81 FR 31520 - Maleic Anhydride; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 97 (May 19, 2016)

This regulation establishes an exemption from the requirement of a tolerance for residues of maleic anhydride (CAS Reg. No. 108-31-6) when used as an inert ingredient (stabilizer) in pesticide formulations applied to growing crops at a maximum concentration not to exceed 3.5% by weight in the pesticide formulation. Exponent, on behalf of Cheminova A/S, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment to an existing requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of maleic anhydride.

[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)]
[Rules and Regulations]
[Pages 31520-31526]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-11837]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0853; FRL-9945-82]


Maleic Anhydride; 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 maleic anhydride (CAS Reg. No. 108-31-6) 
when used as an inert ingredient (stabilizer) in pesticide formulations 
applied to growing crops at a maximum concentration not to exceed 3.5% 
by weight in the pesticide formulation. Exponent, on behalf of 
Cheminova A/S, submitted a petition to EPA under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), requesting an amendment to an existing 
requirement of a tolerance. This regulation eliminates the need to

[[Page 31521]]

establish a maximum permissible level for residues of maleic anhydride.

DATES: This regulation is effective May 19, 2016. Objections and 
requests for hearings must be received on or before July 18, 2016, 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-2014-0853, 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: Susan Lewis, 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-2014-0853 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 
July 18, 2016. 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-2014-0853, 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 6, 2015 (80 FR 18327) (FRL-9924-
00), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP) IN-10771 by 
Exponent on behalf of Cheminova A/S, 1600 Wilson Boulevard, Suite 700, 
Arlington, VA 22209. The petition requested that 40 CFR 180.920 be 
amended by modifying an exemption from the requirement of a tolerance 
for residues of maleic anhydride (CAS Reg. No. 108-31-6) when used as 
an inert ingredient (stabilizer) in pesticide formulations applied to 
growing crops to allow for use at a maximum concentration not to exceed 
5% in formulation. That document referenced a summary of the petition 
prepared by Exponent, the petitioner, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the limitation on the maximum concentration in pesticide 
formulation from 5% to 3.5%. This limitation is based on the Agency's 
risk assessment which can be found at http://www.regulations.gov in 
document, Maleic Anhydride; 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 Products 
under 40 CFR 180.920, in docket ID number EPA-HQ-OPP-2014-0853.

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

[[Page 31522]]

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 maleic anhydride including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with maleic anhydride 
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 maleic anhydride 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.
    Maleic anhydride exhibits relatively low toxicity via oral and 
dermal routes of exposure. Maleic anhydride has been reported to be 
severely irritating to the skin and eyes of rabbits, dermally 
sensitizing to guinea pigs, and is a possible respiratory sensitizer.
    In a six-month repeat dose inhalation study, CD rats, Engle 
hamsters, and Rhesus monkeys were exposed by inhalation (whole body) to 
0, 1.1, 3.3 and 9.8 mg/m\3\ (0, 0.3, 0.8, and 2.4 ppm) maleic anhydride 
for six months. Body weights were decreased in rats at 3.3 and 9.8 mg/
m\3\ (0.8, and 2.4 ppm) in the mid- and high-exposure groups at 
intervals during the study (<10%). However, at study termination, body 
weights were decreased only at the 9.8 mg/m\3\ exposure group (6-8%). 
These decreases in the body weights are not considered as an adverse 
effect. All other effects were limited to the respiratory tract and 
eye. All of these effects were considered indicative of irritation and 
judged to be reversible. The NOAEL for irritation in this study was 3.3 
mg/m\3\ or 0.93 mg/kg/day based on localized eye/nasal irritation 
effects seen at the LOAEL of 9.8 mg/m\3\. The NOAEL for systemic 
toxicity in rats, hamsters and monkeys is 9.8 mg/m\3\, the highest dose 
tested.
    In a 28-day inhalation study with maleic anhydride in Sprague-
Dawley rats, evidence of nasal and ocular irritation (concentration-
dependent) occurred at 12, 32 and 86 mg/m\3\. Reduced body weight gain 
and food consumption as well as increased incidence of hemorrhagic lung 
foci occurred at 32 and 86 mg/m\3\. The NOAEL for the systemic toxicity 
is 12 mg/m\3\ (3 ppm) based on the reduced body weights and food 
consumption seen at the LOAEL of 32 mg/m\3\.
    In a 90-day oral (dietary) study in rats were fed in the diet 0, 
100, 250, or 600 mg/kg/day maleic anhydride for 90 days. At 600 mg/kg/
day, there was slight proteinuria in both sexes, increased relative 
liver weight in males, increased relative/absolute kidney weights in 
both sexes. Macroscopic and microscopic kidney changes, including 
nephrosis were seen in male rats at 100, 250, and 600 mg/kg/day. The 
LOAEL for this study is 100 mg/kg/day. In a separate study, rats were 
fed in the diet 0, 20, or 40 mg/kg/day maleic anhydride, seven days a 
week for 90 days. There were no treatment-related effects. The NOAEL 
for this study is 40 mg/kg/day.
    In a 183-day oral (dietary) study in rats there were renal lesions 
and an increase in the absolute and relative liver and kidney weights 
at 250 mg/kg/day and 600 mg/kg/day. The LOAEL for this study is 250 mg/
kg/day. A NOAEL was not established.
    In a 2-year oral (dietary) study in rats only marginal toxicity was 
observed which was evidenced by small (<6%), but dose-related, decrease 
in body weights of rats. The LOAEL for this study is 32 mg/kg/day and 
the NOAEL for this study is 10 mg/kg/day.
    In a 90-day dietary study in dogs, there were no treatment related 
effects observed at doses up to 60 mg/kg/day, the highest dose tested.
    In an oral (gavage) developmental toxicity study in CD rats, no 
treatment related adverse effects were observed. The NOAEL for both 
maternal and developmental toxicity was 140 mg/kg/day, the highest dose 
tested.
    In a 2-generation oral (gavage) reproductive toxicity study in 
rats, significant mortality occurred in the F0 and 
F1 parental animals and maleic anhydride was toxic to 
parental animals in all dose groups (20, 55 and 150 mg/kg/day of maleic 
anhydride). There was no significant reduction in the percentage of 
pregnant females or the percentage of fertile males. Adverse effects on 
litter size and on pup survival were observed at the dose of 55 mg/kg/
day and above in the F2 litters. Maleic anhydride was toxic 
to parental animals in all dose groups. For parental toxicity the LOAEL 
was 20 mg/kg/day. Although a NOAEL for parental toxicity was not 
established, the selected NOAEL (which is from the 2-year toxicity 
study in the rat) will be protective of the kidney and bladder effects 
seen at the lowest dose tested in this study, since the 2-year toxicity 
study examined those organs and found no effects. The NOAEL for 
offspring toxicity was 55 mg/kg/day based on decreased pup survival 
observed at 150 mg/kg/day.
    Maleic anhydride was negative for mutagenicity or chromosomal 
aberrations in a battery of tests of genotoxicity including a bacterial 
gene mutation test, an in vivo mammalian chromosomal aberration test 
using rat bone marrow and an in vitro chromosomal test.
    In the previously described 2-year dietary study, male and female 
rats were exposed to 0, 10, 32, or 100 mg/kg/day maleic anhydride in 
feed for two years. There were no increases in tumor incidence that 
were considered related

[[Page 31523]]

to maleic anhydride exposure. Additionally in a two-year chronic 
feeding study on Osborne-Mendel rats fed 0, 0.5, 1.0 or 1.5% maleic 
acid in their diets for two years resulted in no treatment-related 
increases in tumors.
    A 1-hour neurotoxicity inhalation study exposed rats to 0.72 mg/L 
of maleic acid which produced generalized inactivity, hyperpnea and 
sedation within 15 minutes of exposure. Gross necropsy revealed no 
significant findings. No neurotoxic effects have been reported in the 
other available studies.
    No immunotoxicity studies on maleic anhydride or maleic acid were 
available in the database.
    In a metabolism study, dogs were fed 60 mg/kg/day maleic anhydride 
for 90 days. Using a one compartment model, uptake rate and elimination 
rate constants were calculated as 3.49 x 10-3 per day and 
8.32 x 10-2 per day, respectively. Based on this model, 99% 
of steady state was reached by day 55 of the study.
    Maleic anhydride is readily hydrolyzed to maleic acid under aqueous 
conditions and is then hydroxylated to malic acid, which participates 
in the Krebs cycle or may be excreted unchanged or in conjugated form.

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 effect was not found in the database for maleic anhdyride.
    The 2-year oral toxicity study in rats was selected for dietary and 
dermal exposure scenarios (all non-acute durations) for this risk 
assessment. The NOAEL in this study was 10 mg/kg/day. The LOAEL was 32 
mg/kg/day based on slight to marginal decreases in body weight. The 
rationale for selecting this study for the dietary is based on the fact 
that this study provided the lowest and most conservative toxicity 
endpoint in the most sensitive species for oral after a long-term 
exposure. No repeat dose dermal toxicity studies are available for 
maleic anhydride; the dermal risk assessment was conducted using the 
most sensitive conservative oral endpoint. An uncertainty factor of 
100x was applied, 10x for interspecies variability and 10x for 
intraspecies variability; the FQPA safety factor was reduced to 1x. No 
dermal absorption studies were available for maleic anhydride or maleic 
acid, therefore, a dermal absorption value was estimated using the 
ratio of an oral LD50 and a dermal LD50. The two 
studies used were the oral rabbit LD50 of 875 mg/kg and the 
dermal rabbit LD50 of 2,620 mg/kg. The resulting estimated 
dermal absorption was 33%. Therefore, a dermal absorption factor of 33% 
will be used for dermal exposure scenarios.
    The 6-month inhalation toxicity study in rats was selected for 
inhalation exposure scenarios (all durations) for this risk assessment. 
The NOAEL in this study was 3.3 mg/m\3\ or 0.93 mg/kg/day based on 
localized eye/nasal irritation effects seen at the LOAEL of 9.8 mg/
m\3\. Since the major effect of maleic anhydride is irritation via 
inhalation, this endpoint is protective of any systemic toxicity seen 
at concentrations of 32 mg/m\3\ and above seen in the 28-day inhalation 
toxicity study. An uncertainty factor of 100x was applied, 10x for 
interspecies variability and 10x for intraspecies variability. The FQPA 
safety factor was reduced to 1x.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to maleic anhydride, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance. EPA assessed 
dietary exposures from maleic anhydride in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide chemical, if a 
toxicological study has indicated the possibility of an effect of 
concern occurring as a result of a 1-day or single exposure. No such 
effects were identified in the toxicological studies for maleic 
anhydride therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. The chronic dietary exposure assessment for 
this inert ingredient utilizes the Dietary Exposure Evaluation Model 
Food Commodity Intake Database (DEEM--FCID), Version 3.16, EPA, which 
includes 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 2003 to 2008. In the absence of actual residue data, the inert 
ingredient evaluation is based on a highly conservative model which 
assumes that the residue level of the inert ingredient would be no 
higher than the highest established tolerance for an active ingredient 
on a given commodity. Implicit in this assumption is that there would 
be similar rates of degradation between the active and inert ingredient 
(if any) 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 model assumes 100 
percent crop treated (PCT) for all crops and that every food eaten by a 
person each day has tolerance-level residues. 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 
case of maleic anhydride, EPA made specific adjustments to the dietary 
exposure assessment to account for the use limitation of maleic 
anhydride (as an inert ingredient in pesticide formulations applied to 
apples with a minimum preharvest interval of 21 days and at maximum 
concentration of 3.5% by weight in all other preharvest uses).
    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 maleic anhydride, a 
conservative drinking water concentration value of 100 ppb based on 
screening level modeling was used to assess the contribution to

[[Page 31524]]

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).
    Maleic anhydride may be used as inert ingredient in pesticide 
products that are registered for specific uses that may result in 
indoor or outdoor residential inhalation and dermal exposures. A 
screening-level residential exposure and risk assessment was completed 
utilizing conservative residential exposure assumptions. The Agency 
assessed short- and intermediate-term dermal and inhalation exposures 
for residential handlers that would result from low pressure handwand, 
hose end sprayer and trigger sprayer for outdoor scenarios of each 
pesticide type, herbicide, insecticide and fungicide and mopping, 
wiping and aerosol sprays for indoor scenarios. The Agency assessed 
post-application short-term dermal exposure for children and adults as 
well as short-term hand-to-mouth exposure for children from contact 
with treated lawns.
    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 maleic anhydride to share a common mechanism of 
toxicity with any other substances, and maleic anhydride does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
maleic anhydride 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 Web site 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. There is no evidence of 
increased quantitative or qualitative susceptibility of rat fetuses to 
the effects of maleic anhydride. In the 2-generation reproduction 
study, the LOAEL for parental toxicity was 20 mg/kg/day. No adverse 
effects on litter size or pup survival were noted at doses up to 55 mg/
kg/day.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1x. That decision is based on the following 
findings:
    i. The toxicity database for maleic anhydride is adequate for 
characterizing the toxicity and assessing the risk from dietary 
exposure.
    ii. There is no indication that maleic anhydride 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 indication that maleic anhydride is an immunotoxic 
chemical and there is no need for an immunotoxicity study or additional 
UFs to account for immunotoxicity.
    iv. There is no evidence that maleic anhydride results in increased 
susceptibility in in utero in rats in the combined repeated dose 
toxicity study with the reproduction/developmental toxicity screening 
studies and prenatal developmental studies.
    v. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on highly conservative model that assumes 100 percent crop treated 
(PCT) for all crops and that every food eaten by a person each day has 
residues of inert ingredient equivalent to the residue level of the 
highest established tolerance for an active ingredient on a given 
commodity. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to maleic anhydride 
in drinking water. EPA used similarly conservative assumptions to 
assess post application exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by maleic anhydride.

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, 
maleic anhydride 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 
maleic anhydride from food and water will utilize 72.4% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in this unit, regarding residential 
use patterns, chronic residential exposure to residues of maleic 
anhydride is not expected.
    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).
    Maleic anhydride 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 exposures to maleic anhydride.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 112 for adults 
and 105 for children. Because EPA's level of concern for maleic 
anhydride is a MOE of 100 or below, these MOEs are not of concern.

[[Page 31525]]

    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).
    Maleic anhydride is currently 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 short-term residential exposures to maleic anhydride.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 178 for adults and 119 for children. Because EPA's 
level of concern for maleic anhydride is a MOE of 100 or below, these 
MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the 
discussion in Unit IV.A., maleic anhydride is not expected to pose a 
cancer risk.
    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 maleic anhydride residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Although EPA is establishing a limitation on the amount of maleic 
anhydride that may be used in pesticide formulations, an analytical 
enforcement methodology is not necessary for this exemption. The 
limitation 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 for sale or 
distribution for use on growing crops with concentrations of maleic 
anhydride exceeding 3.5% by weight of the formulation.

B. Revisions to Petitioned-For Tolerances

    Based upon an evaluation of the data included in the petition, EPA 
is establishing an exemption from the requirement of a tolerance for 
residues of maleic anhydride when used in pesticide formulations as an 
inert ingredient (stabilizer), not to exceed 3.5% by weight of the 
formulation, instead of the 5% limit requested. The basis for this 
revision can be found at http://www.regulations.gov in document Maleic 
Anhydride; 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 Pre-harvest Pesticide 
Products under 40 CFR 180.920 in docket ID number EPA-HQ-OPP-2014-0853.

VI. Conclusions

    Therefore, EPA is amending the existing exemption from the 
requirement of a tolerance under 40 CFR 180.920 for maleic anhydride 
(CAS Reg. No. 108-31-6). In addition to the existing limitation for use 
as an inert ingredient (stabilizer) in pesticide formulations applied 
to growing crops for use in pesticide formulations applied to apples 
with a minimum preharvest interval of 21 days, the Agency is extending 
the exemption for use in all pesticide formulations at a maximum 
concentration not to exceed 3.5% in the pesticide formulation. In order 
to clarify that this extension applies only to maleic anhydride, the 
Agency is separating the existing exemption for maleic anhydride from 
the existing maleic acid exemption.

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). 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: May 6, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

[[Page 31526]]

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:
0
i. Remove the existing entry for ``Maleic acid and maleic anhydride'' 
from the table.
0
ii. Add alphabetically the following entries ``Maleic acid,'' and 
``Maleic anhydride'' to the table to read as follows:


Sec.  180.920  Inert ingredients used preharvest; exemptions from the 
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
       Inert ingredients                Limits                Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Maleic acid...................  For pesticide          Stabilizer.
                                 formulations applied
                                 to apples with a
                                 minimum preharvest
                                 interval of 21 days.
Maleic anhydride (CAS Reg. No.  Not to exceed 3.5% in  Stabilizer.
 108-31-6).                      pesticide
                                 formulations; or for
                                 pesticide
                                 formulations applied
                                 to apples with a
                                 minimum preharvest
                                 interval of 21 days.
 
                              * * * * * * *
------------------------------------------------------------------------


[FR Doc. 2016-11837 Filed 5-18-16; 8:45 am]
 BILLING CODE 6560-50-P