[Federal Register Volume 83, Number 167 (Tuesday, August 28, 2018)]
[Rules and Regulations]
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
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.
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
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
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
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
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,
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
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
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
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
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 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
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
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
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)-,
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)-,
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
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 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.
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,
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,
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
Dated: August 15, 2018.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Program.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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
* * * * *
(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
* * * * * * *
* * * * *
[FR Doc. 2018-18404 Filed 8-27-18; 8:45 am]
BILLING CODE 6560-50-P