4248 Federal Register / Vol. 77, No. 18 / Friday, January 27, 2012 / Rules and Regulations 

In accordance with 33 CFR 117.35(e), 

the drawbridges must return to their 

regular operating schedules 

immediately at the end of the 

designated time period. These 

deviations from the operating 

regulations are authorized under 33 CFR 

117.35. 

Dated: January 11, 2012. 

B.L. Dragon, 

Bridge Program Director, Seventh Coast 

Guard District. 

[FR Doc. 2012–1729 Filed 1–26–12; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0697; FRL–9332–5] 

Cyazofamid; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

cyazofamid in or on basil, fresh and 

dried. This action is in response to 

EPA’s granting of an emergency 

exemption under section 18 of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of the pesticide on basil. This 

regulation establishes a maximum 

permissible level for residues of 

cyazofamid in or on these commodities. 

The time-limited tolerances expire on 

December 31, 2014. 

DATES: This regulation is effective 

January 27, 2012. Objections and 

requests for hearings must be received 

on or before March 27, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2011–0697. All documents in the 

docket are listed in the docket index 

available in http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Princess Campbell, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8033; email address: 

campbell.princess@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. http://ecfr.gpoaccess.gov/ 

cgi/t/text/text-idx?&c=ecfr&tpl=/ 

ecfrbrowse/Title40/40tab_02.tpl. To 

access the harmonized test guidelines 

referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

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–2011–0697 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 March 27, 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–2011–0697, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr. Arlington, VA. Deliveries are 

only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 

408(l)(6) of the Federal Food, Drug, and 

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

346a(e) and 346a(1)(6), is establishing 

time-limited tolerances for combined 

residues of the fungicide cyazofamid, in 

or on fresh basil at 12 parts per million 

(ppm), and on dried basil at 144 ppm. 

These time-limited tolerances expire on 

December 31, 2014. 


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Federal Register / Vol. 77, No. 18 / Friday, January 27, 2012 / Rules and Regulations 4249 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on FIFRA section 18 related 

time-limited tolerances to set binding 

precedents for the application of section 

408 of FFDCA and the safety standard 

to other tolerances and exemptions. 

Section 408(e) of FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. 

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. * * *’’ 

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for 

Cyazofamid on Basil and FFDCA 

Tolerances 

The Illinois Department of 

Agriculture (IDA) submitted a Section 

18 Specific Exemption request (10IL02). 

After having reviewed the submission, 

EPA determined that an emergency 

condition exists for this State, and that 

the criteria for approval of an emergency 

exemption were met. EPA has 

authorized a specific exemption under 

FIFRA section 18 for the use of 

cyazofamid on basil for control of 

downy mildew (Peronospora balbahrii) 

in Illinois. This new food use for 

cyazofamid triggered the requirement 

for the establishment of tolerances 

under FFDCA. 

As part of its evaluation of the 

emergency exemption application, EPA 

assessed the potential risks presented by 

residues of cyazofamid in or on basil. In 

doing so, EPA considered the safety 

standard in section 408(b)(2) of FFDCA, 

and EPA decided that the necessary 

tolerance under section 408(l)(6) of 

FFDCA would be consistent with the 

safety standard and with FIFRA section 

18. Consistent with the need to move 

quickly on the emergency exemption in 

order to address an urgent non-routine 

situation and to ensure that the resulting 

food is safe and lawful, EPA is issuing 

this tolerance without notice and 

opportunity for public comment as 

provided in section 408(l)(6) of FFDCA. 

Although these time-limited tolerances 

expire on December 31, 2014, under 

section 408(l)(5) of FFDCA, residues of 

the pesticide not in excess of the 

amounts specified in the tolerance 

remaining in or on basil after that date 

will not be unlawful, provided the 

pesticide was applied in a manner that 

was lawful under FIFRA, and the 

residues do not exceed a level that was 

authorized by these time-limited 

tolerances at the time of that 

application. EPA will take action to 

revoke these time-limited tolerances 

earlier if any experience with, scientific 

data on, or other relevant information 

on this pesticide indicate that the 

residues are not safe. 

Because these time-limited tolerances 

are being approved under emergency 

conditions, EPA has not made any 

decisions about whether cyazofamid 

meets FIFRA’s registration requirements 

for use on basil or whether permanent 

tolerances for this use would be 

appropriate. Under these circumstances, 

EPA does not believe that this timelimited tolerance decision serves as a 

basis for registration of cyazofamid by a 

State for special local needs under 

FIFRA section 24(c). Nor does this 

tolerance by itself serve as the authority 

for persons in any State other than 

Illinois to use this pesticide on the 

applicable crops under FIFRA section 

18 absent the issuance of an emergency 

exemption applicable within that State. 

For additional information regarding the 

emergency exemption for cyazofamid, 

contact the Agency’s Registration 

Division at the address provided under 

FOR FURTHER INFORMATION CONTACT. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with the factors specified 

in FFDCA section 408(b)(2)(D), 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 expected as a result 

of this emergency exemption request 

and the time-limited tolerances for 

combined residues of cyazofamid on 

fresh basil at 12 ppm, and on dried basil 

at 144 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing time-limited tolerances 

follows. 

A. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern 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 cyazofamid used for 

human risk assessment is discussed in 

Unit III. B. of the final rule published in 

the Federal Register of July 14, 2010 (75 

FR 40745) (FRL–8833–1). 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to cyazofamid, EPA 

considered exposure under the timeVerDate Mar<15>2010 15:16 Jan 26, 2012 Jkt 226001 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 E:\FR\FM\27JAR1.SGM 27JAR1

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4250 Federal Register / Vol. 77, No. 18 / Friday, January 27, 2012 / Rules and Regulations 

limited tolerances established by this 

action as well as all existing cyazofamid 

tolerances in 40 CFR 180.601. EPA 

assessed dietary exposures from 

cyazofamid in food as follows: 

i. Acute exposure. No acute toxicity 

endpoint was identified for cyazofamid 

for the general population including 

infants and children, because no acute 

effects were observed which could be 

attributed to a single-dose exposure. 

Nevertheless, EPA estimated acute 

exposure for the subpopulation, females 

13–49 years, based on the 

developmental toxicity risk. 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). 

Tolerance level residues and 100 

percent crop treated (PCT) assumptions 

were used. Anticipated residues and 

PCT information were not used. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. Tolerance level residues and 100 

PCT assumptions were used. 

Anticipated residues and PCT 

information were not used. 

iii. Cancer. Based on the data 

summarized in Unit III.A., July 14, 2010, 

and at http://www.regulation.gov in 

document ‘‘Cyazofamid. Human Health 

Risk Assessment for Proposed Section 

18 Use on Basil, item 4.4 Dietary 

Exposure and Risk,’’ p.14, EPA has 

concluded that cyazofamid does not 

pose a cancer risk to humans. 

Cyazofamid has been classified as ‘‘not 

likely to be carcinogenic in humans,’’ 

based on the absence of significant 

tumor increases in two rodent 

carcinogenic studies. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for cyazofamid in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of cyazofamid. 

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), the estimated 

drinking water concentrations (EDWCs) 

of cyazofamid for acute exposures are 

estimated to be 136 parts per billion 

(ppb) for surface water and 2.18 ppb for 

ground water. For chronic exposures for 

non-cancer assessments EDWCs are 

estimated to be 133 ppb for surface 

water and 2.18 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 136 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 133 ppb was used to assess the 

contribution to drinking water. 

3. Sources of 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). 

Cyazofamid is currently registered for 

the following uses that could result in 

residential exposures: Commerciallytreated residential turf and ornamentals. 

EPA assessed residential exposure using 

the following assumptions: Nonoccupational handler exposures are not 

expected; however, post-application 

exposure is possible for children and 

adults. Non-occupational/residential 

MOEs were estimated for ‘‘Day 0’’ 

exposure. The post-application 

children’s aggregate MOE (including 

incidental oral exposures) is 1,600. The 

Agency is concerned when MOEs are 

<100. All MOEs, including the 

children’s aggregate, are >100, and 

therefore not a risk concern. 

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.’’ 

EPA has not found cyazofamid to 

share a common mechanism of toxicity 

with any other substances, and 

cyazofamid does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that cyazofamid 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. 

C. 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 

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 

Food Quality Protection Act (FQPA) 

Safety Factor (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. 

The prenatal and postnatal toxicology 

database for cyazofamid includes rat 

and rabbit developmental toxicity 

studies and a 2-generation reproduction 

toxicity study in rats. There was some 

evidence of increased susceptibility 

following in utero exposure to rats in 

the prenatal developmental toxicity 

study; the increased incidence of bent 

ribs in the high dose fetuses was 

considered adverse and was used for 

setting the developmental NOAEL/ 

LOAEL. 

3. Conclusion. EPA has determined 

that reliable data show that 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 for 

cyazofamid is sufficient to characterize 

the hazard, to conduct FQPA 

assessment, and to select toxicity 

endpoints for risk assessment. Under 

current data requirement guidelines, 

functional immunotoxicity data (OPPTS 

780.7800) is a data gap. However, the 

cyazofamid toxicology database does 

not show any evidence of biologically 

relevant effects on the immune system 

that relate to this chemical. The Agency 

does not believe that conducting a 

functional immunotoxicity study will 

result in a lower NOAEL than the 

regulatory dose for this risk assessment, 

and an additional uncertainty factor 

(UF) for the data gap is unnecessary. 

ii. There is no indication that 

cyazofamid is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 


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neurotoxicity for this time-limited 

tolerance. 

iii. There was some evidence of 

increased susceptibility following in 

utero exposure to rats in the prenatal 

developmental toxicity study. As 

described earlier, the increased 

incidence of bent ribs in the high dose 

fetuses was considered adverse and was 

used for setting the developmental 

NOAEL/LOAEL. EPA considers this 

approach conservative and highly 

protective because bent ribs are a 

reversible developmental anomaly 

rather than a malformation. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to cyazofamid 

in drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by cyazofamid. 

D. 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 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 

cyazofamid will occupy 1.2% of the 

aPAD for females 13–49 years, the only 

subpopulation assessed. For the 

population of concern, the acute dietary 

(food and drinking water) risk 

assessment represents acute aggregate 

risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to cyazofamid 

from food and water will utilize <1% of 

the cPAD for children 1–2 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 cyazofamid is not expected. 

3. Short-term and intermediate term 

risk. Short-term and intermediate-term 

risks have been assessed together 

because both scenarios have the same 

endpoints and PODs. Short-intermediate 

term aggregate exposure takes into 

account short-intermediate term 

residential exposure plus chronic 

exposure to food and drinking water 

(considered to be a background 

exposure level). Cyazofamid is currently 

registered for uses that could result in 

short-term and/or intermediate term 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-intermediate term 

residential exposures to cyazofamid. 

Using the exposure assumptions 

described in this unit for shortintermediate term exposures, EPA has 

concluded the combined shortintermediate term food, water, and 

residential exposures result in aggregate 

MOEs of >100 for all scenarios. Because 

EPA’s level of concern for cyazofamid is 

a MOE of 100 or below, these MOEs are 

not of concern. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent (both the rat and the 

mouse) carcinogenicity studies, 

cyazofamid is not expected to pose a 

cancer risk to humans. 

5. 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 cyazofamid 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies 

are available to enforce the tolerance 

expression. Cyazofamid its and 

metabolite CCIM are completely 

recovered (≤80% recovery) using FDA’s 

Multiresidue Protocol D (without 

cleanup). In addition, an acceptable 

high performance liquid 

chromatography/ultraviolet/detector 

(HPLC/UV) method (‘‘Independent 

Laboratory Validation of the Residue 

Method for IKF–916 and CCIM in 

Tomatoes’’, Document Number 013033– 

0, Pyxant Labs Inc., with slight 

modification) is available for use as a 

single analyte confirmatory method. 

The method 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 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 cyazofamid on basil. 

VI. Conclusion 

Therefore, time-limited tolerances are 

established for residues of cyazofamid, 

4-chloro-2-cyano-N,N-dimethyl-5-(4- 

methylphenyl)-1H-imidazole-1- 

sulfonamide,and its metabolites and 

degradates in or on basil, fresh, at 12 

ppm, and basil, dried, at 144 ppm. 

These tolerances expire on December 

31, 2014. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes timelimited tolerances under sections 408(e) 

and 408(l)(6) of FFDCA. 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 


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4252 Federal Register / Vol. 77, No. 18 / Friday, January 27, 2012 / Rules and Regulations 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established in accordance with 

sections 408(e) and 408(l)(6) of FFDCA, 

such as the tolerances 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). 

VIII. 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. 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 18, 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 180.601 is amended by 

revising paragraph (b) to read as follows: 

§ 180.601 Cyazofamid; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for residues of the fungicide 

cyazofamid, including its metabolites 

and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only the sum 

of cyazofamid, 4-chloro-2-cyano-N,Ndimethyl-5-(4-methylphenyl)-1Himidazole-1-sulfonamide and its 

metabolite CCIM, 4-chloro-5-(4- 

methylphenyl)-1H-imidazole-2- 

carbonitrile, calculated as the 

stoichiometric equivalent of 

cyazofamid, resulting from use of the 

pesticide under FIFRA section 18 

emergency exemptions. The tolerances 

expire and are revoked on the date 

specified in the table. 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Basil, dried ............................................................................................................................................................... 144 12/31/14 

Basil, fresh ............................................................................................................................................................... 12 12/31/14 

* * * * * 

[FR Doc. 2012–1815 Filed 1–26–12; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 2 and 95 

[ET Docket No. 09–36; RM–11404; FCC 11– 

176] 

Additional Spectrum for the Medical 

Device Radiocommunication Service 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: This document expands the 

Commission’s Medical Device 

Radiocommunication (MedRadio) 

Service rules to permit the use of new 

wideband medical implant devices that 

employ neuromuscular 

microstimulation techniques to restore 

sensation, mobility, and other functions 

to paralyzed limbs and organs. These 

medical devices hold enormous promise 

to advance the state of medical care, 

lower health costs, and improve the 

quality of life for countless Americans. 

The rules will allow these new types of 

MedRadio devices to access 24 

megahertz of spectrum in the 413–419 

MHz, 426–432 MHz, 438–444 MHz, and 

451–457 MHz bands on a secondary 

basis. 

DATES: Effective February 27, 2012. 

ADDRESSES: Federal Communications 

Commission, 445 12th Street SW., 

Washington, DC 20554. 

FOR FURTHER INFORMATION CONTACT: 

Nicholas Oros, Office of Engineering 

and Technology, 202–418–063, 

Nicholas.oros@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Report 

and Order, ET Docket No. 09–36; RM 

11404, FCC 11–176, adopted November 

30, 2011 and released November 30, 

2011. The full text of this document is 

available for inspection and copying 

during normal business hours in the 

FCC Reference Center (Room CY–A257), 

445 12th Street SW., Washington, DC 

20554. The complete text of this 

document also may be purchased from 

the Commission’s copy contractor, Best 


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