Federal Register / Vol. 83, No. 167 / Tuesday, August 28, 2018 / Rules and Regulations 43767 

to conduct general administration of 

these existing permits, authority to 

process and issue any and all 

subsequent permit actions relating to 

such permits, and authority to enforce 

such permits. 

* * * * * 

[FR Doc. 2018–18529 Filed 8–27–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0474; FRL–9981–27] 

Aspartic Acid, N-(1,2-dicarboxyethyl)-, 

Tetrasodium Salt; 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 aspartic acid, 

N-(1,2-dicarboxyethyl)-, tetrasodium salt 

(CAS Reg. No. 144538–83–0) when used 

as an inert ingredient in antimicrobial 

pesticide products for which, when 

ready for use, the end-use concentration 

does not exceed 5,000 parts per million 

(ppm) of aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt. 

Lanxess Corporation submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of aspartic 

acid, N-(1,2-dicarboxyethyl)-, 

tetrasodium salt, when used in 

accordance with the terms of the 

exemption. 

DATES: This regulation is effective 

August 28, 2018. Objections and 

requests for hearings must be received 

on or before October 29, 2018, 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–2017–0474, 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. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Michael Goodis, 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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR 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–2017–0474 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 October 29, 2018. 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– 

2017–0474, 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. Petition for Exemption 

In the Federal Register of December 

15, 2017 (82 FR 59604) (FRL–9970–50), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–11063) by Lanxess 

Corporation, 111 RIDC Park West Drive, 

Pittsburgh, PA 15275. The petition 

requested that 40 CFR 180.940(a) be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt (CAS 

Reg. No. 144538–83–0) when used as an 

inert ingredient as a chelating agent in 

antimicrobial pesticide formulations 

(food-contact surface sanitizing 

solutions). That document referenced a 

summary of the petition prepared by 

Lanxess Corporation, the petitioner, 

which is available in the docket, http:// 

www.regulations.gov. There were no 

relevant comments received in response 

to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has limited 

the maximum end-use concentration, 

when ready for use, of aspartic acid, N- 

(1,2-dicarboxyethyl)-, tetrasodium salt 

not to exceed 5,000 ppm in 


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antimicrobial formulations. The reason 

for this change is explained in Unit V.B. 

below. 

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 . . . .’’ 

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. 

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 aspartic acid, N- 

(1,2-dicarboxyethyl)-, tetrasodium salt 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt 

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 aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies are discussed in this 

unit. 

In a mammalian metabolism study, 

only 37% of the administered dose was 

systematically available (34.7% urine 

and 2.2% tissues and carcass), and most 

of that was from second phase 

absorption. Primary radioactivity 

recovered after 72 hours was from urine 

and feces, with 68.7% of the radioactive 

dose being excreted in the feces and 

34.7% of the radioactive dose being 

excreted in the urine. 

Aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt 

exhibits low levels of acute toxicity. An 

acute study in rats showed an oral 

Lethal Dose (LD)50 >2,000 milligram/ 

kilogram (mg/kg). The dermal LD50 in 

rats was >2,000 mg/kg. It was not shown 

to be a skin or eye irritant or dermal 

sensitizer. There are no inhalation 

studies available. 

Two 28-day studies (drinking water 

and gavage) were conducted with Wistar 

rats using aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt. 

There were no toxicologically related 

adverse effects seen at dosed up to and 

including 1,750 kg/kg/day or 1,000 mg/ 

kg/day, respectively. 

Aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt was 

administered to rats (drinking water and 

gavage) in two 90-day toxicity studies. 

In both studies effects were seen in the 

kidneys and urinary bladder. In the 

drinking water study, the most sensitive 

endpoint (i.e., moderate diffuse 

transitional cell hyperplasia in the 

urinary bladder) was seen in both the 

main group and satellite groups 

(recovery phase) males exposed to 300 

mg/kg/day and greater. Therefore, the 

NOAEL was 100 mg/kg/day and the 

LOAEL was 300 mg/kg/day based on 

this diffuse transitional cell hyperplasia 

in the urinary bladder. 

In the 90-say gavage study, again 

effects were seen in the kidney and 

urinary bladder, this time the most 

sensitive endpoint was based on the 

effects seen at 1,000 mg/kg/day: 

Hyperplasia of the transitional cell 

epithelium of the bladder, basophilic 

cortical tubules in the kidneys, and 

other urinary changes (e.g., increased 

urinary pH, as well as some changes 

observed in clinical pathology 

(increased blood urea concentrations in 

males; slightly lower blood 

concentrations of potassium and 

chloride)). The NOAEL for this study 

was 200 mg/kg/day and the LOAEL was 

1,000 mg/kg/day based on hyperplasia 

of the transitional cell epithelium of the 

bladder, basophilic cortical tubules in 

the kidneys, and other urinary changes. 

In a developmental toxicity study, 

groups of inseminated female rats were 

treated with aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt daily 

by oral gavage from day 6 to day 19 post 

coitum in doses of 0, 100, 300, or 1,000 

mg/kg/day. Decreased food 

consumption and body weight gain 

were seen in treated females at 1,000 

mg/kg/day. No developmental effects 

were observed in this study at doses up 

to and including 1,000 mg/kg/day. 

Aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt was 

administered to groups of rats in 

drinking water in a one generation 

reproductive toxicity study. 

Reproduction parameters were not 

affected at dose levels up to 16,000 ppm 

(∼2081 mg/kg/day). The body weight 

development of F1 pups was decreased 

at 16,000 ppm. The concentration of 


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4,000 ppm (∼411 mg/kg/day) was 

established as the NOAEL for the parent 

animals based on macroscopic and 

microscopic changes in the kidneys at 

the LOAEL of 16,000 ppm. The 

reproductive NOAEL was 16,000 ppm. 

The offspring toxicity NOAEL was 4,000 

ppm based on decreased body weight 

development of F1 pups seen at 16,000 

ppm. 

Aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt was 

administered in drinking water to 

Wistar rats for up to two years, groups 

of inseminated female rats were treated 

daily by oral gavage from day 6 to day 

19 post coitum in doses of 0, 100, 300, 

or 1,000 mg/kg/day. Decreased food 

consumption and body weight gain 

were seen in treated females at 1,000 

mg/kg/day. No developmental effects 

were observed in this study at doses up 

to and including 1,000 mg/kg/day. 

Body weight development of males 

treated at 1,000 mg/kg/day was slightly 

decreased but statistically significant. 

Water consumption was increased in all 

treated groups; however, at 100 mg/kg/ 

day the differences were slight. 

Increased urine excretion and changed 

feces consistency (soft) observed at 

clinical observation of the animals are 

regarded to be secondary to the 

increased water intake. The most 

consistent finding in the urinalysis was 

an increase of the pH of the urine at 

1,000 mg/kg/day in both sexes at most 

all time points. 

At microscopy of urinary sediment, 

erythrocytes were more frequently 

observed at 1,000 mg/kg/day mainly in 

males at the first three of four time 

points. At necropsy, kidneys weights 

were increased starting at 300 mg/kg/ 

day in females and 1,000 mg/kg/day in 

males. Furthermore, the kidneys of 

females treated for two years showed 

discoloration and increased surface 

changes starting at 300 mg/kg/day. 

Histopathological evaluation of the 

kidneys revealed increased incidence of 

small mineralizations in the renal 

parenchyma in males at 1,000 mg/kg/ 

day, mineralized concretions in the 

renal pelvis in both sexes starting at 300 

mg/kg/day, and increased severity of 

chronic progressive nephropathy (CPN) 

in females starting at 300 mg/kg/day. 

These findings likely indicate a mineral 

imbalance/influence on calcium 

homeostasis, leading to an increased 

incidence of parenchymal and pelvic 

mineralizations. The NOAEL for this 

study was 100 mg/kg/day with a LOAEL 

of 300 mg/kg/day based on increased 

water consumption, increased severity 

of CPN, and macroscopic and 

microscopic changes in the kidney. 

Aspartic acid, N-(1,2-dicarboxyethyl)-, 

tetrasodium salt was not carcinogenic in 

this study. 

There is no evidence that oral 

exposure to aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt 

suppresses or otherwise harms immune 

function in mammalian systems. No 

signs of neurotoxicity were reported in 

acute or repeat-dose oral studies. There 

were also no signs of carcinogenicity in 

the database including the 2-year 

feeding study. Similarly, all tests for 

genotoxicity, mutagenicity, and 

clastogenicity were negative. 

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 (LOC) 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://

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

The point of departure for this risk 

assessment for all durations (except 

acute) and routes of exposure is from 

the two-year drinking water toxicity 

study in rats. The NOAEL is 100 mg/kg/ 

day and the LOAEL is 300 mg/kg/day 

based on increased water consumption, 

CPN, macroscopic and microscopic 

changes in the kidney. Similar effects 

were seen in a 90-day drinking water 

study and the same NOAEL and LOAEL 

were recorded. A 100-fold uncertainty 

factor was used (10X interspecies 

extrapolation, 10X for intraspecies 

variability, and 1X Food Quality 

Protection Act Safety Factor (FQPA 

SF)). The FQPA SF is reduced to 1X 

because the reproductive and 

developmental toxicity database is 

complete and there is no evidence of 

increased risk to infants and children. 

See Section VII below for more 

information on the FQPA SF. 

Because no acute effect was attributed 

to aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt, an 

acute assessment was not conducted. 

When the 100X uncertainty or safety 

factor is applied, the cPAD is 1 mg/kg/ 

day. The residential and aggregate LOC 

is for MOEs that are less than 100 and 

is based on 10X interspecies 

extrapolation, 10X for intraspecies 

variability and 1X FQPA factor. In the 

absence of dermal absorption data, 

dermal absorption is estimated to be 

100% 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from aspartic 

acid, N-(1,2-dicarboxyethyl)-, 

tetrasodium salt in food as follows: 

To assess dietary exposure, the 

Agency calculated the Daily Dietary 

Dose (DDD) and the Estimated Daily 

Intake (EDI) using US Food and Drug 

Administration (FDA) Food Contact 

Surface Sanitizing Solution Dietary 

Exposure Assessment Model. EPA’s 

assessment used FDA’s default 

assumptions for the amount of residual 

solution or quantity of solution 

remaining on the treated surface 

without rinsing with potable water (1 

mg/cm2); surface area of the treated 

surface which comes into contact with 

food (4,000 cm2); and the pesticide 

migration fraction (100%). EPA used an 

application rate of aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt of 

5,000 ppm, which was provided by the 

submitter. EPA also derived exposure 

amounts for population subgroups by 

accounting for body weights and 

adjusting for relative food consumption 

using data from the National Health and 

Nutrition Examination Survey 

(NHANES) (specifically the 2003–2008 

survey data). 

The use of aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt as a 

bleaching stabilizer in the manufacture 

of paper and paperboard has been 

approved by the FDA as an indirect food 

additive in food-contact paper and 

paperboard at levels not to exceed 0.18 

percent by weight of the dry pulp. The 

migration of aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt from 


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food contact paper and paperboard into 

food, and subsequent dietary exposure 

has been including in the overall dietary 

exposure. 

2. Dietary exposure from drinking 

water. The proposed inert ingredient 

will be used in low concentrations in 

food-contact antimicrobial pesticide 

products (food-contact surface 

sanitizing solutions), which will be used 

indoors. This use pattern would not be 

expected to result in measurable levels 

in surface waters or drinking water. 

Therefore, for the purpose of the 

screening-level dietary risk assessment 

to support this request for an exemption 

from the requirement of a tolerance for 

aspartic acid, N-(1,2-dicarboxyethyl)-, 

tetrasodium salt, drinking water values 

were considered negligible and are not 

expected to contribute to the overall 

dose. 

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). Aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt will 

be used in residential settings in 

antimicrobial pesticide products 

applied to food-contact surfaces. As 

such, dermal exposure to aspartic acid, 

N-(1,2-dicarboxyethyl)-, tetrasodium salt 

is possible; therefore, a residential 

exposure assessment was completed. 

The Agency conducted a conservative 

assessment of potential residential 

exposure by assessing aspartic acid, N- 

(1,2-dicarboxyethyl)-, tetrasodium salt 

in antimicrobial pesticide formulations 

used for hard-surface disinfection in 

and around the home. The Agency’s 

residential exposure includes dermal 

exposures only as based on the lack of 

volatility of aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt, 

inhalation exposure is not expected to 

occur. 

The wiping scenario was utilized for 

this assessment. In this scenario, 

residential handlers (i.e., applicators) 

are assumed to be wearing shorts and 

short-sleeve shirts, shoes, and socks 

(and no gloves). Residential postapplication exposures were not assessed 

for this scenario as such exposures 

would be expected to be negligible. 

Reliable exposure data from nonpesticidal uses such as use in cosmetics 

was not available. 

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.’’ EPA has not 

found aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt to 

share a common mechanism of toxicity 

with any other substances, and aspartic 

acid, N-(1,2-dicarboxyethyl)-, 

tetrasodium salt does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt 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 http:// 

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 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

No effects on infants and children were 

seen in either a reproductive or 

developmental study in the absence of 

maternal effects at the limit dose of 

1,000 mg/kg/day. A reproductive study 

showed no effect on reproductive 

parameters or fertility at doses >2,000 

mg/kg/day (16,000 ppm). Decreased 

body weight gain was seen in pups at 

16,000 ppm. This effect was observed in 

the presence of maternal toxicity 

indicating that there is no increase in 

susceptibility to offspring. 

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 aspartic 

acid, N-(1,2-dicarboxyethyl)-, 

tetrasodium salt is complete. 

ii. There is no indication that aspartic 

acid, N-(1,2-dicarboxyethyl)-, 

tetrasodium salt is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that aspartic 

acid, N-(1,2-dicarboxyethyl)-, 

tetrasodium salt results in increased 

susceptibility in in utero rats in the 

prenatal developmental studies or in 

young rats in the reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. In 

order to account for all potential 

exposure, a conservative exposure 

assessment was performed assuming a 

100% transfer coefficient and 100% 

dermal absorption. This model assumes 

a worst case scenario of no gloves, 

shorts and short sleeved shirt. Based on 

these conservative assumptions, EPA 

believes that using this model will not 

underestimate the exposure and risk 

from aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt as an 

inert ingredient in antimicrobial 

pesticide products. 

E. Aggregate Risks and Determination of 

Safety 

Determination of safety section. 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, aspartic acid, N- 

(1,2-dicarboxyethyl)-, tetrasodium salt 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 aspartic acid, 

N-(1,2 dicarboxyethyl)-, tetrasodium salt 

from food will utilize 72% of the cPAD 

for children (1–2 year old), the 

population group receiving the greatest 

exposure. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 


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Federal Register / Vol. 83, No. 167 / Tuesday, August 28, 2018 / Rules and Regulations 43771 

chronic exposure to food and water 

(considered to be a background 

exposure level). Aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt may 

be 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 through food 

and water with short-term residential 

exposure to aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt. 

Using the exposure assumptions 

described above for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 200. Because EPA’s level of 

concern for aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt is a 

MOE of 100 or below, this MOE is 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). 

Aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt may 

be used as an inert ingredient in 

pesticide products that are registered for 

uses that could result in intermediateterm residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposure 

to aspartic acid, N-(1,2-dicarboxyethyl)- 

, tetrasodium salt. 

Using the exposure assumptions 

described above for intermediate-term 

exposures, EPA has concluded the 

combined intermediate-term food, 

water, and residential exposures result 

in aggregate MOEs of 200. Because 

EPA’s level of concern for aspartic acid, 

N-(1,2-dicarboxyethyl)-, tetrasodium salt 

is a MOE of 100 or below, this MOE is 

not of concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in rodent 

carcinogenicity studies, aspartic acid, N- 

(1,2-dicarboxyethyl)-, tetrasodium salt 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 aspartic acid, 

N-(1,2-dicarboxyethyl)-, tetrasodium salt 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is not establishing a numerical 

tolerance for residues of aspartic 

acid, N-(1,2-dicarboxyethyl)-, 

tetrasodium salt in or on any food 

commodities. EPA is establishing 

limitations on the amount of aspartic 

acid, N-(1,2-dicarboxyethyl)-, 

tetrasodium salt that may be used in 

pesticide formulations applied to semipermanent or permanent food-contact 

surfaces. These limitations 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 use in antimicrobial 

pesticide products for sale or 

distribution that exceeds 5,000 ppm of 

aspartic acid, N-(1,2-dicarboxyethyl)-, 

tetrasodium salt in the final formulation 

unless additional data are submitted 

that demonstrate a higher concentration 

would be safe. 

B. Revisions to Petitioned for Tolerances 

Although the petition did not specify 

a limitation on concentration of this 

inert ingredient in end-use 

antimicrobial pesticide formulations, 

the Agency is establishing this 

exemption with the limitation of 5,000 

ppm in pesticide formulations. Based 

upon an evaluation of the data included 

in the petition, unlimited use resulted 

in risks of concern; therefore, EPA is 

establishing a limitation in formulation 

when ready for use, (i.e., the end-use 

concentration is not to exceed 5,000 

ppm) in order to support the safety 

finding for this tolerance exemption. 

This limitation is based on the Agency’s 

risk assessment which can be found at 

http://www.regulations.gov in document 

IN–11063; Aspartic acid, N-(1,2- 

dicarboxyethyl)-, tetrasodium salt: 

Human Health Risk and Ecological 

Effects Assessment of a Food Use 

Pesticide Inert Ingredient in docket ID 

number EPA–HQ–OPP–2017–0474. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.940(a) for aspartic 

acid, N-(1,2-dicarboxyethyl)-, 

tetrasodium salt (CAS Reg. No. 144538– 

83–0) when used as an inert ingredient 

(as a chelating agent) in antimicrobial 

pesticide formulations (food-contact 

surface sanitizing solutions) applied to 

food-contact surfaces in public eating 

places, dairy-processing equipment, and 

food-processing equipment and utensils 

at a maximum of 5,000 parts per million 

(ppm) in final formulation. 

VII. Statutory and Executive Order 

Reviews 

This action establishes an exemption 

from the requirement of 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, 

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 exemption 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, 


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43772 Federal Register / Vol. 83, No. 167 / Tuesday, August 28, 2018 / Rules and Regulations 

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: August 15, 2018. 

Michael L. Goodis, 

Director, Registration Division, Office of 

Pesticide Program. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.940 in paragraph (a), add 

alphabetically the inert ingredient 

‘‘Aspartic acid, N-(1,2-dicarboxyethyl)-, 

tetrasodium salt’’ to the table to read as 

follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide chemical CAS Reg. No. Limits 

*******

Aspartic acid, N-(1,2-dicarboxyethyl)-, tetrasodium salt ............. 144538–83–0 When ready for use, the end-use concentration is not to exceed 5000 ppm. 

* * * * * * * 

* * * * * 

[FR Doc. 2018–18404 Filed 8–27–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 271 

[EPA–R09–2018–RCRA–0267; FRL–9982– 

86—Region 9] 

Hawaii: Final Authorization of State 

Hazardous Waste Management 

Program Revisions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is granting final 

authorization of changes to Hawaii’s 

hazardous waste program submitted to 

EPA in the authorization application. As 

a result of EPA’s authorization, Hawaii’s 

revised program will become part of the 

authorized state hazardous waste 

program, and therefore will be federally 

enforceable. The Agency published a 

proposed rule on June 25, 2018, and 

provided for public comment. No 

substantive comments were received 

that were relevant to our proposed 

action. 

DATES: This final authorization is 

effective August 28, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Laurie Amaro, phone number: 415–972– 

3364, email: amaro.laurie@epa.gov. 

SUPPLEMENTARY INFORMATION: 

A. Authorization of Revisions to 

Hawaii’s Hazardous Waste Program 

On December 13, 2017, Hawaii 

submitted a final complete program 

revision application (with subsequent 

corrections) seeking authorization in 

accordance with 40 CFR 271.21. Having 

received no public comments relevant 

to our proposed authorization, we have 

determined that Hawaii’s hazardous 

waste program revisions satisfy all 

requirements necessary to qualify for 

final authorization. For a list of rules 

that become effective with this final 

action, please see the proposed rule 

published in the Federal Register (83 

FR 29520, June 25, 2018). 

B. What is codification and is EPA 

codifying Hawaii’s hazardous waste 

program as authorized in this rule? 

Codification is the process of placing 

a state’s statutes and regulations that 

comprise the state’s authorized 

hazardous waste program into the Code 

of Federal Regulations. EPA does this by 

referencing the authorized state rules in 

40 CFR part 272. EPA is not codifying 

the authorization of Hawaii’s revisions 

as part of today’s action. 

C. Statutory and Executive Order 

Reviews 

This final authorization revises 

Hawaii’s authorized hazardous waste 

management program pursuant to RCRA 

section 3006 and imposes no 

requirements other than those currently 

imposed by state law. For further 

information on how this authorization 

complies with applicable executive 

orders and statutory provisions, please 

see the proposed rule published in the 

Federal Register (83 FR 29520, June 25, 

2018). 

List of Subjects in 40 CFR Part 271 

Environmental protection, 

Administrative practice and procedure, 

Confidential business information, 

Hazardous waste, Hazardous waste 

transportation, Incorporation by 

reference, Intergovernmental relations, 

Penalties, Reporting and recordkeeping 

requirements. 

Authority: This action is issued under the 

authority of sections 2002(a), 3006, and 

7004(b) of the Solid Waste Disposal Act as 

amended, 42 U.S.C. 6912(a), 6926, and 

6974(b). 

Dated: August 14, 2018. 

Deborah Jordan, 

Acting Regional Administrator, Region 9. 

[FR Doc. 2018–18527 Filed 8–27–18; 8:45 am] 

BILLING CODE 6560–50–P 


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