Aspartic Acid, N-(1,2-dicarboxyethyl)-, Tetrasodium Salt; Exemption From the Requirement of a Tolerance, 43767-43772 [2018-18404]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 83, Number 167 (Tuesday, August 28, 2018)]
[Rules and Regulations]
[Pages 43767-43772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18404]


-----------------------------------------------------------------------

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 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. Please review the visitor instructions and 
additional information about the docket available at https://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: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at https://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: 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 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, https://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

[[Page 43768]]

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-
effect-level (NOAEL) and the lowest-observed-adverse-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

[[Page 43769]]

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 https://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/cm\2\); surface area of the treated surface which comes into contact 
with food (4,000 cm\2\); 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

[[Page 43770]]

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 non-occupational, 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 post-application exposures were not assessed for 
this scenario as such exposures would be expected to be negligible. 
Reliable exposure data from non-pesticidal 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 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 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

[[Page 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 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 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 semi-permanent 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 https://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,

[[Page 43772]]

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]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. In Sec.  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:


Sec.  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-              144538-83-0  When ready for use, the
 dicarboxyethyl)-, tetrasodium                    end-use concentration
 salt.                                            is not to exceed 5000
                                                  ppm.
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-18404 Filed 8-27-18; 8:45 am]
 BILLING CODE 6560-50-P