Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Rules and Regulations 17123 

STATE OF WASHINGTON NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES—Continued 

Name of SIP provision 

Applicable 

geographic or 

nonattainment area 

State 

submittal 

date 

EPA approval date Comments 

Particulate Matter (PM10) Maintenance Plan ...... Kent ..................................... 8/23/99 ................. 3/13/01 .............................

66 FR 14492 ...................

Particulate Matter (PM10) Maintenance Plan ...... Seattle ................................. 8/23/99 ................. 3/13/01 .............................

66 FR 14492 ...................

Particulate Matter (PM10) Maintenance Plan ...... Tacoma ............................... 8/23/99 ................. 3/13/01 .............................

66 FR 14492 ...................

Particulate Matter (PM10) Maintenance Plan ...... Yakima ................................ 7/8/04 ................... 2/8/05 ...............................

70 FR 6591 .....................

Particulate Matter (PM10) Attainment Plan—Revision.Wallula ................................. 11/30/04 ............... 5/2/05 ...............................

70 FR 22597 ...................

Particulate Matter (PM10) Maintenance Plan ...... Spokane .............................. 11/30/04 ............... 7/1/05 ...............................

70 FR 38029 ...................

Particulate Matter (PM10) Maintenance Plan ...... Wallula ................................. 3/29/05 ................. 8/26/05 .............................

70 FR 50212 ...................

Particulate Matter (PM2.5) Clean Data Determination.Tacoma, Pierce County ...... 05/22/12 ............... 09/04/12 ...........................

77 FR 53772 ...................

Visibility and Regional Haze Plans 

Visibility New Source Review (NSR) for non-attainment areas for Washington.Statewide ............................. 6/26/86 .............................

51 FR 23228 ...................

Washington State Visibility Protection Program Statewide ............................. 11/5/99 ................. 6/11/03 .............................

68 FR 34821 ...................

Regional Haze State Implementation Plan— 

TransAlta BART.

Statewide ............................. 12/29/11 ............... 12/6/12 .............................

77 FR 72742 ...................

110(a)(2) Infrastructure and Interstate Transport 

Interstate Transport for the 1997 8-Hour Ozone 

and PM2.5 NAAQS.

Statewide ............................. 1/17/07 ................. 1/13/09 .............................

74 FR 1591 .....................

110(a)(2) Infrastructure Requirements—1997 

ozone standard.

Statewide ............................. 1/24/12 ................. 5/24/12 .............................

77 FR 30902 ...................

Other Federally Mandated Plans 

Oxygenated Gasoline Program .......................... .............................................. 1/22/93 ................. 1/20/94 .............................

59 FR 2994 .....................

Business Assistance Program ............................ .............................................. 11/16/92 ............... 3/8/95 ...............................

60 FR 12685 ...................

Motor Vehicle Inspection & Maintenance Program............................................... 8/21/95 ................. 9/25/96 .............................

61 FR 50235 ...................

Supplementary Documents 

Air Quality Monitoring, Data Reporting and Surveillance Provisions............................................... 4/15/81 .................

Energy Facilities Site Evaluation Council 

(EFSEC) Memorandum of Agreement.

.............................................. 2/23/82 .................

■ 3. Amend the newly designated 

§ 52.2477 by revising the section 

heading and paragraph (a) to read as 

follows: 

§ 52.2477 Original identification of plan 

section. 

(a) This section identified the original 

‘‘Air Quality Implementation Plan for 

the State of Washington’’ and all 

revisions submitted by Washington that 

were federally approved prior to 

December 7, 2012. 

* * * * * 

§ 52.2479 [Removed and reserved] 

■ 4. Remove and reserve § 52.2479. 

§ 52.2491 [Removed and reserved] 

■ 5. Remove and reserve § 52.2491. 

§ 52.2499 [Removed and reserved] 

■ 6. Remove and reserve § 52.2499. 

[FR Doc. 2013–06310 Filed 3–19–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0051; FRL–9381–1] 

Amitraz; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of amitraz in or 

on honey and honeycomb. Arysta 

Lifescience America, Inc. requested the 

tolerance for honey under the Federal 

Food, Drug, and Cosmetic Act (FFDCA). 


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17124 Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Rules and Regulations 

DATES: This regulation is effective 

March 20, 2013. Objections and requests 

for hearings must be received on or 

before May 20, 2013, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2010–0051 is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., 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: 

Stacey Groce, Registration Divison, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–2505; email address: 

groce.stacey@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: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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://www.ecfr.gov/cgi-bin/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–2010–0051 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 May 20, 2013. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2010–0051 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), (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 March 24, 

2010 (75 FR 14154) (FRL–8815–6), EPA 

issued a document pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 9F7673) by Veto-Pharma 

SA, c/o Arysta LifeScience America, 

1450 Broadway, 7th Floor, New York, 

NY 10018. The petition requested that 

40 CFR 180.287 be amended by 

establishing tolerances for residues of 

the insecticide, amitraz, (N’-[2,4- 

dimethylphenyl]-N-[[(2,4- 

dimethylphenyl)imino]methyl]]-Nmethylmethanimidamide) in or on 

honey at 1 part per million (ppm). That 

document referenced a summary of the 

petition prepared by Veto-Pharma, SA 

c/o Arysta, the registrant, which is 

available to the public in the docket, 

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

no comments received in response to 

the notice of filing. 

Based upon review of data supporting 

the petition, EPA is establishing a lower 

tolerance for honey than was requested 

and is establishing a tolerance for 

honeycomb. The reasons for these 

changes are explained in detail 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 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for amitraz including 

exposure resulting from the tolerances 

established by this action. EPA’s 

assessment of exposures and risks 

associated with amitraz follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 


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Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Rules and Regulations 17125 

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. 

Acute toxicity studies in various 

laboratory animals indicate that amitraz 

is moderately toxic via the dermal route, 

and it is slightly toxic via the oral and 

not acutely toxic via inhalation routes of 

exposure. Further, it is not a skin or eye 

irritant, nor is it a skin sensitizer. 

Multiple species display evidence of 

neurotoxicity following exposure to 

amitraz. Clinical signs of neurotoxicity 

were seen across species, sexes, and 

routes of administration. Based on 

available human and animal studies, 

human subjects were shown to be more 

sensitive than any other species tested, 

followed by the dog. In both the oral 

subchronic and chronic studies in dogs, 

signs of central nervous system 

depression were observed along with a 

decrease in pulse rate and hypothermia 

noted in the subchronic study. In both 

the oral subchronic and chronic studies 

and in the 21-day inhalation study in 

the rat, irritability, nervousness and/or 

excitability were observed. In the rabbit 

developmental toxicity study, clinical 

signs that were considered to be related 

to treatment included languor and 

polypnea. Sedation was also observed in 

rabbits in the repeated dose dermal 

study. In the single dose human 

metabolism study, neurotoxic effects 

such as dry mouth, drowsiness, 

decreased temperature, and bradycardia 

were seen within 90 to 160 minutes 

after ingestion and persisted for up to 12 

hours at the lowest dose tested (0.25 

mg/kg/day). 

No developmental toxicity was seen 

at the highest dose tested in two prenatal developmental toxicity studies in 

rats. Two independent developmental 

toxicity studies were available in 

rabbits. Although technical deficiencies 

were encountered in the conduct of 

these studies, no developmental effects 

were seen either at the highest dose 

tested (in one study) or in the presence 

of maternal toxicity (second study). 

When taken together, these studies 

show that (1) amitraz does not cause 

developmental toxicity in this species 

and (2) rabbits are not more sensitive 

than rats since the doses tested in the 

rabbits were higher than the doses 

tested in the rat developmental study 

where no developmental toxicity was 

seen at any dose level. The database 

contains a 1-generation and a 3- 

generation reproduction study in rats. In 

the 1-generation study, no reproductive 

toxicity was seen at the highest dose 

tested and offspring toxicity was seen in 

the presence of parental/systemic 

toxicity. In the 3-generation 

reproduction study, no reproductive 

toxicity was seen at the highest dose 

tested, however, offspring toxicity was 

seen at a lower dose than the dose that 

caused parental/systemic toxicity. 

The CNS effects of amitraz do not 

appear to be cumulative, i.e., do not 

accumulate with increased duration. In 

the 90-day repeat dose dog study, the 

CNS effects appear early on (within 3 

hours of dosing), rapidly end, and recur 

daily after dosing throughout the study. 

In the chronic (2-year) dog study, the 

CNS effects are seen following a single 

dose on the first 2 days of the study, 

with transient hypothermia detected in 

only one female throughout the rest of 

the study, indicative of some potential 

adaptation occurring at lower doses over 

longer periods of testing. The NOAEL 

and LOAEL for the 90-day and chronic 

dog studies are the same, also indicating 

that the CNS effects are not cumulative, 

but are a response to each daily dose 

that is likely reversible if exposure were 

to stop. Additionally, the single dose 

(acute) studies across several species 

show an onset of CNS effects within a 

few hours and recovery within a few 

hours to several days. The human 

metabolism study showed neurotoxic 

effects shortly after dosing, which 

disappeared within 12 hours. Although 

the metabolism study was limited to 

two subjects, both human subjects 

exposed experienced clear CNS effects 

that were consistent with the animal 

data. Because of the reversibility of the 

CNS effects, exposures of all durations 

can be regarded as a series of repeating 

one-day (acute) exposures. 

For other effects, such as body weight 

changes and the tumors in the mouse 

study, those effects are likely to be 

cumulative. However, those effects 

occur at higher dose levels than the CNS 

depression. The human endpoint (0.125 

mg/kg/day) will be protective of other 

longer term systemic effects as it is a 

lower dose level than the dose levels 

where these other systemic effects such 

as body weight change occur. 

Although a mouse carcinogenicity 

study showed that amitraz was 

associated with common tumors (liver 

and lung) in the mouse, EPA has 

determined that quantification of risk 

using a non-linear approach (i.e., RfD) 

for amitraz will adequately account for 

all chronic toxicity, including 

carcinogenicity, that could result from 

exposure to amitraz and its metabolites. 

That conclusion is based on the 

following considerations: (1) No 

carcinogenic response was seen in an 

acceptable rat cancer study; (2) the 

tumors found in the mouse are 

commonly seen in the mouse and were 

only found at a dose that appears to 

have been excessive given the other 

adverse effects seen in the animals; (3) 

amitraz is not mutagenic; and (4) 

although there is limited positive 

mutagenicity data and equivocal 

evidence of cancer for a minor amitraz 

metabolite, that equivocal cancer 

evidence was present only at high doses 

and was not consistent with the tumors 

seen in the amitraz study. 

More detailed information on the 

studies received and the nature of the 

adverse effects caused by amitraz as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

entitled, ‘‘Amitraz: Aggregate Human 

Health Risk Assessment for Section 3 

New Use in Beehives,’’ dated January 8, 

2013, by going to http:// 

www.regulations.gov. The referenced 

document is available in the docket 

established by this action, which is 

described under ADDRESSES. Locate and 

click on the hyperlink for docket ID 

number EPA–HQ–OPP–2010–0051. 

Double-click on the document to view 

the referenced information on pages 15– 

19 of 48. 

B. 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:// 


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www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for amitraz used for human 

risk assessment is shown in the table of 

this unit. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR AMITRAZ FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (General population including infants and 

children).

NOAEL = 0.125 mg/ 

kg/day.

UFH = 10x 

FQPA SF = UFDB =

10x 

Acute RfD = 0.0125 

mg/kg/day.

aPAD = 0.00125 mg/ 

kg/day 

A double-blind randomized crossover study in human subjects. 

LOAEL = 0.25 mg/kg/day based on dry mouth, drowsiness, 

decreased temperature, decreased blood pressure and decreased heart rate. 

Incidental oral short- and intermediate term.NOAEL= 0.125 mg/ 

kg/day.

UFH = 10x 

FQPA SF = UFDB =

10x 

Residential LOC for 

MOE = 100.

A double-blind randomized crossover study in human subjects. 

LOAEL = 0.25 mg/kg/day based on dry mouth, drowsiness, 

decreased temperature, decreased blood pressure and decreased heart rate. 

Dermal (All durations) ............... Oral NOAEL = 0.125 

mg/kg/day.

Dermal Absorption 

Rate = 1.6% 

UFH = 10x 

FQPA SF = UFDB =

10x 

Residential LOC for 

MOE = 100.

A double-blind randomized crossover study in human subjects. 

LOAEL = 0.25 mg/kg/day based on dry mouth, drowsiness, 

decreased temperature, decreased blood pressure and decreased heart rate. 

Inhalation (All durations) ........... Oral NOAEL = 0.125 

mg/kg/day.

UFH = 10x 

FQPA SF = UFDB =

10x 

Residential LOC for 

MOE = 100.

A double-blind randomized crossover study in human subjects. 

LOAEL = 0.25 mg/kg/day based on dry mouth, drowsiness, 

decreased temperature, decreased blood pressure and decreased heart rate. 

Cancer (Oral, dermal, inhalation).EPA has determined that quantification of risk using a non-linear approach (i.e., RfD) will adequately account 

for all chronic toxicity, including carcinogenicity. Because of the reversibility of the CNS effects, exposures of 

all durations can be regarded as a series of repeating one-day (acute) exposures and there is no increase in 

hazard with increasing dosing duration. Therefore, the acute dietary endpoint is protective of the endpoints 

from repeat dosing studies, including cancer dietary exposures. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute). 

RfD = reference dose. UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to amitraz, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing amitraz 

tolerances in 40 CFR 180.287. EPA 

assessed dietary exposures from amitraz 

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 amitraz. 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 conducted a partially 

refined acute dietary analysis using the 

Dietary Exposure Evaluation Model 

DEEM–FCID TM, Version 2.03 and 

assumed exposure through honey, 

imported cottonseed oil, meat and milk 

from dermal treatments of livestock. The 

residue values used for livestock 

products, except for milk, are based 

upon tolerance level residues. Milk 

residues were assessed using the highend result from the original cattle 

dosing study. Percents of livestock 

treated were used. Residues in 

cottonseed oil were estimated using the 

tolerance level and percent crop 

imported. For honey, residue values 

from field trial data and 100% crop 

treated were used. 

ii. Chronic exposure. Based on data 

summarized in Unit lll.A., there is no 

increase in hazard from repeated 

exposures to amitraz; as such the acute 

dietary exposure assessment is 

protective of any chronic dietary 

exposures to amitraz because there is no 

increase in hazard with increasing 

dosing duration. Accordingly, a dietary 

exposure assessment for the purpose of 

assessing chronic dietary risk was not 

conducted. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. If quantitative cancer risk 

assessment is appropriate, cancer risk 

may be quantified using a linear or 

nonlinear approach. If sufficient 

information on the carcinogenic mode 

of action is available, a threshold or 

nonlinear approach is used and a cancer 

RfD is calculated based on an earlier 

noncancer key event. If carcinogenic 

mode of action data is not available, or 

if the mode of action data determines a 

mutagenic mode of action, a default 

linear cancer slope factor approach is 

utilized. Based on the data summarized 

in Unit III.A., the Agency has 

determined that quantification of risk 

using a nonlinear approach (i.e., RfD) 

would adequately account for all 

chronic toxicity, including 

carcinogenicity, that could result from 

exposure to amitraz. Therefore, the 

acute dietary assessment is protective of 


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Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Rules and Regulations 17127 

any cancer effects resulting from amitraz 

residues in food. 

iv. Anticipated residue and percent 

crop treated (PCT) information. 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. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

The Agency estimated the PCT for 

existing uses as follows: Cotton seed oil, 

2%; beef meat, 0.3%; beef meat dried, 

0.3%; beef meat byproducts, 0.3%; beef 

fat, 0.3%; beef kidney, 0.3%; beef liver, 

0.3%; pork meat, 1.2%, pork skin, 1.2%; 

pork meat byproducts, 1.2%; pork fat, 

1.2%; pork kidney, 1.2%; pork liver, 

1.2%; milk fat, 0.3%; milk non-fat 

solids, 0.3%; milk water, 0.3%; milk 

sugar, 0.3%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

For this request, the EPA relied on 

available data in USDA NASS for cattle 

and swine to determine the percent of 

animal heads treated with amitraz. 

NASS does not report the total number 

of dairy cattle treated with a particular 

chemical because the applications vary 

significantly based on product 

formulation, method of application, and 

pest stress at particular locations. 

Rather, they report chemical usage on a 

rate per head per application and rate 

per head per year basis. To determine 

the number of cattle treated, EPA 

divided the total pounds of amitraz 

applied by the total rate per head per 

year, which NASS defines as the 

average number of pounds applied 

counting multiple applications. It was 

assumed that the average rate captures 

the variation in number of cows treated. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which amitraz may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. Drinking water was not included 

in the dietary assessment as it was 

determined that amitraz is not expected 

to enter water-bodies or drinking water 

through the current and proposed uses. 

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). Amitraz 

is currently registered for the following 

uses that could result in residential 

exposures: Pet uses from dog collars and 

spot-on treatments. EPA assessed 

residential exposure using the following 

assumptions: There is a potential for 

residential exposure to amitraz from 

existing pet uses (dog collars and spoton treatments), either from applying 

(handling) the products or from postapplication contact with the treated dog. 

A dermal exposure assessment was 

performed for adults applying the 

amitraz pet products. For postapplication exposure to treated dogs, a 

dermal assessment was performed for 

adults and a dermal and oral (hand to 

mouth) assessment was performed for 

children 1–2 years of age. Handler and 

post-application inhalation exposure is 

expected to be negligible and was not 

quantitatively assessed. EPA did not 

assess intermediate-term or chronic 

residential exposures because amitraz is 

acutely toxic and does not increase in 

potency with repeated dosing. 

Residential exposures of all durations 

can be regarded as a series of repeating 

one-day exposures based on the current 

toxicity database for amitraz, which 

suggests that the central nervous system 

effects of amitraz are not cumulative, 

but are a response to each daily dose. 

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 amitraz to share a common 

mechanism of toxicity with any other 

substances, and amitraz does not appear 

to produce a toxic metabolite produced 

by other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that amitraz does not have a 


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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. 

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 

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 Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The toxicology database is not complete 

to assess susceptibility following preand/or post natal exposure to amitraz. 

There was no evidence of increased 

susceptibility in rats since no 

developmental toxicity was seen at the 

highest dose tested in two independent 

pre-natal developmental toxicity studies 

in rats. Evidence for susceptibility in 

rabbits could not be ascertained due to 

technical deficiencies in the conduct of 

two independent developmental 

studies. However, the concern for the 

lack of susceptibility assessment is 

lessened because (1) in both studies, 

developmental effects occurred in the 

presence of maternal toxicity (one 

study) or at a dose higher than the dose 

that caused maternal toxicity (second 

study); (2) the doses tested in the rabbit 

studies were higher than the doses 

tested in developmental study in rats 

showing that rabbits are not more 

sensitive than rats. Two reproductive 

toxicity studies (1-generation and a 3- 

generation) are available; in the 

1-generation study, no reproductive 

toxicity was seen at the highest dose 

tested and offspring toxicity was seen in 

the presence of parental/systemic 

toxicity. In the 3-generation 

reproduction study, no reproductive 

toxicity was seen at the highest dose 

tested, however, offspring toxicity was 

seen at a lower dose than the dose that 

caused parental/systemic toxicity. Both 

studies were deemed to be unacceptable 

due to technical deficiencies in the 

conduct of these studies. Neurotoxicity 

was seen in a variety of animal studies 

and in human subjects and the database 

does not contain specific neurotoxicity 

studies. 

3. Conclusion. The 10X FQPA Safety 

Factor (for the protection of infants and 

children) is retained in the form of a 

database uncertainty factor (UFDB), due 

to multiple toxicology data deficiencies 

for amitraz (i.e. reproduction, 

immunotoxicity, and DNT studies). 

i. The toxicity database for amitraz is 

incomplete, but adequate for purposes 

of risk assessment. An Extended OneGeneration Reproductive Toxicity 

(EOGRT) study is required for amitraz to 

evaluate the reproductive, neurotoxic, 

and immunotoxic potential of amitraz. 

ii. Various mammalian species in 

multiple studies have demonstrated the 

signs of neurotoxicity for amitraz (i.e., 

sedation, hypothermia, drowsiness, etc). 

The DNT study will be a component of 

the EOGRT study, thus will specifically 

monitor the potential neurotoxicity of 

amitraz in targeted testing. 

iii. As mentioned in Unit III.D.2., the 

toxicology database is not complete to 

assess susceptibility following pre-and/ 

or post natal exposure to amitraz. 

iv. There are no residual uncertainties 

identified in the amitraz exposure 

databases with regard to dietary or 

residential exposure and no outstanding 

exposure data gaps. The dietary 

assessments are based on conservative, 

health protective assumptions regarding 

exposure from food and are designed 

not to underestimate exposures. 

Residential exposures resulting from 

contact with dogs wearing amitraz pet 

collars is conservative. The residential 

risk estimates are based upon protective 

assumptions of application rate, 

duration of exposure, and contact with 

the treated animal. The fraction of 

application rate transferred, while nonchemical specific, represents the best 

data available to assess risk from 

exposures to the amitraz collar and will 

not underestimate risk. Drinking water 

was not included in the dietary 

assessment as it was determined that 

amitraz is not expected to enter waterbodies or drinking water through the 

current and proposed uses. 

A 10X FQPA safety factor is 

considered protective for the following 

reasons: (1) A clear NOAEL was used as 

the point of departure for risk 

assessment; (2) the NOAEL was from the 

most sensitive species; (3) the NOAEL is 

from an adequate study in humans that 

examined the most sensitive endpoint 

(neurotoxicity) seen in the animal data; 

(4) given the existing animal data, EPA 

expects that the most sensitive effect 

found in the EOGRT study will be a 

neurotoxic one; (5) EPA is applying a 

10X intra-species safety factor to 

account for potential variability in the 

sensitivity in humans (including 

potentially greater sensitivity in infants 

and children than in the adults tested in 

the human study); and (6) in the 

3-generation reproduction study, the 

only study showing the potential for 

increased susceptibility in offspring, 

offspring were less than 4X more 

sensitive than adult animals; retention 

of the additional default 10X safety 

factor for the protection of infants and 

children means that there will be a 100X 

factor to account primarily for potential 

sensitivity in the young even though the 

available (though incomplete) data show 

sensitivity in the young of no greater 

than 4X. 

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, at the 99.9th percentile 

of exposure, the acute dietary exposure 

from food to amitraz will occupy 76% 

of the aPAD for children 1–2 years old, 

the population group receiving the 

greatest exposure. 

2. Chronic risk. Based on the data 

summarized in Unit lll.A., there is no 

increase in hazard with increasing 

dosing duration. In general, aggregate 

assessments combine average (chronic) 

dietary exposures with conservative 

residential exposures. However, in the 

case of amitraz, a chronic dietary 

assessment was not performed since the 

acute dietary assessment will result in 

higher estimated exposure levels and 

will therefore be protective of any 

chronic aggregate exposures. 

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). Amitraz is currently 

registered for uses that could result in 

short-term residential exposure. In 

general aggregate assessments combine 

average (chronic) dietary exposures with 

conservative residential exposures. 

However, in the case of amitraz, a 


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chronic dietary assessment was not 

performed since the acute dietary 

assessment will result in higher 

estimated exposure levels and will 

therefore be protective of any chronic 

exposures. As a screening level 

aggregate assessment, residential postapplication exposures from the small to 

medium dog collar uses (the residential 

scenario resulting in the highest 

estimated exposures) were combined 

with acute dietary exposures at the 95th 

percentile of exposure. While 

aggregation using an average 

background exposure would more 

appropriately reflect expected 

exposures, in the absence of a chronic 

dietary assessment, use of acute 

exposures at the 95th percentile of 

exposure provides a high-end aggregate 

risk screen. 

For children 1–2 years old, the most 

highly exposed children’s subgroup, 

and for adults, using the exposure 

assumptions described in this unit for 

short-term exposures, EPA has 

concluded that the combined short-term 

food and residential exposures result in 

aggregate MOEs of 120 and 450, 

respectively. For amitraz, MOEs of 100 

or greater 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 aggregate risk 

assessment was not conducted because 

amitraz is acutely toxic and its potency 

does not increase with repeated dosing. 

Therefore, the acute and short-term 

aggregate assessments are protective of 

intermediate-term aggregate risks 

anticipated from amitraz exposure. 

5. Aggregate cancer risk for U.S. 

population. For the reasons discussed in 

Unit lll.A., (cancer effects are non-linear 

and appear at higher doses than acute 

effects), and Unit lll.E.2., (chronic 

exposures are lower than acute 

exposures), the acute aggregate 

assessment is protective of potential 

cancer risk. 

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 amitraz 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

There are two adequate methods, 

Methods I (designed for animal tissues 

and milk) and II (designed for plant 

commodities) available to enforce the 

proposed tolerances for honey and 

honeycomb. Both are GLC methods with 

electron capture detection (ECD), and 

involve conversion of residues of 

amitraz and its metabolites containing 

the 2,4-dimethylaniline moiety to 2,4- 

DMA using acid and base hydrolysis, 

respectively. 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. There are 

currently no established Codex MRLs 

for residues of amitraz in/or on honey 

or honeycomb. 

C. Revisions to Petitioned-For 

Tolerances 

The petitioner requested a tolerance 

of 1.0 ppm for amitraz in honey. Based 

on field trial data (for honey and 

honeycomb) and using the Organization 

for the Economical Cooperation and 

Development (OECD) calculation 

procedure, the Agency determined that 

a tolerance of 0.2 ppm for amitraz in 

honey would be adequate to cover 

residues from amitraz use in beehives 

and would harmonize with the 

European Union (EU) maximum residue 

level (MRL) for total amitraz in honey. 

The registrant did not request a 

tolerance for honeycomb in its petition 

to the Agency. However, based on the 

honeycomb field trial samples and use 

of the OECD calculation procedure, EPA 

has determined that a tolerance of 9 

ppm is appropriate for honeycomb. 

Finally, the Agency has revised the 

tolerance expression to clarify (1) that, 

as provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of amitraz not specifically 

mentioned; and (2) that compliance 

with the specified tolerance levels is to 

be determined by measuring only the 

specific compounds mentioned in the 

tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the insecticide amitraz, 

(N’-[2,4-dimethylphenyl]-N-[[(2,4- 

dimethylphenyl)imino]methyl]]-Nmethylmethanimidamide), including its 

metabolites and degredates in or on 

honey at 0.2 ppm and honeycomb at 9 

ppm. 

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 


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17130 Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Rules and Regulations 

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) (2 U.S.C. 1501 et seq.). 

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) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: March 7, 2013. 

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 180.287 is amended by 

revising paragraph (a) introductory text 

and by adding, alphabetically, the 

following commodities to the table in 

paragraph (a) to read as follows: 

§ 180.287 Amitraz; tolerances for residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide amitraz (N’-[2,4- 

dimethylphenyl]-N-[[(2,4- 

dimethylphenyl)imino]methyl]]-Nmethylmethanimidamide), including its 

metabolites and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified is to be determined by 

measuring amitraz residues convertible 

to 2,4-dimethylaniline, expressed as the 

stoichiometric equivalent of amitraz, in 

or on the following raw agricultural 

commodities: 

Commodity Parts per 

million 

* * * * * 

Honey ......................................... 0.2 ppm. 

Honeycomb ................................. 9 ppm. 

* * * * * 

* * * * * 

[FR Doc. 2013–06191 Filed 3–19–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2013–0002; Internal 

Agency Docket No. FEMA–8275] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP) that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will not occur and 

a notice of this will be provided by 

publication in the Federal Register on a 

subsequent date. Also, information 

identifying the current participation 

status of a community can be obtained 

from FEMA’s Community Status Book 

(CSB). The CSB is available at http:// 

www.fema.gov/fema/csb.shtm. 

DATES: Effective Dates: The effective 

date of each community’s scheduled 

suspension is the third date (‘‘Susp.’’) 

listed in the third column of the 

following tables. 

FOR FURTHER INFORMATION CONTACT: If 

you want to determine whether a 

particular community was suspended 

on the suspension date or for further 

information, contact David Stearrett, 

Federal Insurance and Mitigation 

Administration, Federal Emergency 

Management Agency, 500 C Street SW., 

Washington, DC 20472, (202) 646–2953. 

SUPPLEMENTARY INFORMATION: The NFIP 

enables property owners to purchase 

Federal flood insurance that is not 

otherwise generally available from 

private insurers. In return, communities 

agree to adopt and administer local 

floodplain management measures aimed 

at protecting lives and new construction 

from future flooding. Section 1315 of 

the National Flood Insurance Act of 

1968, as amended, 42 U.S.C. 4022, 

prohibits the sale of NFIP flood 

insurance unless an appropriate public 

body adopts adequate floodplain 

management measures with effective 

enforcement measures. The 

communities listed in this document no 

longer meet that statutory requirement 

for compliance with program 

regulations, 44 CFR part 59. 

Accordingly, the communities will be 

suspended on the effective date in the 

third column. As of that date, flood 

insurance will no longer be available in 

the community. We recognize that some 

of these communities may adopt and 

submit the required documentation of 

legally enforceable floodplain 

management measures after this rule is 

published but prior to the actual 

suspension date. These communities 

will not be suspended and will continue 

to be eligible for the sale of NFIP flood 

insurance. A notice withdrawing the 

suspension of such communities will be 

published in the Federal Register. 

In addition, FEMA publishes a Flood 

Insurance Rate Map (FIRM) that 

identifies the Special Flood Hazard 

Areas (SFHAs) in these communities. 

The date of the FIRM, if one has been 

published, is indicated in the fourth 

column of the table. No direct Federal 

financial assistance (except assistance 

pursuant to the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act not in connection with a 

flood) may be provided for construction 

or acquisition of buildings in identified 

SFHAs for communities not 

participating in the NFIP and identified 

for more than a year on FEMA’s initial 

FIRM for the community as having 

flood-prone areas (section 202(a) of the 

Flood Disaster Protection Act of 1973, 

42 U.S.C. 4106(a), as amended). This 

prohibition against certain types of 

Federal assistance becomes effective for 

the communities listed on the date 


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