September 30, 2012

1 **SUPPORTING STATEMENT FOR AN**  **I NFORMATION COLLECTION REQUEST (ICR)**  **1. IDENTIFICATION OF THE INFORMATION COLLECTION**  **1(a) .**  **Title of the Information C**  **ollection** Title: Pesticide Data Call

- InProgram OMB Control No.: 2070

- 0174 ; EPA No.: 2288.0 2 **1(b). Short Characterization/Abstract**  This information collection request (ICR) is a renewal of currentl y- approved information collection activities that are unchanged

. Th e Environmental Protection Agency ’s (EPA ), Office of Pesticide Programs (OPP) uses the information collection activities covered by this ICR to acquire the necessary data in support of the statutorily mandated pesticide reviews under four program area s to assess whether the continued registration of an existing pesticide causes an unreasonable adverse effect on human health or the environment and/or pursue appropriate regulatory measures . EPA uses data collected under th is IC R for the following key program areas:  Special Review;
 Reregistration;
 Registration Review; and,
 Tolerance assessment. The information collection activities for these programs share a common statutory authority , similar respondent populations, same data collection mechanism (a DCI and related forms) , and empl oy the same m ethodology

to calculate the related paperwork burden hours and costs

. Please note that this I CR, with the exception of this abstract, is the same as that which is currentl y approved. EPA is not currently making any changes because EPA will be seeking a short renewal of the currentl y approved ICR. Th e short renewal will provide additional time to allow EPA to finish working to restructure the ICR, improve the electronic forms and instructions, and consult with stakeholders and the Office of Man agement and Budget ( OMB ) on those changes and the corresponding adjustments to the burden estimates. This short

- term renewal is necessary because the ICR covers ongoing activities that are required to support the statutorily mandated pesticide reviews. **2. NEED FOR AND USE OF THE COLLECTION**  **2(a). Need/Authority for the Collection** EPA's OPP, under the Assistant Administrator for Chemical Safety and Pollution Prevention (known prior to 2010 as the Office of Prevention , Pesticides and Toxic Substances ) , uses the information collected under this I CR to obtain the data needed by OPP scientists to assess and characterize pesticide risks, and to determine whether the pesticide continues to meet the standards established by

law. Before the Agency determines that specific data are needed, the Agency will first search for available information (i.e., EPA databases for information that may have been submitted to EPA under another ICR, voluntarily , or submitted by another respondent; information that has otherwi se published in the literature; or information that is otherwise publicl y available). Only if the needed dataSeptember 30, 2012

2

is not found will EPA require the submission or generation of the specific data needed. Such data may include toxicology

studies, fish and wildl ife studies, environmental fate studies, chemistry studies and/or other data needed to analyze the potential risks and benefits associated with pesticide chemicals. Sections §3(a) and §12(a)(1) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) require a person to register a pesticide product with the EPA before the pesticide product may be lawfully sold or distributed in the United States. A pesticide registration is a license that allows a pesticide product to be sold and distributed for specific uses under specified terms and conditions such as use instructions and precautions. The proponent of initial or continued registration alway s bears the burden of demonstrating that a pesticide product meets the statutory standard for registration . A pesticide product may

be registered or remain registered onl y if it meets the statutory standard for registration given in section §3(c ) ( 5) of FIFRA , which is as follows: (A) Its composition is such as to warrant the proposed claims for it. (B) Its labeling and other material required to be submitted comply with the requirements of this Act. (C) It will perform its intended function without unreasonable adverse effects on the environment. (D) When used in accordance with widespread and commonly recogni zed practice it will not generall y cause unreasonable adverse effects on the environment. FIFRA §2(bb) defines “unreasonable adverse effects on the environment'' as (1) “any unreasonable risk to man or the environment, taking into account the economic, s ocial, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food Drug and Cosmeti c Act.'' The programs and DCI activities represented in this proposed renewal and consolidation share a common statutory

authority , S ection 3(c ) ( 2 ) ( B) of FIFRA , which authorizes EPA to require pesticide registrants to generate and submit data to the Agency, when such data are needed to maintain an existing registration of a pesticide. EPA’s determination that additional data are needed can occur for various reasons , with the following fo ur reasons being the most common :
 **The Re -**  **registration Program:** Section 4 of FIFRA requires EPA to re
- assess the health and safety data for all pesticide active ingredients registered before November 1, 1984, to determine whether these “older” pesticides meet the criteria for registration that would be expected of a pesticide being registered today for the first time. Section 4 directs EPA to use Section 3(c ) ( 2 ) ( B) authority

to obtain the required data. While, Reregistration Eligibility Decisions are exp ected to be completed b y 2006 for food

- use pesticide ingredients and 2008 for non

- food use pesticide ingredients, the Agency

may still need to issue DCI s after FY 2008 to close out the program. **(Attachment A** **)**

 **The Registration Review Program:** Section 3(g) of FIFRA contains provisions to help achieve the goal of reviewing each pesticide every 15 years to assure that the pesticide continues to pose no risk of unreasonable adverse effects on human health or the environment. Section 3(g) instruct s EPA to use the section 3(c)(2)(B) authority to obtain the required data

. **(Attachment s**  **B and C**  **)**

 **The Special Review Program:** Though rare, EPA may conduct a Special Review if EPASeptember 30, 2012

3

believes that a pesticide poses risks of unreasonable adverse effects on human health or the environment. Section 3(c ) ( 2 ) ( B) of FIFRA provides a means of obtaining any needed data **. (Attachment**  **B )** 

 **Anticipated Residue/Percent Crop Treated Information:** Under section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA), before a pesticide may be used on food or feed crops, the Agency

must establish a tolerance for the pesticide residues on that crop or established an exemption from the requirement to have a tolerance. Section 408(b)(2)(E) and (F) of FFDCA authorize the u se of anticipated or actual residue (ARs) data and percent crop treated (PCT) data to establish, modify , maintain, or revoke a tolerance for a pesticide. (**Attachment D** ) The FFDCA requires that if AR data are used, data must be reviewed five ye ars after a tolerance is initially established. If PCT data are used, the FFDCA affords EPA the discretion to obtain additional data if any or all of several conditions, including but not limited to the following, are met:  the existing data have been found unreliable;  exposure estimates underestimate exposures for any significant population group; and  dietary exposure must be re

- evaluated periodicall y .

 **Enforcement and U**  **nanticipated Incidents:** Inextremely rare instances, a need for a data call

in may ari se from changes in the discovery of deficiencies in previously submitted data, or from the discovery

of specific attributes of the pesticide or its ingredients. This may give rise to concerns such as observed or suspected adverse human health or environme ntal effects attributed to the use of a pesticide. Or such data is needed in support of Agency enforcement cases resulting from consumer complaints about the product, its storage stability , the integrity of its container, or exaggerated advertising claims . This ty pe of DCI is needed because the concern and therefore the need for data arise not from a mandated review program like the programs described above, but from unanticipated circumstances. Section 3(c) (2) (B) of FIFRA provides a means of obtaining any needed data **.** In order to conduct the required re

- evaluation, a Pesticide Registrant may be required to submit specific data necessary

to demonstrate that residues do not exceed the residue levels used to establish the tolerance. Under the authority of section 3(c ) ( 2 ) ( B) of FIFRA, the Agency will issue a DCI to obtain any additional data. **2(b). Practical Utility/Users of the Data** EPA uses the information collected to carry out its statutory

responsibilities under sections s ection 4 of FIFRA, s ection 3(g) of FIFRA, section 6 (b) of FIFRA, and section 408 of FFDCA. Th e data collected allows EPA to assess whether the continued registration of an existing pesticide causes an unreasonable adverse effect on human health or the environment
. The Agency

issues DCIs as part of one or more statutorily mandated review process es and has determined that more information is needed. Agency decisions requiring additional data are usually “triggered” b y the data requirements set forth in 40 CFR part s 150 through 180, with the majority of the data requirements regarding studies captured in 40 CFR part 158. The Agency uses data requirements to ensure that the statutory standards are met. Some of these standards include, but are not limited to, determining if a pesticide can remain registered because it does not causes an unreasonable adverse effect on human health or the environment , section §3(c) (5) andSeptember 30, 2012

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section 2(bb) of FIFRA, the safety standard of section 408 of FFDCA , as amended , directs the Agency to consider aggregate exposures from dietary and other non

- occupational sources when assessing the risks of a pesticide. In addition to dietary exposure, such sources as drinking water and residential use must be considered. Thus, EPA must make the statutory determination that pesticide residues in food or feed will result in a reasonable certainty of no harm to human health from aggregate exposure through dietary , non - occupational, and drinking water routes of exposure. FQPA also dir ects EPA to consider the cumulative effects of pesticides that share a “common mechanism of toxicity ,” consider special sensitivities of infants and children, and consider possible endocrine disruptor effects. EPA must also evaluate the data obtained from registrants to ensure that residues in or on food are not above the residue levels relied on for establishing the tolerance. If the submitted residue data demonstrates that the residue levels are above the levels relied on for establishing the tolerance, EPA will take appropriate action to modify or revoke the tolerance. **2(b)(1) Types of D**  **ata Collected** The data that EPA collect s and review s fall into three general categories: confirmatory data, product

- specific data, and voluntary data. Confirmatory Data . In making a regulatory decision , additional generic studies sometimes are required to confirm the Agency ’s risk assessments, findings, or conclusions about a pesticide, and to help determine whether further use modifications will be necessary to reduce risks of concern. Product

- Spec ific Data . After the existing data supporting a pesticide are evaluated and a regulatory

determination is made , EPA’s focus turns to the information and data required to make regulatory decisions at the product

- specific level. For every end

- use product (that is, every product that contains an active ingredient) , registrants are required to submit certain data specific to the product as formulated and sold (including acute toxicity and product chemistry

studies), revised labeling

. In certain instances, th e Agency

requires that the registrant submi t a Confidential Statement of Formula

. For example: Registrants are required to submit a Confidential Statement of Formula (EPA Form 8570

- 4) to comply with registration

- related requirements under FIFRA section 3, such as when a registrant seeks to add uses for a currentl y- registered pesticide, or when the registrant changes a registered pesticide’s formulation. The requirement is mentioned here since registrants have not alway s submitted the required information immediately to EPA and the deficiency may remain at the time of the regulatory review. The paperwork burden for the submission of Form 8570

- 4 is covered under OMB Control No. 2070

- 0060 (

Application for New/Amended Pesticide Registration ; EPA I CR. No. 0277

. Additional information and data are essential to making the final regulatory decision regarding the particulars of a specific product

. Voluntary Data . FQPA require s EPA to specifically consider a number of factors when making pesticide reregistration and other ty pes of regulatory

decisions. While registrants have historicall y and voluntarily

submitted data to EPA that was not specificall y required/requested , EPA is sued Pesticide Registration (PR) Notice 97

- 1 in light of the FQPA requirement to identify areas in which the Agency may need additional data to fully assess risks under FQPA. The PR notice encouraged registrants to supplement their original reregistration submissions with additional information that may permit more accurate estimates of exposure and/or risk. As a result of PR Notice 97

- 1, EPA received large numbers of voluntarily

submitted studies for pesticides in reregistration, particularl y for large v olume, controversial chemicals. While the reregistration program is near completion, the Agency still anticipates receiving a small number of voluntarily submitted studies from registrants to fulfill other statutory requirements.September 30, 2012

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**3(a). Non duplication** The information collected under th ese program s is specific to the needs of the federal pesticide law negating the need for similar data by other federal agencies or any other office within EPA. P rior to requesting any information the Agency must review existing records for the availability of the information that it is considering requesting. The Agency maintains files on all pesticide chemicals, which includes all correspondence and information/data submitted. Before any DCI is issued, these files are referenced to determine whether the necessary data are already on hand, thereb y eliminating duplicative data requests. For example , a majority of the percent

- crop - treated information can currently be obtained internall y, thus DCI s will only be issued when more data is necessary . The data for anticipated residues, on the other hand, is unique to the requirements of FIFRA, and, therefore, must be submitted to the Agency

. EPA also provides for public comment periods for all the review programs which may modify the DCIrequirements if warranted by information provided by registrants or the public

. OPP publishes a list of data submitters and encourages the registrants to act cooperativel y in the development of data or in its us e. OPP encourages cost
- sharing agreements among manufacturers of specific pesticide chemicals in order to minimize the duplication of laboratory tests and reduce the costs for developing the data . All DCInotices explain the statutory provisions for cost

- sharing agreements under FIFRA. **3(b). Public Notice Required Prior to ICR Submission to OMB** Pursuant to 5 CFR 1320.8(d), EPA publish ed a Federal Register (FR) notice ( See 73 FR 2907; January 16, 2008) notice soliciting comment on this information collection activity and the Agency ’s intent to renew , consolidate and request OMB approval of this I CR. The Agency received onl y one public comment on this consolidated renewal ICR from William M. Mahlburg, Director Government Affairs, Nufarm Americas, In c. Mr. Mahlburg suggested that the Agency re - evaluate the timing set for registrant response to DCIs to provide more time for registrants to respond because technical registrants for numerous active ingredients will be affected by multiple DCI s that are s imultaneous or overlapping. Mr. Mahlburg stated that due to a multitude of end

- use product registrations that Nufarm submits large volumes of studies termed “low burden” and that companies with more than 25 end

- use product registrations with the same acti ve ingredient were constrained b y the Agency’s set DCI response time line and needed additional DCIresponse time to help eliminate the response process burdens associated with high volume registration companies. The Agency

does not expect that a given technical registrant will ty pically receive simultaneous DCI s for multiple active ingredients. However, in situations where a large number of studies are required, the Agency

has responded to requests for time exten sions by staggering when responses are due. In its comment, Nufarm did not submit any new burden data for the Agency to consider. Therefore, there are no new data for the Agency to evaluate. In addition, submissions to the Agency from 1996

- 2004 of voluntary data not required by

the Agency

but which are submitted by registrants to supplement an active ingredient database show that most are considered b y the Agency to be “low burden.” At this time, the Agency does not anticipate changing the low burden hour study projections documented in this I CR. Overall, in developing paperwork burden estimates, EPA assumed that responses (including ones to end

- use product

- specific data) from registrants would not include the following: data already generated at reg istration, submitted under a previous DCI , resubmissions because the original data were not complete or did not meet submission requirements, or preexistingSeptember 30, 2012

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data that can be found in published, peer reviewed literature. Since the commenter did not offer any new burden numbers for the Agency to consider, the Agency

did not change the burden numbers in the final document. **3(c). Consultations** Consultation and/or dialogue between registrants and the Agency concerning data requirements, need for particular information and the protocol to be used to conduct the study are frequent and ongoing. Generally , all programs discussed in this DCI P rogram IC R are intrinsicall y woven with the Agency's p ublic participation review process

. Stakeholders and the public have a number of opportunities for input, consultation and involvement throughout the process, including but not limited to issues such as the need for additional data. Significant public comments will be addressed prior to issuing DCIs. Until the D CIis issued, registrant s are not required to submit data. This integrated public participation framework provides consistent, predictable opportunities for public and stakeholder involvement through public comment periods at regular intervals to help info rm EPA’s regulatory decision making

. EPA’s formalized public participation process for reregistration and tolerance reassessment (See 69 FR 26819, May 14, 2004; also http://www.epa.gov/oppsrrd1/public.htm) recognizes that all pesticides do not present the same degree of risk or complexity of issues, and accordingl y describes the way s in which the Agency tailor the public participation process to the uses and risks of each pesticide and to obtain public input as needed while still making timel y decisions and meeting statutory

deadlines and program goals. The process for registration review, including public participation, is described in the procedural rule for registration review (40 CFR part 155) and is summarized on the Agency ’s web site at http://www.epa.gov/oppsrrd1/registration_review/public_involvement.htm I f appropriate to resolve scientific questions, the Agency may also seek peer review and/or advice from the FIFRA Science Advisory Panel SAP. The FIFRA SAP is a Federal advisory committee established in 1975 under FIFRA that operates in accordance with requirements of the Federal Advisory Committee Act. The FIFRA SAP is composed of a permanent panel consisting of seven members who are appointed b y the EPA Administrator from nominees provided b y the National Institutes of Health and the National Science Foundation. FIFRA, as amended, established a Science Review Board consisting of at least 60 scientists who are available to the FIFRA SAP on an ad hoc basis to assist in reviews conducted b y the Panel. EPA consult ed with a variety of re spondents regarding the information collection activities for this I CR during the renewal and consolidation process. A list of the respondents contacted is below: Ray McAlister, Vice President Science and Regulatory

Affairs CropLife America ray @croplife.us Susan Little, Executive Director Consumer Specialty

Products Association 900 17th Street N. W.. Washington, DC 20005 slittle@cspa.org Daniel Botts, Director FFDA's Environmental & Pest Management Division Minor Crop Farmer Alliance Rebeckah Freeman Adcock, Director, Congressional Relations American Farm Bureau 600 Maryland, Ave., S.W.September 30, 2012

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Technical Comm ittee (Chairman) Florida Fruit & Vegetable Assoc. daniel.botts@ffva.com Suite 1000W Washington, DC 20024 rebeckah@fb.org The cons ult ation questions and any responses received are included in the docket as attachments E
- 1 through E

- 4 for this action. Generall y, the questions and discussions with respondents include d whether the labor rate estimates in the I CR are accurate and whether the estimates of burden and methodology

for arriving at the estimate are correct, and whether respondents would consider submitting the information electronically , such as through web forms and whether the consolidation document was eas y to read

. To date, one respondent, Rebeckah F. Adcock, American Farm Bureau Federation noted that the document was clearl y written and concisely laid out. The Agency did not received any comments regarding the burden. **3(d). Effects of Less Frequent Collection**  Information is collected under this I CR onl y when the Agency has identified a need for the specific data, and onl y on a one - time basis. AR or PCT information is collected one time within the five ye ars preceding the reliance on such data. The AR or PCT information collection is required b y sections 408(b)(2)(E)(I) and 408(b)(2)(F) of the FFDCA and cannot be collected less frequentl y. **3(e). General Guidelines**  The only guideline established under the Paperwork Re duction Act (PRA) that is exceeded in this collection is the time period for retaining records. Pursuant to FIFRA §8, EPA recordkeeping requirements in 40 CFR 169.2(k) state that records containing research data relating to registered pesticides be retain ed as long as the registration is valid and the producer remains in business. Registrations are valid until they are either voluntarily

canceled or withdrawn by the registrant or until EPA has cause to suspend or cancel the registration. Since the averag e period of marketability of a pesticide ranges from 15 to 30 years, the PRA guidelines specifying that data other than health, medical or tax records not be required to be retained for more than three ye ars will be exceeded in this collection activity

. **3(e)(1) .**  **Forms** The forms associated with this I CR may also be used for other information collection activities that are approved under other OMB Control numbers, e.g ., 2070

- 0060. Specificall y :

 Confidential Statement of Formula, (EPA Form 8570

- 4 )

- also approved under OMB Control Number 2070

- 0060

 Formulator's Exemption Statement, (EPA Form 8570

- 27)

- also approved under OMB Control Number 2070

- 0060

 Certification of Compliance with Data Gap Procedures, (EPA Fo rm 8570

- 28)

 Certification of Attempt to Enter into an Agreement with Registrants for Development of Data (EPA Form 8570

- 32)September 30, 2012

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 Certification with Respect to Citation of Data (in Pesticide Registration (PR) Notice 98

- 5) (EPA Form 8570

- 34)

- also approved under OMB Contro l Number 2070

- 0060

 Data Matrix (also in PR Notice 98

- 5) (EPA Form 8570

- 35)

- also approved under OMB Control Number 2070

- 0060

 Summary

of the Ph ys ical/Chemical Properties (EPA Form 8570

- 36 )

- also approved under OMB Control Number 2070

- 0060

 Self

- Certification Statement for the Phy sical/Chemical Properties (EPA Form 8 5 70

- 37 )

- also approved under OMB Control Number 2070

- 0060

 Requirements Status and Registrant’s Response ( EPA Form 6300

- 3 )

 Data Call

- In Response Form ( EPA Form 6300

- 4) F orms 6300

- 3 and 6300

- 4 are automatically generated by

EPA’s computer databases and are pre

populated with information that is specific to each individual registrant that receives a Data Call

- In notice for a given pesticide. These forms are not widely accessibl e to general public

. Instead, EPA will continue to generate the pre

- populated, registrant

- specific forms through the Agency ’s computer s ys tem when preparing to issue Data Call

- In notices. In the past , under the separate renewals for these ICRs and i n ac cordance with 5 CFR 1320.5(a)(1)(iii)(C), EPA discontinue d the display of expiration dates on these forms because the forms had not changed after many years of use and were not expected to change in the future. The OMB approved prior ICR request s , and EP A will continue to omit the expiration dates on these forms. See **Attachment F**  for accessibility to forms. **3(e)(2) .**  **OMB Review of Specific DCIs** When OMB last approved these ICRs in 2005, OMB directed EPA, via the terms of clearance , to seek OMB clearance before issuing a given DCI

. Specificall y , the terms of clearance provided that: EPA must provide OMB with notice and an opportunity to review the DCI. The information sent to OMB shall include basic information on the pesticide, the total number of respondents, the planned schedule for issuance and data submission, a list of required studies, the p ractical utility of the data, and an estimate of the paperwork burden and testing costs. **3(f). Confidentiality**  Except as provided in FIFRA section 10(d)(1)(A), (B) or (C), health and safety data submitted by registrants under FIFRA must be made available by the Agency upon request from anyone not affiliated with a multi

- national pesticide firm. These exceptions, however, specifically p rohibit disclosure of the inert ingredients in a pesticide or of it s manufacturing, quality control processes, sales and production data, or trade secrets.September 30, 2012

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Registrants may

claim at the time of submission that specific data are subject to treatment as con fidential for reasons other than falling within the exclusions for mandatory release. All data subject to such claims, or falling within FIFRA section 10(d)(1)(A), (B), or (C) are handled strictly in accordance with the provisions of the FIFRA Confidential Business Information Security Manual . The manual requires that all CBI must be marked or flagged as such, all CBI must be kept in secure (double

- locked) areas, and all CBI intended to be destroyed must be cleared by a Document Control Officer and shredded

. **3(g). Sensitive questions**  No information of a sensitive or private nature is requested in conjunction with this information collection activity , and this information collection 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 to the information collection activities related to this ICR consist of pesticide Registrants identified b y the North American Industrial Classification System (NAICS) code **325320** (Pesticide and Other Agricultural Chemical Manufacturing). **4(b). Information Requested** Reregistration Over the next three ye ars, EPA expects to issue 137 DCI s for active ingredients and the pesticide products that contain them. The breakdown of the regulatory decisions for the Reregistration Program that EPA expects to make over the next 3 years is as follows: **Type of Decision No.**  **of Pesticide Ingredients**  Reregistration Eligibility

Decisions (REDs) and efficacy data 107 Import tolerances (ingredients with no U.S. registrations) 30 Total 137 Special Review and Registration Review Special Reviews, though rare, are conducted when the Agency determines such a review is warranted. For the sake of the anal ys es presented in Section 6 of this I CR, EPA assumes that it will issue one DCI per ye ar. Over the next 3 years EPA expects to issue 121 DCI s ( 41 annuall y) for the R egistration Review Program. Anticipated Residue and Percent Crop Treated (AR/PCT) R eview sSeptember 30, 2012

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Over the next 3 years, EPA expects to issue 4 AR

- related DCIs and 1 PCT

- related DCI per ye ar. The breakdown of the annual number and type of DCI s is as follows: **Type of DCI Number of**  **DCIs per year** Anticipated Residue G eneration and submission of base set of AR data (“T ype 1”) 2 S ubmission of minimal verification

- of

- use information (“T ype 2”) 1 S ubmission of AR data from publicly available sources (“Ty

pe 3”) 1 Percent Crop Treated S ubmission of PCT data using existing information (“T ype 4”) 1 **Total** 5 Enforcement and Unanticipated Incidents As explained in section 2 of this I CR, DCIs related to enforcement cases and unanticipated incidents are extremely

rare. For the sake of the analy ses presented in Section 6 of this I CR, EPA assumes that it will issue only one DCI for this purpose over the next 3 years .

(i) Data Items, Including Record Keeping Requirements Considering the potential variation in the specific need identified for the individual pesticide under review, the specific data items that may be collected for the individual pesticides under this ICR are also likel y to vary from pesticide to pesticide. However, based on the spec ific need identified for the pesticide, the Agency

may request , or the registrant may voluntaril y submit several types of data, including, but not limited to:

Product Chemistry Residue Chemistry Environmental Fate Toxicology Reentry Protection Spray Drif t Wildlife and Aquatic Organisms Plant Protection Nontarget Insect Product Performance Biochemical Pesticides Microbial Pesticides Exposure Studies Dermal Absorption/Penetration Studies Acute and Subchronic Neurotoxicity Studies Cholinesterase Determ ination Biomonitoring Studies (in Children) M onte Carlo Probabilistic Assessments/Acute and Chronic Dietary Exposure Analy ses Historical Water Monitoring DataSeptember 30, 2012

11 Field Monitoring Studies and Evaluations Runoff and Drift Monitoring Studies Pesticide Removal Studies using Vegetative Filter Strips Retrospective Anal ys es of Surface Water Contamination Analy ses of Use Patterns Research Studies of Applications and Use in Professional Markets Comparative Formulations/Application Methods/Resulting Crop Residue Studies Mechanistic Studies for Carcinogenicity Studies on Potential to React with DNA Monitoring data (States, special monitoring , market basket, single serving, etc.) Field trials, Processing studies, Reduction in residue data (washing, peeling, cooking, etc.), Livestock feeding studies Metabolism studies Percent crop treated data These categories, which are defined in greater detail in 40 CFR Part 158 , basically consist of the criteria for information and/or data that are necessary to make a regulatory finding. (See guidelines and policies to assist registrants with responding to DCIs ; s ee science policy at http://www.epa.gov/pesticides/science/policies.htm and test guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm .) In addition to the categories identified above, the Agency may also require that a special study be conducted to provide c ritical information about the risks and benefits of the pesticide in support of continued registration. Agency requests for special studies would be based on the particular characteristics of the chemical, and the Agency ’s need for such information to make the required statutory finding. (ii) Respondent Activities A pesticide registrant who receives a DCI will generall y engage in the follo wing activities under this I CR: **1. read instructions**  read the DCI letter to understand what data are to be submitted **2. plan activities** plan the activities necessary to comply

with the DCI , or develop options to avoid having to submit data (e.g., exemption/waiver), submit 90

- day

response to EPA **3. create information** conduct research, administer tests, anal yz e data to develop studies, perform laboratory

anal ysis, write study

documents **4. gather information** search for existing data that will satisfy the DCI **5. compile and review** assemble and evaluate data for accurac y and appropriateness for compliance with the DCI **6. complete paperwork** prepare necessary correspondence, documents and packages for submitting data to EPASeptember 30, 2012

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**7. maintain and file** maintain the data and other information submitted to the Agency Registrants who receive a DCI n otice from EPA must notify the Agency

how they intend to comply with the terms of the DCInotice within 90 day s of receipt of the notice. Registrant options for complying with the DCI notice vary greatl y and thus the per respondent burd en can also vary greatl y. A summary of the registrant compliance options are listed below: (iii) Reducing the PRA Burden: Variation of Response to A DCI Voluntary

Cancellation

- Registrants opting to voluntarily cancel their products containing the ac tive ingredient that is subject to the DCI must submit a completed Data Call

- InResponse Form. If a product is voluntarily

cancelled, further sale and distribution of that product after the effective date of cancellation must be in accordance with the exi sting stocks provision of the individual DCInotice. Deletion of Uses

- Registrants choosing to amend their registration to delete the uses of their product to which the requirements appl y must submit the Requirements Status and Registrant's Response Form , a completed application for amendment, a copy of their proposed amended labeling, and all other information required for processing the application. They must also complete a Data Call

In Response Form. If registrants choose to delete the use(s) subjec t to the DCInotice or uses subject to specific data requirements, further sale, distribution, or use of their product after one year from the due date of their 90

- day

response must bear an amended label. Generic Data Exemption

- Registrants are entitled to apply for a generic data exemption from the requirement to submit or cite generic data concerning an active ingredient if the active ingredient in the product is derived exclusively from purchased, registered pesticide produc ts containing the active ingredient. To qualify

for a generic data exemption, a product must meet all of the following requirements:

 The active ingredient(s) in the registered product must be present solel y because of incorporation of another registered product which contains the subject active ingredient(s) and be purchased from a source not connected with the registrant; and,

 Every registrant who is the ultimate source of the active ingredient(s) in the product subject to the DCInotice must be in comp liance with the requirements of the notice and must remain in compliance; and

 The registrant of the product that is the subject of the DCI notice must have provided to EPA an accurate and current "Confidential Statement of Formula" for each of the product s to which the Notice applies. Registrants appl yi ng for the Generic Data Exemption complete and submit a Data Call

- In Response Form along with all supporting documentation. I f a generic data exemption is claimed, the registrant is not required to comple te the Requirements Status and Registrant's Response Form. Generic data exemption cannot be selected as an option for product specific data. Registrants who are granted a Generic Data Exemption rely on the efforts of other persons to provide the Agency with the required data. If the registrant(s) who have committed to generate and submit the required data fail to take appropriate steps to meet the requirements, the Agency will consider that both the submitting and exempted registrants are not in complia nce and will normally

initiateSeptember 30, 2012

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proceedings to suspend the registrations of both registrants’ products unless the registrant who was granted the generic data exemption commits to submit and does submit the required data within the specified time. In such c ases the Agency generally will not grant a time extension for submitting the data. Submission of Required Data

- Registrants choosing this option must agree to either: submit the data required b y the notice within the specified time frame; enter into an agreement with one or more other registrants to develop data jointly ; make offers to cost

- share; submit an existing study that has not been submitted previously to the Agency by anyo ne; submit or cite data to upgrade a study classified by EPA as partially acceptable and upgradeable; or cite an existing study that EPA has classified as acceptable or an existing study that has been submitted but not reviewed b y the Agency. Submission of Data Waiver Request

- A registrant may request either a low volume/minor use waiver or a waiver based on the registrant’s belief that the data requirement(s) do not appl y to their product. In addition to the Requirements Status and Registrant's Response Form, registrants requesting low volume/minor use waivers must submit the following information:

 Total company sales (pounds and dollars) of all registered product(s) containing the active ingredient(s). If applicable to the active ingredient(s), include foreign sales for those products that are not registered in this country but are applied to sugar (cane or beet), coffee, bananas, cocoa, and other such crops, by year for each of the past five years.

 An estimate of the sales (pounds and dollars) of the active ingredient(s) for each major use site, by year for each of the past five years.

 Total direct production cost of product(s) containing the active ingredient(s) by year for the past five years, including information on raw material cost, direct labor cost, advertising, sales and marketing, and any other significant costs, listed separately

.

 Total indirect production cost (e.g. plant overhead, amortized plant and equipment) charged to product(s) containing the active ingredient(s) b y year for the past five ye ars. Exclude all non

recurring costs that were directly related to the active ingredient(s), such as costs of initial registration and any data development.

 A list of each data requirement for which the registrant is requesting a waiver.

 The ty

pe of waiver sought and the estimated cost to the registrant (listed separatel y for each data requirement and associated test) of conducting the testing needed to fulfill each of these data requirements.

 A list of each data requirement for which the registrant is not seeking any waiver and the estimated cost (listed separatel y for each data requirement and associated test) of conducting the testing needed to fulfill each of these data requirements.

 For each of the next ten years, a ye ar - by

- ye ar forecast of company sales (pounds and dollars) of the active ingredient(s), direct production costs of product(s) containing the active ingredient(s) (following the parameters in item c above), indirect production costs of product(s) containing the active ingredient(s) (following the parameters in item d above), and costs of data dev elopment pertaining to the active ingredient(s). In addition, the registrant must provide a description ofSeptember 30, 2012

14

the importance and unique benefits of the active ingredient(s) to users and discuss the use patterns and the effectiveness of the active ingredient (s) relative to registered alternative chemicals and non

- chemical control strategies. Registrants should provide information on any of the following factors in order to assist EPA in making a determination about the importance of an Active ingredient's be nefits:

o documentation of the usefulness of the active ingredient(s) in Integrated Pest Management ;
o description of the beneficial impacts on the environment of use of the active ingredient(s), as opposed to its registered alternatives ;
o information on the breakdown of the active ingredient(s) after use and on its persistence in the environment, and description of the product’s usefulness against pest(s) of public health significance. Failure to submit sufficient information for the Agency to make a determ ination regarding a request for a low volume minor use waiver will result in denial of the request for a waiver. Request for Waiver of Data

- A registrant may also request a waiver if they believe that a particular data requirement should not apply becau se the corresponding use is no longer registered or the requirement is inappropriate. In addition to the Requirements Status and Registrant's Response Form, registrants requesting a waiver of data requirements must submit a rationale explaining why the re gistrant believes the data requirements should not apply , as well as copies of current product labels and a current cop y of the Confidential Statement of Formula for each product. If the Agency determines that a registrant does not qualify for a waiver an d that the data are required for the product(s), the registrant must choose a method of meeting the requirements of the notice within the 90

- day time frame provided b y the notice. Within 30 days of the registrant’s receipt of the Agency's written decision, the registrant must submit a revised Requirements Status and Registrant's Response Form indicating the option chosen.
**5. THE**  **INFORMATION COLLECTED -**  **AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT**  **5(a). Agency Activities** The following Agency

activities are necessary

to conduct a DCI under this ICR: develop DCI correspondence prepare the DCI letter identifying all the data needed answer registrants' questions respond to any questions the registrant may have regarding the DCI review data submissions review data submissions for completeness and appropriateness record DCI submissions record s ubmissions in tracking system for internal review analyze data conduct scientific revie ws of data store data index data and store it in Agency filesSeptember 30, 2012

15

**5(b). Collection Methodology and Management** After initiating a statutorily mandated pesticide review whether a Special Review , closeout of a R eregistration R eview, a Registration Review or a AR or PCT R eview and determining that additional data is needed, the Agency will issue a DCI when the need fo r additional data has been identified

. OPP tracks DCI s and all registrant responses through the Office of Pesticide Programs In formation Network (OPPI N), OPP's general purpose action tracking s ys tem. Additionally , the Reference Files Sy stem (REFS) is used if the registrant voluntarily cancels a product in response to a DCI . The Pesticide Data Management Sy stem (PDMS ) lists the bibliograph y of data submitters for the DCI and OPPI N tracks the submissions. All correspondence associated with the issuance and response to the DCI is filed in the master registration file or ‘registration jacket’ of affected products. Data submitted in response to a DCI is processed, catalogued and archived in the PDMS. Failures to comply with DCI requirements are referred to EPA's Office of Enforcement and Compliance Assurance for appropriate follow

- up actions

. Although the Agency

does not publish the submitted information, and public access to the PDMS bibliograph y is made through the National Pesticides Information Retri eval Sy stem (NPIRS). NPIRS supports searches of the PDMS database by chemical, subject, submission date, laboratory , guideline number, and document ty pe. The public may

request copies of non

confidential studies through FOIA. OPP continues to investigat e the possibility of providing optional electronic data transfer services to the industry

as a means of minimizing the burden of registration activities. The Agency's pesticide program, along with the pesticide industry , recognizes the advantages in terms of accuracy , speed, cost and personnel from electronic data transfer technologies. In addition, OPP continues to consult with industry associations and other federal agencies, and is participating in an Agency

- wide workgroup to develop electronic reporti ng standards intended to facilitate the submission and use of information about pesticides. **5(c). Small Entity Flexibility** Currently , pesticide registrants may be divided into two groups. Approximately 10 percent of the total: manufacture or import chemical active ingredients intended for use as pesticides, sell these active ingredients to other firms for formulation into pesticide products, and/or make the end

- products themselves. The second, and b y far the larger, group of registrants purchase the active ingredients in their pesticide products from members of the first group, and combine them with pesticide inert ingredients or sometimes simply repackage them to make their end

- use products. This second group is primarily comprised of small busines ses. When small businesses use a registered source of the active ingredient to formulate their products, they generally are exempt from generating health and safety data for pesticide active ingredients ("generic data"). Consequently , they

usually need o nly

respond to a DCIfor active ingredient data by claiming the "generic data exemption" (for more detail, see section 4(b)(iii) “Reducing the PRA Burden”September 30, 2012

16

Variation of Response to a DCI” of this document). They do not incur any

other information burden as sociated with the data call

- in. **5(d). Collection Schedule** There is not a collection schedule per se. DCIs are issued when the need is identified. The time frame in which the respondents must then submit the requested material is specifically establish ed for each DCI based on the individual circumstances surrounding the particular DCI and applicable review. F or a variety of reasons, most manufacturers wait to generate new data and/or submit new/existing data until EPA issues the DCI . One of the most important reasons for this is that EPA’s issuance of a DCI is a public statement that the data is needed, and will be relied on, thus “triggering” the data compensation provisions of section 3(g)(1)(B) of FIFRA. As part of the consolation and public participation process, EPA generall y works with respondents to ensure that sufficient time is built into the individual DCI s to allow for respondents to gather and submit the requested information. However, the timing of AR/PCT

related DCIs and respondent data su bmissions is somewhat different. AR DCI s will generall y be issued whenever ARs data is relied upon, either to establish new tolerances or reassess existing tolerances. Registrants have five ye ars before data must generall y be submitted in support of the ARs used. Data must also be periodically reviewed when PCT estimates are relied upon, but in most cases the Agency will be able to internally collect or generate this data. EPA will issue PCT DCI s i n cases where the Agency is unable to obtain the information on its own. In these cases , the registrant must submit data within five ye ars of the use of PCT estimates. Additional time is provided for development of new studies appropriate to the nature of the studies required.
**6. ESTIMATING THE BURDEN AND**  **COST OF THE COLLECTION Meth**  **o dology**  **Used To Estimate t**  **he Burden for DCIs**  To estimate the burden and costs for the paperwork related activities for respondents to comply with DCIs notices issued under any of the review programs , EPA estimates PRA activities to be 35% of the cost to generate new data. This methodology is based on using the average cost estimates for the specific studies requests in each DCI and is only applicable to DCI related data generation

. This approach was adopted because it allows the Agency to consider the potential for there to be greater burden related to a more complex study . The premise is that a more expensive study

probably causes the respondent to incur more burden hours and costs than generating a less expensive study

. The public, registrants, key stakeholders, and OMB developed this percentage from numerous sources of information including agency expertise, consultation with industry, and repeated review on the Agency ’s information collection activities

. To help calculate the PRA costs, the Agency maintains an archive of the basic FIFRA study cost estimates that were developed through survey s of independent testing laboratories, Agency economic analy ses, and registrant comments during ICR renewal periods. To the extentSeptember 30, 2012

17

possible, EPA uses multiple sources to provide test cost estimates, which are updated as needed

. This methodology assumes all recipients of a DCI generate all of the data as specified in the DCInotice

. Using this assumption however, the Agency has chosen to overestimate the burden because not all DCIrecipient s engage in all of the DCI activities. The Agency is aware th at DCIrecipients who engage in a taskforce for data generation, voluntarily cancel the product or affected uses, submit or cite existing data, or are granted a waiver incur fewer burden hours and cost . The Agency actively encourages cost
- sharing agreements among manufacturers of specific pesticide chemicals to minimize the duplication of laboratory tests conducted and to minimize costs for DCI recipients

. C ommon to developing the burden estimates for all DCI s, EPA use s the following general assumptions:

 s tudies were submitted by registrants (not grower groups, or other agencies, etc.);  studies had not been requested under a previous DCI ;  studies were not a request to resubmit because the original study submitted was not c omplete or did not meet the data submission requirements; and  studies submitted that are based on preexisting data and can be found in published, peer reviewed literature were not included. A detailed discussion of the Agency ’s “ Methodology Used to Estima te Paperwork Burden Hours and Costs by the Office of Pesticide Programs for Submission of Required Data/Information for Responding to a Data Call

-In Notice” is available at **Attachment G**  to this document. **Updating Labor Rates** The Agency has updated the estimated wages, benefits and overhead for all labor categories for affected industries, state government, and EPA employees 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 full y loaded rates and overhead costs for this I CR renewal are listed in **Attachment H**  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). Full y loaded wage rates are used to calculate respondent costs. This renewal uses 2003 base data. Unloaded Wage Rate Wages are estimated for l abor 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 (BL S) at http://www.bls.gov/oes/current/oes_nat.htm

. Sectors The specific North American Industry Classification Sy stem (NAI CS) code and website for each sector is included in that sector’s wage rat e table (seeSeptember 30, 2012

18 Attachment G). Within each sector, the wage data are provided by Standard Occupational Classification (SOC). The SOC sy stem is used by Federal statistical agencies to classify workers into occupational categories for the purpose of collectin g, calculating, or disseminating data (see http://www.bls.gov/oes/current/oes_stru.htm). Loaded Wage Rate Unless stated otherwise, all benefits represent 43% of unloaded wage rates,

based on benef

its 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 L oaded Wage Rate We multiply the loaded wage rate b y 50% (EPA guidelines 20

- 70%) to get overhead costs. **Format** For reader clarity this consolidation document contains four separate p arts which discuss
“ Section 6

- Estimating The Burden And Cost Of The Collection

. ” For this section only , discussions regarding PRA burden and costs for each of the review programs have been restructured into separate p arts which allow the reader/reviewer to readily identify the burden activities associated with a particular review program. The parts are labeled as follows: Part 1

– Section 6: Estimating the Burden and Cost of the Collection for the Reregistration R eview program (including reassessing import tolerances). Part 2

– Section 6: Estimating the Burden and Cost o f the Collection for the Special Review and Registration R eview Programs Part 3

– Section 6: Estimating the Burden and Cost of the Collection for the Anticipated Residue and Percent Crop Treated Review Programs Part 4

– Section 6: Estimating the Burden and Cost of the Collection for Enforcement and Unanticipated Incidents **Bottom -**  **line Summary of Annual**  **DCI -**  **Related Respondent**  **Paperwork Burdens and Costs** Collection Activity Burden Hours Costs Reregistration Program DCIs Confirmatory

DCI s 27,213 $1,883,612 Product Specific DCIs 125,414 $2,900,584 Voluntaril y Submitted Low Burden Studies 3,159 $218,641 Voluntaril y Submitted High Burden Studies 9,565 $786,567 Special Review and Registration Review DCIs Special Review DCIs 919 $ 56, 202 Registration Review DCIs 65,374 $4,595,587 Anticipated Residue/Percent Crop Treated DCIs AR DCI s: Base Set of Data 27,272 $1,828,886 AR DCI s: Verification

- of

- use Data 690 $52,940September 30, 2012

19

AR DCI s: Updated Public Source Monitoring Data 548 $39,644 DCI s for Percent Crop Treated Estimates 59 $3,96 6 Enforcement And Unanticipated Incident DCI s Enforcement And Unanticipated Incident DCIs 2,088 $ 140 , 097 **Total** 262,301 $12,506,726 According to the Paperwork Reduction Act, “burden” means the total time, effort, or financial resources expended by 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, analyzing 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 -**  **HQ**   ** OPP** **- 2007**  **- 0923**  , 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 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 min imizing respondent burden, including the use of automated collection techniques. Comments may

be submitted to EPA electronically through http://www.regulations.gov or by mail addressed to Director, Collection Strategies Division, U.S. Environmental Prot ection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. You can also send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 1 7th Street, NW, Washington, DC 20503, Attention: Desk Office f or EPA. Include docket ID No. **EP A**  **- HQ**  **- OPP**  **- 2007**  **- 0923**  and OMB control numbers 2070

- 0057; 2070

- 0107; and 2070

- 0164 in any correspondence but do no t submit any DCI or other related information (e.g., forms, reports, etc.) to these addresses.September 30, 2012

20 **Part 1 -**  Section 6: Estimating the Burden and Cost of the Collection for the Reregistration Review program

(including reassessing import tolerances).September 30, 2012

21

**Part 1**  describes the burden activities associated with the Reregistration review program, which also includes the burden activities associated with import tolerance re assessment. While the final re gulatory

decisions for the Reregistration program are scheduled for completion in 2008, the Agency

will still issue Reregistration DC I s for the life of this ICR

. **6(a) Estimating Respondent Burden** 

**– Reregistration**  The total estimated **annual** burden hours for respondents to comply with th e information collection activity for the Reregistration Program to be **165,351 hours**  , with the total **annual** respondent burden cost estimated to be **$ 5,789,404**  **.** The burden estimate is dependent upon the type or class of chemical under review and whether there is a high , medium or low burden that are directl y related to the complexity of studies, and the cost of such studies required for a particular chemical. Reregistration review burden estimates are based only on Phase 5 (completion) activities and for reassessing existing import tolerances. EPA examined the historical data for confirmatory , product specific and voluntary data that have been submitted for representative pesticides in this program. This information was used to project the estimates in this I CR. As a result of the review, E PA will not adjust the estimated hourly burden per response for any of the respondents for the renewal of this ICR. Over the next three ye ars, EPA expects to issue 137 DCI s for active ingredients and the pesticide products that contain them

. The breakdown of the regulatory decisions for the Reregistration Program that EPA expects to make over the next 3 years is as follows: **Type of Decision No. of Pesticide**  **Ingredients** Reregistration Eligibility

Decisions (REDs) and efficacy data 107 Import tolerances (ingredients with no U.S. registrations) 30 Total 1 37 **6(a)(1). Paperwork Burden Related to the Submission of Confirmatory Data** 

**– R** **eregistration** Confirmatory

data are required of registrants to complete registrant databases and to assist in the evaluation of risk findings. For DCIs involving confirmatory studies, EPA also assumed that only

one respondent

– the manufacturer of the active ingredient

– will provide the data requested (i.e, one registrant will submit an average of 9.8 “confirmatory” studies per DCI , and therefore, there will be only one respo nse submitted to EPA per DCIinvolving confirmatory data. EPA expects to issue 137 confirmatory DCIs over the next 3 years , which equals an average of 45.66 confirmatory DCIs annuall y. See Table 1 below for burden activity details.September 30, 2012

22

**Table 1. Annual Respondent Burden for DCIs Involving Confirmatory Studies** 

Collection Activities Burden Hours Total Mgmt. $1 03.62 /hr Tech.

$ 67.05 /hr Cler.

$ 33.85 /hr Hours Costs 1. Read and discuss test requirements 12 0 0 12 $ 1,243.44 2. Discuss test and protocol with Agency 6 6 0 12 $1, 024.02 3. Plan activities 24 6 0 30 $ 2,889.18 4. Create information 18 299 36 353 $ 23.131.79 5. Gather information 0 30 0 30 $ 2,011.50 6. Process, compile, review information for accuracy 35 48 0 83 $ 6,845.10 7. Complete written forms 0 0 12 12 $ 406.20 8. Record, disclose, display information 11 0 24 35 $ 1,952.22 9. Store, file, or maintain information 11 0 18 29 $ 1,749.12 Total 117 389 90 596 $ 41,252. 57 Estimated Total Annual Respondent Burden & Costs for DCI s Involving Confirmatory Studies: Burden: 596 hours per response x 1 response per DCIx 4 5.66 DCI s = 27,213

. 36 burden hours. Costs: $ 41 , 253 per response x 1 response per DCI x 4 5.66 DCI s = $ 1 , 883 , 611

. 90 **6(a ) (**  **2). Paperwork Burden Related to Voluntarily Submitted Data**  **- Reregistration**  Voluntary

data consist of studies not required b y the Agency but are submitted by registrants to supplement a pesticide database . To account for the burden attributed to voluntarily

submitted data, the Agency inventoried the ty

pes of voluntarily submitted data for a range of chemicals. Based on a sampling of Reregistration Eligibility Decisions (REDs) affecte d by FQPA tolerance reassessment submitted over an eight year period (1996

- 2004), the Agency received 67 voluntary

data submissions. This averages to 8 .375 submissions annually

. In the past, many of voluntarily submitted studies have been existing studies, e.g., studies found in existing literature, or studies that were slightl y modified and resubmitted, or studies of lower cost. Some may

be special studies such as a M onte C arlo , or limited market basket survey , or other studies to provide the Agency with actual exposure data. Regardless of the voluntarily submitted status, the Agency has categorized these data as high, medium or low burden and averaged the burden for these studies as if they represented a cross section of ty pical data requirements. For the next I C R renewal period, EPA recognizes that some registrants will continue to submit voluntary

data to support the activities for the completion of the reregistration review program as well as and the other review programs

. EPA expects to receive 2 5 voluntary such submissions over the next three years; 16 of which are expected to be “low burden” submissionsSeptember 30, 2012

23

and 9 of which are expected to be “high burden” submissions. Thus, EPA expects to receive about 8 vo luntary

submissions annually ; 5.3 of which are expected to be “low burden ” submissions and 3 of which are expected to be “high burden” submissions. For the details of the burden hours and costs s ee Table 2.A and Table 2. B

. **Table 2. A. Annual Responden t Burden for Submissions of Voluntary Low Burden Studies** 

Collection Activities Burden Hours Total Mgmt. $1 03.62 /hr Tech.

$ 67.05 /hr Cler.

$ 33.85 /hr Hours Costs 1. Read and discuss test requirements 12 0 0 12 $ 1 , 243.44 2. Discuss test and protocol with Agency 6 6 0 12 $ 1,024.02 3. Plan activities 24 6 0 30 $ 2 , 889.18 4. Create information 18 299 36 353 $ 2 3, 1 3 1.11 5. Gather information 0 30 0 30 $ 2 , 011.5 0 6. Process, compile, review information for accuracy 35 48 0 83 $ 6 , 845.1 0 7. Complete written forms 0 0 12 12 $ 406.2 0 8. Record, disclose, display information 11 0 24 35 $ 1 , 952.22 9. Store, file, or maintain information 11 0 18 29 $ 1 , 749.12 Total 117 389 90 596 $ 41,252.57 Estimated Total Annual Respondent Burden & Costs for DCI s Involving Voluntary L ow Burden : Burden: 596 hours x 5.3 responses = 3,159 hours Costs: $ 41,253 x 5.3 responses = $ 218,640.90September 30, 2012

24

**Table 2. B. Annual Respondent Burden for Submission of Vol untary High Burden Studies** 

Collection Activities Burden Hours Total Mgmt. $1 03.62 /hr Tech.

$ 67.05 /hr Cler.

$ 33.85 /hr Hours Costs 1. Read and discuss test requirements 72 0 0 72 $ 7,460.64 2. Discuss test and protocol with Agency 36 36 0 72 $ 6,144.12 3. Plan activities 144 36 0 180 $ 17,339.40 4. Create information 108 1,791 215 2,114 $ 145,833.03 5. Gather information 0 179 0 179 $ 12,001.95 6. Process, compile, review information for accuracy 215 287 0 502 $ 41,521.65 7. Complete written forms 0 0 72 72 $ 2,437.20 8. Record, disclose, display information 72 0 144 216 $ 12,335.04 9. Store, file, or maintain information 72 0 108 180 $ 11, 116.4 4 Total 719 2,329 539 3,587 $ 256,189.43 Estimated Total Annual Respondent Burden for DCI s Involving Voluntary High Burden: Burden: 3,587 hours x 3 responses = 9,565 hours Costs: $ 256,189 x 3 responses = $ 768,567 **6(a)(3). Paperwork Burden Related to the Submission of Product**  **- Specific Data** 

**– Rer**  **egistration** P roduct

- specific data is generall y comprised of toxicity and product chemistry

data. In the past f or DCIs involving **product -** **specific data** (sometimes referred to as PDCI s), EPA examined several ty

pical reregistration case s with a ty pical number of batches and EPA’s e stimat e of the number and ty pe of PDCI studies required. EPA noted that while the number pesticide products captured by a RED for an active ingredient (and, therefore, the number of responses per PDCIassociate d with a RED) vary greatl y from 1 to more than 100, the average number of responses per PDCI was three ( 3 )

. It is a common industry practice where the manufacturer of the active ingredient and the companies that use that active ingredient in their products share their financial and scientific resources in order to provide EPA with a complete DCI response . This helps industry avoid a duplication of effort and thereby minimize the burden and cost impacts on each individual company . The industry

practice regarding the citation of data on similar products and the citation of existing data previously

submitted to the Agency could also be the reason that the number of studies called in under the PDCItypically differs significantl y from the number of new stu dies actuall y generated in response to the PD CI

. For example, in 2004 the Agency evaluated a sampling of 95 pesticide product reviews (PDCIs) related to 5 randomly selected pesticideSeptember 30, 2012

25

chemicals to determine the number of new Acute Toxicity and Product Chem istry

studies generated in response to a DCI. Based on this evaluation, it was determined that approximately 18% of the Acute Toxicity data requirements and approximately 10% of the Product Chemistry data requirements were newly generated data. Among the six Acute Toxicity requirements surveyed, (acute oral, acute dermal, acute inhalation, acute eye irritation, acute dermal irritation and dermal sensitization), the Acute eye irritation (870.2400), and Acute dermal irritation (870.2500) studies accounted f or as much as 50% of the new data produced (in equal proportions). The other 50% of the new data is equally distributed between the remaining four study requirements. Among the ten Product Chemistry requirements surveyed, (Storage Stability (830.6317), Corrosion Characteristics (830.6320), Viscosity (830.7100) and the Analy tical Methods (830.1800) guidelines accounted for approximately 90% of the new data produced (in equal proportions). The remaining 10% of the new data was equally distributed between the Flammability (830.6315), pH (830.7000), Density (830.7300), and various requirements for technical/pure active ingredients including Preliminary analy sis (830.1700), Water solubility

(830.7840 or 830.7860), and Vapor pressure (830.7950). The A genc y projects 49 PDCI s (16.33 annually) will be called

- in over the next three ye ars. This equates to about 28% of the 137 DC Is to be issued for this I CR renewal. The Agency will again predict each PDCI will generate about three (3) responses. Table 3 provid es the detail for these burden activities. **Table 3. Annual Respondent Burden Estimates for Product Specific DCI Activities**

Collection Activities Burden Hours Total Mgmt. $10 3.62 /hr Tech.

$ 67.05 /hr Cler.

$ 33.85 /hr Hours Costs
1. Read and discuss test requirements 51 0 0 51 $ 5,284.62 2. Discuss test and protocol with Agency 26 26 0 52 $ 4,437.42 3. Plan activities 102 26 0 128 $ 12,312.54 4. Create information 77 1,280 154 1,511 $ 99,015.64 5. Gather information 0 128 0 128 $ 8,582.40 6. Process, compile, review information for accuracy 154 204 0 358 $ 29,635.68 7. Complete written forms 0 0 51 51 $ 1,726.35 8. Record, disclose, display information 51 0 102 153 $ 8,737.32 9. Store, file, or maintain information 51 0 77 128 $ 7,891.07 Total 512 1,664 384 2,560 $ 177,623.04 Estimated Total Annual Respondent Burden for Product Specific DCI Activities: Burden: 2,560 hours x 3 responses per DCI x 16.33 DCI s = 125,414.40 hours. Costs: $ 177,623 x 3 responses per DCI x 16.33 DCI s = $ 2,900,583.50September 30, 2012

26

**6(b). Estimating Respondent Costs**  **- Reregistration**  The total annual cost for all respondents is estimated to be $ 5,789,404. Respondent costs are based on managerial, technical and clerical burden hours estimated at $10 3.62 , $ 67.05 , and $ 33.85 per hour, respectively

. **6(c). Estimating Agency Burden and Cost -**  **Reregistration** The Agency ’s **annual** burden hours and costs for developing DCI correspondence, communication with registrants, developing documents, tracking and storing the evaluation of the data submissions , and other DCI processing activities is detailed in Table 4 below. For this renewal, EPA projects a slight dec rease in the burden hours and costs associated with the performance of the duties issuing and processing DCI s. The decrease is attributable to the reduction of the number of DCI s, from 142 to 137 , the Agency plans to issue over the next three ye ars. **Tab le 4. Annual Agency Burden Estimates**  **- Reregistration**  Collection Activities Burden Hours Total Mgmt. $ 101.16/hr Tech.

$ 66.88 /hr Cler.

$ 39.23 /hr Hours Costs a. Develop DCI correspondence 948 9,480 948 11,376 $7 66 , 915.97 b. Answer DCI questions from registrants 119 4,740 0 4,859 $ 329 , 049.24 c. Review, evaluate data submission 238 138,029 0 138,267 $ 9 , 231 , 379.52 d. Record DCI submissions 0 0 1,896 1,896 $ 74 , 380.08 e. Store data 0 0 238 238 $ 9 , 336.74 Total Annual Agency Burden 1,305 152,249 3,082 156,636 $ 10 , 411 , 061.55 **6(d). Bottom Line Hours and Cost Tables** 

**– Reregistration**  The total **annual** estimated burden hours and costs for the R ereregistration review program for the next three years is represented in Table 5 below.September 30, 2012

27

**Table 5. Annual Bottom Line Hours And Costs / Master Table**  Collection Activity Burden Hours Costs DCIInvolving Confirmatory Studies 2 7 , 213 $ 1,883,612 Voluntary Low Burden Studies 3,159 $ 218,641 Voluntary

High Burden Studies 9,565 $ 786,567 Product Specific DCIs 125,414 $ 2,900,584 **Total Annual Respondent Burden and Costs 165**  **, 351**  **$ 5**  **, 789**  **, 404**  **Total Annual Agency Burden 156,636**  **$10,411,061.55 6(**  **e ).**  **Reasons for Change in Burden -**  **Reregistration** In th e IC R renewal, EPA projects a slight decrease in the estimated number of DCIs the Agency will issue annually , from 47.33 to 45.66, compared to the last ICR. Consequently , EPA expects that the associated burden will decrease because less DCI response s will b e submitted to the Agency each ye ar. Part of this reduction is also attributable to the reduction of DCI responses for product specific data, 16.33 instead of 30.33 , as reported in the last I CR. However, E PA is projecting it will receive about the same number of voluntaril y submitted data of 8 responses (5.3 low burden and 3 high burden) annually

. EPA’s estimate of the burden breakdown for each individual respondent for each labor category (management, technical and clerical) remains unchanged from the p revious I CR. The overall adjustments in the burden for this I CR result in a net decrease hours annually from 275,063 to 165,351 which is directly related to the decrease in the number of DCI s to be issued. Part of the reduction in the estimated costs, fo r respondents and Agency personnel is attributable to EPA’s methodology which re - estimat ed labor rates for industry

and the Agency

. The de crease is a program adjustment. **6(f). Burden Statement -**  **Reregistration** The annual respondent burden for DCI s and voluntary data submissions under the Reregistration program is estimated to be 165,351 , with a 3

- year respondent burden of 496,053 hours

.September 30, 2012

28 **Part 2**

– Section 6: Estimating the Burden and Cost o f the Collection for the Special Review and Registration Review ProgramsSeptember 30, 2012

29

**Part 2** describes the burden activities associated with the Special Review and Registration Review programs. **6(a) Estimating Respondent Burden** 

**– Special Review**  Special Review Program Special Review s, though rare, are conducted when the Agency determines such a review is warranted. In the Special Review Program, EPA focuses on specific hazards or uses of a pesticide. Special Reviews are not intended to be comprehensive evaluations of the pesticide , instead the DCIs are to address the specific hazard or exposure concerns are that are at issue. The total estimated annual respondent burden hours and costs for Special Review is estimated at 919 burden hours with the total annual respo ndent cost estimated at $ 56,202

. The potential number of Special Review DCIs required, the ty pe of data, and the number of respondents affected is quite variable

. Thus, a Special Review DCI may request data on more than one pesticide, and may involve two or more respondents who are encouraged to join together to provide the needed data. Th e annual burden estimate is based on the following assumptions: (a) that the Agency would issue one DCIunder the Special Review program in any given 12

- month period, and (b) for each Special Review DCI issued there would be one response. The Agency has also assume d an average total test cost of $500,000 per Special Review DCI. Over a three

- ye ar ICR approval period, three responses would be expected and the total respondent burden for Special Review related activities is estimated to be 2,757 hours

. This estimate remains unchanged from the previous I CR. Because of the variabili ty inherent in each Special Review DCI, the estimates serve as a proxy for what the actual burdens are likel y to be. Although the Agency

estimated that an average of 1 respondent per Special Review DCI is expected because historically , a majority of the S pecial Review DCIs has only affected 1 or 2 respondents , on rare occasions, some previous Special Review DCIs have, exceeded this. In recent ye ars, the Agency

has not issued one Special Review DCI each year over a three

- ye ar period. Table 1A details the estimated annual respondent burden hours and costs for Special Review DCIsSeptember 30, 2012

30

**Table 1A: Estimated**  **Annual Burden hours and**  **Cost Estimates for Special Review**

**DCIs per Respondent BURDEN HOURS (per year)**  TOTAL S **COLLECTION ACTIVITIES Mgm** **t. $1**  **03.62 /hr**  **Tech.**

**$ 67.05**  **/hr Cler.** 

**$ 33.85**  **/hr Hrs**  **Cost** 1) Read and discuss test requirements 18 0 0 18 $ 1,865.16 2) Discuss test and protocol with Agency 9 9 0 18 $ 1,536.03 3) Plan activities 0 0 0 0 $0 4) Create information 37 9 0 46 $ 4,437.39 5) Gather information 28 460 0 488 $ 29,617.74 6) Process, compile, review information for accuracy 0 46 0 46 $ 3,084.30 7) Complete written forms 55 74 55 184 $1 2,522.55 8) Record, disclose, display information 0 0 18 18 $ 609.30 9) Store, file, or maintain information 36 0 65 166 $ 5,930.57
TOTAL 183 598 138 919 $ 56,201.85 **Special Review** Estimated Annual Respondent Burden hours and Cost Hours: 919 hours per response X 1 response X 1 DCI= 919 hours Costs: $56,202 per response X 1 response X 1 DCI= $ 56,202 **6(a) (1)**  **Estimating the Respondent Burden**

**– Registration Review**  Registration Review While the agency

projected burden hours and cost of issuing DCI for the Registration Review program in the last I CR, no DCI could be issued until the final procedural rule s for the registration review program were issued. The final rules were published August 9, 2006 (71 FR 45719 ) and became e ffective October 10, 2006. The first dockets for registration review cases were opened in February

2007 and a majority of dockets opened to date have identified the need for additional data in order to complete the preliminary risk assessment. The Agency is activel y developing the internal protocols necessary to issue DCI s under this program

. Estimates includeSeptember 30, 2012

31

additional activities anticipated by the reauthorization of the Pesticide Registration Improvement Act amendments of October 9, 2007. The total estimated **annual** burden hours for respondents to comply with this information collection activity

is 65 , 374 hours with the total **annual** respondent cost estimated t o be $ 4 , 595 , 587

. During Registration Review , EPA will, among other things, update the databases of pesticides to obtain data that were not required when the pesticide was registered or reregistered, but which are now required and determined necessary

. Li ke the Special R eview program, the potential number of Registration review DCIs that will be issued, the ty pe of data, and the number of respondents affected will be quite variable

. Over the next 3 years EPA expects to issue 121 DCI s ( 41 annuall y) for the Registration Review Program. The Agency assumes that one respondent “registrant” will p rovide the data requested. The Agency

estimates one registrant will submit an average of 1.5 studies per DCI. A detailed illustration of the estimated annual respondent burden hours and costs is listed in Table 1B

.September 30, 2012

32

**Table 1B: Estimated Annual Respon dent Burden**  **H ours and Costs for Registration**  **Review DCIs BURDEN HOURS (per year)**  **TOTALS COLLECTION**  **ACTIVITIES Mgmt.**  **$103.62/hr Tech.** 

**67.05/hr Cler.** 

**$33.85/hr Hrs**  **Cost** 1) Read and discuss test requirements 22 0 0 22 $2,279.64 2) Discuss test and protocol with Agency 11 11 0 22 $1,877.37 3) Plan activities 44 11 0 55 $5,296.83 4) Create information 33 544 33 610 $41,011.71 5) Gather information 0 54 0 54 $3,620.70 6) Process, compile, review information for accuracy 65 87 0 152 $12,568.65
7) Complete written forms 0 0 22 22 $744.70 8) Record, disclose, display information 22 0 44 66 $3,769.04 9) Store, file, or maintain information 22 0 38 60 $3,565.94
TOTAL 219 707 137 1,063 $ 74,724.58 **Registration Review** Estimated Annual Respondent Burden Hours and Cost Hours: 1063 hours per response X 1.5 responses X 41 DCI s = 65 , 374.5 hours Costs: $74,725 per response X 1.5 responses X 41 DCI s = $ 4 , 595 , 587.5September 30, 2012

33

**6(b). Estimating Respondent Costs**  **- Special Review**  **and Registration Review**  The estimated **annual** cost for all respondents for Special Review and Registration review is estimated to be $ 3,418,827. Respondent costs are based on managerial, technical and clerical burden hours estimated at $103.62, $67.05, and $33.85 per hour, respectivel y . **6(c). Estimating Agency Burden and Cost**  **- Special Review**  **Reg istration**  **Review Special Review** 

**– Agenc** **y Burden** In this ICR, the estimated average number of Agency burden hours per response for Special Review is the same as in the previous ICR; i.e., 1,348 hours. Over a three

- ye ar ICR approval period, 3 responses are expected and the total Agency burden hour and cost is estimated at 4,044 (1,348 x 3) hours

. See Table 2A for the detail of the Agency burden hours and costs for processing Special R eviews. **Table 2A: Estimated**  **Annual Agency Burden and hours**  **Cost for Special Review DCIs**

**Collection Activities**  **Burden Hours Total** 

**Mgmt. $**  **101.16 /hr**  **Tech.**

**$ 66.88**  **/hr Cler.** 

**$ 39.23**  **/hr Hours**  **Cost** Develop DCI correspondence needed 32 160 60 252 $ 16,291.72 Answer registrants' questions regarding the DCI 4 160 0 164 $ 11,105.44
Review and analyze data submissions 4 880 0 884 $ 59,259.04 Record DCI submissions 0 0 40 40 $ 1,569.20 Store Data 0 0 8 8 $ 313.40 **TOTAL** 40 1,200 108 1,348 $ 88,539.24 Hours: 134 8 per response X 1.5 responses X 1 DCIs = 2,022 Hours Costs: $88,539 per response X 1.5 responses X 1 DCIs = $ 132,808.5 **Registration Review**

**– Agency Burden**  The annual estimated Agency burden hours and costs for Registration Review are illustrated in Table 2B below.September 30, 2012

34

**Table 2B: Estimated**  **Annual Agency Burden Hours and**  **Cost s**  **for Registration Review D**  **CIs**
Collection Activities Burden Hours Total

Mgmt. $ 101.16 /hr Tech.

$ 66.88 /hr Cler.

$ 39.23 /hr Hours Cost Develop DCI correspondence needed 64 320 120 504 $ 32,583.94 Answer registrants' questions regarding the DCI 4 160 0 164 $ 11,105.44
Review and analyze data submissions 4 0 0 4 $ 404.64 Record DCI submissions 0 0 80 80 $ 3,138.40
Store Data 0 0 8 8 $ 265.84 **TOTAL** 72 480 208 760 $4 7,497.76 **Registration Review** Estimated Agency Annual Burden Hours and Costs Hours: 760 per response x 1.5 responses x 41 DCIs = 46,740 hours Costs: $47,498 per response x 1.5 responses x 41 DCI s = $ 2,921,127 **6(d). Bottom Line**  **Burden Hours and Cost Tables / Master Table for**  **Special Review**  **and Reg**  **istration Review**  The estimated total and annual Respondent burden hours and costs are illustrated in Table 3, while the estimated total and annual Agency burden hours and costs are illus trated in Table 4. **Table 3: Bottom Line**  **Respondent Burden**  **Hours and Cost**  **s / Master Table**  Per Response Number of Responses Totals Hours Cost Hours Cost **Special Review** 919 $ 56,202 1 919 $ 56, 202 **Registration Review** 1,063 $ 7 4 , 7 2 5 6 1 65 , 374 $ 4 , 595 , 587 **TOTAL ANNUAL BURDEN**  1,982 $ 130,937 6 2 66,293 $ 4 , 651 , 789
**TOTAL 3**  **YEAR BURDEN**  5,946 $ 392,811 1 8 6 198 , 879 $ 13 , 955 , 367September 30, 2012

35

**Table 4: Bottom Line**  **Agency Burden**  **Hours and Cost**  **s /Master Table**  Per Response Number of Responses Totals Hours Costs Hours Cost **Special Review** 1,348 $ 88,539 1 1,348 $ 88,539 **Registration Review** 760 $ 47,498 61 47,740 $ 2,921,127 **TOTAL ANNUAL BURDEN**  2,108 $13 6,037 62 49,088 $ 3,009,666
**TOTAL 3 YEAR**  **BURDEN** 6,324 $416,340 1 86 140,844 $ 9,028,998
**6(e). Reasons for Change in Burden**  **- Special**  **Review and**  **Reg istration**  **Review** This I CR renewal request will result in a slight increase in the annual respondent burden of 675 h ours, i.e., from 64,699 to 65 , 374 hours, when compared with the previous I CR. Most of the burden increase can be attributed to the increase in the number of DCIs (4 1 DCI s verses 40 DCI s) to be issued under the Registration review program that is now underway . This is a program adjustment. **6(f). Burden Statement -**  **Special Review and Registration**  **Review** The annual respondent burden for the information collection activities under this I CR is estimated to average 919 hours for Special Review DCI s and 65,374 hours for Registration Review DCIs.September 30, 2012

36 **Part 3**

– Section 6 Estimating the Burden and Cost of the Collection for the Anticipated Residue and Percent Crop Treated Review ProgramsSeptember 30, 2012

37

**Part 3** describes the burden activities associated with the Antic ipated Residue and Percent Crop Treated (AR/PCT) review programs

. The AR/PCT review program requires the Agency to re
- evaluate of previous Agency decisions regarding the establishment of a tolerance (maximum residue limit) for pesticide residues on food o r feed crops. The law also requires that tolerance decisions based on ARs or PCT data be verified to ensure that residues in or on food are not above the residue levels relied on for establishing the tolerance. **6(a) Estimating Respondent Burden**  **- AR/PCT**  The annual respondent range between 59 and 13,636 burden hours per DCI, depending upon the ty

pe of DCI response requested. The total estimated burden for this I CR of 28,569 burden hours is based on the Agency ’s estimate of the potential burden and number of responses for each of the following four ty pes of potential DCI s: Ty pe 1

- DCI for anticipated residues requiring a base set of data (13,636 hrs ./response ); Ty pe 2

- DCI for anticipated residues requiring minimum data (69 hrs ./response ); Ty pe 3

- DCI for anticipated residues collected from publicly available sources (137 hrs. /response ); and Ty pe 4

- DCI for percent crop treated using existing information (59 hrs. /hrs response ). After re

- evaluation the burden hours from the last I CR, the Agency is not changing the burden hour estimates from the last I CR renewal period. The following information presents the Agency ’s burden estimates for each type of DCI. **AR DCI Type 1** 

- DCI for anticipated residues requiring a base set of data: Respon dent burden hours for generating and submitting data in response to a DCI for anticipated residues requiring a base set of data to be submitted are estimated at 13,636 burden hours per response. And one response equals one DCI

. EPA also considered the ty pical burden for reading instructions, planning activities, compiling and reviewing the submission, submitting the data to EPA, and related record keeping in estimating the total per response burden and costs. Using the USDA’s P esticide Data Program (PDP) which generates publicl y available monitoring data as the basis, EPA estimated the burden for conducting a monitoring study to gather the necessary data . Portions of the annual respondent burden hours and cost are related to generation of new data for meeting 40 CFR part 158 data requirements for anticipated residues

. In most cases, registrants will be able to get the information from federal and state monitoring programs, thus EPA estimates that no more than two registrants m ight generate their own monitoring data in response to the DCI. The total annual burden hours for a Ty pe - 1 AR DCIis estimated to be 27,272 hours , The Agency projects only two (2) Ty

pe 1 AR DCI s will be issued generating one response per DCI.September 30, 2012

38 **TABLE 1 Type 1**  **AR DCI**  **- Annual**  **Respondent Burden/Cost Estimates for Anticipated Residues Generating Anticipated Residue Data**  BURDEN HOURS (per year) TOTAL ACTIVITIES Mgmt. $10 3.62 Tech.

$ 67.05 Cler.

$ 33.85 Hours Costs 1) Read instructions 2 0 0 2 207.24 2) Plan activities 4 0 0 4 414.48 3) Create information 0 13,600 0 13,600 911,880.00 4) Gather information 0 16 0 16 1,072.80 5) Compile and review 1 8 0 9 640.02 6) Complete paperwork 2 0 2 4 275.01 7) Maintain and file 0 0 1 1 33.85 TOTAL 9 13,624 3 13,636 $ 9 1 4, 443.40 **Type I AR DCI**  B urden : 13,636 per response x 1 response x 2 DCIs = 27,272 h ours

Costs: $ 9 14,443 per response x 1 response x 2 DCIs = $1,828,886 **Type 2 AR DCI** 

- DCI for anticipated residues verification use information data: Minimum data captures the burden for cases in which the respondent verifies that nothing has changed; i.e., the formulation, use rate, geographic distribution of use, etc. have not changed since the ARs where used to establish or reassess the tolerance. The EPA estimates that this verification for u

pdating use information is estimated at 69 burden hours per response. EPA estimates that no more than 10 respondents each year will compl y with a DCIby submitting a base set of data for updating use information. As such, the total respondent burden hours per ye ar are estimated at 690 hours. See Table 2.September 30, 2012

39 **TABLE 2 Type 2**  **AR DCI**  **- Annual Respondent Burden/Cost Estimates for Anticipated Residues**  **Requiring Minimum Data for Verifying Use Information**  Burden Hours (per ye ar) Total Collection Activities Mgmt. $1 03.62 Tech.

$ 67.05 Cler. $

33.85 Hours Costs 1) Read Instructions 8 0 0 8 828.96 2) Plan Activities 16 0 0 16 1657.92 3) Create Information 0 0 0 0 0 4) Gather Information 0 16 0 16 1072.80 5) Compile and Review 2 16 0 18 1280.04 6) Complete Paperwork 2 0 8 10 470.04 7) Submit and File 0 0 1 1 33.85 Total 28 32 9 69 $ 5,293.61 **Type 2 AR DCI**  Burden: 69 per response x 10 responses x 1 DCI= 690 hours

Cost: $5,29 4 per response x 10 responses x 1 DCI = $52,9 4 0. **Type 3 AR DCI** 

- DCI for anticipated residues collected from publicl y available sources: The average respondent burden for submitting a base set of data for updating monitoring information is estimated at 137 burden hours per year. EPA estimates that an average of 4 respondents each ye ar is likely to be able to comply

with a DCI by

submitting data from publicl y available sources. As such, the total annual respondent burden for this ty pe of DCI is estimated to be 548 burden hours. See Table 3.September 30, 2012

40 **TABLE 3 Type 3**  **AR DCI:**  **Annual Respondent Burden/Cost Estimates for Anticipated Residues Collected from Publicly Available Sources**  Burden Hours (per ye ar) Total Collection Activities Mgmt. $10 3.62 Tech.

$ 67.05 Cler.

$ 33.85 Hours Costs 1) Read Instructions 8 0 0 8 828.96 2) Plan Activities 16 0 0 16 1,657.96 3) Create Information 0 0 0 0 0 4) Gather Information 0 60 0 60 4,023.00 5) Compile and Review 2 40 0 42 2889.24 6) Complete Paperwork 2 0 8 10 478.04 7) Submit and File 0 0 1 1 33.85 Total 28 100 9 137 9,911.05 **T ype 3**  **AR DCI** B urden : 137 per response x 4 responses x 1 DCI = 548 h ours.

Cost: $9,911 per response x 4 responses x 1 DCI = $ 39,644 **Type 4 PCT DCI** 

- DCI for percent crop treated using existing information: The annual per respondent burden for generating percent crop treated estimates using existing information is estimated to be 59 burden hours. Percent crop treated estimates are generall y conducted within the Agency , and onl y i n rare instances would a registrant need to gather the information; one DCI per ye ar impacting one respondent is probably an overestimation. The estimated costs assume that cost of purchasing or obtaining percent crop treated information derived from existing, contracted data sources. See Table 4.September 30, 2012

41 **TABLE 4 Type 4**  **PCT DCI**  **- Annual Respondent Burden/Cost Estimates for Percent Crop Treated**  **Using Existing Information** Burden Hours (per ye ar) Total Activities Mgmt. $10 3.62 Tech.

$ 67.05 Cler.

$ 33.85 Hours Costs 1) Read Instructions 1 1 0 2 17 0 .67 2) Plan Activities 0 2 0 2 134.1 3) Create Information 0 8 0 8 536.4 4) Gather Information 0 22 0 22 1475.1 5) Compile and Review 1 20 0 21 1444.62 6) Complete Paperwork 1 0 2 3 17 1

. 32 7) Submit and File 0 0 1 1 33.85 Total 3 53 3 59 $ 3,9 66.06 **Type 4**  **PCT DCI**

- Burden: 59 hours per response x 1 response x 1 DCI= 59 hours

Cost: $3,9 66 per response x 1 response x 1 DCI= $3,9 66 **6(b) Estimating Respondent**  **Costs -**  **AR/PCT DCIs**  The total annual cost for all respondents of AR and PCT DCI s is estimated to be $1,925,43 6 . Respondent costs are based on managerial, technical and clerical burden hours estimated at $103.62, $67.05, and $33.85 per hour, respectively

. **6(c) Estimating Agency Burden and Costs** 

**– AR/PCT**  The Agency ’s **annual** burden hours and costs for developing DCI correspondence, communication with registrants, developing documents, tracking and storing the evaluation of the data submissions, and other DCI processing activities is detailed in Table 5 and Table 6 below. For this renewal, EPA projects the same number of burden hours associated with the performance of the duties issuing and processing AR DCI s as was projected in the last IC R. Thus, like the last I CR, this renewal will project the Agency will process 4 AR DCI s and 1 PCT DCIannual ly

.September 30, 2012

42 **TABLE 5 Annual**  **Estimated Agency Burden**  **Hour and Cost For Processing**  **AR DCIs**  **Types 1**  **- 3**  Burden Hours (per ye ar) Total Collection Activities Mgmt. $ 10 1 .16 Tech.

$ 66.88 Cler.

$ 39.23 Hours Costs Develop DCI notice 1 0 2 3 179.62 Answer Registrants' questions 0 4 5 9 463.67 IN
- process data submissions 0 0 4 4 156.92 Analyze data 1 80 0 81 5451.56 Record and store DCI data 0 0 2 2 78.46 Total 2 84 13 99 $ 6,330.23 **AR DCI s**  **Types 1 -**  **3** Annual Estimated Agency Burden : 99 hours x 16 responses = 1,584 hrs Annual Estimated Agency Cost : $6, 330 x 16 responses = $1 01,280. **TABLE 6 Annual**  **Estimated Agency Burden**  **H our**  **s and Costs**  **for Processing**  **Type 4 -**  **PCT DCI**  **s** Burden Hours (per ye ar) Total Collection Activities Mgmt. $ 101.16 Tech.

$ 66.88 Cler.

$39.23 Hours Costs Develop DCI notice 1 0 2 3 140.39 Answer Registrants' questions 0 4 5 9 463.67 IN
- process data submissions 0 0 4 4 156.92 Analyze data 1 40 0 41 2776.36 Record and store DCI data 0 0 2 2 78.46 Total 2 44 13 59 $ 3615.80 **Type 4 PCT DCIs**

- Estimated Annual Agency Burden Activities Hours : 59 hours x 1 response = 59 h ours C osts : $ 3 , 616 x 1 response = $ 3 , 616September 30, 2012

43

**6(d) Bottom Line Burden Hours and Cost Table**  The total estimated annual respondent burden is 28,569 burden hours (28,509 burden hours for all AR DCI submissions + 59 burden hours for PCT DCIsubmissions), with an associated cost of $1,925,43 6 ($1,921,47 1 or all AR DCIsubmissions + $3, 965 for PCT DCI submissions) see table below

. The total estimated annual Agency burden is 1,643 burden hours (1,584 burden hours for all AR DCIsubmissions + 59 burden hours for PCT DCIsubmissions), with an associated cost of $ 104,896 ($ 101,280 for all AR DCIsubmissions + $3, 616 for PCT DCI submissions). See Table 7 below. **Table 7 .**  **Annual Bottom Line Hours and Costs/Master Table**

Key Activities Hours Costs Respondents Ty

pe 1

- DCI: generating anticipated residue data. 27,272 $ 1,828,886 Ty pe 2

- DCI for submitting minimal verification of use information 690 $52,940 Ty pe 3

- submitting anticipated residue data from publicly available sources 548 $ 39,644 Ty pe 4

- submitting percent crop treated data using existing information. 59 $ 3,96 6 Total estimated respondent burden/costs. 28,569 $ 1,926,43 6 Agency Ty

pe 1

- 3 AR DCIs for managing anticipated residue DCI’s 1,584 101 , 280 Ty pe - 4 PCT DCI s for managing percent crop treated DCI’s. 59 $3, 616
Total Agency

burden/costs. 1,643 $1 04,896 **6(e) Reasons for Change in Burden**  **- AR/PCT**  For this IC R renewal the annual estimated respondent burden hours are 28,569 hours at a cost of $ 1,925,43 6

. There is no increase in the burden hours over the last ICR renewal. However, the costs have decreased slightly due to the adjustment attributable to EPA’s re

estimation of labor rates for industry and the Agency

. This is a program adjustment

. **6(f) Burden Statement**  **- AR/PCT**  The estimated total respondent burden for this I CR over the next three years is 85,707 hours with the annual burden hours ranging from 59 hours to 13,636 hours per response, depending on the type of DCI

.September 30, 2012

44 **Part 4**  **-** Section 6: Estimating the Burden and Cost of the Collection for the Enforcement and Unanticipated In cidentsSeptember 30, 2012

45

**Part 4**  describes the burden activities associated with the Enforcement and Unanticipated In cident DCI activities. **6(a) Estimating Respondent Burden** 

**– Enforcement and Unanticipated Incident**  The to tal estimated annual respondent burden hours and costs for Enforcement and Unanticipated Incident DCI is estimated at 6,266 burden hours for the life of the I CR. The potential number of DCI s required, the ty pe of data, and the number of respondents potentially affected is quite variable. Thus, a this ty pe of DCI may

request data on more than one pesticide, and may

involve two or more respondents who are encouraged to join together to provide the needed data. The variability inherent in this ty pe of DCI means the estimates serve only as a proxy

for what the actual burdens are likely to be. The annual burden estimate is based on the following assumptions: (a) that the Agency would issue only one DCI for this ty pe of activity and onl y once during the life cycle of the ICR and (b) for the DCI issued there would be one response . The Agency has also assume d an average total test cost of $500,000 per Enforcement and Unanticipated Incident DCI. H istorically , there is very little information documenting the need for this ty pe of DCI but such events have occurred. For example one of the worst case s occurred in 197 6 when the Food an Drug Administration (FDA ) conducting a routine inspection uncovered deficiencies in the manner in which studies were being conducted at Industrial Biotest Laboratories, Inc., (IBT) one of the largest independent laboratories in the U.S. at the time. By 1978 EPA and FDA were conducting joint audits of two other IBT facilities and uncovered similar problems and the case had been referred to the Department of Justice. This turned out to be a massive undertaking. Of the 1205 IBT studies identified by EPA, 801 studies , or approximately 66% , were considered significant to regulatory

decisions such as the indu ction of tumors, birth defects, genetic mutations, neurot oxi city

and other chronic reproductive effects. Of the 801 studies considered significant to regulatory

decisions, 594 were found to be invalid b y EPA and Canada. By 1983, EPA warned pesticide pro duct registrants that products supported b y invalid health effects studies conducted b y IB T faced suspension action unless replaced b y other tests or a commitment to further testing. ( EPA Releases Report on IBT Lab Studies ; Warns of Suspension Action , Envi ronmental News EPA Press Release, Monday July 11, 1983) (see also House of Representatives, Committee on Agriculture, Washington, DC, Improving Data

- Pesticide Decisions, July

27 1983 ; Statement of Edwin Johnson, Director, Office of Pesticide Programs, Env ironmental Protection Agency) The estimate of respondent burden hours per response for Enforcement and Unanticipated Incident Activities is 6,266 hours and is based on the same burden hour break down projected in the 2001 I CR OMB 2070

- 0122; EPA N o . 150 3 .04 which the Agency allowed to expire 1 2 / 31 /04. The estimated Agency burden hours is based on Agency estimates similar to the burdens projected for the special review program, 1348 burden hours. While the Agency does not anticipate using any of th ese burden hours, the Agency will project a one time burden estimate for the three year life cycle of ICR. Table 1 lists the potential respondent burden hours and costs and Table 2 lists the potential Agency burden hours and costs and Table 3, lists the po tential three ye ar bottom line totals for Enforcement and Unanticipated Incident Activities

.September 30, 2012

46

**6(b). Estimating Respondent Costs**  **- Enforcement Unanticipated Incident**  **Activities** The estimated **three year** cost for all respondents for Enforcement Unanticipated Incident Activities is estimated to be $ 420,291. Respondent costs are based on managerial, technical and clerical burden hours estimated at $103.62, $67.05, and $33.85 per hour, respectivel y . **TABLE 1. TOTAL**  **RESPONDEN T BURDEN/COST ESTIMATES**  Enforcement and Unanticipated Incident DCI **Burden Hours (per year) Totals**  Collection Activities Mgmt. $1 0 3 .62 Tech.

$ 67.05 Cler.

$ 33.85 Hours Costs 1)Read Instructions 2 0 0 2 207.24 2)Plan Activities 2 0 0 2 207.24 3)Create Information 0 6,249 0 6,249 4 18, 6995.45 4)Gather Information 0 3 0 3 201.15 5)Compile and Review 1 4 0 5 371.82 6)Complete Paperwork 2 0 2 4 274.94 7)Submit and File 0 0 1 1 33.85 **Total** 7 6,256 3 6,266 420,291.69 TOTAL BURDEN HOURS: 6,266 hours x 1 response = 6 , 266 hours TOTAL BURDEN COSTS: $ 420,291 x 1 response = $ 420,291September 30, 2012

47

**6(c). Estimating Agency Burden and Cost**  **- Enforcement Unanticipated Incident**  **Activities TABLE**  **2 :**  **TOTAL AGENCY BURDEN AND HOURS COST** Enforcement And Unanticipated Incident DCI

**Collection Activities**  **Burden Hours Total**  **Mgm t.**  **$101.16/hr Tech.** 

**$66.88/hr Cler.** 

**$39.23/hr Hours**  **Cost** Develop DCI correspondence needed 32 160 60 252 16,291.72 Answer registrants' questions regarding the DCI 4 160 0 164 11,105.44 Revie w and analyze data submissions 4 880 0 884 59,259.04 Record DCI submissions 0 0 40 40 1569.20 Store Data 0 0 8 8 313.84 **TOTAL** 40 1,200 108 1,348 88,539.24 Hours: 134 8 per response X 1 responses X 1 DCI = 134 8 Hours Costs: $88 , 539 per response X 1 responses X 1 DCI = $ 88 , 539 **6(d). Bottom Line Burden Hours and Cost Tables/ Master Table for**  **Enforcement and Unanticipated Incident**  **DCI**
**Table 3: Bottom Line Burden Hours and Costs/ Master Table Enforcement**  **and Unanticipated Incidents**  Number of Responses Hours Cost **Respondents** 6,266 $420,291 1 **Agency** 1348 $88,539 1 **6(e). Reasons for Change in Burden**  **- Enf**  **orcement and Unanticipated Incident DCIs**  This new IC R burden will result in a in crease in the total estimated respondent burden of 6,266 hours for the three year life cycle of this I CR (or 2 , 0 88 burden hours annually) . This is a new program activity

. **6(f). Burden Statement -**  **Enforcement and Unanticipated Incident DCIs** September 30, 2012

48

The total respondent burden for the information collection activities for the three ye ar life cycle of this ICR is estim ated to average 6,266 burden hours for Enforcement and Unanticipated Incident activities. The annualized burden for a single DCI is 2,088 hours. According to the Paperwork Reduction Act, “burden” means the total time, effort, or financial resources expended by 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, analyzing 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 -**  **HQ**   ** OPP** **- 2007**  **- 0923**  , 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 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 minimiz ing respondent burden, including the use of automated collection techniques. Comments may

be submitted to EPA electronically through http://www.regulations.gov or by 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 Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Include docket ID No. **EP A**  **- HQ**  **- OPP**  **- 2007**  **- 0923**  and OMB control numbers 2070

- 0057; 2070

- 0107; and 2070

- 0164 in any correspondence but do not submit any DCI or other related information (e.g., forms, reports, etc.) to these addresses.September 30, 2012

49 **ATTACHMENTS TO THE SUPPORTING STATEMENT** Attachments to the supporting statement are available in the public docket established for this ICR under docket identification number **EPA -**  **HQ -**  **OPP -**  **2007 -**  **0 923**  . These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in this section 6(f) of the supporting statement. **Attachment A**  **: 7**  **U .**  **S .**  **C .**  **136a -**  **1 -**  **Section 4 of the**  **Federal Insecticide, Fungicide, and**

**Rodenticide Act (FIFRA)** . Also available at online at the US House of Representatives’ US Code website **Attachment B**  **: 7 U.S.C. 136a** 

**– Section 3 of FIFRA**  . Also available at online at the US

House of Representatives’ US Code website **Attachment C**  **: 71 FR**  **45719**

**– Pesticides; Procedural for Regulations for Registration** 

**Review; Final Rule .**  Also available online at http://edocket.acce ss.gpo.gov/2006/pdf/E6

- 12904.pdf **Attachment D**  **: 21 U.S.C. 346a** 

**– 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 E**  **: Public comment received from William M. Mahlburg, Director**  **,**

**Government Affairs, Nufarm, Americas, Inc.** E

- 1: Consultation questions and comment received from Rebeckah Freeman Adcock, Director, Congressional Relations , American Farm Bureau E

- 2: Consultation questions for Ray McAlister , Vice President Science and Regulatory

Affairs , CropLife America E

- 3: Consultation questions for Susan Little **,** Ex ecutive Director , Consumer Specialty Products Association E

- 4: Consultation questions for Daniel Botts , Director , FFDA's Environmental & Pest Management Division , Minor Crop Farmer Alliance Technical Committee ( Chairman) , Florida Fruit & Vegetable Assoc iation **Attachment F**  **: Forms that are commonly associated with Data Call**  **- ins** 

– available

electronically

as a PDF file on the internet at http://www.epa.gov/opprd001/forms/ ex cept as otherwise noted. EPA Form No. 8570

- 4
- Confidential Statement of Formula EPA Form No. 8570

- 27

- Formulator's Exemption Statement EPA Form No. 8570

- 28

- Certification of Compliance with Data Gap Procedures EPA Form No. 8570

- 32

- Certification of Attempt to Enter into an Agreement with Registrants for Development of Data Form EPA Form No. 8570

- 34

- Certification with Respect to Citation of Data Form EPA Form No. 8570

- 35

- Data Matrix Form EPA Form No. 8570

- 36

- Summary of the Ph ys ical/Chemical Properties Form EPA Form No. 8570

- 37

- Self

- Certification Statement for theSeptember 30, 2012

50 Phy sical/Chemical Properties EPA Form No. 6300

- 3

- Requirements Status and Registrant’s Response
. This form is computer generated and uniquely pre - populated and sent directl y to individual registrants. Blank copies of this form may otherwise onl y be ac cessed via the docket for this I CR as described above using the docket identifier EPA

- HQ

- OPP

- 2007

- 0923

- 0003. EPA Form No. 6300

- 4

- Data Call

- In Response Form
. This form is computer generated and uniquely pre - populated and sent directl y to individual registrants. Blank copies of this form may otherwise onl y be accessed via the docket for this I CR as described above using the docket identifier EPA

- HQ

- OPP

- 2007

- 0923

- 0003. **A ttachment G:**  **General Methodology Used to Estimate Paperwork Burden Hours and**

**Costs by the Office of Pesticide Programs for Submission of Required Data/Information for Responding to a Data Call**  **- In Notice**  **. Attachment H:**  **Work Sheets to Calculate Industry**  **and EPA Labor Costs**