[Federal Register Volume 76, Number 217 (Wednesday, November 9, 2011)]
[Rules and Regulations]
[Pages 69636-69642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-28643]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0093; FRL-8890-8]
Amides, C5-C9, N-[3-(dimethylamino)propyl]
and amides, C6-C12, N-[3-(dimethylamino)propyl];
Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of amides, C5-C9, N-
[3-(dimethylamino)propyl]; (CAS Reg. No. 1044764-00-2) and amides,
C6-C12, N-[3-(dimethylamino)propyl]; (CAS Reg.
No. 1044764-06-8) when used as inert ingredients (surfactants) in
pesticide formulations applied to growing crops and raw agricultural
commodities after harvest. Monsanto Company 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 amides, C5-C9, N-[3-
(dimethylamino)propyl]; (CAS Reg. No. 1044764-00-2) and amides,
C6-C12, N-[3-(dimethylamino)propyl]; (CAS Reg.
No. 1044764-06-8).
DATES: This regulation is effective November 9, 2011. Objections and
requests for hearings must be received on or before January 9, 2012,
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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2011-0093. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Deirdre Sunderland, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 603-0851; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
[[Page 69637]]
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.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How can I get electronic sccess to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the harmonized test guidelines referenced in
this document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0093 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
January 9, 2012. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0093, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Exemption
In the Federal Register of March 29, 2011 (76 FR 17374) (FRL-8867-
4), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 0E7815) by
Monsanto Company, 1300 I Street NW., Suite 450 East, Washington, DC
20005. The petition requested that 40 CFR 180.910 be amended by
establishing an exemption from the requirement of a tolerance for
residues of amides, C5-C9, N-[3-(dimethylamino)
propyl]; (CAS Reg. No. 1044764-00-2) and amides, C6-
C12, N-[3-(dimethylamino) propyl]; (CAS Reg. No. 1044764-06-
8) when used as an inert ingredient (surfactants) in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest. That notice referenced a summary of the petition
prepared by Monsanto Company, the petitioner, which is available in the
docket, http://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 tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. * * *
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
[[Page 69638]]
Consistent with section 408(c)(2)(A) of FFDCA, 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 amides, C5-
C9, N-[3-(dimethylamino) propyl] and amides, C6-
C12, N-[3-(dimethylamino) propyl] including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with amides,
C5-C9, N-[3-(dimethylamino) propyl] and amides,
C6-C12, N-[3-(dimethylamino) propyl] 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 amides, C5-C9,
N-[3-(dimethylamino) propyl] and amides, C6-C12,
N-[3-(dimethylamino) propyl] 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.
Acute studies revealed low oral and dermal toxicity (OPPTS
Harmonized Test Guidelines 870.1100 and 870.1200). When tested on
rabbits, the chemical was shown to be mildly irritating to the skin and
severely irritating to the eyes (OPPTS 870.2500 and 870.2400). Skin
sensitization studies in guinea pigs showed that amides, C5-
C9, N-[3-(dimethylamino) propyl] was not a skin sensitizer
(OPPTS 870.2600).
Several repeat dose studies were conducted on amides,
C5-C9, N-[3-(dimethylamino) propyl] (OPPTS
870.3050 and 870.3700). A 28-day range finding study on rats showed no
evidence of toxicity at doses up to 300 milligrams/kilograms/day (mg/
kg/day). Systemic toxicity (e.g., lower body weight gain, food
consumption, and effects on red blood cells) were noted at 800 and
1,000 mg/kg/day. Females in the 800 mg/kg/day group also had lower
organ weights of the liver, spleen, and thymus.
A second range finding study administered the test substance to
female rats on gestation days 6-19. All females in the 1,000 mg/kg/day
group were found dead or euthanized in extremis by gestation day 8. In
the 500 mg/kg/day group, two females were euthanized in extremis.
Females in this group exhibited clinical signs of toxicity (e.g.,
rales, increased respiration, gasping, dilated pupils, salivation, and
body weight gains). There were no test-substance related clinical
findings noted up to150 mg/kg/day. Intrauterine growth and survival
were unaffected at dose levels up to 500 mg/kg/day. No external
malformations or developmental variations were noted in this study. The
maternal and developmental NOAELs for this study were 150 and 500 mg/
kg/day, respectively.
A dietary combined 90-day/Reproductive and Developmental Toxicity
Screening study in rats did not show evidence of toxicity at exposures
up to 175 mg/kg/day (OPPTS 870.3650/3100). At the high-dose (600 mg/kg/
day), systemic toxicity was exhibited by clinical findings, lower mean
body weights, body weight gains, and food consumption for males,
toxicology phase females, and reproductive phase females. Lower ovary,
uterus, and pituitary weights were noted for the 600 mg/kg/day
reproductive phase females. In addition, lower litter size, number of
pups born, implantation sites, and mean pup body weights were noted in
the 600 mg/kg/day group in the presence of excessive maternal toxicity.
Therefore, the systemic, reproductive, and developmental NOAELs were
considered to be 175 mg/kg/day.
No carcinogenicity studies are available for the inert ingredients
amides, C5-C9, N-[3-(dimethylamino) propyl] and
amides, C6-C12, N-[3-(dimethylamino) propyl]. The
Agency used a qualitative structure activity relationship (SAR)
database (i.e., DEREK Version 11) to determine if there were structural
alerts suggestive of carcinogenicity. No structural alerts were
identified for the parent nor its potential major metabolite
dimethylaminopropylamine (DMAPA). Based on these results and the
negative findings in both the mutagenicity (OPPTS 870.5100) and
clastogenicity (OPPTS 870.5395) studies along with the lack of evidence
of specific target organ toxicity, the Agency concluded that these
inert ingredients have low potential to be carcinogenic.
Functional observational battery (home cage, handling, open field,
neuromuscular, and physiological observations) and locomotor activity
(no remarkable shifts in the pattern of habituation) were recorded for
Sprague-Dawley rats treated with 600 mg/kg/day of the test substance
and no test-related effects were observed. Although possible evidence
of neurotoxicity was observed in the OPPTS 870.3700 study at 500 mg/kg/
day (dilated pupils) and 1,000 mg/kg/day (dilated pupils and clonic
convulsions) these clinical signs were considered to be due to
generalized toxicity and not of neurologic origin. The Point of
Departure (POD) of 175 mg/kg/day used in this risk assessment is
protective of the effects seen at these dose levels.
The proposed primary route of metabolism is believed to generate
DMAPA which is marketed as an inert ingredient in pesticide
formulations. DMAPA (as an inert) has been recently evaluated by the
Agency and an exemption from tolerance under 40 CFR 180.920 and 180.930
was established.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological PODs and levels of concern to use in
evaluating the risk posed by human exposure to the pesticide. For
hazards that have a threshold below which there is no appreciable risk,
the toxicological POD is used as the basis for derivation of reference
values for risk assessment. PODs are developed based on a careful
analysis of the doses in each toxicological study to determine the dose
at which no adverse effects are observed (the NOAEL) and the lowest
dose at which adverse effects of concern are identified (the LOAEL).
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
The POD used in the risk assessment for short-term, intermediate-
term, and chronic routes of exposure (i.e., oral, dermal, and
inhalation) was from the OPPTS Harmonized Test Guideline 870.3650
toxicity study in rats. The NOAEL is 175 mg/kg/day and the LOAEL is 600
mg/kg/day based on body weight decreases and food consumption for both
sexes and lower absolute and
[[Page 69639]]
relative-to-brain ovary, uterus, and pituitary weights for the
reproductive phase females. A 100 fold uncertainty factor was used for
the chronic exposure (10X interspecies extrapolation, 10X for
intraspecies variability and 1X Food Quality Protection Act (FQPA)
factor).
The residential, occupational, and aggregate level of concern (LOC)
is for MOEs that are less than 100 and is based on 10X interspecies
extrapolation, 10X for intraspecies variability and 1X FQPA factor.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to amides, C5-C9, N-[3-(dimethylamino)
propyl] and amides, C6-C12, N-[3-(dimethylamino)
propyl], EPA considered exposure under the proposed exemption from the
requirement of a tolerance. EPA assessed dietary exposures from amides,
C5-C9, N-[3-(dimethylamino) propyl] and amides,
C6-C12, N-[3-(dimethylamino) propyl] in food as
follows:
The I-Dietary Exposure Evaluation Model (DEEM) is a highly
conservative model with the assumption that the residue level of the
inert ingredient would be no higher than the highest tolerance for a
given commodity. Implicit in this assumption is that there would be
similar rates of degradation between the active and inert ingredient
(if any) and that the concentration of inert ingredient in the
scenarios leading to these highest of tolerances would be no higher
than the concentration of the active ingredient. The model assumes 100
percent crop treated (PCT) for all crops (every food eaten by a person
each day has tolerance-level residues).
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 amides,
C5-C9, N-[3-(dimethylamino) propyl] and amides,
C6-C12, N-[3-(dimethylamino) propyl], a
conservative drinking water concentration value of 100 parts per
billion 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).
These inerts may potentially be added to pesticide formulations
that are used around the home (i.e., fungicides/insecticides/
herbicides). Although there are no known or anticipated residential
uses for these inert ingredients, in order to be protective of any
future uses, a screening level exposure assessment was performed using
high-end exposure scenarios for outdoor residential uses. The Agency
selected representative scenarios, based on end-use product application
methods and labeled application rates.
The mixer/loader/applicator high exposure outdoor scenarios
evaluated were Liquid products: Low Pressure Handwand; Liquid products:
Hose End Sprayer; and Ready to Use (RTU): Trigger Pump Sprayer
Applications.
The Agency believes that the handler scenarios assessed represent
worse-case exposures and risks resulting from the use of outdoor
pesticide products containing these inert ingredients in residential
environments.
Post application high end outdoor residential exposures (i.e.,
Dermal exposure to treated lawns (adults/children), Hand-to-Mouth
activity for toddlers on treated lawns (children), Object-to-Mouth
activity for toddlers on treated lawns (children), and Soil ingestion
from treated soil (children)) were also evaluated.
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 amides, C5-C9, N-[3-
(dimethylamino) propyl] and amides, C6-C12, N-[3-
(dimethylamino) propyl] to share a common mechanism of toxicity with
any other substances. Amides, C5-C9, N-[3-
(dimethylamino) propyl] and amides, C6-C12, N-[3-
(dimethylamino) propyl] may produce the metabolite DMAPA. The toxicity
of this metabolite is addressed in the database. For the purposes of
this tolerance action, therefore, EPA has assumed that amides,
C5-C9, N-[3-(dimethylamino) propyl] and amides,
C6-C12, N-[3-(dimethylamino) propyl] do not have
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. Reproductive and
developmental effects were evaluated in a 90-day study conducted on
Sprague-Dawley (CD) rats. No evidence of toxicity was noted at exposure
levels of 15, 50, and 175 mg/kg/day. Systemic toxicity including lower
mean body weights, body weight gains, and food consumption for both
sexes and lower absolute and relative-to-brain ovary, uterus, and
pituitary weights for the reproductive phase females was exhibited at
600 mg/kg/day. In addition, lower mean live litter size on PND 0,
number of pups born and implantation sites, and lower mean pup weights
were noted in the 600 mg/kg/day group. Therefore, the systemic,
reproductive, and developmental NOAELs are considered to be 175 mg/kg/
day. All reproductive and developmental effects were noted in the
presence of excessive maternal toxicity; therefore, there was no
evidence of increased susceptibility in infants and children.
In addition, an Organization for Economic Cooperation and
Development (OECD) 421 reproduction and developmental toxicity
screening test using the metabolite dimethylaminopropylamine in
Sprague-Dawley rats resulted in parental toxicity at 200 mg/kg/day
based on decreased body weight gain and clinical signs (respiratory
sounds and piloerection). Reproductive and developmental toxicity were
not observed at any dose level.
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:
[[Page 69640]]
i. The toxicity database for amides, C5-C9,
N-[3-(dimethylamino)propyl] and amides, C6-C12,
N-[3-(dimethylamino)propyl] is adequate for assessing the sensitivity
to infants and children.
ii. There is no indication that amides, C5-
C9, N-[3-(dimethylamino)propyl] and amides, C6-
C12, N-[3-(dimethylamino)propyl] are neurotoxic chemicals
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity. Although possible evidence
of neurotoxicity was observed in OPPTS 870.3700 as indicated in the 500
mg/kg/day group (dilated pupils) and the 1,000 mg/kg/day group (dilated
pupils and clonic convulsions), these clinical signs were considered to
be due to generalized toxicity and not of neurologic origin.
iii. There is no evidence that amides, C5-C9,
N-[3-(dimethylamino)propyl] and amides, C6-C12,
N-[3-(dimethylamino)propyl] results in increased susceptibility in in
utero rats.
iv. There are no residual uncertainties identified in the exposure
databases. The food and drinking water assessment is not likely to
underestimate exposure to any subpopulation, including those comprised
of infants and children. The food exposure assessments are considered
to be highly conservative as they are based on the use of the highest
tolerance level from the surrogate pesticides for every food and 100
PCT is assumed for all crops. EPA also made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to amides, C5-C9, N-[3-
(dimethylamino)propyl] and amides, C6-C12, N-[3-
(dimethylamino)propyl] 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
amides, C5-C9, N-[3-(dimethylamino)propyl] and
amides, C6-C12, N-[3-(dimethylamino)propyl].
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,
amides, C5-C9, N-[3-(dimethylamino)propyl] and
amides, C6-C12, N-[3-(dimethylamino)propyl] are
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
amides, C5-C9, N-[3-(dimethylamino)propyl] and
amides, C6-C12, N-[3-(dimethylamino)propyl] from
food and water will utilize 35.7 percent of the cPAD for children 1-2
years old, the population group receiving the greatest exposure. There
are currently no known residential uses for amides, C5-
C9, N-[3-(dimethylamino)propyl] and amides, C6-
C12, N-[3-(dimethylamino)propyl]. Since there are no current
or proposed residential uses, chronic exposure is not expected;
however, inert ingredients are used in a variety of formulations and
have the potential to be used in residential products. A screening
level assessment was conducted for residential exposure and the risk
was below the Agency level of concern.
Although there is a potential for amides, C5-
C9, N-[3-(dimethylamino)propyl] and amides, C6-
C12, N-[3-(dimethylamino)propyl] to produce the metabolite
dimethylaminopropylamine (DMAPA), which is currently approved under 40
CFR 180.920 and 180.930, EPA does not anticipate any risk concerns from
aggregate exposure to DMAPA for the following reasons:
i. Evidence from toxicology studies indicates that metabolization
of amides, C5-C9, N-[3-(dimethylamino)propyl] and
amides, C6-C12, N-[3-(dimethylamino)propyl], to
DMAPA does not occur in significant amounts. The parent chemicals
(i.e., amides, C5-C9, N-[3-(dimethylamino)propyl]
and amides, C6-C12, N-[3-(dimethylamino)propyl])
have a larger and more complete toxicity database which resulted in a
higher no observed adverse effect level (NOAEL) than the metabolite,
DMAPA. The POD NOAEL selected for all exposure scenarios for amides,
C5-C9, N-[3-(dimethylamino)propyl] and amides,
C6-C12, N-[3-(dimethylamino)propyl] is 175 mg/kg/
day versus the NOAEL of 50 mg/kg/day for DMAPA. If DMAPA is a major
metabolite of amides, C5-C9, N-[3-
(dimethylamino)propyl] and amides, C6-C12, N-[3-
(dimethylamino)propyl] then the toxicity endpoints for amides,
C5-C9, N-[3-(dimethylamino)propyl] and amides,
C6-C12, N-[3-(dimethylamino)propyl] and DMAPA
would be comparable.
ii. The previous risk assessment of metabolite DMAPA (as inert
ingredient) indicates that any marginal increase in DMAPA exposure as a
result of the use of amides, C5-C9, N-[3-
(dimethylamino) propyl] and amides, C6-C12, N-[3-
(dimethylamino) propyl] would not alter the DMAPA risk significantly
nor change EPA's conclusion regarding the safety of DMAPA. [Federal
Register August 5, 2009 (74 FR 38924) (FRL-8430-2)]
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). Amides,
C5-C9, N-[3-(dimethylamino) propyl] and amides,
C6-C12, N-[3-(dimethylamino) propyl] have the
potential to be used as inert ingredients in pesticide products that
are registered for uses that could result in short-term residential
exposure, and the Agency has determined that it is appropriate to
aggregate chronic exposure through food and water with short-term
residential exposures to amides, C5-C9, N-[3-
(dimethylamino) propyl] and amides, C6-C12, N-[3-
(dimethylamino) propyl].
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and proposed high-end residential exposure scenarios result in
aggregate MOEs greater than 100. Because EPA's level of concern for
amides, C5-C9, N-[3-(dimethylamino) propyl] and
amides, C6-C12, N-[3-(dimethylamino) propyl] is a
MOE of 100 or below, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Amides, C5-C9, N-[3-(dimethylamino)
propyl] and amides, C6-C12, N-[3-(dimethylamino)
propyl] have the potential to be used as inert ingredients in pesticide
products that are registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to amides,
C5-C9, N-[3-(dimethylamino) propyl] and amides,
C6-C12, N-[3-(dimethylamino) propyl].
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and proposed high-end residential
exposure scenarios result in aggregate MOEs greater than 100. Because
EPA's level of concern for amides, C5-C9, N-[3-
(dimethylamino) propyl] and amides, C6-C12, N-[3-
(dimethylamino) propyl] is a MOE of
[[Page 69641]]
100 or below, these MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in various mutagenicity studies, the lack
of a target organ in any of the toxicity studies conducted, and the
lack of structural alerts suggestive of carcinogenicity in the
structural activity database DEREK Version 11, amides, C5-
C9, N-[3-(dimethylamino) propyl] and amides, C6-
C12, N-[3-(dimethylamino) propyl] are 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 amides, C5-C9, N-[3-(dimethylamino)
propyl] and amides, C6-C12, N-[3-(dimethylamino)
propyl] residues.
V. Other Considerations
A. 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.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for amides, C5-
C9, N-[3-(dimethylamino) propyl] or amides, C6-
C12, N-[3-(dimethylamino) propyl].
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180. 910 for amides, C5-
C9, N-[3-(dimethylamino) propyl]; (CAS Reg. No 1044764-00-2)
and amides, C6-C12, N-[3-(dimethylamino) propyl];
(CAS Reg. No. 1044764-06-8) when used as inert ingredients
(surfactants) in pesticide formulations applied pre- and post-harvest.
VII. Statutory and Executive Order Reviews
This final rule establishes an exemption from the requirement of a
tolerance under section 408(d) of FFDCA 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 final rule has been exempted from review under
Executive Order 12866, this final rule 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 final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance 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 final rule 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 section 408(n)(4) of FFDCA. 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L.104-4).
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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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: October 18, 2011.
Lois Rossi,
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, the table is amended by adding alphabetically the
following inert ingredients to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
[[Page 69642]]
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Amides, C5-C9, N-[3- .............. Surfactant
(dimethylamino) propyl]; CAS
Reg. No. 1044764-00-2.
Amides, C6-C12, N-[3- .............. Surfactant
(dimethylamino) propyl]; CAS
Reg. No. 1044764-06-8.
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2011-28643 Filed 11-8-11; 8:45 am]
BILLING CODE 6560-50-P