Federal Register / Vol. 77, No. 139 / Thursday, July 19, 2012 / Rules and Regulations 42433 

Basis and Purpose 

On May 2, 2012, we published a 

temporary deviation entitled 

‘‘Drawbridge Operations: Niantic River, 

Niantic, CT’’ in the Federal Register (77 

FR 25889) for the Amtrak Railroad 

Bridge, across the Niantic River, mile 

0.0, at Niantic, Connecticut. This 

deviation from the operating regulations 

was authorized under 33 CFR 117.35. 

Cancellation 

The Coast Guard previously issued a 

temporary deviation to Amtrak 

published on May 2, 2012 (77 FR 25889) 

to allow their bridge to remain in the 

closed position from 11 p.m. through 6 

a.m., Monday through Thursday, 

beginning May 15, 2012 until August 

15, 2012. The temporary deviation was 

necessary to facilitate completion of 

machinery installation and lift span 

work at the new railroad bridge. 

In May 2012, the contractor building 

the bridge discovered a minor shift in 

the bascule pier, causing a misalignment 

of the new bridge. Until the pier 

alignment problem is resolved, the work 

anticipated to be completed during the 

closures authorized under the May 2, 

2012 (77 FR 25889) temporary deviation 

could not be completed. 

In order to complete all the remaining 

work and correct the pier alignment 

problem a new temporary deviation is 

required authorizing a 48 hour bridge 

closure from 9 p.m. July 15 to 9 p.m. 

July 17, 2012 and a series of overnight 

closures between July 22 and August 22, 

2012. 

As a result of all the above 

information it was determined that the 

temporary deviation published on May 

2, 2012 (77 FR 25889) must be cancelled 

on July 14, 2012. 

Dated: July 9, 2012. 

Gary Kassof, 

Bridge Program Manager, First Coast Guard 

District. 

[FR Doc. 2012–17580 Filed 7–18–12; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2012–0547] 

Drawbridge Operation Regulations; 

Saugus River, Lynn and Revere, MA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, First Coast 

Guard District, has issued a temporary 

deviation from the regulation governing 

the operation of the General Edwards 

Bridge, mile 1.7, across the Saugus River 

between Lynn and Revere, 

Massachusetts. The deviation is 

necessary to facilitate major bridge 

rehabilitation construction. This 

deviation allows the bridge to remain in 

the closed position during the 

rehabilitation of the electrical and 

mechanical components that lift the 

bridge spans. 

DATES: This deviation is effective from 

September 4, 2012 through February 27, 

2013. 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of docket USCG–2012– 

0547 and are available online at 

www.regulations.gov, inserting USCG– 

2012–0547 in the ‘‘Keyword’’ and then 

clicking ‘‘Search’’. They are also 

available for inspection or copying at 

the Docket Management Facility (M–30), 

U.S. Department of Transportation, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Mr. John W. McDonald, Project 

Officer, First Coast Guard District, 

john.w.mcdonald@uscg.mil, or 

telephone 617–223–8364. If you have 

questions on viewing the docket, call 

Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: The 

General Edwards Bridge, across the 

Saugus River, mile 1.7, between Lynn 

and Revere, Massachusetts, has a 

vertical clearance in the closed position 

of 27 feet at mean high water and 36 feet 

at mean low water. The drawbridge 

operation regulations are listed at 33 

CFR 117.618(b). 

The waterway users are recreational 

vessels of various sizes. During the nonboating season the bridge rarely opens 

since the recreational vessels that transit 

this waterway are normally in winter 

storage. The bridge has opened five 

times since 2010 during the winter 

months. 

The owner of the bridge, 

Massachusetts Department of 

Transportation, requested a temporary 

deviation from the regulations to help 

facilitate rehabilitation of the electrical 

and mechanical components that lift the 

opening spans. 

Under this temporary deviation the 

General Edwards Bridge may remain in 

the closed position from September 4, 

2012 through February 27, 2013. 

Vessels that can pass under the bridge 

in the closed position may do so at any 

time. 

The Coast Guard believes that this 

temporary deviation meets the 

reasonable needs of navigation because 

the recreational users that normally use 

this bridge are recreational vessels that 

do not operate during the winter months 

when this deviation will be in effect. 

In accordance with 33 CFR 117.35(e), 

the bridge must return to its regular 

operating schedule immediately at the 

end of the designated time period. This 

deviation from the operating regulations 

is authorized under 33 CFR 117.35. 

Dated: June 29, 2012. 

Gary Kassof, 

Bridge Program Manager, First Coast Guard 

District. 

[FR Doc. 2012–17577 Filed 7–18–12; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0300; FRL–9354–9] 

Difenoconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

difenoconazole in or on multiple 

commodities identified and discussed 

in this document and amends the 

established tolerances in or on 

vegetable, tuberous and corm, subgroup 

1C and potato, processed waste. In 

addition, this regulation removes 

established tolerances for certain 

commodities/groups superseded by this 

action. The Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective July 

19, 2012. Objections and requests for 

hearings must be received on or before 

September 17, 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–2011–0300, is 

available at http://www.regulations.gov 

or at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 


tkelley on DSK3SPTVN1PROD with RULES
42434 Federal Register / Vol. 77, No. 139 / Thursday, July 19, 2012 / Rules and Regulations 

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: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; email address: 

jackson.sidney@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–2011–0300 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 September 17, 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–2011–0300, 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. Summary of Petitioned-For 

Tolerance 

In the Federal Register of July 20, 

2011 (76 FR 43231) (FRL–8880–1), EPA 

issued a notice pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 1E7852) by Interregional 

Research Project Number 4 (IR–4), IR–4 

Headquarters, 500 College Road East, 

Suite 201 W, Princeton, NJ 08540. The 

petition requested that 40 CFR 180.475 

be amended by establishing tolerances 

for residues of the fungicide, 

difenoconazole, 1-[2-[2-chloro-4-(4- 

chlorophenoxy)phenyl]-4-methyl-1,3- 

dioxolan-2-ylmethyl]-1H-1,2,4,-triazole, 

including its metabolites and degradates 

in or on vegetable, fruiting, group 8–10 

at 0.6 ppm; fruit, citrus, group 10–10 at 

0.6 ppm; fruit, pome, group 11–10 at 1.0 

ppm; and berry, low growing, subgroup 

13–07G, except cranberry at 2.5 ppm; 

and by amending the established 

tolerance in or on vegetable, tuberous 

and corm, subgroup 1C at 0.01 ppm to 

raise to 4.0 ppm. In addition, the 

petition proposes to remove established 

tolerances in or on the raw agricultural 

commodities: Potato, processed waste at 

0.04 ppm; vegetables, fruiting, group 8 

at 0.6 ppm; fruit, citrus, group 10 at 0.6 

ppm; fruit, pome, group 11 at 1.0 ppm; 

and strawberry at 2.5 ppm. That notice 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

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. 

Based upon review of the data 

supporting this petition, EPA denied the 

Petitioner’s request to remove the 

established tolerance on potato, 

processed waste at 0.04 ppm. Moreover, 

the Agency determined that the 

tolerance needs to be raised and the 

commodity terminology changed to 

potato, wet peel at 7.3 ppm. The 

Agency’s rationale for these decisions is 

outlined in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * *’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 139 / Thursday, July 19, 2012 / Rules and Regulations 42435 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for difenoconazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with difenoconazole follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Difenoconazole possesses low acute 

toxicity by the oral, dermal and 

inhalation routes of exposure. It is not 

an eye or skin irritant and is not a 

sensitizer. Subchronic and chronic 

studies with difenoconazole in mice and 

rats showed decreased body weights, 

decreased body weight gains and effects 

on the liver. In an acute neurotoxicity 

study in rats, reduced fore-limb grip 

strength was observed on day 1 in males 

and clinical signs of neurotoxicity were 

observed in females at the limit dose of 

2,000 milligrams/kilograms (mg/kg). In a 

subchronic neurotoxicity study in rats, 

decreased hind limb strength was 

observed in males only at the mid- and 

high-doses. However, the effects 

observed in acute and subchronic 

neurotoxicity studies are transient, and 

the dose-response is well characterized 

with identified no-observed-adverseeffects-levels (NOAELs). No systemic 

toxicity was observed at the limit dose 

in the most recently submitted 28-day 

rat dermal toxicity study. 

There is no concern for increased 

qualitative and/or quantitative 

susceptibility after exposure to 

difenoconazole in developmental 

toxicity studies in rats and rabbits, and 

a reproduction study in rats as fetal/ 

offspring effects occurred in the 

presence of maternal toxicity. There are 

no indications in the available studies 

that organs associated with immune 

function, such as the thymus and 

spleen, are affected by difenoconazole. 

EPA is using the non-linear 

(Reference Dose) approach to assess 

cancer risk. Difenoconazole is not 

mutagenic, and no evidence of 

carcinogenicity was seen in rats. 

Evidence for carcinogenicity was seen 

in mice (liver tumors), but statistically 

significant carcinomas tumors were only 

induced at excessively-high doses. 

Adenomas (benign tumors) and liver 

necrosis only were seen at 300 parts per 

million (ppm) (46 and 58 mg/kg/day in 

males and females, respectively). Based 

on excessive toxicity observed at the 

two highest doses in the study, the 

presence of only benign tumors and 

necrosis at the mid-dose, the absence of 

tumors at the study’s lower doses, and 

the absence of genotoxic effects, EPA 

has concluded that the chronic point of 

departure (POD) from the chronic 

mouse study will be protective of any 

cancer effects. The POD from this study 

is the NOAEL of 30 ppm (4.7 and 5.6 

mg/kg/day in males and females, 

respectively) which was chosen based 

upon only those biological endpoints 

which were relevant to tumor 

development (i.e., hepatocellular 

hypertrophy, liver necrosis, fatty 

changes in the liver and bile stasis). 

Specific information on the studies 

received and the nature of the adverse 

effects caused by difenoconazole as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Difenoconazole. Human Health Risk 

Assessment for Postharvest Use on 

Tuberous and Corm Vegetables 

Subgroup 1C. and Low growing Berry 

Subgroup 13–07G, Except Cranberry,’’ 

dated May 30, 2012 at p. 34 in docket 

ID number EPA–HQ–OPP–2011–0300. 

B. Toxicological POD/Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological POD and levels of concern 

(LOC) to use in evaluating the risk 

posed by human exposure to the 

pesticide. For hazards that have a 

threshold below which there is no 

appreciable risk, the toxicological POD 

is used as the basis for derivation of 

reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for difenoconazole used for 

human risk assessment is discussed in 

Unit III. B. of the final rule published in 

the Federal Register of June 15, 2011 

(76 FR 34877) (FRL–8876–4). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to difenoconazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing difenoconazole tolerances in 40 

CFR 180.475. EPA assessed dietary 

exposures from difenoconazole in food 

as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

Such effects were identified for 

difenoconazole. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA used an 

unrefined acute analysis for food and 

water that assumed tolerance-level 

residues, 100 percent crop treated 

(PCT), and the available empirical or 

dietary exposure evaluation model 

(DEEMTM version 7.81) default 

processing factors. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, a 

refined chronic analysis for food and 

water assumed tolerance-level residues 

for some commodities, average field 

trial residues for the majority of 

commodities, the available empirical or 

DEEMTM version 7.81 default 

processing factors, and 100 PCT. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to difenoconazole. A 

separate quantitative cancer exposure 

assessment is unnecessary since the 

NOAEL (4.7 and 5.6 mg/kg/day in males 

and females, respectively) to assess 

cancer risk is higher than the NOAEL 

(0.96 and 1.27 mg/kg/day in males and 

females, respectively) to assess chronic 

risks and exposure for the purpose of 

assessing cancer risk would be no 


tkelley on DSK3SPTVN1PROD with RULES
42436 Federal Register / Vol. 77, No. 139 / Thursday, July 19, 2012 / Rules and Regulations 

higher than chronic exposure. 

Therefore, the chronic dietary risk 

estimate will be protective of potential 

cancer risk. 

iv. Anticipated residue and PCT 

information. EPA did not use PCT 

information in the dietary assessment 

for difenoconazole and assumed 100 

PCT. EPA used anticipated residues in 

the form of average field trial residues 

for the majority of commodities in the 

chronic dietary exposure assessment. 

Section 408(b)(2)(E) of FFDCA 

authorizes EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide residues 

that have been measured in food. If EPA 

relies on such information, EPA must 

require pursuant to FFDCA section 

408(f)(1) that data be provided 5 years 

after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for difenoconazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

difenoconazole. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) for registered 

and proposed new uses and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

difenoconazole for acute exposures are 

estimated to be 17.4 parts per billion 

(ppb) for surface water and 0.0128 ppb 

for ground water. 

For chronic exposures for non-cancer 

assessments are estimated to be 11.8 

ppb for surface water and 0.0128 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

For acute dietary risk assessment, the 

water concentration value of 17.4 ppb 

was used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 11.8 

ppb was used to assess the contribution 

to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Difenoconazole is currently registered 

for the following uses that could result 

in residential exposures: Ornamentals/ 

golf course turf. EPA assessed 

residential exposure using the following 

assumptions: Adults may be exposed to 

difenoconazole from its currently 

registered use on ornamentals. 

Residential pesticide handlers may be 

exposed to short-term duration (1–30 

days) only. The dermal and inhalation 

(short-term) residential exposure was 

assessed for homeowners mixer/loader/ 

applicator wearing short pants and 

short-sleeved shirts as well as shoes 

plus socks using garden hose-end 

sprayer, pump-up compressed air 

sprayer, and backpack sprayer. 

Residential post-application exposure 

may occur from use of difenoconozole 

on golf course turf. Short-term dermal 

exposure was assessed for postapplication exposure to golf course turf. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

Difenoconazole is a member of the 

triazole-containing class of pesticides. 

Although conazoles act similarly in 

plants (fungi) by inhibiting ergosterol 

biosynthesis, there is not necessarily a 

relationship between their pesticidal 

activity and their mechanism of toxicity 

in mammals. Structural similarities do 

not constitute a common mechanism of 

toxicity. Evidence is needed to establish 

that the chemicals operate by the same, 

or essentially the same, sequence of 

major biochemical events (EPA, 2002). 

In conazoles, however, a variable 

pattern of toxicological responses is 

found. Some events are hepatotoxic and 

hepatocarcinogenic in mice. Some 

induce thyroid tumors in rats. Some 

induce developmental, reproductive, 

and neurological effects in rodents. 

Furthermore, the conazoles produce a 

diverse range of biochemical events 

including altered cholesterol levels, 

stress responses, and altered DNA 

methylation. It is not clearly understood 

whether these biochemical events are 

directly connected to their toxicological 

outcomes. Thus, there is currently no 

evidence to indicate that conazoles 

share common mechanisms of toxicity 

and EPA is not following a cumulative 

risk approach based on a common 

mechanism of toxicity for the conazoles. 

For information regarding EPA’s 

procedures for cumulating effects from 

substances found to have a common 

mechanism of toxicity, see EPA’s Web 

sites at: http://www.epa.gov/pesticides/ 

cumulative and http://www.epa.gov/ 

fedrgstr/EPA_PEST/2002/January/ 

Day_16/. 

Difenoconazole is a triazole-derived 

pesticide. This class of compounds can 

form the common metabolite 1,2,4- 

triazole and two triazole conjugates 

(triazolylalanine and triazolylacetic 

acid). To support existing tolerances 

and to establish new tolerances for 

triazole-derivative pesticides, including 

difenoconazole, EPA conducted a 

human health risk assessment for 

exposure to 1,2,4-triazole, 

triazolylalanine, and triazolylacetic acid 

resulting from the use of all current and 

pending uses of any triazole-derived 

fungicide. The risk assessment is a 

highly conservative, screening-level 

evaluation in terms of hazards 

associated with common metabolites 

(e.g., use of a maximum combination of 

uncertainty factors) and potential 

dietary and non-dietary exposures (i.e., 

high end estimates of both dietary and 

non-dietary exposures). In addition, the 

Agency retained the additional 10x 

Food Quality Protection Act (FQPA) 

safety factor (SF) for the protection of 

infants and children. The assessment 

includes evaluations of risks for various 

subgroups, including those comprised 

of infants and children. The Agency’s 

risk assessment is found in the 

propiconazole reregistration docket at 

http://www.regulations.gov, Docket 

Identification (ID) Number EPA–HQ– 

OPP–2005–0497. The requested 

amended uses of difenoconazole 

resulted in an increase in dietary 

exposure estimates for free triazole or 

conjugated triazoles. Therefore, updated 

dietary exposure analyses were 

conducted. The most recent update for 

triazoles may be found in docket ID 

number EPA–HQ–OPP–2011–0300. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10x) margin of 


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Federal Register / Vol. 77, No. 139 / Thursday, July 19, 2012 / Rules and Regulations 42437 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10x, or uses a different additional SF 

when reliable data available to EPA 

support the choice of a different factor. 

2. Prenatal and postnatal sensitivity. 

EPA determined that the available data 

indicated no increased susceptibility of 

rats or rabbits to in utero and/or 

postnatal exposure to difenoconazole. In 

the prenatal developmental toxicity 

studies in rats and rabbits and the 2- 

generation reproduction study in rats, 

toxicity to the fetuses/offspring, when 

observed, occurred at equivalent or 

higher doses than in the maternal/ 

parental animals. In the prenatal 

developmental toxicity study in rats, 

maternal toxicity was manifested as 

decreased body weight gain and food 

consumption at the LOAEL of 85 mg/kg/ 

day; the NOAEL was 16 mg/kg/day. 

Developmental toxicity in this study 

was manifested as alterations in fetal 

ossifications at 171 mg/kg/day; the 

developmental NOAEL was 85 mg/kg/ 

day. In a developmental toxicity study 

in rabbits, maternal and developmental 

toxicity were seen at the same dose level 

(75 mg/kg/day). Maternal toxicity in 

rabbits was manifested as decreased 

body weight gain and decreased food 

consumption, while developmental 

toxicity was manifested as decreased 

fetal weight. In a 2-generation 

reproduction study in rats, there were 

decreases in maternal body weight gain 

and decreases in body weights of F1

males at the LOAEL of 12.5 mg/kg/day; 

the parental systemic and off spring 

toxicity NOAEL was 1.25 mg/kg/day. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1x. That decision is 

based on the following findings: 

i. The toxicity database is complete 

except for results of a recently 

submitted immunotoxicity study 

required as a part of new data 

requirements in the 40 CFR part 158 for 

conventional pesticide registration. 

However, the existing toxicology 

database for difenoconazole does not 

show any evidence of treatment-related 

effects on the immune system. The 

overall weight of evidence suggests that 

this chemical does not directly target 

the immune system. Accordingly, the 

Agency does not believe that findings 

from the ongoing review of the 

immunotoxicity study will result in a 

lower POD than that currently in use for 

overall risk assessment, and therefore, a 

database uncertainty factor is not 

needed to account for lack of this study. 

ii. The acute and subchronic 

neurotoxicity studies in rats are 

available. These data show that 

difenoconazole exhibits some evidence 

of neurotoxicity, but the effects are 

transient or occur at the limit dose. EPA 

concluded that difenoconazole is not a 

neurotoxic compound. Based on the 

toxicity profile, and lack of 

neurotoxicity, a developmental 

neurotoxicity study in rats is not 

required. 

iii. There is no evidence that 

difenoconazole results in increased 

susceptibility of rats or rabbit fetuses to 

in utero and/or postnatal exposure in 

the developmental and reproductive 

toxicity data. 

iv. There are no residual uncertainties 

identified in the exposure databases. A 

conservative dietary food exposure 

assessment was conducted. Acute 

dietary food exposure assessments were 

performed based on tolerance-level 

residues, 100 PCT, and the available 

empirical or (DEEMTM version 7.81) 

default processing factors. 

Chronic dietary exposure assessments 

were based on tolerance-level residues 

for some commodities, average field 

trial residues for the majority of 

commodities, the available empirical or 

(DEEMTM version 7.81) default 

processing factors, and 100 PCT. These 

are conservative approaches and are 

unlikely to understate the residues in 

food commodities. 

EPA also made conservative 

(protective) assumptions in the ground 

water and surface water modeling used 

to assess exposure to difenoconazole in 

drinking water. Post-application 

residential exposure of children is not 

expected. These assessments will not 

underestimate the exposure and risks 

posed by difenoconazole. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

difenoconazole will occupy 27% of the 

aPAD for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to difenoconazole 

from food and water will utilize 75% of 

the cPAD for children 1 to 2 years old, 

the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

difenoconazole is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Difenoconazole is currently registered 

for uses that could result in short-term 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to difenoconazole. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 200 or greater. Because EPA’s 

level of concern for difenoconazole is a 

MOE of 100 or below, these MOEs are 

not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, difenoconazole 

is not registered for any use patterns 

that would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

difenoconazole. 


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42438 Federal Register / Vol. 77, No. 139 / Thursday, July 19, 2012 / Rules and Regulations 

5. Aggregate cancer risk for U.S. 

population. As discussed in Unit III.A., 

the chronic dietary risk assessment is 

protective of any potential cancer 

effects. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

difenoconazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

gas chromatography with nitrogen/ 

phosphorus detection (GC/NPD) method 

AG–575B, is available to enforce the 

tolerance expression for residues of 

difenoconazole in/on plant 

commodities. An adequate enforcement 

method, liquid chromatography coupled 

with tandem mass spectrometry (LC/ 

MS/MS) method REM 147.07b, is 

available for the determination of 

residues of difenoconazole and CGA– 

205375 in livestock commodities. 

Adequate confirmatory methods are also 

available. 

The methods may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

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 

United Nations 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. 

Codex maximum residue levels 

(MRLs) for residues of difenoconazole 

per se have been established at 0.5 ppm 

for tomato; 0.5 ppm for pome fruits; and 

0.02 ppm for potato. Based on the 

available magnitude of the residue data, 

harmonization with these established 

Codex MRLs is not possible because, the 

Codex MRLs are too low to adequately 

cover residues resulting from the 

proposed use rates in the United States. 

Canadian MRLs for residues of 

difenoconazole have been established at 

0.6 ppm for a number of fruiting 

vegetables and 1.0 ppm for a number of 

pome fruit, and are in agreement with 

proposed U.S. tolerances. The data for 

vegetable, tuberous and corm, subgroup 

1C at 4.0 ppm was a joint review 

between EPA and the Health Canada 

Pest Management Regulatory Agency 

(PMRA). The two agencies are in 

agreement regarding tolerance level for 

subgroup 1C. 

C. Revisions to Petitioned-For 

Tolerances 

The Petitioner proposed removal of 

the established tolerance in or on 

potato, processed waste at 0.04 ppm. 

However, the Agency has determined 

that this tolerance needs to be retained 

and raised to 7.3 ppm. Further, the 

commodity definition should be 

changed to potato, wet peel. The potato 

processing data indicate that residues of 

difenoconazole do not concentrate in 

flakes and chips but do concentrate in 

wet peel. Based on the highest-averagefield-trial value for residues in/on 

potatoes (2.34 ppm) and the average 

processing factor (3.1×), expected 

residues could be as high as 7.3 ppm in 

potato, wet peel. Because this value is 

higher than the recommended 4.0 ppm 

tolerance for vegetable, tuberous and 

corm, subgroup 1C, a separate tolerance 

is needed in potato, wet peel at 7.3 ppm. 

The Petitioner’s proposed commodity 

terminology for berry, low growing, 

subgroup 13–07G, except cranberry was 

corrected to comply with current crop 

terminology policy. 

V. Conclusion 

Therefore, tolerances are established 

for residues of difenoconazole, 1-[2-[2- 

chloro-4-(4-chlorophenoxy)phenyl]-4- 

methyl-1,3-dioxolan-2-ylmethyl]-1H1,2,4,-triazole, including its metabolites 

and degradates, in or on Berry, low 

growing, subgroup 13–07G, except 

cranberry at 2.5 ppm, Fruit, citrus, 

group 10–10 at 0.60 ppm, Fruit, pome, 

group 11–10 at 1.0 ppm, and Vegetable, 

fruiting, group 8–10 at 0.60 ppm; and by 

revising the established tolerance in or 

on Vegetable, tuberous and corm, 

subgroup 1C at 0.01 ppm by increasing 

the residue level to 4.0 ppm. The 

difenoconazole tolerances are further 

amended by correcting the commodity 

terminology for Potato, processed waste 

to read Potato, wet peel and increasing 

the tolerance level from 0.04 ppm to 7.3 

ppm. In addition, this regulation 

removes established tolerances in or on 

Vegetables, fruiting, group 8, Fruit, 

citrus, group 10, Fruit, pome, group 11 

and Strawberry, as these commodities 

are included in new crop groups or 

subgroups for which tolerances are 

established by this action. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) 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 FFDCA section 408(d), 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 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 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 139 / Thursday, July 19, 2012 / Rules and Regulations 42439 

‘‘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). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 11, 2012. 

Lois Rossi, 

Director, Registration 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 180.475, the table to 

paragraph (a)(1) is amended as follows: 

■ i. Remove the entries for ‘‘Fruit, citrus, 

group 10,’’ ‘‘Fruit, pome, group 11,’’ 

‘‘Potato, processed waste,’’ 

‘‘Strawberry,’’ and ‘‘Vegetables, fruiting, 

group 8.’’ 

■ ii. Add alphabetically new entries for 

Berry, low growing, subgroup 13–07G, 

except cranberry; Fruit, citrus, group 

10–10; Fruit, pome, group 11–10; 

Potato, wet peel; and Vegetable, fruiting, 

group 8–10, as shown below. 

■ iii. Revise the entry in the table to 

paragraph (a)(1) for ‘‘Vegetable, tuberous 

and corm, subgroup 1C’’. 

The added and revised text read as 

follows: 

§ 180.475 Difenconazole, tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

*****

Berry, low growing, subgroup 

13–07G, except cranberry .... 2 .5 

*****

Fruit, citrus, group 10–10 ......... 0 .60 

Fruit, pome, group 11–10 ......... 1 .0 

*****

Potato, wet peel ........................ 7 .3 

*****

Vegetable, fruiting, group 8–10 0 .60 

Vegetable, tuberous and corm, 

subgroup 1C ......................... 4 .0 

* * * * * 

[FR Doc. 2012–17628 Filed 7–18–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 679 

[Docket No. 111207737–2141–02] 

RIN 0648–XC113 

Fisheries of the Exclusive Economic 

Zone Off Alaska; Pacific Ocean Perch 

in the West Yakutat District of the Gulf 

of Alaska 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS is prohibiting directed 

fishing for Pacific ocean perch in the 

West Yakutat District of the Gulf of 

Alaska (GOA). This action is necessary 

to prevent exceeding the 2012 total 

allowable catch (TAC) of Pacific ocean 

perch in the West Yakutat District of the 

GOA. 

DATES: Effective 1200 hrs, Alaska local 

time (A.l.t.), July 16, 2012, through 2400 

hrs, A.l.t., December 31, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Steve Whitney, 907–586–7269. 

SUPPLEMENTARY INFORMATION: NMFS 

manages the groundfish fishery in the 

GOA exclusive economic zone 

according to the Fishery Management 

Plan for Groundfish of the Gulf of 

Alaska (FMP) prepared by the North 

Pacific Fishery Management Council 

under authority of the MagnusonStevens Fishery Conservation and 

Management Act. Regulations governing 

fishing by U.S. vessels in accordance 

with the FMP appear at subpart H of 50 

CFR part 600 and 50 CFR part 679. 

The 2012 TAC of Pacific ocean perch 

in the West Yakutat District of the GOA 

is 1,692 metric tons (mt) as established 

by the final 2012 and 2013 harvest 

specifications for groundfish of the (77 

FR 15194, March 14, 2012). 

In accordance with § 679.20(d)(1)(i), 

the Administrator, Alaska Region, 

NMFS (Regional Administrator), has 

determined that the 2012 TAC of Pacific 

ocean perch in the West Yakutat District 

of the GOA will soon be reached. 

Therefore, the Regional Administrator is 

establishing a directed fishing 

allowance of 1,592 mt, and is setting 

aside the remaining 100 mt as bycatch 

to support other anticipated groundfish 

fisheries. In accordance with 

§ 679.20(d)(1)(iii), the Regional 

Administrator finds that this directed 

fishing allowance has been reached. 

Consequently, NMFS is prohibiting 

directed fishing for Pacific ocean perch 

in the West Yakutat District of the GOA. 

After the effective date of this closure 

the maximum retainable amounts a 

§ 679.20(e) and (f) apply at any time 

during a trip. 

Classification 

This action responds to the best 

available information recently obtained 

from the fishery. The Acting Assistant 

Administrator for Fisheries, NOAA 

(AA), finds good cause to waive the 

requirement to provide prior notice and 

opportunity for public comment 

pursuant to the authority set forth at 5 

U.S.C. 553(b)(B) as such requirement is 

impracticable and contrary to the public 

interest. This requirement is 

impracticable and contrary to the public 

interest as it would prevent NMFS from 

responding to the most recent fisheries 

data in a timely fashion and would 

delay the closure of directed fishing for 

Pacific ocean perch in the West Yakutat 

District of the GOA. NMFS was unable 

to publish a notice providing time for 

public comment because the most 


tkelley on DSK3SPTVN1PROD with RULES