Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations 47291 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this 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). 

XI. 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 174 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 30, 2012. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 174—[AMENDED] 

■ 1. The authority citation for part 174 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 174.532 is revised to read 

as follows: 

§ 174.532 Bacillus thuringiensis eCry3.1Ab 

protein in corn; exemption from the 

requirement of a tolerance. 

Residues of Bacillus thuringiensis 

eCry3.1Ab protein in corn, in or on the 

food and feed commodities of corn; 

corn, field; corn, sweet; and corn, pop 

are exempt from the requirement of a 

tolerance when Bacillus thuringiensis 

eCry3.1Ab protein in corn is used as a 

plant-incorporated protectant. 

[FR Doc. 2012–19319 Filed 8–7–12; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 


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47292 Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations 

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 nonoccupational 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. 


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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 nonoccupational 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., 


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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 


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Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations 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 


wreier-aviles on DSK5TPTVN1PROD with RULES
47296 Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations 

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] 

■ 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: 

§ 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0875; FRL–9348–8] 

Flutriafol; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

and amends tolerances for residues of 

Flutriafol [((±)-a-(2-fluorophenyl)-a-(4- 

fluorophenyl)-1H-1,2,4-triazole-1- 

ethanol], including its metabolites and 

degradates in or on multiple 

commodities which are identified and 

discussed later in this document. 

Cheminova A/S, c/o Cheminova, Inc. 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

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–2010–0875, 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: 

Tamue L. Gibson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–9096; email address: 

gibson.tamue@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 those engaged in the 

following activities: 

• 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 to provide 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 EPA’s tolerance 

regulations at 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–2010–0875 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–2010–0875, 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. 


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