Lloyd/LaMay in docket ID number 

EPA–HQ–OPP–2008–0710). 

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 

PABS and any other substances. PABS 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance exemption, therefore, EPA has 

assumed that PABS does not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at https:// 

www.epa.gov/pesticides/cumulative. 

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 


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Federal Register / Vol. 87, No. 42 / Thursday, March 3, 2022 / Rules and Regulations 11969 

data available to EPA support the choice 

of a different factor. 

The Agency has concluded that there 

is reliable data to determine that infants 

and children will be safe if the FQPA SF 

of 10X is reduced to 1X for the chronic 

dietary assessment for the following 

reasons. The toxicity database for 

surrogate chemicals to PABS contains a 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test, multi-generation 

reproduction toxicity and mutagenicity 

studies. There is no indication of 

immunotoxicity or neurotoxicity in the 

available studies on surrogate 

chemicals; therefore, there is no need to 

require an immunotoxicity or 

neurotoxicity study. Fetal susceptibility 

is not observed in the available studies. 

In the multi-generation reproduction 

toxicity study in rats, maternal and 

offspring toxicity, which manifested as 

hyperplasia of the fore and glandular 

stomachs, and occult blood in the feces 

were observed at the same dose, 144 

mg/kg/day. The cRfD of 0.72 mg/kg/day 

is based on the effects seen in this 

study. No reproduction toxicity is seen 

in the available studies. Based on the 

adequacy of the toxicity database, the 

conservative nature of the exposure 

assessment and the lack of concern for 

prenatal and postnatal susceptibility, 

the Agency has concluded that there is 

reliable data to determine that infants 

and children will be safe if the FQPA SF 

of 10X is reduced to 1X. 

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. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, PABS is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to PABS from 

food and water will utilize 83% of the 

cPAD for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. 

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). 

PABS is currently used as an inert 

ingredient in pesticide products that are 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure from food and water with 

short-term residential exposures to 

PABS. 

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 273 for adults. For children, 

the aggregate MOE is 115. Because 

EPA’s level of concern for PABS is an 

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). 

PABS is currently used as an inert 

ingredient in pesticide products that are 

registered for uses that could result in 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to PABS. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in aggregate MOEs of 430 for adults. For 

children the aggregate MOE is 117. 

Children’s residential exposure includes 

total exposures associated with contact 

with treated lawns (dermal and hand-tomouth exposures). Because EPA’s level 

of concern for PABS is an MOE of 100 

or below, these MOEs are not of 

concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

PABS 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 PABS 

residues. 

V. Other Considerations 

Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is not establishing a numerical 

tolerance for residues of PABS in or on 

any food commodities. EPA is 

establishing a limitation on the amount 

of PABS that may be used in pesticide 

formulations. This limitation will be 

enforced through the pesticide 

registration process under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (‘‘FIFRA’’), 7 U.S.C. 136 et seq. EPA 

will not register any pesticide 

formulation for food use where PABS 

exceeds 40% in the final pesticide 

formulations for non-residential use or 

5% in the final pesticide formulations 

for indoor and outdoor residential use. 

EPA will also not register any pesticide 

formulations for antimicrobials where 

PABS exceeds 250 ppm. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 for PABS (CAS 

Reg. No. 10043–02–4) when used as an 

inert ingredient (carrier, adjuvant, 

buffer, stabilizer) in pesticide 

formulations applied in/on growing 

crops pre- and post-harvest, limited to 

40% in non-residential formulations 

and 5% in formulations for residential 

indoor and outdoor use; and under 40 

CFR 180.940(a) in antimicrobial 

formulations applied to food-contact 

surfaces in public eating places, dairyprocessing equipment, food-processing 

equipment and utensils, limited to 250 

ppm end-use concentration in 

formulations. 

VII. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

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, 


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11970 Federal Register / Vol. 87, No. 42 / Thursday, March 3, 2022 / Rules and Regulations 

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 tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or Tribal Governments, on the 

relationship between the National 

Government and the States or Tribal 

Governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this action. In 

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act (UMRA) (2 U.S.C. 1501 et 

seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

VIII. 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: February 24, 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 § 180.910, amend table 1 to 

180.910 by adding in alphabetical order 

the inert ingredient ‘‘Polyammonium 

Bisulfate (CAS Reg. No. 10043–02–4)’’ 

to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

TABLE 1 TO 180.910 

Inert ingredients Limits Uses 

*******

Polyammonium Bisulfate (CAS Reg. No. 

10043–02–4).

Not to exceed 40% in non-residential formulations. Not to exceed 5% in outdoor and indoor formulations for residential 

use.

Carrier, adjuvant, buffer, and 

stabilizer. 

* * * * * * * 

■ 3. In § 180.940, amend table 1 to 

paragraph (a) by adding in alphabetical 

order an entry for ‘‘Polyammonium 

Bisulfate’’ to read as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

TABLE 1 TO PARAGRAPH (a) 

Pesticide chemical CAS Reg. No. Limits 

*******

Polyammonium Bisulfate ........................... 10043–02–4 When ready for use, the end-use concentration is not to exceed 250 ppm. 

* * * * * * * 

[FR Doc. 2022–04368 Filed 3–2–22; 8:45 am] 

BILLING CODE 6560–50–P 


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