Federal Register / Vol. 77, No. 163 / Wednesday, August 22, 2012 / Rules and Regulations 50613 

Authority: 42 U.S.C. 7401 et seq. 

Subpart MM—Oregon 

■ 2. Section 52.1970 is amended by 

adding paragraph (c)(151)(ii)(B) to read 

as follows: 

§ 52.1970 Identification of plan. 

* * * * * 

(c) * * * 

(151) * * * 

(ii) * * * 

(B) The remaining portions of the 

December 20, 2010, SIP revision, which 

relate to establishing reasonable 

progress goals, and a long term strategy 

to achieve these reasonable progress 

goals. 

* * * * * 

■ 3. Section 52.1973 is amended by 

adding paragraph (g)(2) to read as 

follows: 

§ 52.1973 Approval of plans. 

* * * * * 

(g) * * * 

(2) EPA approves the remaining 

portions of the Regional Haze SIP 

revision submitted by the Oregon 

Department of Environmental Quality 

on December 20, 2010, and adopted by 

the Oregon Department of 

Environmental Quality Commission on 

December 9, 2010, as meeting the 

requirements of the Clean Air Act 

section 169A and 40 CFR 51.308(d)(1) 

regarding establishing reasonable 

progress goals, and 51.308(d)(3) for 

developing a long term strategy to 

achieve these goals. 

[FR Doc. 2012–20496 Filed 8–21–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0950; FRL–9359–5] 

Didecyl Dimethyl Ammonium 

Carbonate and Didecyl Dimethyl 

Ammonium Bicarbonate; Exemption 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

exemption from the requirement of a 

tolerance for residues of Didecyl 

Dimethyl Ammonium Carbonate and 

Didecyl Dimethyl Ammonium 

Bicarbonate, jointly referred to as 

DDACB on food contact surfaces when 

applied or used in public eating places, 

dairy processing equipment, and/or 

food processing equipment and utensils. 

Lonza, Inc. submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

amendment which would provide for an 

increase in the final use concentration 

of DDACB in products eligible for the 

exemption from the requirement of a 

tolerance. As amended, the regulation 

will exempt solutions from the 

requirement of tolerance residues 

resulting from contact with surfaces 

treated with solutions where the enduse concentration of the DDACB does 

not exceed 400 parts per million (ppm). 

DATES: This regulation is effective 

August 22, 2012. Objections and 

requests for hearings must be received 

on or before October 22, 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–2011–0950, is 

available at http://www.regulations.gov 

or 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: 

Velma Noble, Antimicrobials Division 

(7510P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–6233; email address: 

noble.velma@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Dairy Cattle Milk Production 

(NAICS code 11212). 

• Food manufacturing (NAICS code 

311). 

• Beverage Manufacturing (NAICS 

code 3121). 

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– 

OPP–2011–0950 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 22, 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–2011–0950, 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 statue. 

• 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 


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50614 Federal Register / Vol. 77, No. 163 / Wednesday, August 22, 2012 / Rules and Regulations 

information about dockets generally, is 

available at http://www.epa.gov/ 

dockets. 

II. Background and Statutory Findings 

In the Federal Register of December 8, 

2011 (76 FR 76674) (FRL–9328–8), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

tolerance petition (PP 0F7758) by Lonza 

Inc., 90 Boroline Road, Allendale NJ 

07401. The petition requested that 40 

CFR 180.940(a), be amended by 

establishing concentration limits for 

DDACB in end use solutions eligible for 

tolerance exemption. That notice 

referenced a summary of the petition 

prepared by Lonza Inc., the registrant, 

which is available in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

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 

FFDCA section 408(c)(2)(B), in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), 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 * * *.’’ 

Consistent with FFDCA section 

408(c)(2)(A), and the factors specified in 

FFDCA section 408(c)(2)(B), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for DDACB 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with DDACB follows. 

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 

DDACB, part of the Aliphatic Alkyl 

Quaternary group of compounds, are 

discussed in this unit. In assessing the 

proposed toxicity, the toxicological 

endpoints were extracted from the 

DDAC RED (EPA–HQ–2006–0338). 

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– 

2005–0338 Toxicology Disciplinary 

Chapter for the Reregistration Eligibility 

Decision (RED) for Didecyl Dimethyl 

Ammonium Chloride (DDAC). 

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 Exposure 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 

concerning exposures from the pesticide 

residues 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. In evaluating dietary 

exposure to DDACB, EPA considered 

exposure under the petitioned-for 

exemption as well as all existing 

aliphatic alkyl quaternaries exemptions 

or tolerances in (40 CFR 180.940(a)). 

EPA assessed dietary exposures from 

DDACB in food as follows: 

Aliphatic alkyl quaternaries are to be 

used as sanitizers on appliances, 

beverage bottling, counter tops, food 

packaging, refrigerators, tables, and 

utensils. The use of these actives in 

antimicrobial products for use on food 

or feed-contact surfaces and in 

agricultural premises may result in 

pesticide residues in human food. 

Residues from treated surfaces, such as 

appliances, countertops, equipment, 

and utensils can migrate to food coming 

into contact with the treated and rinsed 

surfaces and can be ingested by humans. 

The Agency assessed acute and 

chronic dietary exposures from the use 

of DACB as a disinfectant and foodcontact sanitizer on utensils, 

countertops, and in food/beverage 

processing facilities. The assessment 

calculated the Daily Dietary Dose (DDD) 

and the Estimated Daily Intake (EDI) 

using modified Food and Drug 

Administration (FDA) methodologies for 

utensils and the Indirect Dietary 

Residential Exposure Model (IDREAM) 

for countertops. 

The EDI calculations presented in this 

assessment for treated indirect dietary 

exposures resulting from sanitizing 

utensils assumed that food would 

contact 4,000 cm2 (which represents 

contact with treated china, glass, and 

silverware used by an individual who 

regularly eats three meals per day at an 

institutional or public facility) and that 

the residual solution remaining on the 

surface or pesticide migration fraction is 

1 milligram/centimeter (mg/cm2) of 

treated area. The body weights used for 

this assessment were 70 kilograms (kg) 

for an adult male, 60 kg for an adult 

woman, and 10 kg for an infant. Based 

on data provided in a new residue 

study, Transferability Equivalence 


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Federal Register / Vol. 77, No. 163 / Wednesday, August 22, 2012 / Rules and Regulations 50615 

among Quats and Measured Food 

Surrogate Transfer Efficiency (Master 

Record Identification Number 

46870703), a conservative transfer rate 

of 43% was used to demonstrate the 

amount of residues on the surface that 

will be transferred to food and 

subsequently ingested. The maximum 

application rate for DDACB on utensils 

is 0.0033 lbs active ingredient (a.i.) per 

gallon of treatment solution. 

There are two levels of refinement for 

assessing dietary exposure to 

antimicrobial products used on 

countertops. The three dimensional 

approach, Tier 2, was utilized for this 

assessment. This conservative approach 

uses food consumption and preparation 

patterns, food-specific conversion 

factors that relate the surface area 

contacting the countertop with the 

corresponding weight of the food item, 

transfer efficiency, and likelihood of 

contact with a countertop. Food 

ingredients, as presented in the model, 

are separated into nine categories and 

reflect a person’s daily diet. Based on 

the structure of the model, available 

countertop residues are estimated and 

presented as the amount of residue that 

is expected to be available for each of 

the nine food categories. These 

calculated available residues are then 

combined with the food consumption 

rate, as extracted from the USDA 

Continuing Survey for Food Intake by 

Individuals (CSFII) consumption data, 

and a total daily exposure value is 

provided as the output. This value is 

then compared to the toxicological 

endpoint to determine risk to those 

consuming foods that have come into 

contact with a freshly sanitized 

countertop. 

For the assessment of the food 

bottling/packaging use, EPA assumed a 

100% transfer rate because the food is 

potentially in contact with the treated 

surfaces for very long periods of time. 

The maximum application rate for 

DDACB for bottling/packing of food is 

0.0033 lbs a.i. per gallon of treatment 

solution. EDI values were calculated 

using an approach similar to that used 

for treated food utensils. Exposure was 

assumed to occur through the ingestion 

of three food products that might be 

packaged with treated material: 

Beverages (alcoholic and non-alcoholic), 

egg products, and milk. A calorie intake 

modification factor of 0.64 was applied 

to the EDI for a child to account for the 

differences between intake values 

among children and adults. 

2. Drinking water exposure. DDACB 

outdoor uses are as an algaecide in 

wood preservative treatment and a 

slimicide in secondary oil field uses. 

The oil field uses are considered to be 

contained. The other uses are not 

expected to significantly contaminate 

drinking water sources. Therefore, the 

DDACB contributions for drinking water 

exposure are considered to be negligible 

and are not quantified. 

B. Other Non-Occupational Exposure 

The term ‘‘residential exposure’’ is 

used in this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). DDACB is currently registered 

for the following residential non-dietary 

sites: Homes and day-care nurseries. 

EPA assessed residential exposure using 

the following assumptions: 

• Residential exposure may occur 

during the application as well as post 

application of DDACB to indoor hard 

surfaces (e.g., mopping, trigger pump 

sprays, wiping). 

• The residential handler scenarios 

were assessed to determine dermal and 

inhalation exposures. 

• Residential post application 

scenarios such as children’s exposure to 

treated toys and floors were also 

assessed to determine dermal and 

incidental oral exposures. 

• Surrogate dermal, inhalation, and 

incidental oral unit exposure values 

were estimated using Pesticide Handler 

Exposure Database (PHED) data and the 

Chemical Manufactures Association 

Antimicrobial Exposure Assessment 

Study (EPA, 1999). 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. 

Specific information on the 

residential exposure assessment for 

DDACB can be found at http:// 

www.regulations.gov. Docket ID Number 

EPA–HQ–OPP–2006–1024, Review of 

Petition to Amend 40 CFR 180.940 to 

add Didecyl Dimethyl Ammonium 

Carbonate/Bicarbonate. 

C. Additional Safety Factor for the 

Protection of 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 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 (FQPA) 

safety factor (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 safety 

factor value based on the use of 

traditional uncertainty/safety factors 

and/or special FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

There is no evidence that Aliphatic 

Alkyl ammonium chloride 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 safety factor to 1X except for 

assessments addressing inhalation 

exposure. For inhalation exposure 

assessments the 10X FQPA safety factor 

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 safety factor of 

10X has been applied to the oral 

endpoint to calculate inhalation risks in 

order to be protective of any 

uncertainties associated with route-toroute 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 

2-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. 


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50616 Federal Register / Vol. 77, No. 163 / Wednesday, August 22, 2012 / Rules and Regulations 

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.’’ 

EPA’s risk assessment for the Group I 

Cluster is based on an assessment of the 

cumulative exposure to all aliphatic 

alkyl quaternary compounds. The 

individual exposure scenarios in the 

DDAC assessments (as well as the 

aggregate assessment in the Aliphatic 

Alkyl Quaternary (DDAC) Reregistration 

Eligibility Decision (RED)) were 

developed by assuming that a DDAC 

compound was used on 100% of the 

surfaces authorized on the label that 

could result in human exposure and 

summing the percent active ingredients 

on the labels for all of the aliphatic alkyl 

quaternary compounds when used in 

combination. Thus, because the risk 

assessment for DDAC accounts for 

exposures to all of the aliphatic alkyl 

quaternary compounds, there is no need 

for a separate cumulative risk 

assessment for those compounds. The 

Agency has not identified any other 

substances as sharing a common mode 

of toxicity with DDACB. 

VI. Aggregate Risks and Determination 

of Safety 

1. Dietary risk from food and feed 

uses. EPA compares the estimated 

dietary exposures to an acute 

population adjusted dose (aPAD) and a 

chronic population adjusted dose 

(cPAD), 0.1 mg/kg/day, which are the 

same value for DDACB. Generally, a 

dietary exposure estimate that is less 

than 100% of the aPAD or the cPAD 

does not exceed the Agency’s LOC. 

The antimicrobial indirect food use 

acute and chronic risk estimates from 

exposure to treated utensils and 

countertops are below the Agency’s 

LOC. For adult males, the acute and 

chronic dietary exposure risk estimates 

are 9.9% for utensils and 0.8% for 

countertops. The aPAD and cPAD for 

adult females (13–69) is 11.5% for 

utensils. The aPAD from countertops for 

adult females is 0.8% and the cPAD is 

0.5%. For children ages 1–2, the most 

highly exposed population subgroup, 

the acute and chronic dietary risk 

estimates are 68.9% for utensils and 

2.6% and 1.8%, respectively for acute 

and chronic dietary risks for 

countertops. Therefore, dietary exposure 

estimates are below Agency’s LOC for 

all population subgroups. The 

antimicrobial indirect food use chronic 

risk estimates from exposure to treated 

food packaging and beverage bottles are 

also below the Agency’s LOC. 

Specific information on the dietary 

exposure assessment for DDACB can be 

found at http://www.regulations.gov. 

Docket ID Number EPA–HQ–2006– 

1024, Review of Petition to Amend 40 

CFR 180.940 to add Didecyl Dimethyl 

Ammonium Carbonate/Bicarbonate. 

2. Non-occupational risk. Aggregate 

exposure takes into account residential 

exposure plus chronic exposure to food 

and water (considered to be a 

background exposure level). Using the 

exposure assumptions described in this 

unit for other non-occupational 

exposures, the MOEs are greater than 

the target of 1,000 for the inhalation 

route of exposure and 10 for dermal 

exposure, with the exception of the 

short term dermal exposures in females 

which has an MOE of 9. However, there 

is no significant concern for the 

proposed increase in use concentrations 

from 240 ppm to 400 ppm, with regard 

to dermal exposure, considering the 

contributing MOEs used to calculate the 

MOE of 9 were derived using 

conservative assumptions for the unit 

exposures and quantity handled. 

Furthermore there is a low likelihood 

that all scenarios (mopping, wiping, 

trigger pump spraying, immersing items 

into a solution and wearing treated 

clothing items) that were used to derive 

an MOE of 9 for dermal exposure would 

occur simultaneously. 

Based on the toxicological and 

exposure data discussed in this 

preamble, EPA concludes that DDACB 

will not pose a risk under reasonably 

foreseeable circumstances. Accordingly, 

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 

DDACB residues. 

VII. Other Considerations 

An analytical method for food is not 

needed. Food-contact sanitizers are 

typically regulated by the State health 

departments to ensure that the food 

industry is using products in 

compliance with the regulations in 40 

CFR 180.940. The end-use solution that 

is applied to the food-contact surface is 

analyzed not food items that may come 

into contact with treated surface. An 

analytical method is available to analyze 

the use dilution that is applied to foodcontact surfaces. A titration method is 

used to determine the total amount of 

quaternary compound. If the use 

solution is a mixture of ADBAC and 

DDACB, then high pressure liquid 

chromatogram with ultraviolet visible 

(HPLC–UV) is used to determine the 

amount of ADBAC. The amount of 

DDACB is determined by calculating the 

difference between the total amount of 

quaternary compounds and ADBAC. 

VIII. Conclusion 

This regulation amends the 

exemption from the requirement of a 

tolerance for residues of DDACB under 

40 CFR 180.940(a) resulting from an 

increase in the final use concentration 

from 240 ppm to 400 ppm on food 

contact surfaces in public eating 

establishments, on dairy processing 

equipment and food processing 

equipment and utensils. 

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 


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Federal Register / Vol. 77, No. 163 / Wednesday, August 22, 2012 / Rules and Regulations 50617 

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 

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, Aliphatic 

alkyl quaternaries, Food-contact 

sanitizers, Pesticides and pests, 

Quaternary ammonium compounds, 

Reporting and recordkeeping 

requirements. 

Dated: August 9, 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. In § 180.940(a), the table is 

amended by revising in its entirety, the 

entry for ‘‘Quaternary ammonium 

compounds, didecyl dimethyl 

ammonium carbonate/didecyl dimethyl 

ammonium bicarbonate’’ which 

immediately preceeds the pesticide 

chemical which reads in part ‘‘Silver 

ions resulting * * *’’ to read as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide chemical CAS Reg. No. Limits 

*******

Quaternary ammonium compounds, didecyl dimethyl 

ammonium carbonate/didecyl dimethyl ammonium bicarbonate.

148788–55–0/148812–654– 

1.

When ready for use, the end-use concentration of these 

specific ammonium compounds is not to exceed 400 

ppm of active quaternary ammonium compound. 

* * * * * * * 

* * * * * 

[FR Doc. 2012–20663 Filed 8–21–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0766; FRL–9354–3] 

RIN 2070–AJ28 

Pesticide Tolerance Crop Grouping 

Program III; Revisions to General 

Tolerance Regulations 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This final rule revises the 

current pesticide tolerance crop 

grouping regulations, which allow for 

the establishment of tolerances for 

multiple related crops based on data 

from a representative set of crops. This 

rule expands upon existing stone fruit 

and tree nut crop groups by establishing 

new crop subgroups and adding new 

commodities. This is the third in a 

series of planned crop group updates 

expected to be promulgated over the 

next several years. 

DATES: This final rule is effective 

October 22, 2012. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2006–0766 is 

available electronically at 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, Room 3334, 

1301 Constitution Ave. NW., 

Washington, DC 20460. 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: 

Laura Nollen, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; email address: 

nollen.laura@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. What action is the agency taking? 

This final rule, under the provisions 

of section 408 of the Federal Food, Drug, 

and Cosmetic Act (FFDCA), 21 U.S.C. 

346a, amends EPA’s regulations 

governing crop group tolerances for 

pesticides. Specifically, the rule 

expands upon existing stone fruit and 

tree nut crop groups by adding new 

commodities and establishes crop 

subgroups for the new stone fruit crop 

group. This final rule is the third in a 

series of planned crop group updates 

expected to be promulgated in the next 

several years. 


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