Salicylaldehyde; Exemption From the Requirement of a Tolerance, 17611-17615 [2016-07085]
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Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
17611
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
[EPA–HQ–OPP–2015–0019; FRL–9944–12]
A. Does this action apply to me?
Salicylaldehyde; Exemption From the
Requirement of a Tolerance
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).
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of salicylaldehyde
(2-hydroxybenzaldehyde, CAS Reg. No.
90–02–8) when used as an inert
ingredient (penetration aid) in pesticide
formulations applied to growing crops
and raw agricultural commodities under
40 CFR 180.910 at a concentration not
to exceed 14% by weight of the
pesticide formulation. Ag-Chem
Consulting LLC, on behalf of Omex
Agrifluids 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 salicylaldehyde.
DATES: This regulation is effective
March 30, 2016. Objections and requests
for hearings must be received on or
before May 31, 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).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2015–0019, is
available at https://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 https://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
ADDRESSES:
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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 https://
www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2015–0019 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 May 31, 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–
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Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations
2015–0019, by one of the following
methods:
• Federal eRulemaking Portal: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
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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–10777) by Ag-Chem
Consulting LLC, 12208 Quinque Lane,
Clifton, VA 20124 on behalf of Omex
Agrifluids, 24730 Avenue 13, Madera,
CA 93637. The petition requested that
40 CFR 180.910 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of salicylaldehyde (CAS Reg. No. 90–
02–8) when used as an inert ingredient
(penetration aid) in pesticide
formulations applied to growing crops
or to raw agricultural commodities after
harvest at a concentration not to exceed
14% by weight of the pesticide
formulation. That document referenced
a summary of the petition prepared by
Ag-Chem Consulting LLC, on behalf of
Omex Agrifluids, the petitioner, which
is available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients
that are not active ingredients as defined
in 40 CFR 153.125 and include, but are
not limited to, the following types of
ingredients (except when they have a
pesticidal efficacy of their own):
Solvents such as alcohols and
hydrocarbons; surfactants such as
polyoxyethylene polymers and fatty
acids; carriers such as clay and
diatomaceous earth; thickeners such as
carrageenan and modified cellulose;
wetting, spreading, and dispersing
agents; propellants in aerosol
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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 exemption is ‘‘safe.’’
Section 408(c)(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 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
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aggregate exposure for salicylaldehyde
including exposure resulting from the
exemption established by this action.
EPA’s assessment of exposures and risks
associated with salicylaldehyde 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 salicylaldehyde as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
are discussed in this unit.
The acute oral toxicity of
salicylaldehyde was examined in male
rats and mice. The general oral lethal
amount of salicylaldehyde is estimated
to be 500 mg/kg in mice. The dermal
LD50 for salicylaldehyde was
determined to be greater than 23,000
mg/kg. Dermal irritation studies found
salicylaldehyde to be irritating, with
eschar formation and scarring 14 days
after administration.
No adverse effects attributable to a
single exposure to salicylaldehyde were
seen in the toxicity databases. In a
combined repeated dose toxicity study
with the reproduction/developmental
toxicity screening test, toxicity was not
observed in parental animals nor in
reproductive parameters at doses up to
160 mg/kg/day, the highest dose tested.
Fetal susceptibility was observed.
Reduced bodyweight and offspring
mortality after 4 days of nursing were
observed at 160 mg/kg/day. The NOAEL
was 40 mg/kg/day. There was no
evidence of neurotoxicity or
immunotoxicity in the combined
repeated dose toxicity with the
reproduction/developmental toxicity
screening test.
Salicylaldehyde was negative for
mutagenicity in the Ames test and gave
a positive response in the chromosome
aberrations test using Chinese hamster
cells (in vitro). An in vivo micronucleus
assay was negative. Since the in vivo
study is more reliable than the in vitro
assays, the weight of evidence suggests
that salicylaldehyde is unlikely to be
mutagenic.
There are no cancer studies available
for salicylaldehyde. According to a
DEREK (Nexus) (structural activity
relationship) report, there are no
structural alerts for carcinogenicity.
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Based on predicted rapid metabolism
and excretion, lack of specific target
organ toxicity in the repeat dose toxicity
study, lack of mutagenicity concerns,
and lack of any structural alerts for
carcinogenicity, salicylaldehyde is not
expected to be carcinogenic to humans
at anticipated dietary concentrations.
The metabolism of salicylaldehyde in
rabbits demonstrated that 75% of single
dose of salicylaldehyde was excreted in
the urine as glucuronic acid and sulfate
conjugates of vanillic acid.
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 https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
No acute toxicological endpoint of
concern has been identified for
salicylaldehyde. On the basis of the
repeated dose and reproductive/
developmental toxicity screening study,
a no observed adverse effect level
(NOAEL) for offspring toxicity for
salicylaldehyde was 40 mg/kg bw/day
based on reduced body weight and
increased mortality in pups at 160 mg/
kg/day. The standard 10X factors for
intra- and inter-species were applied in
establishing he chronic reference dose
(cRfD) of 0.4 mg/kg/day (40 mg/kg/day/
100). Based on the reduced FQPA Safety
Factor for salicylaldehyde of 1X, the
chronic population adjusted dose
(cPAD) is equivalent to the chronic
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reference dose (cRfD) at 0.4 mg/kg//day.
The chronic oral NOAEL is also
applicable to the short- and
intermediate-term dermal and
inhalation exposure routes.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to salicylaldehyde, EPA
considered exposure under the
proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from
salicylaldehyde in food as follows:
Acute dietary assessments take into
account exposure estimates from dietary
consumption of food and drinking
water. Chronic dietary assessments take
into account dietary food and drinking
water. The Agency assessed the dietary
exposures to salicylaldehyde as an inert
ingredient used in pesticide
formulations applied to growing crops
and livestock.
No adverse effects attributable to a
single exposure to salicylaldehyde were
seen in the toxicity databases; therefore,
an acute dietary risk assessment is not
appropriate.
In conducting the chronic dietary
exposure assessment to salicylaldehyde
an inert ingredient used in pesticide
formulations applied to growing crops,
raw agricultural commodities, and
livestock, the Dietary Exposure
Evaluation Model/Food Commodity
Intake Database (DEEM–FCID) TM,
Version 3.16 was used. EPA used food
consumption information from the U.S.
Department of Agriculture’s National
Health and Nutrition Examination
Survey, What We Eat in America,
(USDA/NHANES/WWEIA). This dietary
survey was conducted from 2003 to
2008. As to residue levels in food, no
residue data were submitted for
salicylaldehyde. In the absence of
specific residue data, EPA has
developed an approach that 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 https://www.regulations.gov in
docket ID number EPA–HQ–OPP–2008–
0738.
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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
salicylaldehyde, a conservative drinking
water concentration value of 100 ppb
based on screening level modeling was
used to assess the contribution to
drinking water for the chronic dietary
risk assessments for parent compound.
These values were directly entered into
the dietary exposure model.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables).
There are no current or proposed
residential uses for salicylaldehyde;
however, it is possible that
salicylaldehyde may be used as an inert
ingredient in pesticide products. A
highly conservative residential exposure
assessment was performed in which it
was assumed that all residential use
pesticide products would contain
salicylaldehyde as an inert ingredient. A
complete description of the approach
used to assess possible residential
exposures from salicylaldehyde can be
found in https://www.regulations.gov in
document ‘‘Salicylaldehyde; Human
Health Risk Assessment and Ecological
Effects Assessment to Support Proposed
Exemption from the Requirement of a
Tolerance When Used as an Inert
Ingredient in Pesticide Formulations,’’
pp. 15 in docket ID number EPA–HQ–
OPP–2015–0019.
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 or exemption from 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 salicylaldehyde to
share a common mechanism of toxicity
with any other substances, and
salicylaldehyde does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that salicylaldehyde 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
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https://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 evidence of increased
susceptibility of infants and children
due to exposure to salicylaldehyde. In a
combined repeated dose toxicity study
with the reproduction/developmental
toxicity screening test, offspring toxicity
was manifested as decreased body
weights and increased mortality in the
absence of maternal toxicity at doses up
to 160 mg/kg/day. The offspring toxicity
NOAEL was 40 mg/kg/day. However,
there are no to low concerns for this
susceptibility since there is a clear, well
defined offspring toxicity NOAEL and
this study is being used to establish the
cRfD.
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
salicylaldehyde includes the battery of
acute studies, mutagenicity studies and
a combined repeated dose toxicity study
with the reproduction/developmental
toxicity screening test.
ii. There is no evidence of
neurotoxicity in the available studies,
therefore there is no need for a
developmental neurotoxicity study.
iii. There is no evidence of
immunotoxicity in the available
database, therefore there is no need for
an immunotoxicity study.
iv. There are low to no concerns for
the increased susceptibility seen in the
combined repeated dose toxicity study
with the reproduction/developmental
toxicity screening test.
v. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 14% by
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weight in the formulation (the
maximum allowable use rate) and
tolerance-level residues.
EPA made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to salicylaldehyde 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 salicylaldehyde.
E. Aggregate Risks and Determination of
Safety
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, salicylaldehyde 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 salicylaldehyde
from food and water will utilize 13% of
the cPAD for the U.S. population and
49% of the cPAD for children 1–2 years
old, the population group receiving the
greatest exposure.
3. Short- and intermediate-term risk.
Short- and intermediate-term aggregate
exposure takes into account short-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Salicylaldehyde may be used as inert
ingredients in pesticide products 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 salicylaldehyde. Using the
exposure assumptions described in this
unit, EPA has concluded the combined
short- and intermediate-term food,
water, and residential exposures result
in short- and intermediate-term
aggregate MOEs of 430 for adults and
170 for children (1–2 years old).
Because EPA’s level of concern for
salicylaldehyde is a MOE of 100 or
below, these MOEs are not of concern.
4. Aggregate cancer risk for U.S.
population. Based on a DEREK
structural alert analysis and the lack of
mutagenicity, salicylaldehyde not
expected to pose a cancer risk to
humans.
5. Determination of safety section.
Based on these risk assessments, EPA
concludes that there is reasonable
certainty that no harm will result to the
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general population, or to infants and
children from aggregate exposure to
salicylaldehyde 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. EPA
is establishing a limitation on the
amount of salicylaldehyde that may be
used in pesticide formulations applied
to growing crops. That 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
formulation for use on growing crops for
sale or distribution that exceed 14% of
salicylaldehyde.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.910 for residues
salicylaldehyde (CAS Reg. No. 90–02–8)
when used as an inert ingredient
(penetration aid) in pesticide
formulations applied to growing crops
and raw agricultural commodities after
harvest at a concentration not to exceed
crops at no more than 14% by weight
of the pesticide formulation.
VII. Statutory and Executive Order
Reviews
This action establishes an exemption
from the requirement of a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). 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
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17615
Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations
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: March 22, 2016.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.910, add alphabetically the
inert ingredient ‘‘Salicylaldehyde’’ to
the table to read as follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
*
Inert ingredients
Limits
*
*
Salicylaldehyde (CAS Reg. No. 90–
02–8).
*
*
*
*
Not to exceed 14% by weight of pesticide formulation ....................................
*
*
*
[FR Doc. 2016–07085 Filed 3–29–16; 8:45 a.m.]
BILLING CODE 6560–50–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 64
[Docket ID FEMA–2016–0002; Internal
Agency Docket No. FEMA–8429]
Suspension of Community Eligibility
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
asabaliauskas on DSK3SPTVN1PROD with RULES
AGENCY:
This rule identifies
communities where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP) that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
SUMMARY:
VerDate Sep<11>2014
16:23 Mar 29, 2016
Jkt 238001
*
Uses
*
program. If the Federal Emergency
Management Agency (FEMA) receives
documentation that the community has
adopted the required floodplain
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur and
a notice of this will be provided by
publication in the Federal Register on a
subsequent date. Also, information
identifying the current participation
status of a community can be obtained
from FEMA’s Community Status Book
(CSB). The CSB is available at https://
www.fema.gov/fema/csb.shtm.
DATES: The effective date of each
community’s scheduled suspension is
the third date (‘‘Susp.’’) listed in the
third column of the following tables.
FOR FURTHER INFORMATION CONTACT: If
you want to determine whether a
particular community was suspended
on the suspension date or for further
information, contact Patricia Suber,
Federal Insurance and Mitigation
Administration, Federal Emergency
Management Agency, 500 C Street SW.,
Washington, DC 20472, (202) 646–4149.
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
*
*
Penetration aid.
*
*
The NFIP
enables property owners to purchase
Federal flood insurance that is not
otherwise generally available from
private insurers. In return, communities
agree to adopt and administer local
floodplain management measures aimed
at protecting lives and new construction
from future flooding. Section 1315 of
the National Flood Insurance Act of
1968, as amended, 42 U.S.C. 4022,
prohibits the sale of NFIP flood
insurance unless an appropriate public
body adopts adequate floodplain
management measures with effective
enforcement measures. The
communities listed in this document no
longer meet that statutory requirement
for compliance with program
regulations, 44 CFR part 59.
Accordingly, the communities will be
suspended on the effective date in the
third column. As of that date, flood
insurance will no longer be available in
the community. We recognize that some
of these communities may adopt and
submit the required documentation of
legally enforceable floodplain
SUPPLEMENTARY INFORMATION:
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Agencies
[Federal Register Volume 81, Number 61 (Wednesday, March 30, 2016)]
[Rules and Regulations]
[Pages 17611-17615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07085]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0019; FRL-9944-12]
Salicylaldehyde; 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 salicylaldehyde (2-hydroxybenzaldehyde,
CAS Reg. No. 90-02-8) when used as an inert ingredient (penetration
aid) in pesticide formulations applied to growing crops and raw
agricultural commodities under 40 CFR 180.910 at a concentration not to
exceed 14% by weight of the pesticide formulation. Ag-Chem Consulting
LLC, on behalf of Omex Agrifluids 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 salicylaldehyde.
DATES: This regulation is effective March 30, 2016. Objections and
requests for hearings must be received on or before May 31, 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-2015-0019, is available at https://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 https://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: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2015-0019 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
May 31, 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-
[[Page 17612]]
2015-0019, by one of the following methods:
Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://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-10777) by
Ag-Chem Consulting LLC, 12208 Quinque Lane, Clifton, VA 20124 on behalf
of Omex Agrifluids, 24730 Avenue 13, Madera, CA 93637. The petition
requested that 40 CFR 180.910 be amended by establishing an exemption
from the requirement of a tolerance for residues of salicylaldehyde
(CAS Reg. No. 90-02-8) when used as an inert ingredient (penetration
aid) in pesticide formulations applied to growing crops or to raw
agricultural commodities after harvest at a concentration not to exceed
14% by weight of the pesticide formulation. That document referenced a
summary of the petition prepared by Ag-Chem Consulting LLC, on behalf
of Omex Agrifluids, the petitioner, which is available in the docket,
https://www.regulations.gov. There were no comments received in response
to the notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(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 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 salicylaldehyde including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with salicylaldehyde
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 salicylaldehyde 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.
The acute oral toxicity of salicylaldehyde was examined in male
rats and mice. The general oral lethal amount of salicylaldehyde is
estimated to be 500 mg/kg in mice. The dermal LD50 for
salicylaldehyde was determined to be greater than 23,000 mg/kg. Dermal
irritation studies found salicylaldehyde to be irritating, with eschar
formation and scarring 14 days after administration.
No adverse effects attributable to a single exposure to
salicylaldehyde were seen in the toxicity databases. In a combined
repeated dose toxicity study with the reproduction/developmental
toxicity screening test, toxicity was not observed in parental animals
nor in reproductive parameters at doses up to 160 mg/kg/day, the
highest dose tested. Fetal susceptibility was observed. Reduced
bodyweight and offspring mortality after 4 days of nursing were
observed at 160 mg/kg/day. The NOAEL was 40 mg/kg/day. There was no
evidence of neurotoxicity or immunotoxicity in the combined repeated
dose toxicity with the reproduction/developmental toxicity screening
test.
Salicylaldehyde was negative for mutagenicity in the Ames test and
gave a positive response in the chromosome aberrations test using
Chinese hamster cells (in vitro). An in vivo micronucleus assay was
negative. Since the in vivo study is more reliable than the in vitro
assays, the weight of evidence suggests that salicylaldehyde is
unlikely to be mutagenic.
There are no cancer studies available for salicylaldehyde.
According to a DEREK (Nexus) (structural activity relationship) report,
there are no structural alerts for carcinogenicity.
[[Page 17613]]
Based on predicted rapid metabolism and excretion, lack of specific
target organ toxicity in the repeat dose toxicity study, lack of
mutagenicity concerns, and lack of any structural alerts for
carcinogenicity, salicylaldehyde is not expected to be carcinogenic to
humans at anticipated dietary concentrations.
The metabolism of salicylaldehyde in rabbits demonstrated that 75%
of single dose of salicylaldehyde was excreted in the urine as
glucuronic acid and sulfate conjugates of vanillic acid.
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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
No acute toxicological endpoint of concern has been identified for
salicylaldehyde. On the basis of the repeated dose and reproductive/
developmental toxicity screening study, a no observed adverse effect
level (NOAEL) for offspring toxicity for salicylaldehyde was 40 mg/kg
bw/day based on reduced body weight and increased mortality in pups at
160 mg/kg/day. The standard 10X factors for intra- and inter-species
were applied in establishing he chronic reference dose (cRfD) of 0.4
mg/kg/day (40 mg/kg/day/100). Based on the reduced FQPA Safety Factor
for salicylaldehyde of 1X, the chronic population adjusted dose (cPAD)
is equivalent to the chronic reference dose (cRfD) at 0.4 mg/kg//day.
The chronic oral NOAEL is also applicable to the short- and
intermediate-term dermal and inhalation exposure routes.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to salicylaldehyde, EPA considered exposure under the proposed
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from salicylaldehyde in food as follows:
Acute dietary assessments take into account exposure estimates from
dietary consumption of food and drinking water. Chronic dietary
assessments take into account dietary food and drinking water. The
Agency assessed the dietary exposures to salicylaldehyde as an inert
ingredient used in pesticide formulations applied to growing crops and
livestock.
No adverse effects attributable to a single exposure to
salicylaldehyde were seen in the toxicity databases; therefore, an
acute dietary risk assessment is not appropriate.
In conducting the chronic dietary exposure assessment to
salicylaldehyde an inert ingredient used in pesticide formulations
applied to growing crops, raw agricultural commodities, and livestock,
the Dietary Exposure Evaluation Model/Food Commodity Intake Database
(DEEM-FCID) TM, Version 3.16 was used. EPA used food consumption
information from the U.S. Department of Agriculture's National Health
and Nutrition Examination Survey, What We Eat in America, (USDA/NHANES/
WWEIA). This dietary survey was conducted from 2003 to 2008. As to
residue levels in food, no residue data were submitted for
salicylaldehyde. In the absence of specific residue data, EPA has
developed an approach that 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 https://www.regulations.gov in
docket ID number EPA-HQ-OPP-2008-0738.
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 salicylaldehyde, a
conservative drinking water concentration value of 100 ppb based on
screening level modeling was used to assess the contribution to
drinking water for the chronic dietary risk assessments for parent
compound. These values were directly entered into the dietary exposure
model.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
There are no current or proposed residential uses for
salicylaldehyde; however, it is possible that salicylaldehyde may be
used as an inert ingredient in pesticide products. A highly
conservative residential exposure assessment was performed in which it
was assumed that all residential use pesticide products would contain
salicylaldehyde as an inert ingredient. A complete description of the
approach used to assess possible residential exposures from
salicylaldehyde can be found in https://www.regulations.gov in document
``Salicylaldehyde; Human Health Risk Assessment and Ecological Effects
Assessment to Support Proposed Exemption from the Requirement of a
Tolerance When Used as an Inert Ingredient in Pesticide Formulations,''
pp. 15 in docket ID number EPA-HQ-OPP-2015-0019.
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 or
exemption from 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 salicylaldehyde to share a common mechanism of
toxicity with any other substances, and salicylaldehyde does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
salicylaldehyde 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
[[Page 17614]]
https://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 evidence of
increased susceptibility of infants and children due to exposure to
salicylaldehyde. In a combined repeated dose toxicity study with the
reproduction/developmental toxicity screening test, offspring toxicity
was manifested as decreased body weights and increased mortality in the
absence of maternal toxicity at doses up to 160 mg/kg/day. The
offspring toxicity NOAEL was 40 mg/kg/day. However, there are no to low
concerns for this susceptibility since there is a clear, well defined
offspring toxicity NOAEL and this study is being used to establish the
cRfD.
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 salicylaldehyde includes the battery
of acute studies, mutagenicity studies and a combined repeated dose
toxicity study with the reproduction/developmental toxicity screening
test.
ii. There is no evidence of neurotoxicity in the available studies,
therefore there is no need for a developmental neurotoxicity study.
iii. There is no evidence of immunotoxicity in the available
database, therefore there is no need for an immunotoxicity study.
iv. There are low to no concerns for the increased susceptibility
seen in the combined repeated dose toxicity study with the
reproduction/developmental toxicity screening test.
v. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 14% by weight in the formulation (the maximum allowable use rate)
and tolerance-level residues.
EPA made conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to salicylaldehyde 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 salicylaldehyde.
E. Aggregate Risks and Determination of Safety
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,
salicylaldehyde 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
salicylaldehyde from food and water will utilize 13% of the cPAD for
the U.S. population and 49% of the cPAD for children 1-2 years old, the
population group receiving the greatest exposure.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short-term residential exposure
plus chronic exposure to food and water (considered to be a background
exposure level).
Salicylaldehyde may be used as inert ingredients in pesticide
products 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 salicylaldehyde. Using the exposure assumptions described in this
unit, EPA has concluded the combined short- and intermediate-term food,
water, and residential exposures result in short- and intermediate-term
aggregate MOEs of 430 for adults and 170 for children (1-2 years old).
Because EPA's level of concern for salicylaldehyde is a MOE of 100 or
below, these MOEs are not of concern.
4. Aggregate cancer risk for U.S. population. Based on a DEREK
structural alert analysis and the lack of mutagenicity, salicylaldehyde
not expected to pose a cancer risk to humans.
5. Determination of safety section. Based on these risk
assessments, EPA concludes that there is reasonable certainty that no
harm will result to the general population, or to infants and children
from aggregate exposure to salicylaldehyde 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. EPA is establishing a
limitation on the amount of salicylaldehyde that may be used in
pesticide formulations applied to growing crops. That 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 formulation for
use on growing crops for sale or distribution that exceed 14% of
salicylaldehyde.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for residues salicylaldehyde (CAS Reg.
No. 90-02-8) when used as an inert ingredient (penetration aid) in
pesticide formulations applied to growing crops and raw agricultural
commodities after harvest at a concentration not to exceed crops at no
more than 14% by weight of the pesticide formulation.
VII. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). 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
[[Page 17615]]
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: March 22, 2016.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.910, add alphabetically the inert ingredient
``Salicylaldehyde'' to the table to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
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Inert ingredients Limits Uses
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* * * * * * *
Salicylaldehyde (CAS Reg. No. 90-02-8). Not to exceed 14% by weight of Penetration aid.....................
pesticide formulation.
* * * * * * *
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[FR Doc. 2016-07085 Filed 3-29-16; 8:45 a.m.]
BILLING CODE 6560-50-P