Document ID: EPA-HQ-OPP-2018-0091-0003
Agency: epa
Document Type: Rule
Title: Tolerance Exemptions: Calcium Formate
Posted Date: 2018-12-04T05:00Z

[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Rules and Regulations]
[Pages 62475-62479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26353]

[[Page 62475]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0091; FRL-9986-06]

Calcium Formate; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of calcium formate (CAS Reg. No. 544-17-2) 
when used as an inert ingredient (carrier) in pesticide formulations 
applied to growing crops only. ADAMA Agan, Ltd. c/o Makhteshim Agan of 
North America, Inc. 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 calcium formate.

DATES: This regulation is effective December 4, 2018. Objections and 
requests for hearings must be received on or before February 4, 2019, 
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-2018-0091, 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 L. Goodis, Director, 
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 http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this 
document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.''

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-2018-0091 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 
February 4, 2019. 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-2018-0091, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of April 11, 2018 (83 FR 15528) (FRL-9975-
57), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11075) by 
ADAMA Agan, Ltd. c/o Makhteshim Agan of North America, Inc., 3120 
Highwoods Blvd., Suite 100, Raleigh, NC 27604. The petition requested 
that 40 CFR 180.920 be amended by establishing an exemption from the 
requirement of a tolerance for residues of calcium formate (CAS Reg. 
No. 544-17-2) when used as an inert ingredient (carrier) in pesticide 
formulations applied to growing crops only. That document referenced a 
summary of the petition prepared by ADAMA Agan, LTD, the petitioner, 
which is available in the docket, http://www.regulations.gov.
    This is based on the Agency's risk assessment which can be found at 
http://www.regulations.gov in document: Calcium Formate; Human Health 
Risk Assessment in docket ID number EPA-HQ-OPP-2018-0091. No comments 
were received in response to the notice published by EPA.

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

[[Page 62476]]

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 calcium formate including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with calcium 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.
    The toxicity database on calcium formate is somewhat limited. 
Consequently, studies on appropriate surrogates were used to supplement 
the database on calcium formate. Formic acid, sodium formate, potassium 
formate and ammonium formate were selected as appropriate surrogates 
since they are either the acid form of calcium formate or other salts 
of formic acid.
    Calcium formate is not expected to be acutely toxic based on acute 
toxicity data. There are no subchronic or chronic studies on calcium 
formate, although there are studies on potassium formate. These studies 
show effects based on reduced body weight gain. A two-year study with 
potassium formate indicates the compound is not carcinogenic to Wistar 
rats.
    In mutagenicity studies with calcium formate, sodium formate and 
methyl formate, results of the test were negative for all chemicals. 
The weight-of-evidence suggests that calcium is not expected to be 
mutagenic.
    There are no available developmental toxicity studies on calcium 
formate; however, both a rat and rabbit developmental toxicity study 
have been conducted on sodium formate. In the rat study, the maternal 
and developmental no-observed-adverse-effect-level (NOAEL) was 
considered the highest dose tested at 945 milligram/kilogram/day (mg/
kg/day). In the rabbit study, the maternal and developmental toxicity 
NOAEL was also the highest dose tested at 1,000 mg/kg/day. A five-
generation rat reproductive toxicity study on calcium formate has been 
conducted with a NOAEL of >200 mg/kg/day (only dose tested). In a 
three-generation reproduction study in rats via drinking water, no 
treatment related effects were observed in the parental animals and off 
springs at doses up to 200 mg/kg/day.
    No studies were submitted for immunotoxicity. However, the toxicity 
studies available did not show any signs of immunotoxicity up to limit 
doses. Therefore, immunotoxicity is not of concern.
    There are no available studies for neurotoxicity. However, the 
functional observation battery performed in the 90-day oral toxicity 
study did not show any signs of neurotoxicity up to limit doses. 
Therefore, neurotoxicity is not of concern.
    A metabolism study is available in the toxicity database. Calcium 
formate breaks down into calcium and formate ions. Calcium ions are 
ubiquitous in the natural environment and can be considered as having 
little toxicity or hazard. Formate ions are readily converted to carbon 
dioxide in the environment by biodegradation or photooxidation.
    Specific information on the studies received and the nature of the 
adverse effects caused by calcium formate as well as the NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at http://www.regulations.gov in the document Calcium 
Formate Risk Assessment at page 7 in docket ID number EPA-HQ-OPP-2018-
0091.

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

[[Page 62477]]

complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    No toxicological endpoints of concern were identified for calcium 
formate based on available toxicity studies on surrogate chemicals. 
Formic acid, sodium formate, potassium formate and ammonium formate 
were selected as appropriate surrogates since they are either the acid 
form of calcium formate or other salts of formic acid. Most of the 
available studies on these substances were not conducted up to the 
limit dose. The highest dose of 200 mg/kg/day in a lifelong study in 
rats via drinking water did not produce any systemic toxicity (IUCLID, 
Calcium formate, 2001). Therefore, a conservative risk assessment was 
conducted using a NOAEL of 200 mg/kg/day for chronic dietary and short- 
and intermediate-term dermal exposure risk estimates. An uncertainty/
safety factor of 100X (10X for interspecies variability and 10X for 
interspecies extrapolation) was used. The Food Quality Protection Act 
(FQPA) factor of 10X was reduced to 1X, therefore, the chronic 
Reference Dose (cRfD) of 2 mg/kg/day is equal to the chronic Population 
Adjusted Dose (cPAD). A 100% dermal absorption factor is assumed for 
converting oral to dermal equivalent doses in the absence of dermal 
toxicity or dermal absorption studies.
    For short and intermediate term inhalation exposure, the route 
specific study was used. The NOAEL of 0.62 mg/l (32 parts per million 
(ppm)) was observed in a 90-day inhalation toxicity study in rats 
(IUCLID, Formic acid, 2000). The uncertainty factor is 100X (10X for 
interspecies variability and IOX for interspecies extrapolation). The 
FQPA factor of 10 X was reduced to 1X.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to calcium formate, EPA considered exposure under the proposed 
exemption from the requirement of a tolerance. EPA assessed dietary 
exposures from calcium formate in food as follows:
    Because no endpoint was identified for acute exposure, an acute 
exposure assessment was not conducted.
    In conducting the chronic dietary exposure assessment using the 
Dietary Exposure Evaluation Model DEEM-FCID\TM\, EPA used food 
consumption information from the U.S. Department of Agriculture's 
National Health and Nutrition Examination Survey, what we eat in 
America, (NHANES/WWEIA). This dietary survey was conducted from 1994-
98. As to residue levels in food, no residue data were submitted. 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 of tolerances 
would be no higher than the concentration of the active ingredient.
    The Agency believes the assumptions used to estimate dietary 
exposures lead to an extremely conservative assessment of dietary risk 
due to a series of compounded conservatisms. First, assuming that the 
level of residue for an inert ingredient is equal to the level of 
residue for the active ingredient will overstate exposure. The 
concentration of active ingredients in agricultural products is 
generally at least 50 percent of the product and often can be much 
higher. 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, 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 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, and 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.
    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 calcium formate, a 
conservative drinking water concentration value of 100 parts per 
billion (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).
    There are no known or anticipated residential uses for calcium 
formate and therefore, residential exposure is not expected.
    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

[[Page 62478]]

substances that have a common mechanism of toxicity.''
    EPA has not found calcium formate to share a common mechanism of 
toxicity with any other substances, and calcium formate does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
calcium formate 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

    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 pre-natal and post-natal 
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 is 
available to EPA to support the choice of a different factor.
    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:
    1. Toxicological studies were identified for calcium formate in the 
publicly available databases. However, calcium formate breaks down into 
calcium and formate ions. Calcium ions are ubiquitous in the natural 
environment and can be considered as having little toxicity or hazard 
risk. The toxicological database for calcium formate is limited. There 
is available data on formic acid and related formate compounds (such as 
ammonium, sodium and methyl formate), which can serve as suitable 
surrogates for calcium formate. Studies conducted with methanol are 
also applicable to formate compounds, since methanol is metabolized 
into formic acid. Therefore, the database is considered adequate for 
FQPA assessment.
    2. There is no evidence of increased susceptibility of infants and 
children in the available reproduction and developmental toxicity 
studies with calcium formate and/or sodium formate. No developmental or 
maternal systemic toxicity was observed in rats at doses up to 200 mg/
kg/day when calcium format was administered via drinking water. No 
developmental or maternal toxicity was observed in mice at doses up to 
750 mg/kg gavage dose of sodium formate on gestation day 8. No evidence 
of increased susceptibility was observed following pre- and post-natal 
exposure to calcium formate. In a multigeneration reproduction study 
(three to five generations), no parental, reproductive or offspring 
toxicity was observed at doses up to 200 mg/kg/day.
    3. No neurotoxicity studies are available in the database. However, 
there is no evidence of clinical signs of neurotoxicity in the 
database, nor evidence of susceptibility in the young in the database. 
Therefore, EPA concluded that the developmental neurotoxicity study is 
not required. There is no evidence of immunotoxicity in the available 
database.
    4. The dietary food exposure assessment utilizes highly 
conservative default assumptions that would not under estimate the 
dietary risk to all populations. For the purpose of the screening level 
dietary risk assessment to support this request for an exemption from 
the requirement of a tolerance for ammonium formate, a value of 100 ppb 
for drinking water based on screening level modeling was used for the 
chronic dietary risk assessment. The value of 100 ppb is considered to 
be a high end, conservative assumption that is not likely to 
underestimate drinking water risks.
    Taking into consideration the available information, EPA concludes 
the additional 10X FQPA safety factor can be reduced to 1X. These 
assessments will not underestimate the exposure and risks posed by 
calcium formate.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on calcium. EPA 
has determined that there is a reasonable certainty that no harm to any 
population subgroup will result from aggregate exposure to calcium 
formate under reasonable foreseeable circumstances. Therefore, the 
establishment of an exemption from tolerance under 40 CFR 180.920 for 
residues of calcium formate when used as an inert ingredient in 
pesticide formulations applied is safe under FFDCA section 408.
    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, 
calcium formate is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure analysis, EPA has concluded that risk 
estimates for chronic exposure to calcium formate from food and water 
are not of concern (<100% cPAD with a risk estimate at 31.2% of the 
cPAD for children 1-2 years old, the population group receiving the 
greatest exposure. There are no residential uses for calcuim formate.
    3. Short-and intermediate term risk. Short- and intermediate-term 
toxicological endpoints were established; however, calcium formate is 
not registered for any use patterns that would result in short- or 
intermediate-term residential exposure. Short- and intermediate-term 
risk is assessed based on short- and intermediate-term residential 
exposure plus chronic dietary exposure. Because there is no short- or 
intermediate-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess short-term risk), no 
further assessment of short- or intermediate-term risk is necessary, 
and EPA relies on the chronic dietary risk assessment for evaluating 
short- and intermediate-term risk for calcium formate.
    4. Aggregate cancer risk U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, calcium formate is not expected to pose a cancer risk to 
humans.
    5. 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 calcium formate residues.

V. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.920 for calcium formate (CAS Reg. No. 544-
17-2) when used as an inert ingredient (carrier) in pesticide 
formulations applied to growing crops only.

[[Page 62479]]

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), or 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, 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: November 14, 2018.
Donna Davis,
Acting 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.  180.920, add alphabetically the inert ingredient to the 
table to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

 
------------------------------------------------------------------------
         Inert ingredients              Limits              Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Calcium formate (CAS Reg. No. 544-  ..............  Carrier
 17-2).
 
                              * * * * * * *
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[FR Doc. 2018-26353 Filed 12-3-18; 8:45 am]
 BILLING CODE 6560-50-P