[Federal Register Volume 77, Number 153 (Wednesday, August 8, 2012)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19399]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Residues of Didecyl Dimethyl Ammonium Chloride; 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 Didecyl dimethyl ammonium chloride
(DDAC) in or on broccoli grown from treated seeds when applied by
immersion. Pace Chemicals Ltd. submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA) requesting an exemption
from the requirement of a tolerance. This regulation eliminates the
need to establish a maximum permissible level for residues of DDAC in
or on broccoli seed.
DATES: This regulation is effective August 8, 2012. Objections and
requests for hearings must be received on or before October 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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0139, is available either
electronically through http://www.regulations.gov or in hard copy at
the OPP Docket in the Environmental Protection Agency Docket Center
(EPA/DC), located in EPA West, Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC 20460-0001. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is (202) 566-1744, and the
telephone number for the OPP Docket is (703) 305-5805. Please review
the visitor instructions and additional information about the docket
available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Tracy Lantz, Antimicrobials Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 308-6415; email address: email@example.com.
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
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0139 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 October 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-2011-0139, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register of September 7, 2011 (76 FR 55329) (FRL-
8886-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP) 0F7747 by Pace Chemicals Ltd., 8321 Willard Street,
Burnaby, British Columbia, V3N 2X3. The petition requested that 40 CFR
part 180 subpart D be amended by establishing an exemption from the
requirement of a tolerance for residues of Didecyl dimethyl ammonium
chloride on broccoli grown from treated seeds when applied by
immersion. This notice referenced a summary of the petition prepared by
the petitioner Pace Chemicals Ltd which is available in the docket,
http://www.regulations.gov. A comment was received on the notice of
filing. EPA's response to these comments is discussed in Unit VII.C.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which 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 performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information 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. The nature of the toxic effects caused by Didecyl
dimethyl ammonium chloride, part of the Aliphatic Alkyl Quaternary
group of compounds, are discussed in this unit.
The Aliphatic Alkyl Quaternaries are corrosive and highly
irritating to the eye and skin, with moderate acute toxicity by oral,
dermal, and inhalation routes of exposure. These chemicals are
classified as ``not likely'' to be human carcinogens based on negative
carcinogenicity in rat and mouse feeding studies using doses above the
limit dose. There is no evidence of these chemicals being associated
with increased susceptibility of infants and children based on two
developmental toxicity studies and a 2-generation reproductive toxicity
study. Lastly, they are negative for mutagenicity and neurotoxicity.
Specific information on the studies received and the nature of the
toxic effects from the toxicity studies can be found at http://www.regulations.gov. Docket ID Number EPA-HQ-OPP-2006-0338 Toxicology
Disciplinary Chapter for the Reregistration Eligibility Decision (RED)
for Didecyl Dimethyl Ammonium Chloride (DDAC).
Toxic Endpoints--For hazards that have a threshold below which
there is no appreciable risk, the dose at which no adverse effects are
observed (NOAEL) from the toxicology study identified as appropriate
for the risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in
variations in sensitivity among members of the human population as well
as other unknowns. A detailed discussion of EPA's conclusions regarding
the toxic endpoints for the Aliphatic Alkyl Quaternaries can be found
at 73 FR 37852 (July 2, 2008).
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other sources, including drinking
water from ground water or surface water and exposure through pesticide
use in gardens, lawns, or buildings (residential and other non-
A. Dietary Exposure
1. Food. Studies have not been submitted measuring residues of
Didecyl dimethyl ammonium chloride (DDAC) in broccoli resulting from
treatment of broccoli seed. Instead, EPA estimated the DDAC residue
concentration that could theoretically result in broccoli heads from
the proposed seed treatment use. The number of broccoli seed/pound (lb)
is about 144,000 (Oregon State University, Commercial Vegetable
Production Guides. Broccoli. Brassica oleracea (Italica Group). Last
revised August 6, 2004). The proposed treatment rate is 1,200 milligram
(mg) DDAC/100 g seed.
Seed are to be soaked for 10 minutes and then dried.
The highest seeding rate for broccoli is 1.5 pound per acre (lb/A)
(680 g/acre). The lower end of yield in a major broccoli-producing
state is 13,000 lb/A in AZ (USDA/NASS; 2003-08). If 680 g seed are
treated with 1,200 mg DDAC/100 g, a total of 8.2 g DDAC would be
applied to the seed. If all the DDAC is retained by the seed and the
680 g of seed/acre are planted, the equivalent application rate would
be 0.0181 lb DDAC/acre. If all the DDAC were absorbed and translocated
to the 13,000 lb of harvested broccoli, the maximum theoretical residue
level in broccoli would be 1.4 parts per million (ppm).
The intent of the proposed DDAC seed treatment, however, is to
control pathogens on the surface of the broccoli seed which is the
major way a number of serious diseases of crucifers are spread and not
to control pathogens in soil. Therefore, draining and triple rinsing
are conducted to reduce DDAC residues on the seed and there is no
intended adsorption (binding) of the DDAC to the seed because the
registrant is not claiming residual protection of seed from pathogens
in the soil. However, while not intended, it is likely that traces of
DDAC would have adsorbed to the seed coat during the 10-minute soaking
Taking the draining and rinsing of seed into account, EPA has made
a conservative estimate of how much of the theoretical estimate of 1.4
ppm of DDAC on broccoli could actually be present. After seed are
soaked in the DDAC solution for 10 min, the solution is drained. EPA
estimates that at least 90% of the solution volume will drain off,
leaving 10%. This would reduce the theoretical value of 1.4 ppm DDAC in
harvested broccoli to 0.14 ppm. This is considered to be reasonable
because the treatment solution volume is typically 2 liter (L) for each
100 g of seed and most of the DDAC will be eliminated by draining
because of DDAC's solubility in water. Virtually no absorption of
solution into the seeds is expected within the 10-minute soaking time.
Also, if more than traces of solution were absorbed by seed, this would
be detrimental to the seed treatment process because metabolic
processes would be activated which would reduce seed viability and
increase rotting. Another 90% of the DDAC from the drained seed is
expected to be removed by the three water rinses which would reduce the
calculated value of 0.14 ppm to 0.014 ppm. This is reasonable because
most of the DDAC is in solution in the film of water between the
drained seed and, due to its water solubility; the three rinses are
expected to remove any free DDAC remaining.
Although there is no known plant uptake and metabolism studies
available for Aliphatic Alkyl Quaternaries similar to DDAC, there are
data indicating that DDAC is stable to hydrolysis and will bind tightly
to soil. Thus, EPA expects traces of DDAC to be adsorbed (bound) to
both the seed coat and the soil surrounding each seed. Considering its
immobility, there is little likelihood that DDAC would be absorbed
through the seed coat, translocated through the seed and developing
shoot, and ultimately concentrated in the harvested broccoli head. This
issue was addressed in an earlier EPA decision (K. Leifer, P. Wagner,
OPP, RD, 8/1/06 http://www.epa.gov/opprd001/inerts/dialkyl.pdf)
reassessing the safety of three tolerance exemptions for DDAC when used
as an inert ingredient (preservative) in pesticide formulations
applied: To growing crops (40 CFR 180.920), postharvest to crops (40
CFR 180.910), or to livestock (40 CFR 180.930). In that decision, EPA
concluded that soil application of DDAC to growing crops under 40 CFR
180.920 would not result in systemic uptake by plants because the DDAC
would be bound to soil and, therefore, unavailable for plant uptake.
Due to the strong binding of DDAC to the seed coat, cellulose, lignin,
organic matter, and clay particles, EPA believes that the calculated
concentration of 0.014 ppm DDAC in harvested broccoli heads/side shoots
is a great overestimate. Given that the calculated concentration for
DDAC in broccoli is both very small (0.014 ppm) and considered to be a
large overestimate, dietary exposures to DDAC from use in treatment of
broccoli seed are expected to be negligible.
2. Drinking water exposure. Contamination of drinking water with
Didecyl dimethyl ammonium chloride residues is expected to be
negligible as the treatment rate is very low (8.2 g/acre or 0.0181 lb/
acre) and the use is expected to be minor. Crucifer seed production is
carried out in only a few small areas of the country. In addition,
based on data indicating that DDAC is stable to hydrolysis and binds
tightly to soil, these residues are expected to be immobilized by
components of the soil and sediments. DDAC is classified as a
surfactant possessing a charged moiety (N\+\) and components that are
nonpolar/lipophilic (the two 10-carbon alkyl groups). These components
provide DDAC with properties allowing it to adsorb both to clay
particles (via cation exchange) and organic matter (via hydrophobic
attraction of the two alkyl groups). It adsorbs rapidly to soil and
sediments but is not readily desorbed. It also binds to cellulose and
lignin (organic matter) thus permitting its use as a wood preservative.
The only other Aliphatic Alkyl Quaternaries outdoor uses in
addition to growing crops are as algaecides in decorative/swimming
pools, antisapstain wood preservative treatment, once-through cooling
tower treatment, and oil field uses. The pond and oil field uses are
considered to be contained. The other uses are not expected to
significantly contaminate drinking water sources. Therefore, the
Aliphatic Alkyl Quaternaries contributions to drinking water exposure
are considered to be negligible and are not quantified.
It should be noted that the Agency estimated water concentrations
resulting from the antisapstain and cooling tower uses to which aquatic
animals may be exposed. These levels were not considered appropriate
for use in the drinking water assessment due to the very conservative
nature of the models used, that the model estimates runoff/point source
concentrations and not water body concentrations, and the fact that the
models do not account for dilution.
Specific information on the dietary and drinking water exposure
assessments for Aliphatic Alkyl Quaternaries can be found at http://www.regulations.gov. Docket ID Number EPA-HQ-OPP-2006-0338 Dietary Risk
Assessment on DDAC and Tier 1 Drinking Water Assessment for Alkyl
Dimethyl Benzyl Ammonium Chloride (ADBAC) & Didecyl Dimethyl Ammonium
B. Other Non-Occupational Exposure
No residential exposure to DDAC residues is expected from this
proposed seed treatment use.
In general, residential exposure assessment considers all potential
non-occupational pesticide exposure, other than exposure due to
residues in food or in drinking water. Exposures may occur during and
after application as a hard surfaces disinfectant (e.g., walls, floors,
tables, fixtures), to textiles (e.g., clothing, diapers) to swimming
pools and to carpets. Each route of exposure (oral, dermal, inhalation)
is assessed, where appropriate, and risk is expressed as a Margin of
Exposure (MOE), which is the ratio of estimated exposure to an
Residential exposure may occur during the application of Aliphatic
Alkyl Quaternaries to indoor hard surfaces (e.g., mopping, wiping,
trigger pump sprays), carpets, swimming pools, wood as a preservative,
diaper treated during washing and clothes treated with fabric spray),
and humidifiers. The residential handler scenarios were assessed to
determine dermal and inhalation exposures. Surrogate dermal and
inhalation unit exposure values were estimated using Pesticide Handler
Exposure Database (PHED) data and the Chemical Manufacturers
Association Antimicrobial Exposure Assessment Study (USEPA, 1999), and
the SWIMODEL 3.0 was utilized to conduct exposure assessments of
pesticides found in swimming pools and spas (Versar, 2003). Note that
for this assessment, EPA assumed that residential users complete all
elements of an application (mix/load/apply) without the use of personal
The duration for most residential exposures is believed to be best
represented by the short-term duration (1 to 30 days). The short-term
duration was chosen for this assessment because the residential handler
and postapplication scenarios are assumed to be performed on an
episodic, not daily basis.
Based on toxicological criteria and the potential for exposure, the
Agency has conducted dermal and inhalation exposure assessments for
Aliphatic Alkyl Quaternaries residential use. Specific information on
the residential exposure assessment for Aliphatic Alkyl Quaternaries
can be found at http://www.regulations.gov. Docket ID Number EPA-HQ-
OPP-2006-0338 Didecyl Dimethyl Ammonium Chloride (DDAC) Occupational
and Residential Exposure Assessment.
C. Safety Factor for Infants and Children
1. In general. Section 408 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 data base 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 Food Quality
Protection Act safety factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X when reliable data do not
support the choice of a different factor, or, if reliable data are
available, EPA uses a different additional FQPA SF value based on the
use of traditional uncertainty/safety factors and/or special FQPA SFs,
2. Prenatal and postnatal sensitivity. There is no evidence that
Aliphatic Alkyl Quaternaries result in increased susceptibility in in
utero rats or rabbits in the prenatal developmental studies or in young
rats in the 2-generation reproduction study.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA SF to 1X
except for assessments addressing inhalation exposure. For inhalation
exposure assessments the 10X FQPA SF is retained. Those decisions are
based on the following findings:
i. The toxicity database for Aliphatic Alkyl Quaternaries is
complete except for a 90-day inhalation toxicity study in the rat which
was requested in the Aliphatic Alkyl Quaternary Reregistration
Eligibility Document. Due to the absence of the 90-day inhalation
toxicity study, a FQPA SF of 10x has been applied to the oral endpoint
to calculate inhalation risks in order to be protective of any
uncertainties associated with route-to-route extrapolation.
ii. There is no indication that Aliphatic Alkyl Quaternaries are
neurotoxic chemicals and there is no need for a developmental
neurotoxicity study or additional uncertainty factors to account for
iii. There is no evidence that Aliphatic Alkyl Quaternaries result
in increased susceptibility in in utero rats or rabbits in the prenatal
developmental toxicity studies or in young rats in the two-generation
reproductive toxicity study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessment was performed based on
10% transfer rate and tolerance-level residues. Similarly conservative
Residential SOPs were used to assess post-application exposure to
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
Aliphatic Alkyl Quaternaries.
V. Cumulative Effects From Substances With a Common Mechanism of
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.''
The Aliphatic Alkyl Quaternaries are a group (Group I cluster from
PR Notice 88-2) of structurally similar quaternary ammonium compounds
that are characterized by having a positively charged nitrogen
covalently bonded to two alkyl group substituent's (at least one
C8 or longer) and two methyl substituent's. In finished
form, these quaternary ammonium compounds are salts with the positively
charged nitrogen (cation) balanced by a negatively charged ion (anion).
The anion for the quaternary ammonium compounds in this cluster is
chloride or bromide. Dimethyl Didecyl ammonium chloride, or DDAC, was
chosen as the representative chemical for the Group I Cluster in PR
notice 88-2. On that basis, the toxicology database for DDAC is
accepted as representative of the hazard for this class of quaternary
EPA's risk assessment for the Group I Cluster is based on an
assessment of the exposure to all aliphatic alkyl quaternary compounds.
Although grouped in 1988 based on structural similarity, a formal
determination of common mechanism has not been conducted. The
individual exposure scenarios in the DDAC assessments (as well as the
aggregate assessment in the RED) were developed by assuming that a DDAC
compound was used on 100 percent of the food contact surfaces
authorized on the label that could result in human exposure. Thus, the
risk assessment for DDAC accounts for exposures to all of the Aliphatic
Alkyl Quaternary compounds. The Agency has not identified any other
substances as sharing a common mechanism of toxicity with Didecyl
dimethyl ammonium chloride.
Didecyl dimethyl ammonium chloride does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that DDAC does not have a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
VI. Determination of Safety for U.S. Population, Infants and Children
Conservative estimates indicate that there is no reasonable
expectation that anything greater than negligible residues of DDAC will
be present in broccoli as a result of the proposed seed treatment use.
EPA has previously. http://www.regulations.gov, Docket ID Number EPA-
HQ-OPP-2006-0572 determined that risks from aggregate exposure are
safe, 72 FR 51180 (September 6, 2007); 73 FR 37852 (July 2, 2008) this
seed treatment use adds essentially zero additional exposure so the
prior aggregate risk conclusion remains applicable. The only change in
this assessment is the retention of the FQPA 10X safety factor for
inhalation risks which makes the level of concern MOEs of 1000 or
below. The MOEs for residential handler inhalation risks were all
>=3400 and thus are not of concern. Adult and child inhalation risks
were found to be of concern in the Reregistration Eligibility Document
as a result of breathing mist from treated humidifier water; this was
the only child's inhalation scenario. To eliminate this risk, Didecyl
dimethyl ammonium chloride has been restricted to use in evaporative
humidifiers. Evaporative humidifiers, unlike other types of
humidifiers, do not generate and expel treated droplets or mist. The
Didecyl dimethyl ammonium chloride will volatilize in, at most,
negligible amounts from treated water in evaporative humidifiers.
Aliphatic Alkyl Quaternaries are salts that are very soluble in water
and have a negligible vapor pressure; as a result, they have a very low
Henry's Law Constant which means they have a negligible tendency to
volatilize from an aqueous solution such as that in treated humidifier
Accordingly, in reliance on the previous safety finding, and the
determinations made in that rulemaking document and this document, EPA
finds that there is a reasonable certainty that no harm will result to
the general population or to infants and children from aggregate
exposure to Didecyl dimethyl ammonium chloride residues. Further, EPA
concludes that the proposed use will not pose a risk under reasonable
foreseeable circumstances. Therefore, EPA finds that exempting DDAC
from the requirement of a tolerance when used as a broccoli seed
treatment will be safe.
VII. 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 Didecyl dimethyl ammonium
chloride in broccoli.
C. Response to Comments
The Agency received one comment in response to the notice of filing
for this petition. The commenter stated that they did not approve of
the toxic chemical ``dimethyl (mercury) ammnia chloride'' being
approved by the Agency.
In response to this comment, the Agency notes that mercury is not a
component or degradate of Didecyl dimethyl ammonium chloride. EPA
comprehensively evaluated the safety of DDAC in the http://www.regulations.gov, Docket ID Number EPA-HQ-OPP-2006-0572. The
commenter has provided no basis for EPA to vary from its prior
evaluation of the risk posed by DDAC.
Therefore, an exemption from the requirements of a tolerance is
established for residues of Didecyl dimethyl ammonium chloride in or on
broccoli grown from treated seeds when applied by immersion.
IX. Statutory and Executive Order Reviews
This final rule establishes 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
X. 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
Dated: July 23, 2012.
Joan Harrigan Farrelly,
Director, Antimicrobials Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1317 is added to subpart D to read as follows:
Sec. [emsp14]180.1317 Pesticide chemicals; exemption from the
requirements of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Didecyl dimethyl ammonium chloride in or on broccoli
resulting from the use of Didecyl dimethyl ammonium chloride as a seed
treatment at a treatment concentration of 1200 ppm prior to planting by
[FR Doc. 2012-19399 Filed 8-7-12; 8:45 am]
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