August 12, 2014

Page 1 of 29 **SUPPORTING STATEMENT FOR AN INFORMATION COLLECTION REQUEST (ICR)** 

**1. IDENTIFICATION OF TH**  **E INFORMATION COLLEC TION**  **1(a). Title**  **and Numbers of the Information Collection**  **Title: Pesticide Program Public Sector Collections**  **(FIFRA Sections 18 & 24(c)) OMB No.**  **: 2070 -**  **0182 EPA No**  **.: 2311.0 2**  **1(b). Short Characterization/Abstract**  This Information Collection Request (I CR) covers the paperwork burden under the Paperwork Reduction Act (PRA) associated with two ty pes of pesticide registration requests made b y s tates, U.S. Territories, or Federal a gencies. Specificall y, this I CR covers emergency exemption requests , which allow for an unregistered use of a pesticide, and requests b y states to register a pesticide use to meet a special local need (SLN). Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes the Environmental Protection Agency (EPA) to grant emergency exemp tions to states , U.S. Territories, and Federal agencies to allow an unregistered use of a pesticide for a limited time if EPA determines that emergency conditions exist

. Section 18 requests include unregistered pesticide use exemptions for specific agricultural , public health , and quarantine purpose s . Section 24(c) of FIFRA authorizes the EPA to grant permission to a particular s tate to register additional uses of a federall y registered pesticide for distribution and use within that s tate to meet a SL

N. These information collection activities are ongoing and are included together in this ICR because the programs they represent share similar respondent populations, state governments and other federal agencies seeking exemptions or other modifications to the federal pesticide registration program defined in FIFRA. **Applications and Summary Repo rt for Emergency Exemption**  **(FIFRA §18)** Section 18 of FIFRA authorizes EPA to grant emergency exemptions to states and Federal agencies to allow an unregistered use of a pesticide for a limited time if EPA determines that emergency conditions exist. Generall y, a Section 18 emergency exemption is requested when growers encounter an agricultural 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 ye t approved for use on that particular site. Section 18 also allows EPA to grant unregistered pesticide use exemptions for other specific purposes such as protecting endangered species, the environment, public health , or for quarantine purposes . Most re quests for emergency exemptions are made by state lead agricultural agencies, although federal agencies such as the United States Departments of Agriculture (USDA),August 12, 2014

Page 2 of 29 Defense (DOD) and Interior (USDI) also request exemptions. Most of the requests are relate d to an agricultural pest problem, so the process is often initiated when growers in a particular region identify an urgent, non

- routine situation that registered pesticides will not alleviate. When this happens, the growers contact their state lead agenc y (usually a state’s department of agriculture) and request that the state agency make a request to EPA for a Section 18 emergency

exemption. The state agenc y evaluates the growers’ request and submit s their request to EPA for emergency exemptions they

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

. **Notice of Pesti cide Registration by States to M**  **eet a Special Local Need (FIFRA §24(c))**  Section 24(c) of FIFRA authorizes the States to regis ter additional uses of federall y registered pesticides for distribution and use within the State to meet a special local need (SL N)

. A State

- issued registration under FIFRA Section 24(c) is deemed a federal registration for the purpose of the pesticide's use within the State's boundaries. A State must notify EPA, in writing, of any

action it takes, i.e., when it issues, amends, or revokes a State registration. The Agency has 90 day s to disapprove the registration. In such cases, the State is responsibl e for notifying the affected registrant. **2. NEED FOR AND USE OF**  **THE COLLECTION 2(a)**  **. Need/Authority for the Collection**  **Applications and Summary Report for Emergency Exemption (FIFRA §18)**  This information collection allows the Agency to collect the necessary data to expeditiously

make statutory

determinations to grant or deny a S ection 18 request. Unexpected changes in climatic conditions, development of pest resistance , and/or importation of pests are some of the unpredictable situation s that could necessitate a S ection 18 emergency

exemption request. In these situations, there is sometimes an urgent need for the use of a pesticide , a use that may be unregistered and for which there is insufficient time to obtain registration. Requests for Section 18 emergency exemptions, i.e., the submission of applications, are made at the discretion of a state, U.S. territory, or F ederal agency . Should one of these entities apply

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 warrant an exemption and that the risks are acceptable, EPA ty picall y approves the emergency exemption request. EPA will deny an emergency 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 process.August 12, 2014

Page 3 of 29 In some emergency situations , there is insufficient time for a formal S ection 18 application to be made by the state and review ed by the Agency . In such cases , a state agency may temporaril y by

pass the normal Section 18 application process and declare a “ crisis exemption ” which allows for the immediate use of an unregistered pesticide for no longer than 15 day s, unless a specific exemption request has been submitted to EPA. The state declaring the crisis exemption must coordinate the declaration with EPA prior to releasin g it to the users of the pesticide . EPA performs a cursory review of the use to ensure there are no concerns. If any 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 th e crisis with, or has already submitted, an emergency 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 b y the Federal Food, Drug an d Cosmetic Act (FFDCA) for any pesticide uses to commercial agricultural items under emergency exemptions, including crisis exemptions. Producers of minor crops are especiall y reliant on the emergency exemption program. Agricultural pests of national importance that are controlled largel y through Section 18s include brown marmorated stink bugs and varroa mites. Most recently , the Section 18 emergency

exemption program is also supporting the Asian citrus ps yl lid invasive species agricultural initiative. Less frequentl y, emergency exemption requests are submitted in order to combat pests which pose a threat to public health. On January

27, 2006, EPA published a final rule (71 FR 4495) revising the regulations g overning emergency exemptions, which became effective on March 28, 2006. The final rule, 40 CFR P art 166, contains two primary revisions to the application, review and approval process for specific exemptions. The first major revision was to create a streamlined recertification application for eligible repeat emergency exemption requests. The second major revision was to clarify the definition of significant economic loss and revision of data requirements for documenting loss. Section 18 of FIFRA (see **Attach ment A** **- 1**  ) states in part that, "The Administrator may , at [his/her] discretion, exempt any federal or state agency

from any provision of this Act if [s]he determines that emergency conditions exist that require such exemption

. " Under this provision, EPA m ay

temporaril y authorize federal or state agencies to allow use of pesticide products under emergency conditions. Detailed regulations regarding the procedures for emergency exemptions are codified at 40 CFR Part 166 (see **Attachment B**   ** 1** **).** Section 408 of the Federal Food, Drug, and Cosmetic Act (see **Attachment A** **- 3**  ) requires that EPA establish tolerances, 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. Thus, data collected under this collection also allows the Agency establish tolerances or tolerance exemptions for Section 18 emergency uses . When the Agency establishes a tolerance, there must be a finding that there is “reasonable certainty that no harm” will result to human health from aggregate and cumulative exposure to the pesticide,August 12, 2014

Page 4 of 29 as required b y the health

- based standard. For Section 18 actions, these Agency tol erance setting activities must be undertaken in a timel y m anner . Their expiration dates are established by

a final rulemaking published in the Federal Register . The time

- limited tolerances for pesticide emerg ency exemptions are codified at 40 CFR 176, se e **Attachment C**  **. Notice of Pesti**  **cide Registration by States to M eet a Special Local Need**  **(FIFRA §24(c))** EPA requires this information to ensure that the States do not issue any registrations that might conflict with other requirements in FIFRA, or with Section 408 of FFDCA, which require that a tolerance exist for any pesticide used on a food or feed commodity (**Attachment A** **- 3**  ). FIFRA Section 24(c)(3) mandates that if the Administrator determines that a registration issued by a State is inconsistent with the FFDCA or if the use of a pesticide registered b y the State constitutes an imminent hazard, the Administrator may disapprove the registration. **2(b) .**  **Practical Utility/Users of the Data** The data collected by

the Agency under FIFRA Section 18 for the temporary use of a pesticide product for an unregistered use allow s EPA to evaluate whether such use will mitigate an emergency

situation. Generall y, the data submitted must support the Agency’s evaluation of whether: 1) an emergency exists; 2) use of the pe sticide under the exemption will be protective of human health and the environment; and 3) the requested product will be effective in allaying the emergency

. Information contained in the application and follow

- up reporting is essential for gauging the emergency nature of the situation , the effectiveness of the product , the risks of the treatment program, and the economic loss based on the new tiered thresholds for significant economic loss determination. The potential respondents to the SL N information collection activity are the States, which FIFRA Section 2(aa) defines to include Washington, D.C., Puerto Rico, the U.S. Virgin Islands, Guam and the islands of the Pacific Territory , and American Samoa. The information "users" are the Agency decision mak ers at the U.S. EPA Office of Pesticide Programs (OPP) . The information is used to ensure conformity with FIFRA and FFDCA. The States are required to collect, from the manufacturer or grower groups, adequate information to support the Section 24(c) appli cation for registration or amendment. Both the State and the manufacturer or grower group are required to keep records. **3. NON DUPLICATION, CON**  **SULTATIONS, AND OTHE R COLLECTION**  **CRITERIA 3(a)**  **. Non duplication**  This information collection activity is unique and is administered by EPA pursuant to FIFRA. There is no possibility of duplication by

any other federal agency

.August 12, 2014

Page 5 of 29 **3(b) .**  **Public Notice Required Prior to ICR submission to OMB**  Pursuant to 5 CFR 1320.8(d), in proposing to renew this I CR, EPA is publi shing a notice in the Federal Register that provides a 60

- day public notice and comment period. The materials related to the proposed renewal of this ICR, as well as any comments submitted during the public comment period may be accessed as described in s ection 6(f) of this supporting statement. **3(c) .**  **Consultations Applications and Summary Report for Emergency Exemption**  **(FIFRA §18) and**  **Notice of Pesti**  **cide Registration by States to M eet a Special Local Need**  **(FIFRA §24(c))** Under 5 CFR 1320.8(d)(1), agencies are required to consult with potential ICR respondents and data users about specific aspects of I CR’s before submitting an original or renewal I CR to OMB for review and approval. During the development of this I CR, EPA staff will contact appropri ate stakeholders and ask them for their assessment of the regulatory burden estimates expressed by the Agency

in this ICR. A summary of these consultations , and the Agency ’s responses to them, will be provided in the final supporting statement submitted to OMB for review and approval

. **3(d) .**  **Effects of Less Frequent Collection** As discussed above, there is no collection schedule for th ese information collection activities , per se. This activity is conducted onl y once per application for a FIFRA Section 18 or Section 24(c) registration. Therefore , it is not possible for EPA to reduce the frequency of the collection. **3(e) .**  **General Guidelines Applications and Summary Report for Emergency Exemption**  **(FIFRA §18)** EPA requires the states to maintain record s of the first food use of a pesticide under an emergency

exemption for two years following the date of expiration. Generall y, an applicant for an emergency exemption is not required to maintain data beyond the date that the summary

report has been receiv ed b y the Agency. 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 ye ars ; therefore, this time limit will not be exceeded in this program. OMB regulation s require agencies to provide a statement indicating whether the proposed collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology , e.g., permitting electronic submission of responses, and an explanation of the decision (5 CFR 1320.5(a)(iii)(E)). OPP does offer the option of electronic submission of emergency exemption requests, or Section 18 applications. States m ay e - mail applications to OPP inAugust 12, 2014

Page 6 of 29 Word or pdf format. **Notice of Pesti cide Registration by States to M**  **eet a Special Local Need (FIFRA §24(c))**  The recordkeeping activities briefly described in this program exceed OMB’s guideline that agencies not require that records be retained for more t han 3 years (5 CFR 1320.5(d)(2)(iv)). As authorized under FIFRA Section 8, EPA regulations require that registrants retain records containing research data relating to registered pesticides (including all data submitted to EPA in support of a registration

- see 40 CFR 169.2(k)) for as long as the registration is valid and the producer is in business. However, the burden related to the recordkeeping requirements is covered under another ICR (see OMB Control No. 2070

- 0028, Recordkeeping Requirements for Producers of Pesticides under Section 8 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (EPA ICR No. 0143) ). In addition, this information collection does not include any estimated burden or costs related to the third party

activities ass ociated with pesticide product labeling. In 1995, OMB determined, in the context of OMB Control No. 2070

- 0060, Application for New and Amended Pesticide Registration (EPA ICR No. 0277) , that the Agency does not need to estimate burden or costs for the third party disclosure requirement involving the registrant’s disclosure of product specific information to potential users and the general public through the pesticide labeling. This activity is not considered to be a collection of information subject to approval under the PRA because the information that must be included as the product labeling has been approved and provided by EPA. (5 CFR 1320.3(c)(2)). Although a pilot project to develop a full y electronic SL N submission option is underway , OPP is not offering a full y electronic SL N submission option at this time

. Extensive guidance regarding the SLN submission process is available to states via the OPP Internet site at: http://www.epa.gov/opprd001/24c/

. **3(f) .**  **Confidentiality Applications and Summary Report for Emergency Exemption**  **(FIFRA §18)** Although EPA urges submitter s to minimize the amount of Confidential Business In formation (CBI) contained in Section 18 requests , some data and/or information sub mitted to the Agency

in conjunction with this rule may be claimed as trade secret or commercial or financial information and will be protected from disclosure b y EPA under FIFRA Section 10 and the associated regulations codified at 40 CFR Part 2, Subpart B . In general, EPA works to make information relative to Section 18 decisions and supporting data easily available 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 informatio n that is necessary to protect CBI.August 12, 2014

Page 7 of 29 Trade secret information and CBI are handled strictly in accordance with the FIFRA CBI Security Manual. This manual contains instructions relative to all contact with confidential documents, including the responsibil ities of EPA employees; physical security measures; CBI materials within EPA, such as CBI ty ping procedures (documents ty ped internally or on contract); and internal division procedures. The manual dictates that: (1) all CBI mu st be marked or flagged as such by the submitter of that information , (2) all CBI must be kept in secure, double

- locked areas, and (3) all CBI for destruction must be cleared b y a document control officer and shredded. **Notice of Pesti cide Registration by States to M**  **eet a Special Loc al Need**  **(FIFRA §24(c))** The Agency

estimates that less than 0.1% of the 24(c) registrations are for new products, thereb y requiring the submission of a Confidential Statement of Formula. In addition, any

data and/or information brought to the Agency in conjunction with the submi ssion of 24(c) registrations may be claimed as trade secret, commercial or financial information and must be protected from disclosure by EPA under FIFRA Section 10 and the associated regulation as contained in 40 CFR Part 2, Subpart B. All CBI data submi tted to EPA under FIFRA is handled strictly in accordance with the provisions of the FIFRA CBI Security Manual

. **3(g) .**  **Sensitive Questions** No information of a sensitive or private nature is requested in conjunction with this ICR . Further, this informatio n collection activity complies with the provisions of the Privacy Act of 1974 and OMB circular A

- 108. **4. THE RESPONDENTS AND**  **THE INFORMATION REQU ESTED**  **4(a) .**  **Respondents/NAICS Codes** Respondents affected b y the collection activities under this I CR include federal and state agencies which regulate pesticides or pesticide products , with the vast majority done b y states, as well as pesticide registrants for the Section 24(c) applications

. Section 2(aa) of FIFRA defines s tate to include any of the 50 s tates, 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. The North American Industrial Classification Sy stem (NAI CS) code assigned to the states and federal government agencies responding to this information collection is 999200 , State Government

. The NAICS code used for registrants is 325300, Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing.August 12, 2014

Page 8 of 29 **4(b) (i)**  **. Information Requested**  **Applications and Summary Report for Emergency Exemption (FIFRA §18)**  To apply for an exemption, an application must be submitt ed in writing by the head of a f ederal or state agency , the Governor of the state involved, or their official designee. If a desi gnee has been delegated authority to request exemptions, written authorization of such delegation must accompany the request or be on file with EPA (See **Attachment A -**  **1** )

. Applications for specific, quarantine, or public health exemptions must contain the following information: **Data Item Description**  **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 specific 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 l abeling to be used in connection with proposed use. **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 qualifications of appl icators 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.August 12, 2014

Page 9 of 29 **Data Item Description**  **Effectiveness of proposed use**  Application must contain data, discussion of field trials, and other evidence that

provide the basis for the conclusion that the proposed 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 residues and mu st 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 species, benefi cial 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 li kely to be of co ncern to other F ederal 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 registrant or basic**  **m anufacturer**  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**  **enforcement 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 as suring such compliance. **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 Secti on 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 exemption applications , depending on the type of exemption :August 12, 2014

Page 10 of 29 **Data Item Description**  **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 pe sticide, 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 known 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 the introduced pest and the means of its introduction and spread into the area, if known.
 economic impact of controll ing 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 o f the health problems that are expected to occur without the pesticide use; and availability of medical treatment for the health problem. **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 started or will begin and end;
 an estimate of the level or residues of the pesticide expected to result from use und

er 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.August 12, 2014

Page 11 of 29 To comply

with the reporting and record keeping requirements for specific, quarantine, and public health exemptions, the exemption holder must provide the following data items to EPA: **Data Item Description**  **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 be 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 any unexpected adverse effects that resulted from the use of the pesticide under the exemption;
 results of any 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 grante d for a minimum of two years following the date of expiration of the exemption. On request by 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. **Notice of Pesti cide Registration by States to M**  **eet a Special Local Need (FIFRA §24(c))**  Application for a 24(c) registration : Applicants for State registrations under FIFRA Section 24(c) to meet a special local need (ty picall y pesticides manufacturers and grower groups) must submit the following information directl y to the s tate using EPA Form 8570

- 25, Application for/Notification of State Registration of a Pesticide to Meet a Speci al Local Need (**Attachment G** ) , and EPA Form 8570

- 4, Confidential Statement of Formula (**Attachment F**  ) , when applicable: **Data Item Description**  **Identity of contact person(s)**  Name and address of the applicant and any other person whose name will

appear on the labeling or in the directions for use. **Description of the** The name of the pesticide product, and, if the application is for anAugust 12, 2014

Page 12 of 29 **Data Item Description**  **pesticide** amendment to a federally registered product the EPA registration number of

that product. **Proposed product labeling**  A copy of the proposed labeling, including all claims made for the product as

well as directions for its use to meet the special local need, consisting of:
 For a new product, a copy of the complete proposed labeling; or,
 For an additional use of a federally registered product, a copy of proposed supplemental labeling and a copy of the labeling for the federally registered product.
 If a State classifies for restricted use a product or use, which is not required to be so classified under FIFRA, supplemental la beling for the product or use containing additional appropriate precautions, and a statement that the product or use is for restricted use within the State may be required. **Proposed product formulation**  The complete formula of the product, if the applicati on is for a new product

registration. **Other relevant information about**  **product** Any other information that is required to be reviewed prior to registration.
Information following the issuance of a 24(c) registration: A s soon as practical after a registration is issued , the following information must be provided: **Data Item Description**  **Copy of the final printed labeling**  New product labeling must contain:

 A statement identifying the State where registration is to be valid.
 The special local need registration number assigned by the State.
 For an additional use of a federally registered product, the State must require that at the time of sale, labeling from the federally registered product be accompanied by supplemental labeling. Information Requested by EPA to verify an SLN registration : Within ten working days from the date a State issues, amends or revokes a registration, the State is required to notify EPA, in writing, of the action. Using EPA Form 8570

- 25 where applicable, notification of State registration or amendments thereto, must include the following : **Data Item Description**  **Effective Date**  Effective date of the registration or amendment.

 Notification of revocation of a registration by a State shall indicate the effective date of revocation, and shall state the reasons for revocation. **Product Information**   Confidential statement of the formula of any new product, and

 A copy of the draft labeling reviewed and approved by the State, provided that labeling previously approved by the Administrator as part of a federal registration need not be submitted. **Final Product Labeling**  State must send EPA a copy of the final printed labeling approved by the

State within 60 days after t he effective date of the registration or amendment.August 12, 2014

Page 13 of 29 **Data Item Description**  **Other relevant information**  The Agency may request, when appropriate, that a State submit any data used

by the State to determine that unreasonable adverse effects will not be caused. **4(b)(ii) .**  **Respondent Activities Applications and Summary Report for Emergency Exemption**  **(FIFRA §18)** To obtain permi ssion to use an unregistered pesticide product under emergency conditions, an applicant must petition EPA in writing , provide information addressing the data items listed above , and commit to the submission of the summary report on the use. Section 18 emergency e xemption applications are submitted to the Risk Integration , Minor Use, and Emergency

Response Branch (Mail Code 7505P), Registration Division, Office of Pesticide Programs, U.S. Environmental Protection Agency , 1200 Penns yl vania Avenue., N.W., Washington, D.C., 20460. EPA Form No. 8570

- 4, Confidential Statement o f Formula (**Attachment F** ) , is the single form associated with the emergency exemption program, and is used for the final report. This form is being used for this I CR but is covered by a different ICR

- Application for New and Amended Pesticide Registration (OMB No. 2070

- 0060, EPA ICR No. 0277). In order to participate in the program, the applicant must complete the following tasks :

 Read the applicable FIFRA requirements and CFR regulations.  Process, compile, and review the requested data.  Generate application correspondence and a follow

- up summary report.  Store, file , or maintain the information. **Notice of Pesticide Regi stration by States to M**  **eet a Special Local Need (FIFRA §24(c))**  Applicant Activities: **Data Item Description**  **Gather data** Proposed label, product formulation (if applicable), name of applicant, name of product, federal registration number (if applicable), and any other information required by the State. **Submit materials to the State**  Compile necessary data and materials. Comp lete application for State registration (EPA Form 8570

- 25) and submit to State **Store, file, and maintain the information**  Applicant must maintain records of information submitted to the State for as long as the State registration is active. State Activities:August 12, 2014

Page 14 of 29 **Data Item Description**  **Compile information** Organize data submitted by registrant (or grower group) to develop the SLN justification. Registrant must maintain records of information submitted to the State. **Review information** Evaluate the data: 1. Determine whether there is a special local need for the registration; 2. Determine that use of the product for which registration is sought will not cause unreasonable adverse effects on humans or the environment; 3. For use of a product with public health claims, determine that the product warrants the claims made, i.e., efficacy determination; 4. Review the proposed labeling submitted with the application to determine State and federal compliance; 5. Issue or amend State registration. **Notify Federal Government**  Complete and submit EPA Form 8570

- 25 and all accompanying data and materials. Respond to any Agency questions or concerns. **Store, file, and maintain the data**  Maintain copies of the information and data submitted to EPA. **Respond to Registrant (if necessary)**  Notify registrant if Federal Government disapproves the State's registration.

**5. THE INFORMATION COLL**  **ECTED -**  **AGENCY ACTIVITIES, COLLECTION METHODOLO**  **GY, AND INFORMATION MANAGEMENT**  **5(a) .**  **Agency Activities Applications and Summary Report for**  **Emergency Exemption (FIFRA §18)**  EPA regulations at 40 CFR part 176, entitled “Time

- Limited Tolerances for Pesticide Emergency Exemptions,” provide a process to ensure timely decisions on any

tolerance

related issue in response to a request for an emergen cy exemption for a pesticide to be used on food or feed. 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 OPP , Registration Division, Risk Integration, Minor Use, an d 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 certainty of no harm” to human health resulting from aggregate and cumulative exposure, and that it presents no undue hazard to humans or the environment (See **Attachment B -**  **1** ). Once the determinations are made, the applicant is notified in writing.August 12, 2014

Page 15 of 29 The tolerance is publi shed 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 informati on submitted for scientific accuracy

.  Perform a biological, ecological, and economic analysis and a multi

- disciplinary risk assessment of the requested use and then forward a regulatory recommendation on the proposed exemption along with a draft notificati on 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 fo r the requested use.  OPP 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 s ite. **Notice of Pesti**  **cide Registration by States to M eet a Special Local Need**  **(FIFRA §24(c)) Activity**  **Description Read and record State**  **** **submitted information** EPA Form 8570

- 25 and the application is screened, jacket created, and information is recorded in electronically for tracking purposes. **Review data submissions** Review materials for adherence to federal requirements of label integrity, lack of imminent risk, and the existence of appropriate tolerances. **Publish summary of 24(c)s** Publish, on a regular basis, in the Federal Register, a summary of all State registrations received and those disapproved. **Notify State (if necessary)** Notify the State if the registration is disapproved. **Store/file/maintain the data** Maintains an electronic reference file on all FIFRA Section 24(c) applications received and approved. **5(b) .**  **Collection Methodology and Management Applications and Summary Report for Emergency Exemption**  **(FIFRA §18)** When applications for emergency exempti ons are received b y EPA, they are jacketed and filed b y the name of the state, territory or federal agency , by the date, and by

the number of the submission for that entity . The application is tracked in EPA’s data system 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.August 12, 2014

Page 16 of 29 **Notice of Pesti cide Registration by States to M**  **eet a Special Local Need (FIFRA §24(c))**  The Section 24(c) application form and any supporting materials are received and date

- marked to start the 90

- day clock. They

are screened for completeness, a master file jacket is created for the incoming application, and the case is assigned a unique identi fier. Id entifying information then is extracted for the required FR Notice of receipt, for the Pesticide Product Information System (PPI S) inventory of all 24(c) actions, and for tracking records. The file then is reviewed for substantive acceptability , and any s cientific data is routed for review b y appropriate specialists. When all reviews are completed a decision is made to accept or disapprove the application. If the decision is to disapprove the application, the State is notified, and a notice of disapproval is published in the FR. The disapproval is recorded in the PPI S data base. If the decision is to accept the application, this is recorded in the master file, and no further action is required. **5(c) .**  **Small Entity Flexibility** Small entities are not impacted b y this IC R . Section s 18 and 24 of FIFRA apply directly onl y to State, territorial, and federal government agencies; it does not apply to other entities. States are not “small entities” as defined by the Regulatory

Flexibility

Act. While pesticide manufacturers and grower groups may be involved in EPA

- State activities under this I CR, any activities they

undertake are in response to FIFRA Section 24, which expressly

delegates certain pesticide registration authority to States. These entities must comply

with State procedures to obtain a special local need registration under FIFRA Section 24(c). Consequently , the Agency cannot offer them any flexibility without intruding on the processes established by each state. **5(d) .**  **Collection Sch edule**  There is no collection schedule associated with this IC R , per se. This information collection activity

is initiated by

the States or b y certain federal agencies when they appl y for a F IFRA Section 24(c) registration, or determine that they are conf ronted with an emergency situation and subsequently submit an emergency exemption application to EPA under FIFRA Section 18

. **6. ESTIMATING THE BURDE**  **N AND COST OF THE CO LLECTION**  The respective burden and cost estimates for PRA activities for the Section 18 and Section 24(c) programs are presented in this section, along with the methodology for developing the estimates

.August 12, 2014

Page 17 of 29 **6(a) .**  **Estimating Respondent Burden Hours**  The estimates of burden hours per request or application were developed with input from respon dents for both programs and used in the currently

- approved ICR. EPA believes that these previous burden estimates are still valid. Therefore, there is no change in the estimated respondent burden hours per application for either program in this I CR. The estimated burden hours per response (request or application) , for each respondent collection activity

by labor category , is presented in separate tables for Sections 18 and 24(c) in section 6(b) (along with costs per response). The total average respondent burden hours per request is derived b y adding the burden for all activities for each labor category and then summing across labor categories. The total annual respondent burden is calculated as the total burden hours per request times the number of req uests (applications) received annuall y and is shown in tables for each collection in section 6(b) (along with total annual costs). The estimated number of applications submitted annually has been updated for this ICR. The number of applications received annually for Section 18 has increased since the currentl y- approved IC R , while the number of applications received under Section 24(c) has decreased . The estimates used in this I CR of the number of applications submitted annually under Section 18 and Section 24(c) are based on three

- ye ar averages of applications actuall y received for each program for the years 2011 through 201 3
. **Applications and Summary Report for Emergency Exemption (FIFRA**  **§18 )**  Applicant (State Agency) Burden Hours The estimated average burden of 99 hours per emergency exemption request is presented in Table 1

. The total annual response burden associated with submitting application s and summary reports for emergency

exempti on s is estimated to be 1 8,315 burden hours per year for the next three years. The number of emergency exemption applications received b y EPA has increased from an average of 128 per ye ar for the ye ars 2009

- 2011 to an average of 185 per ye ar for the ye ars 2011

- 2013
. The total annual respondent burden is shown in Table 2 (along with total annual costs)

. The important trends seen in the applications received in the past three years are:

 successful transition of many widely used, minor crop , Section 18 emergency pesticide uses to full registrations and tolerances under Section 3 labels , thereby eliminating numerous, long

- running (repeat) applications from many states ;  continuing pest management challenges that are national in scope that trigger emergency exemption requests, e.g., the use of potassium salt of hop beta acids and amitraz in beehives to control varroa mite and reliance on Section 18 requests to respond to agricultural species threats such as invasive stink bugs and Asian citrus psyllid. The Agency

expects that some of these factors will persist and expects to receive anAugust 12, 2014

Page 18 of 29 average of about 185 applications annually for the next three years. However, the Agency is unable to estimate precisely how many requests will be submitted in the future. **Notice of Pesti cide Registration by States to M**  **eet a Special Local Need (FIFRA §24(c))**  Registrant Burden Hours The Agency

estimates the average burden for applicants (registrants) for s tate registrations under FIFRA Section 24(c) to equal approximately 3 9 hours per application , as presented in Table 3 . The Agency expects that approximately 305 applications will be submitted annually

during the next 3 years, based on the annual average from 2011

- 2013
. The estimated number of applications has decreased sl ightly from 325 applicati ons annually in the currentl y- approved IC R. The Agency estimates an annual applicant (registrant) burden of 11,895 hours , shown in Table 4

. State Agency

Burden Hours EPA estimates the s tate a gency burden to average 13 hours per response , as shown in Table 5 . The Agency

estimates an annual State Agency burden of 3,965 hours (see Table 6)

. Overall Burden Hours The overall respondent burden associated with this collection , which is the sum of registrant and state agency burden, is estimated to be 15,860 hours per ye ar , presented in Table 7 . No changes have been made in the requirements for Section 24(c) applications, and no changes have been made to the overall provisions of this information collection activity

. **6(b) .**  **Estimatin g Respondent Costs**  The costs for respondents to respond to the information collection requirements are calculated b y using the estimated burden per response, the number of responses annuall y, and the appropriate wage rates for each activity. The methodo logy and sources for wage rates used is presented in the subsection below. The cost per response (application or request) is calculated by multiplying the burden hours for each respondent collection activity by the wage rate for the affected labor category
. The cost for each collection activity per application is summed across labor categories (e.g., managerial, technical, and clerical). Then the total cost for each collection activity is summed for the total cost per application. The applicable w age rates and these costs are presented in separate tables for Sections 18 and 24(c) (along with burden hours) below

. The total annual costs for each labor category are calculated b y multiplying the total annual burden hours for that category by the app licable wage rate. Total costs for each labor category are then summed to get the total annual costs for the collection. These costs are presented below in separate tables for each of the two collections.August 12, 2014

Page 19 of 29 Methodo l ogy

for Calculation of Full y Lo aded Wage Rate s For this I CR, the Agency revised the estimated wages, benefits , and overhead for all labor categories for affected industry , state government, and EPA employees based on the most recent publicl y available data from the US Bureau of Labor Statistics

. The methodology for calculating the wage rates is the same for both the emergency exemption and SL N collections , and are based on 201 3 wage data (see Attachment H) . The calculation of the wage rate s uses base wage data for each sector and labor type 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) based on that data

. Full y loaded wage 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

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

. Sectors: The specific North American Industry Classif ication System (NAICS) code and website for each sector is included in that sector’s wage rate table in **Attachment H**
. Within each sector, the wage data are provided by Standard Occupational Classification (SOC). The SOC sy stem is used by Federal statisti cal 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 R ate : Unless stated otherwise, all benefits represent 4 4 % of unloaded wage rates, based on average rate of benefits for all civilian non

- farm workers (see http://www.bls.gov/news.release/ecec.t01. htm )

. I f any sectors are listed for which 4 4 % is not applicable; the applicable percentage will be stated. Fully Loaded W

age Rate: The l oaded wage rate is multiplied by 50% (EPA guidelines suggest 20

- 70%) to get overhead costs. **Applications and Summary Report for Emergency Exemption**  **(FIFRA §18)** For Section 18 emergency exemption requests , the state government is the applicant and the only

respondent

. Table 1 shows the costs per emergency exemption request (or application) of each collection activity , and the total cost per request

. The total estimated respondent costs for completing a Section 18 application and summary report are $5, 872 per response.August 12, 2014

Page 20 of 29 **Table 1. FI**  **FRA §18**

**– Applicant**  **( State Government** **) Burden**  **Hours and Cost Estimates**  **per Emergency Exemption Request** 
**COLLECTION ACTIVITY Burden per**  **A pplication (hours)**  **1 Total**  **2 M**  **anagerial $**  **8 5.69**  **/ hr.**  **Tech nical** 

**$ 5**  **8.59 /** **hr. Clerical** 

**$ 40.41**  **/ hr.**  **Hours Costs**  Read FIFRA and FQPA requirements and CFR regulations 4 .0 4 .0 0. 0 8 .0 $ 5 77 Process, compile, and review the requested data for accuracy and appropriateness 0 .0 74 .0 0 .0 74 .0 $ 4, 336 Generate application correspondence and follow

- up summary report 0 .0 15 .0 0 .0 15 .0 $ 8 79 Store/maintain/submit information 0 .0 0 .0 2 .0 2 .0 $ 81 **Totals 4**  **.0 93**  **.0 2**  **.0 99**  **.0 $**  **5, 872**  1 Hourly wage rates are fully loaded wage rates based on NAICS 999200 (State Government) from U

. S

. Dept
. of Labor, Bureau of Labor Statistics, May 2013. See Attachment H for wage calculations. 2 Totals may not sum due to rounding Table 2 shows the total annual costs for management, technical, and clerical time, as well as the estimated total annual respondent burden hours (18,315 hours) and costs ( $ 1.09 million) o f filing Section 18 applications and summary reports
. **Table 2. FI**  **FRA §18**

**– Total Annual Applicant (**  **State Government )**  **Burden Hours and**  **Cost Estimates Labor Category**  **Burden Hours**

**per Application**  **Number of**

**A pplications**  **Total Annual**

**Hours Labor Rate** 

**($/ hr.**  **) Total Annual** 

**Costs** Managerial 4 .0 1 85 740 $ 82.63 $ 63,411 Technical 93 .0 1 85 1 7,205 $ 57.68 $ 1,008,041 Clerical 2 .0 1 85 370 $ 39.20 $ 1 4,952 **Totals 99**  **.0** 1 85 **1 8,315**  **--- $**  **1,086,403 Notice of Pesti**  **cide Registration by States to M eet a Special Local Need**  **(FIFRA §24(c))** For Section 24(c) applications for SL N registrations, respondents include both pesticide product registrants and state governments, as each bears a burden for an application. Costs for the two respondent groups are presented separatel y, and then summed tog ether, in the tables below. Table 3 displays estimates of the cost per SL N registration application for registrants, both by collection activity

and the total. Total costs per application to registrants are estimated to be $3, 305
.August 12, 2014

Page 21 of 29 **Table 3**  **. FI**  **FRA §24(c) -**  **Applicant (Registrant)**  **Burden Hours and**  **Cost Estimates per Application** 
**COLLECTION ACTIVITY Burden per**  **A pplication (hours)**  **1 Total**  **2 M**  **anagerial $12**  **4.42 /** **hr. Tech**  **nical**

**$ 69.92**  **/ hr.**  **Clerical**

**$3 9.16**  **/ hr.**  **Hours Costs**  Gather data 5.0 12.5 0.0 17.5 $ 1, 496 Submit materials to s tate 9.0 5.5 1.0 15.5 $ 1, 544 Store/file/maintain the data 0.0 1.0 5.0 6.0 $ 2 66 **Totals** 14.0 19.0 6.0 39.0 $ 3, 305 1 Hourly wages rates are fully loaded wage rates based on NAICS 325300 ( Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing) from U.S. Dept. of Labor, Bureau of Labor Statistics, May 201 3 . See Attachment H for wage calculations. 2 Totals may not sum due to rounding.
Table 4 shows the total annual burden hours and costs for management, technical, and clerical time, as well as the estimated total annual respondent (registrant) burden hours ( 11,895 hours) and costs ( $ 1.01 million) o f filing Section 24(c) applications

. **Table 4. FIFRA §24(c) -**  **Total Annual Applicant (Re gistrant) Burden Hours and Cost**  **Estimates** Labor Category Burden Hours

per Application Number of

A pplications Total Annual

Hours Labor Rate ($/hr. ) Total Annual Costs Managerial 14 .0 3 05 4, 270 $ 12 4.42 $ 5 31,273 Technical 19 .0 3 05 5,795 $ 6 9.92 $ 405,186 Clerical 6 .0 3 05 1 ,830 $ 3 9.16 $ 7 1,663 **Totals 39**  **.0 3**  **05 1**  **1,895 $**  **1,008,123** Table 5 present s estimates of costs per application for state governments, by collection activity

and total for Section 24(c) applications.August 12, 2014

Page 22 of 29 **Table 5**  **. FI**  **FRA §24(c)**

**– Applicant (**  **State Agency** **) Burden**  **Hours and Cost Estimat**  **es per**  **Application**
**COLLECTION ACTIVITY Burden per**  **A pplication (hours)**  **1 Total**  **3 M**  **anagerial $8**  **5.69 /** **hr. Tech**  **nical**

**$5 8.59**  **/ hr.**  **Clerical**

**$ 40.41**  **/ hr.**  **Hours Costs**  Com pile information 0.0 1.0 0.0 1.0 $5 9 Revie w submission information 0.0 5.5 0.0 5.5 $ 3 22 Com plete and transmit paperwork to EPA 2 0.0 5.4 0.4 5.8 $ 3 33 Store/file/maintain the data 0.0 0.0 0.1 0.1 $ 4 Respond to r egistrant (if necessary) 0.0 0.4 0.2 0.6 $ 3 2 **Totals 0.0**  **12.3 0.7**  **13 .0**  **$7 17**  1 Hourly wages rates are fully loaded wage rates based on NAICS 999200 ( State Government) , U.S. Dept. of Labor, Bureau of Labor Statistics , May 20 1 3 . See Attachment H for wa ge calculations. 2 Includes label revisions, SLN registration cancellations, and other follow

- up actions data. 3 Totals may not sum due to rounding. Table 6 shows the total annual burden hours and costs for management, technical, and clerical time, as well as the total annual respondent (state agency) burden hours (3,965 hours) and costs ($228,428) of filing Section 24(c) applications. **Table 6**  **. FIFRA §24(c)**  **- Total Annual Applicant (**  **State Agency** **) Burden Hours and Cost Estimates**  **Labor Category Burden Hours** 

**per Application**  **Number of**

**A pplications**  **Total Annual**

**Hours Labor Rate** 

**($/ hr.**  **) Total Annual** 

**Costs** Managerial 0 .0 3 05 0 $ 8 5.69 $ 0 Technical 12.3 3 05 3, 752 $ 5 8.59 $ 2 19,800 Clerical 0.7 3 05 2 14 $ 40.41 $ 8, 628 **Totals 13.0**  **3 05**  **3,965 $**  **2 2**  **8 ,428**  Table 7 shows the total annual combined burden hours and costs for registrants and states for Section 24(c) application s . The total annual burden hours of the Section 24(c) program for respondents is approximately 15,680 hours at a cost of $ 1
. 2 4 million.August 12, 2014

Page 23 of 29 **Table 7**  **. FIFRA §24(c) -**  **Total Annual Applicant ( Registrant and State**  **Agency ) Burden**  **Hours and Cost Estimates** Applicant Burden Hours

per Application Number of

Applications Total Annual

Hours Cost per

Application Total Annual

Costs Registrant 39 .0 3 05 1 1,895 $ 3, 305 $ 1,008,123 State 13 .0 3 05 3,965 $ 7 17 $ 22 8 ,428 **Totals** 52 .0 3 05 1 5,860 $ 4,023 $ 1,23 6,551 **6(c) .**  **Estimating Agency (EPA)**  **Burden and Cost** Methodology

for Estimating Agency

Burden and Cost The EPA estimates Agency burden hours using employee time accounting data from OPP Divisions that provide significant support and anal ys is for the FIFRA Section 18 emergency

exemption and Section 24(c) speci al local need program s . The data is taken from the Time and Attendance Information System (TAIS), which archives the Agency ’s Full Time Equivalents (FTEs) for most OPP program activities. The TAI S sy stem tracks time for seven of OPP’s nine divisions. The two divisions that are not tracked b y TAI S, the Field and External Affairs Division (FEAD) and the Information Technology and Resource Management Division (ITRMD) , contribute only minimally

if at all to the Secti on 18 and 24(c) programs. ITRMD provides the preliminary data processing and tracking for many OPP I CR activities including tolerance petitions. These s ys tems are integrated for efficient processing, tracking, and maintaining data but they do not readily lend themselves to a clear burden breakdown b y IC R activity

. The Agency believes that using data from the TAIS accuratel y reflects the time spent on implementing and administering emergency exemption and SL N activities than former estimates

. Total annual FTEs are presented below, in separate tables for sections 18 and 24(c), by labor category

and OPP Division, and summed for division and OPP totals. Other tables show estimated annual burden hours for each program, by multiplying 2,080 hours in a work ye ar by the FTEs. The cost s per burden hour are the fully loaded wage rates, which are estimated in the same manner as they

are for respondents. The fully loaded wage rate for the Agency is based on NAI CS 999100 , Federal government

. **(See Attachme nt H)**  The total annual burden hours for each labor category

are estimated b y the applicable wage rate to get the total cost per category . Then labor category estimates are summed to get total estimated annual agency costs for each program. Six of the seven OPP divisions reporting in TAIS reported time for the Section 18 and 24(c) programs. These are the Registration Division (RD), the Biopesticides and Pollution Prevention Division (BPPD), and the Antimicrobial Division (AD), the Health Eff ects Division (HED), the Biological and Economic Analysis Division (BEAD), and the Environmental Fate and Effects Division (EFED)

. The Pesticide Re

- evaluation DivisionAugust 12, 2014

Page 24 of 29 (PRD) (formerly

the Special Review and Registration Division (SRRD)) did not report labor hours for either program. Total annual FTEs are presented below, in separate tables for Sections 18 and 24(c), b y labor category and OPP Division, and summed for Division and OPP totals. Other tables show estimated annual burden hours for each program by multiplying 2,080 hours in a work year b y the FTEs. **Applications and Summary Report for Emergency Exemption (FIFRA §18)** Table 8 displays annual average FTEs b y labor category and OPP division from TAI S data from 2011

- 2013 for Section 18 activities

. Six of the seven OPP divisions that report in TAI S participated in Section 18 activities. The number of FTEs in each category is summ ed and rounded up to the next full FTE to account for minor activities of the two OPP divisions that do not use the TAI S sy stem and to account for other small fractions of FTEs that are less than 0.1. The data indicate that the estimated number of Agency FTE’s dedicated to Section 18 emergency

exemption activities is approximately 1 managerial FTE, 5 technical FTEs, and 1 clerical FTE , for to tal of 7 FTEs allocated to emergency exemption activities. **Table 8**  **. Average Annual**  **Agency FTEs Supporting Section 18**  **Activities , 2011**  **- 2013**  **FTE Type RD**  **BEAD EFED**  **A D**  **BPP D**  **HED OPP**  **Total** Managerial 0. 3 0. 1 0.0 0.0 0.0 0. 0 1 Technical 2.9 0.8 0. 2 0. 0 0. 0 0. 2 5 Clerical 0. 2 0.1 0.0 0.0 0.0 0. 0 1 **Totals 2**  **3.5 1.**  **0 0.**  **2 0.**  **0 0.**  **0 0.**  **2 7**  1 O PP total for each labor category is rounded up to the next full FTE. 2 Division totals do not sum to OPP total due to rounding. Table 9 displays the Agency burden hours, wage rates, and total costs of supporting the Section 18 program. The total annual Agency burden for Section 18 activities is approximately 1 4,560 hours per ye ar , based on 2011

- 2013 average s ; the total annual Agency cost of the Section 18 program are approximately $1. 17 million. **Table 9**  **. Total Annual**  **Agency H**  **ours, Hourl y Wage Rate**  **s ,**  **a nd Total Costs**  **b y**  **Labor Category**  **Supporting Section 18**  **Activities FTE Type**  **FTEs**

**(rounded) Hours /** 

**FTE** 1 **Total**

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

**wage rates ($/** **hr. )**  **2 Annual**  **per**

**FTE cost Total Cost**  Managerial 1 2,080 2,080 $1 20.26 $2 50,141 $2 50,141 Technical 5 2,080 10,400 $7 9.40 $1 65,152 $ 825,760 Clerical 1 2,080 2,080 $4 4.74 $ 93,059 $ 93,059 **OPP total s**  **7 2,080**  **14,560 $1,**  **168,960** 1 Hours per FTE = 40 hours/week × 52 weeks/year 2 See Attachment H for data sources and calculations of fully loaded wage rates.August 12, 2014

Page 25 of 29 **Notice of Pesti cide Registration by States to M**  **eet a Special Local Need**  **(FIFRA §24(c))** Table 10 displays annual average FTEs by labor category

and OPP division from TAI S data from 2011

- 2013 for Section 24(c) activities. Six of the seven OPP divisions that report in TAIS participated in Section 18 activities. The number of FTEs in each category is summed and rounded up to the next full FTE to account for minor activities of the two OPP divisions that do not use the TAI S sy stem and to account for other small fractions of FTEs that are less than 0.1. The data indicat e that the estimated number of Agency FTE’s dedicated to Section 24(c) activities is approximately 1 managerial FTE, 1 technical FTEs, and 1 clerical FTE, for a total of 3 FTEs allocated to SLN activities. **Table 10**  **. Average Annual**  **Agency FTEs Supporting Section 24(c)**  **Activities , 2011**  **- 2013**  **FTE Type** RD BEAD EFED AD BPPD HED **OPP Total**  **1** Managerial 0.2 0.0 0.0 0.0 0.0 0.0 **1** Technical 1.5 0.0 0.1 0.0 0. 1 0.0 **2** Clerical 0.1 0.0 0.0 0.0 0.0 0.0 **1 Totals**  **2 1.8**  **0.0 0.1**  **0.0 0.0**  **0.0 4**  1 O PP total for each labor category is rounded up to the next full FTE. 2 Division totals do not sum to OPP total due to rounding. Table 11 displays the Agency burden hours, wage rates, and total costs of supporting the Section 24(c) program. The total annual Agency burden for Section 24(c) activities is approximately 8,320 hours per year , based on 2011

- 2013 averages; the total annual Agency cost of the Section 24(c) program is approximately $670 thousand. **Table 11**  **. Total Annual**  **Agency Hours,**  **Hourly Wage Rate , and**  **Total Costs by**  **Labor Category**  **Supporting Section 24(c)**  **Activities FTE Type**  **FTEs Hours /**  **FTE 1**  **Total**

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

**wage rates ($/** **hr. )**  **2 Annual**  **per**

**FTE cost Total Cost**  Managerial **1** 2,080 2,080 $120.26 $250,141 $250,141 Technical **2** 2,080 4,160 $79.40 $165,152 $ 330,304 Clerical **1** 2,080 2,080 $44.74 $93,059 $93,059 **Totals 4**  **2,080** 8,320 **--- ---**  **$ 673,504** 
1 Hours per FTE = 40 hours/week × 52 weeks/year 2 See Attachment H for data sources and calculations of fully loaded wage rates.August 12, 2014

Page 26 of 29 **6(d) .**  **Bottom Line Burden Hours and Cost**  **Table s**  **Table 1**  **2 .**  **FI FRA §18**  **- Total**  **Annual Burden and Cost Estimates**  **for Applications and S**  **ummary Report s**  **for Emergency Exemption s**  Previous Estimates Current Estimates Hours Costs Hours Costs Respondents (state agencies) 12,672 $739,013 18,315 $1,086,403 Agency 18,720 $1,381,327 14,560 $1,168,960 **Table 1 3**  **. FI**  **FRA §24(c) -**  **Total Annual Burden and Cost Summary for**  **Notice of Pesticide Registration by Stat**  **es to M eet a Special Local Need**  Previous Estimates Current Estimates Hours Costs Hours Costs Respondents (registrants & states) 16,900 $1,234,905 15,860 $ 1,236,551 Agency 2,895 $219,612 8,320 $ 673,504 **Table 1 4**  **. Co**  **mbined Respondent**  **Burden for thi**  **s ICR** Programs Previous Estimates Current Estimates Hours Costs Hours Costs Section 18 12,672 $739,013 18,315 $1,086,403 Section 24(c) 16,900 $1,234,905 15,860 $ 1,236,551 **Total 29,572**  **$ 1,973,918**  **34,175 $**  **2,332,954 6(e)**  **. Reasons for Change in Burden**  The reasons for changes to the estimated burden are described below for each program . **Applications and Summary Report for Emergency Exemption (FIFRA §18)**  Although the estimated unit burden for a given Section 18 application is unchanged , EPA estimates an increase in the number of section 18 application submission s and estimated annual burden relative to the existing , approved collection . EPA estimates that the total annual respondent burden has in creased from 12,672 hours to about 18,315 hours

. The in crease corresponds with an increase in the average number of Sec tion 18s requested per ye ar , from 128 to 185
. Although EPA does not require Section 18s and cannot estimate precisel y how many submissions will be received in the future, the Agency expects to receive approximately 185 Section 18 applications annually over the next three years. As a result of the increase in the number of applications and updating the wage rates, the estimated respondent cost increased from $ 739 thousand to $ 1.086 million.August 12, 2014

Page 27 of 29 **Notice of Pesti cide Registration by States to M**  **eet a Special Loca l Need**  **(FIFRA §24(c))** There is no change in the estimated respondent burden hours per SLN application for this IC R from the currently

- approved ICR for Section 24(c) applications , for either registrants or states

. The total annual respondent burden estimat e (registrants + states) has decreased slightly from 16,900 to 15,860 hours due to a small decrease in the average number of petitions received annuall y, from about 325 to 305
. Although EPA does not require Section 24(c) s and cannot estimate precisely how many submissions will be received in the future, the Agency

expects to receive approximately 305 Section 24(c) applications annually over the next three years. As a result of the decrease in the number of applications and updating the wage rates, the estimated respondent cost increased slightly from $ 1.235 million to $ 1.23 7 million

. **6(f) .**  **Burden Statement** The respondent burden for collection of information associated with the Applications and Summary

Report for Emergen cy

Exemption rule is estimated to average 99 hours per application. The respondent burden for the Notice of Pesti cide Registration by States to M eet a Special Local Need rule is estimated to average 52 hours per response (39 hours per registrant and 13 hours per State), including time for compiling the information/data submitted by

the registrant, reviewing the information for special local needs determination, completing paperwork to notify the federal government, storing/filing/maintaining the data, and responding back to the registrant if the registration is disapproved by EPA. The burden estimate includes hours spent by the registrant in preparing the application for submission to EPA. According to the Paperwork Reduction Act, “burden” is defined at 5 CFR 1320.3(b)

. The agency

may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection will appear o n all form s associated with this I CR . In addition OMB control numbers for EPA’s regulations, after initial display in the final rule, are listed in 40 CFR P art 9. The Agency

has established a public docket for this I CR under Docket ID No. EPA

HQ

- OPP

- 2014

- 0567 , which is available for online viewing at http://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 facility is open from 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 suggested methods for minimizing respondent burden, including the use of automated collection techniques. Comments may

be submitted to EPA electronically through http://www.regulations.gov or b y mail addressed to Director, Collection Strategies Division, U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. You can also send comments to the Office of Information and RegulatoryAugust 12, 2014

Page 28 of 29 Affairs, Office of Management and Budget, 72 5 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Include docket ID No. EPA

- HQ

- OPP

- 20 14

- 0 56 7 in any correspondence.August 12, 2014

Page 29 of 29 **ATTACHMENTS TO THE SUPPORTING STATEMENT** Attachments to the supporting statement are available in the public do cket established for this ICR under docket identification number **EPA -**  **HQ -**  **OPP -**  **2014 -**  **0567**
. These attachments are available for online viewing at http://www.regulations.gov or otherwise accessed as described in Section 6(f) of the supporting statement. **Attachment A -**  **1 7 U.S.C. 136p**  **- Section 18 of the**  **Federal Insecticide, Fungicide,**

**and Rodenticide Act (FIFRA)** . Also available at online at the US House of Representatives’ US Code website

. **Attachment A -**  **2 7 U.S.C. 136v**  **- Section 24(c) of the Federal Insecticide,** 

**Fungicide, and Rodenticide Act (FIFRA).** Also available online at : http://www.epa.gov/opp00001/regulating/fifra.pdf

. **Attachment A -**  **3 21 U.S.C 346a**  **- Tolerances and exemptions for pesticide chemical** 

**residues, Section 408 of the Federal Food, Drug and Cosmetic Act**  **(FFDCA).** Also available at online at the US House of Representatives’ US Code website

. **Attachment B -**  **1 40 CFR**  **part 166 -**  **Exemption of Federal and State Agencies fo r** 

**Use of Pesticides under Emergency Conditions** . Also available online at the National Archives and Records Administration’s Electronic CFR Website

. **Attachment B -**  **2 40 CFR part 162**  **- State Registration of Pesticide Products**  **.** Also

available online at the National Archives and Records Administration’s Electronic CFR Website

. **Attachment C 40 CFR Part 176**  **- Time**  **- Limited Tolerances for Pesticide** 

**Emergency Exemptions.** Also available online at the National Archives and Records Administration’s Electronic CFR Website

. **Attachment F EPA Form No. 8570**  **- 4**  **- Confidential Statement of Formula.**  Also

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

- 4.pdf

. **Attachment G EPA Form 8570**  **- 25**  **- Application for/Notification of State** 

**Registration of a Pesticide to Meet a Special Local Need.** This attachment can be also accessed via the internet at : http://www.epa.gov/opprd001/forms/8570

- 25.pdf

. **Attachment H Labor Wage Formulas.**