Document ID: EPA-HQ-OPP-2011-0139-0003
Agency: epa
Document Type: Rule
Title: Exemptions from Requirements of Tolerances: Residues of Didecyl dimethyl ammonium chloride
Posted Date: 2012-08-08T04:00Z

[Federal Register Volume 77, Number 153 (Wednesday, August 8, 2012)]
[Rules and Regulations]
[Pages 47291-47296]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19399]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0139; FRL-9356-6]

Residues of Didecyl Dimethyl Ammonium Chloride; 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 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: lantz.tracy@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. 
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 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-

[[Page 47292]]

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 
by statute.
     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-
occupational exposures).

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.

[[Page 47293]]

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 
time.
    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 
Chloride (DDAC).

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 
appropriate NOAEL.
    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, 
textiles (e.g.,

[[Page 47294]]

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 
protective equipment.
    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, 
as appropriate.
    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 
neurotoxicity.
    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 
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.''
    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 
ammonium compounds.
    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 
proposed

[[Page 47295]]

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 
water.
    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.

VIII. Conclusion

    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 
note).

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

[[Page 47296]]

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: July 23, 2012.
Joan Harrigan Farrelly,
Director, Antimicrobials 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. 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 
immersion.

[FR Doc. 2012-19399 Filed 8-7-12; 8:45 am]
BILLING CODE 6560-50-P