[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11837]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Maleic Anhydride; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of 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.
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: RDFRNotice[email protected].
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
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
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
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
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
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
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
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
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
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
drinking water for the chronic dietary risk assessments for parent
compound. These values were directly entered into the dietary exposure
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
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/
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
i. The toxicity database for maleic anhydride is adequate for
characterizing the toxicity and assessing the risk from dietary
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.
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
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
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.
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
Dated: May 6, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.920:
i. Remove the existing entry for ``Maleic acid and maleic anhydride''
from the table.
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.
to apples with a
interval of 21 days.
Maleic anhydride (CAS Reg. No. Not to exceed 3.5% in Stabilizer.
formulations; or for
to apples with a
interval of 21 days.
* * * * * * *
[FR Doc. 2016-11837 Filed 5-18-16; 8:45 am]
BILLING CODE 6560-50-P