Propanamide, 2-hydroxy-N, N-dimethyl- ; Exemption from the Requirement of a Tolerance, 26141-26146 [2016-10227]
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Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Rules and Regulations
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: April 25, 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 § 180.515, the table in paragraph
(a) is revised to read as follows:
■
§ 180.515 Carfentrazone-ethyl; tolerance
for residues.
(a) * * *
Parts per
million
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Commodity
Acerola ........................................
Almond, hulls ..............................
Animal feed, nongrass, crop
group 18, forage .....................
Animal feed, nongrass, crop
group 18, hay ..........................
Animal feed, nongrass, crop
group 18, seed ........................
Artichoke, globe ..........................
Asparagus ...................................
Atemoya ......................................
Avocado ......................................
Banana .......................................
Berry, low growing, subgroup
13–07G ...................................
Birida ...........................................
Bushberry subgroup 13–07B ......
Cacao bean, bean ......................
Cactus .........................................
Caneberry subgroup 13A 1 .........
Caneberry subgroup 13–07A .....
Canistel .......................................
Cattle, fat ....................................
Cattle, meat ................................
Cattle, meat byproducts .............
Cherimoya ..................................
Coffee, bean, green ....................
Cotton, gin byproducts ...............
Cotton, hulls 1 .............................
Cotton, meal 1 .............................
Cotton, refined oil 1 .....................
Cottonseed subgroup 20C .........
Custard apple .............................
Date, dried fruit ...........................
Feijoa ..........................................
Fig ...............................................
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Parts per
million
Commodity
0.10
0.20
2.0
5.0
15.0
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.1
0.10
0.10
0.10
0.10
0.10
0.10
0.10
10
0.60
0.35
1.0
0.20
0.10
0.10
0.10
0.10
Fish .............................................
Fruit, citrus, group 10–10 ...........
Fruit, pome, group 11–10 ...........
Fruit, small vine climbing, subgroup 13–07F, except Fuzzy
kiwifruit ....................................
Fruit, stone, group 12–12 ...........
Goat, fat ......................................
Goat, meat ..................................
Goat, meat byproducts ...............
Grain, aspirated grain fractions ..
Grain, cereal, group 15 (except
rice grain and sorghum grain)
Grain, cereal, group 16, forage ..
Grain, cereal, group 16, hay ......
Grain, cereal, group 16, stover ..
Grain, cereal, group 16, straw ....
Grass, forage ..............................
Grass, hay ..................................
Guava .........................................
Herbs and spices group 19 ........
Hog, fat .......................................
Hog, meat ...................................
Hog, meat byproducts ................
Hop, dried cones ........................
Horse, fat ....................................
Horse, meat ................................
Horse, meat byproducts .............
Horseradish ................................
Ilama ...........................................
Jaboticaba ..................................
Kava, roots .................................
Kiwifruit .......................................
Longan ........................................
Lychee ........................................
Mango .........................................
Milk .............................................
Noni ............................................
Nut, tree, group 14–12 ...............
Olive ............................................
Palm heart ..................................
Palm heart, leaves ......................
Papaya ........................................
Passionfruit .................................
Pawpaw ......................................
Peanut ........................................
Peanut, hay ................................
Peppermint, tops ........................
Persimmon ..................................
Pomegranate ..............................
Poultry, meat byproducts ............
Psyllium, seed ............................
Pulasan .......................................
Quinoa, grain ..............................
Rambutan ...................................
Rapeseed, forage .......................
Rapeseed subgroup 20A ............
Rice, grain ..................................
Rice, straw 1 ................................
Sapodilla .....................................
Sapote, black ..............................
Sapote, mamey ..........................
Sheep, fat ...................................
Sheep, meat ...............................
Sheep, meat byproducts ............
Shellfish ......................................
Sorghum, grain ...........................
Soursop ......................................
Soybean, seed ............................
Spanish lime ...............................
Spearmint, tops ..........................
Star apple ...................................
Starfruit .......................................
PO 00000
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0.30
0.10
0.10
0.10
0.10
0.10
0.10
0.10
1.8
0.10
1.0
0.30
0.80
3.0
5.0
8.0
0.10
2.0
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.05
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
1.3
1.0
0.10
0.10
0.10
0.10
0.10
0.10
0.30
0.25
0.10
0.10
0.10
0.10
0.10
0.10
Parts per
million
Commodity
Stevia ..........................................
Strawberrypear ...........................
Sugar apple ................................
Sugarcane ..................................
Sunflower, subgroup 20B ...........
Tea, dried ...................................
Teff, forage .................................
Teff, grain ...................................
Teff, hay ......................................
Teff, straw ...................................
Ti, leaves ....................................
Ti, roots .......................................
Vanilla .........................................
Vegetable, brassica, leafy, group
5 ..............................................
Vegetable, bulb, group 3–07 ......
Vegetable, cucurbit, group 9 ......
Vegetable, foliage of legume, except soybean, subgroup 7A ....
Vegetable, fruiting, group 8–10 ..
Vegetable, leafy, except brassica, group 4 ...........................
Vegetable, leaves of root and
tuber, group 2 .........................
Vegetable, legume, group 6 .......
Vegetable, root and tuber, group
1 ..............................................
Wasaba, roots ............................
Wax jambu ..................................
0.10
0.10
0.10
0.15
0.10
0.10
1.0
0.25
0.30
3.0
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
0.10
1 Effective Date to be removed: May 18,
2016.
*
*
*
*
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[FR Doc. 2016–10235 Filed 4–29–16; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0524; FRL–9944–10]
Propanamide, 2-hydroxy-N, Ndimethyl- ; Exemption from the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of propanamide,
2-hydroxy-N, N-dimethyl- (CAS Reg.
No. 35123–06–9) when used as an inert
ingredient (solvent/co-solvent) in
pesticides applied to growing crops and
raw agricultural commodities after
harvest under 40 CFR 180.910 or in
pesticides applied to animals under 40
CFR 180.930 limited to maximum
concentration of 20% by weight in the
pesticide formulation. Spring Trading
Company, LLC on behalf of BASF
Corporation submitted a petition to EPA
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting
establishment of an exemption from the
SUMMARY:
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Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Rules and Regulations
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of propanamide, 2-hydroxyN, N-dimethyl-.
DATES: This regulation is effective May
2, 2016. Objections and requests for
hearings must be received on or before
July 1, 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–2015–0524, 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:
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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
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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–2015–0524 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 1, 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–
2015–0524, 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 September
9, 2015 (80 FR 54257) (FRL–9933–26),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide
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petition (PP IN–10782) by Spring
Trading Company, LLC (10805 W.
Timberwagon Circle Spring, TX 77380)
on behalf of BASF Corporation (100
Campus Drive, Florham Park, NJ 07932).
The petition requested that 40 CFR
180.910 and 40 CFR 180.930 be
amended by establishing exemptions
from the requirement of a tolerance for
residues of propanamide, 2-hydroxy-N,
N-dimethyl- (CAS Reg. No. 35123–06–9)
when used as an inert ingredient
(solvent/co-solvent) in pesticide
formulations applied to growing crops
and raw agricultural commodities after
harvest or in pesticides applied to
animals, respectively. That document
referenced a summary of the petition
prepared by Spring Trading Company,
LLC on behalf of BASF Corporation, the
petitioner, which is available in the
docket, https://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 limited
the maximum concentration of
propanamide, 2-hydroxy-N, N-dimethyl
to 20% by weight in pesticide
formulations. The reasons for this
change are explained in Unit V.B.
below.
III. Inert Ingredient Definition
Inert ingredients are all ingredients
that are not active ingredients as defined
in 40 CFR 153.125 and include, but are
not limited to, the following types of
ingredients (except when they have a
pesticidal efficacy of their own):
Solvents such as alcohols and
hydrocarbons; surfactants such as
polyoxyethylene polymers and fatty
acids; carriers such as clay and
diatomaceous earth; thickeners such as
carrageenan and modified cellulose;
wetting, spreading, and dispersing
agents; propellants in aerosol
dispensers; microencapsulating agents;
and emulsifiers. The term ‘‘inert’’ is not
intended to imply nontoxicity; the
ingredient may or may not be
chemically active. Generally, EPA has
exempted inert ingredients from the
requirement of a tolerance based on the
low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and
Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
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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 propanamide, 2hydroxy-N, N-dimethyl- including
exposure resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with propanamide, 2hydroxy-N, N-dimethyl- 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
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the nature of the adverse effects caused
by propanamide, 2-hydroxy-N, Ndimethyl- as well as the no-observedadverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies are
discussed in this unit.
Propanamide, 2-hydroxy-N, Ndimethyl- is of low acute oral, dermal
and inhalation toxicity in rats; all lethal
dose (LD)50s are greater than 1,000 mg/
kg. Dermal irritation is not observed in
rabbits. It is mildly irritating to the eyes
of rabbits. It is not a dermal sensitizer
in mice in the lymph node assay.
The toxicity studies summarized
below were all conducted with
propanamide, 2-hydroxy-N, N-dimethylexcept the chronic toxicity study. That
study was conducted with N, Ndimethylacetamide, a structurally
similar chemical. The only difference
between the two chemicals is that N, Ndimethylacetamide is missing a
hydroxyl group on a carbon atom. Both
compounds are expected to undergo
similar metabolism (in this case, Noxidation) by cytochrome P450 enzymes
and have similar toxicological profiles;
therefore, the Agency has determined
the data to be suitable for evaluating
propanamide.
In rats, 90 days of oral exposure to
propanamide, 2-hydroxy-N, N-dimethylresults in increased cholesterol and
triglyceride levels, increased liver
weights and centrilobular hypertrophy
at 1,000 milligrams/kilogram/day (mg/
kg/day), the limit dose. The NOAEL is
500 mg/kg/day. Reproduction
parameters, estrus cyclicity and sperm
parameters were also evaluated in this
study and were found to be unaffected
at 1,000 mg/kg/day.
A developmental toxicity study in rats
showed no maternal toxicity at 500 mg/
kg/day, the highest dose tested.
Quantitative fetal susceptibility was
observed as reduced body weight in
pups at 500 mg/kg/day. The
developmental NOAEL was 200 mg/kg/
day.
Propanamide, 2-hydroxy-N, Ndimethyl- was not mutagenic in the
Chinese hamster ovary (CHO) cells
HGPRT locus gene mutation assay or the
micronucleus test.
Propanamide, 2-hydroxy-N, Ndimethyl- is not expected to be
carcinogenic based on the absence of
structural alerts using Deductive
Estimation of Risk from Existing
Knowledge (Derek) Nexus program and
the lack of mutagenicity. It is not
expected to be neurotoxic based on the
functional observation battery or on
motor activity in the 90-day oral toxicity
study in rats.
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26143
Immunotoxicity studies for
propanamide, 2-hydroxy-N, N-dimethylwere not available for review. However,
evidence of immunotoxicity was not
observed in the submitted studies.
Chronic studies with propanamide,
2-hydroxy-N, N-dimethyl- are not
available for review. However, a chronic
study conducted for 12 months in rats
treated with N, N-dimethylacetamide, a
structurally similar chemical, was used
as surrogate data. In this study toxicity
manifested as reduced bodyweight was
observed at 300 mg/kg/day. The NOAEL
is 100 mg/kg/day.
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.
An acute effect was not found in the
database therefore an acute dietary
assessment is not necessary. The
chronic reference dose (cRfD) as well as
the toxicity endpoint applicable to all
exposure scenarios was based on the 12month chronic toxicity study in rats. In
this study, the NOAEL was 100 mg/kg/
day based on reduced bodyweights at
300 mg/kg/day, the LOAEL. This
represents the lowest NOAEL in the
most sensitive species in the toxicity
database. The standard uncertainty
factors were applied to account for
interspecies (10x) and intraspecies (10x)
variations. The Food Quality Protection
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Act Safety Factor (FQPA SF) was
reduced to 1x. Default values of 100%
absorption were used in dermal and
inhalation toxicity endpoint selection.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to propanamide, 2-hydroxy-N,
N-dimethyl-, EPA considered exposure
under the proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from
propanamide, 2-hydroxy-N, N-dimethylin food as follows:
Dietary exposure (food and drinking
water) to propanamide, 2-hydroxy-N, Ndimethyl- can occur following ingestion
of foods with residues from treated
crops and animals. Because no adverse
effects attributable to a single exposure
of propanamide, 2-hydroxy-N, Ndimethyl- are seen in the toxicity
databases, an acute dietary risk
assessment is not necessary. For the
chronic dietary risk assessment, EPA
used the Dietary Exposure Evaluation
Model software with the Food
Commodity Intake Database (DEEM–
FCIDTM, Version 3.16, and food
consumption information from the U.S.
Department of Agriculture’s (USDA’s)
2003–2008 National Health and
Nutrition Examination Survey, What We
Eat in America (NHANES/WWEIA). As
to residue levels in food, no residue data
were submitted for propanamide, 2hydroxy-N, N-dimethyl-. In the absence
of specific residue data, EPA has
developed an approach which uses
surrogate information to derive upper
bound exposure estimates for the
subject inert ingredient. Upper bound
exposure estimates are based on the
highest tolerance for a given commodity
from a list of high use insecticides,
herbicides, and fungicides. One
hundred percent crop treated (PCT) was
assumed, default processing factors, and
tolerance-level residues for all foods and
use limitations of not more than 20% by
weight in pesticide formulations. 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 screeninglevel dietary risk assessment to support
this request for an exemption from the
requirement of a tolerance for
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propanamide, 2-hydroxy-N, Ndimethyl-, a conservative drinking water
concentration value of 100 parts per
billion (ppb) based on screening level
modeling was used to assess the
contribution to drinking water for the
chronic dietary risk assessments for
parent compound. These values were
directly entered into the dietary
exposure model.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables).
Propanamide, 2-hydroxy-N, Ndimethyl- may be used in inert
ingredients in products that are
registered for specific uses that may
result in residential exposure, such as
pesticides used in and round the home.
The Agency conducted an assessment to
represent worst-case residential
exposure by assessing propanamide, 2hydroxy-N, N-dimethyl- in pesticide
formulations (outdoor scenarios) and in
disinfectant-type uses (indoor
scenarios).
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 propanamide, 2hydroxy-N, N-dimethyl- to share a
common mechanism of toxicity with
any other substances, and propanamide,
2-hydroxy-N, N-dimethyl- does not
appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that
propanamide, 2-hydroxy-N, N-dimethyldoes 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
https://www.epa.gov/pesticides/
cumulative.
D. Safety Factor for Infants and
Children
Section 408(b)(2)(C) of FFDCA
provides that EPA shall apply an
additional tenfold (10X) margin of safety
for infants and children in the case of
threshold effects to account for prenatal
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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 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.
The toxicity database for
propanamide, 2-hydroxy-N, N-dimethylcontains a subchronic, developmental,
chronic and mutagenicity studies. There
is no indication of neurotoxicity or
immunotoxicity in the available studies;
therefore, there is no need to require
neurotoxicity or immunotoxicity
studies. Quantitative fetal susceptibility
was observed in the developmental
study in rats. Fetal toxicity (reduced
bodyweight) was observed at 500 mg/
kg/day, the highest dose tested, while
toxicity was not observed in maternal
animals. The developmental NOAEL
was 200 mg/kg/day. However, fetal
effects are not of concern since the cRfD
(1mg/kg/day) will be protective of
effects seen at 500 mg/kg/day. In
addition, the Agency used conservative
exposure estimates, with 100 PCT,
tolerance-level residues, conservative
drinking water modeling numbers, and
a worst-case assessment of potential
residential exposure for infants and
children. Based on the adequacy of the
toxicity and exposure databases and the
lack of concern for prenatal and
postnatal sensitivity, the Agency has
concluded that there is reliable data to
determine that infants and children will
be safe if the FQPA SF of 10x is reduced
to 1x.
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
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and no acute dietary endpoint was
selected.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to propanamide,
2-hydroxy-N, N-dimethyl- from food
and water will utilize 28.4% of the
cPAD for children 1–2 years old, the
population group receiving the greatest
exposure.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
Propanamide, 2-hydroxy-N, Ndimethyl- may be used as an inert
ingredient 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 propanamide, 2-hydroxyN, N-dimethyl-. Using the exposure
assumptions described above, EPA has
concluded that the combined short-term
aggregated food, water, and residential
exposures result in MOEs of 115 for
both adult males and females. Adult
residential exposure combines high-end
dermal and inhalation handler exposure
from liquids/trigger sprayer/home
garden with a high-end postapplication dermal exposure from
contact with treated lawns. Adult
residential exposure combines high-end
dermal and inhalation handler exposure
from liquids/trigger sprayer/home
garden with a high-end postapplication dermal exposure from
contact with treated lawns. EPA has
concluded the combined short-term
aggregated food, water, and residential
exposures result in an aggregate MOE of
154 for children. Children’s residential
exposure includes total exposures
associated with contact with treated
lawns (dermal and hand-to-mouth
exposures). As the level of concern is for
MOEs that are lower than 100, these
MOEs are not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Propanamide, 2-hydroxy-N, Ndimethyl- may be used as an inert
ingredient in pesticide products 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 intermediate-term
residential exposures to propanamide,
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2-hydroxy-N, N-dimethyl-. Using the
exposure assumptions described above,
EPA has concluded that the combined
intermediate-term aggregated food,
water, and residential exposures result
in aggregate MOEs of 591 for adult
males and females. Adult residential
exposure combines indoor hard surface,
wiping with a high-end post-application
dermal exposure from contact with
treated lawns. As the level of concern is
for MOEs that are lower than 100, this
MOE is not of concern. EPA has
concluded the combined intermediateterm aggregated food, water, and
residential exposures result in an
aggregate MOE of 214 for children.
Children’s residential exposure includes
total exposures associated with contact
with treated surfaces (dermal and handto-mouth exposures). As the level of
concern is for MOEs that are lower than
100, this MOE is not of concern.
5. Aggregate cancer risk for U.S.
population. Based on a DEREK
structural alert analysis, the lack of
mutagenicity and the lack of specific
organ toxicity in the chronic toxicity
study, propanamide, 2-hydroxy-N, Ndimethyl- is not expected to pose a
cancer risk to humans.
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
propanamide, 2-hydroxy-N, Ndimethyl-.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is not establishing a numerical
tolerance for residues of propanamide,
2-hydroxy-N, N-dimethyl- in or on any
food commodities. EPA is establishing a
limitation on the amount of
propanamide, 2-hydroxy-N, N-dimethylthat 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 exceeds 20% by weight of
propanamide, 2-hydroxy-N, Ndimethyl-.
B. Revisions to Petitioned-For Tolerance
Exemptions
Based upon an evaluation of the data
included in the petition, EPA is
establishing an exemption from the
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26145
requirement of a tolerance for residues
of propanamide, 2-hydroxy-N, Ndimethyl when used in pesticide
formulations as an inert ingredient
(solvent/co-solvent), not to exceed 20%
by weight of the formulation, instead of
the unlimited use requested. When
considering unlimited use resulted in
aggregate risks of concern, the petitioner
revised their request to seek a 20%
limitation by weight of formulation. The
basis for this revision can be found at
https://www.regulations.gov in document
‘‘Propanamide, 2-hydroxy-N, Ndimethyl-; 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’’ in
docket ID number EPA–HQ–OPP–2015–
0524.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.910 for residues of
propanamide, 2-hydroxy-N, N-dimethyl(Reg. No. 35123–06–9) when used as an
inert ingredient (solvent/co-solvent) at a
maximum concentration of 20% by
weight in pesticide formulations
applied to growing crops or raw
agricultural commodities after harvest
and under 40 CFR 180.930 when used
in pesticide formulations applied to
animals.
VII. Statutory and Executive Order
Reviews
This action establishes exemptions to
the requirement for 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
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Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the exemptions in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
*
*
*
Propanamide, 2-hydroxy-N, N-dimethyl- (CAS Reg. No. 35123–06–9)
*
*
3. In § 180.930, add alphabetically the
inert ingredient to the table to read as
follows:
■
*
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
2. In § 180.910, add alphabetically the
inert ingredient to the table to read as
follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
*
*
*
*
*
*
*
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*
*
Limits
*
*
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*
Solvent/co-solvent.
Uses
*
*
Not to exceed 20% by weight in
pesticide formulation.
*
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Solvent/co-solvent
*
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*
Uses
[FR Doc. 2016–10227 Filed 4–29–16; 8:45 am]
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*
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
*
*
Therefore, 40 CFR chapter I is
amended as follows:
Not to exceed 20% by weight in
pesticide formulation.
*
Propanamide, 2-hydroxy-N, N-dimethyl- (CAS Reg. No. 35123–06–9)
*
Dated: April 21, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
*
Inert ingredients
*
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Limits
*
*
List of Subjects in 40 CFR Part 180
Authority: 21 U.S.C. 321(q), 346a and 371.
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
Inert ingredients
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
02MYR1
*
]]>Agencies
[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)]
[Rules and Regulations]
[Pages 26141-26146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10227]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0524; FRL-9944-10]
Propanamide, 2-hydroxy-N, N-dimethyl- ; 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 propanamide, 2-hydroxy-N, N-dimethyl-
(CAS Reg. No. 35123-06-9) when used as an inert ingredient (solvent/co-
solvent) in pesticides applied to growing crops and raw agricultural
commodities after harvest under 40 CFR 180.910 or in pesticides applied
to animals under 40 CFR 180.930 limited to maximum concentration of 20%
by weight in the pesticide formulation. Spring Trading Company, LLC on
behalf of BASF Corporation submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment
of an exemption from the
[[Page 26142]]
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of propanamide, 2-
hydroxy-N, N-dimethyl-.
DATES: This regulation is effective May 2, 2016. Objections and
requests for hearings must be received on or before July 1, 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-2015-0524, 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-2015-0524 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 1, 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-2015-0524, 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 September 9, 2015 (80 FR 54257) (FRL-
9933-26), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10782) by Spring Trading Company, LLC (10805 W. Timberwagon Circle
Spring, TX 77380) on behalf of BASF Corporation (100 Campus Drive,
Florham Park, NJ 07932). The petition requested that 40 CFR 180.910 and
40 CFR 180.930 be amended by establishing exemptions from the
requirement of a tolerance for residues of propanamide, 2-hydroxy-N, N-
dimethyl- (CAS Reg. No. 35123-06-9) when used as an inert ingredient
(solvent/co-solvent) in pesticide formulations applied to growing crops
and raw agricultural commodities after harvest or in pesticides applied
to animals, respectively. That document referenced a summary of the
petition prepared by Spring Trading Company, LLC on behalf of BASF
Corporation, the petitioner, which is available in the docket, https://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
limited the maximum concentration of propanamide, 2-hydroxy-N, N-
dimethyl to 20% by weight in pesticide formulations. The reasons for
this change are explained in Unit V.B. below.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will
[[Page 26143]]
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 propanamide, 2-hydroxy-N, N-
dimethyl- including exposure resulting from the exemption established
by this action. EPA's assessment of exposures and risks associated with
propanamide, 2-hydroxy-N, N-dimethyl- 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 propanamide, 2-hydroxy-N, N-dimethyl-
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.
Propanamide, 2-hydroxy-N, N-dimethyl- is of low acute oral, dermal
and inhalation toxicity in rats; all lethal dose (LD)50s are
greater than 1,000 mg/kg. Dermal irritation is not observed in rabbits.
It is mildly irritating to the eyes of rabbits. It is not a dermal
sensitizer in mice in the lymph node assay.
The toxicity studies summarized below were all conducted with
propanamide, 2-hydroxy-N, N-dimethyl- except the chronic toxicity
study. That study was conducted with N, N-dimethylacetamide, a
structurally similar chemical. The only difference between the two
chemicals is that N, N-dimethylacetamide is missing a hydroxyl group on
a carbon atom. Both compounds are expected to undergo similar
metabolism (in this case, N-oxidation) by cytochrome P450 enzymes and
have similar toxicological profiles; therefore, the Agency has
determined the data to be suitable for evaluating propanamide.
In rats, 90 days of oral exposure to propanamide, 2-hydroxy-N, N-
dimethyl- results in increased cholesterol and triglyceride levels,
increased liver weights and centrilobular hypertrophy at 1,000
milligrams/kilogram/day (mg/kg/day), the limit dose. The NOAEL is 500
mg/kg/day. Reproduction parameters, estrus cyclicity and sperm
parameters were also evaluated in this study and were found to be
unaffected at 1,000 mg/kg/day.
A developmental toxicity study in rats showed no maternal toxicity
at 500 mg/kg/day, the highest dose tested. Quantitative fetal
susceptibility was observed as reduced body weight in pups at 500 mg/
kg/day. The developmental NOAEL was 200 mg/kg/day.
Propanamide, 2-hydroxy-N, N-dimethyl- was not mutagenic in the
Chinese hamster ovary (CHO) cells HGPRT locus gene mutation assay or
the micronucleus test.
Propanamide, 2-hydroxy-N, N-dimethyl- is not expected to be
carcinogenic based on the absence of structural alerts using Deductive
Estimation of Risk from Existing Knowledge (Derek) Nexus program and
the lack of mutagenicity. It is not expected to be neurotoxic based on
the functional observation battery or on motor activity in the 90-day
oral toxicity study in rats.
Immunotoxicity studies for propanamide, 2-hydroxy-N, N-dimethyl-
were not available for review. However, evidence of immunotoxicity was
not observed in the submitted studies.
Chronic studies with propanamide, 2-hydroxy-N, N-dimethyl- are not
available for review. However, a chronic study conducted for 12 months
in rats treated with N, N-dimethylacetamide, a structurally similar
chemical, was used as surrogate data. In this study toxicity manifested
as reduced bodyweight was observed at 300 mg/kg/day. The NOAEL is 100
mg/kg/day.
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.
An acute effect was not found in the database therefore an acute
dietary assessment is not necessary. The chronic reference dose (cRfD)
as well as the toxicity endpoint applicable to all exposure scenarios
was based on the 12-month chronic toxicity study in rats. In this
study, the NOAEL was 100 mg/kg/day based on reduced bodyweights at 300
mg/kg/day, the LOAEL. This represents the lowest NOAEL in the most
sensitive species in the toxicity database. The standard uncertainty
factors were applied to account for interspecies (10x) and intraspecies
(10x) variations. The Food Quality Protection
[[Page 26144]]
Act Safety Factor (FQPA SF) was reduced to 1x. Default values of 100%
absorption were used in dermal and inhalation toxicity endpoint
selection.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to propanamide, 2-hydroxy-N, N-dimethyl-, EPA considered
exposure under the proposed exemption from the requirement of a
tolerance. EPA assessed dietary exposures from propanamide, 2-hydroxy-
N, N-dimethyl- in food as follows:
Dietary exposure (food and drinking water) to propanamide, 2-
hydroxy-N, N-dimethyl- can occur following ingestion of foods with
residues from treated crops and animals. Because no adverse effects
attributable to a single exposure of propanamide, 2-hydroxy-N, N-
dimethyl- are seen in the toxicity databases, an acute dietary risk
assessment is not necessary. For the chronic dietary risk assessment,
EPA used the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCIDTM, Version 3.16, and
food consumption information from the U.S. Department of Agriculture's
(USDA's) 2003-2008 National Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEIA). As to residue levels in food, no
residue data were submitted for propanamide, 2-hydroxy-N, N-dimethyl-.
In the absence of specific residue data, EPA has developed an approach
which uses surrogate information to derive upper bound exposure
estimates for the subject inert ingredient. Upper bound exposure
estimates are based on the highest tolerance for a given commodity from
a list of high use insecticides, herbicides, and fungicides. One
hundred percent crop treated (PCT) was assumed, default processing
factors, and tolerance-level residues for all foods and use limitations
of not more than 20% by weight in pesticide formulations. 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 propanamide, 2-
hydroxy-N, N- dimethyl-, a conservative drinking water concentration
value of 100 parts per billion (ppb) based on screening level modeling
was used to assess the contribution to drinking water for the chronic
dietary risk assessments for parent compound. These values were
directly entered into the dietary exposure model.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
Propanamide, 2-hydroxy-N, N-dimethyl- may be used in inert
ingredients in products that are registered for specific uses that may
result in residential exposure, such as pesticides used in and round
the home. The Agency conducted an assessment to represent worst-case
residential exposure by assessing propanamide, 2-hydroxy-N, N-dimethyl-
in pesticide formulations (outdoor scenarios) and in disinfectant-type
uses (indoor scenarios).
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 propanamide, 2-hydroxy-N, N-dimethyl- to share a
common mechanism of toxicity with any other substances, and
propanamide, 2-hydroxy-N, N-dimethyl- does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that propanamide, 2-
hydroxy-N, N-dimethyl- 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 https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for 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 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.
The toxicity database for propanamide, 2-hydroxy-N, N-dimethyl-
contains a subchronic, developmental, chronic and mutagenicity studies.
There is no indication of neurotoxicity or immunotoxicity in the
available studies; therefore, there is no need to require neurotoxicity
or immunotoxicity studies. Quantitative fetal susceptibility was
observed in the developmental study in rats. Fetal toxicity (reduced
bodyweight) was observed at 500 mg/kg/day, the highest dose tested,
while toxicity was not observed in maternal animals. The developmental
NOAEL was 200 mg/kg/day. However, fetal effects are not of concern
since the cRfD (1mg/kg/day) will be protective of effects seen at 500
mg/kg/day. In addition, the Agency used conservative exposure
estimates, with 100 PCT, tolerance-level residues, conservative
drinking water modeling numbers, and a worst-case assessment of
potential residential exposure for infants and children. Based on the
adequacy of the toxicity and exposure databases and the lack of concern
for prenatal and postnatal sensitivity, the Agency has concluded that
there is reliable data to determine that infants and children will be
safe if the FQPA SF of 10x is reduced to 1x.
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
[[Page 26145]]
and no acute dietary endpoint was selected.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
propanamide, 2-hydroxy-N, N-dimethyl- from food and water will utilize
28.4% of the cPAD for children 1-2 years old, the population group
receiving the greatest exposure.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Propanamide, 2-hydroxy-N, N-dimethyl- may be used as an inert
ingredient 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 propanamide, 2-hydroxy-N, N-
dimethyl-. Using the exposure assumptions described above, EPA has
concluded that the combined short-term aggregated food, water, and
residential exposures result in MOEs of 115 for both adult males and
females. Adult residential exposure combines high-end dermal and
inhalation handler exposure from liquids/trigger sprayer/home garden
with a high-end post- application dermal exposure from contact with
treated lawns. Adult residential exposure combines high-end dermal and
inhalation handler exposure from liquids/trigger sprayer/home garden
with a high-end post- application dermal exposure from contact with
treated lawns. EPA has concluded the combined short-term aggregated
food, water, and residential exposures result in an aggregate MOE of
154 for children. Children's residential exposure includes total
exposures associated with contact with treated lawns (dermal and hand-
to-mouth exposures). As the level of concern is for MOEs that are lower
than 100, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Propanamide, 2-hydroxy-N, N-dimethyl- may be used as an inert
ingredient in pesticide products 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
intermediate-term residential exposures to propanamide, 2-hydroxy-N, N-
dimethyl-. Using the exposure assumptions described above, EPA has
concluded that the combined intermediate-term aggregated food, water,
and residential exposures result in aggregate MOEs of 591 for adult
males and females. Adult residential exposure combines indoor hard
surface, wiping with a high-end post-application dermal exposure from
contact with treated lawns. As the level of concern is for MOEs that
are lower than 100, this MOE is not of concern. EPA has concluded the
combined intermediate-term aggregated food, water, and residential
exposures result in an aggregate MOE of 214 for children. Children's
residential exposure includes total exposures associated with contact
with treated surfaces (dermal and hand-to-mouth exposures). As the
level of concern is for MOEs that are lower than 100, this MOE is not
of concern.
5. Aggregate cancer risk for U.S. population. Based on a DEREK
structural alert analysis, the lack of mutagenicity and the lack of
specific organ toxicity in the chronic toxicity study, propanamide, 2-
hydroxy-N, N-dimethyl- is not expected to pose a cancer risk to humans.
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 propanamide, 2-hydroxy-N, N- dimethyl-.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
propanamide, 2-hydroxy-N, N-dimethyl- in or on any food commodities.
EPA is establishing a limitation on the amount of propanamide, 2-
hydroxy-N, N-dimethyl- 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 exceeds 20% by weight of propanamide, 2-
hydroxy-N, N- dimethyl-.
B. Revisions to Petitioned-For Tolerance Exemptions
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 propanamide, 2-hydroxy-N, N-dimethyl when used in pesticide
formulations as an inert ingredient (solvent/co-solvent), not to exceed
20% by weight of the formulation, instead of the unlimited use
requested. When considering unlimited use resulted in aggregate risks
of concern, the petitioner revised their request to seek a 20%
limitation by weight of formulation. The basis for this revision can be
found at https://www.regulations.gov in document ``Propanamide, 2-
hydroxy-N, N-dimethyl-; 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'' in docket ID number EPA-HQ-OPP-2015-0524.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for residues of propanamide, 2-
hydroxy-N, N-dimethyl- (Reg. No. 35123-06-9) when used as an inert
ingredient (solvent/co-solvent) at a maximum concentration of 20% by
weight in pesticide formulations applied to growing crops or raw
agricultural commodities after harvest and under 40 CFR 180.930 when
used in pesticide formulations applied to animals.
VII. Statutory and Executive Order Reviews
This action establishes exemptions to the requirement for 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
[[Page 26146]]
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemptions in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 21, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.910, add alphabetically the inert ingredient to the
table to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Propanamide, 2-hydroxy-N, N- Not to exceed 20% Solvent/co-
dimethyl- (CAS Reg. No. 35123- by weight in solvent.
06-9). pesticide
formulation.
* * * * * * *
------------------------------------------------------------------------
0
3. In Sec. 180.930, add alphabetically the inert ingredient to the
table to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Propanamide, 2-hydroxy-N, N- Not to exceed 20% Solvent/co-solvent
dimethyl- (CAS Reg. No. 35123- by weight in
06-9). pesticide
formulation.
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2016-10227 Filed 4-29-16; 8:45 am]
BILLING CODE 6560-50-P
