March 30, 2010

Page 1 of 18 SUPPORTING STATEMENT FOR AN INFORMATION COLLECTION REQUEST (ICR)

1. IDENTIFICATION OF THE INFORMATION COLLECTION 1(a) Title of the Information Collection: Plant
- Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting OMB No.: 2070

- 0142 EPA I CR No.: 1693.0 6 1(b) Short Characterization/Abstract The Environmental Protection Agency (EPA) is responsible for the regulation of pesticides as authorized by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Prio r to EPA granting a registration, the manufacturer of the pesticide must demonstrate to the Agency that the use of the pesticide product will not result in any unreasonable adverse effects to humans or the environment. EPA is also responsible under the Fed eral Food, Drug, and Cosmetic Act (FFDCA) for establishing a tolerance or exemption from the requirement of a tolerance for pesticide residues on food or feed.
T he Agency

promulgated a final rule , codified at 40 CFR part 174 , that addresses the regulatory status of pesticidal substances that are produced b y plants (plant

- incorporated protectants). A plant

- incorporated protectant (PIP) is defined in the final rule as “ the pesticidal substance that is intended to be produced and used in a living plant and t he genetic material necessary for the production of such a substance. ” The rule (Attachment A) exempts a wide range of PI P s from registration requirements under FIFRA, and it imposes two new requirements on manufacturers of some PIP s. This Information Col lection Request (ICR) covers the two information collection related provisions contained in the rule, i.e., the provision that requires registrants that make Confidential Business Information (CBI) claims to substantiate such claims when they are made, and the provision that requires manufacturers of PIP s exempted from requirements of registration under the final rule to report adverse effects to the Agency

. The current CBI regulations at 40 CFR part 2 require that claimants substantiate their CBI claims f or their own records when the claim is made, and subsequently provide the substantiation to EPA only if requested. The substantiation, however, is not required to be included with the submission to EPA in which the CBI claims are made. The burden associat ed with the existing requirement is already approved by OMB. Although 40 CFR 174 requires the claimant to include the CBI substantiation in the PIP

related submissions to EPA, it is difficult to identify an y additional burden that such a requirement might actually impose. Nevertheless, the Agency has chosen the conservative approach of including potential burden and costs for preparing and submitting the CBI substantiation at the time of submission of the information containing the CBI claim as required by the rule.March 30, 2010

Page 2 of 18 The provisions of 40 CFR 174 that are related to information collection activities which are part of registration activities, e.g., data requirements for pesticide registrations, are already approved b y OMB under the PRA, and that approval i s not impacted by the clarification provided in the final rule. In formation collection activities related to pesticide registration are approved under OMB Control Nos. 2070

- 0060 (Application for New or Amended Pesticide Registration), 207 0

- 0024 (Tolerance Petitions for Pesticides on Food/Feed Crops and New Inert In gredients), and 2070

- 0040 (Application for Experimental Use Permit ( EUP) to Ship and Use a Pesticide for Experimental Purposes Only). This ICR, therefore, discusses the paperwork burdens associated with the requirement for registrants to substantiate CBI claims when they are made, and the requirement for manufacturers of PIP s exempted from registration requirements under the final rule to report adverse effects to the Agency within 30 day s.

2. NEED FOR AND USE OF THE COLLECTION 2(a) Need/Authority for the Collection Although FIFRA requires the registration of most pesticides, it also authorizes the Agency ’s regulation of unregistered pesticides. FIFRA section 3(a) provides that, to the e xtent necessary to prevent unreasonable adverse effects on the environment, the Administrator may limit the distribution, sale, or use of any pesticide that is not registered under section 3 of FIFRA, or subject to an experimental use permit under section 5 of FIFRA, or subject to an emergency exemption under section 18 of FIFRA. Pesticides that are "not registered" include pesticides that are exempt from FIFRA requirements under section 25(b) (Attachment B). FIFRA section 2(bb) defines the term "unreason able adverse effects on the environment" to mean: “(1) an y unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary

risk from residues th at 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 Cosmetic Act” (7 U.S.C. 136(bb)). Section 25(b)(2) of FIFRA allows EPA to exempt, by regulation, any

pesticide from some or all of the requirements of FIFRA, if the pesticide is of a character which is unnecessary to be subject to FIFRA in order to carry out the purposes of that Act (7 U.S.C. 136w(b)(2)). EPA interprets FIFRA section 25(b)(2) to authorize EPA to exempt a pe sticide or category of pesticides that EPA determines poses a low probability of risk to the environment, and that is not likely to cause unreasonable adverse effects to the environment even in the absence of regulatory oversight under FIFRA. To determin e whether a pesticide qualifies for an exemption under section 25(b)(2), EPA evaluates both the potential risks and benefits of the use of the pesticide. In evaluating a pesticide under the first exemption criterion, whether use of the pesticide poses a lo w probability of risk to the environment, EPA considers the extent of the potential risks caused b y use of the pesticide to the environment, including humans and other animals, plants, water, air and land. Potential risks to humans include dietary risks as well as non

- dietary risks such as those resulting fromMarch 30, 2010

Page 3 of 18 occupational or residential exposure to the pesticide. EPA uses the FFDCA section 408 standard in evaluating dietary

risks. EPA will not exempt pesticides under section 25(b)(2) that fail the low prob ability

of risk criterion. In evaluating a pesticide under the second exemption criterion, whether the use of the pesticide is likely

to cause unreasonable adverse effects on the environment even in the absence of regulatory

oversight under FIFRA, EPA ba lances all the potential risks to human health, including an y dietary

risks, and risks to the remainder of the environment from use of the pesticide against the potential benefits associated with its use. In balancing risks and benefits, EPA considers the economic, social, and environmental costs and benefits of the use of the pesticide. If the pesticide meets both exemption criteria, EPA may exempt the pesticide from regulation under FIFRA section 25(b)(2). Under FFDCA section 408(a) (Attachment C), a pe sticide chemical residue in or on food is not safe unless EPA has issued either: a tolerance for the residue and the residue is within the tolerance limits, or an exemption from the requirement of a tolerance for the residue (21 U.S.C. 346a(a)(1)). FFDCA s ection 408 authorizes EPA to determine a residue is safe and exempt from the requirement of a tolerance if the Administrator “. . . has determined that there is a reasonable certaint y that no harm will result from aggregate exposure to the pesticide chemic al residue, including all anticipated dietary exposures and all other exposures for which there is reliable information” (21 U.S.C. 346a(c)( 2)(A)). Section 408 of the FFDCA also directs EPA to specificall y consider harm that may result to infants and child ren as a result of pesticide chemical residues. A determination that a pesticide chemical meets the safety standard of section 408( a) of the FFDCA may

also be relevant to whether a pesticide qualifies for a FIFRA section 25(b)(2) exemption with respect to human health risks arising from oth er routes of exposure. However, FIFRA does not provide for exemption of a pesticide in food based solel y upon consistency with the FFDCA section 408 exemption standard. At a minimum, EPA also must evaluate risks arisi ng from occupational exposure to humans and determine that such risks meet both exemption criteria. In addition, EPA must evaluate the risks to the environment from the pesticide and determine both that the pesticide poses only a low probability

of environmental risks, and that use of the pesticide is not likely to cause an y unreasonable adverse effects on the remainder of the environment in the absence of regulation under FIFRA. 2(b) Practical Utility/Users of the Data EPA believes that requiring the substantiation of CBI claims for PI Ps at the time of submission to the Agency will help ensure a timely EPA response to submissions for PIPs , protect the public’s right to access information consistent with FIFRA, and ensure that information qualifying as CBI is properl y protected from unauthorized disclosures. Since registrants are already required to ensure that CBI claims are proper prior to asserting the CBI protection for information submitted to EPA, this requirement simply affects the time at which the substantiation is submitted to the Agency , i.e., it requires the inclusion of this substantiation with the submission.March 30, 2010

Page 4 of 18 T he Agency ’s anal ys is of the potential risks and benefits of PIPs has led it to conclude that the categories of PIPs described in 40 CFR part 174, subpart B warrant exemption

. However, it is possible that there may be unforeseeable adverse effects to human health or the environment from the testing and use of otherwise exempted PIPs , as the exemptions at subpart B are broad and cover literall y thousands of potential substances, some of which under certain use conditions have the potential to be toxic. The Agency th erefore included, as a condition of exemption, a requirement to report to EPA within 30 day s any factual adverse effects as sociated with these otherwise exempt PIPs . These reporting requirements are similar to reporting requirements imposed on registrants under FIFRA section 6(a)(2) for registered pesticides. However, since the 6(a)(2) reporting requirement applies to registered pesticides and man y PI P s are exempted from registration requirements , the separate reporting requirement is necessary in order to obtain an y information on unforeseen adverse effects from the exempted PIP s. The information supplied to substantiate cla ims of confidentiality will be used by

the Agency to determine whe ther CBI claims compl y with the confidentiality provisions of FIFRA. Earl y substantiation of CBI claims will enable the Agency to promptly release information supporting PIP s registration de cisions , without delaying registrations in order to obtain CBI substantiation once a decision has been made to register a PIP , while still protecting legitimate CBI. The adverse effects reports on exempted PIP s will be utilized by the Agency

to evaluate adverse effects to determine if an y additional regulatory actions are warranted. These reports will also enable the Agency

to report to appropriate oversight bodies and the public its evaluation of such adverse effects and will help support any additional decision on regulatory oversight.

3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3(a) Non duplication In fulfilling its mission as the Federal agency primarily responsible for the regulation of pesticides, EPA works closely wi th the U.S. Department of Agriculture (USDA) which has responsibilities under the Federal Plant Protection Act (FPPA), and the U.S. Food and Drug Administration (FDA) which has responsibilities under the FFDCA. EPA, USDA and FDA consult and exchange inform ation when such consultation is helpful in resolving safety questions. The three agencies also strive for consistency between program s , adopting consistent approaches, to the extent permitted by the respective statutory

authorities. A consistent approach b etween agencies is easier for the regulated community to understand. It is also more likely to conserve resources, as submitters would more likely be able to use data developed for one agency to meet requirements posed by another agency

for the same or sim ilar products. Generally , respondents are not required to submit applications or any other related data or information regarding testing to an y other federal agency or to an y other EPA program office. However, there may

be requirements under the FPPA for plants that produce PIP s. Under the FPPA, the USDA's Animal and Plant Health Inspection Service (APHI S) regulates field testingMarch 30, 2010

Page 5 of 18 of geneticall y altered plants, while EPA will have regulatory oversight of the pesticide substances produced b y those plants. In instances where review under the FPPA may be triggered, the respondent will need to contact APHIS for a determination of whether the plant containing a PIP is a plant pest that will need a permit. Inaddition, registrants may be required to obtain an experimental use permit (EUP) for PIPs

- related field trials. In such cases, registrants would be expected to compl y with the applicable EUP requirements. As described in section 1(b) of this supporting statement, the paperwork activities associated with EUPs are addressed in a separate ICR. Inan y case, there is no known duplication related to the requirements covered in this I CR, i.e., the up

- front CBI substantiation or the submission of adverse effects reports for exempted PIP s. Each respondent must subm it information unique to his/her product application, or allegation received, and will do so only once on occasion. 3(b) Public Notice Required Prior to ICR Submission to OMB In preparing to renew this I CR, EPA published a notice in the Federal Regist er which provided a 60

- day

public notice and comment period on the draft ICR (see 7 2 FR 1 1862 ; March 1 4 , 200 7 ). EPA did not receive comment in response to this notice

. 3(c) Consultations In developing its approach to PIP s, EPA requested advice from two scientific advisory groups at three meetings. In 1992, a subpanel of the FIFRA Scientific Advisory Panel (SAP) reviewed a draft proposed policy statement and answered a series of scientific questions concerned primaril y with EPA’s proposed exemptions un der FIFRA. The following year, a Subcommittee of the EPA Biotechnology Science Advisory

Committee (BSAC) met to address a series of scientific questions concerned primaril y with EPA’s proposed exemptions under the FFDCA. In 1994, a joint meeting of these two groups met to address a series of scientific questions on approaches to PIP s under both FIFRA and FFDCA. Advice from these scientific advisory groups was considered in developing the provisions codified at 40 CFR 174

. In addition to the public consult ation described above, consultation and/or dialogue between industry

and m anagers in the Biopesticides and Pollution Prevention Division (BPPD) of the Office of Pesticide Programs (OPP) occurs on an informal, on

- going, as

- needed basis, during the submissio n and review of an application for EUP or registration. Experience has shown that if an y sort of problem arises , be it technical , administrative, or otherwise, or, if there are suggestions for improvements in the program, the applicants will not hesitate to inform BPPD. Any

questions or consultations connected with a particular submission are addressed in a meeting or telephone conversation with the applicant, and do not necessarily occur at specified intervals. In addition to the informal consultations a bove, EPA will publish a notice in the Federal Register concerning the renewal of this ICR. The Agency will consult with stakeholders who activel y interact with the Agency through the use of this collection instrument and will solicit stakeholder assessment of the regulatory burden estimates expressed by the Agency

in this IC R.March 30, 2010

Page 6 of 18 3(d) Effects of Less Frequent Collection Not applicable. The information is submitted either in conjunction with the application or when an adverse effect occurs for an exempted PIP . This activity is conducted only

once per "event," and therefore, there are no available means by which the Agency

can reduce the frequency

. 3(e) General Guidelines The collection activities covered b y this ICR comply with the guidelines p rovided under the PRA and the implementing regulations issued by OMB.

. 3(f) Confidentiality Although the EPA urges submitters to minimize the amount of information that is claimed as CBI, an y data and/or information submitted to the Agency may be claimed as trade secret, or commercial or financial information and will be protected from disclosure b y the EPA under FIFRA section 10 and the associated regulations as contained in 40 CFR Part 2, Subpart B. When information that is claimed as trade secret or CBI is provided to the Agency , such information is subject to the protections and procedures set forth in FIFRA Section 10. Nothing in this rule affects those protections. Even if a registrant fails to include the required substantiation for any CBI claims mad e in the PIP application when that application is submitted to EPA, the Agency intends to still handle such claims in accordance with the FIFRA Confidential Business Information Security Manual. This manual contains instructions relative to all contact with confidential documents, including responsibility

of EPA employees, phy sical securit y measures, CBI materials within EPA, CBI ty

ping procedures (documents ty ped internally

or by contract), and interdivisional routing procedures. The manual dictates all CB I must be marked or flagged as such, that it must be kept in secure, i.e., double

- locked areas, and that all CBI to be destro ye d must be cleared b y a document control officer and placed in EPA's paper shredder. 3(g) Sensitive Questions Not applicable. No information of a sensitive or private nature is requested in conjunction with this collection activity . Further, 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 The respondents for the information collection activities contained in this ICR include producers and importers of PIP s. These entities may be classified under the following North American Indu strial Classification Sy stem (NAI CS) codes:March 30, 2010

Page 7 of 18 32532 Pesticides and Other Agricultural Chemical Manufacturing 54171 Research and Development in the Physical, Engineering, and Life

Sciences 325414 Biological Products (except Diagnostic) Manufacturing 611310 Colleges, Universities, and Professional Schools 422910 Farm Supplies Wholesalers 422930 Flower, Nursery Stock, and Florists’ Supplies (Wholesalers) 4(b) Information Requested (i) Data items, including record keeping requirements Regis trants must continue to review the regulations regarding CBI, review the materials in their submission for which claims are being made; and ensure that CBI claims are properl y made. Pursuant to 40 CFR 174 , registrants must submit a substantiation for an y C BI claim made for information for PI P s submitted to EPA. The Agency is not imposing any

new requirements regarding the basis for making a CBI claim, or the points that must be addressed to substantiate any CBI claim that is made. These requirements already exist in 40 CFR part 2. In addition, EPA is not imposing any

specific form or format for these substantiations. (See 40 CFR 174.9) Manufacturers of PI P s exempted from registration requirements must submit to EPA any information they

subsequently

obtain regarding adverse effects on human health or the environment alleged to have been caused b y the exempted PIP . The Agency anticipates that the entities will obtain adverse effects information during the normal course of business, and then will make a report to the Agency with adequate background information for the Agency to be able to make a decision to either ask for additional information or to act on the information presented. The Agency

does not foresee an y extra data collection effort to find adverse e ffects beyond the normal course of business but rather envisions these effects being discovered from ongoing studies of various PIP s or customer complaints. Although EPA specifies the content of any adverse effects report submitted to EPA, EPA is not impos ing any specific form or format for these reports. (See 40 CFR 174.71) In addition, entities may

also be asked to respond to Agency questions that arise based on the submission, whether it be the CBI substantiation, or the adverse effects report. Such fo llow

up activities are assumed as part of the initial burden estimates. Should further information be necessary , e.g., should the adverse effect information reported to EPA indicate the need for a study or other additional information, an y additional Agenc y requirement would come in the form of a data call

- in covered under the existing regulations and ICR (Data Call

- In s: Special Review and Registration Review; OMB Control No. 2070

- 0057; EPA IC R No. 922) . This I CR is not intended to address such activities.

(ii) Respondent Activities The requirements for up

- front CBI substantiation an d adverse effects reporting are separate requirements that only occur on occasion. The CBI substantiation occurs when an entit yMarch 30, 2010

Page 8 of 18 is submitting PIP related information to EPA that contains CBI claims pursuant to 40 CFR part 2. The adverse effects reporting occurs when an entity obtains information regarding adverse effects on human health or the environment alleged to have been caused by the exempted PIP

. Although each activ ity

is distinct, a ty

pical respondent for each activity is expected to engage in the following activities: Read R egulations The respondent needs to become familiar with the regulations governing

CBI substantiation or adverse effects reporting as they pertain to PIPs

. Plan Activities The respondent must develop/amend and implement a plan to ensure

compliance with these requirements. The registrant is also encouraged to consult with the Agency

. Gather In formation The information necessary to provide the required substantiation or any

information obtained on adverse effects must be assembled. Review In formation The respondent must check the CBI substantiation for accuracy and completeness, or verify

that the adverse effects report accuratel y reflects the information they

have obtained. Complete Paperwork The information must be compiled into a document(s) or report(s) and

prepared for submission to EPA. Submit In formation The respondent must submit the information to the Office of Pesticide

Progr ams as required. Store, Maintain, and File In formation The final rule does not contain any new recordkeeping requirements. Please note however that FIFRA section 8, and the related regulations in 40 CFR part 169, require registrants to store and maintain certain information related to their pesticide products. Since no new recordkeeping requirements were imposed by this rule, EPA did not include any related burden in this I CR.
5. THE INFORMATION COLLECTED

– AGENCY ACTIVITIES, COLLECTION METHODOLOGIES , AND INFORMATION MANAGEMENT 5(a) Agency Activities The Agency

must evaluate the CBI substantiations when submitted, and process any adverse effect reports for exempted PIP s when received. Although these activities are distinct and separate, the Agenc y is expected to engage in the following activities: Consult with the registrant The Agency will respond to any

questions either in writing, or verball y via meetings or by telephone, and provide an y other assistance or guidance requested. Record submi ssions Whether the submission involves an application package for the registration of a PI P , or an adverse effects report for allegations related to an exempted PI P , the submission is recorded or logged in by the Agency

to document its receipt. The Agency will create anMarch 30, 2010

Page 9 of 18 electronic record of the necessary information for routing and tracking purposes. Review submissions The Agency will review the incoming materials with CBI claims to evaluate the CBI substantiations for completeness and appropriateness, and will review the incoming adverse effects reports to determine what, if an y, substantive review or action might be necessary as follow

- up to the alleged adverse effects. Store the information The Agency will maintain the information contained in the s ubmitted application package, including the CBI substantiation that was submitted, and will maintain an y adverse effects report(s) submitted. 5(b) Collection Methodology and Management Respondents to this I CR providing substantiation of CBI claims at the time the claims are made must necessarily

s ubmit the information as part of their larger package for registration of a pesticide product , since it is parts of that package that are claimed as CBI . Although EPA is working to allow electronic submissi on of registration packages, they are currentl y submitted by mail. All information received by the Agency

pertaining to CBI substantiation or adverse effects for exempted PIP s will be routed to the Biopesticides and Pollution Prevention Division (BPPD) of the Office of Pesticide Programs (OPP). It will be pin

- punched by date, screened, and entered into the Office of Pesticide Programs Information Network (OPPIN). For registration packages involving PIP s, a file will be created and the application package will be forwarded to the appropriate Manager within BPPD. The Manager assures that the initial OPPI

N entry is correct, reviews the information, and if necessary, routes the submitted data through scientific and/or administrative review. If the scientific information indicates that the submission is deficient in any manner, the submitter has the option of attempting to correct the deficiency . If the submission indicates that information claimed as CBI warrants said claim, the applicant is notified and the i nformation is marked as such. The Agency will continue current practice of treating information claimed as CBI as such, until a CBI determination is made. I f a determination is made that a CBI claim is not warranted or the claim is not substantiated, the r egistrant will be notified that the information claimed as CBI, does not qualify as CBI because it does not meet the regulatory requirements. They

will be given an opportunity to respond as provided in the existing regulations. The package will then be pro cessed accordingl y. For adverse effects reports related to exempted PI P s, a file will be created and the report will be forwarded to the appropriate product Manager within BPPD. The Manager assures that the initial OPPI

N entry is correct, reviews the inf ormation, and determines the appropriate review and next steps based on the contents of the report, routing the report through scientific and/or administrative review, as appropriate. If an adverse effect report indicates that additional action is warrante d or necessary , the Agency will take appropriate action. 5(c) Sm all Entity FlexibilityMarch 30, 2010

Page 10 of 18 In promulgating the requirements codified at 40 CFR 174 , the Agency considered potential small entity

impacts, and has taken steps to minimize potential impacts to the extent permitted. EPA believes that the CBI substantiation is fairly eas y to provide for information which warrants CBI claims. The entity , regardless of size, is already required to make the CBI determination prior to submitting its registration appli cation to EPA. The rule simply requires that the information be provided with the submission to substantiate the CBI claim. This is reflected in the relatively low cost estimate for CBI substantiation for a PIP submission. This relativel y small cost r epres ents a reasonable step to e nsure the public has access to all non

confidential information on PIP s once they are registered. In addition, the Agency

has taken steps to ensure that only the person who produces the exempted PIP for sale and distribution is responsible for adverse effects reporting, and onl y if they obtain the adverse effects information. The Agency has designed such reporting to be minimal and has placed the burden on the Agency to take additional action beyond the entity making the report. 5(d) Collection Schedule The CBI substantiation occurs onl y upon submission of claims of confidentiality and the adverse effects reporting only occur s on occasion. There is no collection schedule per se associated with these collection activities. Th ese activities are conducted once per submission.
6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6(a) Estimating Respondent Burden Burdens for this anal ys is consist primarily of the administrative burden associated with the drafting and submiss ion of the CBI substantiation and the adverse effects reports. The burden estimates are based on the Agency ’s experience regarding existing burden estimates related to CBI substantiation and adverse effects reporting for conventional pesticides, and provid e reasonable estimates for the average time necessary to perform each activity

for each submission. For purposes of this I CR, EPA is assuming that no more than 54 PIP

- related registration applications with associated CBI substantiations will be submitted over the three

- year approval period for this ICR , or 18 per year
. This estimate is based on the average number of submissions with CBI per ye ar over the last two years. Based on the number of EUP applications over the last two years, EPA estimates 6 EUP applications per year, each of which requires a CBI list of EUP cooperators. Based on the number of PI P applications over the last two years, EPA estimates that there may

be up to 12 new PIP applications each year, each of which may contain CBI.
Tabl e 1

– Average Respondent Burden and Cost Estimates per Submission for Substantiation of CBI Claims Made in a Plant
- Incorporated Protectant R egistration Application Burden and Cost Estimates Totals Activities Mgmt. Tech. Clerical Burden CostsMarch 30, 2010

Page 11 of 18 ($10 9 .8 2 /hr) ($6 0 . 39 /hr) ($3 5 . 89 /hr) (hrs) ($) Read Regulations 1 2 0 3 230.60 Plan Activities 2 4 0 6 461.19 Gather Information 0 4 0 4 241.56 Review Information 2 1 1 4 315.92 Complete Paperwork 0 1 2 3 132.17 Submit Information 0.5 0.5 0.5 1.5 1 03.05 Totals 5.5 12.5 3.5 21.5 1,484.48 Estimated Total Annual Respondent Burden: 18 events x 21.5 hours = 387 h ours Estimated Total Annual Respondent Cost: 18 events x $1,48 4

. 4 8 = $ 26,72 1 Although the Agency

does not anticipate an y adverse effect reports to be submitted for exempted PIP s, this I CR includes an estimate of one such report being submitted over the three

ye ar approval period for this I CR. The per

- submission estimate is therefore divided by 3 to provide an average annual burden and cost t o include in the total annual estimates for this I CR. The total annual average burden and costs for the adverse effects report is calculated as follows:
Table 2
- Average Respondent Burden and Cost Estimates per Submission for Submitting an Adverse Effec ts Report for an Exempt Plant
- Incorporated Protectant Burden and Cost Estimates Totals Activities Mgmt.

($10 9 .8 2 /hr) Tech.

($6 0 . 39 /hr) Clerical

($3 5 . 89 /hr) Burden

(hrs) Costs

($) Read Regulations 0.5 1 0 1.5 115.30 Plan Activities 0.5 0.5 0 1 85.10 Gather Information 0 1 0 1 60.39 Review Information 0.5 0.5 0 1 85.10 Complete Paperwork 0 0.5 1 1.5 66.08 Submit Information 0 0.5 0.5 1.0 48.14 Cost for Mailing 0 0 0 0 0.44 Totals 1.5 4 1.5 7 60.56 Assuming a single adverse e ffects report submitted over three year period: Estimated Total Annual Respondent Burden: (1 event x 7 hours) ÷ 3 = 2.3 hours Estimated Total Annual Respondent Cost: (1 event x $460. 56 ) ÷ 3 = $15 4 6(b) Estimating Respondent Costs Consistent with rece nt I CR renewals, OPP is using labor cost estimates from Agency economists with respect to wages, benefits and overhead for all labor categories for affected industries, state government, and EPA employees. This approach uses a transparent and consistent m ethodology

employing publicl y - available data to provide more accurate estimates and allow eas y replication of the calculations. Methodology : The methodology uses data on each sector and labor ty pe for an Unloaded wage rate (hourl y wage rate), and calculates the Loaded wage rate (unloaded wage rate + benefits), and the Fully loaded wage rate (loaded wage rate + overhead). Fully loaded wage rates are used to calculate the Agency ’s staffing costs.March 30, 2010

Page 12 of 18 Unloaded Wage Rate: Wages are estimated for labor ty pes (management, technical, and clerical) within applicable sectors. The Agency uses average wage data for the relevant sectors available in the National Industry

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

. Sectors: The specific North American Industry Classification Sy stem (NAICS) code and website for each sector is included in that sector’s wage rate table. Within each sector, the wage data 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 collecting, 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 benefits for all c ivilian 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. Ful ly L oaded Wage Rate: We multiply the loaded wage rate b y 50% (EPA guidelines 20

- 70%) to get overhead costs. Attachments F and F.1 contain worksheets providing the breakout of these costs. Costs are indexed to 2008 data. To derive the labor rates for this I CR, Agency economists estimated the wages for the management, technical, and clerical labor categories using the methodology described in Attachment E . The respondent costs for this renewal for managerial, technical and clerical rates are estimated at $10 9 .8 2 , $6 0

. 39 , and $3 5

. 89 per hour, respectively . These labor rates are fully loaded and include benefits and overhead costs. Since CBI substantiations are simply added to the registration application package and are not submitted separately , there are no additional costs related to the transmittal of this information to the Agency. The costs for submitting the registration application package are already included under the existing I CRs. These respondent burden and cost estimates may also represent an upper bound because the anal ys is assumes that all PIP

- related registration applications may include information that the registrants will claim as CBI which will need to be substantiated. It is likel y that registrants will recognize, over time, that it is in their interest to make all information on PIP s publicly available to improve the transparency of the regulatory process. 6(c) Estimating Agency Burden and Costs The Agency

will incur burden and costs while performing the various activities neces sary to review CBI substantiation submissions and any adverse effects reports submitted for exempted plant

- incorporated protectants. These activities are described in Section 5 of this I CR and may include the tracking and review of submissions, requests fo r additional information, or consultations with applicants. Tables 3 and 4 provide the average EPA burden and cost estimates for performing these activities.March 30, 2010

Page 13 of 18 Table 3
- Average Burden and Cost Estimates per Submission for EPA Activities related to CBI Su bstantiation Burden and Cost Estimates Totals Activities Mgmt. ($ 107.56 /hr) Tech.

($ 71.58 /hr) Clerical

($ 41.21 /hr) Burden

(hrs) Costs

($) Consult With Registrant 1 3 0.5 4.5 342.91 Record Submissions 0 0.5 1 1.5 77.00 Review Submissions 1 2 0 3 250 .73 Store the Information 0 0.5 1 1.5 77.00 Totals 2 6 2.5 10.5 747.64 Estimated Total Annual Agency Burden: 18 events x 10.5 hours = 189 h ours Estimated Total Annual Agency Cost: 18 events x $ 747.64 = $ 13,457

.

Table 4
- Average Burden and Cost Esti mates per Submission for EPA Activities related to an Adverse Effects Report Submitted for an Exempt Plant
- Incorporated Protectant Activities Burden and Cost Estimates Totals Mgmt. ($ 107.56 /hr) Tech.

($ 71.58 /hr) Clerical

($ 41.21 /hr) Burden

(hrs) Costs

( $) Consult With Registrant 0.5 1 0.5 2 145.97 Record Submissions 0 0.5 1 1.5 77.00 Review Submissions 1 1 0 2 179.14 Store the Information 0 0.5 0.5 1 56.40 Totals 1.5 3 2 6.5 458.50 Assuming a single adverse effects report might be submitted over the 3 year approval period for the IC R, the total annual average burden and costs for EPA activities related to the adverse effects report is calculated as follows:
Estimated Total Annual Agency Burden: (1 event x 6.5 hours) ÷ 3 = 2. 2 hours Estimated Total Annual Agency Co st: (1 event x $ 458.50 ) ÷ 3 = $ 15 3 In addition, the Agency

may determine that additional follow

- up action is necessary for either ty pe of submission and will be providing necessary guidance for these requirements. 6(d) Bot tom Line Burden and Cost Table The following table presents the total estimated annual burden and costs for this I CR:
Table 5

– Total Annual Burden and Cost Estimates Respondent Agency Activities Burden (hrs) Costs ($) Burden (hrs) Costs ( $) CBI Substantiations 387 26,721 189 13,457 Adverse Effects Reports 2 154 2 153March 30, 2010

Page 14 of 18 Totals 389 26,87 5 191 13,610 Columns and Rows may

not add due to rounding 6(e) Reasons for Change in Burden The expected number of responses requ iring CBI subst antiation has increased from 14 in the last I CR approval to 18 for this I CR renewal . T he number of adverse effect reporting submissions remains the same. The increase in the expected number of responses is primarily driven by an expected in crease in the number of applications for experimental use permits requiring CBI substantiation

. The total burden hours per respondent has not changed for this ICR renewal. However, because of the increase in CBI substantiations, the total annual burden estimate has i ncreased from 303 to 389 h ours. The annual costs have also increased from $ 20,879 to $26,875. The increase in CBI substantiations is the primary reason for the increase in costs, although part of the cost increase is due to the rise in labor cost when indexed to 2008 dol lars. The annual burden increase represent s an adjustment. 6(f) Burden Statement The total annual respondent burden for the collection of information contained in this ICR is estimated to be 389 hours. The annual respondent burden for the collection of information associated with the substantiation at the time of submission for CBI claims related to a PI P registration application is estimated to average 21.5 hours per submission, and the annual respondent burden for the coll ection of information associated with the reporting of adverse effects for exempted PIP s is estimated to average 7 hours per submission. As defined b y the PRA and 5 CFR 1320.3(b), “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 . This includes the time needed to review instructions; develop, acquire, install, and utilize technology and sy stems for the purpose of collecting, validat ing, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with an y previously

applicable instructions and requirements; train personnel to be able to respond to a co llection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An A gency may not conduct or sponsor, and a person is not required to respond to, a collection of informati on unless it display s a currently valid OMB control number. The OMB control numbers for EPA’s regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or for m, if applicable. The Agency has established a public docket for this I CR under Docket ID No. EPA

- HQ

OPP

- 2010

- 0281 , which is available for online viewing at www.regulations.gov, or in person viewing at the OPP Regulatory Public Docket in Rm. S

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

through Friday , excluding legal holiday s. The docket telephone number is (703)March 30, 2010

Page 15 of 18 305

- 5805. You may

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

- HQ

- OPP

- 20 10

- 0281 and OMB Control No. 2070

- 0142 , to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: Public Information and Records Integrity Branch (PIRIB), Mail Code: 7502P, Office of Pesticide Programs (OPP), Environmental Protection Agency , 1200 Pennsylvania Ave., NW, Washington, DC 20460, and (2) OMB b y mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.

ATT ACHMENTS 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

- 2010

- 0281 . These attachments are available for online viewing at www.re gulations.gov or otherwise accessed as described in section 6(f) of the supporting statement.
Attachment A: 40 CFR part 174
- Procedures And Requirements For Plant
Incorporated Protectants . Available online at the National Archives and Records Administration’s Electronic CFR Webpage Attachment B 7 USC 136w(b)
- FI FRA Section 25(b )

. Available on line at the US House

of Representatives’ Office of the Law Revision Counsel ’s US Code website Attac hment C : 7 USC 346a(a)
- FFDCA Section 408(a)

. Available online at the US

House of Representatives’ Office of the Law Revision Counsel ’ s US Code website Attachment D: Record of Consultations

- Reserved Attachment E : Worksheet for Estimating OPP ICR Wage Rates for Industry, State

and EPA Labor Costs; See attachment below Attachment F : Display Related to OMB Control #2070
- 0142

-ReservedMarch 30, 2010

Page 16 of 18March 30, 2010

Page 17 of 18 Attachment E Work Sheets used to Calculate Registrant Labor Costs This attachment is available as part of the electronic docket EPA
- HQ
- OPP
- 20 10
- 0281 and is part of the ICR’s Supporting Statement

. NAICS: 325300 Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing Labor Category : Formula Managerial Technical Clerical Unloaded Hourl y Rate 1 = W $51.01 $28.05 $16.67 Benefits Percentage 2 Lb = B/W 44% 44% 44% Benefits per hour B = W*Lb $22.20 $12.21 $7.26 Loaded Hourl y Rate Wb = W + B = W(1+Lb) $73.21 $40.26 $23.93 Overhead Percentage 3 Lo = OH/Wb 50% 50% 50% Overhead per hour OH = Wb*L o $36.61 $20.13 $11.96 Fully L oaded Hourly Rate Wf = Wb + OH = W + B + OH $109.82 $60.39 $35.89

1. Data Source: BLS http://www.bls.gov/oes/current/naics4_325300.htm May 2008 data NAI CS 325300

- Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing Standard Occupational Codes: Management: 11

- 0000, Management Occupations Technical: 19

- 0000, L ife, Phy sical, and Social Science Occupations Cleri cal: 43

- 0000, Office and Administrative Support Occupations 2. Fringe benefits/wage per hour. 3. U. S. Environmental Protection Agency , EPA Air Pollution Control Cost Manual, Sixth Edition , EPA

- 452

- 02

- 001, January 2002, pg. 2

- 34. The loading for indirect costs is within the range of 20

- 70% of the load labor rate (wage + benefits) suggested in EPA guidance.March 30, 2010

Page 18 of 18 Attachment E .1 Work Sheets used to Calculate EPA and Federal Government Labor Costs This attachment is available as part of the electr onic docket EPA
- HQ
- OPP
- 20 10
- 0281 and is part of the ICR’s Supporting Statement

NAICS: 999100 Federal Executive Branch Labor Category : Formula Managerial Technical Clerical Unloaded Hourl y Rate 1 = W $49.96 $33.25 $19.14 Benefits Percentage 2 Lb = B/W 44% 44% 44% Benefits per hour B = W*Lb $21.75 $14.47 $8.33 Loaded Hourl y Rate Wb = W + B = W(1+Lb) $71.71 $47.72 $27.47 Overhead Percentage 3 Lo = OH/Wb 50% 50% 50% Overhead per hour OH = Wb*L o $35.85 $23.86 $13.74 Fully L oaded Hourly Rate W f = Wb + OH = W + B + OH $107.56 $71.58 $41.21

1. Data Source: BLS http://www.bls.gov/oes/current/naics4_999100.htm May 2008 data NAI CS 999100

- Federal Executive Branch Standard Occupational Codes: Management: 11

- 0000, Management Occupations Technical: 19

- 0000, L ife, Phy sical, and Social Science Occupations Clerical: 43

- 0000, Office and Administrative Support Occupations 2. Fringe benefits/wage per hour. 3. U. S. Environmental Protection Agency , EPA Air Pollution Control Cost Manual, Sixth Edition , EPA

- 452

- 02

- 001, January 2002, pg. 2

- 34. The loading for indirect costs is within the range of 20

- 70% of the load labor r ate (wage + benefits) suggested in EPA guidance.