November 8 , 2011
**SUPPORTING STATEMENT FOR AN INFORMATION COLLECTION REQUEST (ICR)**  **1. IDENTIFICATION OF THE INFORMATION COLLECTION**  **1(a) Title of the Information Collection**  Application and Summary Report for an Emergency Exemption for Pesticide s OMB No.: 2070

- 0032 EPA No.: 0596.0 8 **1(b) Short Characterization/Abstract**  This Information Collection Request (ICR) is a renewal of an existing I CR that is currentl y approved b y OMB and is due to expire July 31, 20 12 . Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes the Environmental Protection Agency (EPA) to grant emergency exemptions to s tates and Federal agencies to allow an unregistered use of a pesticide for a limited time if EPA determines that emerg ency conditions exist

. A Section 18 action arises when growers and others encounter a pest problem on a site for which there is either no registered pesticide available, or for which there is a registered pesticide that would be effective but is not yet a pproved for use on that particular site. Section 18 also allows EPA to grant unregistered pesticide use exemptions for public health and quarantine reasons. Most requests for emergency exemptions are made by state lead agricultural agencies, although a gencies such as the United States Departments of Agriculture (USDA), Defense (DOD) and Interior (USDI) also request exemptions. This process is generally initiated when growers in particular regions identify an urgent, non
- routine situation which register ed pesticides will not alleviate. The growers contact their state lead agency (usually a state’s department of agriculture) and request that the state agency apply to EPA for a Section 18 emergency exemption for a particular use. The state agency evaluat es the requests and submits requests to EPA for emergency

exemptions they

believe are warranted. The uses are requested for a limited period of time to address the emergency situation only

.
**2. NEED FOR AND USE OF THE COLLECTION**  **2(a) Need/Authority for**  **the Collection** This information collection allows the Agency to access needed data to expeditiously make statutory

determinations to grant or den y a section 18 request. Unexpected changes in climatic conditions, development of pest resistance and/ or impo rtation of pests are some of the unpredictable situations that could give rise to a section 18 emergency exemption request. In these situations there is an immediate need for a pesticide for a use for which it is not registered and for which there is insu fficient time to obtain registration. Requests for Section 18 emergency exemptions, i.e., the submission of applications, are at the discretion of a state, U.S. territory , or federal agency . Should one of these entities appl yNovember 8 , 2011

for an emergency

exemption, EPA requests the information and data identified under Section 4(b) “Information Requested” of this supporting statement. If EPA determines that conditions exist which require an exemption and the risks are acceptable, EPA typically approves the emergency exemption request. EPA will deny an exemption request if the pesticide use may cause unreasonable adverse effects to human health or the environment, or if emergency criteria are not met. A state may withdraw an exemption request at any point in the pro cess. In unpredictable emergency situations when insufficient time for a formal section 18 application and review process is available to address the problem, a state agency may issue a crisis exemption which allows for the immediate use of an unregistered pesticide for no longer than 15 day s, unless an application for the specific exemption request has been submitted to EPA. The state issuing the crisis exemption must coordinate the declaration with EPA prior to releasing it to the users. EPA performs a cursory review of the use to ensure there are no concerns. If an y concerns are noted, EPA confers with the state and under extreme cases may not allow a crisis to be declared. If the state follows up the crisis with, or has already submitted, an emerg ency

exemption request, the use may continue under the crisis until EPA has made a decision on the request. EPA must establish the appropriate time

- limited tolerance(s) required by the Federal Food, Drug and Cosmetic Act (FFDCA) for an y pesticide uses to commercial agricultural items under emergency exemptions, including crisis exemptions. EPA receives an average of approximately 159 section 18 requests per y ear. Producers of minor crops are especially reliant on the emergency exemption program. L ess f requently , emergency

exemption applications are submitted in order to combat pests which pose a threat to public health. Other pests of national importance include zebra mussels and varroa mites. The section 18 emergency

exemption program is also supporti ng the stink bug invasive species agricultural initiatives. On January

27, 2006, EPA published a final rule (71 FR 4495) revising the regulations governing emergency

exemptions. EPA received considerable stakeholder involvement and identified several op portunities to streamline and improve the pesticide emergency exemption process without compromising protection for human health and the environment The new section 18 rule became effective on March 28, 2006. The final rule, 40 CFR part 166, contains two primary

revisions to the application, review and approval process for specific exemptions. Section 18 of FIFRA (see **Attachment A** ) states in part that, "The Administrator may , at [his/her] discretion, exempt any federal or state agency

from any provisi on of this Act if [s]he determines that emergency conditions exist that require such exemption". Under this provision, EPA may temporaril y authorize federal or state agencies to allow use of pesticide products under emergency

conditions. Detailed regulat ions regarding the procedures for emergency exemptions are contained in 40 CFR Part 166 (see **Attachment B**  **).** Section 408 of the Federal Food, Drug, and Cosmetic Act ( see **Attachment C** ) requires that EPA establish tolerances, or maximum legal limits for all pesticide residues in food, including those resulting from Section 18 emergency uses. Tolerances established for emergency

exemptions are time

- limited to correspond to the use season or multiple use seasons.November 8 , 2011

Thus, data collected under this collection al so a llow s the Agency establish tolerances or tolerance exemptions for section 18 emergency actions. When the Agency establishes a tolerance, there must be a finding that there is “reasonable certaint y that no harm” will result to human health from aggregate and cumulative exposure to the pesticide, as required by the health

based standard. For section 18 actions, the se Agency tolerance setting activities decisions must be conducted in a timely

manner , and their expiration dates, are established by a final rulemaking published in the Federal Register

. The t ime

- limited tolerances for pesticide emergency exemptions are codified at 40 CFR 176, see **Attachment D.**  **2(b) Practical Utility/Users of the Data**  EPA uses the information collected to carry out its statutory

responsibilities under FIFRA section 18

. This data collected allows EPA to evaluate an application for a permit for the temporary

use of a pesticide product for an unregistered use and whether such use will mitigate an emergency

situation. Gene rally , the data submitted must support the A gency ’s evaluation of whether: 1) an emergency exists; 2) use of the pesticide under the exemption will be protective of human health and the environments; and 3) the requested product ’s effectiveness in allaying the emergency

. The application and follow

- up reporting is essential to weighing the emergency nature of the situation as well as the effectiveness, risks of the treatment program, and comparing the cost impacts based on the new tiered thresholds for signi ficant economic loss determination.

**3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION**  **CRITERIA 3(a)**  **Non duplication** This information collection activity is unique and is administered by EPA pursuant to FIFRA. The possibility

of duplication does not exist by an y other federal agency. **3(b) Public Notice and Opportunity to Comment**  In preparing the renew al for this I CR, EPA publis hed a notice in the Federal Register (72 FR 30794) on June 4, 2007 which provide d a 60

- day public notice and comment p eriod on the draft ICR. The Agency

did not receive any

public comments on the draft renewal ICR. **3(c) Consultations**  Consultation and/or dialogue between states and the Agency during the submission and review of an application are frequent and ongoin g. Questions or consultations pertaining to a particular submission are addressed in meetings or telephone conversations with the applicant and do not necessarily

occur at specified intervals. In addition to communications regarding specific exemption re quests, Agency staff participates in stakeholder training workshops with state pesticide regulatory representatives. These communications permit an exchange of problems and questions on the program in general and other relevant issues. For example, OPP s taff members conducted a series of training workshops at headquarters and several regional locations for stakeholders. Consultations responses will be posted during the second comment period. See **Attachment E .** November 8 , 2011

**3(d) Effects of Less Frequent Collection**  As discussed above, there is no collection schedule for this information collection activity , per se. State and federal agencies initiate the information collection activity when they prepare an emergency

exemption application for submission to EPA. Stat e and federal agencies determine the frequency

in which to pursue an emergency exemption request with EPA. EPA does not solicit or request the exemption application. **3(e) General Guidelines**  EPA requires the states to maintain records of the first food use of a pesticide under an emergency

exemption for two years following the date of expiration. Generally , an applicant for an emergency

exemption is not required to maintain data beyond the date that the summary report has been received by the Agency

. Therefore, the OMB guidelines codified in 5 CFR 1320.6 indicate that data, other than health, medical, or tax records, need not be retained for more than three years and will not be exceeded in this program. **3(f) Confidentiality**  Although the EPA urge s the submitter to minimize the amount of claimed Confidential Business Information (CBI), certain limited all data and/or information brought to the Agency in conjunction with this rule may be claimed as trade secret, or commercial or financial informatio n and will be protected from disclosure by the EPA under FIFRA section 10 and the associated regulation as contained in 40 CFR Part 2, Subpart B. In general, EPA works to make information relative to section 18 decisions and supporting data easil y availab le to the public (e.g. web site postings of program information, and public distribution of decision documents). Growers and industry

stakeholders need to be made aware of section 18 exemptions. Thus, as a rule, claims of confidentiality are not made on emergency exemption applications. On certain rare occasions, the manufacturer of the requested producer may have product formulation information that is necessary to protect CBI. When trade secret information or Confidential Business Information is pro vided to the Agency , such information is protected from disclosure under FIFRA Section 10, as amended and EPA's confidentiality

regulation, Title 40 CFR, Subpart B. Data submitted to the Agency are handled strictly

in accordance with the FIFRA CBI Securit y Manual. This manual contains instructions relative to all contact with confidential documents, including responsibility of EPA employees; phy sical security measures; CBI materials within EPA, such as CBI t yping procedures (documents typed internall y or on contract); and division internal procedures. The manual dictates that: (1) all CBI must be marked or flagged as such , (2) all CBI must be kept in secure, double

- locked areas, and (3) all CBI for destruction must be cleared by a document control office r and placed in the Office of Prevention, Pesticides and Toxic Substances paper shredder. **3(g) Sensitive Questions**  No information of a sensitive or private nature is requested in conjunction with thisNovember 8 , 2011

collection activity . Further, this information col lection activity complies with the provisions of the Privacy

Act of 1974 and OMB circular A

- 108.

**4. THE RESPONDENTS AND THE INFORMATION REQUESTED**  **4(a) Respondents/NAICS Codes**  Respondents affected b y the collection activities under this I CR are federa l and state agencies which regulate pesticides or pesticide products. The North American Industrial Classification Sy stem (NAI CS) code assigned to the states and federal government agencies responding to this information is 9 241 , The Administration of Env ironmental Quality Programs subsector groups of government establishments primarily engaged in the administration of environmental quality

. Section 2(aa) of FIFRA defines State to include any of the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, the Trust Territory of the Pacific Islands, and American Samoa. **4(b) Information Requested**  To apply for an exemption, an application must be submitted in writing by the head of a federal or state ag ency , the Governor of the state involved, or their official designee. If a designee has been delegated authority to request exemptions, written authorization of such delegation must accompany the request or be on file with the EPA. Applications for spec ific, quarantine, or public health exemptions must contain the following information: **Identity of contact person(s)**  Name and telephone number of one or more qualified experts who may be

contacted if questions arise concerning the application. **Description of the**  **pesticide** Description of pesticide(s) proposed for the use under the exemption.

For a federally registered pesticide :  registration number and name of pesticide product (if a specific product is requested), or formulation(s) requested (if a specif ic product is not desired), and
 copy of any additional labeling proposed for the emergency exemption. For an unregistered pesticide product , copy of:
 EPA Form No. 8570

- 4 Confidential Statement of Formula (or reference to one already submitted to the Agency), and
 Complete labeling to be used in connection with proposed use.November 8 , 2011

**Description of the proposed use**  Application must identify all of the following:
 sites to be treated, including locations within the state,
 method of application,
 rate of application of active ingredient and product,
 total acreage or other appropriate unit proposed to be treated,
 total amount of pesticide proposed to be used (active ingredient and product), and
 all applicable restrictions and requirements concerning proposed use and qual ifications of applicators using the pesticide. **Alternative methods of control**  Detailed explanation of why the pesticide(s), currently registered for the

particular use proposed in the application, is not available in adequate supplies and/or effective to the degree needed to control the emergency. If the applicant states that an available registered pesticide is ineffective for the given situation, the statement must be supported by field data that demonstrate this, or if such data are unavailable, statements by qualified agricultural experts, extension personnel, university personnel or other persons similarly qualified in the field of pest control. In addition, a detailed explanation must be provided of why alternative practices, if available, either would not provide adequate control or would not be economically or environmentally feasible. **Effectiveness of proposed use**  Application must contain data, discussion of field trials, and other evidence that

provide the basis for the conclusion that the propo sed pesticide treatment will be effective in dealing with the emergency. **Discussion of residues for food**  **uses** If proposed use is expected to result in residues of the pesticide in or on food or

feed, application must list the food likely to contain such r esidues and must contain an estimate of the maximum amount of the residue likely to result from the proposed use, together with the information on which such estimates are based. **Discussion of risk information**  Potential risks to human health, endangered s pecies, beneficial organisms, and

the environment expected to result from the proposed use, together with references to data and other supporting information. **Coordination with other affected state**  **or federal agencies**

. If the proposed pesticide use is likely to be of concern to other federal or state

agencies, application must indicate that such agencies have been contacted prior to submission of the application, and any comments received from such agencies must be submitted to EPA. **Notification of regist**  **rant or basic manufacturer** 

. Statement that the registrants of all pesticide products proposed for use or, if

appropriate, the basic manufacturer, support the request for a specific, quarantine, or public health exemption. **Description of proposed**  **enforceme nt**  **program** . Explanation of the authority of the applicant or related state or federal agency

for ensuring that use of the pesticide under the proposed exemption would comply with any special requirements imposed by EPA and a description of the program and procedures for assuring such compliance.November 8 , 2011

**Progress toward registration** 

. Prior to submitting an application for a repeat specific or public health

exemption, the federal or state agency must contact the registrant regarding the progress being made toward registration of the proposed use and include this information in the section 18 application. This information must also include a summary of study deficiencies and data gaps, and registrant's timetable for completing requirements for registration.
**In addition, the following information must be provided:**  **For a specific exemption**  All of the following, as appropriate, must be provided concerning the nature of

the emergency:
 scientific and common name of the pest or pest complex;
 events that brought about the emergency condition;
 anticipated risks to endangered or threatened species, beneficial organisms, or the environment that would be remediated by the proposed use of the pesticide; and
 anticipated significant economic loss that would occur without the use of the requested registered pesticide, together with data and other supporting information, that addresses the historical net and gross revenues for the site, the estimated net and gross revenues for the site without use of the proposed pesticide, and the estimated net and gross revenues for the site with use of the proposed pesticide. **For a quarantine exemption**  A quarantine exemption may be authorized in an emergency condition to

control the introduction or spread of any pest new to and therefore kno wn to be widely prevalent or distributed within and throughout the United States and its territories. The application for the quarantine exemption must include the following information:
 scientific and common name of the pest or pest complex;
 origin of th e introduced pest and the means of its introduction and spread into the area, if known.
 economic impact of controlling versus not controlling the pest via the proposed pesticide treatment. **For a public health exemption**   Scientific and common name of pest or pest complex; if the pest is a vector, a description of the disease it is expected to transmit ; and
 ma gnitude of the health problems that are expected to occur without the pesticide use; and availability of medical treatment for the health problem.November 8 , 2011

For a crisis exemption, **only** the following information must be provided: The state or federal agency issuing the crisis exemption must coordinate any

crisis declaration in advance with EPA prior to initiating the use. The notice must include:
 name of active ingredient authorized for the crisis use, including the common name and the Chemical Abstracts Service (CAS) number;
 crop or site on which the pesticide is to be used;
 use pattern (method, number, and rate of applications);
 dates that applications s tarted or will begin and end;
 an estimate of the level or residues of the pesticide expected to result from use under the crisis exemption (for food crops); and
 discussion of the emergency situation and any other pertinent information available at the time , including why time was insufficient to request a specific or quarantine exemption, and intentions with respect to requesting a specific exemption for this use.

**4(c) Data Items, Including Record keeping requirements**  EPA Form No. 8570

- 4, Confidentia l Statement of Formula , ( **Attachment F**  ) is the single form associated with either application for, or summary reports on, an emergency exemption. To comply with the reporting and record keeping requirements for specific, quarantine, and public health exempt ions, the exemption holder must provide the following data items to EPA:November 8 , 2011

**Unexpected adverse effects**  **information** Any

unexpected adverse effects resulting from the use of a pesticide under a crisis, specific, quarantine, or public health exemption must b e reported immediately

to the Agency

. **Final reports** A report summarizing the results of pesticide use under a specific,

quarantine, and public health exemption must be submitted to EPA within six months of the expiration of the exemption unless otherwise specified by the Agency . The information in this report must include the following:
 total acreage, amount of commodity or other unit treated and the total quantity of the pesticide used;
 discussion of the effectiveness of the pesticide in dealing with the emergency

condition;
 description of an y unexpected adverse effects that resulted from the use of the pesticide under the exemption;
 results of an y monitoring required and/or carried out under the exemption;
 any enforcement actions taken in connection with the exemption;
 method(s) of disposition of food crops, if required to be destroyed; and
 any other information requested by the Administrator.
**Records** Records for all treatments involving the first food use of a pesticide will be

maintained by

the state or federal agency for which an emergency exemption was granted for a minimum of two years following the date of expiration of the exemption. On request b y EPA, these records must be made available to the Administrator. Records must include the following;
 locations where the pesticide was applied;
 dates of application (range); and
 total quantity

of the pesticide used.
**4(d) Applicant Activities**  To obtain a permit to use an unregistered pesticide product under emergency conditions, an applicant must pe tition EPA in writing and provide information addressing the data items listed above and commit to the submission of the summary report on the action taken to meet the emergency

Section 18 Emergency

Exemption applications are submitted to the Risk Integrat ion Minor Use, and Emergency Response Branch (Mail Code 7505P), Registration Division, Office of Pesticide Programs, U.S. Environmental Protection Agency , 1200 Pennsylvania Avenue., N.W., Washington, D.C., 20460. In order to participate in the program, the applicant must:

 Read germane FIFRA requirements and CFR regulations.
 Process, compile, and review the requested data for accuracy and appropriateness.
 Generate application correspondence and follow

- up summary report.  Store, file or maintain the information.November 8 , 2011

**5. THE INFORMATION COLLECTED** 
**-- AGENCY ACTIVITIES, COLLECTION**  **METHODOLOGY, AND INFORMATION MANAGEMENT 5(a)**  **Agency Activities** On October 25, 2000, EPA published a Final Rule in the Federal Register (65 FR 64125) entitled “Time

- Limited Tolerances for Pesticide Emergency Exemptions.” This rule, which became effective on November 24, 2000, set into place a process to ensure timely decisions on any tolerance

- related issue in response to a request for an emergency exemption for a pesticide to be used on food or feed. Under this rule, time

- limited tolerance petitions related to FIFRA Section 18 are evaluated on a case

- by

- case basis to determine if adequate reliable data are available to make the required safety finding mandated under FFDCA Section 408 and FQPA. Applications for emergency exemptions are submitted by U.S. states and territories, and federal agencies at their discretion. These applications are received b y the Office of Pesticide Programs (OPP), Registration Division, Risk Integration, M inor Use, and Emergency Response Branch, where they

are reviewed for completeness. The application package is routed to scientists and economists within OPP to determine whether the proposed emergency exemption is warranted, that there is “reasonable cert aint y of no harm” to human health resulting from aggregate and cumulative exposure, and that it presents no undue hazard to humans or the environment. Once the determinations are made, the applicant is notified in writing. The tolerance is published in the Federal Register. The Agency

conducts the following activities when responding to an emergency exemption application under FIFRA section 18:

 Route the application/report to appropriate scientists and economists for review.
 Review information submitted for scientific accuracy

.  Perform a biological, ecological, and economic analy sis and a multi

- disciplinary risk assessment of the requested use and then forward a regulatory recommendation on the proposed exemption along with a draft notification to EPA management.  Make the FQPA finding of “reasonable certainty of no harm” to human health resulting from aggregate and cumulative exposure. Establish a time

- limited tolerance if required.
 Conduct an assessment of the progress toward registration for the req uested use.
 O PP Director (or designee) makes final decision.
 Notify

applicant of decision.
 Prepare and publish Federal Register Notice (for applicable food use requests).
 Record electronic data in Agency 's data sy stem and internet cite. **5(b) Collection**  **Methodology and Management** When applications for emergency exemptions are received by EPA, they

are jacketed and filed by the name of the state, territory or federal agency , by

the date, and by

the number of the submission for that entity . The applicati on is tracked in EPA’s data s ys tem as an active pending request through the determination process, and subsequent receipt of the summary report, after which the exemption becomes a historical file and the regulatory action is closed.November 8 , 2011

**5(c) Small Entity**  **Flexibility** No flexibility

for small entities exists under this information collection activity . Section 18 of FIFRA applies directly onl y to State, territorial, and federal government agencies; it does not apply to other entities. States are not “smal l entities” as defined b y the Regulatory Flexibility Act. **5(d) Collection Schedule**  There is no collection schedule associated with this information collection activity , per se. This information collection activity is initiated by

the States or b y cert ain federal agencies when they

determine that they

are confronted with an emergency situation and subsequently submit an emergency

exemption application to EPA under FIFRA Section 18.

**6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION**  The total annual r esponse burden associated with submitting an application for Emergency

Exemption (Section 18) is estimated to be 49,500 burden hours per year at a cost of $2,472,770 indexed to 2006 dollars for the next three ye ars. The number of applications received b y EPA has decreased from an average of 494 per year for the years 2004

- 2006 to an average of about 159 per year for the ye ars ranging from 2008

- 2010. The important trends seen in the applications received in the past three ye ars are:

 the successful transition of a high number of minor crop section 18 programs to full registrations and tolerances under section 3 labels;
 there are continuing pest management challenges that are national in scope that trigger emergency

exemption requests (e.g. the use of po tassium salt of hop beta acids and fenp yroximate in beehives to control varroa mite; expanding reliance on section 18 programs to plan for and respond to agricultural species threats

- such as invasive stink bugs and quarantine exemptions to control invasive mussel species. The Agency

expects that some of these factors will persist and projects that it will process an average of 159 applications annually for the next three years. **6(b) Estimating Respondent Costs**  Agency economists revised the estimated wages, benefits and overhead for all labor categories for affected industries, state government, and EPA employ ees based on publicly available data from the US Bureau of Labor Statistics. The formulas used to estimate the labor rates and formulas used to derive the fully loaded rates and overhead costs for this ICR are listed in **Attachment G** 

. Methodology: The methodology uses data on each sector and labor ty pe for an Unloaded wage rate (hourl y wage rate), and calculates the Loaded wage rate (unloaded wage rate + benefits), and the Fully loaded wage rate (loaded wage rate + overhead). Fully loaded wageNovember 8, 2011

Page 12 of 16 rates are used to calculate respondent costs. Unloaded Wage Rate: Wages are estimated for labor ty pes (management, technical, and clerical) within applicable sectors. The Agency uses average wage data for the relevant sectors available in the National Industry

- Specific Occupational Employ ment and Wage Estimates from the Bureau of Labor Statistics (BLS) at http://www.bls.gov/oes/current/oes_nat.htm

. Sectors: The specific North American Industry Classification Sy stem (NAICS) code and website for each sector is included in that sector’s wage rate table. Within each sector, the wage data ar e provided b y Standard Occupational Classification (SOC). The SOC sy stem is used by Federal statistical agencies to classify workers into occupational categories for the purpose of collecting, calculating, or disseminating data (see http://www.bls.gov/oes/current/oes_stru.htm ). Loaded W

age Rate : Unless stated otherwise, all benefits represent 43% of unloaded wage rates, based on benefits for all civilian non

- farm workers, from http://www.bls.gov/news.release/ecec.t01.htm . However, if other sectors are listed for which 43% is not applicable; the applicable percentage will be stated. Fully Loaded W

age Rate: We multiply

the loaded wa ge rate b y 50% (EPA guidelines 20

- 70%) to get overhead costs. For Section 18 emergency exemption requests, the state government is the applicant and the only respondent. Labor rates for the applicant are based on NAI CS 999200, State Government. To deri ve the labor rates for Section 18 applicants , EPA estimated the wages for the management, technical, and clerical activities using the methodology described above. The fully loaded wage rates used to calculate the state respondent costs for this ICR are e stimated at $82.63, $57.68, and $39.20 per hour, which are the state government wage rates for managerial, technical, and clerical labor hours, respectivel y. Table 1 shows the total burden hours for each respondent collection activity by labor category

an d the total costs of each activity based on the wage rates. For example, the total cost for the state applicant to “Read FIFRA and FQPA requirements and CFR regulations” is $561, calculated as 4 hours of managerial labor at $82.63 per hour plus 4 hours of technical labor at $57.68 per hour. In total, the burden hours for completing a Section 18 application are estimated at 99 hours, 4 managerial hours, 93 technical hours, and 2 clerical hours. Using this burden estimate and the full y loaded wage rates fo r state governments, the Agency estimated the applicant labor costs to be approximately $5,774 per response.November 8, 2011

Page 13 of 16 **Table 1. FIFRA §18**

**– Applicant (State Government) Burden Hours and Cost Estimates per**  **Emergency Exemption Request** COLLECTION ACTIVITY **Burden per application (hours)**  **1 Total**  Managerial $82.63/hr Technical

$57.68/hr Clerical

$39.20/hr Hours Costs ($) Read FIFRA and FQPA requirements and CFR regulations 4 4 0 8 $ 561 Process, compile, and review the requested data for accuracy and appropriat eness 0 74 0 74 $ 4,269 Generate application correspondence and follow

- up summary

report 0 15 0 15 $ 865 Store/maintain/submit information 0 0 2 2 $ 78 **Totals 4**  **93 2**  **99 $ 5,774**  1 Hourly wages rates are fully

loaded wage rates based on NAICS 999200

– State Government, from U.S. Dept. of Labor, Bureau of Labor Statistics, May 2010. See Attachment H for wage calculations. 2 Totals may

not sum due to rounding.

Each ye ar, there are approximately 159 Section 18 requests from states. At 99 hours per request, the total annual burden to state government applicants of filing Section 18 applications is approximately

15,740 hours. Table 2 shows the calculations for total annual costs. The total management, technical, and clerical hours ar e multiplied times the annual number of requests and by the fully loaded wage rates to get total annual respondent costs of $917,993 for filing Section 18 applications (See Table 2). Table 2. FIFRA §18

– Total Annual Applicant (State Government) Burden Ho urs and Cost Estimates Labor Category Total Burden

Hours per Request Number of

applications Total Annual

Hours Labor Rate

($/hr) Costs ($) Managerial 4 159 636 $82.63 $ 52,551 Technical 93 159 14,787 $57.68 $ 852,975 Clerical 2 159 318 $39.2 0 $ 12,466 Totals 99 159 15,741

--- $ 917,993
**6(c) Estimating Agency Burden and Cost**  The estimated cost to the federal government of the Section 18 Emergency Exemption was calculated b y using the method described above for this revisio n. The TAI S data displayed in Table 6 indicate that the estimated number of Agency FTE’s dedicated to Section 18 emergency

exemption activities is approximately 0.7 managerial FTE s , 6.3 technical FTEs, and 0.5 clerical FTE s , for total of 7.6 FTEs allocate d to emergency exemption activities.November 8, 2011

Page 14 of 16 **Table 6. Distribution of Agency FTEs Supporting Section 18 Activities 1**  FTE T ype AD BEAD BPPD EFED HED RD PRD OPP Total 1 Managerial 0.0 0.2 0.0 0.0 0.0 0.5 0.0 0.7 Technical 0.1 1.4 0.1 0.3 0.1 4.3 0.0 6.3 Cleri cal 0.0 0.1 0.0 0.0 0.0 0.3 0.0 0.5 **Totals 0.1**  **1.7 0.1**  **0.4 0.1**  **5.1 0.0**  **7.6** 1 OPP Total is rounded up to the next FTE. Using total burden hours of 2,080 per FTE, the total annual Agency burden hours for Section 18 activities are approximately 1 5,751 per ye ar, averaged over the years 2008

- 2010. Table 7 shows the breakdown of these burden hours into managerial, technical, and clerical and the calculations for deriving total Agency cost. Multiplying the 2010 full y loaded hourl y wage rates for managerial, technical, and clerical hours by the respective burden hours in each category , the annual cost total annual Agency cost of the Section 18 program is approximately $1. 17 million. **Table 7. OPP Hours by employment class, hourly wage rate, and total cost s**  **FTE Type FTEs** 

**(rounded) Hours /** 

**FTE Total** 

**burden hours**  **Fully loaded**

**wage rates ($/hr)**  **1 Annual** 

**per FTE cost**  **Total Cost** Managerial 0.7 2,080 1,522 $ 120 $ 249,285 $ 182,415 Technical 6.3 2,080 13,158 $ 72 $ 148,881 $ 941,849 Clerical 0.5 2,080 1,071 $ 43 $ 89,875 $ 46,274 **OPP totals 7.6**  **15,751 $ 1,**  **170,538** 1 See Attachment H for data sources and calculations of fully loaded wage rates.
**6(d) Bottom Line Burden Hours and Cost Tables**  **Table 10. FIFRA §18**
**- Total Burden and Cost Est**  **imates for Applications and Summary Report for Emergency Exemption**  Previous Estimates Current Estimates Hours Costs Hours Costs Respondents (state governments) 49,500 $ 2,472,770 15,741 $ 917,993 Agency 54,000 $ 3,637,575 15,751 $ 1,170,53 8 Total 103,500 $6,110,345 31,492 $ 2,088,530 **6(e) Reasons for Change in Burden**  There is no change in the estimated respondent burden hours per application for this information collection activity from the former ICR. The fully loaded hourly

wage rates were updated which caused a slight increase in the respondent burden cost per application. However, the total annual respondent burden cost has decreased due to a change in the average number ofPage 15 of 16

Section 18s requested per year from 494 to 159. For the next renewal cycle the Agency projects it will receive approximately 159 Section 18 applications each ye ar over the next three years. The Agency

believes that respondents will experience some burden reduction over the next three ye ars due to the streamli ned recertification process for Section 18 applications discussed in Section 2 of this document. For example, during the 2010 use season, EPA identified 97 exemptions that were eligible for the less data

- intensive application process through the recertifi cation program. Further, in 2010, the Agency made registration decisions for 36 use determinations which negated the need for additional applications to be submitted for those same uses. Although EPA expects the streamlined recertification process will result in some burden reduction, there is insufficient information available to the Agency at this time to fully

assess the impact of these changes. **6(f) Burden Statement**  The annual respondent burden for collection of information associated wi th the rule is estimated to average 99 hours per application. According to the Paperwork Reduction Act, “burden” means the total time, effort, or financial resources expended b y persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency . For this collection, it is the time reading the regulations, planning the necessary data collection activities, conducting tests, anal yz ing data, generating reports and completing other required paperwork, and storing, filing, and maintaining the data. The agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it display s a currently valid OMB control number. The OMB control number for this information collection appears at the beginning and the end of this document. In addition OMB control numbers for EPA’s regulations, after initial display in the final rule, are listed in 40 CFR part 9. The Agency has established a public docket for this I CR under Docket ID No. EPA

- H Q

OPP

- 2007

- 0320 , which is available for online viewing at www.regulations.gov, or in person viewing at the OPP Regulatory Public Docket in Rm. S

- 4400, One Potomac Yard (South Building), 2777 S. Cry stal Drive, Arlington, VA. This docket facilit y is open fr om 8:30 a.m. to 4 p.m., Monday

through Friday , excluding legal holiday s. The docket telephone number is (703) 305

- 5805. You may

submit comments regarding the Agency 's need for this information, the accuracy of the provided burden estimates and any sugges ted methods for minimizing respondent burden, including the use of automated collection techniques. Submit your comments, referencing Docket ID No. EPA

- HQ

- OPP

- 2007

- 0320 and OMB Control No. 2070

- 0 03 2 , to (1) EPA online using www.regulations.gov (our prefer red method), or by mail to: Public Information and Records Integrity Branch (PIRIB), Mail Code: 7502P, Office of Pesticide Programs (OPP), Environmental Protection Agency , 1200 Pennsylvania Ave., NW, Washington, DC 20460, and (2) OMB b y mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.Page 16 of 16 **ATTACHMENTS TO THE SUPPORTING STATEMENT** Attachments to the supporting statement are available in the pu blic docket established for this ICR under docket identification number **EPA**
**- HQ** 
**- OPP** 
**- 2007** 
**- 0**  **737** . These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in sect ion 6(f) of the supporting statement. **Attachment A: 7 U.S.C. 136p** 
**- Section 18 of the**  **Federal Insecticide, Fungicide, and**

**Rodenticide Act** . Also available at online at the US House of Representatives’ US Code website **Attachment B: 40 CFR Part 166** 
**- Exemption of Federal and State Agencies for**  **Use of**

**Pesticides under Emergency Conditions** . Also available online at the National Archives and Records Administration’s Electronic CFR Website **Attachment C: 21 U.S.C 346a** 
**- Tolerances and exemptions for pesticide chemical** 

**residues, FFDCA section 408.** Also available at online at the US House of Representatives’ US Code website **Attachment D** : **40 CFR Part 176**
**- Time** 
**- Limited Tolerances for Pest**  **icide Emergency**

**Exemptions** . Also available online at the National Archives and Records Administration’s E lectronic CFR Website **Attachment E: Reserved**  **Attachment F: EPA Form No. 8570** 
**- 4** 
**- Confidential Statement of Formula.**  Also

available online at http://www.epa.gov/opprd001/forms/8570

- 4.pdf **At tachment**  **G :**  **State Government and EPA Labor Wage Formulas Attachment H:**  **Display Related to OMB Control #2070**
**- 0**  **032**

- Listings of Related

Regulations in 40 CFR 9.1