SUPPORTING STATEMENT FOR AN
INFORMATION COLLECTION REQUEST (ICR)
Title: Pesticide Program Public Sector Collections (FIFRA Sections 18 & 24(c))
EPA ICR No.: 2311.04
OMB Control No.: 2070-0182
EPA Form Nos.: EPA Form 8570-4 (Confidential Statement of Formula); and EPA Form 8570-25 (Application for/Notification of State Registration of a Pesticide to Meet a Special Local Need).
Docket No.: EPA-HQ-OPP-2017-0619
This Information Collection Request (ICR) covers the paperwork burden under the Paperwork Reduction Act (PRA) associated with two types of pesticide registration requests made by States, U.S. Territories, or Federal agencies. Specifically, this ICR covers emergency exemption requests, which allow for an unregistered use of a pesticide, and State registrations of a pesticide use to meet a special local need (SLN). Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes the Environmental Protection Agency (EPA) to grant emergency exemptions to States, U.S. Territories, and Federal agencies to allow an unregistered use of a pesticide for a limited time if EPA determines that emergency conditions exist. FIFRA Section 18 requests include unregistered pesticide use exemptions for specific agricultural, public health, quarantine and crisis purposes. FIFRA Section 24(c) authorizes any particular State to register additional uses of a federally registered pesticide for distribution and use within that state to meet a SLN.
These information collection activities are ongoing and are included together in this ICR because the programs they represent share similar respondent populations, state governments and other federal agencies seeking exemptions or modifications to federally registered pesticide products as defined in FIFRA.
FIFRA Section 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, a specific emergency exemption under FIFRA Section 18 is requested when growers encounter an agricultural pest problem on a site for which there is either no registered pesticide available or for which there is a registered pesticide that would be effective but is not yet approved for use on that particular site. Moreover, there is the potential to experience significant economic loss as a result of not having an available pesticide. FIFRA Section 18 also allows EPA to grant unregistered pesticide use exemptions for other purposes such as public health, quarantine and crisis purposes.
Most requests for emergency exemptions under FIFRA Section 18 are made for agricultural commodities by state departments of agricultural, although a state department of health or federal agency such as the Centers for Disease Control (CDC) may request an exemption for public health use. Other federal agencies such as the United States Departments of Agriculture (USDA), Defense (DOD) and Interior (USDI) also request exemptions. As mentioned, the majority of the requests are related to an agricultural pest problem, so the process is often initiated when growers in a particular region identify an urgent, non-routine situation that registered pesticides will not alleviate. When this happens, the growers contact their State lead agency (usually a state’s department of agriculture) and request that the State agency make a request to EPA for an emergency exemption under FIFRA Section 18. The State agency evaluates the growers’ request and submits their request to EPA for emergency exemptions they believe are warranted. The uses are requested for a limited period of time to address the emergency situation only.
FIFRA Section 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 Section 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 disapprove the State registration. In cases of EPA disapproval of a State registration under FIFRA Section 24(c), the State is responsible for notifying the affected registrant.
EPA is currently developing a new ICR that will consolidate this and several other approved ICRs. The consolidated ICR will include any updates to the information collection activities covered by this ICR. The renewal of this ICR will ensure there is no lapse in approval of this ICR while the new, consolidated ICR is under development. When the consolidated ICR is approved, EPA plans to discontinue this ICR.
This information collection allows the Agency to collect the necessary data to expeditiously make statutory determinations to grant or deny a Section 18 request. Unexpected changes in climatic conditions, natural disasters, development of pest resistance, and/or importation of pests are some of the unpredictable situations that could necessitate a Section 18 emergency exemption request. In these situations, there is sometimes an urgent need for the use of a pesticide, a use that may be unregistered and for which there is insufficient time to obtain registration.
Requests for Section 18 emergency exemptions, i.e., the submission of applications, are made at the discretion of a State, U.S. territory, or Federal agency. Should one of these entities apply for an emergency exemption, EPA requests the information and data identified under Section 4(b) “Information Requested” of this supporting statement. If EPA determines that conditions exist which warrant an exemption and that the risks are acceptable, EPA typically approves the emergency exemption request. EPA will deny an emergency exemption request if the pesticide use may cause unreasonable adverse effects to human health or the environment, or if emergency criteria are not met. A state may withdraw an exemption request at any point in the process.
In some emergency situations, there is insufficient time for a formal Section 18 application to be made by the State and reviewed by the Agency. In such cases, a State agency may temporarily bypass the normal Section 18 application process and declare a “crisis exemption” which allows for the immediate use of a pesticide for no longer than 15 days, unless a specific exemption request has been submitted to EPA. The state declaring the crisis exemption must seek concurrence of the declaration from EPA prior to releasing it to the users of the pesticide. EPA performs a cursory review of the use to ensure there are no concerns. If any concerns are noted, EPA confers with the state and under extreme cases may not allow a crisis to be declared. If the state follows up the crisis with, or has already submitted, a specific, public health or quarantine emergency exemption request, the use may continue under the crisis until the EPA has made a decision on the request and/or the use season has ended. EPA must establish the appropriate time-limited tolerance(s) required by the Federal Food, Drug and Cosmetic Act (FFDCA) to support any pesticide uses to commercial agricultural commodities under emergency exemptions, including crisis exemptions.
Producers of minor crops are especially reliant on the emergency exemption program. Agricultural pests of national importance that are managed largely through Section 18s include the sugarcane aphid and the Asian citrus psyllid. Most recently, the Section 18 emergency exemption program has supported public health exemptions to help manage the spread of the Zika virus through mosquitoes.
On January 27, 2006, EPA published a final rule (71 FR 4495) revising the regulations governing emergency exemptions, which became effective on March 28, 2006. The final rule, 40 CFR Part 166, contains two primary revisions to the application, review and approval process for specific exemptions. The first major revision was to create a streamlined recertification application for eligible repeat emergency exemption requests. The second major revision was to clarify the definition of significant economic loss and revision of data requirements for documenting loss.
FIFRA section 18 (see Attachment A-1) states in part that, "The Administrator may, at [his/her] discretion, exempt any Federal or State agency from any provision of this Act if [s]he determines that emergency conditions exist that require such exemption." Under this provision, EPA may temporarily authorize federal or state agencies to allow use of pesticide products under emergency conditions. Detailed regulations regarding the procedures for emergency exemptions are codified at 40 CFR Part 166 (see Attachment B-1).
FFDCA Section 408 (see Attachment A-3) requires that EPA establish tolerances, maximum legal limits for all pesticide residues in food, including those resulting from Section 18 emergency uses. Tolerances established for emergency exemptions are time-limited to correspond to the use season or multiple use seasons. Thus, data collected under this collection also allows the Agency to establish tolerances or tolerance exemptions for Section 18 emergency uses. When the Agency establishes a tolerance, there must be a finding that there is “reasonable certainty that no harm” will result to human health from aggregate and cumulative exposure to the pesticide, as required by the health-based standard. For FIFRA Section 18 actions, these Agency time-limited tolerance setting activities must be undertaken in a timely manner. Their expiration dates are established by a final rulemaking published in the Federal Register. The time-limited tolerances for pesticide emergency exemptions are codified at 40 CFR 176, see Attachment C.
This information is required to ensure that the States do not issue any registrations that might conflict with other requirements in FIFRA, or with FFDCA Section 408, which require that a tolerance exist for any pesticide used on a food or feed commodity (Attachment A-3). FIFRA Section 24(c)(3) mandates that if the 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 (Attachment A-2). 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 (Attachment B-2).
The data collected by the Agency under FIFRA Section 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: 1) an emergency condition exists; 2) use of the pesticide under the exemption will be protective of human health and the environment; and 3) the requested product will be effective in allaying the emergency. Information contained in the application and follow-up reporting is essential for gauging the emergency nature of the situation, the effectiveness of the product, the risks of the treatment program, and the economic loss based on the new tiered thresholds for significant economic loss determination.
The potential respondents to the SLN information collection activity are the States, which FIFRA Section 2(aa) defines to include any of the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, the Trust Territory of the Pacific Islands, and American Samoa. The information "users" are the Agency decision makers at the U.S. EPA Office of Pesticide Programs (OPP). The information is used to ensure conformity with FIFRA and FFDCA. The States are required to collect, from the manufacturer or grower groups, adequate information to support the Section 24(c) application for registration or amendment. Both the State and the manufacturer or grower group are required to keep records.
This information collection activity is unique and is administered by EPA pursuant to FIFRA. There is no possibility of duplication by any other federal agency.
Pursuant 5 CFR 1320.8(d) of the OMB regulations implementing the PRA, EPA provided a 60-day opportunity for public review and comment on the proposed renewal of this ICR, which was announced in the Federal Register of August 17, 2020 (85 FR 50022). EPA did not receive any comments in response to that previously provided public review opportunity. The proposed renewal ICR and related Federal Register document can be found in the docket identified as EPA-HQ-OPP-2017-0619, which can be accessed at http://www.regulations.gov.
In addition, EPA is providing an additional 30-day opportunity for public review and comment on the ICR submitted to OMB for review and approval, which is announced in the Federal Register at the time of its submission to OMB. The Federal Register document, along with this Supporting Statement and accompanying materials, are located in the same docket. Any additional public comments will also be added to this same docket.
In addition to the Federal Register notice that provided a 60-day opportunity for public review and comment on the proposed renewal of this ICR, the Agency previously sent consultation requests, as required under 5 CFR 1320.8(d)(1), to three representatives from state pesticide agencies who interact with the Agency through the use of this collection instrument. EPA staff sought feedback on the burden estimates in the ICR, the clarity of instructions provided, and other questions pertaining to the requirements of the program. Three representatives responded to the Agency’s request, indicating that they believed that all labor costs have been accounted for in this supporting statement and that the burden and labor cost estimates seemed accurate. Based on this feedback, EPA did not adjust its estimates as presented during the public comment period.
A list of the state agencies contacted, the questions sent to the representatives, and the responses to those questions are attached to the ICR (see Attachment F).
In addition, EPA is currently developing a new ICR that will consolidate this and several other approved ICRs. The consolidated ICR will include any updates to the information collection activities covered by this ICR.
As discussed above, there is no collection schedule for these information collection activities, per se. This activity is conducted only once per application for a FIFRA Section 18 or Section 24(c) registration. Therefore, it is not possible for EPA to reduce the frequency of the collection.
EPA requires the States to maintain records of the first food use of a pesticide under an emergency exemption for two years following the date of expiration. Generally, an applicant for an emergency exemption is not required to maintain data beyond the date that the summary report has been received by the Agency. The OMB guidelines codified in 5 CFR 1320.6 indicate that data, other than health, medical, or tax records, need not be retained for more than three years; therefore, this time limit will not be exceeded in this program.
OMB regulations require agencies to provide a statement indicating whether the proposed collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and an explanation of the decision (5 CFR 1320.5(a)(iii)(E)). OPP does offer the option of electronic submission of emergency exemption requests, or Section 18 applications. States may e-mail applications to OPP in Word or pdf format.
The recordkeeping activities briefly described in this program exceed OMB’s guideline that agencies not require that records be retained for more than 3 years (5 CFR 1320.5(d)(2)(iv)). As authorized under FIFRA Section 8, EPA regulations require that registrants retain records containing research data relating to registered pesticides (including all data submitted to EPA in support of a registration - see 40 CFR 169.2(k)) for as long as the registration is valid and the producer is in business. However, the burden related to the recordkeeping requirements is covered under another ICR (see OMB Control No. 2070-0028, Recordkeeping Requirements for Producers of Pesticides under Section 8 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (EPA ICR No. 0143)).
In addition, this information collection does not include any estimated burden or labor costs related to the third-party activities associated with pesticide product labeling. In 1995, OMB determined, in the context of OMB Control No. 2070-0060, Application for New and Amended Pesticide Registration (EPA ICR No. 0277), that the Agency does not need to estimate burden or labor costs for the third-party disclosure requirement involving the registrant’s disclosure of product specific information to potential users and the general public through the pesticide labeling. This activity is not considered to be a collection of information subject to approval under the PRA because the information that must be included as the product labeling has been approved and provided by EPA. (5 CFR 1320.3(c)(2)).
Although a pilot project to develop a fully electronic SLN submission option is underway, OPP is not offering a fully electronic SLN submission option at this time. Extensive guidance regarding the SLN submission process is available to states via the OPP Internet site at: http://www.epa.gov/opprd001/24c/.
Although EPA urges submitters to minimize the amount of Confidential Business Information (CBI) contained in Section 18 requests, some data and/or information submitted to the Agency in conjunction with this rule may be claimed as trade secret or commercial or financial information and will be protected from disclosure by EPA under FIFRA Section 10 and the associated regulations codified at 40 CFR Part 2, Subpart B. In general, EPA works to make information relative to Section 18 decisions and supporting data easily available to the public (e.g. web site postings of program information, and public distribution of decision documents). Growers and industry stakeholders need to be made aware of Section 18 exemptions. Thus, as a rule, claims of confidentiality are not made on emergency exemption applications. On certain rare occasions, the manufacturer of the requested product may have formulation information that is necessary to protect CBI.
Trade secret information and CBI are handled strictly in accordance with the FIFRA CBI Security Manual. This manual contains instructions relative to all contact with confidential documents, including the responsibilities of EPA employees; physical security measures; CBI materials within EPA, such as CBI typing procedures (documents typed internally or on contract); and internal division procedures. The manual dictates that: (1) all CBI must be marked or flagged as such by the submitter of that information, (2) all CBI must be kept in secure, double-locked areas, and (3) all CBI for destruction must be cleared by a document control officer and shredded.
The Agency estimates that less than 0.1% of the FIFRA Section 24(c) registrations are for new products, thereby requiring the submission of a Confidential Statement of Formula. In addition, any data and/or information brought to the Agency in conjunction with the submission of FIFRA Section 24(c) registrations may be claimed as trade secret, commercial or financial information and must be protected from disclosure by EPA under FIFRA Section 10 and the associated regulation as contained in 40 CFR Part 2, Subpart B. All CBI data submitted to EPA under FIFRA is handled strictly in accordance with the provisions of the FIFRA CBI Security Manual.
No information of a sensitive or private nature is requested in conjunction with this ICR. Further, this information collection activity complies with the provisions of the Privacy Act of 1974 and OMB circular A-108.
Respondents affected by the collection activities under this ICR include Federal and State agencies which regulate pesticides or pesticide products, with the vast majority done by States, as well as pesticide registrants for the Section 24(c) applications. Section 2(aa) of FIFRA defines state to include any of the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, the Trust Territory of the Pacific Islands, and American Samoa. The North American Industrial Classification System (NAICS) code assigned to the States and Federal government agencies responding to this information collection is 999200, State Government. The NAICS code used for registrants is 325300, Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing.
To request an FIFRA Section 18 emergency exemption, an application must be submitted in writing 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 (See Attachment A-1).
Applications for specific, quarantine, or public health exemptions must contain the following information:
Data Item |
Description |
Identity of contact person(s) |
Name and telephone number of one or more qualified experts who may be contacted if questions arise concerning the application. |
Description of the pesticide |
Description of pesticide(s) proposed for the use under the exemption. For a federally registered pesticide:
For an unregistered pesticide product, copy of:
|
Description of the proposed use |
Application must identify all of the following:
|
Alternative methods of control |
Detailed explanation of why the pesticide(s), currently registered for the particular use proposed in the application, is not available in adequate supplies and/or effective to the degree needed to control the emergency. If the applicant states that an available registered pesticide is ineffective for the given situation, the statement must be supported by field data that demonstrate this, or if such data are unavailable, statements by qualified agricultural experts, extension personnel, university personnel or other persons similarly qualified in the field of pest control. In addition, a detailed explanation must be provided of why alternative practices, if available, either would not provide adequate control or would not be economically or environmentally feasible. |
Effectiveness of proposed use |
Application must contain data, discussion of field trials, and other evidence that provide the basis for the conclusion that the proposed pesticide treatment will be effective in dealing with the emergency. |
Discussion of residues for food uses |
If proposed use is expected to result in residues of the pesticide in or on food or feed, application must list the food likely to contain such residues and must contain an estimate of the maximum amount of the residue likely to result from the proposed use, together with the information on which such estimates are based. |
Discussion of risk information |
Potential risks to human health, endangered species, beneficial organisms, and the environment expected to result from the proposed use, together with references to data and other supporting information. |
Coordination with other affected state or federal agencies |
If the proposed pesticide use is likely to be of concern to other Federal or state agencies, application must indicate that such agencies have been contacted prior to submission of the application, and any comments received from such agencies must be submitted to EPA. |
Notification of registrant or basic manufacturer |
Statement that the registrants of all pesticide products proposed for use or, if appropriate, the basic manufacturer, support the request for a specific, quarantine, or public health exemption. |
Description of proposed enforcement program |
Explanation of the authority of the applicant or related state or federal agency for ensuring that use of the pesticide under the proposed exemption would comply with any special requirements imposed by EPA and a description of the program and procedures for assuring such compliance. |
Progress toward registration
|
Prior to submitting an application for a repeat specific or public health exemption, the federal or state agency must contact the registrant regarding the progress being made toward registration of the proposed use and include this information in the Section 18 application. This information must also include a summary of study deficiencies and data gaps, and registrant's timetable for completing requirements for registration. |
In addition, the following information must be provided for exemption applications, depending on the type of exemption:
Data Item |
Description |
For a specific exemption |
All of the following, as appropriate, must be provided concerning the nature of the emergency:
|
For a quarantine exemption |
A quarantine exemption may be authorized in an emergency condition to control the introduction or spread of any pest new to and therefore known to be widely prevalent or distributed within and throughout the United States and its territories. The application for the quarantine exemption must include the following information:
|
For a public health exemption |
|
For a crisis exemption, only the following information must be provided: |
The state or federal agency issuing the crisis exemption must coordinate any crisis declaration in advance with EPA prior to initiating the use. The notice must include:
|
To comply with the reporting and record keeping requirements for specific, quarantine, and public health exemptions, the exemption holder must provide the following data items to EPA:
Data Item |
Description |
Unexpected adverse effects information |
Any unexpected adverse effects resulting from the use of a pesticide under a crisis, specific, quarantine, or public health exemption must be reported immediately to the Agency. |
Final reports |
A report summarizing the results of pesticide use under a specific, quarantine, and public health exemption must be submitted to EPA within six months of the expiration of the exemption unless otherwise specified by the Agency. The information in this report must include the following:
any other information requested by the Administrator. |
Records |
Records for all treatments involving the first food use of a pesticide will be maintained by the state or federal agency for which an emergency exemption was granted for a minimum of two years following the date of expiration of the exemption. On request by EPA, these records must be made available to the Administrator. Records must include the following;
|
Notice of State Pesticide Registrations to Meet a Special Local Need (FIFRA §24(c))
Application for a 24(c) registration: Applicants for State registrations under FIFRA Section 24(c) to meet a special local need (typically pesticides manufacturers and grower groups) must submit the following information directly to the State using EPA Form 8570-25, Application for/Notification of State Registration of a Pesticide to Meet a Special Local Need (Attachment E), and EPA Form 8570-4, Confidential Statement of Formula (Attachment D), when applicable:
Data Item |
Description |
Identity of contact person(s) |
Name and address of the applicant and any other person whose name will appear on the labeling or in the directions for use. |
Description of the pesticide |
The name of the pesticide product, and, if the application is for an amendment to a federally registered product the EPA registration number of that product. |
Proposed product labeling |
A copy of the proposed labeling, including all claims made for the product as well as directions for its use to meet the special local need, consisting of:
|
Proposed product formulation |
The complete formula of the product, if the application is for a new product registration. |
Other relevant information about product |
Any other information that is required to be reviewed prior to registration. |
Information following the issuance of a 24(c) registration: As soon as practical after a registration is issued, the following information must be provided:
Data Item |
Description |
Copy of the final printed labeling |
New product labeling must contain:
|
Information Requested by EPA to verify an SLN registration: Within ten working days from the date a State issues, amends or revokes a registration, the State is required to notify EPA, in writing, of the action. Using EPA Form 8570-25 where applicable, notification of State registration or amendments thereto, must include the following:
Data Item |
Description |
Effective Date |
|
Product Information |
|
Final Product Labeling |
State must send EPA a copy of the final printed labeling approved by the State within 60 days after the effective date of the registration or amendment. |
Other relevant information |
The Agency may request, when appropriate, that a State submit any data used by the State to determine that unreasonable adverse effects will not be caused. |
To obtain permission to use an unregistered pesticide product under the emergency exemption program, an applicant must petition EPA in writing, provide information addressing the data items listed above, and commit to the submission of the summary report on the use. Section 18 emergency exemption applications are submitted electronically to the [email protected] and/or hardcopy to the Document Processing Desk (EMEX), Office of Pesticide Programs (7504P), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C., 20460-0001.
EPA Form No. 8570-4, Confidential Statement of Formula (Attachment D), is the single form associated with the emergency exemption program for an unregistered product. This form is being used for this ICR but is covered by a different ICR - Application for New and Amended Pesticide Registration (OMB No. 2070-0060, EPA ICR No. 0277).
In order to participate in the program, the applicant must complete the following tasks:
Read the applicable FIFRA requirements and CFR regulations.
Process, compile, and review the requested data.
Generate application correspondence and a follow-up summary report.
Store, file, or maintain the information.
Applicant Activities:
Data Item |
Description |
Gather data |
Proposed label, product formulation (if applicable), name of applicant, name of product, federal registration number (if applicable), and any other information required by the State. |
Submit materials to the State |
Compile necessary data and materials. Complete application for State registration (EPA Form 8570-25) and submit to State |
Store, file, and maintain the information |
Applicant must maintain records of information submitted to the State for as long as the State registration is active. |
State Activities:
Data Item |
Description |
Compile information |
Organize data submitted by registrant (or grower group) to develop the SLN justification. Registrant must maintain records of information submitted to the State. |
Review information |
Evaluate the data: 1. Determine whether there is a special local need for the registration; 2. Determine that use of the product for which registration is sought will not cause unreasonable adverse effects on humans or the environment; 3. For use of a product with public health claims, determine that the product warrants the claims made, i.e., efficacy determination; 4. Review the proposed labeling submitted with the application to determine State and federal compliance; 5. Issue or amend State registration. |
Notify Federal Government |
Complete and submit EPA Form 8570-25 and all accompanying data and materials. Respond to any Agency questions or concerns. |
Store, file, and maintain the data |
Maintain copies of the information and data submitted to EPA. |
Respond to Registrant (if necessary) |
Notify registrant if Federal Government disapproves the State's registration. |
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 tolerance petitions related to FIFRA Section 18 are evaluated on a case-by-case basis to determine if adequate reliable data are available to make the required safety finding mandated under FFDCA Section 408 and FQPA.
Applications for emergency exemptions are submitted by U.S. States and Territories, and Federal agencies at their discretion. These applications are received by OPP, Registration Division, Minor Use and Emergency Response Branch, where they are reviewed for completeness. The application package is routed to scientists and economists within OPP to determine whether the proposed emergency exemption is warranted, that there is “reasonable certainty of no harm” to human health resulting from aggregate and cumulative exposure, and that it presents no undue hazard to humans or the environment (See Attachment B-1). Once the determinations are made, the applicant is notified in writing. The tolerance is published in the Federal Register.
The Agency conducts the following activities when responding to an emergency exemption application under FIFRA Section 18:
Route the application/report to appropriate scientists and economists for review.
Review information submitted for scientific accuracy.
Perform a biological, ecological, and economic analysis and a multi-disciplinary risk assessment of the requested use and then forward a regulatory recommendation on the proposed exemption along with a draft notification to EPA management.
Make the FQPA finding of “reasonable certainty of no harm” to human health resulting from aggregate and cumulative exposure. Establish a time-limited tolerance if required.
Conduct an assessment of the progress toward registration for the requested use.
OPP Director (or designee) makes final decision.
Notify applicant of decision.
Prepare and publish Federal Register Notice (for applicable food use requests).
Record electronic data in Agency's data system and Internet site.
Activity |
Description |
Read and record State-submitted information |
EPA Form 8570-25 and the application is screened, jacket created, and information is recorded in electronically for tracking purposes. |
Review data submissions |
Review materials for adherence to federal requirements of label integrity, lack of imminent risk, and the existence of appropriate tolerances. |
Publish summary of 24(c)s |
Publish, on a regular basis, in the Federal Register, a summary of all State registrations received and those disapproved. |
Notify State (if necessary) |
Notify the State if the registration is disapproved. |
Store/file/maintain the data |
Maintains an electronic reference file on all FIFRA Section 24(c) applications received and approved. |
When applications for emergency exemptions are received by EPA, they are jacketed and filed by the name of the state, territory or federal agency, by the date, and by the number of the submission for that entity. The application is tracked in EPA’s data system as an active pending request through the determination process, and subsequent receipt of the summary report, after which the exemption becomes a historical file and the regulatory action is closed.
The FIFRA Section 24(c) application form and any supporting materials are received and date-marked to start the 90-day clock. They are screened for completeness, a master file jacket is created for the incoming application, and the case is assigned a unique identifier. The file then is reviewed for substantive acceptability, and any scientific data is routed for review by appropriate specialists. When all reviews are completed a decision is made to accept or disapprove the application.
If the decision is to disapprove the application, the State is notified within the 90-day window, and a notice of disapproval is published in the FR. If the EPA determines there are no issues with the State registration, then a record of acknowledgement is recorded in the master file, and no further action is required.
Small entities are not impacted by this ICR. FIFRA Sections 18 and 24(c) 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.
While pesticide manufacturers and grower groups may be involved in EPA-State activities under this ICR, any activities they undertake are in response to FIFRA Section 24(c), which expressly delegates certain pesticide registration authority to States. These entities must comply with State procedures to obtain a special local need registration under FIFRA Section 24(c). Consequently, the Agency cannot offer them any flexibility without intruding on the processes established by each State.
There is no collection schedule associated with this ICR, per se. This information collection activity is initiated by the States or by certain federal agencies when they apply for a FIFRA Section 24(c) registration, or determine that they are confronted with an emergency situation and subsequently submit an emergency exemption application to EPA under FIFRA Section 18.
The respective burden and cost estimates for PRA activities for the Section 18 and Section 24(c) programs are presented in this section, along with the methodology for developing the estimates.
The estimates of burden hours per request or application were developed with input from respondents for both programs and used in the currently-approved ICR. EPA believes that these previous burden estimates are still valid. Therefore, there is no change in the estimated respondent burden hours per application for either program in this ICR.
The estimated burden hours per response (request or application), for each respondent collection activity by labor category, is presented in separate tables for Sections 18 and 24(c) in section 6(b) of this ICR (along with labor costs per response). The total average respondent burden hours per request is derived by adding the burden for all activities for each labor category and then summing across labor categories. The total annual respondent burden is calculated as the total burden hours per request times the number of requests (applications) received annually and is shown in tables for each collection in section 6(b) of this ICR (along with total annual labor costs).
The estimated number of applications submitted annually has been updated for this ICR. The number of applications received annually for both Section 18 and Section 24(c) has decreased since the currently-approved ICR. The estimates used in this ICR of the number of applications submitted annually under Section 18 and Section 24(c) are based on three-year averages of applications actually received for each program for the years 2014 through 2016.
The estimated average burden of 99 hours per emergency exemption request is presented in Table 1. The total annual response burden associated with submitting applications and summary reports for emergency exemptions is estimated to be 14,157 burden hours per year for the next three years. The number of emergency exemption applications received by EPA has decreased from an average of 185 per year for the years 2011- 2013 to an average of 143 per year for the years 2014-2016. The total annual respondent burden is shown in Table 2 (along with total annual labor costs). The important trends seen in the applications received in the past three years are:
successful transition of many widely used, minor crop, Section 18 emergency pesticide uses to full registrations and tolerances under Section 3 labels, thereby eliminating numerous, long-running (repeat) applications from many states;
continuing pest management challenges that are national in scope that trigger emergency exemption requests, e.g., the use of sulfoxaflor in sorghum and clothianidin in citrus to control sugarcane aphid and Asian citrus psyllid, respectively, as well as reliance on Section 18 requests to respond to public health threats such as the Zika virus spread through mosquitoes.
The Agency expects that some of these factors will persist and expects to receive an average of about 143 applications annually for the next three years. However, the Agency is unable to estimate precisely how many requests will be submitted in the future.
Registrant Burden Hours
The Agency estimates the average burden for applicants (registrants) for state registrations under FIFRA Section 24(c) to equal approximately 39 hours per application, as presented in Table 3. The Agency expects that approximately 223 applications will be submitted annually during the next 3 years, based on the annual average from 2014-2016. The estimated number of applications has decreased significantly from 305 applications annually in the currently-approved ICR. The Agency estimates an annual applicant (registrant) burden of 8,697 hours, shown in Table 4.
State Agency Burden Hours
EPA estimates the state agency burden to average 13 hours per response, as shown in Table 5. The Agency estimates an annual State Agency burden of 2,899 hours (see Table 6).
Overall Burden Hours
The overall respondent burden associated with this collection, which is the sum of registrant and state agency burden, is estimated to be 11,596 hours per year, presented in Table 7. No changes have been made in the requirements for Section 24(c) applications, and no changes have been made to the overall provisions of this information collection activity.
The labor costs for respondents to respond to the information collection requirements are calculated by using the estimated burden per response, the number of responses annually, and the appropriate wage rates for each activity. The methodology and sources for wage rates used is presented in the subsection below.
The labor cost per response (application or request) is calculated by multiplying the burden hours for each respondent collection activity by the wage rate for the affected labor category. The labor cost for each collection activity per application is summed across labor categories (e.g., managerial, technical, and clerical). Then the total labor cost for each collection activity is summed for the total labor cost per application. The applicable wage rates and these labor costs are presented in separate tables for Sections 18 and 24(c) (along with burden hours) below.
The total annual labor costs for each labor category are calculated by multiplying the total annual burden hours for that category by the applicable wage rate. Total costs for each labor category are then summed to get the total annual labor costs for the collection. These associated labor costs are presented below in separate tables for each of the two collections.
For this ICR, the Agency revised the estimated wages, benefits, and overhead for all labor categories for affected industry, state government, and EPA employees based on the most recent publicly available data from the US Bureau of Labor Statistics. The methodology for calculating the wage rates is the same for both the emergency exemption and SLN collections, and are based on 2016 wage data (see Attachment G). The calculation of the wage rates uses base wage data for each sector and labor type for an Unloaded wage rate (hourly wage rate) and calculates the Loaded wage rate (unloaded wage rate + benefits) and the Fully loaded wage rate (loaded wage rate + overhead) based on that data. Fully loaded wage rates are used to calculate respondent labor costs.
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) (see 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 in Attachment G. 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 average rate of benefits for all civilian non-farm workers (see http://www.bls.gov/news.release/ecec.t01.htm). If any sectors are listed for which 46% is not applicable; the applicable percentage will be stated.
Fully Loaded Wage Rate: The loaded wage rate is multiplied by 50% (EPA guidelines suggest 20-70%) to get overhead costs.
For Section 18 emergency exemption requests, the state government is the applicant and the only respondent. Table 1 shows the labor costs per emergency exemption request (or application) of each collection activity, and the total labor cost per request. The total estimated respondent labor costs for completing a Section 18 application and summary report are $6,394 per response.
Table 1. FIFRA §18 – Applicant (State Government) Burden Hours and Labor Cost Estimates per Emergency Exemption Request
COLLECTION ACTIVITY |
Burden per Application (hours) 1 |
Total 2 |
|||
Managerial |
Technical |
Clerical |
Hours |
Costs ($) |
|
$92.95 /hr. |
$63.83/hr. |
$43.24/hr. |
|||
Read FIFRA and FQPA requirements and CFR regulations |
4.0 |
4.0 |
0.0 |
8.0 |
$627 |
Process, compile, and review the requested data for accuracy and appropriateness |
0.0 |
74.0 |
0.0 |
74.0 |
$4,723 |
Generate application correspondence and follow-up summary report |
0.0 |
15.0 |
0.0 |
15.0 |
$957 |
Store/maintain/submit information |
0.0 |
0.0 |
2.0 |
2.0 |
$86 |
Totals |
4.0 |
93.0 |
2.0 |
99.0 |
$6,394 |
|
Table 2 shows the total annual labor costs for management, technical, and clerical time, as well as the estimated total annual respondent burden hours (14,157 hours) and labor costs ($914,409) of filing Section 18 applications and summary reports.
Table 2. FIFRA §18 – Total Annual Applicant (State Government) Burden Hours and Labor Cost Estimates
Labor Category |
Burden Hours per Application |
Number of Applications |
Total Annual Hours |
Labor Rate ($/hr.) |
Total Annual Costs |
Managerial |
4 |
143 |
572 |
$92.95 |
$53,167 |
Technical |
93 |
143 |
13,299 |
$63.83 |
$848,875 |
Clerical |
2 |
143 |
286 |
$43.24 |
$12,367 |
Totals |
99 |
143 |
14,157 |
|
$914,409 |
For Section 24(c) applications for SLN registrations, respondents include both pesticide product registrants and state governments, as each bears a burden for an application. Labor costs for the two respondent groups are presented separately, and then summed together, in the tables below. Table 3 displays estimates of the labor cost per SLN registration application for registrants, both by collection activity and the total. Total labor costs per application to registrants are estimated to be $3,286.
Table 3. FIFRA §24(c) - Applicant (Registrant) Burden Hours and Labor Cost Estimates per Application
COLLECTION ACTIVITY |
Burden per Application (hours) 1 |
Total 2 |
|||
Managerial
|
Technical
|
Clerical
|
Hours |
Costs |
|
$124.81 /hr. |
$67.19/hr. |
$43.74 /hr. |
|||
Gather data |
5.00 |
12.50 |
0.00 |
17.50 |
$1,464 |
Submit materials to state |
9.00 |
5.50 |
1.00 |
15.50 |
$1,537 |
Store/file/maintain the data |
0.00 |
1.00 |
5.00 |
6.00 |
$286 |
Totals |
14.00 |
19.00 |
6.00 |
39.00 |
$3,286 |
1 Hourly wages rates are fully loaded wage rates based on NAICS 325300 (Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing) from U.S. Dept. of Labor, Bureau of Labor Statistics, May 2016. See Attachment G for wage calculations. 2 Totals may not sum due to rounding. |
Table 4 shows the total annual burden hours and costs for management, technical, and clerical time, as well as the estimated total annual respondent (registrant) burden hours (8,697 hours) and labor costs ($732,865) of filing Section 24(c) applications.
Table 4. FIFRA §24(c) - Total Annual Applicant (Registrant) Burden Hours and Labor Cost Estimates
Labor Category |
Burden Hours per Application |
Number of Applications |
Total Annual Hours |
Labor Rate ($/hr.) |
Total Annual Costs |
Managerial |
14.0 |
223 |
3,122 |
$124.81 |
$389,657 |
Technical |
19.0 |
223 |
4,237 |
$67.19 |
$284,684 |
Clerical |
6.0 |
223 |
1,338 |
$43.74 |
$58,524 |
Totals |
39.0 |
223 |
8,697 |
|
$732,865 |
Table 5 presents estimates of labor costs per application for state governments, by collection activity and total for Section 24(c) applications.
Table 5. FIFRA §24(c) – Applicant (State Agency) Burden Hours and Labor Cost Estimates per Application
COLLECTION ACTIVITY |
Burden per Application (hours) 1 |
Total 3 |
|||
Managerial |
Technical |
Clerical |
Hours |
Costs |
|
$92.95 /hr. |
$63.83 /hr. |
$43.24/hr. |
|||
Compile information |
0.0 |
1.0 |
0.0 |
1.0 |
$64 |
Review submission information |
0.0 |
5.5 |
0.0 |
5.5 |
$351 |
Complete and transmit paperwork to EPA 2 |
0.0 |
5.4 |
0.4 |
5.8 |
$362 |
Store/file/maintain the data |
0.0 |
0.0 |
0.1 |
0.1 |
$4 |
Respond to registrant (if necessary) |
0.0 |
0.4 |
0.2 |
0.6 |
$34 |
Totals |
0.0 |
12.3 |
0.7 |
13.0 |
$781 |
1 Hourly wages rates are fully loaded wage rates based on NAICS 999200 (State Government), U.S. Dept. of Labor, Bureau of Labor Statistics, May 2016. See Attachment G for wage calculations. 2 Includes label revisions, SLN registration cancellations, and other follow-up actions data. 3 Totals may not sum due to rounding. |
|||||
Table 6 shows the total annual burden hours and labor costs for management, technical, and clerical time, as well as the total annual respondent (state agency) burden hours (2,899 hours) and labor costs ($181,829) of filing Section 24(c) applications.
Table 6. FIFRA §24(c) - Total Annual Applicant (State Agency) Burden Hours and Labor Cost Estimates
Labor Category |
Burden Hours per Application |
Number of Applications |
Total Annual Hours |
Labor Rate ($/hr.) |
Total Annual Costs |
Managerial |
0.0 |
223 |
0 |
$92.95 |
$0 |
Technical |
12.3 |
223 |
2,743 |
$63.83 |
$175,079 |
Clerical |
0.7 |
223 |
156 |
$43.24 |
$6,750 |
Totals |
13.0 |
223 |
2,899 |
|
$181,829 |
Table 7 shows the total annual combined burden hours and labor costs for registrants and states for Section 24(c) applications. The total annual burden hours of the Section 24(c) program for respondents is approximately 11,596 hours at a labor cost of $914,694.
Table 7. FIFRA §24(c) - Total Annual Applicant (Registrant and State Agency) Burden Hours and Labor Cost Estimates
Applicant |
Burden Hours per Application |
Number of Applications |
Total Annual Hours |
Cost per Application |
Total Annual Costs |
Registrant |
39.0 |
223 |
8,697 |
$3,286 |
$732,865 |
State |
13.0 |
223 |
2,899 |
$781 |
$181,829 |
Totals |
52.0 |
223 |
11,596 |
$4,068 |
$914,694 |
The EPA estimates Agency burden hours using employee time accounting data from OPP Divisions that provide significant support and analysis for the FIFRA Section 18 emergency exemption and Section 24(c) special local need programs. The data is taken from the Time and Attendance Information System (TAIS), which archives the Agency’s Full Time Equivalents (FTEs) for most OPP program activities. The TAIS system tracks time for seven of OPP’s nine divisions. The two divisions that are not tracked by TAIS, the Field and External Affairs Division (FEAD) and the Information Technology and Resource Management Division (ITRMD), contribute only minimally if at all to the Section 18 and 24(c) programs. ITRMD provides the preliminary data processing and tracking for many OPP ICR activities including tolerance petitions. These systems are integrated for efficient processing, tracking, and maintaining data but they do not readily lend themselves to a clear burden breakdown by ICR activity. The Agency believes that using data from the TAIS accurately reflects the time spent on implementing and administering emergency exemption and SLN activities than former estimates.
Total annual FTEs are presented below, in separate tables for Sections 18 and 24(c), by labor category and OPP Division, and summed for division and OPP totals. Other tables show estimated annual burden hours for each program, by multiplying 2,080 hours in a work year by the FTEs.
The labor costs per burden hour are the fully loaded wage rates, which are estimated in the same manner as they are for respondents. The fully loaded wage rate for the Agency is based on NAICS 999100, Federal government. (See Attachment G) The total annual burden hours for each labor category are estimated by the applicable wage rate to get the total labor cost per category. Then labor category estimates are summed to get total estimated annual agency labor costs for each program.
Six of the seven OPP divisions reporting in TAIS reported time for the Section 18 and 24(c) programs. These are the Registration Division (RD), the Biopesticides and Pollution Prevention Division (BPPD), and the Antimicrobial Division (AD), the Health Effects Division (HED), the Biological and Economic Analysis Division (BEAD), and the Environmental Fate and Effects Division (EFED). The Pesticide Re-evaluation Division (PRD) (formerly the Special Review and Registration Division (SRRD)) did not report labor hours for either program. Total annual FTEs are presented below, in separate tables for Sections 18 and 24(c), by labor category and OPP Division, and summed for Division and OPP totals. Other tables show estimated annual burden hours for each program by multiplying 2,080 hours in a work year by the FTEs.
Table 8 displays annual average FTEs by labor category and OPP division from TAIS data. The estimates in this ICR are unchanged from the currently-approved ICR. EPA does not expect that the number, or proportional allocation of FTEs by division, supporting Section 18 applications to have changed dramatically since the last ICR. Six of the seven OPP divisions that report in TAIS participated in Section 18 activities. The number of FTEs in each category is summed and rounded up to the next full FTE to account for minor activities of the two OPP divisions that do not use the TAIS system and to account for other small fractions of FTEs that are less than 0.1. The data indicate that the estimated number of Agency FTE’s dedicated to Section 18 emergency exemption activities is approximately 1 managerial FTE, 5 technical FTEs, and 1 clerical FTE, for total of 7 FTEs allocated to emergency exemption activities.
Table 8. Average Annual Agency FTEs Supporting Section 18 Activities, 2014-2016
FTE Type |
RD |
BEAD |
EFED |
AD |
BPPD |
HED |
OPP Total |
Managerial |
0.3 |
0.1 |
0.0 |
0.0 |
0.0 |
0.0 |
1 |
Technical |
2.9 |
0.8 |
0.2 |
0.0 |
0.0 |
0.2 |
5 |
Clerical |
0.2 |
0.1 |
0.0 |
0.0 |
0.0 |
0.0 |
1 |
Totals2 |
3.4 |
1.0 |
0.2 |
0.0 |
0.0 |
0.2 |
7 |
1 OPP total for each labor category is rounded up to the next full FTE. 2 Division totals do not sum to OPP total due to rounding. |
Table 9 displays the Agency burden hours, wage rates, and total labor costs of supporting the Section 18 program. The total annual Agency burden for Section 18 activities is approximately 14,560 hours per year; the total annual Agency labor cost of the Section 18 program are approximately $1.22 million.
Table 9. Total Annual Agency Hours, Hourly Wage Rates, and Total Labor Costs by Labor Category Supporting Section 18 Activities
FTE Type |
FTEs (rounded) |
Hours / FTE 1 |
Total burden hours |
Fully loaded wage rates ($/hr.) 2 |
Annual per FTE cost |
Total Cost |
Managerial |
1 |
2,080 |
$127.07 |
$264,306 |
$264,306 |
|
Technical |
5 |
2,080 |
10,400 |
$83.40 |
$173,472 |
$867,360 |
Clerical |
1 |
2,080 |
2,080 |
$47.14 |
$98,051 |
$98,051 |
OPP totals |
7 |
2,080 |
14,560 |
|
|
$1,229,717 |
1 Hours per FTE = 40 hours/week × 52 weeks/year 2 See Attachment G for data sources and calculations of fully loaded wage rates. |
Table 10 displays annual average FTEs by labor category and OPP division from TAIS data. The estimates in this ICR are unchanged from the currently-approved ICR. EPA does not expect that the number, or proportional allocation of FTEs by division, supporting Section 24(c) applications to have changed dramatically since the last ICR. Six of the seven OPP divisions that report in TAIS participated in Section 18 activities. The number of FTEs in each category is summed and rounded up to the next full FTE to account for minor activities of the two OPP divisions that do not use the TAIS system and to account for other small fractions of FTEs that are less than 0.1. The data indicate that the estimated number of Agency FTE’s dedicated to Section 24(c) activities is approximately 1 managerial FTE, 2 technical FTEs, and 1 clerical FTE, for a total of 4 FTEs allocated to SLN activities.
Table 10. Average Annual Agency FTEs Supporting Section 24(c) Activities, 2014-2016
FTE Type |
RD |
BEAD |
EFED |
AD |
BPPD |
HED |
OPP Total 1 |
Managerial |
0.2 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
1 |
Technical |
1.5 |
0.0 |
0.1 |
0.0 |
0.1 |
0.0 |
2 |
Clerical |
0.1 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
1 |
Totals 2 |
1.8 |
0.0 |
0.1 |
0.0 |
0.0 |
0.0 |
4 |
1 OPP total for each labor category is rounded up to the next full FTE. 2 Division totals do not sum to OPP total due to rounding. |
Table 11 displays the Agency burden hours, wage rates, and total labor costs of supporting the Section 24(c) program. The total annual Agency burden for Section 24(c) activities is approximately 8,320 hours per year; the total annual Agency labor cost of the Section 24(c) program is approximately $709 thousand.
Table 11. Total Annual Agency Hours, Hourly Wage Rate, and Total Labor Costs by Labor Category Supporting Section 24(c) Activities
FTE Type |
FTEs |
Hours / FTE 1 |
Total burden hours |
Fully loaded wage rates ($/hr.) 2 |
Annual per FTE cost |
Total Cost |
Managerial |
1 |
2080 |
2,080 |
$127.07 |
$264,306 |
$264,306 |
Technical |
2 |
2080 |
4,160 |
$83.40 |
$173,472 |
$346,944 |
Clerical |
1 |
2080 |
2,080 |
$47.14 |
$98,051 |
$98,051 |
Totals |
4 |
2080 |
8,320 |
|
|
$709,301 |
1 Hours per FTE = 40 hours/week × 52 weeks/year 2 See Attachment G for data sources and calculations of fully loaded wage rates. |
Table 12. FIFRA §18 - Total Annual Burden and Labor Cost Estimates for Applications and Summary Reports for Emergency Exemptions
|
Previous Estimates |
Current Estimates |
||
Hours |
Costs |
Hours |
Costs |
|
Respondents (state agencies) |
18,315 |
$1,086,403 |
14,157 |
$914,409 |
Agency |
14,560 |
$1,168,960 |
14,560 |
$1,229,717 |
Table 13. FIFRA §24(c) - Total Annual Burden and Labor Cost Summary for Notice
of Pesticide Registration by States to Meet a Special Local Need
|
Previous Estimates |
Current Estimates |
||
Hours |
Costs |
Hours |
Costs |
|
Respondents (registrants & states) |
15,860 |
$1,236,551 |
11,596 |
$914,694 |
Agency |
8,320 |
$673,504 |
8,320 |
$709,301 |
Table 14. Combined Respondent Burden for this ICR
Programs |
Previous Estimates |
Current Estimates |
||
Hours |
Costs |
Hours |
Costs |
|
Section 18 |
18,315 |
$1,086,403 |
14,157 |
$914,409 |
Section 24(c) |
15,860 |
$1,236,551 |
11,596 |
$914,694 |
Total |
34,175 |
$2,332,954 |
25,753 |
$1,829,103 |
Although the estimated unit burden for a given Section 18 application is unchanged, EPA estimates an increase in the number of FIFRA Section 18 application submissions and estimated annual burden relative to the existing, approved collection. EPA estimates that the total annual respondent burden has decreased from 18,315 hours to about 14,157 hours. This decrease corresponds with a decrease in the average number of Section 18s requested per year, from 185 to 143. Although EPA does not require Section 18s and cannot estimate precisely how many submissions will be received in the future, the Agency estimates that it could receive approximately 143 Section 18 applications annually over the next three years. The overall result of the decrease in the number of applications and updating the wage rates was that the estimated respondent labor cost decreased from $1.09 million to $914,409.
There is no change in the estimated respondent burden hours per SLN application for this ICR from the currently-approved ICR for FIFRA Section 24(c) applications, for either registrants or states. The total annual respondent burden estimate (registrants + states) has decreased from 15,860 to 11,596 due to a significant decrease in the average number of petitions received annually, from about 305 to 223. Although EPA does not require States to issue Section 24(c) registrations and cannot estimate precisely how many submissions will be received in the future, the Agency estimates that it could receive approximately 223 Section 24(c) applications annually over the next three years. As a result of the increase in the number of applications and updating the wage rates, the estimated respondent labor cost decreased from $1.24 million to $914,694.
The respondent burden for collection of information associated with the Applications and Summary Report for Emergency Exemption rule (FIFRA Section 18) is estimated to average 99 hours per application. The respondent burden for the Notice of State Pesticide Registrations to Meet a Special Local Need rule (FIFRA Section 24(c)) is estimated to average 52 hours per response (39 hours per registrant and 13 hours per State), including time for compiling the information/data submitted by the registrant, reviewing the information for special local needs determination, completing paperwork to notify the federal government, storing/filing/maintaining the data, and responding back to the registrant if the registration is disapproved by EPA. The burden estimate includes hours spent by the registrant in preparing the application for submission to EPA.
In the context of the Paperwork Reduction Act (PRA), “burden” is defined at 5 CFR 1320.3(b). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.
The Agency has established a public docket for this ICR that is available for online viewing at https://www.regulations.gov, or in person viewing at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave., NW., Washington, DC 20460-0001. The EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (202) 566-1744 and the telephone number for the OPP docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket at https://www.epa.gov/dockets.
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, identified by the docket ID number listed on page 1, to both EPA and OMB as follows:
• To EPA online using https://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.
• To OMB via email to [email protected]. Address comments to OMB Desk Officer for EPA.
EPA's policy is that all comments received will be included in the docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.
Attachments to the supporting statement are available in the public docket established for this ICR under docket identification number EPA-HQ-OPP-2017-0619. These attachments are available for online viewing at http://www.regulations.gov or otherwise accessed in person as described in Section 6(f) of the supporting statement.
Attachment A-1 |
7 U.S.C. 136p - Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Also available at online at the US House of Representatives’ hhttps://www.agriculture.senate.gov/imo/media/doc/FIFRA.pdf |
Attachment A-2 |
7 U.S.C. 136v - Section 24(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Also available online at: https://www.agriculture.senate.gov/imo/media/doc/FIFRA.pdf |
Attachment A-3 |
21 U.S.C 346a - Tolerances and exemptions for pesticide chemical residues, Section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA). Also available at online at the US House of Representatives’ https://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapIV-sec346a.pdf |
Attachment B-1 |
40 CFR part 166 - Exemption of Federal and State Agencies for Use of Pesticides under Emergency Conditions. Also available online at the National Archives and Records Administration’s https://www.gpo.gov/fdsys/pkg/CFR-1996-title40-vol11/pdf/CFR-1996-title40-vol11-part166.pdf |
Attachment B-2 |
40 CFR part 162 - State Registration of Pesticide Products. Also available online at the National Archives and Records Administration’s https://www.gpo.gov/fdsys/pkg/CFR-1996-title40-vol11/pdf/CFR-1996-title40-vol11-part162.pdf |
Attachment C |
40 CFR Part 176 - Time-Limited Tolerances for Pesticide Emergency Exemptions. Also available online at the National Archives and Records Administration’s https://www.gpo.gov/fdsys/pkg/CFR-2005-title40-vol23/pdf/CFR-2005-title40-vol23-part176.pdf |
Attachment D
|
EPA Form 8570-4 - Confidential Statement of Formula. Also available online at https://www.epa.gov/sites/production/files/2013-07/documents/8570-4_0.pdf |
Attachment E |
EPA Form 8570-25 - Application for/Notification of State Registration of a Pesticide to Meet a Special Local Need. This attachment can be also accessed via the internet at: https://www.epa.gov/sites/production/files/2013-08/documents/8570-25.pdf |
Attachment F |
Summary of Consultations for the Renewal ICR, entitled "Pesticide Program Public Sector Collections (FIFRA Sections 18 & 24(c)) (Renewal)” |
Attachment G |
Labor Wage Formulas |
Page
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | SUPPORTING STATEMENT FOR AN |
| Author | CSMOOT |
| File Modified | 0000-00-00 |
| File Created | 2021-01-12 |