                             SUPPORTING STATEMENT
                  FOR AN INFORMATION COLLECTION REQUEST (ICR)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION
 
      1(a)	Title of the Information Collection

      TITLE: Application for New and Amended Pesticide Registration 
      
      OMB No. 2070-0060		EPA No. 0277.17

      1(b)	Short Characterization/Abstract

      This information collection program is designed to provide the Environmental Protection Agency (EPA) with necessary data to evaluate an application of a pesticide product as required under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA) of August 3, 1996 (see Attachment A). Under FIFRA, EPA must evaluate pesticides comprehensively before they can be marketed and used in the United States to ensure that they will not pose unreasonable adverse effects to human health and the environment. Pesticides that meet this test are granted a license or "registration" which permits their distribution, sale and use according to requirements set by EPA to protect human health and the environment.
      
      Pursuant to FIFRA Section 33--Pesticide Registration Service Fees, the Consolidated Appropriations Act of 2004 established the Pesticide Registration Improvement Act, or PRIA (see Attachment B).  This new system created a registration service fee system for applications specific to pesticide registrations, amended registrations, and associated tolerance actions.  Since its approval, PRIA has been reauthorized twice (2007, and 2013).  Under PRIA, EPA is required to make a determination on the application within specified decision time frames.
      
      In evaluating a pesticide registration application, EPA assesses a wide range of potential human health and environmental effects associated with use of the product. The producer of the pesticide must provide data from tests done according to EPA guidelines or other test methods that provide acceptable data. These tests must determine whether a pesticide has the potential to cause adverse effects on humans, wildlife, fish and plants, including endangered species and non-target organisms, as well as possible contamination of surface water or groundwater from leaching, runoff and spray drift. The assessments involve to short-term toxicity and long-term effects such as cancer and reproductive system disorders. EPA also must approve the language that appears on each pesticide label. A pesticide product can only be used according to the directions on the labeling accompanying it at the time of sale, through its use and disposal. Labeling instructions must be carefully and precisely followed in order to ensure safe use.
      
      An individual or entity wanting to obtain a registration for a pesticide product must submit an application package consisting of information relating to the identity and composition of the product, proposed labeling, and supporting data (or compensation for others' data) for the product, as outlined in 40 CFR part 158. The EPA bases registration decisions for pesticides on its evaluation of a battery of test data provided primarily by applicants for registration. Required studies include testing to show whether a pesticide has the potential to cause unreasonable adverse human health or environmental effects. The Agency currently collects data on physical chemistry, toxicology, environmental fate, ecological effects, worker exposure, residue chemistry, environmental chemistry, and product performance.  All or part of this information may be required depending on use and type of product.  If EPA's evaluation of the data shows that the statutory requirements of FIFRA are met, a registration is approved. 
      
      Registrants may seek, at their discretion, to amend a registration by submitting data and revised proposed labeling to EPA.  Also, registrants of EPA-registered pesticide products at times become subject to regulations or guidance which necessitate labeling revisions. The revised labeling is submitted to the Agency as an amendment along with the completed application (EPA Form 8570-1 and other forms as needed; see Attachment C).  

      In the context of its conventional pesticide registration activities, EPA operates a reduced risk program that offers an incentive through a shortened regulatory review schedule for proposed uses that might be beneficial to the public and the environment owing to their risk profile, compared to alternatives for pest control.  The reduced risk program is described in a policy notice known as, the Reduced-Risk Initiative (PR Notice 97-3, "Guidelines for Expedited Review of Conventional Pesticides under Reduced-Risk Initiative and for Biological Pesticides;" see Attachment D). The guidance in this notice is intended to give expedited review timeframes to new registrations of pesticide products that can be expected to accomplish one or more of the following:
      
      (1)	Reduce the risks of pesticides to human health.
      
      (2)	Reduce the risks of pesticides to nontarget organisms.
      
      (3)	Reduce the potential for contamination of groundwater, surface water, or other valued environmental resources.
      
      (4)	Broaden the adoption of integrated pest management strategies, or make such strategies more available or more effective.

      Applicants for the registration of such products provide an explanation accompanied by relevant supporting information, including associated tolerance petitions for special consideration based on these factors. (The paperwork burden for tolerance petitions is not included in the estimates for the current ICR. They are covered in a separate ICR under OMB No. 2070-0024, Tolerance Petitions for Pesticides on Food/Feed Crops and New Inert Ingredients.) Products that are successfully classified as presenting the potential to reduce risk will receive earlier registration and consequent earlier marketability.


2.	NEED FOR AND USE OF THE COLLECTION

      2(a)	Need/Authority for the Collection
      
      Authorizing legislation is contained in Section 3 of FIFRA, as amended. Governing regulations and guidelines are contained in 40 CFR parts 152, 156, 158 (Attachments E, F and G, respectively), and in PR Notice (PRN) 97-3. Label amendments, 40 CFR 156, may be required to maintain continued registration following a regulatory review (e.g., registration review). Labeling amendments pertaining to groups of products may be implemented through a PRN or Federal Register Notices (FRN).

      2(b)	Practical Utility/Users of the Data

	The information collected under this ICR is used to support registration decisions for new or amended pesticides. Once all data reviews are completed satisfactorily, the labeling is determined to be adequate, and the product is determined to meet the statutory standards of FIFRA, registration is issued to the applicant.


3.	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

      3(a)	Non-duplication

      Duplication will not occur in this program, as each applicant must submit information unique to the particular product being offered for registration. If the product is not unique, existing data may be referenced by the applicant as described in this ICR's Section 5(c) below, entitled "Small Entity Flexibility." On amended applications, the applicant is able to refer to any previously submitted information, thereby satisfying data requirements without the burden of providing duplicate information or additional data development.
      
      3(b)	Public Notice Required Prior to ICR Submission to OMB
      
      In proposing to renew this ICR, EPA is providing a 60-day public notice and comment period. The materials related to the proposed renewal of this ICR may be accessed as described in section 6(f) of this supporting statement.
      
	3(c)	Consultations

      Under 5 CFR 1320.8(d)(1), agencies are required to consult with potential ICR respondents and data users about specific aspects of ICRs before submitting an original or renewal ICR to OMB for review and approval.  In accordance with this regulation, EPA will consult with representative stakeholders during the public comment period. See Attachment H.

      3(d)	Effects of Less Frequent Collection

      Not applicable. The Section 3 information collection activity is initiated by applicants for registration. Information is submitted in conjunction with the application. There is no set means by which the EPA can reduce the frequency. If the information were not submitted, EPA would be unable to fulfill its statutory responsibilities relative to the review and registration of pesticides and protection of human health and the environment.

      3(e)	General Guidelines

      Pesticide labels:  In accordance with a determination made by the Office of Management and Budget (OMB) in 1995, the third party disclosure requirement, which involves the registrant's disclosure of product specific information to potential users and the general public through the pesticide label, is not considered a collection of information. This is because the information that must be included as the product labeling is approved and provided to the registrant by EPA as part of the original registration (5 CFR 1320.3(c)(2)). As such, this ICR does not include any third party burden or cost estimates specifically associated with the labeling activities that are a part of the original registration. Please note, however, that whenever any general labeling changes initiated by the Agency result in an estimated burden of more than 5,000 burden hours, EPA must seek OMB concurrence. In such cases, EPA must provide OMB with a brief description of the general labeling change, along with the estimated burden and costs. OMB has agreed to notify EPA of any comments or questions within 10 days of receiving the information, after which EPA may proceed with the labeling change.

      Long-term recordkeeping:  The recordkeeping activities briefly described in this ICR exceed OMB's guideline that agencies not require that records be retained for more than 3 years (5 CFR 1 320.5(d)(2)(iv)). As authorized under FIFRA section 8, EPA regulations under 40 CFR part 169.2(k) require that registrants retain records containing research data relating to registered pesticides, including all data submitted to EPA in support of a registration, for as long as the registration is valid and the producer is in business. However, the burden related to the recordkeeping requirements is covered under another ICR (see OMB Control No. 2070-0028, Recordkeeping Requirements for Producers of Pesticides under Section 8 of FIFRA).

      Electronic submissions:  OMB regulations require agencies to provide a statement indicating whether the proposed collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and an explanation of the decision (5 CFR 1320.5(a)(iii)(E)).  As will be discussed later in this section, OPP is taking the first step towards offering a fully electronic submission option through the current ICR.
       
      Ordinarily, registrants would be required to submit three paper copies of study data to EPA; however, registrants need only submit two paper copies if they submit the required study data in Adobe Acrobat Portable Document Format (PDF) on a compact disc. Extensive guidance regarding available electronic submission option is available to registrants via the OPP Internet site at http://www2.epa.gov/pesticide-registration/electronic-submissions-pesticide-applications.
      
      There are currently two methods by which companies can assemble the e-submission discs for electronic-Submission (or "e-Submissions). In both methods, the files to be submitted along with an XML data file containing information about the files and the submission itself are "zipped" into a single file and placed on a disc (CD/DVD) for submission to the EPA. The first is a newer method introducing the use of a "builder" application. The second, introduced in July 2008, requires the manual editing of the XML file. The XML method of information exchange from industry to EPA is based on a harmonized XML schema used by Canada's PMRA, which OPP has adapted. This harmonization assures industry that a documentation package submitted to one participating regulatory agency can also be submitted to the other participating agency, increasing standardization and decreasing the burden on industry. Additional information about both e-submission methods can be accessed at: http://www2.epa.gov/pesticide-registration/assembly-electronic-packages-and-discs.
      
EPA encourages electronic submissions for the following regulatory actions:
   * New pesticide active ingredients.
   * New pesticide products containing already-registered pesticide active ingredients.
   * Amendments to registered pesticide products.
   * Experimental use permits.
   * Petitions for food tolerance.
   * Distributor products.
   * Endocrine Disruptor Screening Program (EDSP) Orders.
	Overall, EPA is investigating opportunities for technological improvements which focus on information collection using fully electronic tools. The ability to electronically submit information required for registration reduces the burden of sending, receiving, and archiving paper submissions, and eliminates the need for multiple data entries across forms. One of OPP's priority areas in developing such electronic tools is related to electronic submission of data and labels. Some of the tools under this initiative are the electronic Confidential Statement of Product Specifications (CSPS) form (to be used in lieu of the Confidential Statement of Formula or CSF) the SmartLabel, and the web-based portal.  

      The development of a web-based submission portal is a critical step in the realization of EPA's long-term vision for secure data exchange between registrants and the Agency. Whereas current registration applications require an ink signature, the web-based portal will use EPA's Central Data Exchange (CDX) to allow applicants to electronically sign and securely submit the required information. The use of CDX is intended to save registrants' and the Agency's time and resources by simplifying data submissions, receipt confirmation, information access and reporting.
      
      The web-based submission portal initiative is expected to leverage existing collaboration between Canada and the US toward a harmonized single portal usable for electronic submissions to either Agency. In 2014, under the U.S. - Canada Regulatory Cooperation Council's (RCC) Crop Protection Products Initiative, EPA and Canada's Pest Management Regulatory Agency (PMRA) developed a joint product specification form (see Attachment I). The Confidential Statement of Product Specifications (CSPS) form is intended to provide an optional, fully electronic alternate to the Confidential Statement of Formula, or CSF (EPA Form 8570-4). The proposed joint form (CSPS) is a combined and harmonized version of the CSF form and Canada's Statement of Product Specification Form (SPSF). The harmonized form reflects a baseline level of information already submitted to either agency in the registration application. While there are some differences between PMRA and EPA information requirements, many CSPS data elements are overlapping. Some data elements on the form are specific to EPA or PMRA requirements, and PMRA requirements that do not overlap with EPA's will not be required for a US registration application. A guidance document as well as detailed form instructions are available to help the applicant determine which fields are required to be completed based on their product type, and the types of content for those fields. For the electronic version of the CSPS, `tool tips,' help text and validation tools will be available while using the electronic wizard module.
       
      EPA's CSF is currently submitted only on paper, and as a result, no structured data are collected. Each time any change is needed, some of the common data must be re-entered and submitted on a different form. Because the CSPS would collect structured data, submitters who opt to use the electronic version would be able to access information already stored in the data system to partially complete their submissions such that the data would not need to be reentered for every submission. As most CSF forms submitted to EPA are modifications to previously submitted versions, adoption of an electronic reporting option is anticipated to result in significant time savings for the applicant and the reviewing agency or agencies. 
      
      In addition, the electronic wizard module would perform error checks and validations, flagging issues that registrants may need to address before being permitted to advance to the next step in a given submission. One of the error checks performed in the CDX module is CBI claims. If the submitter of the CSPS checks a box to indicate a response includes CBI, the field provided for substantiation of that claim cannot be left blank. This technology is expected to provide significant improvement in data accuracy by reducing common errors such as mathematical calculations. The electronic wizard module would also greatly enhance registrants' ability to correctly designate information for pesticide product types and for food use applications (e.g., with antimicrobial and inert ingredients).

      3(f)	Confidentiality

      Although the EPA urges the submitter to minimize the amount of claimed Confidential Business Information (CBI), all data and/or information brought to the Agency in conjunction with this rule that may be claimed as trade secret, commercial, or financial information, will be protected from disclosure by EPA under FIFRA Section 10 and 40 CFR Part 2, Subpart B.

	3(g)	Sensitive Questions

      Not applicable. No information of a sensitive or private nature is requested in conjunction with this collection activity. In addition, this information collection activity complies with the provisions of the Privacy Act of 1974 and OMB circular A-108.
      
      3(h)	OMB Terms of Clearance
      
      Upon approval of the expiring ICR, OMB issued the following terms of clearance:
      
      The agency is required to display the OMB Control Number and inform respondents of its legal significance in accordance with 5 CFR 1320.5(b).
      
EPA has addressed these terms, as shown in the forms in Attachment C.
      
      
4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

      4(a)	Respondents - NAICS Codes

      The information collection under this ICR affects individuals or entities engaged in activities related to the registration of pesticide products. There are approximately 1,751 pesticide respondents holding at least one pesticide registration. The North American Industrial Classification System (NAICS) assigned to the parties responding to this information are as follows:

 Category
NAICS codes
 Examples of potentially affected
 entities
 Pesticide and other agricultural
 chemical manufacturing
32532
Individuals or entities engaged in activities related to the registration of a pesticide product.

      4(b)	Information Requested

		(i)	Data items, including recordkeeping requirements

      There are two main categories of applicants for registration: those requiring submission of a full complement of supporting data (e.g., new active ingredients); and those requiring submission of less data (e.g., amendments, for currently registered chemicals). These have been described as Types A and B, respectively. In "Type A" activities, applicants for new active ingredients will be required to submit a full complement of physical chemistry, toxicology, environmental fate, ecological effects, worker exposure, residue chemistry, environmental chemistry, and product performance, as identified in 40 CFR 158.
      
      "Type B" activities involve a registrant or applicant assembling and submitting an application for registration of a new or amended product that contains a currently registered active ingredient. Generally, "Type B" activities involve less data and complexity than "Type A" activities. "Type B" activities include a range of actions from Fee for Service to the less involved label amendments and notifications. The items that must be submitted or cited in this application include product specific data, administrative forms, product labeling, and a CSF. The product specific data specified in 40 CFR 158 must be generated by the registrant/applicant or cited from an identical or substantially similar product. There are several types of amendments, or "Type B" activities, including "me-too" products that require little or no data. Applicants for "me-too" products (i.e., pesticide products claimed to be identical or substantially similar in composition and use to a product currently registered by the EPA) may be required only to use the forms listed below to certify that the applicant intends to rely on data previously submitted to the EPA by another producer, has contacted the appropriate company (owning the data that the applicant is referencing), and offered to pay reasonable compensation for the use of the data.

      In addition to the two main categories, EPA operates a reduced risk program that offers an incentive through an expedited review timeframe for new ingredients or proposed new uses of conventional pesticides that might be beneficial to the public and the environment owing to their risk profile, compared to alternatives for pest control. These activities are described as "Type C" in this ICR. 
      
      "Type C" activities involve a registrant or applicant assembling and submitting an application for registration of a new active ingredient or a new use for a currently registered active ingredient. In addition to the registration application itself, "Type C" activities require that the registrant provide a "reduced risk" rationale document addressing risk reduction parameters described in PR Notice 97-3. The items required to be submitted in applications for "reduced risk" chemicals include generic data, product specific data, administrative forms, product labeling, and a CSF. Administrative forms usually include the application for registration, data compensation form, a data matrix, the CSF, and copies of the complete labeling. Applicants for "Type C" registrations provide an explanation accompanied by relevant supporting information, including associated tolerance petitions for special consideration based on these factors. (The paperwork burden for tolerance petitions is covered in a separate ICR under OMB No. 2070-0024.) Products that are successfully classified as presenting potentially reduced risk will receive earlier registration and consequent earlier marketability.
      
Response Type

Description/Example
Type A

New A.I.s & New Uses
Description: "Type A" activities support the registration of new active ingredients and new uses. They involve a registrant or applicant assembling and submitting an application for registration of a new active ingredient or a new use for a currently registered active ingredient. The items required to be submitted in this application include generic data, product specific data, as specified in 40 CFR 158. Administrative forms usually include the application for registration and the data compensation forms, a data matrix, the CSF, and copies of the complete labeling. EPA encourages electronic submission of these application types.

Example: An example of a "Type A" activity would be an application for registration of a new active ingredient (a.i.). Typically, for new a.i.'s, applications must be submitted for at least two new products -- the manufacturing use product (either imported or made in the U.S. that may be formulated into end-use products) and at least one end-use product (that bears directions for the intended end uses). An applicant would need to determine generic and product specific data required by 40 CFR 158 for the new a.i. (taking into account the use patterns sought), generate those data, and submit them with the application. For a new a.i., the generic data consists of certain acute, sub-chronic, and chronic toxicology; environmental fate; ecological effects (birds, fish, invertebrates); and product chemistry. The applicant would format the complete data and submit along with the other items required for an application, as described above.
Type B

New or Amended Products Using Currently
Registered
A.I.s
Description: "Type B" activities involve a registrant or applicant assembling and submitting an application for registration of a new or amended product that contains a currently registered active ingredient. Generally, "Type B" activities involve less data and complexity than "Type A" activities. "Type B" activities include both Fee for Service actions, as well as less involved label amendments and notifications. Individually, "Type B" activities often present low burden, but the number of such submissions is high, translating to a large work load for the Agency. The items that must be submitted or cited in this application include product specific data, administrative forms, product labeling, and a CSF. The product specific data specified in 40 CFR 158 must be generated by the registrant/applicant or cited from an identical or substantially similar product. If submitted, the data must be formatted properly and with the correct number of copies. Administrative forms usually include the application for registration, data compensation form, a data matrix, the CSF, and copies of the complete labeling. EPA encourages electronic submission of these application types.

Example: An applicant might seek registration of a new product containing an active ingredient that is already registered. Often, the formulation of this product is identical or substantially similar to that of a currently registered end-use product. This is called a "me-too" registration. In this case, the applicant only needs to cite data from another product (selective method) or from all products containing that a.i. (cite-all method) to support the new product. The applicant also submits the labeling and other administrative forms without submitting any data. If a product is not substantially similar to another product, the applicant must submit product specific data (acute toxicity and product chemistry) for that product. Nevertheless, this kind of application is far less complicated than a "Type A" application.
Type C

Reduced Risk A.I.s & Uses
Description: "Type C" activities support the registration of new active ingredients and new uses that may qualify as "reduced risk" and be given expedited processing. "Type C" activities involve a registrant or applicant assembling and submitting an application for registration of a new active ingredient or a new use for a currently registered active ingredient. The items required to be submitted in this application include generic data, product specific data, administrative forms, product labeling, and a CSF. The generic and product specific data specified in 40 CFR 158 must be generated by the registrants, formatted properly, and submitted with the correct number of copies. Administrative forms usually include the application for registration, data compensation form, a data matrix, the CSF, and copies of the complete labeling. In addition to the registration application itself, "Type C" activities require that the registrant provide a "reduced risk" rationale document addressing risk reduction parameters described in PR Notice 97-3. EPA encourages electronic submission of these application types.

Example: An example of a "Type C" activity would be an application for registration of a new active ingredient (a.i.) where a "reduced risk" rationale per PR Notice 97-3 is also submitted with the registration application. All of the data requirements and administrative forms described under "Type A" applications must be addressed for "Type C" applications, and in addition the "reduced risk" rationale document must be provided.  A new a.i. or new use associated with "Type C" activity is less likely to have risk concerns that would require refined risk assessment on the Agency's part, or require additional information on the registrant's part to address risk concerns. An application determined by the Agency to be "reduced risk" is provided an expedited decision time frame under PRIA. This kind of application is of equal complexity to the "Type A" activity, but more complex than "Type B."
      
      In addition to the annual reporting and record keeping burden associated with a Section 3 registration, the Agency may promulgate guidance that encourages registrants to submit amended labeling for their pesticide products. The combined burden for such labeling guidance may be considered representative of the additional labeling burden placed on registrants by the Agency, and may enable EPA to create a "generic" new labeling burden. Significant modification of an existing registration would typically require scientific data.  However, data are not typically required for revised labeling regulations or guidance. EPA posts accepted and approved labels to a web site
      
      The completion and submission of the following forms is necessary to register a pesticide product (see Attachment C):

1. EPA Form 8570-1, Application for Pesticide Registration, Amendment, Other;
2. EPA Form 8570-4, Confidential Statement of Formula (CSF)
3. EPA Form 8570-27, Formulator's Exemption Statement
4. EPA Form 8570-34, Certification With Respect to Citation of Data
5. EPA Form 8570-35, Data Matrix
6. EPA Form 8570-36, Summary of the Physical/chemical Properties
7. EPA Form 8570-37, Self-certification Statement for the Physical/Chemical Properties

      (ii) 	Respondent Activities

Respondent Paperwork Activity
Description
1. Read instructions
Read germane FIFRA legislation, 40 CFR regulations, application form instructions, the Reduced-Risk policy, applicable guidance and correspondence, and germane labeling PR and FR notices;
 
2. Plan activities
Decide whether pesticide seeking registration is a "me-too" pesticide, as this will determine succeeding activities;

3. Create information
Arrange for testing of any physical chemistry, toxicological, environmental fate, ecological effects, worker exposure, residue chemistry, environmental chemistry, product performance, and efficacy data that appear to be required by germane regulations to support registration.

4. Gather information
Canvass/contact other chemical firms holding EPA registrations, if any, to determine whether it would be appropriate to share or rely on testing data already submitted by another company;

5. Compile and review
Assemble data, evaluate for accuracy, appropriateness, and completeness;

6. Complete paperwork
Complete all appropriate application documents;

7. Store/maintain data
File and maintain copies of all registration data submitted to the Agency.


5.	THE INFORMATION COLLECTED  -  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT.

      5(a)	Agency Activities
      
      In general, the degree and level of Agency activities in the review of data submissions will depend on the complexity of the product being registered, and whether it is identical or substantially similar to other products already registered. Products containing active ingredients present in currently registered products and proposed for uses currently registered ("me-too" registrations) may require only a minimal review for completeness of the application, the adequacy of the labeling, and the satisfaction of data compensation requirements. 
      
      A product containing a new active ingredient will require multiple data reviews related to physical chemistry, toxicology, environmental fate, ecological effects, worker exposure, residue chemistry, environmental chemistry, and product performance prior to approval. Therefore many divisions may be actively involved in the data analysis and agency determination of OPP registration actions. For conventional pesticides, the application is reviewed by ITRMD, the Registration Division (RD), the Health Effects Division (HED), and the Environmental Fate and Effects Division (EFED), and Biological and Economic Analysis Division (BEAD).  For biological/biopesticide pesticides, the application is reviewed by ITRMD, and the Biopesticides and Pollution Prevention Division (BPPD). Applications for antimicrobial pesticide products are reviewed by ITRMD and the Antimicrobials Division (AD). The Agency notifies an applicant when an application is incomplete or is found to be deficient. The applicant is permitted to correct the deficiencies and submit the corrections.
      
      Registrants submitting registration applications for new pesticide products that may fall within the scope of the Reduced-Risk Initiative may provide a written rationale with any supporting information on why their pesticide may qualify for special consideration. This rationale with supporting information will be reviewed and evaluated and, if the pesticide demonstrates the opportunity for risk reduction, the EPA uses this finding as a factor in determining a shorter review time. This policy specifies the standard format for registrants to use when providing justification for a reduced-risk pesticide to facilitate efficient processing within OPP.
      
      Once issued, a registration also may be amended in various ways, such as adding or deleting uses, modifying the labeling, or altering the product composition in minor ways. To request these changes, the registrant is required to submit an application for amended registration on EPA Form 8570-1, along with all appropriate additional forms, labeling and supporting data.  
      
      Notifications are registration modifications, without need of data review, that require the shortest review and approval or denial time.  Unlike a new active ingredient or a new use, Notifications are reviewed only by the division responsible for registering the product.
      
      Label reviews are most often accomplished by a Product Manager, or Team Leader, in one of the three regulatory divisions within EPA's Office of Pesticide Programs (OPP) responsible for pesticide registration: the Registration Division, the Antimicrobials Division, and the Biopesticides and Pollution Prevention Division.  These divisions ensure that revisions comply with the applicable labeling requirement or guidance.
      
      A general category of OPP's activities related to the information collection described in this ICR is summarized below:

   1. Receive Application
   
      The pesticide registration application package, complete with the required forms, necessary data, and proposed labels, is received by the Front-End Processing Unit in the Information Technology and Resources Management Division (ITRMD).  After screening the application for administrative completeness, ITRMD refers the complete application and any accompanying data to the appropriate regulatory division. ITRMD is responsible for entering the registration action into OPP's central tracking database system, called OPPIN. If the application form is accompanied by data to support the registration application (e.g., new active ingredients and new uses), ITRMD will forward the registration data package to a contractor for inputting into the tracking database. After this is completed, the data package is routed to the appropriate regulatory division for processing.

   2. Review Application
      
      The regulatory divisions, based on the registration action, assign the packages for appropriate evaluation. Each scientific discipline reviews the data and may develop a Data Evaluation Report (DER) and appropriate risk assessments that summarize the data review. 
      
      If the registration application is clearly for a "me-too" pesticide product or use, then the product may be registered on an expedited basis by the reviewer. If its similarity to a pesticide currently registered by the EPA is questionable, it may be sent for a short interdisciplinary review. The Program Manager or Team Leader ensures that the database is updated by identifying where it is sent for review. If the registration action is clearly not for a "me-too" pesticide product or use, then action is taken to correct the assignment of the registration action and to route the data to the appropriate scientific evaluation group for full data reviews. 

   3. Make Registration Decision
            
      The Program Manager or Team Leader examines all of the scientific reviews and proposed labeling and determines whether the product may be registered. If the product contains an active ingredient not currently registered by EPA, the review summary is included as part of a decision package and referred to the Director of OPP for a final decision on whether or not to register a pesticide.  When a new food use is sought, a tolerance or exemption is established for an already registered active ingredient (e.g., new use), the final decision is made by the Division Director of the registering division.
         
      If the registration action is for revised labeling in response to a Pesticide Registration Notice, the revised labeling submitted along with appropriate EPA forms will be reviewed by a Program Manager or Team Leader for compliance with the applicable Pesticide Registration Notice and, following the registration decision, entered into the tracking database.

   4. Notify Applicant
      
      OPP sends a Notice of Registration to the applicant informing the applicant that the product has been registered and specifying any conditions of registration. For labeling amendments, a letter is sent to the applicant stating approval/disapproval. If the label amendment is approved, a stamped master label is sent to the registrant. 
            
   5. Store and Maintain Data
      
      OPP stores, files, and maintains copies of any registration notices and labeling information.

      5(b)	Collection Methodology and Management

      All registration actions are entered into OPP's central database system, called OPPIN, to track progress toward registration. Registration actions accompanied by data (e.g., products containing new active ingredients or new uses) are also entered into the database to track progress toward registration. Once a product has been registered, pertinent status information regarding the product is revised in the tracking database. 
      
      The system contains the following types of information: new or amended product registrations, suspensions, cancellations, product active ingredients, product uses, and use deletions. ITRMD maintains official registration file jackets, in which copies of the application, EPA's reviews, registration approvals, correspondence, label, the CSF and other related information are all retained.

      5(c)	Small Entity Flexibility

      EPA Form 8570-27 ("Formulator's Exemption Statement") reduces the data submission burden on an applicant for registration of a product that uses an EPA-registered pesticide product as the source of its active ingredient. This form exempts the applicant from furnishing the generic data that already were submitted by the company registering the source product.

      The Agency also has cataloged and computerized its pesticide data base so that one can easily determine whether a particular study has been submitted, and by whom it was submitted. This identifies, by chemical and site(s), each item of data in the EPA files. As a result, applicants encounter little difficulty in identifying available data needed to support an application for registration.

      5(d)	Collection Schedule

      Not applicable. The activity is conducted only as a registration application is received for consideration. There is no set schedule for the submission of this information to EPA.


6.	ESTIMATING BURDEN AND COST OF THE COLLECTION

      Paperwork burden from pesticide registration comes from two sources: burden from preparing and filing the registration application and burden associated with data generation.  Previous versions of this ICR did not contain estimates of burden associated with data generation.  Estimates of paperwork burden hours and costs from both sources are provided in this section.  
      
      Paperwork burden from the application process and from data generation varies by the type of application.  For paperwork burden from the application process, applications are grouped into three types -- Type A, Type B, and Type C -- as previously described.  Estimates of burden and cost from the application process is described for each of these three categories in Section 6(a).  
      
      Paperwork burden from data generation does not occur with all types of registrations, only those that require submission of data.  Only new active ingredients (AI), new uses, new products, and some label amendments require data.  Data required for registration of new uses is limited to residue data necessary to establish a new tolerance.  Therefore, paperwork burden from data generation for new uses would be covered by the Tolerance ICR (OMB Control No. 2070-0024 and is not discussed in this ICR.  Estimates of paperwork burden and the costs of data generation associated with new AIs and new products is discussed in Section 6(b).  
      
      Tables 1-A and 1-B show the total annual paperwork burden estimates (hours) for this information collection.  Annual aggregate paperwork burden for all respondent Section 3 activities is estimated to be 1.61 million hours: 145,213 hours for application activities and 1.38 million hours from data generation.  There are currently an estimated 1,751 pesticide registrants holding at least one pesticide registration.  The number of pesticide registrants has increased since the last ICR renewal from 1,683 to 1,751, an increase of 68 registrants.  

      The total annual costs associated with paperwork burden from the application process are estimated to be approximately $12.47 million per year.
      
         *          "Type A" activities are estimated to cost approximately $2.76 million per year.
         *          "Type B" activities are estimated to cost approximately $9.32 million per year.
         *          "Type C" activities are estimated to cost approximately $389 thousand per year.


Table 1-A: Annual Information Collection Paperwork Burden Estimates for Application Process
                             Application Category
                      Number of registrants (respondents)
                           Average annual responses
                    Average annual responses per respondent
                          Burden per response (hours)
                     Average annual burden per respondent
                         Average annual burden (hours)
                                    Type A
                                     1,751
                                      197
                                     0.113
                                      194
                                      22
                                    38,218
                                    Type B
                                     1,751
                                     7,273
                                     4.154
                                      14
                                      58
                                    101,827
                                    Type C
                                     1,751
                                       8
                                     0.005
                                      646
                                       3
                                     5,168
                                   All Types
                                     1,751
                                     7,478
                                     4.271
                                       
                                      83
                                    145,213


      The total annual costs associated with paperwork burden from data generation are estimated to be approximately $96.25 million per year.
      
         *          Paperwork burden of data generation for new active ingredients (AI) is estimated to cost approximately $62.59 million per year.
         *          Paperwork burden of data generation for new products is estimated to cost approximately $33.66 million per year. 


Table 1-B: Annual Information Collection Paperwork Burden Estimates for Data Generation
                               Registration Type
                      Number of registrants (respondents)
                           Average annual responses
                    Average annual responses per respondent
                     Average Burden per response (hours) 1
                 Average annual burden per respondent (hours)
                        Average annual burden (hours) 2
                                    New AI
                                     1,751
                                      30
                                     0.017
                                    37,078
                                      628
                                    897,149
                                  New Product
                                     1,751
                                      695
                                     0.397
                                      625
                                      248
                                    482,531
                                   All Types
                                     1,751
                                      725
                                     0.414
                                       
                                      876
                                   1,379,680

1 Average burden hours per response across the three registering divisions. See Tables 6-A and 6-B for details.
2 Average annual burden hours are calculated as the sum of average annual burden hours for each registration type and cannot be computed from the values in this table. See Tables 6-B and 7-B for details.

      To calculate the costs of paperwork burden from the application process and from data generation, the burden hours were multiplied by current wages.  Agency economists revised the estimated wages, benefits and overhead for all labor categories for the affected industry 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 fully loaded wage rates and overhead costs for this ICR renewal are presented in Attachment J.  Cost estimates are provided in the following sections.

      6(a)	Respondent Paperwork Burden Hours and Cost from Application Process

	This section describes the methodologies and provides estimates of respondent paperwork burden hours and costs from the application process.  The reporting and recordkeeping burden associated with the Section 3 application process for registering of pesticides may be thought of in terms of three general categories of burden (including most registration actions except those pertaining to setting tolerances and inert ingredients).  
      
      To determine the appropriate number of applications (responses) for each category, EPA averaged data on pesticide registration activities from 2012-2014.  When the Agency receives applications for registrations and amendments to registrations, these actions are tracked in the Office of Pesticide Programs central database system, called OPPIN.  From this system, the Agency can provide reporting on actual numbers of applications, broken down by several major types.  Each registering division further tracks applications in greater detail.  Information from the central database and supplemental divisional tracking is used as the basis of the burden estimates.
      
      The average number of responses annually has changed from the last ICR renewal from 8,136 to 7,478, a decrease of about eight percent.  Table 2 shows the average number of applications per year by type and division.  Across all registering divisions, there were 7,478 Section 3 registration actions annually, on average, during the years 2012-2014.  These included an average of 197 "Type A" activities, 7,273 "Type B" activities, and 8 "Type C" activities.  


Table 2: Average Annual Number of Actions by Type and Division, 2012-2014 average
                                       
                                      AD
                                     BPPD
                                      RD
                                 All Divisions
                                    Type A
                                      16
                                      22
                                      159
                                      197
                                    Type B
                                     2,254
                                      575
                                     4,444
                                     7,273
                                    Type C
                                       0
                                       0
                                       8
                                       8
                               All Action Types
                                     2,270
                                      597
                                     4,612
                                     7,478

      Table 3-A presents estimates for burden hours and costs per "Type A" registration application.  Each "Type A" application is estimated to require 26 management hours, 128 technical hours, and 40 clerical hours for a total of 194 hours per application at a cost of 14,019.

Table 3-A: Estimated Burden/Cost per "Type A" Registration Application
                         Collection Activities,
Type A
                                 Burden Hours
                                     Total

                                     Mgmt
                                   Technical
                                   Clerical
                                     Hours
                                     Costs

                                    $121.72
                                    $72.01
                                    $40.93

                                       

                                   per hour
                                   per hour
                                   per hour

                                       
Read Instructions
                                      18
                                       0
                                       0
                                      18
                                    $2,191
Plan activities
                                       4
                                       0
                                       0
                                       4
                                     $487
Gather/create information
                                       0
                                      120
                                       0
                                      120
                                    $8,641
Compile and review
                                       4
                                       8
                                       0
                                      12
                                    $1,063
Complete paperwork
                                       0
                                       0
                                      30
                                      30
                                    $1,228
Store/maintain data
                                       0
                                       0
                                      10
                                      10
                                     $409
                                     TOTAL
                                      26
                                      128
                                      40
                                      194
                                    $14,019


	Table 3-B presents the total annual burden hours and costs by division for "Type A" registration applications.  Registrants spend a total of 3,104 burden hours at a cost of $224 thousand to prepare and submit "Type A" applications to the Antimicrobial Division, 4,203 burden hours at a cost of $304 thousand to prepare and submit "Type A" applications to the Biopesticides and Pollution Prevention Division, and 30,911 hours at a cost of $2.234 million to prepare and submit "Type A" applications to the Registration Division.  The total paperwork burden and cost associated with preparing and submitting "Type A" registration applications to EPA is estimated at $2.762 million per year.


Table 3-B: Total Annual Burden and Cost by Division for "Type A" Applications 1
Labor Category 2
                                      AD
                                     BPPD
                                      RD
                                     Total

                                     Hrs.
                                     Cost
                                     Hrs.
                                     Cost
                                     Hours
                                     Cost
                                     Hours
                                     Cost
Management
                                      416
                                    $50,636
                                      563
                                    $68,569
                                     4,143
                                   $504,245
                                     5,122
                                   $623,450
Technical
                                     2,048
                                   $147,476
                                     2,773
                                   $199,708
                                    20,395
                                  $1,468,620
                                    25,216
                                  $1,815,804
Clerical
                                      640
                                    $26,195
                                      867
                                    $35,473
                                     6,373
                                   $260,861
                                     7,880
                                   $322,528
                                     TOTAL
                                     3,104
                                   $224,307
                                     4,203
                                   $303,749
                                    30,911
                                  $2,233,726
                                    38,218
                                  $2,761,782

1 Hours are calculated by multiplying hours per labor category from Table 3-A by the average number of applications for that division from Table 2.  For example, 416 management hours for AD is calculated as 26 management hours per "Type A" application multiplied by 16 "Type A" applications in AD per year. 
2 Hours and wages used to calculate the totals for each labor category are from Table 3-A.


      Table 4-A presents estimates for burden hours and costs per "Type B" applications/notifications.  Each "Type B" application is estimated to require 8 management hours, 2 technical hours, and 4 clerical hours for a total of 14 hours per application at a cost of 1,282.  


Table 4-A: Estimated Burden/Cost per "Type B" Application/Notification
                         Collection Activities,
Type B
                                 Burden Hours
                                     Total

                                     Mgmt
                                   Technical
                                   Clerical
                                     Hours
                                     Costs

                                    $121.72
                                    $72.01
                                    $40.93



                                   per hour
                                   per hour
                                   per hour


Read Instructions
                                       7
                                       0
                                       0
                                       7
                                     $852
Plan activities
                                      0.5
                                       0
                                       0
                                      0.5
                                      $61
Gather/create information
                                       0
                                      1.5
                                       0
                                      1.5
                                     $108
Compile and review
                                      0.5
                                      0.5
                                       0
                                       1
                                      $97
Complete paperwork
                                       0
                                       0
                                       3
                                       3
                                     $123
Store/maintain data
                                       0
                                       0
                                       1
                                       1
                                      $41
                                     TOTAL
                                       8
                                       2
                                       4
                                      14
                                    $1,282
   
   
	Table 4-B presents the total annual burden hours and costs by division for "Type B" applications/notifications.  Registrants spend a total of 31,551 burden hours at a cost of $2.888 million to prepare and submit "Type B" applications to the Antimicrobial Division, 8,055 burden hours at a cost of $737 thousand to prepare and submit "Type B" applications to the Biopesticides and Pollution Prevention Division, and 62,221 hours at a cost of $5.695 million to prepare and submit "Type B" applications to the Registration Division.  The total paperwork burden and cost associated with preparing and submitting "Type B" applications to EPA is estimated at $9.321 million per year.
   
   
Table 4-B: Total Annual Burden and Cost by Division for "Type A" Applications 1
Labor Category 2
                                      AD
                                     BPPD
                                      RD
                                     Total

                                     Hrs.
                                     Cost
                                     Hrs.
                                     Cost
                                     Hrs.
                                     Cost
                                     Hours
                                     Cost
Management
                                    18,029
                                  $2,194,530
                                     4,603
                                   $560,237
                                    35,555
                                  $4,327,714
                                    58,187
                                  $7,082,481
Technical
                                     4,507
                                   $324,573
                                     1,151
                                    $82,860
                                     8,889
                                   $640,073
                                    14,547
                                  $1,047,505
Clerical
                                     9,015
                                   $368,970
                                     2,301
                                    $94,194
                                    17,777
                                   $727,626
                                    29,093
                                  $1,190,790
Total
                                    31,551
                                  $2,888,074
                                     8,055
                                   $737,290
                                    62,221
                                  $5,695,413
                                    101,827
                                  $9,320,777

1 Hours are calculated by multiplying hours per labor category from Table 4-A by the average number of applications for that division from Table 2.  For example, 18,029 management hours for AD is calculated as 8 management hours per "Type B" application multiplied by 2,254 "Type B" applications in AD per year. 
2 Hours and wages used to calculate the totals for each labor category are from Table 4-A.


      Table 5-A presents estimates for burden hours and costs per "Type C" reduced risk application.  Each "Type C" application is estimated to require 102 management hours, 448 technical hours, and 96 clerical hours for a total of 646 hours per application at a cost of $49 thousand.


Table 5-A: Estimated Burden/Cost per "Type C" Reduced Risk Application 
                         Collection Activities,
Type C
                                 Burden Hours
                                     Total

                                     Mgmt
                                   Technical
                                   Clerical
                                     Hours
                                     Costs

                                    $121.72
                                    $72.01
                                    $40.93



                                   per hour
                                   per hour
                                   per hour


Read Instructions
                                      22
                                       0
                                       0
                                      22
                                    $2,678
Gather Information
                                       0
                                      368
                                       0
                                      368
                                    $26,500
Process, Compile, and Review Info
                                      80
                                      80
                                       0
                                      160
                                    $15,498
Record and Report Info
                                       0
                                       0
                                      72
                                      72
                                    $2,947
Store, File, and Maintain Info
                                       0
                                       0
                                      24
                                      24
                                     $982
                                     TOTAL
                                      102
                                      448
                                      96
                                      646
                                    $48,605


      Table 5-B presents the total annual burden hours and costs for "Type C" reduced risk applications.  Registrants spend a total of 5,168 burden hours at a cost of $389 thousand to prepare and submit "Type C" applications to the Registration Division.  The Antimicrobial Division and the Biopesticides and Pollution Prevention Division do not receive "Type C" applications.


Table 5-B: Total Annual Burden and Cost for "Type C" Reduced Risk Applications 1
Labor Category 2
                                      RD

                                     Hours
                                     Cost
Management
                                      816
                                    $99,324
Technical
                                     3,584
                                   $258,084
Clerical
                                      768
                                    $31,434
Total
                                     5,168
                                   $388,842

1 Hours and costs are calculated using the same method as Tables 3-B and 4-B.
2 Hours and wages used to calculate the totals for each labor category are from Table 5-A.


      6(b)	Respondent Paperwork Burden Hours and Cost from Data Generation

      To calculate the burden and costs associated with the paperwork activities involved in data generation, the Agency starts with the cost of the test, typically the market price for the test as identified by laboratories that offer testing services.  The Agency maintains an archive of the basic FIFRA study cost estimates that were developed through surveys of independent testing laboratories, Agency economic analyses, and registrant comments during ICR renewal periods. To the greatest extent possible, EPA uses multiple sources to provide test cost estimates, which are updated as needed.
      
      EPA uses 35% of the estimated total test cost to calculate the total potential cost for the paperwork activities related to data generation.  The 35% of test cost is disaggregated by labor category, and then burden hours are extrapolated by using the loaded labor rates.  To disaggregate by labor category, the Agency considered the estimated distribution of paperwork activity across the labor categories represented and the existing methodology assumption that paperwork activities for data generation mostly involve the technical staff to perform the tests, with fewer activities related to management and clerical staff.

      Figure 1 illustrates the method for calculating the paperwork burden of data generation.  

              Calculate 35% of the Total Cost of Data Generation
Divide 35% of the Total Cost into Labor Categories:
20% for Managerial 
65% for Technical
15% for Clerical
Divide cost for each category by Fully Loaded Labor Wage Rate for that Labor Category
                        Burden Hours by Labor Category
              Calculate 35% of the Total Cost of Data Generation
Divide 35% of the Total Cost into Labor Categories:
20% for Managerial 
65% for Technical
15% for Clerical
Divide cost for each category by Fully Loaded Labor Wage Rate for that Labor Category
                        Burden Hours by Labor Category
Figure 1: Method for Calculating Paperwork Burden from Test Costs
  
  
  Similar to the data call-in or DCI ICR (OMB Control No. 2070-0174), this approach assumes and incorporates the following core considerations:
  
  (1) Registrants generate all of the data as specified in the CFR without any changes, and none of the data is waived.
      
  (2) All data generation is performed by an independent laboratory.
      
  (3)	Paperwork burden is disaggregated by labor category as follows:
  
   a. Managerial (20%)
   b. Technical (65%)
   c. Clerical (15%)
   
  (4)	Labor rates are fully loaded, meaning that they include the estimated costs of wages, overhead, and benefits paid to an employee. See Attachment J. 

	Using this methodology, Tables 6-A and 6-B below estimate the paperwork burden associated with registering a new AI and a new product for each of the three registering divisions: the Antimicrobial Division (AD), the Biopesticides and Pollution Prevention Division (BPPD), and the Registration Division (RD).  The costs of registering a new AI vary depending on use parameters, e.g., food or non-food use, indoor or outdoor use pattern.  The data costs used to calculate paperwork burden are an average of total costs across different types of uses that might be registered in that division.  

      Table 6-A shows that the average cost of data for registering a new AI ranges from an average of $4.65 million for a new biopesticide to an average of $8.97 million for a new conventional chemical.  The paperwork burden, 35% of the cost of data generation, ranges from $1.63 million to $3.14 million or between 23 thousand and 45 thousand hours of burden.  


Table 6-A: Estimates of Paperwork Burden Hours from Data Generation for New AIs
Division
                               Data Cost ($000s)
                                Paperwork Cost 
                                    ($000s)
                                  Managerial
                                   Technical
                                   Clerical
                                     Total
                                       


                                     Hours
                                     FTEs
                                     Hours
                                     FTEs
                                     Hours
                                     FTEs
                                     Hours
                                     FTEs
AD
                                    $8,550
                                    $2,993
                                     4,918
                                      2.4
                                    27,016
                                     13.0
                                    10,969
                                      5.3
                                    42,903
                                     20.6
BPPD
                                    $4,645
                                    $1,626
                                     2,672
                                      1.3
                                    14,677
                                      7.1
                                     5,959
                                      2.9
                                    23,308
                                     11.2
RD
                                    $8,973
                                    $3,141
                                     5,161
                                      2.5
                                    28,352
                                     13.6
                                    11,511
                                      5.5
                                    45,024
                                     21.6



      Table 6-B shows the calculation of average annual burden hours and costs from paperwork from data generation for new AIs.  The burden per registration is taken from Table 6-A.  Average annual burden hours is calculated from the average annual responses and burden per registration.  Average annual costs is calculated from the average annual responses and average paperwork cost from Table 6-A.


Table 6-B: Estimates of Annual Paperwork Burden Hours and Cost from Data Generation for New AIs

                          Burden per Registration [1]
                           Average Annual Responses
                          Average Annual Burden Hours
                            Average Annual Cost [2]
Antimicrobial
                                    42,903
                                       2
                                    85,806
                                  $5,986,000
Biochemical
                                    23,308
                                      20
                                    466,156
                                  $32,520,000
Conventional
                                    45,024
                                       8
                                    345,187
                                  $24,081,000
TOTAL
                                       
                                      30
                                    897,149
                                  $62,587,000

1  Burden per registration for New AIs from Table 1-B is the average of these values.
2 Numbers do not compute due to rounding.


      Table 7-A shows that the cost of data for registering a new product ranges from $115 thousand to $155 thousand.  The paperwork burden, 35% of the cost of data generation, ranges from $36 thousand to $54 thousand or between 520 and 777 hours of burden.  


Table 7-A: Estimates of Paperwork Burden Hours from Data Generation for New Products
Division
                                 Data Cost[1]
                               Paperwork Cost[1]
                                  Managerial
                                   Technical
                                   Clerical
                                     Total
                                       


                                     Hours
                                     FTEs
                                     Hours
                                     FTEs
                                     Hours
                                     FTEs
                                     Hours
                                     FTEs
AD
                                   $103,800
                                    $36,300
                                      60
                                     0.03
                                      328
                                     0.16
                                      133
                                     0.06
                                      520
                                     0.25
BPPD
                                   $115,400
                                    $40,400
                                      66
                                     0.03
                                      365
                                     0.18
                                      148
                                     0.07
                                      579
                                     0.28
RD
                                   $155,000
                                    $54,200
                                      89
                                     0.04
                                      489
                                     0.24
                                      199
                                     0.10
                                      777
                                     0.37

--------------------------------------------------------------------------------
1 Rounded to nearest hundred.


      Table 7-B shows the calculation of average annual burden hours and costs from paperwork from data generation for new AIs.  The burden per registration is taken from Table 7-A.  Average annual burden hours is calculated from the average annual responses and burden per registration.  Average annual costs is calculated from the average annual responses and average paperwork cost from Table 7-A.


Table 7-B: Estimates of Annual Paperwork Burden Hours and Cost from Data Generation for New Products

                          Burden per Registration [1]
                           Average Annual Responses
                          Average Annual Burden Hours
                             Average Annual Cost 2
Antimicrobial
                                      520
                                      172
                                    89,325
                                  $6,231,500
Biochemical
                                      579
                                      68
                                    39,187
                                  $2,733,733
Conventional
                                      777
                                      456
                                    354,019
                                  $24,697,133
TOTAL
                                       
                                      695
                                    482,531
                                  $33,662,367

1  Burden per registration for New Products from Table 1-B is the average of these values.
2 Numbers do not compute due to rounding.


      The costs used to estimate paperwork burden of data generation in this analysis are conservative because they assume that all new active ingredients generate and submit all data required in 40 CFR Part 158 when, in practice, some of the data requirements may be waived based on specific use patterns or label restrictions.  Data waivers would make the average cost of data generation (and the resulting paperwork burden) lower for both new active ingredients and new products.  Also, all new products in this analysis are assumed to require toxicology data and product chemistry data to register.  In cases where products are substantially similar to other products, they can cite other data rather than generating data.  Again, this approach returns conservative estimates of paperwork burden for data generation.


      6(c)	Estimating Agency Burden and Cost

      The Agency is using FIFRA Section 3 registration activity data from the Time and Attendance Information System (TAIS), which archives the Agency's Full Time Equivalents (FTEs) for most OPP program activities.  The projected burden figures use 2012-2014 data, which includes burden hours from internal OPP Divisions that provide significant support and analysis for the FIFRA Section 3 ICR registration program including the Registration Division (RD), the Biopesticides and Pollution Prevention Division (BPPD), the Antimicrobial Division (AD), the Health and Effects Division (HED), the Biological and Economic Analysis Division (BEAD), and the Environmental Fate and Effects Division (EFED).  Thus, six OPP Divisions work together to complete the activities related to OPP registration actions.  The Agency believes using this data source reflects the changes to the internal operations for implementing and administering the FIFRA Section 3 registration activities.  The major impetus for internal program realignment was to implement the requirements of the Food Quality Protection Act of 1996 and the Pesticide Registration Improvement Act of 2003 (PRIA) as reauthorized.

      Using this source of data, the estimated number of Agency FTEs dedicated to Section 3 registration and registration support activities is approximately 26 managerial FTEs, 171 technical FTEs, and 7 clerical FTEs as shown in Table 8 below.  The aggregated Agency estimated FTE dedicated to Section 3 activities is 205 and the burden hours are 426,400.  

      To determine Agency costs, the Agency used the Bureau of Labor Statistics estimates of 2014 labor rates for the North American Industry Classification System (NAICS) code for the Federal Executive Branch (NAICS 999100).  The managerial labor rate is based on the Standard Occupational Code (SOC) for management occupations; the technical labor rate is based on the SOC for life, physical and social science occupations; and the clerical labor rate is based on the SOC for office and administrative support occupations.  The fully loaded hourly mean wage rate estimate is $121.79 for managerial occupations, $80.02 for technical occupations, and $45.56 for clerical occupations. (See Attachment J for wage calculations.)

      To calculate the Agency's estimated annual cost of Section 3 activities, the number of FTE's allocated to registration activities (Table 8) is multiplied by these fully loaded labor rates and by 2,080 hours per FTE, which is estimated to be about $6.70 million for management; $28.44 million for technical; and $703 thousand for clerical.  The total estimated Agency cost is $35.84 million.


Table 8: Distribution of Agency FTEs Supporting FIFRA Section 3 Registration Activities 1
                                       
                                     BEAD
                                      RD
                                     EFED
                                      HED
                                      AD
                                     BPPD
                                  Total FTEs
                                  Hourly wage
                             Total Annual Cost[2]
                                  Managerial
                                      2.9
                                      7.4
                                      2.4
                                      7.1
                                      3.2
                                      3.4
                                     26.4
                                   $121.79 
                                  $6,698,844
                                   Technical
                                     16.5
                                     54.6
                                     14.7
                                     38.1
                                     22.7
                                     24.2
                                     170.9
                                    $80.02 
                                  $28,441,551
                                   Clerical
                                      0.7
                                      2.0
                                      0.7
                                      1.5
                                      1.1
                                      1.4
                                      7.4
                                    $45.56 
                                   $703,397
                                     Total
                                     20.2
                                     64.1
                                     17.8
                                     46.7
                                     26.9
                                     29.0
                                     204.7
                                       
                                  $35,843,792

1 Numbers in the table may not add due to rounding.
2 Total annual cost is calculated using the number of hours per FTE multiplied by the number of FTEs and the hourly wage.  For example, total annual cost of managerial FTES is calculated as 2,080 hours/FTE x 26.4 FTEs x $121.79. 


	6(d)	Bottom Line Burden Hours and Cost

      Table 9 presents the estimates for total annual hours and cost, for both respondents and the agency, associated with Section 3 activities.  The total respondent burden is 1.52 million hours annually at a cost of $108.72 million.  The majority of this paperwork burden, 1.38 million hours, is associated with data generation.


Table 9: Estimated Annual Total Hours and Cost

                                 ANNUAL TOTAL

                                   Responses
                                     Hours
                                     Costs
TOTAL RESPONDENT BURDEN
                                     8,203
                                   1,524,893
                                 $108,720,767
  Application Process
                                     7,478
                                    145,213
                                  12,471,401
   Annual "Type A" Responses
                                      197
                                    38,218
                                  $2,761,782 
   Annual "Type B" Responses
                                     7,273
                                    101,827
                                  $9,320,777 
   Annual "Type C" Responses
                                       8
                                     5,168
                                   $388,842 
  Data Generation
                                      725
                                   1,379,680
                                  96,249,367
   New AIs
                                      30
                                    897,149
                                  $62,587,000
   New Products
                                      695
                                    482,531
                                  $33,662,367
TOTAL AGENCY BURDEN
                                       
                                    425,873
                                 $35,843,792 


      The annual respondent paperwork burden for the application process has decreased by about 23,000 hours due to fewer applications in each category.  There were 52 fewer "Type A" responses, 599 fewer "Type B" responses, and 7 fewer "Type C" responses annually on average in the years 2012-2014 than there were in the years 2008-2010.  Agency burden also reflects the lower number of responses in this renewal cycle; agency hours decreased from 478,400 (230 FTEs) to 425,873 (205 FTEs).
      
      The increase in total respondent burden is not a change in paperwork burden per se but rather a change in what is included in this ICR. Paperwork burden from data generation was not previously included in these burden estimates.  EPA included estimates of that burden in this renewal; the estimates follow the methodology used to estimates the paperwork burden of data call-ins or DCIs (OMB Control No. 2070-0174).  

      6(f)	Burden Statement 

      Overall, there is a difference of 1,356,689 hours in the total estimated respondent burden compared with that identified in the current ICR approved by OMB.  This change reflects EPA's updating of the methodology used to estimate the paperwork burden, and including a previously unaccounted for burden for study data generation.  However, there is a decrease of approximately 23,000 hours in the total estimated respondent burden for the registration application process compared with that identified in the ICR currently approved by OMB. This decrease reflects EPA's receipt of fewer number of applications. This change is an adjustment.

      The annual average reporting and recordkeeping burdens for a registration application are estimated to range from 14 hours to 646 hours, depending upon the type of activity.  Estimates for the respondent's application burden for collection of information average 194 hours per application for "Type A" activities (which include new active ingredients and new uses) and 14 hours per application for "Type B" activities (which include amendments and notifications).  The burden estimate for "Type C" reduced risk applications, which are handled only by RD, is an average of 646 hours per response.  
      
      The annual average reporting and recordkeeping burdens for data generation associated with registration of new active ingredients and new products are estimated to range from 520 hours to 45,000 hours, depending on the type of activity and division.  For new active ingredients, estimates for the respondent's paperwork burden for data generation average 45,024 hours for a new conventional, 42,903 for a new antimicrobial, and 23,308 for a new biopesticide.  For new products, estimates for the respondent's paperwork burden for data generation average 777 hours for a new conventional product, 520 hours for a new antimicrobial, and 579 hours for a new biopesticide. 
       
      The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPP-2015-0332, which is available for online viewing at www.regulations.gov or in person viewing at the EPA Docket Center Public Reading Room, EPA West Building, Room 3334, 1301 Constitution Avenue, NW, Washington, DC 20004.  The EPA/DC is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding federal holidays.  The docket telephone number is (202) 566-1744.  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-2015-0332 and OMB Control No. 2070-0060, to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460., and (2) OMB by 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.

      
                       ATTACHMENTS TO THE SUPPORTING STATEMENT
      
      Attachments to the supporting statement are available in the public docket established for this Information Collection Request (ICR) under the docket identification number EPA-HQ-OPP-2015-0332. These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in the sections below.  

Attachment A:
7 U.S.C. 136a  -  Section 3 of FIFRA. Also available at US Code website
Attachment B:
7 U.S.C. 136w-8  -  Section 33 of FIFRA. Pesticide registration service fees. Also available online at US Code website.
Attachment C:
Forms for Pesticide Registration.  http://www.epa.gov/opprd001/forms/
      C  -  1.      EPA Form 8570-1 - Application for Pesticide, Registration, Amendment, Other
      C  -  2.      EPA Form No. 8570-4 - Confidential Statement of Formula
      C  -  3.      EPA Form No. 8570-27 - Formulator's Exemption Statement
      C  -  4.      EPA Form No. 8570-34 - Certification with Respect to Citation of Data Form
      C  -  5.      EPA Form No. 8570-35 - Data Matrix Form
      C  -  6.      EPA Form No. 8570-36 - Summary of the Physical/Chemical Properties Form
      C  -  7.      EPA Form No. 8570-37 - Self-Certification Statement for the Physical/Chemical Properties
Attachment D:
Pesticide Registration (PR) Notice 97-3  -  Guidelines for Expedited Review of Conventional Pesticides under the Reduced-Risk Initiative and for Biological Pesticides. Also available at online at http://www.epa.gov/PR_Notices/pr97-3.html
Attachment E:
40 CFR 152  -  Pesticide Registration and Classification Procedures. Also available online at the National Archives and Records Administration's Electronic CFR Website
Attachment F:
40 CFR 156  -  Labeling Requirements for Pesticides and Devices. Also available at: Electronic CFR Website.
Attachment G: 
40 CFR 158  -  Data Requirements For Registration. Also available online at the Electronic CFR Website.
Attachment H:
Consultation:  List of Standard Questions & Responses (Reserved)
Attachment I:
Proposed New e-CSF with Instructions and Relevant Information
Attachment J:
Work Sheets used to Calculate Pesticide Registrant Industry Labor Costs; Work Sheets used to Calculate EPA and Federal Government Labor Costs
Attachment K:
Display Related to OMB Control #2070-0060  -  Listings of Related Regulations in 40 CFR 9.1. Also available at: Electronic CFR Website.  

