[Federal Register Volume 85, Number 119 (Friday, June 19, 2020)]
[Rules and Regulations]
[Pages 37013-37019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13030]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0048; and EPA-HQ-OPP-2019-0327; FRL-10009-36]


Formic Acid and Sodium Formate; Exemption From the Requirement of 
a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of formic acid when used as an inert 
ingredient limited to 25% in pesticide formulations applied to growing 
crops pre- and post-harvest (adjuvant, pH buffering agent, or pH 
adjuster) and applied in/on animals (pH adjuster). In addition, this 
rule establishes an exemption from the requirement of a tolerance for 
residues of sodium formate when used as an inert ingredient (adjuvant, 
pH buffering agent) in pesticide formulations applied to growing crops 
pre- and post-harvest. The Monsanto Company and the Spring Trading 
Company on behalf of Stoller Enterprises, Inc., submitted petitions to 
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting 
establishment of these exemptions. This regulation eliminates the need 
to establish a maximum permissible level for residues of formic acid 
and sodium formate when used in accordance with the terms of these 
exemptions.

DATES: This regulation is effective June 19, 2020. Objections and 
requests for hearings must be received on or before August 18, 2020, 
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 dockets for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2019-0048 and EPA-HQ-OPP-2019-
0327 are 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 note that due to the public health emergency the EPA Docket 
Center (EPA/DC) and Reading Room was closed to public visitors on March 
31, 2020. Our EPA/DC staff will continue to provide customer service 
via email, phone, and webform. For further information on EPA/DC 
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. 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 Publishing 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 numbers EPA-HQ-OPP-2019-0048 and/or EPA-HQ-OPP-2019-0327 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 August 18, 2020. 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 numbers EPA-HQ-OPP-2019-0048 and/or 
EPA-HQ-OPP-2019-0327, 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

[[Page 37014]]

information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of May 13, 2019 (84 FR 20843) (FRL-9991-
91), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11136) by 
Monsanto Company (1300 I Street, NW, Suite 450 East, Washington, DC 
20005). The petition requested that 40 CFR be amended by establishing 
exemptions from the requirement of a tolerance for residues of formic 
acid (CAS Reg No. 64-18-6) and sodium formate (CAS Reg No. 141-53-7) 
when used as inert ingredients (adjuvants, pH buffering agents) in 
pesticide formulations applied to growing crops and raw agricultural 
commodities after harvest under 40 CFR 180.910. In addition, in the 
Federal Register of August 2, 2019 (84 FR 37818) (FRL-9996-78), EPA 
issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, 
announcing the filing of a pesticide petition (PP IN-11264) by the 
Spring Trading Company (203 Dogwood Trail, Magnolia, TX 77354) on 
behalf of Stoller Enterprises, Inc. (9090 Katy Freeway, Suite 400, 
Houston, TX 77024). The petition requested that 40 CFR be amended by 
establishing exemptions from the requirement of a tolerance for 
residues of formic acid (CAS Reg No. 64-18-6) when used as an inert 
ingredient (pH adjuster) in pesticide formulations applied to growing 
crops and raw agricultural commodities after harvest under 40 CFR 
180.910 and applied in/on animals under 40 CFR 180.930. The documents 
referenced summaries of petitions prepared by Monsanto Company, LLC 
(docket EPA-HQ-OPP-2019-0048) and Spring Trading Company on behalf of 
Stoller Enterprises, Inc. (docket EPA-HQ-OPP-2019-0327). The documents 
are available in the aforementioned dockets, http://www.regulations.gov. No substantive, relevant comments were received on 
the notices of filing.

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 formic acid and sodium formate 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with formic 
acid and sodium formate 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 formic acid and sodium formate as well 
as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies can be 
found at http://www.regulations.gov in the document Formic Acid and 
Sodium Formate; Human Health Risk Assessment and Ecological Effects 
Assessment to Support Proposed Exemption from the Requirement of a 
Tolerance When Used as an Inert Ingredient in Pesticide Formulations at 
page 7 in docket ID number EPA-HQ-OPP-2019-0048 and Formic Acid; Human 
Health Risk Assessment and Ecological Effects Assessment to Support 
Proposed Exemption from the Requirement of a Tolerance When Used as an 
Inert Ingredient in Pesticide Formulations at page 7 in docket ID 
number EPA-HQ-OPP-2019-0327.
    Formic acid and sodium formate exist in an equilibrium in aqueous 
solutions and the toxicological profiles of formic acid and its salts 
are expected to be similar. Therefore, data on dissociative salts, such 
as sodium formate and potassium diformate are used to bridge data gaps 
for formic acid.
    Formic acid and sodium formate are of low acute toxicity via oral, 
dermal and inhalation routes of exposure. They are not dermal or eye 
irritants in rabbits. They are not dermal sensitizers in the guinea 
pig.
    Repeated dose oral toxicity studies, developmental, and 2-
generation reproduction toxicity studies show that formic acid and 
sodium formate are not toxic at doses less than 1,000 mg/kg/day, the 
limit dose, in rats, mice and rabbits. Portal of entry effects are 
observed in toxicity studies via the inhalation route of exposure. 
Systemic

[[Page 37015]]

effects are seen at a high dose in chronic oral toxicity and 
carcinogenicity studies in rats and mice. However, no cancers or tumors 
were observed; therefore, formic acid and sodium formate are not 
expected to be carcinogenic. Formic acid and sodium formate are not 
considered mutagenic based on negative results in the bacterial reverse 
mutation assay, mammalian cell gene mutation assay, mammalian cell 
cytogenetics assays.
    Neurotoxicity and immunotoxicity studies are not available for 
review. However, evidence of neurotoxicity and immunotoxicity is not 
observed in the submitted studies.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    An acute toxicity endpoint was not identified for formic acid and 
sodium formate; therefore, an acute dietary assessment was not 
performed. The 52-, 80- and 104-week chronic/carcinogenicity toxicity 
studies in rats and mice are considered co-critical studies and are 
selected for the chronic dietary exposure scenario. The NOAELs are 400 
mg/kg/day (142 mg/kg/day formic acid), and the lowest observed adverse 
effect levels (LOAELs) are 2,000 mg/kg/day (708 mg/kg/day formic acid) 
based on decreased reduced bodyweight gain and body weight. This 
represents the lowest NOAEL in the database in the most sensitive 
species. The developmental toxicity study in rats was selected for 
short-term incidental oral and dermal exposure scenarios. The NOAEL is 
945 mg/kg/day, the highest dose tested. The LOAEL is not established. 
The 90-day oral toxicity in rats is selected for intermediate-term 
incidental oral and dermal exposure scenarios. The NOAEL is 3,000 mg/
kg/day, the highest dose tested. The LOAEL is not established. The 2-
week toxicity study via inhalation is selected for short-term 
inhalation exposure scenarios. The NOAEC is 31 ppm (18.36 mg/kg/day). 
The LOAEC is 64 ppm (36.72 mg/kg/day) based on squamous metaplasia, 
necrosis, and inflammation in the upper respiratory tract. The 90-day 
toxicity study via inhalation in mice is selected for intermediate- and 
long-term inhalation exposure scenarios. The NOAEC is 32 ppm. The LOAEC 
is 64 based on degeneration of olfactory epithelia. The Food Quality 
Protection Act (FQPA) safety factor of 10x is applied to the inhalation 
exposure scenario only to account for the extrapolation from subchronic 
to chronic inhalation exposure scenarios. The standard inter- and 
intra-species uncertainty factors of 10x are applied. The default 
factor of 100% is applied for dermal and inhalation absorption rates.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to formic acid and sodium formate, EPA considered exposure 
under the proposed exemption from the requirement of a tolerance. EPA 
assessed dietary exposures from formic acid and sodium formate in food 
as follows:
    No adverse effects attributable to a single exposure of endpoint 
was identified for formic acid and sodium formate; therefore, an acute 
dietary exposure assessment was not conducted.
    In conducting the chronic dietary exposure assessment using the 
Dietary Exposure Evaluation Model DEEM-FCIDTM, Version 3.16, EPA used 
food consumption information from the U.S. Department of Agriculture's 
(USDA's) 2003-2008 National Health and Nutrition Examination Survey, 
What We Eat in America (NHANES/WWEIA). As to residue levels in food, no 
residue data were submitted for formic acid and sodium formate. In the 
absence of specific residue data, EPA has developed an approach which 
uses surrogate information to derive upper bound exposure estimates for 
the subject inert ingredient. Upper bound exposure estimates are based 
on the highest tolerance for a given commodity from a list of high use 
insecticides, herbicides, and fungicides. A complete description of the 
general approach taken to assess inert ingredient risks in the absence 
of residue data is contained in the memorandum entitled ``Alkyl Amines 
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and 
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,'' 
(D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
    In the dietary exposure assessment, the Agency assumed that the 
residue level of the inert ingredient would be no higher than the 
highest tolerance for a given commodity. Implicit in this assumption is 
that there would be similar rates of degradation (if any) between the 
active and inert ingredient and that the concentration of inert 
ingredient in the scenarios leading to these highest levels of 
tolerances would be no higher than the concentration of any active 
ingredient.
    The Agency believes the assumptions used to estimate dietary 
exposures lead to an extremely conservative assessment of dietary risk 
due to a series of compounded conservatisms. First, assuming that the 
level of residue for an inert ingredient is equal to the level of 
residue for the active ingredient will overstate exposure. The 
concentrations of active ingredient in agricultural products are 
generally at least 50 percent of the product; however, formic acid is 
assessed at 25%. Further, pesticide products rarely have a single inert 
ingredient; rather there is generally a combination of different inert 
ingredients used which additionally reduces the concentration of any 
single inert ingredient in the pesticide product in relation to that of 
the active ingredient.
    Second, the conservatism of this methodology is compounded by EPA's 
decision to assume that, for each commodity, the active ingredient 
which will serve as a guide to the potential level of inert ingredient 
residues is the active ingredient with the highest tolerance level. 
This assumption overstates residue values because it would be highly 
unlikely, given the high number of inert ingredients, that a single 
inert ingredient or class of ingredients would be present at the level 
of the active ingredient in the highest tolerance for every commodity. 
Finally, a third compounding conservatism is EPA's assumption that all 
foods contain the inert ingredient at

[[Page 37016]]

the highest tolerance level. In other words, EPA assumed 100 percent of 
all foods are treated with the inert ingredient at the rate and manner 
necessary to produce the highest residue legally possible for an active 
ingredient. In summary, EPA chose a very conservative method for 
estimating what level of inert residue could be on food, then used this 
methodology to choose the highest possible residue that could be found 
on food and assumed that all food contained this residue. No 
consideration was given to potential degradation between harvest and 
consumption even though monitoring data shows that tolerance level 
residues are typically one to two orders of magnitude higher than 
actual residues in food when distributed in commerce.
    Accordingly, although sufficient information to quantify actual 
residue levels in food is not available, the compounding of these 
conservative assumptions will lead to a significant exaggeration of 
actual exposures. EPA does not believe that this approach 
underestimates exposure in the absence of residue data.
    In the dietary assessment, EPA also considered exposures due the 
use of formic acid as a miticide, as a direct and indirect food 
additive and its natural occurrence in some foods; and sodium formate 
as an indirect food substance. Based on information on the typical 
concentrations of and use patterns as a miticide, direct and indirect 
food additive, the Agency believes that exposures to formic acid and 
sodium formate that might result from these uses would be markedly less 
than the conservatively-estimated exposures resulting from pesticide 
use and would not meaningfully contribute to aggregate exposures.
    2. Dietary exposure from drinking water. For the purpose of the 
screening level dietary risk assessment to support this request for an 
exemption from the requirement of a tolerance for formic acid and 
sodium formate, a conservative drinking water concentration value of 
100 ppb based on screening level modeling was used to assess the 
contribution to drinking water for the chronic dietary risk assessments 
for parent compound. These values were directly entered into the 
dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    The term ``residential exposure'' is used in this document to refer 
to non-occupational, non-dietary exposure (e.g., for lawn and garden 
pest control, indoor pest control, termiticides, and flea and tick 
control on pets). Formic acid and sodium formate may be used as an 
inert ingredient in pesticide products that are registered for specific 
uses that may result in residential exposure. A conservative 
residential exposure and risk assessments were completed for pesticide 
products containing formic acid and sodium formate as inert 
ingredients. The Agency assessed pesticide products containing formic 
acid and sodium formate using exposure scenarios used by OPP's 
Antimicrobials Division to represent conservative residential handler 
exposure. Further details of this residential exposure and risk 
analysis can be found at http://www.regulations.gov in the memorandum 
entitled: ``JITF Inert Ingredients. Residential and Occupational 
Exposure Assessment Algorithms and Assumptions Appendix for the Human 
Health Risk Assessments to Support Proposed Exemption from the 
Requirement of a Tolerance When Used as Inert Ingredients in Pesticide 
Formulations,'' (D364751, 5/7/09, Lloyd/LaMay in docket ID number EPA-
HQ-OPP-2008-0710).
    Formic acid and sodium formate may be also be used in laundry 
detergents, rust remover, household cleaners, personal care products, 
and cosmetics. The Agency does not have sufficient data to 
quantitatively assess exposures to formic acid and sodium formate that 
might result from these uses. However, based on the typical 
concentrations of and use patterns of formic acid and sodium formate, 
the Agency believes that exposures that might result from these uses 
would be markedly less than the conservatively estimated exposures 
resulting from pesticide use and would not meaningfully contribute to 
aggregate exposures.
    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 formic acid and sodium formate to share a common 
mechanism of toxicity with any other substances, and formic acid and 
sodium formate do not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that formic acid and sodium formate do 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. The Agency has concluded 
that there is reliable data to determine that infants and children will 
be safe if the FQPA SF of 10x is reduced to 1x for the assessment of 
all exposure scenarios except for the long-term inhalation exposure 
scenario for the following reasons. The toxicity database for formic 
acid and sodium formate contains subchronic, developmental, 
reproduction, chronic/carcinogenicity and mutagenicity studies. There 
is no indication of immunotoxicity or neurotoxicity in the available 
studies; therefore, there is no need to require an immunotoxicity or 
neurotoxicity study. No fetal susceptibility is observed in 
developmental toxicity studies in the rat and rabbit or the 2-
generation reproduction toxicity study. Neither maternal, offspring nor 
reproduction toxicity is observed in any of the studies. The FQPA 10x 
safety factor is retained for the long-term inhalation exposure 
scenario to account for the extrapolation from the use of a subchronic 
inhalation toxicity study to chronic inhalation exposure scenarios. 
Therefore, based on the adequacy of the toxicity database, the 
conservative nature of the exposure assessment and the lack of concern 
for prenatal and postnatal sensitivity, the Agency has concluded that 
there is reliable data to determine that infants and children will

[[Page 37017]]

be safe if the FQPA SF of 10x is reduced to 1x all exposure scenarios, 
except for long-term inhalation exposure scenarios in which the 10x is 
retained.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
formic acid and sodium formate are 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 
formic acid and sodium formate from food and water will utilize 25% of 
the cPAD for children 1 to 2 years old, the population group receiving 
the greatest exposure.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Formic acid and sodium formate are currently used as inert 
ingredients in pesticide products that are registered for uses that 
could result in short-term residential exposures; however, the Agency 
has determined that it is not appropriate to aggregate chronic exposure 
through food and water with short-term residential exposures to formic 
acid and sodium formate. The mode of action of the toxicological effect 
must be the same across routes of exposure in order to aggregate the 
exposures; in this case, the toxic effects differ by route and 
duration. Therefore, to produce an aggregate risk estimate in 
situations in which it is not appropriate to aggregate exposures due to 
differing toxicological effects, risk measures are calculated 
separately for each route and duration for a given toxic effect for 
each hypothetical ``individual.''
    Short-term aggregated residential pesticidal dermal exposures can 
occur and result in an MOE of 1,184 for adults. Adult residential 
dermal exposure combines high-end handler dermal exposure from indoor 
aerosol spray/trigger pump and post-application dermal exposure to 
treated lawns. EPA has concluded the short-term aggregated residential 
pesticide dermal exposure results in an MOE of 1,184 for children. 
Children's residential exposure includes total exposures associated 
with contact with treated surfaces (dermal and hand-to-mouth 
exposures). Short-term aggregated residential pesticidal inhalation 
exposures result in an MOE of 3,500 for adults. Adult residential 
inhalation exposure is based on high-end handler inhalation exposure 
from indoor aerosol spray/trigger pump. Post-application inhalation 
exposure is considered negligible. As the level of concern is for MOEs 
that are lower than 100, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    For reasons stated above, intermediate-term aggregated residential 
aggregated risks were calculated for each route of exposure. 
Intermediate-term pesticidal dermal exposures result in MOEs of 23,000 
for adults. Adult residential dermal exposure is based on post-
application exposure to treated lawns. Short-term aggregated 
residential pesticidal inhalation exposures result in an MOE of 3,500 
for adults. Adult residential inhalation exposure is based on high-end 
handler inhalation exposure from indoor aerosol spray/trigger pump. 
Post-application inhalation exposure is considered negligible. As the 
level of concern is for MOEs that are lower than 100, these MOEs are 
not of concern.
    5. Long-term risks. Long-term aggregate exposure takes into account 
short-term residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Long-term residential pesticidal uses of formic acid and sodium 
formate are not expected. However, long-term residential exposure is 
possible due to their use in household products, personal care 
products, and cosmetics. The Agency does not have sufficient data to 
quantitatively assess exposures to formic acid and sodium formate that 
might result from these uses. In the absence of actual residential 
exposure data resulting from such uses, the Agency considered 
information on the typical concentrations of and use patterns of 
household cleaning products, personal care products, and cosmetics 
containing formic acid and sodium formate. The available data indicate 
that exposures to formic acid and sodium formate that might result from 
these uses would be markedly less than the conservatively estimated 
exposures resulting from pesticide use. Therefore, the Agency believes 
that any contribution to aggregate exposure is negligible.
    6. Aggregate cancer risk for U.S. population. Based on the lack of 
tumors in the carcinogenicity studies in rats and mice and the lack of 
mutagenicity, formic acid and sodium formate are not expected to be 
carcinogenic. Therefore, formic acid and sodium formate are not 
expected to pose a cancer risk to humans.
    7. 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 formic acid and sodium formate 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 
formic acid and sodium formate in or on any food commodities. EPA is 
establishing limitations on the amount of formic acid and sodium 
formate that may be used in pesticide formulations applied pre- and 
post-harvest. 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 food use that exceeds 25% of formic acid 
and sodium formate in the final pesticide formulation.

B. Revisions to Petitioned-for Tolerances

    In concentrations above 25% of the formulation, formic acid has 
miticidal activity. Therefore, EPA is limiting the use of formic acid 
in pesticide formulations to 25% by weight to ensure that it is 
functioning as an adjuvant and pH buffering agent and not acting as a 
pesticide active ingredient.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are 
established for residues of formic acid (CAS Reg No. 64-18-6), when 
used as an inert ingredient (adjuvant, pH buffering agent, or pH 
adjuster) limited to 25% in pesticide formulations applied to growing 
crops and raw

[[Page 37018]]

agricultural commodities after harvest under 40 CFR 180.910 and when 
used as an inert ingredient (pH adjuster) applied in/on animals under 
40 CFR 180.930. In addition, an exemption from the requirement of a 
tolerance is established for residues of sodium formate (CAS Reg No. 
141-53-7) when used as an inert ingredient (adjuvant, pH buffering 
agent) in pesticide formulations applied to growing crops and raw 
agricultural commodities after harvest (under 40 CFR 180.910).

VII. Statutory and Executive Order Reviews

    This action establishes exemptions from the requirement of a 
tolerance under FFDCA section 408(d) in response to petitions 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 exemptions in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal Governments, on the relationship between the National Government 
and the States or Tribal Governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: May 29, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
    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.  180.910, add alphabetically the inert ingredients ``Formic 
Acid (CAS Reg. No. 64-18-6)''; and ``Sodium Formate (CAS Reg No. 141-
53-7)'' to table 1 to read as follows:


Sec.  180.910   Inert ingredients used pre- and post-harvest; 
exemptions from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
         Inert ingredients              Limits              Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Formic Acid (CAS Reg. No. 64-18-6)             25%  adjuvant, pH
                                                     buffering agent, pH
                                                     adjuster.
 
                              * * * * * * *
Sodium Formate (CAS Reg. No. 141-   ..............  adjuvant, pH
 53-7).                                              buffering agent.
 
                              * * * * * * *
------------------------------------------------------------------------


0
3. In Sec.  180.930, add alphabetically the inert ingredient ``Formic 
Acid (CAS Reg. No. 64-18-6)'' to the table to read as follows:


Sec.  180.930   Inert ingredients applied to animals; exemptions from 
the requirement of a tolerance.

* * * * *

[[Page 37019]]



------------------------------------------------------------------------
         Inert ingredients              Limits              Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Formic Acid (CAS Reg. No. 64-18-6)             25%  pH adjuster.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2020-13030 Filed 6-18-20; 8:45 am]
BILLING CODE 6560-50-P


