Document ID: EPA-HQ-OPP-2020-0273-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-08-13T04:00Z

Supporting Statement Under the Paperwork Reduction Act
                                       
   Identification of the Information Collection  -  Title and Numbers	
      Title: Consolidated Pesticide Registration Activities 
   	OMB Control Number: 2070-[TBD]
   	EPA ICR Number: 2624.01
   	Docket ID Number: EPA-HQ-OPP-2020-0273

Table of Contents
 EXECUTIVE SUMMARY................................................................................................................................2
      1(a). Note to Reviewers .............................................................................................................................2
      1(b). Abstract................................................................................................................................................3
      
 NEED FOR AND USE OF THE COLLECTION................................................................................................5
      2(a). Need / Authority for the Collection.................................................................................................5
      2(b). Practical Utility / Users of the Data.................................................................................................7
      
 NON-DUPLICATION, CONSULTATION, AND OTHER COLLECTION CRITERIA........................................8
      3(a). Non-duplication..................................................................................................................................8
      3(b). Public Notice and Consultations.......................................................................................................8
      3(c). Effects of Less Frequent Collection..................................................................................................9
      3(d). General Guidelines.............................................................................................................................9
      3(e). Small Entity Flexibility......................................................................................................................10
      3(f). Confidentiality....................................................................................................................................11
      3(g). Sensitive Questions..........................................................................................................................11
      3(h). Use of Technology to Facilitate Collection Activities..................................................................11
      
 AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT............12
      4(a). Agency Activities...............................................................................................................................12
      4(b). Collection Methodology and Management..................................................................................13
      4(c). Estimated Agency Costs...................................................................................................................13
      4(d). Collection Schedule..........................................................................................................................14
      
 THE RESPONDENTS AND INFORMATION COLLECTION (IC) ACTIVITIES.............................................14
      5(a). Respondents  -  NAICS Codes...........................................................................................................14
      5(b). Information Collection Activities....................................................................................................15
            5(b)(i). Methodology Use to Estimate the Burden for Activities Related to Pesticide     Registration..................................................................................................................................15
      5(b)(ii). Information Collection Activities and Associated Burden.......................................16
      5(b)(iii). Total Estimated Respondent IC Burden and Costs..................................................25
 BURDEN STATEMENT................................................................................................................................26
      ATTACHMENTS...........................................................................................................................................27

 EXECUTIVE SUMMARY
   FORMS: THIS ICR COVERS THE FORMS LISTED IN TABLE 1 (Attachment A): 

                         Table 1: Applicable EPA Forms
EPA Form No.
Form Title
8570-1
Application for Pesticide Registration / Amendment
8570-4
Confidential Statement of Formula
8570-4
Electronic Confidential Statement of Formula (eCSF)
8570-5
Notice of Supplemental Distribution of a Registered Pesticide Product
8570-17
Application for an Experimental Use Permit to Ship and Use a Pesticide for Experimental Purposes Only
8570-25
Application for/Notification of State Registration of a Pesticide to Meet a Special Local Need
8570-27
Formulator's Exemption Statement
8570-34
Certification with Respect to Citation of Data
8570-35
Data Matrix
8570-36
Summary of the Physical/Chemical Properties
8570-37
Self-Certification Statement for the Physical/Chemical Properties

   1(a). Note to Reviewers
   
This is a new information collection request (ICR) that consolidates the collection activities covered by eight ICRs that are currently approved by the Office of Management and Budget (OMB) under the separate OMB control numbers identified in Table 2 (Attachment B). Although each ICR currently has a unique schedule, this new consolidated ICR is intended to replace the individual ICRs which will not be renewed once they expire. As a result, the ICRs will have one consolidated schedule including the same comment period, reducing the number of schedules and comment periods for interested stakeholders to track. This consolidation is due to the shared collection method or anticipated collection method of the information via the Pesticide Submission Portal in the U.S. Environmental Protection Agency's (EPA, or Agency) Central Data Exchange (CDX) and fulfils OMB Terms of Clearance on several of the ICRs. This consolidation is expected to clarify the capabilities of the Pesticide Submission Portal for respondents as well as streamline the Agency's ICR tracking, renewal, and development process. 

Table 2: Previously Approved ICRs Being Consolidated
OMB Control No. 
ICR Title
2070-0024
Tolerance Petitions for Pesticides on Food/Feed Crops and New Inert Ingredients
2070-0039
Submission of Unreasonable Adverse Effects Information Under FIFRA 6(a)(2)
2070-0040
Experimental Use Permits (EUPs) for Pesticides 
2070-0044
Notice of Supplemental Distribution of a Registered Pesticide Product
2070-0052
Compliance Requirement for Child Resistant Packaging 
2070-0060
Application for New and Amended Pesticide Registration
2070-0142
Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting
2070-0182
Pesticide Program Public Sector Collections (FIFRA §18/24(c))

1(b). Abstract

      The eight consolidated ICRs enable the EPA to acquire the necessary data to support the statutorily mandated information collection activities pertaining to the pesticide registration process under 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), specifically:
 Pesticide registration
 Pesticide use
 Pesticide sale and distribution 
 Pesticide permitting activities
 Determinations regarding whether a product must be regulated under FIFRA 
 Pesticide tolerances 
The collection activities vary and are dependent on the request from the Agency, respondent or both to fulfill the associated requirement or voluntary submission. Due to the diverse nature of the collections and affected industries, the term "respondent" will be used to refer to those engaging in any or all of the collections described in this ICR, unless a specific term offers more clarity.

In general, before an individual or entity can sell or distribute pesticides in the United States, EPA must evaluate the pesticides thoroughly to ensure that they meet federal safety standards to protect human health and the environment. EPA grants a "registration" or license that permits a pesticide's distribution, sale, and use only after the company meets the scientific and regulatory requirements.  

The Agency currently collects data on physical chemistry, toxicology, environmental fate, ecological effects, worker exposure, residue chemistry, environmental chemistry, and product performance. The information required is dependent on the use and type of product (OMB Control No. 2070-0060). This data is also used to determine whether the pesticide product must be sold and distributed in child-resistant packaging (CRP) or if it qualifies for an exemption from CRP requirements by meeting certain criteria regarding toxicity and use (OMB Control No. 2070-0052).

A respondent 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 a statement that they have offered to pay for use of someone else's data) for the product, as mentioned above and outlined in 40 Code of Federal Regulations (CFR) part 158. Standard pesticide registrations do not require Confidential Business Information (CBI) substantiations to be submitted at the time the CBI claim is made. However, under 40 CFR part 174, respondents claiming CBI for plant-incorporated protectant registrations must submit a substantiation with the CBI claim. Plant-incorporated protectants (PIPs) are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. EPA regulates both the pesticidal substance in the plant and the necessary genetic material for production of the pesticide -- the plant itself is not regulated (OMB Control No. 2070-0142).

If a respondent seeks to register a pesticide product developed for food or feed crops, they must ascertain if the Agency has established a tolerance or a tolerance exemption for the active ingredient in the product on those crops. If not, the respondent may petition the Agency to establish a pesticide tolerance or exemption for the active ingredient on the specific crop or crop groupings. Or the respondent may petition the Agency to establish a blanket tolerance exemption for all food commodities. Under FFDCA, EPA is responsible for regulating pesticides used to protect crops grown for human food and animal feed and for setting limits on the amount of pesticide residues that may remain in or on foods. These limits on pesticide residues left on foods are called "tolerances," or maximum residue limits. A pesticide should have a tolerance or tolerance exemption to be used on food or feed crops. In setting tolerances and tolerance exemptions, EPA must make a finding that the tolerance is "safe," meaning that there is a reasonable certainty of no harmful effects of human health from aggregate exposure through dietary, non-occupational, and drinking water routes of exposure (OMB Control No. 2070-0024).

The timeframes for the tolerances actions are established by the Pesticide Registration Improvement Act (PRIA) as amended in 2018. The vast majority of actions to establish tolerances or tolerance exemptions are taken in response to petitions from registrants for the establishment of new tolerances for an existing pesticide ingredient. The Agency may also initiate tolerance actions.
      
Pesticide tolerances are also needed to support the interstate movement of pesticide-treated foods in commerce.  The Food and Drug Administration (FDA) is responsible for tolerance enforcement.  Food commodities found to contain pesticide residues in excess of established tolerances are considered adulterated, and are subject to seizure by FDA, and may result in civil penalties.

After a registration is approved, under FIFRA §6(a)(2), registrants are still required to submit any factual information they acquire regarding adverse effects associated with their pesticidal products. It is up to the Agency to determine whether or not that factual information constitutes an unreasonable adverse effect to human health and the environment. In addition, manufacturers of PIPs exempted from registration requirements are also required to report adverse effects to the Agency (OMB Control No. 2070-0039).  

At any time, a pesticide registrant may sell or distribute registered pesticides under an Agency-approved alternate brand name in addition to the registered primary brand name, or under a different entity's name and address.  The sale and distribution is called "supplemental distribution," and the product is called a "distributor product."  EPA requires pesticide registrants who enter into supplemental distribution agreements with other companies to submit EPA Form 8570-5, Notice of Supplemental Distribution of a Registered Pesticide Product. Supplemental registrations are only an extension of a currently federally registered pesticide product (OMB Control No. 2070-0044).

Registrants may seek, at their discretion, to amend a registration by submitting data and/or proposed, revised label to EPA. Also, EPA often issues regulatory decisions or guidance that applies to some registered pesticide products and requires labeling revisions to be implemented by the registrant. The revised label is submitted to the Agency as an amendment along with a cover letter, EPA Form 8570-1, and other forms, and necessary data as needed (OMB Control No. 2070-0060).

In the context of its registration activities for conventional pesticides, EPA operates a reduced risk program. This program 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 (OMB Control No. 2070-0060). The reduced risk program is described in an EPA 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").

Special Circumstances for Pesticide Registration

Field-testing undertaken for submission as part of the registration process to provide data on a pesticide's chemical properties, safety, and efficacy necessarily involves an unregistered product. Therefore, EPA must frequently authorize the sale and distribution of an unregistered pesticide for testing purposes by means of an experimental use permit (EUP) under FIFRA §5. The EUP establishes limited conditions for the application and disposal of the pesticide material used in the tests. Pesticides registered under an EUP may not be sold or distributed other than through approved participants in the test program, and use is limited to the conditions specified in the EUP. If the food/feed treated under the terms of an EUP is to be shipped in commerce, the applicant must also submit a petition for a temporary tolerance pursuant to FFDCA §408 (21 U.S.C. 346a) unless a tolerance is already established (OMB Control No. 2070-0040).  

FIFRA §18 authorizes EPA to grant emergency exemptions to States, U.S. Territories, and Federal agencies to allow an unregistered use of a registered pesticide for a limited time, in a specific geographic area, if EPA determines that emergency pest conditions exist. This typically arises when agricultural producers encounter a pest problem on a site for which there is either no registered pesticide available, or for which there is a registered pesticide that would be effective but is not yet approved for use on that particular site. Exemptions may also be approved for public health and quarantine reasons (OMB Control No. 2070-0182).

FIFRA §24(c) authorizes any state to register a new pesticide product for any use, or a federally-registered product for an additional use, as long as there is both a demonstrated "special local need" (SLN), and a tolerance, exemption from a tolerance, or other clearance under FFDCA. EPA has the authority to acknowledge or disapprove the State's SLN (OMB Control No. 2070-0182).

There are several actions that are anticipated to be implemented within the next three years. The respondent burden associated with the following activities is estimated in this ICR and will be further updated in future iterations as the details of these programs are finalized and data is collected about the programs. These actions include the "Antimicrobial Performance Evaluation Program Strategy," and the draft guidance, "Interim Process for Evaluation Potential Synergistic Effects of Pesticides During the Registration Process." 
NEED FOR AND USE OF THE COLLECTION
   2(A). Need/Authority for the Collection

   The collections in this ICR are authorized by two Federal statutes: 
 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); and 
 Section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA). 

In 1996, the Food Quality Protection Act (FQPA) amended FIFRA and FFDCA. More information on FQPA can be found on EPA's website: https://www.epa.gov/laws-regulations/summary-food-quality-protection-act

FIFRA 

FIFRA governs the registration, distribution, sale, and use of pesticides in the United States and was established to ensure that, when applied as instructed, pesticides will not cause unreasonable risk to human health or the environment. It also authorizes the Agency's regulation of exempt and unregistered pesticide products (Attachment C). 

FIFRA §3 authorizes EPA to regulate pesticide registrations and outlines the process through which EPA examines a pesticide product's formula; the site or crop on which it is to be used; the amount, frequency and timing of its use; and storage and disposal practices and product performance for public health pests. EPA evaluates the product to ensure that it will not have unreasonable adverse effects on humans, the environment and non-target species. Plant-incorporated protectants are also regulated under this statute. Once registered, the pesticide's use must be consistent with the approved directions for use on the pesticide's label.

FIFRA §5 authorizes EPA to regulate experimental use permits (EUPs) and make certain that the permit was issued for genuine experimental purposes rather than as a form of temporary registration. Under the existing EUP regulations, small-scale experimental uses of pesticides are exempt from the EUP requirements. EPA has discretionary authority to exempt particular testing operations from the EUP requirements under certain conditions.  Also, 40 CFR 172.3 allows EPA authority to require EUPs for testing operations even when the exemption conditions of 40 CFR 172.3(b) and (c) are met.

FIFRA §6(a)(2) requires that any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment due to the use of the pesticide, the registrant shall submit such information to the EPA. Registrants have no obligation to create or seek adverse effects' information.  Such activities may be conducted by the registrant in support of pesticide registration under FIFRA §3 and registration review under FIFRA §3(g).  

FIFRA §18 authorizes EPA to grant emergency exemptions to states and Federal agencies to allow an unregistered use of a pesticide for a limited time if EPA determines that an emergency condition exists.  Generally, an emergency exemption under FIFRA §18 is requested when growers encounter a highly problematic agricultural pest problem on a site for which there is either no registered pesticide available or for which there is a registered pesticide that is no longer effective at controlling the specific pest responsible for the emergency condition. FIFRA §18 also allows EPA to grant unregistered pesticide use exemptions for other purposes such as public health, quarantine and crisis purposes and if there is the potential to experience significant economic loss as a result of not having an available pesticide. State government officials, not registrants, are typically the respondents for this program area.   

FIFRA §24(c) authorizes the States to register additional uses of federally registered pesticides for distribution and use within the State to meet a special local need (SLN).  A State must notify EPA -- in writing -- of any action it takes, i.e., when it issues, amends, or revokes a State registration.  A State-issued registration under FIFRA §24(c) is deemed a federal registration for the purpose of the pesticide's use within the State's boundaries after 90 days.  As such, the EPA has 90 days to acknowledge or disapprove the State registration.  In cases of EPA disapproval of a State registration under FIFRA §24(c), the State is responsible for notifying the affected registrant.  FIFRA §24(c)(3) mandates that if the Agency determines that a registration issued by a State is inconsistent with the FFDCA or if the use of a pesticide registered by the State constitutes an imminent hazard, the Agency may disapprove the registration. Detailed regulations regarding the procedures for the States to register additional uses of federally registered pesticides for distribution and use within the State to meet a special local need are codified at 40 CFR Part 162.

FIFRA §25(c)(3) authorizes EPA to establish standards for packaging of pesticide products and pesticidal devices. The law requires that these standards are designed to be consistent with those under the Poison Prevention Packaging Act, administered by the Consumer Product Safety Commission (CPSC).
Compliance regulations are contained in 40 CFR Part 157.

FFDCA

FFDCA §408 authorizes EPA to set tolerances and exemptions for pesticide or inert ingredient residues on foods (Attachment D). The agency takes these tolerance actions either on its own initiative pursuant to FFDCA §408(e) or in response to a petition filed pursuant to FFDCA §408(d). Under FFDCA §408(d), any person may file a petition with EPA, proposing the issuance of a regulation establishing, modifying, or revoking (a) a tolerance for a pesticide chemical residue in or on food, or (b) an exemption from the requirement to have a tolerance for such residue. FFDCA §408(d)(4) directs the agency to issue a final regulation establishing, modifying, or revoking a tolerance for the pesticide chemical residue or an exemption of the pesticide chemical residue from the requirement of a tolerance, or issue an order denying the petition.
   
Under FFDCA §408(e), at any time the agency may issue a regulation establishing, modifying, suspending, or revoking (a) a tolerance for a pesticide chemical residue in or on food, or (b) an exemption from the requirement to have a tolerance for such residue.  When initiating such actions, FFDCA §408(e)(2) requires the Agency to issue a notice of proposed rulemaking to provide an opportunity for public comment.

In the absence of a tolerance or tolerance exemption for a pesticide residue, a food containing such a residue is subject to seizure by the government. Similarly, food or feed commodities found to contain residues of a pesticide without or in excess of established tolerances are considered adulterated, and are subject to seizure by FDA, and may result in civil penalties.

   2(b). Practical Utility/Users of the Data
   
The collections in this ICR are necessary for EPA to fulfill its statutory mandates under FIFRA and FFDCA. The information collected supports regulatory decisions that ensure that pesticide products in the marketplace do not cause any unreasonable risk to humans or the environment, taking into account their economic, social, and environmental costs and benefits of their use. They also ensure that pesticide residues on food pose no aggregate dietary risk and are consistent with the rigorous standards set under FFDCA §408. Several examples, among others, of how EPA uses the collections to regulate registered and exempt pesticide products include the following:

 Make pre-application determinations of whether products need regulation under FIFRA. 
 Ensure the efficacy of registered antimicrobial pesticide products targeting public health pests that are available in the marketplace.
 Protect children and adults from serious illness or injury resulting from accidental ingestion or contact with a pesticide product by ensuring proper product packaging. 
 Protect the public's right to access information consistent with FIFRA and ensure that information qualifying as CBI is properly protected from unauthorized disclosures.
 Determine whether a request for an EUP is justified to allow for pesticide research. 
 Ascertain the cause/effect relationship when a pesticide is registered and later found to have adverse effects and allow the Agency to review new data which may contain important health data.  

The adverse effects information submitted under FIFRA §6(a)(2) after the registration process is considered by EPA in conjunction with other information to determine whether the terms and conditions of pesticide products containing a specific active ingredient should change during the registration review process or at other times. Registrants have indicated that the type of information collected under FIFRA §6(a)(2) is valuable to them as well.  Registrants may actively seek unanticipated and/or adverse effects information as part of product stewardship, which improves customer relations, minimizes liability, or protects or expands market share.  

The requirement of respondents to report adverse effects associated with exempt PIPs products within 30 days is necessary in order to obtain any information on unforeseen adverse effects from the exempted PIPs. These reporting requirements are similar to, but separate from, reporting requirements imposed on registrants under FIFRA §6(a)(2) for registered pesticides. The FIFRA §6(a)(2) reporting requirement applies to registrants and many PIPs are exempted from registration requirements.

These collections also allow the Agency to acquire the necessary data to make statutory determinations to grant or deny a FIFRA §18 request.  Unexpected changes in climatic conditions, natural disasters, pandemics, development of pest resistance, and/or importation of invasive pests are some of the unpredictable situations that could necessitate a FIFRA §18 emergency exemption request.  In these situations, there is an urgent need for the use of a pesticide, a use that may be unregistered and for which there is insufficient time to obtain a FIFRA §3 registration.

Similarly, to address existing or imminent pest problems, States may register a new pesticide product for any use, or an additional use of a federally registered pesticide under FIFRA §24(c) if it's determined that currently registered pesticide products are not available or effective against the target pest/use site scenario. 

 NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA
   3(A). NON-DUPLICATION
   
These collections are unique and are administered by EPA pursuant to FIFRA and FFDCA §408 as amended by FQPA. The collections are specific to the needs of the Federal pesticide laws which negate the need for similar data by other Federal agencies or EPA offices.

Respondents submit information unique to their pesticide registration. If the product is not unique, existing data may be referenced. On amended applications, the applicant can refer to any previously submitted information that they own, thereby satisfying data requirements without the burden of providing duplicate information or additional data development. EPA's registration program allows for collaboration through data citation and ensuring that original data generators/submitters are compensated when their data are cited in another application.

   3(b). Public Notice and Consultations 
   
Pursuant to 5 CFR 1320.8(d), in proposing this new ICR, the EPA will publish a Federal Register Notice providing a 60-day public comment period. Attachment H is reserved for public comments & EPA responses. Under 5 CFR 1320.8(d)(1), Federal Agencies are required to consult with respondents about the information collections before submitting approval requests to OMB. In accordance with this regulation, EPA staff will contact representatives from a cross section of stakeholders to seek feedback on the burden estimates in this ICR, and on the clarity of the information collection process. Attachment G is reserved for responses to consultation questions.

   3(c). Effects of Less Frequent Collection
   
Not applicable. Collection activities are initiated by respondents for the pesticide registration actions in this ICR on an "as needed" basis. Respondents' submission of data is voluntary, and for the pursuit of a pesticide registration or determination to sell and distribute their pesticide product under FIFRA and FFDCA as amended by FQPA. There are no set means by which the EPA can reduce the frequency except to eliminate the collection altogether. If the information were not submitted, EPA would be unable to fulfill its statutory responsibilities to regulate pesticides and protect human health and the environment.

   3(d). General Guidelines
   
Long-term recordkeeping

 With the exception of data records related to emergency exemptions which are only required to be maintained for two years after their production, all other recordkeeping activities in this ICR exceed OMB's guideline that agencies not require that records be retained for more than three years (5 CFR 1320.5(d)(2)(iv)). As authorized under FIFRA §8, 40 CFR 169.2(k),  respondents are required to retain records containing research data relating to a registered pesticide, including all data submitted to EPA in support of a registration, for as long as the registration is valid, and the pesticide producer is in business. 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 FIFRA §8.

Third-party disclosure of label information

Labeling regulations under 40 CFR 156 require registrants to display product-specific information to potential users and the general public through the pesticide label that is approved by EPA. The required information for the label is gathered and prepared by the registrant and submitted as part of the application for registration. The burden and cost of preparing and submitting the label information to EPA are included in this ICR as part of the burden associated with preparing the application for registration. 

This ICR does not, however, include any third-party burden or cost estimates for providing the pesticide label on each product to disclose safety information to potential users and the general public. The use of the pesticide label to accomplish this disclosure is not a collection of information as defined by the Paperwork Reduction Act (PRA) and OMB implementing regulations (5 CFR 1320.3(c)(2)). This determination was made by OMB in the context of implementing the 1995 PRA amendments and related OMB final regulations of 1995. In general, OMB explained that the new third-party disclosure provision added to the PRA in 1995 was not intended to require Federal Agencies to estimate burden for the required disclosure of important health and safety information on product labels, in particular if the label or language for the label is specifically provided by law (e.g., the Surgeon General warnings required to be on the labels of alcohol or tobacco products), or required to be approved by an Agency.
   
   3(e). Small Entity Flexibility 
   
The Agency believes that the burden imposed on small entities by these collections has been reduced to the minimal level at which these programs can effectively function under the requirements specified in FIFRA and FFDCA and the regulations for the enforcement of FIFRA and FFDCA as amended by FQPA. Much of the information needed for the collections is generated simultaneously by the respondent as part of the normal data gathered during research and development to satisfy baseline pesticide registration requirements. In other cases, EPA has taken the following measures to reduce small entity burden when applicable: 

 Respondents seeking a pesticide registration under FIFRA §3 can complete EPA Form 8570-27 ("Formulator's Exemption Statement") which 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 were already submitted by the company registering the source product.
         
 The Agency also maintains a pesticide database so that respondents can easily determine whether a particular study has been submitted, and by whom it was submitted, as well as the specific chemical and site(s). As a result, applicants encounter little difficulty in identifying available data needed to support an application for registration.

For EUPs, the Agency has identified the minimum amount of data required to conduct a risk assessment of the proposed research. These data requirements are flexible and may be adjusted as appropriate to the specific product under review.  Prior to the initiation of any small-scale field testing involving genetically-altered or non-indigenous microbial pest control agents, the respondent must submit a notification to the Agency so that a determination can be made as to whether an EUP is required. Because the notification requirements have been designed from the outset to minimize the burden on respondents, there are no special measures taken for small businesses since the burden is considered to be at a minimal level.	

Regardless of the size of the registrant, FIFRA §6(a)(2) regulations provide simplified reporting and extended reporting timeframes for most incident reports.  Currently, there is no standard reporting format prescribed in the regulations, therefore, the submitters can use a format of their choosing to report incidents.  While the Agency does not mandate a specific format for the required submission, EPA has worked with industry to develop guidance that both facilitates submissions and simplifies compliance.

At times, small entities seek a tolerance or an exemption from the requirement of a tolerance for pesticide residues resulting from registered uses. Tolerances are PRIA actions with fees established by Congress with the provision of fee waivers and fee exemptions in certain circumstances. The EPA's website is a resource for the public on fees and the process for seeking a waiver or exemption of fees: http://www2.epa.gov/pria-fees/pria-fee-waivers-small-businesses.

Small entities are not impacted by collections under FIFRA §§ 18 and 24(c) which apply directly to State, U.S. Territories, and Federal Agencies only; it does not apply to other entities.  States are not "small entities" as defined by the Regulatory Flexibility Act. No PRIA fees or monetary collection is connected with either section 18 or 24c activities.  

   3(f). Confidentiality

Trade secret or Confidential Business Information (CBI) is information submitted to the Agency that is considered proprietary and confidential to the submitter. CBI can include the manufacturing process, product formulation and/or supporting data. When CBI is submitted to the Agency, the information is protected from disclosure under FIFRA §10 and it is handled strictly in accordance with the provisions of the FIFRA Confidential Business Information Security Manual.

Much of the information submitted pursuant to FIFRA §6(a)(2) constitutes FIFRA §10(d)(1) safety and efficacy information.  On September 28, 1999, the Agency issued a class determination that safety and efficacy information submitted under FIFRA §6(a)(2) is not entitled to confidential treatment.  The determination enables the Agency to respond more quickly and efficiently to requests for information submitted under FIFRA §6(a)(2).  
      
   3(g). Sensitive Questions
   
 Not applicable. No information of a sensitive or private nature is requested in conjunction with these collection activities. In addition, these collections comply with the provisions of the Privacy Act of 1974 and OMB circular A-108. 
 
   3(h). Use of Technology to Facilitate Collection Activities

In 2015, the Office of Pesticide Programs (OPP) debuted the Pesticide Submission Portal (PSP; hereafter referred to as "the Portal"), a new electronic system for submitting packages. This system allows for electronic submissions for numerous regulatory actions. The Portal is accessed through EPA's Central Data Exchange (CDX) and requires user registration for which the paperwork burden is covered under "Cross-Media Electronic Reporting Rule" ICR, OMB No. 2025-0003. 

The Portal allows respondents to submit a variety of data related to their pursuit of a pesticide registration, determination, or exemption, some of which include:
 New pesticide active ingredient registrations.
 New pesticide products containing already-registered pesticide active ingredients.
 Amendments to registered pesticide products.
 Experimental use permits for pesticide products.
 FIFRA §6(a)(2) pesticide adverse effect studies.
 Petitions for food tolerances.
 Pesticide distributor products.
 PRIA Pre-application submissions
 Inert ingredient clearance requests.
Currently, FIFRA §18 emergency exemptions, FIFRA §24(c) SLN applications, and FIFRA §6(a)(2) incident report submissions are only accepted via paper or electronically through email. However, EPA anticipates Portal updates that will allow these collections to be submitted through the Portal in the next three years. 

When the Portal launched, respondents were initially quick to adopt it. However, shortly thereafter, Portal adoption plateaued. After five years, only about 50 percent of submissions are sent through the Portal.  Data collected since the Portal's launch also shows mixed Portal usage. While respondents may submit some packages through the Portal, they still choose to send others via mail. At this time, the Portal does not offer electronic forms or store any data after the respondent submits their package. Due to the slow adoption of the Portal, mixed Portal usage, and delay of technological advancements for key respondent activities through the Portal, the EPA is unable to define any further respondent burden savings at this time that have not already been accounted for previously.

As mentioned, at this time, EPA continues to accept paper, CD and DVD submissions for the aforementioned bulleted collections. However, EPA encourages applicants to take advantage of the Portal to forego the courier costs to send application materials to EPA and to avoid having to submit multiple copies of any pieces of their application which is required for paper submissions. Additional benefits of using the Portal include a status indicator that allows registrants to track the movement of their submissions and automatically generated Master Record Identification (MRID) numbers. Guidance for electronic submission through the Pesticide Portal is available to applicants at https://www.epa.gov/pesticide-registration/electronic-submissions-pesticide-applications.

EPA continues to investigate opportunities for technological improvements which focus on using fully electronic tools for information collections. Some of the electronic tools being developed under this initiative include software that supports a fully online electronic Confidential Statement of Formula (eCSF), formerly the Confidential Statement of Product Specifications (CSPS), and the Office of Pesticide Programs Electronic Label (OPPEL), formerly SmartLabel.  The Agency anticipates using these electronic tools as they become fully operational as part of the aforementioned bulleted collections. EPA anticipates that submissions via these electronic tools will take less time to prepare than paper or current web-based submissions. It is anticipated that the burden associated with these collections will decrease as these electronic tools become a part of standard business practice. Any burden modifications associated with the anticipated OPPEL and eCSF tools will be evaluated in future iterations of this ICR when the tools are fully implemented and once EPA has data on the frequency of use of these tools for electronic submissions and the time required to complete this type of submission. It is important to note that the proposed or draft changes to the PSP are not covered by the ICR until they are submitted to and approved by OMB.

 AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT
   4(A). AGENCY ACTIVITIES

Although the collections in this ICR are distinct and separate, the Agency performs the following general actions in response to a submission: 

 Receive submission and fee payment, if applicable
 Record receipt of submission
 Review application for completeness and acceptability; resolve any deficiencies with respondent
 Take action on submission
 Notify respondent of action taken
 Store and maintain applicable data

   4(b). Collection Methodology and Management
   
Collection submissions are received either through the Portal, email, or mail; printed to produce a paper copy, if applicable; pin-punched by date, screened, and entered into OPP's central data system, the Pesticide Registration Information System (PRISM), to track their progress through their respective registration process. The database continually tracks all registration actions from the registration-pending stage through to full registration approval and until a product is canceled. The database maintains information on both currently registered products and previously registered products, thereby acting as a pesticide registration historical file.  

A folder, or "jacket," containing all relevant documents is then created for the submission package and sent to the respective Product Manager (PM) for appropriate action. ITRMD maintains official file jackets, in which copies of the submission, EPA's reviews, registration approvals, correspondence, label, the CSF and other related information are all retained.

      4(c). Estimated Agency Costs

To determine Agency costs, the Agency used the Bureau of Labor Statistics estimates of 2018 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 $ 143.29 for managerial occupations, $74.95 for technical occupations, and $ 47.78 for clerical occupations. (Attachment I and Attachment J)
   	
                                   Table 3: Annual Agency Burden Estimates for all ICs

IC Category
Hours
Costs
IC 1: Application for an EUP -- Chemical Pesticides
 
 
IC 2: Application for an EUP -- Plant-Incorporated Protectants (PIPs)
 
 
Total:
                                                                          1,922
                                                                      $174,410 
IC 3: Plant-Incorporated Protectants - Substantiation of Confidential Business Information Claims 
 
 
IC 4: Plant-Incorporated Protectants -- Adverse Effects Reporting
 
 
Total:
                                                                            254
                                                                       $22,021 
IC 5: "Type A" application for registration of a new active ingredient or a new us e for a currently registered active ingredient
 
 
IC 6: "Type B" application for registration of a new or amended product that contains a currently registered active ingredient 
 
 
IC 7: "Type C" application for registration of new conventional active ingredients or uses that may qualify as "reduced risk" chemicals and/or OP replacements
 
 
IC 8: Data generation for new AIs and new products
 
 
Total:
                                                                        369,127
                                                                   $33,929,979 
IC 9: Notice of pesticide registration by states to meet a Special Local Need under FIFRA §24(c) 
 
 
IC 10: Application for emergency exemption for pesticides FIFRA §18 
 
 
Total:
                                                                         22,880
                                                                    $1,994,894 
IC 11: FIFRA §6(a)(2) Incident submissions 
 
 
IC 12: FIFRA §6(a)(2) Study submissions 
 
 
IC 13: FIFRA §6(a)(2) Training (Not Applicable) 
 
 
Total:
                                                                         24,825
                                                                     $2,020,859
IC 14: Compliance requirement for child-resistant packaging 
 
 
Total:
                                                                            256
                                                                       $20,009 
IC 15: Notice of supplemental distribution of a registered pesticide product
 
 
Total:
                                                                          1,260
                                                                      $119,245 
IC 16: Tolerance petitions for pesticides on food/feed crops and new inert ingredients 
 
 
IC 17: IR-4 Tolerance petitions for pesticides on food/feed crops and new inert ingredients
 
 
Total:
                                                                         33,821
                                                                    $2,920,000 
Grand total: 
                                                                        454,345
                                                                   $41,201,417 
*Numbers may not sum due to rounding.

   4(d). Collection Schedule
   
Not applicable. The activities are conducted only as a submission is received for consideration. There is no set schedule for the submission of this information to EPA
   
 THE RESPONDENTS AND INFORMATION COLLECTION (IC) ACTIVITIES
5(A). Respondents  -  NAICS Codes 
   
The North American Industrial Classification System (NAICS) codes associated with industries most likely affected by the paperwork requirements are described below. EPA recognizes that while this list may not be comprehensive, it represents a broad spectrum of large and small entities who are engaged in the preregistration of pesticides, pesticide registration process, pesticide post-registration activities and those seeking pesticide tolerances or exemptions. 

                                       
                             Table 4: NAICS Codes
                                  NAICS Code
NAICS Code Description
325320
Pesticide and Other Agricultural Chemical Manufacturing
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
325300
Pesticide and Other Agricultural Chemical Manufacturing
999200
State Government
424690
Other Chemical and Allied Products Merchant Wholesalers
561710
Exterminating and Pest Control Service
541600
Management, Scientific, and Technical Consulting Services

5(b). Information Collection Activities 

      5(b)(i) Methodology Used to Estimate the Burden for Activities Related to Pesticide Registration

Respondent burden for each collection is divided into two types: burden hours per collection and burden costs per collection. Burden hours are dependent on the collection, processes and submission rate and vary greatly among each collection. There is no methodology that can generally be applied to determine the burden hours per collection. Burden costs are also subjective depending on the collection; however, EPA generally follows the below methodology to calculate the respondent costs once individual collection burden hours are determined. 

 OPP uses labor cost estimates based on Bureau of Labor Statistics (BLS) data with respect to wages, benefits and overhead for all labor categories for affected industries and EPA employees. This approach uses a transparent and consistent methodology employing publicly available data to provide more accurate estimates and allow easy replication of the calculations (Attachment K). 
 

Table 5: Methodology for Calculating Fully Loaded Wage Rates
Methodology
The methodology uses data on each sector and labor type for an Unloaded wage rate (hourly wage rate) then 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 respondent costs. This ICR uses 2018 Bureau of Labor Statistics (BLS) data.

Unloaded Wage Rate
Wages are estimated for labor types (management, technical, and clerical) within applicable sectors. The Agency uses average wage data for the relevant sectors available in the National Industry-Specific Occupational Employment 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 System (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 system 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 46% of unloaded wage rates, based on benefits for all civilian nonfarm workers, from http://www.bls.gov/news.release/ecec.t01.htm. However, if other sectors are listed for which 46% is not applicable, the applicable percentage will be stated.

Fully Loaded Wage Rate
We multiply the loaded wage rate by 50% (EPA guidelines 20-70%) to get overhead costs.

	5(b)(ii) Information Collection Activities and Associated Burden

The information collections, or ICs, are grouped based off the ICR from which they were a part of for the purpose of this consolidation. This is intended to provide clarity to respondents for the first iteration of this ICR. 

Table 6. Previously Approved ICRs Being Consolidated and Their Associated IC(s)

                                       
                  Previously Approved ICRs Being Consolidated
                               Associated IC(s)
OMB Control No. 
ICR Title

2070-0040
Experimental Use Permits (EUPs) for Pesticides
IC 1: Applications for EUPs - Chemical Pesticides
IC 2: Application for EUPs - Plant Incorporated Protectants (PIPs)
2070-0142
Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting
IC 3: Plant-Incorporated Protectants- Substantiation of Confidential Business Information
IC 4: Plant-Incorporated Protectants - Adverse Effects Reporting
2070-0060
Application for New and Amended Pesticide Registration
IC 5: "Type A" application for registration of a new active ingredient or a new use for a currently registered active ingredient
IC 6: "Type B" application for registration of a new or amended product that contains a currently registered active ingredient
IC 7: "Type C" application for registration of new conventional active ingredients or uses that may qualify as "reduced risk" chemicals and/or OP replacements
IC 8:  Data Generation (for New AIs & New Products)
2070-0182
Pesticide Program Public Sector Collections (FIFRA §18/24(c))
IC 9: Notice of Pesticide Registration by States to Meet a Special Local Need (FIFRA 24(c)) 
IC 10: Application for Emergency Exemption for Pesticides (FIFRA 18)
2070-0039
Submission of Unreasonable Adverse Effects Information Under FIFRA 6(a)(2)
IC 11: FIFRA Section 6(a)(2) Submissions  -  Incidents
IC 12: FIFRA Section 6(a)(2) Submissions  -  Studies 
IC 13: FIFRA Section 6(a)(2)  -  Training
2070-0052
Compliance Requirement for Child Resistant Packaging
IC 14: Compliance Requirement for Child-Resistant Packaging

2070-0044
Notice of Supplemental Distribution of a Registered Pesticide Product
IC 15: Notice of Supplemental Distribution of a Registered Pesticide Product
2070-0024
Tolerance Petitions for Pesticides on Food/Feed Crops and New Inert Ingredients
IC 16: Tolerance Petitions for Pesticides on Food/Feed Crops and New Inert Ingredients
IC 17: IR-4 Tolerance Petitions for Pesticides on Food/Feed Crops and New Inert Ingredients

IC#1: Application for EUPs  -  Chemical Pesticides 
IC#2: Application for EUPs - Plant Incorporated Protectants (PIPs)
Respondent NAICS Codes: 325320 Pesticide and Other Agricultural Chemical Manufacturing

Information Collection Activities
In general, EUPs are issued for:
 Pesticides containing any chemical or combination of chemicals that have not been included in any previously registered pesticide; and 
 Registered pesticides for which a use, e.g., application to a specific crop is not registered with the Agency. 
   There are two main types of EUP applications submitted to the Agency: those for chemical pesticides and those for plant-incorporated protectants. For both application types, the respondent is required to submit EPA Form 8570-17, "Application for Experimental Use Permit to Ship and Use a Pesticide for Experimental Purposes Only," for a permit to generate information or data necessary to register a pesticide under FIFRA §3. The type of information to be submitted with the application depends on whether the product is already registered and whether a tolerance is required for the testing covered under the EUP. This information is necessary in order to grant and effectively monitor the EUP. The respondent must also provide the Agency with a final report on the results of the experimental program which includes information such as: amount of the product applied; the crops or sites treated; any observed adverse effects; any adverse weather conditions which may have inhibited the program; the goals achieved; and the disposition of containers, unused pesticide material, and affected food/feed commodities.
If the product is not intended to be used as a pesticide, an EUP would not be needed to test the product. Additionally, there are certain tests and circumstances that are exempt from the requirements of an EUP because they are presumed not to involve unreasonable adverse effects.
IC #3: Plant-Incorporated Protectants - Substantiation of Confidential Business Information Claims
IC# 4: Plant-Incorporated Protectants - Adverse Effects Reporting

Respondent NAICS Codes

 32532 Pesticides and Other Agricultural Chemical Manufacturing
 54171 Research and Development in the Physical, Engineering, and Life Sciences
 325414 Biological Product (except Diagnostic) Manufacturing 
 611310 Colleges, Universities, and Professional Schools
 422910 Farm Supplies Wholesalers  -  NOT VALID (NV)
 422930 Flower, Nursery Stock, and Florists' Supplies Merchant Wholesalers 
Information Collection Activities
   A plant-incorporated protectant (PIP) is defined as "the pesticidal substance that is intended to be produced and used in a living plant and the genetic material necessary for the production of such a substance." Those claiming CBI for PIPs registrations must submit substantiations at the time they submit their registration application. The current CBI regulations at 40 CFR part 2 require that claimants substantiate their CBI claims for their own records when the claim is made, and subsequently provide the substantiation to EPA only if requested. The PIPs 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.

If a determination is made that a CBI claim is not warranted or the claim is not substantiated, the registrant 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 processed accordingly. 

Manufacturers of PIPs exempted from registration requirements must submit any information they subsequently obtain regarding adverse effects on human health or the environment alleged to have been caused by 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 decide to either ask for additional information or to act on the information presented. The requirements for up-front CBI substantiation and adverse effects reporting are separate requirements that only occur on occasion.

IC# 5: "Type A" application for registration of a new active ingredient or a new use for a currently registered active ingredient 
IC# 6: "Type B" application for registration of a new or amended product that contains a currently registered active ingredient
IC# 7: "Type C" application for registration of new conventional active ingredients or uses that may qualify as "reduced risk" chemicals and/or OP replacements
IC# 8: Data Generation (for New AIs & New Products)

Respondent NAICS Codes

 32532 Pesticide and Other Agricultural Chemical Manufacturing
Information Collection Activities

      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.
Application materials include: 
 Application cover letter.
 Forms for pesticide registration applications.
 Supporting data, if applicable. 
 Draft labeling that meets the regulatory requirements set out in 40 CFR 152.50.
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 are described as Types A and B, respectively. In "Type A" activities, applicants for new active ingredients will be required to submit administrative forms, product labeling, a CSF, as well as a full complement of physical chemistry, toxicology, environmental fate, ecological effects, worker exposure, residue chemistry, environmental chemistry, and product performance data, as identified in 40 CFR 158. 
      
"Type B" activities involves a respondent 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 respondent 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 described above, the 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 respondent assembling and submitting a reduced risk application for registration of a new active ingredient with "reduced risk" or a new use for a currently registered active ingredient that has "reduced risk." 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 anticipated benefits for the public compared to currently labeled products for special consideration based on these factors. Products that are successfully classified as presenting a potentially reduced risk will likely receive earlier registration, reduced PRIA fees, and earlier marketability.

The completion and submission of the following forms is necessary to register a pesticide product:

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

IC 9: Notice of Pesticide Registration by States to Meet a Special Local Need (FIFRA 24(c))
IC 10: Application for Emergency Exemption for Pesticides (FIFRA 18)

Respondent NAICS Codes
 999200 State Government
 325300 Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing

Information Collection Activities

      The data collected by the Agency under FIFRA §18 for the temporary use of a pesticide product for an unregistered use allows EPA to evaluate whether such use will mitigate an emergency situation.  Generally, the data submitted must support the Agency's evaluation of whether:
      
       An emergency condition exists;
       The use of the pesticide under the exemption will be protective of human health and the environment; and 
       The requested product will be effective in allaying the emergency.  
         
Information contained in the application and follow-up reporting is essential for gauging the emergency nature of the situation, the effectiveness of the product, the risks of the treatment program, and the economic loss based on the new tiered thresholds for significant economic loss determination.

To request a FIFRA §18 emergency exemption, an application must be submitted by the head of a Federal or State agency, the Governor of the State involved, or their official designee.  If a designee has been delegated authority to request exemptions, written authorization of such delegation must accompany the request or be on file with EPA. In addition, and when granted by EPA, the respondent must provide:

 Unexpected adverse effects information	, if any.
 Reporting summarizing the results of pesticide use must be submitted to EPA within six months of the expiration of the exemption unless otherwise specified by the Agency.
 Records for all treatments involving food use of a pesticide will be maintained by the State or Federal agency for which an emergency exemption was granted for a minimum of two years following the date of expiration of the exemption. Upon request by EPA, these records must be made available to the Agency.

EPA will deny an emergency exemption request if the pesticide use may cause unreasonable adverse effects to human health or the environment, or if emergency criteria are not met.  A state may withdraw an exemption request at any point in the process.

In some emergency situations, there is insufficient time for a formal FIFRA §18 application to be made by the State and reviewed by the Agency.  In such cases, a State agency may temporarily bypass the normal FIFRA §18 application process and supporta "crisis exemption" which allows for the immediate use of a pesticide for no longer than 15 days. EPA regulations at 40 CFR part 176, entitled "Time-Limited Tolerances for Pesticide Emergency Exemptions," provide a process to ensure timely decisions on any tolerance-related issue in response to a request for an emergency exemption for a pesticide to be used on food or feed. Time-limited tolerances are established as needed to support food uses which have been approved under a FIFRA section 18 emergency basis. 

Applicants for State registrations under FIFRA §24(c) must submit the following information directly to the State:

 EPA Form 8570-25, Application for/Notification of State Registration of a Pesticide to Meet a Special Local Need.
 In a small number of instances and if appropriate, EPA Form 8570-4, Confidential Statement of Formula.
      
As soon as practical after a registration is issued, a copy of the final printed labeling containing a statement identifying the State where registration is to be valid and special local need registration number assigned by the State must be provided. Within ten working days from the date a State issues, amends or revokes a registration, the State is required to notify EPA, in writing, of the action.  

IC# 11: Compliance Requirement for Child-Resistant Packaging

Respondent NAICS Codes

 325320 Pesticide and Other Agricultural Chemical Manufacturing
 424690 Other Chemical and Allied Products Merchant Wholesalers
 561710 Exterminating and Pest Control Service
Information Collection Activities

 	Most pesticide products are not subject to CRP requirements. For any product not subject to CRP requirements, registrants have no paperwork burden associated with this IC. Pesticide products that are automatically exempt from (or not subject to) CRP requirements are any of the following:
 
       Pesticide products classified for restricted use
       Pesticide products not for residential use
       Pesticide products in large package sizes
       Pesticide products with low toxicity
 
 Respondents may also assert that an exemption from the CRP requirement is warranted because CRP is not technically feasible, practicable, or appropriate. Each request for an exemption is unique, and the documentation necessary to support an exemption is unique.
 
 The applicant or registrant of a pesticide product that is subject to CRP requirements must certify to the Agency that the packaging for the product meets the standards of 40 CFR 157.32, or, in rarely applicable cases, request an exemption from the requirement. In order to meet the standards of Part 157.32, the package must have been tested following the required testing protocols, and the results must confirm the acceptability of the package. Child resistant effectiveness (CRE) and senior adult use effectiveness (SAUE) testing are required, in addition to testing for compatibility and durability. If access to the actual raw testing data is necessary for EPA to reach sound conclusions, the Agency may also require submission of the CRP testing data and final report. 
 
 The EPA notes that for products subject to CRP requirements, CRP certification is required when a product is initially registered, and when the registration is amended as a result of any modification in the composition, labeling, or packaging. In addition, certification must be submitted to the EPA if the Agency determines, in accordance with 40 CFR 157.24(a)(1)(ii), 2(ii), or (b)(4), that a currently registered product is required to be packaged in child-resistant packaging, and the certification was not previously submitted.
 
 For pesticide products subject to CRP requirements, there are three types of responses to this collection, only one of which is necessary for approval of each pesticide product as CRP compliant, as a condition of registration:
 
   :: 	Certification statement, without raw testing data submitted
   :: 	Certification statement, with raw testing data submitted
   :: 	Request for exemption

 The Agency solicits packaging manufacturers to voluntarily submit samples of CRPs that claim child resistance, identify the packaging, its manufacturer, and list the package's classification according to the ASTM International Standard D3475, "Standard Classification of Child-Resistant Packages." The Agency will compile and update the information on an ongoing basis on its CRP Website. 
 The CRP Website provides a service to CRP manufacturers and pesticide registrants by displaying the various types of CRP in the marketplace which, in turn, should facilitate compliance with the CRP regulations. An Agency request for, and the public's submission of, these packaging samples is not a collection of information for the purposes of the OMB Paperwork Reduction Act regulations. OMB's regulations define "information" such that it excludes "samples of products or of any other physical objects" (see 5 CFR 1320.3(h)(2)). Therefore, EPA is not required to estimate the burden associated with submitting these packaging samples.

IC# 12: Notice of Supplemental Distribution of a Registered Pesticide Product 

Respondent NAICS Codes

 325320 Pesticide and Other Agricultural Chemical Manufacturing

Information Collection Activities

      For each distributor product, the basic product registrant must send to EPA the completed form 8570-5, "Notice of Supplemental Distribution of a Registered Pesticide Product," signed by both the basic product registrant and the distributor. Responsibility for regulatory compliance rests primarily with the basic product registrant.  However, both the registrant and the distributor may be held liable for any violation of FIFRA.  

Before sale and distribution of EPA-registered pesticides, a company must have an EPA-assigned company number.  If the distributor company is different from the registrant of the product and has not previously obtained an EPA company number, the company needs to obtain one before submitting the form to EPA. 

Distributor products must be the same as the registered product and may not be repackaged (must remain in the producer's unopened container). Distributor product labels must bear qualifications such as "distributed by," or "sold by," and the labeling must bear the same claims as the basic registered product -- with the exception of deletion of specific claims. Distributor products must reflect any changes in formulation or labeling made to the basic registered product within the same timeframe imposed on that product.  In addition, although the distributed product's name may be different from that of the registered product, it may not be misleading.

IC# 13: FIFRA §6(a)(2) Submissions - Incidents
IC# 14: FIFRA §6(a)(2) Submissions - Studies
IC# 15: FIFRA §6(a)(2) - Training

Respondent NAICS Codes

 325300 Pesticide and Other Agricultural Chemical Manufacturing
      
Information Collection Activities

      Pesticide registrants may collect adverse effects information in the normal course of business, such as following up on consumer complaints to gather more information. Regardless of how the information comes into the possession of the registrant, once the registrant acquires information subject to submission under FIFRA §6(a)(2), as defined by the regulations, the registrant must submit it to EPA.  

As further defined by the final rule implementing the FIFRA §6(a)(2) requirements (62 FR 49639), registrants are required to report on: 

 Studies showing new or more severe toxicological responses than previously reported of any type in any strain of test organism, (40 CFR 159.165). 
 The fact that a study has been discontinued before planned, if submission of information concerning the study is, or would have been, required (40 CFR 159.167).
 Epidemiological or exposure studies of human population groups indicating greater exposure than previously reported (40 CFR 159.170). 
  Information on excess residues on food or feed, and residues in surface water, ground water or drinking water (40 CFR 159.178). 
  Information on metabolites, degradates, contaminants or impurities which may be of toxicological concern (40 CFR 159.179). 
 Incidents involving toxic or adverse effects to human or other non-target organisms (40 CFR 159.184). 
 Studies, incidents, or other information showing lack of efficacy of certain pesticide products with public-health related uses, plus certain information for any incident of a pest having developed resistance to any pesticide (40 CFR 159.188). 

The Agency accepts incident reports using the voluntary forms as well as incidents formatted in other ways.  The voluntary forms may well serve as the foundation for standardized forms.  

In addition, in compliance with 40 CFR 159.160, a former registrant is required to submit information for a period of 5 years after the registration of the pesticide product has been cancelled or transferred to another registrant. Certain exceptions to this 5-year former registrant obligation exist.
      
Another aspect of the respondents' burden is ongoing employee training on compliance with 6(a)(2) reporting requirements.  New employees would require training and experienced employees are likely to receive refresher training.  Each company would plan training and track the status of training efforts.  

Since the last ICR was approved, the EPA has found it necessary to request additional data in certain subject areas under 40 CFR 159.  In 2009, EPA noticed an increase in adverse reaction reports involving the use of spot-on pesticide products for pets.  Incidents in pets ranged from skin irritation to death, and several class-action lawsuits were filed against the product producers and registrants. EPA formed a veterinarian team to thoroughly analyze the existing data. EPA also partnered with the Food and Drug Administration's Center for Veterinary Medicine and Health Canada's Pest Management Regulatory Agency, EPA's counterpart agency in Canada, on the review of this analysis. In order to advance the EPA's efforts to mitigate adverse effects from spot-on products used on pets the Agency meet with spot on product manufacturers to discuss product-specific mitigation (https://www.epa.gov/pets/meetings-registrants-pet-spot-products). 

By March 2010, EPA announced the results of the evaluation (https://www.epa.gov/pets/epa-evaluation-pet-spot-products-analysis-and-plans-reducing-harmful-effects#report, and after consulting with industry, EPA began requiring more standardized post market surveillance reporting on adverse effects and submission of sales information so the Agency can better evaluate incident rates.). Based on the evaluation, and after receiving over 1100 public comments on the proposed pet spot on analysis and mitigation plan (Docket ID No. EPA-HQ-OPP-2010-0229-0001).

EPA initiated changes to mitigate the adverse effects of spot-on products, which asked companies provide a standardized report for pet incidents, and implement label changes for spot on products for cats and dogs to prevent unreasonable adverse effects and ensure the safety of these products.  

IC# 16: Tolerance Petitions for Pesticides on Food/Feed Crops and New Inert Ingredients
IC# 17: IR-4 Tolerance Petitions for Pesticides on Food/Feed Crops and New Inert Ingredients

Respondent NAICS Codes

 325320 Pesticide and Other Agricultural Chemical Manufacturing
 541600 Management, Scientific, and Technical Consulting Services
Information Collection Activities

      EPA sets tolerances as part of the process of regulating pesticides. In the absence of a tolerance or exemption for a pesticide residue, food or feed commodities containing such residues are subject to seizure by the government. In cases where there is an absence of an EPA-established tolerance for the intended crop of a pesticide registration for human food or animal feed purposes, a registrant can petition the EPA to establish a tolerance. 

Section 408 of FFDCA requires petitioners to submit "an information summary of the petition and of the data, information and arguments submitted or cited in support of the petition." FQPA requires EPA to consider additional information in order to make the necessary regulatory decisions, described in the appendices to Pesticide Registration (PR) Notice No. 97-1. EPA encourages petitioners to submit supplemental information with their petitions to help EPA determine whether there is a reasonable certainty that no harm will result from aggregate exposure. A detailed description of information requested in this collection, including data items, record keeping requirements, and respondent activities, are provided in Attachment B-1 to this ICR. While any entity can file a tolerance petition with the agency, such petitions typically come from those businesses engaged in the manufacturing of pesticides and the Interregional Research Project No.4 (IR-4).

Tolerance petitions are subject to fees under PRIA. PRIA established registration service fees for pesticide registration actions. However, in support of minor crop producers, petitions from the IR-4 program are exempt from the PRIA fee. To qualify for the IR-4 provisions for this fee exemption, EPA requires that the registration application is solely associated with a tolerance petition submitted in connection with IR-4, and the action must be considered to be in the public interest.  A document that describes the process is attached and more information can be accessed at the following link: http://www2.epa.gov/pria-fees/guidance-ir-4-exemptions.  

Some pesticides are exempted from the requirement to have a tolerance. EPA may grant exemptions in cases where the pesticide residues do not pose a dietary risk under reasonably foreseeable circumstances.  

	5(b)(iii) Total Estimated Annual IC Respondent Burden 

              Table 7: Annual IC Respondent Burden Summary Table
                                  IC Category
Responses
Burden (hours)
Cost
IC 1: Application for an EUP -- Chemical Pesticides
                                                                            8.3
                                                                            273
                                                                       $20,028 
IC 2: Application for an EUP -- Plant-Incorporated Protectants (PIPs)
                                                                              2
                                                                            294
                                                                       $21,850 
IC 3: Plant-Incorporated Protectants - Substantiation of Confidential Business Information Claims 
                                                                             24
                                                                            516
                                                                       $45,412 
IC 4: Plant-Incorporated Protectants -- Adverse Effects Reporting
                                                                            0.3
                                                                            2.3
                                                                          $195 
IC 5: "Type A" application for registration of a new active ingredient or a new us e for a currently registered active ingredient
                                                                            213
                                                                         41,322
                                                                     $3,244,017
IC 6: "Type B" application for registration of a new or amended product that contains a currently registered active ingredient 
                                                                          7,221
                                                                        101,094
                                                                   $10,740,140 
IC 7: "Type C" application for registration of new conventional active ingredients or uses that may qualify as "reduced risk" chemicals and/or OP replacements
                                                                              5
                                                                          3,230
                                                                     $263,895  
IC 8: Data generation for new AIs and new products
                                                                            789
                                                                      1,416,831
                                                                  $106,315,000 
IC 9: Notice of pesticide registration by states to meet a Special Local Need under FIFRA §24(c) 
                                                                            223
                                                                         11,596
                                                                    $1,016,325 
IC 10: Application for emergency exemption for pesticides FIFRA §18 
                                                                            143
                                                                         14,157
                                                                      $942,338 
IC 11: FIFRA §6(a)(2) Incident submissions 
                                                                        107,798
                                                                        255,481
                                                                   $18,793,325 
IC 12: FIFRA §6(a)(2) Study submissions 
                                                                            237
                                                                            770
                                                                       $54,530 
IC 13: FIFRA §6(a)(2) Training 
                                                                         17,424
                                                                         44,867
                                                                    $3,506,132 
IC 14: Compliance requirement for child-resistant packaging 
                                                                             31
                                                                          3,535
                                                                      $267,444 
IC 15: Notice of supplemental distribution of a registered pesticide product
                                                                          1,885
                                                                            603
                                                                       $57,628 
IC 16: Tolerance petitions for pesticides on food/feed crops and new inert ingredients 
                                                                            139
                                                                        239,914
                                                                   $25,391,013 
IC 17: IR-4 Tolerance petitions for pesticides on food/feed crops and new inert ingredients
                                                                             26
                                                                         45,214
                                                                    $4,213,383 
Total
                                                                      136,168.6
                                                                      2,179,699
                                                                  $174,892,655 
*Numbers may not sum due to rounding.

 BURDEN STATEMENT

   6(a). Burden Statement
   

                    Table 8: Estimated Total Annual Burden
 
Burden (hours)
Costs
Respondent
                                                                      2,179,699
                                                                  $174,892,655 
Agency
                                                                        454,345
                                                                   $41,201,417 
Total
                                                                      2,634,044
                                                                  $216,094,072 
*Numbers may not sum due to rounding.

 Under the PRA, burden is defined at 5 CFR 1320.3(b).

This information collection combines the burdens from eight previously approved ICRs. The total combined respondent and Agency burden hours from those ICRs is estimated at 2,634,044 hours. The total burden hours requested for this ICR is 2,634,044. The EPA estimates no quantifiable change in burden hours between the current burden request and the previously approved requests due to: 

 No changes to program activities or means of collection methods that would streamline processes and trigger burden hour adjustments 
 Mixed Portal usage by respondents 
 Several of the collections cannot yet be submitted through the Portal
 No new IC categories

The total combined cost burden from these eight previously approved ICRs is $211,290,735. The total cost burden requested for this ICR is $216,094,072  -  an increase of $4,803,337. The difference between the current cost burden request and the previously approved requests is due only to adjustments in EPA's estimates of the wage rates and material costs that were revised to reflect 2018 dollars for this ICR. EPA believes that adjustments have been regularly made to the costs associated with mailing over the course of time and with the steady adoption of electronic submissions. 

      6(b).	Docket Information 
       
The Agency has established a docket for this ICR under Docket ID No. EPA-HQ-OPP-2020-0273, which is available for online viewing at http://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-2020-0273 and OMB Control No. 2070-XXX, to both EPA and OMB as follows: 

 To EPA online using http://www.regulations.gov (our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave., NW, Washington, DC 20460, and 
 To OMB via email to oira_submission@omb.eop.gov. Address comments to OMB Desk Officer for EPA.

 ATTACHMENTS
   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-2020-0273. These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in the sections below. 

Attachment A
Forms for Pesticide Registration 

             A -- 1.   EPA Form 8570-1: Application for Pesticide, Registration/Amendment
             A -- 2.   EPA Form No. 8570-4: Confidential Statement of Formula
             A -- 3.   EPA Form No. 8570-4: Electronic Confidential Statement of Formula (eCSF) 
             A  -  4.    EPA Form No. 8570-5: Notice of Supplemental Distribution of a Registered Pesticide Product
             A  -  5.   EPA Form No. 8570-17: Application for an Experimental Use Permit to Ship and Use a Pesticide for 
             Experimental Purposes Only
             A  -  6. EPA Form No. 8570-25: Application for/Notification of State Registration of a Pesticide to Meet a
                          Special Local Need       
             A  -  7. EPA Form No. 8570-27: Formulator's Exemption Statement
             A  -  8. EPA Form No. 8570-34: Certification with Respect to Citation of Data
             A  -  9. EPA Form No. 8570-35: Data Matrix
             A  -  10. EPA Form No. 8570-36:  Summary of the Physical/Chemical Properties
             A  -  11. EPA Form No. 8570-37: Self-Certification Statement for the Physical/Chemical Properties
Attachment B 
Previously Approved ICRs Being Consolidated 

               B  -  1. OMN No. 2070-0024; Tolerance Petitions for Pesticides on Food/Feed Crops and New Inert Ingredients                              
               B  -  2. OMB No. 2070-0039; Submission of Unreasonable Adverse Effects Information Under FIFRA 6(a)(2)
               B  -  3. OMB No. 2070-0040; Experimental Use Permits (EUPs) for Pesticides
               B  -  4. OMB No. 2070-0044; Notice of Supplemental Distribution of a Registered Pesticide Product
               B  -  5. OMB No. 2070-0052; Compliance Requirement for Child Resistant Packaging 
               B  -  6. OMB No. 2070-0060; Application for New and Amended Pesticide Registration 
               B  -  7. OMB No. 2070-0142; Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting
               B  -  8. OMB No. 2070-0182; Pesticide Program Public Sector Collections (FIFRA 18/24(c)
Attachment C
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
Attachment D
Federal Food, Drug, and Cosmetic Act (FFDCA) Section 408 
Attachment E
U.S. Code of Federal Regulations (CFR); title 40: Protection of Environment; parts 152-180
Attachment F
Pesticide Registration Notices

             F  -  1. PRN 97-1
             F  -  2. PRN 97-3
             F  -  3. PRN 97-9
             F  -  4. PRN 1998-3
             F  -  5. PRN 1998-4
             F  -  6. PRN 2011-3
Attachment G
Reserved for Consultation Questions and Respondent Answers
Attachment H
Reserved for Public Comments & EPA Responses
Attachment I
Consolidated Respondent Burden Graphs

Attachment J
Consolidated Agency Burden Graphs

Attachment K
Labor Wage Formulas for the ICs of Each Previously Approved ICR Being Consolidated

           K -- 1. Labor Wage Formulas for OMB No. 2070-0182
           K  -  2  -  1.  Labor Wage Formulas for OMB No. 2070-0040
           K  -  2  -  2. Labor Wage Formula for OMB No. 2070-0040
           K  -  3. Labor Wage Formulas for OMB No. 2070-0039
           K  -  4  -  1.  Labor Wage Formulas for OMB No. 2070-0024
           K  -  4  -  2.  Labor Wage Formulas for OMB No. 2070-0024
           K  -  4  -  3. Labor Wage Formulas for OMB No. 2070-0024
           K  -  5. Labor Wage Formulas for OMB No. 2070-0044
           K  -  6. Labor Wage Formulas for OMB No. 2070-0052
           K  -  7. Labor Wage Formulas for OMB No. 2070-0060
           K  -  8. Labor Wage Formulas for OMB No. 2070-0142
Attachment L
Class Determination Regarding Confidentiality of 6(a)(2) Information 
Attachment M
Industry's Voluntary 6(a)(2) Incident Reporting Forms & Guidance Documents
Attachment N
Requirements for Approval of Supplemental Distribution
Attachment O
Registration Service Fees Guidance on IR-4
Attachment P 
Pesticide Registration Improvement Extension Act of 2018
Attachment Q
Factors for IR-4 Public Interest Finding
Attachment R
Setting Tolerances for Pesticide Residues in Food
Attachment S
Pesticide Submission Portal (PSP): Screen Shots, Instructions and Related Guidance
Attachment T
Annual Reporting and Recordkeeping Burden Hours Per IC