                           SUPPORTING STATEMENT FOR
                   AN INFORMATION COLLECTION REQUEST (ICR)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

      a)	Title:	Submission of Unreasonable Adverse Effects Information under FIFRA Section 6(a)(2)

             	ICR Nos.:  OMB No. 2070-0039; EPA No. 1204.13

b)	Abstract

      Section 6(a)(2) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires pesticide registrants to submit information to the Agency which may be relevant to the balancing of the risks and benefits of a pesticide product.  The statute requires the registrant to submit any factual information that it acquires regarding adverse effects associated with its pesticidal products, and it is up to the Agency to determine whether or not that factual information constitutes an unreasonable adverse effect.  In order to limit the amount of less meaningful information that might be submitted to the Agency, the EPA has limited the scope of factual information that the registrant must submit.  The Agency's regulations at 40 CFR part 159 provide a detailed description of the reporting obligations of registrants under FIFRA section 6(a)(2).

2.	NEED FOR AND USE OF THE COLLECTION

      a)	Need/Authority for the Collection

      This information collection stems from a non-discretionary statutory requirement.  Submission of information about unreasonable adverse effects is specifically required under FIFRA section 6(a)(2) of (7 U.S.C. 136d(a)(2)) see Attachment A:

      "If at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, he shall submit such information to the Administrator."

      The Agency's FIFRA section 6(a)(2) regulations are codified in the Code of Federal Regulations (CFR) at 40 CFR part 159 (Attachment B), and Agency guidance is available in Pesticide Registration (PR) Notice 98-3 (Attachment C).

      In terms of scope, please note that in CSMA and NACA v. EPA, 484 F. Supp. 513 (1980), the U.S. District Court for the District of Columbia agreed with EPA that FIFRA section 6(a)(2) covers all information relevant to EPA's determination of whether a pesticide may cause unreasonable adverse effects.  The Court agreed that permissible information includes the same type of information as that provided by a registrant as part of an application for registration.  The Court specifically rejected the argument that the responsibility for determining what constitutes an unreasonable adverse effect shifts to industry once EPA has granted a registration.

      b)	Practical Utility/Users of the Data

      The Office of Pesticide Programs (OPP) is the primary user of the information that registrants submit to the Agency under FIFRA section 6(a)(2).  The information submitted is an essential component of the Agency's pesticide registration and registration review programs which also require the submission of important information regarding a pesticide's adverse effects, information which may not have been available at the time of the Agency's initial review of a registration application.  Because this information has potentially significant consequences for human health or the environment, the Agency's determination with regard to the registration of the pesticide may have been different if the information had been available earlier.  If warranted by the information provided, EPA may seek to amend the registration in order to address the concerns raised by the information.

      The adverse effects information submitted under section 6(a)(2) provides an important means of focusing EPA attention on key problem areas regarding the use of a particular pesticide.  This information is considered by EPA in conjunction with other information to determine whether pesticide products containing a specific active ingredient should be reregistered, or whether the terms and conditions of registration should be changed.  This type of information may also be pertinent to granting emergency exemptions under section 18 of FIFRA.

      Registrants perform studies in support of registration applications, in response to data call-ins issued by EPA, or voluntarily for their own purposes.  The Agency has the authority to call-in data (a.k.a. DCI "data call-in") under section 3(c)(2)(B) of FIFRA, and the accounting for the burden hours and costs for all OPP program DCIs is documented in the ICR entitled the Pesticide Data Call-In Program ICR, OMB #2070-0174; EPA # 2288.02.  The outcome of studies, whether they demonstrate known effects or new adverse effects, are carefully analyzed by registrants and presented to the Agency.  The 6(a)(2) rule does not impose the requirement to perform studies but merely to identify and promptly submit adverse effects information to the Agency when they are identified.

      A number of 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, improving customer relations, minimizing liability, or protecting or expanding market share.  According to feedback that EPA has received, registrants acquire and use this information to determine whether actual product use patterns reveal risk issues that did not emerge when the data were developed for the original registration application.  These registrants believe that it is an integral part of their product stewardship program and that collecting, analyzing and reacting to adverse effects information is essential to the way in which they conduct business as a routine matter.  For example, Consumer Specialty Products Association (CSPA), the trade association for registrants of antimicrobial pesticide products, has a voluntary stewardship program for their members called Product Care(R) (https://www.cspa.org/sustainability/product-care-stewardship/).  As noted on the CSPA Product Care[(R)] website, Product Care[(R)] companies routinely gather marketplace and incident information and evaluate it and make appropriate product changes. However, the stewardship programs are not required by the Paperwork Reduction Act (PRA) and are at the registrant's discretion. Therefore, these programs are not directly related to burden due to the information collection.
3.	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

      a)	Non-Duplication

      The information required to be submitted under this ICR is generally available only from registrants who have opted to secure registration of their pesticide product(s).  The only feasible means of collecting the required information is from pesticide registrants because it is either health and safety data that is generated, owned or used by the registrants, or it is submitted to registrants by consumers and other interested parties.  This information collection avoids duplication by limiting the submission requirements under FIFRA section 6(a)(2) to information which has not been submitted to the OPP previously.  Further, it exempts information submitted under section 8(e) of the Toxic Substances Control Act (TSCA).  Information in published articles is generally also exempt from submission.

	d) 	Consultations

      As required under 5 CFR 1320.8(d)(1), EPA will consult with a cross-section of pesticide registrants seeking feedback on the adverse effect information reporting requirements and processes, as well as an assessment of the burden estimates associated with this effort. Any comments received will be placed in the docket EPA-HQ-OPP-2017-0687. (Attachment D)

      c)	Public Notice Required Prior to ICR submission to OMB

      As part of the renewal process, EPA will publish a notice in the Federal Register prior to submitting the ICR to OMB. Pursuant to 5 CFR 1320.8(d), any public comments received will be placed in the EPA docket, EPA-HQ-OPP-2017-0687, for this action.

      d)	Effect of Less Frequent Collection

      Under FIFRA section 6(a)(2), the information collection activity is a one-time, non-repetitive submission of information.  As such, there is no set interval for multiple collections.  The information is submitted one time, according to the timeframes described in the rule for various categories of information.

      e)	General Guidelines

      Section 6(a)(2) regulations do not prescribe specific recordkeeping requirements, but the EPA requirements in 40 CFR 169.2(k) state that records containing research data relating to registered pesticides be retained as long as the registration is valid and the producer remains in business.  Registrations are valid until they are either voluntarily canceled or withdrawn by the registrant or until EPA has cause to suspend or cancel the registration.  Since the typical period of marketability of a pesticide ranges from 15 to 30 years, the PRA guidelines specifying that data other than health, medical or tax records not be required to be retained for more than 3 years will be exceeded for those studies which are required to support registration or registration review under FIFRA section 3, and which show adverse effects that make them reportable under section 6(a)(2).  The burdens associated with this recordkeeping requirement have already been approved by OMB under another ICR and are therefore excluded from this ICR.

      e)	Confidentiality

      Much of the information submitted pursuant to section 6(a)(2) constitutes FIFRA section 10(d)(1) safety and efficacy information.  On September 28, 1999, the Agency issued a class determination that safety and efficacy information submitted under section 6(a)(2) of FIFRA is not entitled to confidential treatment, Attachment E.  The determination enables the Agency to respond more quickly and efficiently to requests for information submitted under section 6(a)(2).

      Data submitted to the Agency are handled in accordance with the provisions of the FIFRA Confidential Business Information (CBI) Security Manual which provides procedures for protecting information claimed as confidential in accordance with FIFRA section 10.  If the information is not protected under FIFRA section 10, and it is not otherwise protected from release under the Freedom of Information Act (FOIA), EPA is obligated to make it available to members of the public upon request under FOIA.

      f)	Sensitive Questions

      If information of a sensitive nature is submitted as part of this information collection, the Agency will protect it appropriately, as provided by the Privacy Act or other relevant statutes.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

      a)	Respondents/NAICS Codes
      Potential respondents affected by the collection activities under this ICR include anyone who holds or ever held a registration for a pesticide product issued under FIFRA section 3 or 24(c).  The North American Industrial Classification System (NAICS) code is 325300 (Pesticide and Other Agricultural Chemical Manufacturing).
      b)	Information Requested
            i)	Data Items
      As further defined by the final rule implementing the FIFRA section 6(a)(2) requirements (62 FR 49639), registrants are required to report on:

      (1)  Studies showing new or more severe toxicological responses than previously reported of any type in any strain of test organism, (40 CFR 159.165).
      (2) 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).
      (3)  Epidemiological or exposure studies of human population groups indicating greater exposure than previously reported (40 CFR 159.170).
      (4)  Information on excess residues on food or feed, and residues in surface water, ground water or drinking water (40 CFR 159.178).
      (5)  Information on metabolites, degradates, contaminants or impurities which may be of toxicological concern (40 CFR 159.179).
      (6)  Incidents involving toxic or adverse effects to human or other non-target organisms (40 CFR 159.184).
      (7)  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); and
      (8) Other information which may be relevant to risk/benefit determinations of any type (40 CFR 159.195).

      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.

      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 (https://www.regulations.gov/document?D=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.

      Additionally, in 2013, new concerns about neonicotinoid pesticides and the loss of bee colonies and the economic impact on the industry that bee colony collapse creates.   EPA requested more documentation from registrants for these products (see Attachment F).  In response to numerous bee kills and colony losses worldwide, registrants of certain neonicotinoid products were asked to report honeybee kill incidents quickly and in fuller detail.  EPA is concerned about declines in pollinator health and is working to protect bees and other pollinators from pesticide risks through regulatory actions, voluntary changes to pesticide use by registrants and research programs aimed at increasing the understanding of factors associated with declining pollinator health.  This information will assist the EPA in its attempt to understand what role pesticides may be playing in pollinator declines.

            ii)	Respondent Activities

      Respondents must:

      (1) read the final rule or instructions;
      (2) plan activities to ensure required information is identified and submitted;
      (3) process, compile, and review information for accuracy and appropriateness;
      (4) complete written instruments to effectuate a submission; and
      (5) submit the information to EPA.

      Under FIFRA section 6(a)(2), as implemented by the regulations in 40 CFR part 159, pesticide registrants have no obligation to create or seek out adverse effects information.  Such activities may be conducted by the registrant in support of pesticide registration under FIFRA section 3 and registration review under section 3(g).  The burden for these activities is approved by OMB under separate ICRs.  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 section 6(a)(2), as defined by the regulations, the registrant must submit it to EPA.

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

      a)	Agency Activities

      The Agency will continue the following activities with regard to the FIFRA section 6(a)(2) program: 1) answering questions and providing guidance to respondents; 2) receiving and recording data submissions; 3) storing the data submitted; and 4) screening and analyzing the information for significance.

      b)	Collection Methodology and Management

      The regulation allows flexibility in the method or format for the required submission.  In essence, the regulation specifies the types of data that should be reported to the extent the information is available and the reporting time-frames.  For incident information (but not studies), these vary according to the significance of the information.

      Scientific studies containing 6(a)(2) information are assigned Master Record Identifier Numbers (MRIDs), as are all other pesticide studies submitted to OPP.  Preliminary notification letters for 6(a)(2) science studies are assigned sequential tracking numbers in a separate series.  Adverse effects incident reports are entered into a computerized database which can track incidents by chemical, submitter, type of incident, location, date of submission, and other parameters.  All 6(a)(2) submissions are screened by subject matter experts throughout the pesticide program.  Data are forwarded to and reviewed by pesticide product managers and science reviewers for relevance to the regulatory status of the pesticide product(s) to which the submitted information pertains.  The public may access the data by making a request under FOIA.

      OPP has created a CDX portal for the submission of studies.  A 6(a)(2) study may be submitted electronically just as easily as a non-6(a)(2) study, but it requires more screening and tracking.  Electronic incident submissions through the CDX portal is now possible, but it requires further database design.  EPA will continue to work with registrants to improve fields and methods to support electronic submission.  The submission technique would need to comply with the Agency's electronic submission standards.

      Finally, OPP has been working to integrate its existing databases into its Office of Pesticide Programs Information Network (OPPIN) system.  The current Incident Data System has been partially integrated with the Office of Pesticide Programs Information System.  It draws on live chemical, product, and registration number data from OPPIN in cataloging new incidents.  That development was seen as an essential precursor to electronic submission of incident data.

      It should be noted that at the time the final regulations went into effect in 1998 and at the request of the regulated community, OPP staff worked with industry representatives and trade associations on voluntary forms for incident reporting.  This was done by the trade associations as a service for their members.  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, see Attachment G.

      c)	Small Entity Flexibility

      Regardless of the size of the registrant, the 6(a)(2) regulations provide simplified reporting and extended reporting time-frames for most incident reports.  At the present time there is no standard reporting format prescribed in the regulations, so the submitters can use a format of their choosing for incidents.  While the Agency does not mandate a specific format for the required submission, as noted above, EPA has worked with industry to provide one to facilitate submissions.  To further simplify compliance, EPA has issued detailed guidance (Attachment C).

      The requirements of FIFRA section 6(a)(2) related to studies fall largely on basic producers, i.e., registrants that produce the active ingredient from raw materials, because they are the registrants most likely to generate and possess data subject to the information collection.  Formulators (companies that do not manufacture active ingredients) are exempt from generating most health effects data required to support registration except for product-specific acute toxicity studies.

      Both basic producers and formulators, however, may register and market end use products and receive incident reports from distributors and users of their products as well as other sources such as state regulatory agencies.  The number of incident reports associated with a pesticide product depends on such variables as the volume of sales of that product and whether it is sold to the general public or is restricted to experienced and trained applicators.  Some registrants put toll-free telephone numbers on their labels making it easy for consumers to contact them with incident reports.  Other registrants, however, do not.  Thus, it is difficult to generalize about the relative burden of incident reporting in terms of small versus large companies.

      d)	Collection Schedule

      The information required to be submitted under FIFRA section 6(a)(2) is not based on any schedule because the information is non-repetitive in nature.  As such, the information required to be submitted by respondents is generally on an "as received basis."  The regulations establish time-frames within which reportable information received by registrants must be submitted to EPA.  The reporting time-frames vary according to the organism exposed and the relative severity or rarity of the alleged effects.  Allegations of human deaths must be reported individually by registrants within 15 days of acquiring the information.  Other serious and rare incidents are reported individually.  Generally, they may be accumulated for one month and submitted by the end of the month following the accumulation period.  Minor or common incidents are reported as aggregate counts of incidents and effects for each product registration number or active ingredient.  They may be accumulated for three months and submitted by the end of the second month following the accumulation period.

6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

      a)  Estimating Respondent Burden

      To estimate the respondent burden, the Agency is using updated current statistics on the number of registrants of active products.  For burden estimates related to study and incident data submissions, actual statistics for fiscal year (FY) 2013-2015 were used.

      As of October 2017, there were 1,452 registrants with active registrations.  The total number of registrations were 18,028 and the number of registrations held by each registrant ranged from 1 to 834.  The average number of registrations was 12 and the median was 2.  644 registrants held only 1 registration, 216 registrants held 2 registrations, 294 registrants held between 3 and 5 registrations, 126 registrants held between 6 and 10 registrations, 120 registrants held between 11 and 50 registrations, 19 registrants held between 51 and 100 registrations and 33 registrants held more than 100 registrations.

      Former registrants have an obligation to report adverse effects information for 1 year after the cancellation or transfer of their product so long as the former registrant holds no active registrations.  Since stocks of the formerly registered products diminish, it is unlikely these former registrants would acquire or submit much adverse effects information to the Agency.  Former registrants, therefore, are not included in the estimated 1,452 respondents assumed for this analysis.

 	The Agency received an average of 237 studies annually from FY 2013 through FY 2015.  For purposes of this analysis, the Agency assumes 237 study-related submissions will be received each year for the duration of this information collection renewal.

      From FY 2013 through FY 2015 the Agency received an average of 891 incident-related submissions per year from registrants containing an average of 107,798 incidents per year.  Of these, 6,858 incidents were individually reported and 100,940 were reported as aggregate statistics on the yearly average.  A total of 202 registrants (14% of current registrants) submitted incident reports during this time period.  Registrants may report for themselves alone or they may report for themselves and related entities such as their divisions or subsidiaries.  Registrant task forces such as the (DEET) Issues Task Force or the Metam Task Force may report specific types of incidents or studies for their member registrants.

      A small number of incidents, an average of 717 per year, were reported by parties other than registrants.  These include states, EPA regional offices, and private groups and individuals.  These parties are not required to report adverse effects information to the Agency, but their reports are received and processed in the same way as registrant-submitted information.

      For purposes of this ICR renewal, the Agency estimates that it will continue to receive 107,798 incident reports from the regulated community each year.  It is the estimated number of incidents that drives the burden estimates in this analysis, not the total number of registrants or number of registrants represented by current incident reporting.

      The level of registrant reporting would be substantially higher had it not been for action taken by the Agency to eliminate certain types of incident reports.  The final regulations included the following as a condition for reporting incidents:

      40 CFR 159.184(a)(2) - The registrant is aware or has been informed that the person or non-target organism suffered a toxic or adverse effect or may suffer a delayed or chronic adverse effect in the future.  (Emphasis added)

A literal interpretation of the italicized language above could have resulted in registrants reporting all asymptomatic exposures.  Those are cases in which someone alleges exposure to a pesticide, but is experiencing no symptoms.  Or someone may call a registrant to ask if they may get sick after an exposure or to express concern that they may get sick in the future as a result of an exposure.  (These were referred to as `may suffer' incidents.)  OPP consulted with a major poison control center to determine the volume of asymptomatic exposure calls they receive.  According to the poison control center's statistics for a major pesticide company, nearly half the calls they handled were asymptomatic exposures.  In order to focus resources, both the Agency's and registrants', on a manageable volume of useful incident reports, the Agency eliminated the requirement to report most `may suffer' incidents.  This was accomplished in PR Notice 98-4 (Attachment D), which referenced the Agency's authority under part 159.155 of the FIFRA 6(a)(2) regulations to eliminate specified requirements by written notice to registrants. Elimination of the requirement is still in effect.

      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.  For purposes of determining the number of employees that need to be trained on adverse effects information reporting, EPA assumed an average of 10 employees per registrant or 17,500 individuals requiring training each year.  This estimate is an average; the actual number would range from one person in a small company to several dozens in a large company.  The Agency does not believe that a high proportion of people in any company need detailed training in 6(a)(2) requirements.  Most employees who are likely to receive information concerning the effects of pesticide products are simply made aware of the need to pass information along to an appropriate individual or unit within the company that evaluates reports and prepares submissions to the Agency.

      b)	Estimating Respondent Costs

  Estimating Labor Costs

      Consistent with recent ICR renewals, OPP is using labor cost estimates from Agency economists with respect to wages, benefits and overhead for all labor categories for affected industries, state government, and EPA employees.  This approach uses a transparent and consistent methodology employing publicly-available data to provide more accurate estimates and allow easy replication of the calculations.

      Methodology.	The methodology uses publicly available 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).  Fully loaded wage rates are used to calculate the Agency's staffing 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 NAICS code and website for each sector is included in that sector's wage rate table in Attachment H.  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 46.4% of unloaded wage rates, based on benefits for all civilian non-farm workers, from http://www.bls.gov/news.release/ecec.t01.htm.  However, if other sectors are listed for which 46.4% is not applicable, the applicable percentage will be stated.

      Fully Loaded Wage Rate.  The fully loaded wages include benefits and overhead costs. The loaded wage rate is multiplied by 50% (EPA guidelines 20-70%) to get overhead costs.  Costs are indexed to 2016 data.  Attachment H contains worksheets providing the breakout of these costs for respondents and the Federal Government.

      Using these data and methodology, Agency economists estimated the wages for the management, technical, and clerical labor categories.  The fully loaded wage rates used to calculate the respondent costs for this renewal are $124.81, $67.19, and $43.74 per hour for managerial, technical, and clerical labor hour costs, respectively.

      Tables 1 - 5 summarize the annual burden hours and costs to registrants for compliance with the section 6(a)(2) requirements.  The estimates include the paperwork burden costs of submitting studies and incident reports (calculated separately) and the costs of employee 6(a)(2) training.  Tables 1 (a and b) and 2 (a and b) present per study and per incident estimates of respondent burden and costs along with the annual totals for each category.

    Table 1a. Respondent Burden and Cost Estimates per Submission - STUDIES

                    Burden Hours (per study) by Labor Type
                                     Total
Collection Activities
                                  Managerial
                                   Technical
                                   Clerical
                                     Hours
                                   Costs ($)

                                   $124.81
                                    $67.19
                                    $43.74

Read Instructions
                                     0.10
                                     0.20
                                     0.00
                                     0.30
                                    $25.92
Create Information
                                     0.00
                                     1.00
                                     0.00
                                     1.00
                                    $67.19
Compile and Review
                                     0.10
                                     0.55
                                     0.00
                                     0.65
                                    $49.44
Complete Paperwork
                                     0.00
                                     0.10
                                     0.50
                                     0.60
                                    $28.59
Store and Maintain Data
                                     0.00
                                     0.20
                                     0.50
                                     0.70
                                    $35.31
Total (per study)
                                     0.20
                                     2.05
                                     1.00
                                     3.25
                                    $206.45
Totals may not sum due to rounding.

        Table 1b. Annual Respondent Burden and Cost Estimates - STUDIES
Labor Category
                           Burden Hours per Request
                             Number of Submissions
                              Total Annual Hours
                               Labor Rate ($/hr)
                                   Costs ($)
Managerial
                                     0.20
                                      237
                                      47
                                    $124.81
                                    $5,916
Technical
                                     2.05
                                      237
                                      486
                                    $67.19
                                    $32,646
Clerical
                                     1.00
                                      237
                                      237
                                    $43.74
                                    $10,367
TOTAL (per year)
                                     3.25
                                      237
                                      770

                                    $48,929

Totals may vary between tables due to rounding.

   Table 2a. Respondent Burden and Cost Estimates per Submission - INCIDENTS

                  Burden Hours (per study) by Labor Category
                                     Total
Collection Activities
                                  Managerial
                                   Technical
                                   Clerical
                                     Hours
                                   Costs ($)

                                   $124.81
                                    $67.19
                                    $43.74

Read Instructions
                                     0.00
                                     0.10
                                     0.00
                                     0.10
                                     $6.72
Create Information
                                     0.00
                                     0.55
                                     0.00
                                     0.55
                                    $36.96
Compile and Review
                                     0.25
                                     0.60
                                     0.00
                                     0.85
                                    $71.52
Complete Paperwork
                                     0.00
                                     0.00
                                     0.55
                                     0.55
                                    $24.06
Store and Maintain Data
                                     0.00
                                     0.12
                                     0.20
                                     0.32
                                    $16.81
Total (per incident)
                                     0.25
                                     1.37
                                     0.75
                                     2.37
                                    $156.06
Totals may not sum due to rounding.

       Table 2b. Annual Respondent Burden and Cost Estimates - INCIDENTS
Labor Category
                           Burden Hours per Request
                             Number of Submissions
                              Total Annual Hours
                               Labor Rate ($/hr)
                                   Costs ($)
Managerial
                                     0.25
                                    107,798
                                    26,950
                                    $124.81
                                  $3,363,625
Technical
                                     1.37
                                    107,798
                                    147,683
                                    $67.19
                                  $9,923,286
Clerical
                                     0.75
                                    107,798
                                    80,849
                                    $43.74
                                  $3,536,422
TOTAL (per year)
                                     2.37
                                    107,798
                                    255,481

                                  $16,823,333
Totals may vary between tables due to rounding.

	Table 3. exhibits the estimated annual respondent burden and costs estimates for all studies and incidents under this information collection.

Table 3. Total Annual Respondent Burden and Cost Estimates for Studies and Incidents

                           Per Submission Estimates
                      Total Submissions Expected per Year
                                    Totals

                                 Burden Hours
                                   Costs ($)

                                 Burden Hours
                                   Costs ($)
Studies
                                     3.25
                                    $206.45
                                     237
                                      770
                                    $48,929
Incidents
                                     2.37
                                    $156.06
                                   107,798
                                    255,481
                                  $16,823,333
TOTAL

                                   108,035
                                    256,252
                                  $16,872,261
Totals may vary between tables due to rounding.

      Table 4. presents the respondent burden and cost estimates for training activities.

     Table 4. Registrant Burden and Cost Estimates for Training Activities

                        Burden Hours by Labor Category
                             Total (per activity)
                         Expected Activities each Year
                         Total Annual Burden and Costs
Training Activity
                                  Managerial
                                   Technical
                                   Clerical
                                     Hours
                                   Costs ($)

                                     Hours
                                   Costs ($)

                                   $124.81
                                    $67.19
                                    $43.74

Plan Training
                                     0.50
                                     0.10
                                     0.00
                                     0.60
                                    $69.13
                                     1,452
                                                                            871
                                   $100,370
Conduct Employee Training
                                     0.50
                                     1.50
                                     1.00
                                     3.00
                                    $206.94
                                    14,520
                                                                         43,560
                                  $3,004,725
Follow-up, Tracking
                                     0.00
                                     0.10
                                     0.20
                                     0.30
                                    $15.47
                                     1,452
                                                                            436
                                    $22,459
Total (per year)

                                    17,424
                                                                         44,867
                                  $3,127,554
Totals may not sum due to rounding.

 	Table 5. exhibits the estimated total annual respondent burden and costs for all activities, including study and incident reporting and training activities.

Table 5. Studies + Incidents + Training - Total Annual Respondent Burden and Cost for Respondents
                          Submission Type or Activity
                   Total Submissions or Activities each Year
                                    TOTALS

                                     Hours
                                   Costs ($)
Studies
                                     237
                                      770
                                   $48,929
Incidents
                                   107,798
                                    255,481
                                 $16,823,333
Training Activities
                                    17,424
                                    44,867
                                  $3,127,554
TOTAL (per year)
                                   125,459
                                    301,118
                                 $19,999,815
Totals may not sum due to rounding.

 Estimating Capital, and Operations and Maintenance Costs

      There are no capital expenditures or operation and maintenance costs associated with this information collection activity.

      c)	Estimating Agency Burden and Cost

      Agency activities include: screening 6(a)(2) submissions by subject matter experts to determine the significance of the information; information management activities to record, file, and track the submissions; communicating with registrants, providing guidance on the requirements; and management and oversight of the process.

      The EPA fully loaded employee costs for this renewal for managerial, technical, and clerical rates are estimated at $127.07, $83.40, and $47.14 per hour, respectively.  The fully loaded wage rates for EPA employees were calculated using the same method that was used for the respondent wage rates; the calculation of wage rates is in Attachment H.  Screening and managing submitted information involves a mixture of technical and clerical skills; no managerial labor time is involved in these tasks.

      The Agency burden estimate does not include the effort to fully review a 6(a)(2) study or to prepare the resulting documents.  Nor does the burden estimate include the effort to take regulatory action that may result from 6(a)(2) adverse effects information.  The burden associated with those activities is covered under other ICRs.  This ICR does include the costs of subject matter experts reviewing incident reporting.

	As stated before, the Agency is also collecting additional incident data for spot-on pet products, one herbicide, and neonicotinoids related to effects on pollinators.  These data were required in order to investigate the higher than expected incident numbers.  Thus, the Agency is receiving and needing to analyze extra data and thus has an increased burden of information for analysis.  To account for this, Agency burden hours have been adjusted upwards for this renewal. Tables 6 through 8 illustrate the estimated Agency burden and costs.  Tables 6 (a and b) and 7 (a and b) below present per study and per incident Agency burden and costs.

      Table 6a. Agency Burden and Cost Estimates per Submission - STUDIES
Collection Activities
                 Burden Hours per Submission by Labor Category
                                     Total

                                  Managerial
                                   Technical
                                   Clerical
                                     Hours
                                   Costs ($)

                                    $127.07
                                    $83.40
                                    $47.14

Screen submitted information
                                     0.00
                                     2.00
                                     0.00
                                     2.00
                                    $166.80
Record, file, and track submissions
                                     0.00
                                     3.60
                                     0.90
                                     4.50
                                    $342.66
Total (per study)
                                     0.00
                                     5.60
                                     0.90
                                     6.50
                                    $509.46
Totals may not sum due to rounding.

          Table 6b. Annual Agency Burden and Cost Estimates - STUDIES
Labor Category
                           Burden Hours per Request
                             Number of Submissions
                              Total Annual Hours
                               Labor Rate ($/hr)
                                   Costs ($)
Managerial
                                     0.00
                                      237
                                       0
                                    $127.07
                                      $0
Technical
                                     5.60
                                      237
                                     1,327
                                    $83.40
                                   $110,686
Clerical
                                     0.90
                                      237
                                      213
                                    $47.14
                                    $10,056
TOTAL (per year)
                                     6.50
                                      237
                                     1,541

                                   $120,742
Totals may vary between tables due to rounding.

     Table 7a. Agency Burden and Cost Estimates per Submission - INCIDENTS
Collection Activities
                 Burden Hours per Submission by Labor Category
                                     Total

                                  Managerial
                                   Technical
                                   Clerical
                                     Hours
                                   Costs ($)

                                    $127.07
                                    $83.40
                                    $47.14

Screen Submitted Information
                                     0.000
                                     0.135
                                     0.000
                                     0.135
                                    $11.26
Record, File and Track Submissions
                                     0.000
                                     0.023
                                     0.033
                                     0.056
                                     $3.47
Communications, Guidance
                                     0.000
                                     0.025
                                     0.000
                                     0.025
                                     $2.08
Total (per incident)
                                     0.000
                                     0.183
                                     0.033
                                     0.216
                                    $16.82
Totals may not sum due to rounding.

         Table 7b. Annual Agency Burden and Cost Estimates - INCIDENTS
Labor Category
                           Burden Hours per Request
                             Number of Submissions
                              Total Annual Hours
                               Labor Rate ($/hr)
                                   Costs ($)
Managerial
                                    0.000
                                    107,798
                                       0
                                    $127.07
                                      $0
Technical
                                    0.183
                                    107,798
                                    19,727
                                    $83.40
                                  $1,645,203
Clerical
                                    0.033
                                    107,798
                                     3,557
                                    $47.14
                                   $167,710
TOTAL (per year)
                                    0.216
                                    107,798
                                    23,284

                                  $1,812,913
Totals may vary between tables due to rounding.

	Table 8. presents the combined total annual Agency burden and costs estimates for studies and incidents.

            Table 8. Total Annual Agency Burden and Cost Estimates

                           Per Submission Estimates
                      Total Submissions Expected per Year
                                    Totals

                                     Hours
                                   Costs ($)

                                 Burden Hours
                                   Costs ($)
Studies
                                     6.50
                                    $509.46
                                     237
                                     1,541
                                   $120,742
Incidents
                                     0.216
                                    $16.82
                                   107,798
                                    23,284
                                  $1,812,913
TOTAL (per year)

                                   108,035
                                    24,825
                                  $1,933,656
Totals may vary between tables due to rounding

      d)  Bottom Line Hours and Costs Tables

      Table 9. displays the total burden hours and costs of FIFRA section 6(a)(2) requirements for respondents and the Agency from Tables 1  -  8.
                             Table 9. MASTER TABLE
                                     TOTAL

                                     Hours
                                   Costs ($)
                  Annual Respondent Burden and Cost Estimates
                                    301,118
                                 $19,999,815
                    Annual Agency Burden and Cost Estimates
                                    24,825
                                  $1,933,656
                                     TOTAL
                                    325,943
                                 $21,933,471

      The average respondent burden is 3.25 hours per study and 2.37 hours per incident (average 2.81 hours per response), and the total annual respondent burden is 301,118 hours.  The average per respondent burden is 207 hours (301,118 total hours  1,452 total potential respondents), and the average cost is $13,774 per respondent ($19,999,815 total cost  1,452 total potential respondents).  Not all of the potential respondents are likely to submit information each year.  This calculation is a simple average of the burden and does not reflect the more likely potential respondent burden which is characterized by the type of submission, the number of registrations held, and the number of incidents that need to be reported.

       Reasons for Change in Burden

      The estimated total respondent burden is expected to increase by 26,104 hours from 275,014 hours to 301,118 hours, with an expected increase in estimated costs from $16,827,821 to $19,999,815.  The increase in burden hours and cost is primarily due to the expected increase in the number of responses, as discussed further below.  Total burden hour estimates associated with studies are increased because the estimated annual number of study submissions increased from 153 studies to 237.

      The number of responses is expected to increase by 16% from 93,000 in the last ICR approval to approximately 108,000 for this ICR renewal.  The increase is due to EPA's revised expectations regarding the number of incident reports that will be submitted to the Agency, which reflects historical information on the number of responses received.  The increase in the number of incident reports has also prompted the need for additional information discussed in section 4 of this supporting statement.  Since the last ICR was approved, the EPA has found it necessary to request additional data in certain subject areas under 40 CFR 159. First, due to a significant increase in the number of adverse incidents for spot-on domestic animal pet products from several registrants, 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.  Second, the Agency requested additional information from the registrant of an herbicide to help explain circumstances for incidents of alleged tree and plant damage.  Finally, new concerns about neonicotinoid pesticides and the loss of bee colonies led to EPA's request for more documentation from registrants for these products.

      Calculations of labor rates and related burden costs have changed for both EPA and respondents due to changes in the base wages and an increase in the percentage of benefits.  For this renewal, the Agency updated the fully loaded wage rates for all labor categories for both Agency employees and respondents.  The Agency burden has increased, which reflects an increase in the number of incident submissions and more communication relating to incident data.

      f)	Burden Statement

      The annual public reporting and recordkeeping burden for this collection of information is estimated to average 2.81 hours per response.  The total annual "respondent" (applicant) burden is estimated to be 301,118 hours, with an average potential per respondent burden of 207 hours.   "Burden" is defined in 5 CFR 1320.3(b). The Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information subject to the PRA unless it displays a currently valid OMB control number.  The OMB control numbers for certain regulations in Title 40, after initial display in the Federal Register, are listed in 40 CFR part 9, and may appear on the information collection instrument as applicable, i.e., form or instructions, and in the Federal Register.

	The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPP-2017-0687, 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, in Rm. S-3334, 1301 Constitution Avenue, NW, Washington, DC. This docket facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding federal holidays.  The docket telephone number is<PHONE_NUMBER>.  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 docket identification (ID) number EPA-HQ-OPP-2017-0687 and OMB control number 2070-0039, 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.

	:: To OMB via email to<EMAIL_ADDRESS>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.

7.	LIST OF ATTACHMENTS

	All of the attachments listed below can be found in the docket for this ICR, which is accessible electronically through http://www. regulations.gov . On the main page, select Advanced Search from the menu bar at the top and select Docket Search. Enter the Docket ID Number, EPA-HQ-OPP-2017-0687 in the Docket ID field. Click on the Submit button. From the results page, you will be able to link to the docket view or directly open select documents found in the docket.

ATTACHMENT A:
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)  -  Section 6(a)(2) (7 USC 136(d)(2))
https://www.gpo.gov/fdsys/pkg/USCODE-2016-title7/pdf/USCODE-2016-title7-chap6-subchapII-sec136d.pdf

ATTACHMENT B:
FIFRA Section 6(a)(2) Reporting Requirements - Codified as 40 CFR part 159 subpart D. Reporting Requirements for Risk/Benefit Information
https://www.gpo.gov/fdsys/pkg/CFR-2016-title40-vol26/pdf/CFR-2016-title40-vol26-part159-subpartD.pdf

ATTACHMENT C:
PR Notice 1998-3 - Guidance on Final FIFRA 6(a)(2) Regulations for Pesticide Product
https://www.epa.gov/pesticide-registration/pesticide-registration-notices-year
see also PR Notice 1998-4 - Additional Guidance on Final FIFRA Section 6(a)(2) Regulations for Pesticide Product Registrants)
https://www.epa.gov/pesticide-registration/pesticide-registration-notices-year

ATTACHMENT D:
                  Reserved for  -  Record of Consultations

                  ATTACHMENT E:
                  Class Determination Regarding Confidentiality of 6(a)(2) Information
                  https://archive.epa.gov/ogc/documents/web/pdf/1-99.pdf

                  ATTACHMENT F:
                  Pollinator Protection Letter to Registrants
                  https://www.epa.gov/sites/production/files/2013-11/documents/bee-july2013-letter.pdf

                  ATTACHMENT G:
                  Industry's Voluntary 6(a)(2) Incident Reporting Forms & Guidance Documents see
                  https://www.epa.gov/pesticide-incidents/incident-reporting-pesticide-manufacturers-registrants

                  ATTACHMENT H:
Worksheet for Estimating OPP ICR Wage Rates for Respondent and Agency Labor Costs are
available as an attachment to Docket EPA-HQ-OPP-2017-0687.


[Federal Register Volume 76, Number 90 (Tuesday, May 10, 2011)]
[Proposed Rules]
[Pages 26996-27000]
[FR Doc No: 2011-11278]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Parts 531 and 533

[Docket No. NHTSA-2011-0056]

Notice of Intent To Prepare an Environmental Impact Statement for
New Corporate Average Fuel Economy Standards

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice of intent; request for scoping comments.

-----------------------------------------------------------------------

SUMMARY: Pursuant to the National Environmental Policy Act (NEPA),
NHTSA plans to prepare an Environmental Impact Statement (EIS) to
analyze the potential environmental impacts of the agency's Corporate
Average Fuel Economy program for passenger automobiles (referred to
herein as ``passenger cars'') and non-passenger automobiles (referred
to herein as ``light trucks''). The EIS will consider the potential
environmental impacts of new fuel economy standards for model years
2017-2025 passenger cars and light trucks that NHTSA will be proposing
pursuant to the Energy Independence and Security Act of 2007.
    This notice initiates the NEPA scoping process by inviting comments
from Federal, State, and local agencies, Indian tribes, and the public
to help identify the environmental issues and reasonable alternatives
to be examined in the EIS. This notice also provides guidance for
participating in the scoping process and additional information about
the alternatives NHTSA expects to consider in its NEPA analysis. In
preparing this notice, NHTSA has shared the document with the Council
on Environmental Quality (CEQ), the Environmental Protection Agency
(EPA), and the Department of Energy (DOE).

DATES: The scoping process will culminate in the preparation and
issuance of a Draft EIS, which will be made available for public
comment. To ensure that NHTSA has an opportunity to fully consider
scoping comments and to facilitate NHTSA's prompt preparation of the
Draft EIS, scoping comments should be received on or before June 9,
2011. NHTSA will try to consider comments received after that date to
the extent the rulemaking schedule allows.

ADDRESSES: You may submit comments to the docket number identified in
the heading of this document by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery or Courier: U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m. Eastern
time, Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Regardless of how you submit your comments, you should mention the
docket number of this document.
    You may call the Docket at<PHONE_NUMBER>.
    Note that all comments received, including any personal information
provided, will be posted without change to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For technical issues, contact Angel
Jackson, Fuel Economy Division, Office of International Vehicle, Fuel
Economy and Consumer Standards, telephone:<PHONE_NUMBER>; for legal
issues, contact Carrie Gage, Legislation & General Law Division, Office
of the Chief Counsel, telephone:<PHONE_NUMBER>, at the National Highway
Traffic Safety

Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590.

SUPPLEMENTARY INFORMATION: In a forthcoming notice of proposed
rulemaking (NPRM), NHTSA intends to propose Corporate Average Fuel
Economy (CAFE) standards for model years (MYs) 2017-2025 passenger cars
and light trucks pursuant to the Energy Policy and Conservation Act
(EPCA), as amended by the Energy Independence and Security Act of 2007
(EISA).\1\ In connection with this action, NHTSA will prepare an
Environmental Impact Statement (EIS) to analyze the potential
environmental impacts of the proposed CAFE standards and reasonable
alternative standards pursuant to the National Environmental Policy Act
(NEPA) and implementing regulations issued by the Council on
Environmental Quality (CEQ) and NHTSA.\2\ NEPA instructs Federal
agencies to consider the potential environmental impacts of their
proposed actions and those of possible alternative actions. To inform
decisionmakers and the public, the EIS will compare the potential
environmental impacts of the agency's Preferred Alternative and a
spectrum of alternatives, including a ``no action'' alternative. As
required by NEPA, the EIS will consider direct, indirect, and
cumulative impacts of the proposed action and alternatives and will
discuss impacts in proportion to their significance.
---------------------------------------------------------------------------

    \1\ EISA is Public Law 110-140, 121 Stat. 1492 (December 19,
2007). Portions of EPCA related to fuel economy are codified at 49
U.S.C. 32901 et seq.
    \2\ NEPA is codified at 42 U.S.C. 4321-4347. CEQ's NEPA
implementing regulations are codified at 40 CFR Parts 1500-1508, and
NHTSA's NEPA implementing regulations are codified at 49 CFR Part
520.
---------------------------------------------------------------------------

    Background. EPCA, as amended by EISA, sets forth extensive
requirements concerning the establishment of CAFE standards. It
requires the Secretary of Transportation \3\ to establish average fuel
economy standards at least 18 months before the beginning of each model
year and to set them at ``the maximum feasible average fuel economy
level that the Secretary decides the manufacturers can achieve in that
model year.'' \4\ When setting ``maximum feasible'' fuel economy
standards, the Secretary is required to ``consider technological
feasibility, economic practicability, the effect of other motor vehicle
standards of the Government on fuel economy, and the need of the United
States to conserve energy.'' \5\ NHTSA construes the statutory factors
as including environmental and safety considerations.\6\
---------------------------------------------------------------------------

    \3\ NHTSA is delegated responsibility for implementing the EPCA
fuel economy requirements assigned to the Secretary of
Transportation. 49 CFR 1.50, 501.2(a)(8).
    \4\ 49 U.S.C. 32902(a).
    \5\ 49 U.S.C. 32902(f).
    \6\ For environmental considerations, see Center for Auto Safety
v. NHTSA, 793 F.2d 1322, 1325 n. 12 (DCCir. 1986); Public Citizen v.
NHTSA, 848 F.2d 256, 262-3 n. 27 (DCCir. 1988) (noting that ``NHTSA
itself has interpreted the factors it must consider in setting CAFE
standards as including environmental effects''); Center for
Biological Diversity v. NHTSA, 538 F.3d 1172, 1196 (9th Cir. 2008).
For safety considerations, see, e.g., Competitive Enterprise Inst.
v. NHTSA, 956 F.2d 321, 322 (DCCir. 1992) (citing Competitive
Enterprise Inst. v. NHTSA, 901 F.2d 107, 120 n.11 (DCCir. 1990)).
---------------------------------------------------------------------------

    As amended by EISA in December 2007, EPCA further directs the
Secretary, after consultation with the Secretary of Energy and the
Administrator of the Environmental Protection Agency (EPA), to
establish average fuel economy standards separately for passenger cars
and for light trucks manufactured in each model year beginning with MY
2011. In doing so, the Secretary of Transportation is required to
comply with special provisions relating to the standards for model
years 2011-2030. The Secretary is required to ``prescribe annual fuel
economy standard increases that increase the applicable average fuel
economy standard ratably beginning with model year 2011 and ending with
model year 2020,'' \7\ and those standards must ``achieve a combined
fuel economy average for model year 2020 of at least 35 miles per
gallon for the total fleet of passenger and non-passenger automobiles
manufactured for sale in the United States for that model year.'' \8\
For MYs 2021-2030, the passenger car and light truck standards must
simply be the ``maximum feasible'' average fuel economy standard for
each of those fleets for each model year.\9\ Additionally, the
standards for passenger cars and light trucks must be ``based on 1 or
more vehicle attributes related to fuel economy'' and expressed ``in
the form of a mathematical function,'' and may be established for not
more than five model years.\10\ EISA also mandates a minimum standard
for domestically manufactured passenger cars.\11\
---------------------------------------------------------------------------

    \7\ 49 U.S.C. 32902(b)(2)(C).
    \8\ Id. Sec.  32902(b)(2)(A).
    \9\ Id. Sec. Sec.  32902(b)(2)(B), 32902(f).
    \10\ Id. Sec. Sec.  32902(b)(3)(A), 32902(b)(3)(B).
    \11\ Id. Sec.  32902(b)(4) (``each manufacturer shall also meet
the minimum standard for domestically manufactured passenger
automobiles, which shall be the greater of (A) 27.5 miles per
gallon; or (B) 92 percent of the average fuel economy projected by
the Secretary for the combined domestic and non-domestic passenger
automobile fleets manufactured for sale in the United States by all
manufacturers in the model year * * * .'').
---------------------------------------------------------------------------

    On May 19, 2009, President Obama announced a new National Fuel
Efficiency Policy for establishing consistent, harmonized, and
streamlined requirements to improve fuel economy and reduce greenhouse
gas (GHG) emissions for all new passenger cars and light trucks sold in
the United States.\12\ Pursuant to that announcement, NHTSA and EPA
finalized the first-ever joint rulemaking to establish fuel economy
standards and GHG standards for light duty vehicles on April 1, 2010.
NHTSA established CAFE standards under EPCA/EISA and EPA established
GHG emissions standards under the Clean Air Act.\13\ The CAFE standards
covered MY 2012-2016 passenger cars and light trucks and were estimated
to require a combined average fleet-wide fuel economy of 34.1 mpg by
2016.\14\
---------------------------------------------------------------------------

    \12\ President Obama Announces National Fuel Efficiency Policy,
The White House, May 19, 2009. Available at: http://www.whitehouse.gov/the_press_office/President-Obama-Announces-National-Fuel-Efficiency-Policy/ (last visited Mar. 4, 2011).
    \13\ See 42 U.S.C. 7521(a).
    \14\ The EPA GHG standards were estimated to require a combined
average fleet-wide level of 250 grams/mile CO2-equivalent
for MY 2016, which is equivalent to 35.5 mpg if all of the
technologies used to reduce GHG emissions are tailpipe
CO2 reducing technologies. The 250 g/mi CO2
equivalent level assumes the use of credits for air conditioning
improvements worth 15 g/mi in MY 2016.
---------------------------------------------------------------------------

    Following the first phase of the National Program, in a
Presidential Memorandum issued May 21, 2010, President Obama requested
that EPA and NHTSA build on the first joint rulemaking to continue a
coordinated National Program to improve fuel efficiency and reduce
greenhouse gas emissions of light-duty vehicles for MYs 2017-2025.\15\
The Memorandum stated that the National Program should seek to produce
joint Federal standards that are harmonized with applicable State
standards, achieve substantial annual progress in reducing
transportation sector GHG emissions and fossil fuel consumption, and
strengthen the industry and enhance job creation in the United States.
As part of implementing this program, the President asked that the
Administrators of EPA and NHTSA work with the State of California to
develop a technical assessment to inform the rulemaking process.\16\
The President also requested that the two agencies issue a Notice of
Intent to Issue a Proposed Rule that announces plans for setting
stringent fuel economy and

greenhouse gas emissions standards for light-duty vehicles for MY 2017
and beyond. On October 1, 2010, NHTSA and EPA jointly issued that
notice concurrently with the Interim Joint Technical Assessment
Report.\17\
---------------------------------------------------------------------------

    \15\ See The White House, Office of the Press Secretary,
Presidential Memorandum Regarding Fuel Efficiency Standards (May 21,
2010), available at http://www.whitehouse.gov/the-press-office/presidential-memorandum-regarding-fuel-efficiency-standards (last
visited Mar. 8, 2011).
    \16\ See Interim Joint Technical Assessment Report, available
at: http://www.nhtsa.gov/staticfiles/rulemaking/pdf/cafe/2017+CAFE-
GHG--Interim--TAR2.pdf (Sept. 2010)
    \17\ See 75 FR 62739 (Oct. 13, 2010).
---------------------------------------------------------------------------

    In response to the President's call to provide greater certainty
and incentives for long-term innovation by manufacturers, NHTSA is
planning to set CAFE standards for MY 2017-2025 passenger cars and
light-duty trucks, and NHTSA intends to do this in a joint rulemaking
with EPA, in which EPA will set GHG standards for the same model years
and vehicles. As noted above, however, NHTSA's statutory authority
allows the agency to take final action prescribing CAFE standards in
increments of no more than five model years.\18\ In order to address
this statutory limitation, NHTSA is considering proposing standards for
the MY 2017-2025 timeframe, with the express condition that the
standards for MYs 2022-2025 would be subject to a mid-term technology
assessment and review. NHTSA would adopt standards for MYs 2017-2025,
but standards for MYs 2022-2025 would not become effective at the
established level unless and until NHTSA affirmed in a later rulemaking
that they were, based on information available at the time of the later
rulemaking, the maximum feasible standards for those model years. This
condition would appear in the regulations. Because these two NHTSA
actions would be proposed together to increase the efficiency of the
light-duty fleet, and because they would be part of a joint NHTSA/EPA
rulemaking for a coordinated National Program covering MYs 2017-2025,
NHTSA plans to address the potential environmental impacts of the
proposed alternatives for the full MY 2017-2025 period in a single EIS,
notwithstanding the provision for a mid-term technology assessment and
review.\19\ NHTSA specifically seeks comment on the agency's proposed
approach of analyzing the action for the MY 2017-2025 period in a
single EIS.
---------------------------------------------------------------------------

    \18\ 49 U.S.C. 32902(b)(3)(B).
    \19\ See 40 CFR 1508.18(b)(3) (including as federal actions
under NEPA ``[a]doption of programs, such as a group of concerted
actions to implement a specific policy or plan; systematic and
connected agency decisions allocating agency resources to implement
a specific statutory program or executive directive.'').
---------------------------------------------------------------------------

    As required by statute, NHTSA's upcoming NPRM will propose separate
attribute-based standards for MY 2017-2025 passenger cars and for MY
2017-2025 light trucks.\20\ As in the last CAFE rulemaking, NHTSA plans
to propose vehicle footprint as the attribute. Each individual vehicle
model would have a specific fuel economy target based on the fuel
economy capability of those motor vehicles having the same footprint as
that vehicle model.\21\ Fuel economy targets would reflect, in part,
NHTSA's analysis of the technological and economic capabilities of the
industry within the rulemaking timeframe. A manufacturer's CAFE
standard, in turn, would be based on the target levels set for its
particular mix of vehicles in that model year. Compliance would be
determined by comparing a manufacturer's harmonically averaged fleet
fuel economy levels in a model year with a required fuel economy level
calculated using the manufacturer's actual production levels and the
targets for each vehicle it produces.\22\
---------------------------------------------------------------------------

    \20\ See 49 U.S.C. 32902(b)(3)(A).
    \21\ Vehicle models made by different manufacturers would have
the same fuel economy target if they had the same quantity of the
attribute upon which the standards are based.
    \22\ While manufacturers may use a variety of flexibility
mechanisms to comply with CAFE, including credits earned for over-
compliance and production of flexible-fuel vehicles, NHTSA is
statutorily prohibited from considering manufacturers' ability to
use flexibility mechanisms in determining what level of CAFE
standards would be maximum feasible. See 49 U.S.C. 32902(h).
---------------------------------------------------------------------------

    Under NEPA, the purpose of and need for an agency's action inform
the range of reasonable alternatives to be considered in its NEPA
analysis.\23\ In developing alternatives for analysis in the EIS, NHTSA
must consider EPCA's requirements for setting CAFE standards. As
discussed above, EPCA requires the agency to determine what level of
CAFE stringency would be the ``maximum feasible'' for each model year,
a determination the agency makes based on the consideration of four
statutory factors: technological feasibility, economic practicability,
the effect of other standards of the Government on fuel economy, and
the need of the United States to conserve energy.\24\
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    \23\ 40 CFR 1502.13.
    \24\ See 49 U.S.C. 32902(f).
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    The alternatives that NHTSA plans to consider are:
     A ``no action'' alternative, which assumes, for purposes
of NEPA analysis, that NHTSA would not issue a rule regarding CAFE
standards.\25\ NEPA requires agencies to consider a ``no action''
alternative in their NEPA analyses and to compare the effects of not
taking action with the effects of the reasonable action alternatives in
order to demonstrate the different environmental effects of the action
alternatives. The recent EISA amendments to EPCA direct NHTSA to set
new CAFE standards and do not permit the agency to take no action on
fuel economy.\26\ This ``No Action Alternative'' is also referred to as
the ``baseline.''
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    \25\ See 40 CFR 1502.14(d).
    \26\ CEQ has explained that ``[T]he regulations require the
analysis of the no action alternative even if the agency is under a
court order or legislative command to act. This analysis provides a
benchmark, enabling decisionmakers to compare the magnitude of
environmental effects of the action alternatives. . . . Inclusion of
such an analysis in the EIS is necessary to inform the Congress, the
public, and the President as intended by NEPA. [See 40 CFR
1500.1(a).]'' Forty Most Asked Questions Concerning CEQ's National
Environmental Policy Act Regulations, 46 FR 18026 (1981) (emphasis
added).
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     Alternatives calculated at the upper point and at the
lower point of the range between 2% and 7%, representing annual fuel
economy stringency increases from the MY 2016 standards, from 2017
through 2025. The calculations and the related evaluation of impacts
would be performed separately for passenger cars and light trucks at
each of these points so as to demonstrate their effects independently,
since car and truck standards could increase at different rates from
one another and at different rates in different years. These
alternatives would bracket the range of actions the agency may select.
     The Preferred Alternative, reflecting annual stringency
increases for both passenger cars and light trucks that fall at levels
between the upper and lower bounds identified above. NHTSA has not yet
identified its Preferred Alternative.
    Thus, NHTSA plans to analyze the impacts of eight different
standards for the DEIS: Two points bracketing the possible action
alternatives for cars (2% per year and 7% per year) and two points
bracketing the possible alternatives for trucks (2% per year and 7% per
year), as well as a No Action Alternative and Preferred Alternative for
cars and a No Action Alternative and Preferred Alternative for trucks.
    NHTSA has tentatively concluded that this range of annual
percentage increases would satisfy EPCA's requirement that the
standards be ``maximum feasible'' for each model year, based on the
different ways NHTSA could weigh EPCA's four statutory factors. For
example, the most stringent average annual increase NHTSA is
considering for both passenger cars and light trucks (7%) weighs energy
conservation and climate change considerations more heavily and
technological feasibility and economic practicability less heavily. In
contrast, the least stringent annual increase

NHTSA is considering (2%) places more weight on technological
feasibility and economic practicability.
    This range reflects differences in the degree of technology
adoption across the fleet, in costs to manufacturers and consumers, and
in conservation of oil and related reductions in greenhouse gases. For
example, the most stringent average annual increase NHTSA is evaluating
would require greater adoption of technology across the fleet,
including more advanced technology, than the least stringent annual
increase NHTSA is evaluating. As a result, the most stringent annual
increase would impose greater costs and achieve greater energy
conservation and related reductions in greenhouse gases.
    This range of stringencies, along with the analysis for the
Preferred Alternative, would provide a broad range of information for
NHTSA to use in evaluating and weighing the statutory factors of
technological feasibility, economic practicability, and energy
conservation. It would allow for consideration of differences and
uncertainties in the way in which key economic inputs (e.g., the price
of fuel and the social cost of carbon) and technological inputs are
estimated or valued.
    The agency may select one of the above-identified levels of average
increase for passenger cars and one for light trucks as its Preferred
Alternative or it may select a level of stringency that falls between
those extremes. The percentage increases in stringency are ``average''
increases and may either be constant throughout the period or may vary
from year to year, but the average yearly increase over that period
will equal the percentage increase selected.
    Within the range identified above, NHTSA may consider setting more
stringent standards for the earlier years of the rule than for the
later years, or, alternatively, setting less stringent standards for
the earlier years of the rule than for the later years, depending on
our assessment of what would be ``maximum feasible'' for those time
periods for each fleet. In addition, NHTSA may consider setting
standards for passenger cars and light trucks that increase at
different rates between the high and low levels the agency is
considering, depending on the agency's determination of the maximum
feasible level for each fleet over time.
    Planned Analysis: While the main focus of NHTSA's prior CAFE EIS
for light duty vehicles (i.e., the EIS for MYs 2012-2016) was the
quantification of impacts to energy, air quality, and climate, and
qualitative analysis of cumulative impacts resulting from climate
change, it also addressed other potentially affected resources. NHTSA
conducted a qualitative review of impacts of the alternatives on other
potentially affected resources, such as water resources, biological
resources, land use, hazardous materials, safety, noise, historic and
cultural resources, and environmental justice.
    Similar to past EIS practice, NHTSA plans to analyze environmental
impacts related to fuel and energy use, emissions including GHGs and
their effects on temperature and climate change, air quality, natural
resources, and the human environment. NHTSA also will consider the
cumulative impacts of the proposed standards for MY 2017-2025
automobiles together with any past, present, and reasonably foreseeable
future actions.
    NHTSA anticipates uncertainty in estimating the potential
environmental impacts related to climate change. To account for this
uncertainty, NHTSA plans to evaluate a range of potential global
temperature changes that may result from changes in fuel and energy
consumption and GHG emissions attributable to new CAFE standards. It is
difficult to quantify how the specific impacts due to the potential
temperature changes attributable to new CAFE standards may affect many
aspects of the environment. NHTSA will endeavor to gather the key
relevant and credible information.
    NHTSA intends to rely upon the Intergovernmental Panel on Climate
Change (IPCC) 2007 Fourth Assessment Report and subsequent updates,
Reports of the U.S. Climate Change Science Program (CCSP) and the
current U.S. Global Change Research Program (U.S. GCRP), National
Academies and National Research Council assessments of climate impacts,
and the EPA Endangerment and Cause or Contribute Findings for
Greenhouse Gases under Section 202(a) of the Clean Air Act and the
accompanying Technical Support Document (referred to collectively
hereinafter as the EPA Endangerment Finding), as sources for recent
``summar[ies] of existing credible scientific evidence which is
relevant to evaluating the reasonably foreseeable significant adverse
impacts on the human environment.'' \27\ NHTSA believes that the IPCC
Fourth Assessment Report, the CCSP and U.S. GCRP Reports, the National
Academies and National Research Council assessments, and the EPA
Endangerment Finding are the most recent, most comprehensive summaries
available, but recognizes that subsequent research may provide
additional relevant and credible evidence not accounted for in these
Reports. NHTSA may consider such subsequent information as well, to the
extent that it provides relevant and credible evidence.
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    \27\ 40 CFR 1502.22(b)(3); see 40 CFR 1502.21. IPCC reports are
available at http://www.ipcc.ch/ (last visited Mar. 8, 2011).
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    NHTSA expects to rely on previously published EISs, incorporating
material by reference ``when the effect will be to cut down on bulk
without impeding agency and public review of the action.'' \28\
Therefore, the NHTSA NEPA analysis and documentation will incorporate
by reference relevant materials, including portions of the agency's
prior NEPA documents, where appropriate.
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    \28\ 40 CFR 1502.21.
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    Scoping and Public Participation: NHTSA's NEPA analysis for the MY
2017-2025 CAFE standards will consider the direct, indirect and
cumulative environmental impacts of proposed standards and those of
reasonable alternatives. The scoping process initiated by this notice
seeks public comment on the range of alternatives under consideration,
on the impacts to be considered, and on the most important issues for
in-depth analysis in the EIS.\29\
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    \29\ See 40 CFR 1500.5(d), 1501.7, 1508.25.
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    NHTSA invites the public to participate in the scoping process\30\
by submitting written comments concerning the appropriate scope of the
NEPA analysis for the proposed CAFE standards to the docket number
identified in the heading of this notice, using any of the methods
described in the ADDRESSES section of this notice. NHTSA does not plan
to hold a public scoping meeting, because written comments will be
effective in identifying and narrowing the issues for analysis.
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    \30\ Consistent with NEPA and implementing regulations, NHTSA is
sending this notice directly to: (1) Federal agencies having
jurisdiction by law or special expertise with respect to the
environmental impacts involved or authorized to develop and enforce
environmental standards; (2) the Governors of every State, to share
with the appropriate agencies and offices within their
administrations and with the local jurisdictions within their
States; (3) organizations representing state and local governments
and Indian tribes; and (4) other stakeholders that NHTSA reasonably
expects to be interested in the NEPA analysis for the MYs 2017-2025
CAFE standards. See 42 U.S.C. 4332(2)(C); 49 CFR 520.21(g); 40 CFR
1501.7, 1506.6.
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    All comments to the relevant scoping process are welcome. NHTSA is
especially interested in comments concerning the evaluation of climate
change impacts. In particular, NHTSA requests:

     Peer-reviewed scientific studies that have been issued
since the EPA Endangerment Finding and that address or may inform: (a)
The impacts of CO2 and other GHG emissions that may be
associated with any of the alternatives under consideration; (b) the
impacts on climate change that may be associated with these emission
changes; or (c) the time periods over which such impacts may occur.
NHTSA is particularly interested in peer reviewed studies analyzing the
potential impacts of climate change within the United States or in
particular geographic areas of the United States.
     Comments on how NHTSA should estimate the potential
changes in temperature that may result from the changes in
CO2 emissions projected from setting MY 2017-2025 CAFE
standards, and comments on how NHTSA should estimate the potential
impacts of temperature changes on the environment.
     Comments on how NHTSA should discuss or estimate any
localized or regional impacts of potential increased penetration of
alternative fuel vehicles, including upstream emissions and impacts
regarding waste and disposal of advanced batteries.\31\
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    \31\ In determining maximum feasibility, NHTSA may not consider
the fuel economy of ``dedicated vehicles,'' including vehicles that
operate only on natural gas, hydrogen, and electricity. 49 U.S.C.
32901(a); 49 U.S.C. 32902(h). NHTSA, however, recognizes that
potential future increases in alternative fuel vehicle penetration
could cause environmental impacts relevant to this EIS.
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     Comments on what timeframe NHTSA should use to evaluate
the environmental impacts that may result from setting MY 2017-2025
CAFE standards.
    NHTSA is also interested in comments on how the agency is planning
to structure the proposed alternatives. Subject to the statutory
constraints of EPCA/EISA, a variety of potential alternatives could be
considered within the purpose and need for the proposed rulemaking,
each falling along a theoretically infinite continuum of potential
standards. As described above, NHTSA plans to address this issue by
identifying alternatives at the upper and lower bounds of a range
within which we believe the statutory requirement for ``maximum
feasible'' would be satisfied, as well as identifying and analyzing the
impacts of a preferred alternative. In this way, NHTSA expects to
bracket the potential environmental impacts of the standards it may
select.\32\
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    \32\ Should NHTSA ultimately choose to set standards at levels
other than the Preferred Alternative, we believe that this
bracketing will properly inform the decisionmaker, so long as the
standards are set within its parameters.
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    NHTSA seeks comments on what criteria should be used to choose the
Preferred Alternative, given the agency's statutory requirement of
setting ``maximum feasible'' fuel economy standards that increase
ratably.\33\ When suggesting an approach, please explain how it would
satisfy EPCA's factors (technological feasibility, economic
practicability, the effect of other motor vehicle standards of the
Government on fuel economy, and the need of the United States to
conserve energy).\34\
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    \33\ See 49 U.S.C. 32902(f).
    \34\ Note that NHTSA is statutorily prohibited from considering
flexibility mechanisms in determining what standards would be
maximum feasible. In determining maximum feasibility, NHTSA also
must consider dual fueled vehicles to be operated only on gasoline
or diesel fuel and, as noted above, may not consider the fuel
economy of ``dedicated vehicles,'' including vehicles that operate
only on natural gas, hydrogen, and electricity. 49 U.S.C. 32901(a);
49 U.S.C. 32902(h).
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    Two important purposes of scoping are identifying the significant
issues that merit in-depth analysis in the EIS and identifying and
eliminating from detailed analysis the issues that are not significant
and therefore require only a brief discussion in the EIS.\35\ In light
of these purposes, written comments should include an Internet citation
(with a date last visited) to each study or report you cite in your
comments if one is available. If a document you cite is not available
to the public online, you should attach a copy to your comments. Your
comments should indicate how each document you cite or attach to your
comments is relevant to the NEPA analysis and indicate the specific
pages and passages in the attachment that are most informative.
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    \35\ 40 CFR 1500.4(g), 1501.7(a).
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    The more specific your comments are, and the more support you can
provide by directing the agency to peer-reviewed scientific studies and
reports as requested above, the more useful your comments will be to
the agency. For example, if you identify an additional area of impact
or environmental concern you believe NHTSA should analyze, or an
analytical tool or model you believe NHTSA should use to evaluate these
environmental impacts, you should clearly describe it and support your
comments with a reference to a specific peer-reviewed scientific study,
report, tool or model. Specific, well-supported comments will help the
agency prepare an EIS that is focused and relevant and will serve
NEPA's overarching aims of making high quality information available to
decisionmakers and the public by ``concentrat[ing] on the issues that
are truly significant to the action in question, rather than amassing
needless detail.'' \36\ By contrast, mere assertions that the agency
should evaluate broad lists or categories of concerns, without support,
will not assist the scoping process for the proposed standards.
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    \36\ 40 CFR 1500.1(b).
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    Please be sure to reference the docket number identified in the
heading of this notice in your comments. NHTSA intends to provide
notice to interested parties by e-mail. Thus, please also provide an e-
mail address (or a mailing address if you decline e-mail
communications).\37\ These steps will help NHTSA manage a large volume
of material during the NEPA process. All comments and materials
received, including the names and addresses of the commenters who
submit them, will become part of the administrative record and will be
posted on the Web at http://www.regulations.gov.
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    \37\ If you prefer to receive NHTSA's NEPA correspondence by
U.S. mail, NHTSA plans to provide its NEPA publications via CD.
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    Based on comments received during scoping, NHTSA expects to prepare
a draft EIS for public comment by September 2011 and a final EIS by
June 2012.\38\ The agency expects to issue a final rule in July 2012.
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    \38\ 40 CFR 1506.10.
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    Separate Federal Register notices will announce the availability of
the draft EIS, which will be available for public comment, and the
final EIS, which will be available for public inspection. NHTSA also
plans to continue to post information about the NEPA process and this
CAFE rulemaking on its Web site (http://www.nhtsa.gov).

    Issued: May 4, 2011.
Christopher J. Bonanti,
Associate Administrator for Rulemaking.
[FR Doc. 2011-11278 Filed 5-9-11; 8:45 am]
BILLING CODE 4910-59-P