Supporting Statement for an Information Collection Request (ICR)
Under the Paperwork Reduction Act (PRA)
EXECUTIVE SUMMARY
Identification of the Information Collection  -  Title and Numbers
                                                                         Title:
Final Rule-related ICR Amendment for Pesticide Product Performance Data Requirements for Products Claiming Efficacy Against Certain Invertebrate Pests (RIN 2070-AJ49)
                                                                   EPA ICR No.:
0277.23
                                                               OMB Control No.:
2070-0060
                                                                 Docket ID No.:
EPA-HQ-OPP-2020-0124
Abstract:
This information collection request (ICR) represents an amendment to an existing ICR entitled "Application for New and Amended Pesticide Registration," identified as EPA ICR No. 0277.22 and approved under OMB Control No.: 2070-0060. The amendment focuses on the information collection activities in the final rule entitled "Pesticide Product Performance Data Requirements for Products Claiming Efficacy Against Certain Invertebrate Pests" (RIN 2070-AJ49). (See Attachment A). In this rule, EPA codifies certain activities related to product performance data requirements to support registration of pesticidal products claiming efficacy against three categories of invertebrate pests. Those identified to be of significant public health importance (e.g., ticks, mosquitoes, cockroaches, etc.), wood-destroying insects (e.g., termites), and certain invasive invertebrate species (e.g., Asian longhorned beetle). The two latter categories are non-agricultural pests considered to be of significant economic or ecological importance. Product performance data (efficacy studies) document how well the pesticide performs the intended function (such as killing or repelling) against an invertebrate pest.
Product performance data is only a fraction of the information collection activities associated with the registration of a pesticide product under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3. This amendment recalculates the burden by decreasing the hourly burden for a small portion of the product performance data, generally efficacy data, that may be submitted to the Agency as part of the registration of pesticidal products package.
The Product Performance Rule ICR references the Section 3 ICR. The publication of the final rule will reduce burden to registrants, and will have no significant impact on Agency burden. The Rule will reduce the number of incomplete submissions of data (IC #2) to the Agency by 12 per year, each of which has an estimated burden of 14 hours. Currently, EPA estimates in the Section 3 ICR that 7,273 similar submissions are sent to the EPA annually, at a cost of 102,000 hours. A reduction of 12 submissions would reduce the number of submissions to 7,261 and reduce the hour burden by 168 hours annually. Further, the Rule will clarify data requirements and will result in reduced data generation costs (IC #4) equivalent to 4,515 hours annually. EPA estimates that the total average annual burden hours from data generation for new and amended products is 482,500 hours, so the Rule will reduce burden due to data generation to under 479,000 hours. In total, EPA estimates that the Product Performance Rule will reduce burden hours annually by 4,683 hours (4515+168). IC #1, IC #3, and Agency burden will not be impacted by this rule.
The total respondent burden calculated in the Application for New and Amended Pesticide Registration ICR is $108.7 million annually. With the final rule, that burden will be lowered to $108.4 million annually. This is primarily existing burden not attributable to this final rule and covered under EPA ICR No. 0277 and approved under OMB Control No.: 2070-0060.
Subsequent to the publication of the Notice of Proposed Rule Making, the ICR entitled "Application for New and Amended Pesticide Registration," (OMB Control No.: 2070-0060) was renewed and the total approved burden was increased from 1,524,893 to 1,562,517 hours. When adjusted to account for this burden change, which is unrelated to this final rule, this final rule reduces the burden by 4683 hours from 1,562,517 to 1,557,834.
Table 1: IC Summary Table: Annual Burden and Cost over the Three-Year ICR Period
                                  IC Category
                                   Responses
                                    Burden
                               Burden Reduction
                                  Respondents
IC #2: "Type B" application for registration of a new or amended product that contains a currently registered active ingredient
                                                                           7261
                                                                         101659
                                                                            168
IC #4: Data Generation (for New AIs & New Products)
                                                                            695
                                                                         478016
                                                                           4515
                                                                   Annual Total
                                                                           7956
                                                                        579,675
                                                                          4683
                                    Agency
IC #2: "Type B" application for registration of a new or amended product that contains a currently registered active ingredient
                                                                            N/A
                                                                            N/A
                                                                            N/A
IC #4: Data Generation (for New AIs & New Products)
                                                                            N/A
                                                                            N/A
                                                                            N/A
                                                                   Annual Total
                                                                            N/A
                                                                            N/A
                                                                           N/A

Supporting Statement
 Explain the circumstances that make the collection of information necessary.

The ICR entitled "Application for New and Amended Pesticide Registration," EPA ICR No. 0277.22 and approved under OMB Control No.: 2070-0060 (Ref. 1), is designed to provide the EPA with the necessary information to evaluate an application for the registration of a pesticide product, as required under Section 3 of the FIFRA, and the relevant regulations at 40 CFR 158 and section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (see Ref. 2, 3, and 4. Under FIFRA, EPA must evaluate pesticides comprehensively before they can be marketed and used in the United States to ensure that they will not pose unreasonable adverse effects to human health and the environment. This registration evaluation includes determining whether the composition of the pesticide warrants the proposed claims for it, the pesticide's labeling complies with all applicable requirements (e.g., is not false or misleading), and the pesticide will perform its intended function without unreasonable adverse effects on human health and the environment. See FIFRA Section 3(c)(5). Pesticides that meet this test are granted a license or "registration" which permits their distribution, sale and use according to requirements set by EPA to protect human health and the environment.
Due to the Paperwork Reduction Act (PRA) burden changes precipitated by the final rule, this amendment recalculates by decreasing some of the hourly burden activity associated with information collections categorized as Type B actions. The Agency reviews an average of 7,273 Type B actions annually. Product performance data is categorized by the Agency as a Type B action. A subset of product performance data, specifically, product efficacy reviews, account for about 60 reviews, on average, every year, or less than one percent of the total product performance data that may be submitted to the Agency as part of a registration review package.
Product performance data (efficacy studies) document how well the product performs the intended function (such as killing or repelling) against an invertebrate pest. This rule changes the regulatory mechanism by which this information would be collected, but for the most part, the data requirements that EPA is codifying are consistent with EPA's current practices in data supporting applications for registration of a pesticide product that bears a pesticidal claim against one or more of these pests. Additionally, the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) requires EPA to finalize product performance data requirements by September 30, 2021 (see Ref. 6). Specifically, the Act states that, "The Administrator shall, not later than September 30, 2021, issue regulations prescribing product performance data requirements for any pesticide intended for preventing, destroying, repelling, or mitigating any invertebrate pest of significant public health or economic importance specified in clauses (i) through (iv) of subparagraph (B) [bed bugs; premise (including crawling insects, flying insects, and baits), pests of pets (including pet pests controlled by spot-ons, collars, shampoos, powders, or dips), and fire ants]."
 Indicate how, by whom, and for what purpose the information is to be used.
Except for a new collection, indicate the actual use the Agency has made of the information received from the current collection.
This action is issued under the authority of sections 3, 5, 10, 12, and 25 of FIFRA (7 U.S.C. 136 - 136y), as amended. Under FIFRA section 3(c)(2)(A), EPA is required to specify "the kinds of information which will be required to support the registration of a pesticide and shall revise such guidelines from time to time." EPA's codification of these data requirements is in 40 CFR part 158. This information collection is used by EPA to review submittal of the product performance information, the efficacy studies and other information to make registration determinations under FIFRA.
 Describe whether, and to what extent, the collection of information involves the
use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
Applications for pesticide registration can be submitted electronically, including forms, studies, and draft product labeling. EPA also offers the use of the Pesticide Submission Portal (PSP), a fully electronic alternative as an option for submitting registration forms electronically. The PSP leverages the Agency's existing Central Data Exchange (CDX) to provide a secure method of submitting information within a secure online environment. CDX requires initial user registration for which the paperwork burden estimate is covered under "Cross-Media Electronic Reporting Rule" ICR, OMB No. 2025-0003.
EPA will continue to accept paper applications but encourages applicants to take advantage of the more efficient PSP option and forego physical transmission costs to submit information to EPA. For electronic submissions, applicants do not need to submit multiple copies of any pieces of their application, the requirement for multiple copies of data and five copies of draft labeling only applies to paper submissions. Extensive guidance regarding available several electronic submission options is available to registrants via the Office of Pesticide Program's (OPP) website at http://www2.epa.gov/pesticide-registration/electronic-submissions-pesticide-applications.
4. Describe efforts to identify duplication.
Duplication should not occur in this program, as EPA has the sole authority to regulate pesticides in the United States and establish efficacy data requirements under 40 CFR part 158. Therefore, this information is not requested by other agencies.
EPA supports data sharing (subject to data compensation as directed by FIFRA) to reduce the potential for duplicative studies being submitted to EPA.
 If the collection of information impacts small businesses or other small entities,
describe the methods used to minimize burden.
EPA offers direct assistance to small entities, facilitating their compliance with the requirements for obtaining an exemption.
 Describe the consequence to Federal program or policy activities if the collection
is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.
The burden assumes a minimum of one submittal per product registration which is the least possible collection that allows the Agency to conduct the statutorily required review.
This information collection is only conducted as a registration application is received for consideration. There is no set schedule for submission of this information to EPA.
 Explain any special circumstances that require the collection to be conducted in
a manner inconsistent with OMB guidelines.
The only guideline established under the Paperwork Reduction Act (PRA) that is exceeded in this collection is the time period for retaining records. The recordkeeping activities applicable to pesticide registrants exceeds OMB's guideline that agencies do not require records be retained for more than three years (5 CFR 1320.5(d)(2)(iv)). As authorized under FIFRA Section 8, EPA regulations under 40 CFR 169.2(k) require registrants to retain records containing research data relating to a registered pesticide, including all data submitted to EPA in support of a registration, for as long as the registration is valid, and the producer is in business. However, the burden related to the recordkeeping requirements is covered under another ICR (see OMB Control No. 2070-0028, Recordkeeping Requirements for Producers of Pesticides under Section 8 of FIFRA).
 If applicable, provide a copy and identify the date and page number of
publications in the Federal Register of the Agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken in response to the comments. Specifically, address comments received on cost and hour burden. Describe efforts to consult with persons outside EPA to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.
Pursuant to 5 CFR 1320.11(b), the proposed rule announced the availability of this ICR and provided a 60-day public comment opportunity (Ref. 5). Comments received on the proposed rule are addressed in the final rule. EPA did not receive any public comment on the draft ICR amendment.
 Explain any decision to provide any payment or gift to respondents, other than
remuneration of contractors or grantees.
This question is not applicable to this ICR.
 Describe any assurance of confidentiality provided to respondents and the basis
for the assurance in statute, regulation, or Agency policy.
The EPA implements procedures to protect any confidential, trade secret or proprietary information from disclosure that provide strict instructions regarding access to and contact with documents confidential business information (CBI). In accordance with FIFRA Section 10 and 40 CFR Part 2, Subpart B, EPA will protect from disclosure all data and/or information brought to the Agency in conjunction with this information collection that may be claimed as confidential, trade secret, commercial, or financial information.
11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.
No information of a sensitive or private nature is requested in conjunction with these information collection activities, and these information collection activities comply with the provisions of the Privacy Act of 1974 and OMB Circular A-108, as amended, "Responsibility for the Maintenance of Records about Individuals by Federal Agencies."
 Provide estimates of the hour burden of the collection of information.
       Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.
       If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens.
       Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included under `Annual Cost to Federal Government'.
The paperwork burden associated with the rule is based on the information and activities identified in existing ICR and is considered to off-set or serve as an alternative burden for that estimated in the existing ICR. The methodology and approach is consistent with that used for the existing ICR entitled "Application for New and Amended Pesticide Registration," identified as EPA ICR No. 0277 and approved under OMB Control No.: 2070-0060 (see Ref. 1). The full population of respondents for that ICR was 1,751. There are two main categories of applicants for registration: those requiring submission of a full complement of supporting data (e.g., new active ingredients); and those requiring submission of less data (e.g., amendments, for currently registered chemicals). These have been described as Type A and B, respectively. For the reasons described below, EPA considers requests for label claims against pests of significant public health importance, wood-destroying, and invasive species pests to be Type B actions. Table 2 presents the estimated burden and cost estimate per submission for Type B actions.
       Table 2: Estimated Average Burden and Cost per Type B Submission

        Collection Activities, Type B
                                       Burden Hours
                                         Total

                                      Mgmt.
                                    Technical
                                    Clerical
   Hours
    Costs

                                   $132.14/hr
                                    $87.24/hr
                                    $48.83/hr

 Read Instructions
                                       7
                                       0
                                       0
                                       7
                                       $852
 Plan activities
                                       0.5
                                       0
                                       0
                                        0.5
                                       $61
 Gather/create information
                                       0
                                       1.5
                                       0
                                        1.5
                                       $108
 Compile and review
                                       0.5
                                       0.5
                                       0
                                       1
                                       $97
 Complete paperwork
                                       0
                                       0
                                       3
                                       3
                                       $123
 Submit information

 Store/maintain data
                                       0
                                       0
                                       1
                                       1
                                       $41
 Third party disclosure

                                         TOTAL
                                       8
                                       2
                                       4
                                        14
                                      $1,282
*Numbers may not sum due to rounding.
EPA notes that "Type B" activities involve a registrant or applicant assembling and submitting an application for registration of a new or amended product that contains a currently registered active ingredient. Because this rulemaking is about publishing the standards for label claims, the impacted activities would generally be "Type B" activities. "Type A" actions include applications for new active ingredients. Submission of applications for new active ingredients may also include product labeling, and so in some cases Type A actions may be influenced by the rule. However, EPA did not observe any cases of this in our 60-product sample of submissions. Further, Type B actions are more than 20 times as common as Type A actions, so the majority of the burden reduction from this rule will be from Type B actions. Type C actions are applications for a new active ingredient or a new use of a currently registered active ingredient but also include a "reduced risk" rationale document addressing risk reduction parameters. The Type C reduced risk rationale is not impacted by the rule. EPA did not observe any cases of this in our 60-product sample of submissions. Type B actions are almost 1,000 times as common as Type C actions, and so will account for the majority of the burden reduction from this rule.
EPA does not expect the final rule to significantly change the estimates of the paperwork burden from the submission process. As documented in the September 24, 2020, Application for New and Amended Pesticide Registration ICR, the Agency reviews 7,273 Type B actions annually.
Product efficacy reviews account for about 60 reviews, on average, every year, or less than one percent of the total product performance data (Type B actions); thus, the burden of these particular actions has little measurable effect on the overall average. EPA has not estimated the burden associated with applications for efficacy reviews specifically, but it is probably greater than the average Type B action. In particular, the burden associated with the first two steps Reading Instructions and Planning Activities, may be high because requirements have not been codified and it may be difficult for applicants to ascertain what information should be submitted. Codifying the requirements would make it easier for applicants to obtain the information they need, reducing the burden of seeking that information and identifying the appropriate studies.
EPA estimates the total average annual cost of paperwork burden from data generation for new and amended products is $33.7 million. This rule will save $315,000 annually, or 1% of the total paperwork burden from data generation. EPA estimates that the total average annual burden hours from data generation for new and amended products is 483,000 hours. The rule will reduce the burden by 4,515 hours, or 1% of the estimated total hourly burden from data generation.
EPA estimates that annually 12 data packages are submitted to the EPA that lack the appropriate efficacy data to support the requested label claims. EPA expects the rule to eliminate this category of waste because applicants would know what data are required. A reduction of 12 applications per year with an estimated paperwork burden of $1,282 implies a cost savings of approximately $15,000 annually resulting from the rule. Each action is estimated to take 14 hours  -  a reduction of 12 applications per year implies a reduction in burden hours of 168 annually. When the rule is finalized, assuming the annual baseline for data packages remains as projected, EPA expects the number of Type B actions to decline from 7,273 to 7,261 per year over the next three years.
In the long run, EPA expects the rule to lead to increased clarity among registrants about EPA data requirements, and the reduction in uncertainty resulting from the rule may lead registrants to submit more data packages. If registrants increased the number of data packages submitted to the Agency by more than 12 annually, this would result in increased total submissions, and associated total burden, but with fewer incomplete data packages. The Agency does not have information on whether the clarity resulting from the implementing the rule will result in an increase or decrease in the number of total submissions to the Agency relative to prior to the publication of the rule.
 Provide an estimate for the total annual cost burden to respondents or
recordkeepers resulting from the collection of information.
 The cost estimate should be split into two components: (a) a total capital and start-up cost component (annualized over its expected useful life) and (b) a total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.
 If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collections services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.
 Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.
There are no capital investment or maintenance and operational costs for this information collection.
14. Provide estimates of annualized cost to the Federal government.
The incremental burden for the Agency associated with codifying the product performance data requirements is uncertain. The final rule will result in clarity for registrants which may lead to registrants submitting fewer incomplete packages, thus reducing the burden for the Agency. However, given the small number of product performance data submissions relative to the total number of submissions reviewed by the Agency, the burden will not change measurably. Moreover, the increase in clarity may encourage registrants to submit more packages and this may translate to an increased Agency burden. Therefore, the direction and extent of Agency burden in the long term is uncertain but likely to be very small.
The estimated number of Agency FTEs dedicated to the currently approved Section 3 ICR registration and registration support activities is approximately 24 managerial FTEs, 146 technical FTEs, and 7 clerical FTEs. The aggregated Agency estimated FTE dedicated to Section 3 activities is 177 and the burden hours are 369,127. The fully loaded hourly mean wage rate estimate is $132.14 for managerial occupations, $87.24 for technical occupations, and $48.83 for clerical occupations. To calculate the Agency's estimated annual cost of Section 3 activities, the number of FTE's allocated to registration activities is multiplied by these fully loaded labor rates and by 2,080 hours per FTE, which is estimated to be about $6.68 million for management occupations; $26.56 million for technical occupations; and $689 thousand for clerical occupations. The total estimated Agency cost is $33.93 million.
15. Explain the reasons for any program changes or adjustments reported in Items 13 (or 14) of OMB Form 83-I.
EPA estimates the final rule will result in an average of 12 fewer submissions of incomplete data packages that do not support desired label claims, saving registrants $15,000 in paperwork costs related to application submission. Further, the Agency estimates the final rule will reduce unnecessary data generation paperwork burden by $315,000 annually. This is a total annual reduction in paperwork burden of $330,000 on average, equivalent to an annual reduction   in burden hours of 4,683. This is a program change.
The final rule will reduce the cost of registrant paperwork burden from the submission process by 0.15%. The rule will reduce the average cost of paperwork burden from    data generation for new and amended products by 1%. Due to the relatively small impact of the rule, the Agency concludes that the rule will not substantively change the burden estimates calculated in the Application for New and Amended Pesticide Registration ICR (#0277.20).
The Agency does not expect an immediate substantial increase in the number of registrations due to the codification of the rule as there is a significant effort of resources and time involved in developing new products. For this reason, EPA expects that the savings presented above will remain accurate for the period covered by this ICR. However, in the long run, the clarity resulting from the rule may encourage registrants to submit more data packages to the Agency. The Agency does not possess information to indicate whether registrants would submit more packages after the publication of the rule, nor does the Agency possess information to indicate how many more packages registrants would submit.
16. For collections whose results will be published, outline the plans for tabulation and publication.
Not applicable. EPA does not plan to publish the results for this collection.
17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons why display would be inappropriate.
This question is not applicable to this ICR.
18. Explain each exception to the certification statement identified in Item 19 of OMB Form 83-I.
EPA does not request an exception to the certification of this information collection.
REFERENCES
 Currently Approved ICR. "Application for New and Amended Pesticide Registration," EPA ICR No. 0277.22 and approved under OMB Control No.: 2070-0060. Located in the public docket at https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=202005-2070-003.
 Statutory Authority  -  FIFRA Section 3, 7 U.S.C. 136a. EPA provides a summary of this law, along with a link to the U.S. Code, on our website: https://www.epa.gov/laws-regulations/summary-federal-insecticide-fungicide-and-rodenticide-act.
 Current Regulations  -  40 CFR part 158. An electronic version of part 158, entitled "Data Requirements for Pesticides," is maintained by the Government Printing Office here: https://www.ecfr.gov/.
 Statutory Authority  -  Section 408 of the Federal, Food, Drug and Cosmetic Act (FFDCA), see 21 U.S.C. 346a. Tolerances and exemptions for pesticide chemical residues. EPA provides a summary of this law, along with a link to the U.S. Code, on our website: https://www.epa.gov/laws-regulations/summary-federal-food-drug-and-cosmetic-act.
 Proposed Rule; Pesticide Product Performance Data Requirements for Products Claiming Efficacy Against Certain Invertebrate Pests" (RIN 2070-AJ49). Located in this docket at https://www.regulations.gov/document/EPA-HQ-OPP-2020-0124-0003.
 Statutory Authority  -  Pesticide Registration Improvement Extension Act of 2018 (PRIA 4). See https://www.congress.gov/116/plaws/publ8/PLAW-116publ8.pdf.
LIST OF ATTACHMENTS
The attachments for the ICR supporting statement established for the final rule are available in the public docket for the final rule under identification number EPA-HQ-OPP-2020-0124. These attachments are available for online viewing at https://www.regulations.gov or otherwise accessed as described in the sections below.
Attachment
Description
                                       A
Final Rule; Pesticide Product Performance Data Requirements for Products Claiming Efficacy Against Certain Invertebrate Pests (RIN 2070-AJ49). At submission this final rule was pending publication, and a copy of the published rule is located in this docket.


[Federal Register Volume 87, Number 205 (Tuesday, October 25, 2022)]
[Notices]
[Pages 64507-64508]
[FR Doc No: 2022-23124]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4662-DR; Docket ID FEMA-2022-0001]

Nebraska; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Nebraska (FEMA-4662-DR), dated July 27, 2022,
and related determinations.

DATES: The declaration was issued July 27, 2022.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated July 27, 2022, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Nebraska resulting from severe storms and straight-line winds on
May 12, 2022, is of sufficient severity and magnitude to warrant a
major disaster declaration under the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''). Therefore, I declare that such a major disaster
exists in the State of Nebraska.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.

    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Andrew P. Meyer, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Nebraska have been designated
as adversely affected by this major disaster:

    Antelope, Boone, Burt, Cedar, Cuming, Custer, Dixon, Garfield,
Greeley, Holt, Knox, Logan, Pierce, Polk, Sherman, Thurston, Valley,
Wayne, Wheeler, and York Counties for Public Assistance.
    All areas within the State of Nebraska are eligible for
assistance under the Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-23124 Filed 10-24-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 240 (Friday, December 13, 2019)]
[Notices]
[Page 68225]
[FR Doc No: 2019-26839]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87689; File No. SR-CboeBYX-2019-013]

Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of
Withdrawal of a Proposed Rule Change To Amend the Fee Schedule Assessed
on Members To Establish a Monthly Trading Rights Fee

December 9, 2019.
    On August 1, 2019, Cboe BYX Exchange, Inc. (``BYX'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend the BYX Fee Schedule to establish a
monthly Trading Rights Fee to be assessed on Members. The proposed rule
change was immediately effective upon filing with the Commission
pursuant to Section 19(b)(3)(A) of the Act.\3\ The proposed rule change
was published for comment in the Federal Register on August 21,
2019.\4\ The Commission received one comment letter on the proposed
rule change, and one response letter from the Exchange.\5\ On September
27, 2019, the Commission temporarily suspended the proposed rule change
and instituted proceedings to determine whether to approve or
disapprove the proposed rule change.\6\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ See Securities Exchange Act Release No. 86685 (August 15,
2019), 84 FR 43627.
    \5\ See Letters from: Theodore R. Lazo, Managing Director and
Associate General Counsel, SIFMA, dated September 12, 2019; Adrian
Griffiths, Assistant General Counsel, Cboe, dated September 25,
2019. Comment letters are available on the Commission's website at:
https://www.sec.gov/comments/sr-cboebyx-2019-013/srcboebyx2019013.htm.
    \6\ See Securities Exchange Act Release No. 87140, 84 FR 52917
(October 3, 2019).
---------------------------------------------------------------------------

    On November 21, 2019, the Exchange withdrew the proposed rule
change (SR-CboeBYX-2019-013).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-26839 Filed 12-12-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Pages 83140-83141]
[FR Doc No: 2020-28035]

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

Federal Aviation Administration

Notice of Meeting of the National Parks Overflights Advisory
Group

ACTION: Notice of meeting.

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

SUMMARY: The Federal Aviation Administration (FAA) and the National
Park Service (NPS), in accordance with the National Parks Air Tour

Management Act of 2000, announce the next meeting of the National Parks
Overflights Advisory Group (NPOAG). This notification provides the
date, format, and agenda for the meeting.

DATES: The NPOAG will meet on January 22, 2021 from 10:30 a.m. to 1:30
p.m. Pacific Time.

ADDRESSES: The meeting will be conducted virtually. Prior to the
meeting, information about how the public can view the meeting will be
posted on the NPOAG website (https://www.faa.gov/about/office_org/headquarters_offices/arc/programs/air_tour_management_plan/parks_overflights_group/).

FOR FURTHER INFORMATION CONTACT: Keith Lusk, AWP-1SP, Special Programs
Staff, Federal Aviation Administration, Western-Pacific Region
Headquarters, 777 South Aviation Boulevard, Suite 150, El Segundo, CA
90245, telephone:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The National Parks Air Tour Management Act of 2000 (NPATMA),
enacted on April 5, 2000, as Public Law 106-181, required the
establishment of the NPOAG within one year after its enactment. The Act
requires that the NPOAG be a balanced group of representatives of
general aviation, commercial air tour operations, environmental
concerns, and Native American tribes. The Administrator of the FAA and
the Director of NPS (or their designees) serve as ex officio members of
the group. Representatives of the Administrator and Director serve
alternating 1-year terms as chairperson of the advisory group.
    The duties of the NPOAG include providing advice, information, and
recommendations to the FAA Administrator and the NPS Director on:
implementation of Public Law 106-181; quiet aircraft technology; other
measures that might accommodate interests to visitors of national
parks; and at the request of the Administrator and the Director, on
safety, environmental, and other issues related to commercial air tour
operations over national parks or tribal lands.

Agenda for the January 22, 2021 NPOAG Meeting

    The agenda for the meeting will be posted on the NPOAG website
(https://www.faa.gov/about/office_org/headquarters_offices/arc/programs/air_tour_management_plan/parks_overflights_group/) one week
prior to the meeting and focus primarily on current FAA and NPS work to
prepare air tour management plans at 23 parks nationwide as a result of
a recent court order.

Attendance at the Meeting and Submission of Comments

    Although this is not a public meeting, interested persons may
attend virtually and can view the meeting and listen to the
proceedings. Information about how the public can view the meeting will
be posted on the NPOAG website (https://www.faa.gov/about/office_org/headquarters_offices/arc/programs/air_tour_management_plan/parks_overflights_group/) prior to the meeting. To submit written
comments regarding the meeting or to sign up for verbal public comment,
contact the person listed under FOR FURTHER INFORMATION CONTACT. Verbal
comment time will be limited to 3 minutes each and the number of
commenters may be capped. Written comments will not be limited or
capped and will be included in the meeting notes.

Record of the Meeting

    If you cannot attend the virtual NPOAG meeting, a summary record of
the meeting will be made available under the NPOAG section of the FAA
ATMP website at:

http://www.faa.gov/about/office_org/headquarters_offices/arc/programs/air_tour_management_plan/parks_overflights_group/minutes.cfm

or through the Special Programs Staff, Western-Pacific Region
Headquarters, 777 South Aviation Boulevard, Suite 150, El Segundo, CA
90245, telephone:<PHONE_NUMBER>.

    Issued in El Segundo, CA on December 15, 2020.
Keith Lusk,
Program Manager, Special Programs Staff, Western-Pacific Region.
[FR Doc. 2020-28035 Filed 12-18-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 197 (Thursday, October 11, 2018)]
[Notices]
[Pages 51460-51461]
[FR Doc No: 2018-22071]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2006-0971; FRL-9982-83-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; National Volatile Organic Compound Emission
Standards for Aerosol Coatings (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), National Volatile Organic
Compound Emission Standards for Aerosol Coatings (EPA ICR No. 2289.04,
OMB Control No. 2060-0617), to the Office of Management and Budget
(OMB) for review and approval in accordance with the Paperwork
Reduction Act (PRA). This is a proposed extension of the ICR, which is
currently approved through October 31, 2018. Public comments were
previously requested via the Federal Register on April 18, 2018, during
a 60-day comment period. This notice allows for an additional 30 days
for public comments. A fuller description of the ICR is given below,
including its estimated burden and cost to the public. An agency may
not conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.

DATES: Additional comments may be submitted on or before November 13,
2018.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2006-0971, to (1) EPA online using https://www.regulations.gov (our
preferred method), by email to [email protected], or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW, Washington, DC 20460, and (2) OMB via email
to [email protected]. Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public 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.

FOR FURTHER INFORMATION CONTACT: Ms. Kaye Whitfield, Sector Policies
and Programs Division (Mail Code D243-02), Office of Air Quality
Planning and Standards, U.S. Environmental Protection Agency, Research
Triangle Park, North Carolina 27711; telephone number:<PHONE_NUMBER>;
fax number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
https.www.regulations.gov or in person at the EPA Docket Center, WJC
West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The
telephone number for the Docket Center is<PHONE_NUMBER>. For additional
information about the EPA's public docket, visit https://www.epa.gov/dockets.
    Abstract: The EPA is required under section 183(e) of the Clean Air
Act (CAA) to regulate volatile organic compound (VOC) emissions from
the use of consumer and commercial products. Pursuant to CAA section
183(e)(3), the EPA published a list of consumer and commercial products
and a schedule for their regulation (60 FR 15264). Aerosol coatings are
included on the list, and the standards for such coatings are codified
at 40 CFR part 59, subpart E. The reports required under the standards
enable the EPA to identify coating formulations manufactured, imported,
or distributed in the United States, and to determine the product-
weighted reactivity. The ICR addresses the burden for activities
conducted in 3-year increments after promulgation of the National VOC
Emission Standards for Aerosol Coatings. Regulated entities read
instructions to determine how they are affected by the rule. They are
required to submit initial notifications when an aerosol coating is
manufactured and notification of changes in the initial report, to
report formulation data and exemptions claimed, and to maintain
records. In addition, regulated entities are required to submit
triennial reports that include formulation data and VOC usage.
    Form Numbers: None.
    Respondents/affected entities: Manufacturers, distributors, and
importers of aerosol coatings (North American Industry Classification

System (NAICS) Code 32551, ``Paint and Coating Manufacturing,'' and
NAICS Code 325998, ``All Other Miscellaneous Chemical Production and
Preparation Manufacturing'').
    Respondent's obligation to respond: Mandatory under 40 CFR part 59,
subpart E.
    Estimated number of respondents: 65 (total).
    Frequency of response: Annual, triennial.
    Total estimated burden: 12,259 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $855,113 (per year), includes no annualized
capital or operation and maintenance costs.
    Changes in Estimates: There is a decrease of 6 hours in the total
estimated respondent burden compared with the ICR currently approved by
OMB. This decrease is due to addressing calculation errors in the
previously approved ICR.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2018-22071 Filed 10-10-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3719-3723]
[FR Doc No: 2015-01144]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0177]

Crash Weighting Analysis

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice; request for public comment.

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

SUMMARY: FMCSA announces a study to inform decision making about the
feasibility of using a motor carrier's role in crashes as an indicator
of future crash risk in response to stakeholder interest

and as part of the Agency's commitment to continuous improvement. This
study assesses (1) whether Police Accident Reports (PARs) provide
sufficient, consistent, and reliable information to support crash
weighting determinations; (2) whether a crash weighting determination
process would offer an even stronger predictor of crash risk than
overall crash involvement and how crash weighting would be implemented
in the Agency's Safety Measurement System (SMS); and (3) how FMCSA
might manage a process for making crash weighting determinations,
including the acceptance of public input. This notice advises the
public of the availability of the study report for review and comment,
along with a request for feedback on what steps the Agency should take
regarding crash and PAR data quality.

DATES: Comments must be received on or before February 23, 2015.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2014-0177 using any of the
following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m., ET, Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this notice. Note that DOT posts all comments received without
change to www.regulations.gov, including any personal information
included in a comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The on-line Federal document management system
is available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: For information concerning this study,
contact Ms. Dee Williams, Chief, Compliance Division, Federal Motor
Carrier Safety Administration, 1200 New Jersey Avenue SE., Washington,
DC 20590, Telephone<PHONE_NUMBER> or by email<EMAIL_ADDRESS>If
you have questions on viewing or submitting material to the docket,
contact Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2014-0177), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online or by fax, mail, or hand delivery, but please use only one of
these means. FMCSA recommends that you include your name and a mailing
address, an email address, or a phone number in the body of your
document so the Agency can contact you if it has questions regarding
your submission.
    To submit your comment online, go to http://www.regulations.gov and
put the docket number, ``FMCSA-2014-0177'' in the ``Keyword'' box, and
click ``Search.'' When the new screen appears, click on ``Comment
Now!'' button and type your comment into the text box in the following
screen. Choose whether you are submitting your comment as an individual
or on behalf of a third party and then submit. If you submit your
comments by mail or hand delivery, submit them in an unbound format, no
larger than 8\1/2\ by 11 inches, suitable for copying and electronic
filing. If you submit comments by mail and would like to know that they
reached the facility, please enclose a stamped, self-addressed postcard
or envelope.
    FMCSA will consider all comments and material received during the
comment period and may change this notice based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov and
insert the docket number, ``FMCSA-2014-0177'' in the ``Keyword'' box
and click ``Search.'' Next, click ``Open Docket Folder'' button and
choose the document listed to review. If you do not have access to the
Internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., e.t., Monday through Friday, except Federal holidays.

II. Background

    The FMCSA is dedicated to reducing crashes, injuries, and
fatalities involving large trucks and buses. The Compliance, Safety,
Accountability (CSA) program is FMCSA's enforcement model that allows
the Agency and State Partners to address motor carrier safety problems
before crashes occur. The foundation of CSA is the SMS, which
quantifies the on-road safety performance of motor carriers to
prioritize enforcement resources.
    The SMS uses recordable crash records involving commercial motor
vehicles (CMVs) that are submitted by the States through the Agency's
Motor Carrier Management Information System (MCMIS) to assess motor
carriers' crash risk and prioritize them for safety interventions using
the SMS Crash Indicator. To define recordable crash, the Agency relies
on the definition of ``accident'' found in 49 CFR 390.5, which means
(1) except as provided in paragraph (2) of the definition, an
occurrence involving a CMV operating on a highway in interstate or
intrastate commerce that results in: (i) A fatality; (ii) bodily injury
to a person who, as a result of the injury, immediately receives
medical treatment away from the scene of the accident; or (iii) one or
more motor vehicles incurring disabling damage as a result of the
accident, requiring the motor vehicle(s) to be transported away from
the scene by a tow truck or other motor vehicle. (2) The term accident
does not include: (i) An occurrence involving only boarding and
alighting from a stationary motor vehicle; or (ii) an occurrence
involving only the loading or unloading of cargo.
    A CMV is also defined at 49 CFR 390.5, as any self-propelled or
towed

motor vehicle used on a highway in interstate commerce to transport
passengers or property when the vehicle: (1) Has a gross vehicle weight
rating or gross combination weight rating, or gross vehicle weight or
gross combination weight, of 4,536 kg (10,001 pounds) or more,
whichever is greater; or (2) is designed or used to transport more than
eight passengers (including the driver) for compensation; or (3) is
designed or used to transport more than 15 passengers, including the
driver, and is not used to transport passengers for compensation; or
(4) is used in transporting material found by the Secretary of
Transportation to be hazardous under 49 U.S.C. 5103 and transported in
a quantity requiring placarding under regulations prescribed by the
Secretary under 49 CFR, subtitle B, chapter I, subchapter C.
    Because the crash data reported to FMCSA by the States does not
specify a motor carrier's role in the crash, the Crash Indicator uses
all of a motor carrier's recordable crashes, and is not available
publicly. The Crash Indicator does weight crashes based on crash
severity, however, with more weight given to fatality and injury
crashes than to those that meet the definition of an accident only
because one or more vehicles was towed from the scene.
    Research on this issue conducted by FMCSA, as well as independent
organizations, has demonstrated that crash involvement, regardless of
role in the crash, is a strong indicator of future crash risk. In fact,
the Crash Indicator is one of the strongest predictors of crashes
within the SMS. FMCSA's recently completed SMS Effectiveness Test (ET)
shows that motor carriers above the Intervention Threshold in the Crash
Indicator have a future crash rate that is 85 percent higher than the
national average (https://csa.fmcsa.dot.gov/Documents/CSMS_Effectiveness_Test_Final_Report.pdf). This document and related
reports are available in the docket of this notice.
    Since FMCSA has implemented the SMS, some stakeholders have
expressed concern that the Crash Indicator may not identify the highest
risk motor carriers for intervention because it looks at all crashes
without regard to the role of the carrier in the crash. In response to
stakeholder interest and as part of the Agency's commitment to
continuous improvement, FMCSA has completed a study on the feasibility
of using a motor carrier's role in crashes as an indicator of future
crash risk. The analysis focused only on the three broad questions
below addressing the procedural issues surrounding a crash weighting
program and the feasibility of implementing such a program; it did not
focus on any other implications of the program. The three analysis
questions are separate analyses designed to inform Agency decisions.
     Do PARs provide sufficient, consistent, and reliable
information to support crash weighting determinations?
     Would a crash weighting determination process offer an
even stronger predictor of crash risk than overall crash involvement,
and how would crash weighting be implemented in the SMS?
     Depending upon the analysis results for the questions
above, how might FMCSA manage the process for making crash weighting
determinations, including public input to the process?
    The Agency's research plan was posted on the Agency's Web site at
http://csa.fmcsa.dot.gov/documents/CrashWeightingResearchPlan_7-2012.pdf on July 23, 2012. The resulting report is titled ``Crash
Weighting Analysis'' and is in the docket associated with this notice.
The draft research was peer reviewed, and the peer review
recommendations are also in the docket.

III. Summary of Analysis

    The discussion below summarizes the results of the three questions
addressed in this analysis. Each question is addressed independently.
The FMCSA seeks comments on the analyses' approaches and results.
    Because FMCSA does not receive PARs from the States, the Agency
created a database for analysis using 10,892 PARs obtained from two
national datasets: The National Highway Traffic Safety Administration
(NHTSA) Fatality Analysis Reporting System (FARS) and the National
Motor Vehicle Crash Causation Survey (NMVCCS).
    Depending upon State procedures, most PARs do not indicate the
reason for a crash; therefore, the FMCSA employed a review process
based on the process developed for FMCSA's Large Truck Crash Causation
Study (LTCCS), particularly the methodology for assigning the
``critical event'' and the ``critical reason'' for the critical event.
This methodology focuses on pre-crash events, such as vehicle and
driver actions/movements, driver condition, and the environment at the
crash scene, to identify the circumstances leading to the crash.\1\ The
critical event is the event that immediately led to the crash and that
put the vehicle or vehicles on a course that made the crash
unavoidable. The critical reason is the immediate reason for the
critical event or the failure leading to the critical event, for
example, if a CMV driver drives too fast for the roadway type.
---------------------------------------------------------------------------

    \1\ For details on the LTCCS methodology, go to http://www.ai.fmcsa.dot.gov/ltccs/default.asp?page=method.
---------------------------------------------------------------------------

    The FMCSA reviewed the PARs and determined the critical event and
critical reason to identify a motor carrier's role in a crash and
assign a crash weighting for analysis purposes. In order to derive the
most robust analysis of each study question, the Agency used several
crash data sources, including PARs, the NMVCCS, and the MCMIS.

Question 1: Do PARs provide sufficient, consistent, and reliable
information to support crash weighting determinations?

    One of the key questions for this study is whether FMCSA could make
reliable crash weighting determinations based solely on PARs, since the
PAR is often perceived as the most common and timely record of a crash.
This analysis (1) reviewed PAR sufficiency for determining a motor
carrier's role in a crash; (2) compared a sample of PARs with other
data sets to assess the reliability of the information on the PARs; and
(3) assessed the feasibility of identifying (coding) the motor
carrier's role for particular types of crash events without reviewing
the PAR.
    In this study, FMCSA reviewed and coded three years of crash data,
a total of 10,892 PARs from the FARS and NMVCCS, to identify the
critical reason for the crash. Ninety-one percent of the PARs met the
criteria to be reviewed for a critical reason determination (at least
one vehicle involved in the crash was a CMV, the CMV was regulated by
FMCSA, and the crash met the criteria for a recordable crash). Nine
percent could not be reviewed because it could not be determined from
the PAR that all of these criteria were met. Of the 91 percent of the
PARs that could be reviewed, 3 percent could not be coded for a
critical reason due to incomplete, inconsistent, or insufficient
information.
    The PARs were then reviewed to determine how reliably (or
accurately) they depicted the circumstances of the crash. Specific
fields on the PARs were compared to the information in related fields
in the FARS, which provides more robust information than the PAR alone.
The FMCSA did not attempt to infer these data fields from the narrative
sections of the PAR.
    The following table provides an overview of the match rate between
PARs and FARS. The Agency was unable, in this type of analysis, to
establish which record, the PAR or

FARS, was more accurate, but simply identified the fact that the two
data sources were not in agreement.

----------------------------------------------------------------------------------------------------------------
            Data field                  PAR/FARS  match          PAR/FARS  non-match        Missing PAR data
----------------------------------------------------------------------------------------------------------------
Driver Contributing Factors......  12.6%....................  5.3%....................  82.0%
First Harmful Event..............  46.9.....................  5.6.....................  47.5
Traffic-Way Flow.................  52.4.....................  14.9....................  32.8
Weather Conditions...............  95.7.....................  3.2.....................  1.1
Roadway Surface Conditions.......  96.7.....................  2.3.....................  1.0
----------------------------------------------------------------------------------------------------------------

    The FMCSA also compared the critical reasons assigned for this
study with those assigned in matching records from the NMVCCS, which
employs a similar critical reason determination process. The analysis
found that the majority of the critical reason determinations, about 90
percent, matched between these two data sources.
    The Agency also assessed the practicality of coding crashes for two
types of crash events using information available in the MCMIS as an
approach to crash weighting that would not require reviewing an actual
PAR: (1) Single-vehicle crashes deemed to be ``attributable'' to the
motor carrier; and (2) both single- and multiple-vehicle crashes with
associated post-crash inspection records indicating a pre-crash out-of-
service (OOS) condition on the CMV involved. Single-vehicle
attributable crashes are those for which the MCMIS event code
description did not indicate a collision with a pedestrian; a motor
vehicle in transport; an animal; work zone maintenance equipment; or
other/unknown movable object or ``other.'' It was hypothesized that the
critical reason for these two types of crashes would be assigned to the
CMV if the PARs were reviewed. Analysis results suggest that the coding
of single-vehicle crashes without a PAR review is feasible, but is
dependent upon accurate data as to the number of vehicles involved. For
crashes with a pre-crash OOS condition, PAR reviewers did not assign
the critical reason to the CMV in a majority of cases as they did not
consider the post-crash inspection results, but the PAR alone.

Question 2: Would a crash weighting determination process offer an even
stronger predictor of crash risk than overall crash involvement, and
how would crash weighting be implemented in the SMS?

    This portion of the crash weighting analysis assumed PAR
sufficiency and reliability and looked at whether a crash weighting
methodology in the SMS Crash Indicator BASIC would provide a sharper
view of the highest risk motor carriers by identifying motor carriers
with higher future crash rates. Crash weights were derived based on (1)
the critical reason assignments for the 10,892 PARs that were reviewed;
and (2) on 671 single-vehicle attributable crashes identified in the
MCMIS.
    The Agency employed various statistical and analytical approaches
to assess crash weighting benefits. The analysis used crash data from
2009-2010 to define Crash Indicator percentiles, then tracked the
future (January 2011 to June 2012) crash rate of motor carriers above
the Intervention Threshold.
    The analysis applied two approaches for modifying crash weights and
analyzed the effect of each on the crash-predictive strength of the
current Crash Indicator. The first applied higher severity weights for
crashes where the critical reason was assigned to the CMV and for
single-vehicle attributable crashes and applied lower weights for
crashes that were reviewed but not assigned to the CMV. The second
approach simply removed crashes that were reviewed but not assigned to
the CMV. Both of these approaches were applied to the same two sets of
crashes: All crashes and fatal crashes only.
    Results showed that modifying the Crash Indicator by changing the
crash weights based on a motor carrier's role in a crash does not
appear to improve its ability to predict future crash rates when all
crashes are considered. Modifying the Crash Indicator to include crash
weighting improves its ability to predict future crash rates when only
fatal crashes are considered. When the crash weighting methodology was
applied, the carriers that were identified for intervention had future
crash rates that are 1.8 percent to 5.0 percent higher, when removing
crashes not assigned to the CMV during the PAR review. Fatal crashes
are, however, less than 3 percent of all crashes in the MCMIS.

Question 3: How might FMCSA manage the process for making crash
weighting determinations, including public input to the process?

    The objective of this part of the analysis was to identify how a
crash weighting process might be structured and, based on this process,
estimate the resources required for both start-up and ongoing
implementation.
    Implementing a crash weighting effort on a national scale requires
a method for uniformly acquiring the final PARs for all or a subset of
crashes; a process and system for uniform analysis; and a method for
receiving and analyzing public input.
    It must be noted that FMCSA does not currently receive PARs from
the States and that they may be difficult to obtain, due to the
requirements for secure data collection and storage, which creates a
significant, albeit unknown, cost to the Agency. The annual costs for
reviewing and coding PARs, including the acceptance of public input,
will vary depending upon the number of PARs reviewed, the number of
appeals, and the crash weighting determination process established by
the Agency. This analysis estimates potential costs of between $3.9
million and $11.2 million annually.
    The analysis also provided some insight into the amount of time it
would take to make these determinations. The data provided some
indication that the timeframe for the entire crash weighting
determination process, from the submission of the crash report through
the determination process, could be so significant as to make the value
of the determination questionable for the purposes of use in the SMS,
given the 24-month analysis period used by the SMS.

IV. Request for Comments

    The Agency completed the study to inform decision making concerning
the feasibility of using a motor carrier's role in crashes as an
indicator of future crash risk. Based on the information that is
provided, what steps should the Agency

take regarding crash and PAR data quality? Are there other data,
research, or related materials FMCSA should take into consideration?

    Dated: January 16, 2015.
T.F. Scott Darling, III,
Acting Administrator.
[FR Doc. 2015-01144 Filed 1-21-15; 8:45 am]
BILLING CODE 4910-EX-P


Ward Penberthy 06/ 03/ 2003 07: 50 AM To: Mary Dominiak/ DC/ USEPA/ US@ EPA cc: Charles Auer/ DC/ USEPA/ US@ EPA, ( bcc: Mary Dominiak/ DC/ USEPA/ US) Subject: Updated Materials for PFOA Meeting, June 6, 2003 To Interested Parties and Meeting Attendees:

Attached please find an amended draft agenda and a revised list of interested parties for the upcoming public meeting, to be held June 6, 2003, on the enforceable consent agreement ( ECA) development process for perfluorooctanoic acid ( PFOA) and fluorinated telomers. These documents replace earlier versions transmitted on May 21, 2003 ( OPPT 2003 0012 0056).

The revised list of groups and individuals registered as interested parties for the purpose of participating in or monitoring the ECA negotiations includes parties whose requests for status at the meeting were delayed by EPA's mail processing system. The amended draft agenda indicates time granted to the five parties who specifically requested the ability to make brief, three to five minute opening statements. The amended agenda also clarifies that members of the public who did not register as interested parties will be given preference during the half hour public comment period near the close of the meeting, since interested parties will be able to participate in the earlier discussions during the meeting.

Additional groups and individuals who did not request interested party status have also indicated that they will attend the meeting. Other Federal partners may also participate, including the U. S. Consumer Product Safety Commission. Meeting attendees other than interested parties are not required to notify the Agency in advance, but prior notice will expedite security processing into the EPA building.

Also attached to this message is a copy of an enforceable consent agreement previously concluded by the Agency. Every ECA is unique. This sample ECA is provided solely as an example of the level of detail and the type of information generally contained in a simple ECA for a single chemical. EPA anticipates that ECAs concluded through this process on PFOA and telomers will involve different testing and reflect significantly greater complexity. New ECAs will also include additional standard language addressing information quality issues.

Participants and meeting attendees are reminded that the meeting on June 6, 2003 will begin at noon and conclude at 5: 00 PM. You are also reminded that photo identification will be required for access to the meeting location.

If you have questions concerning this meeting, please contact Mary Dominiak by telephone at 202 564 8104, or by email at dominiak. mary@ epa. gov.

Sincerely,

Ward Penberthy Associate Director Chemical Control Division MIBK ECA Example. pdAmended Interested Parties List Amended 6 6 03 draft agenda. PUBLIC MEETING Enforceable Consent Agreement Development for Perfluorooctanoic acid ( PFOA) and Fluorinated Telomers Location: Environmental Protection Agency ( EPA), East Bldg. Rm. 1153 1201 Constitution Ave., NW, Washington, DC 20460 Date: Friday, June 6, 2003; 12: 00 PM  5: 00 PM Draft Agenda 12: 00  12: 30 Introduction of Participants   Opening Remarks and ECA Process ( EPA)   Charles M. Auer, Director Office of Pollution Prevention and Toxics ( OPPT)

12: 30  12: 55 Opening Statements by Interested Parties ( 3 to 5 minutes each) ° Center for Regulatory Effectiveness ° Little Hocking Water Association ° Environmental Working Group ° DuPont ° Telomer Research Program 12: 55  1: 10 Overview of EPA Preliminary Framework Document for ECA Data Development for PFOA and Telomers ° Telomer Data Needs ° Fluoropolymer Data Needs ° Rationales for Proposed Fate Testing and Monitoring/ Sampling 1: 10  2: 00 General Discussion Among EPA and Interested Parties of Data Needs for Identifying PFOA Sources and Pathways of Exposure 2: 00  2: 10 Break 2: 10  4: 00 Identification and Discussion Among EPA and Interested Parties of ECA Opportunities and Approaches ° ECA Topics Amenable to Quick Resolution ° Telomer ECAs ° Fluoropolymer ECAs ° Other Additional ECA Opportunities?

4: 00  4: 20 Next Steps 4: 20  4: 50 Public Comment ( Open mike: maximum time 3 minutes per speaker) Members of the public not registered as Interested Parties will be given preference, since Interested Parties can participate in earlier discussions.

4: 50  5: 00 OPPT Closing Remarks U. S. EPA Amended " Interested Parties" List for June 6, 2003 Meeting June 2, 2003 List of " Interested Parties" for PFOA and Telomer ECA Negotiations As of this date, the following groups and/ or individuals have requested status as " interested parties" for the purpose of monitoring or participating in ECA negotiations on PFOA and fluorinated telomers. Please be advised that, due to security delays in the processing of mail to Federal facilities, additional " interested party" registrations may be received between this date and the June 6, 2003 meeting. Updated lists will be provided as needed at and before the meeting. Additional parties may attend as observers without providing prior notice to the Agency.

3M Advanced Polymer, Inc. AGA Chemicals American Council on Science and Health American Chemistry Council American Fiber Manufacturers Association, Inc. Asahi Glass Co., Ltd. Asahi Glass Fluoropolymers USA, Inc. ATOFINA Chemicals, Inc. Bennett & Williams ( Environmental Consultants) Chamber of Commerce of the Mid Ohio Valley Ciba Specialty Chemicals Corporation Clariant GmbH Daikin America Dainippon Ink & Chemicals Davis, Pickering & Co., Inc. Department of the Navy DuPont DuPont Textiles and Interiors, Inc. Dyneon Environmental Health Research Foundation Environmental Working Group Fire Fighting Foam Coalition Vicky Gheen ( Private Citizen) Hughes Associates, Inc. International Imaging Industry Association Little Hocking Water Association, Inc. Miteni S. p. A. Mitsubishi International Corporation Ohio Environmental Protection Agency Ohio River Valley Water Sanitation Commission OMNOVA Solutions Parkersburg Wood County Area Development Corporation Rich Purdy Regenerative Products Solvay Solexis, Inc. Society of the Plastics Industry/ Fluoropolymer Manufacturers Group Telomer Research Program Tennant Rentals The Area Roundtable The Carpet and Rug Institute The Center for Regulatory Effectiveness Tuppers Plains Chester Water District United Bank, West Virginia University of Pennsylvania Medical Center W. L. Gore & Associates, Inc. Walki Wisa Ltd. West Virginia Class Action Plaintiffs West Virginia Department of Environmental Protection ENFORCEABLE CONSENT AGREEMENT FOR METHYL ISOBUTYL KETONE September 14, 1998 ENFORCEABLE CONSENT AGREEMENT FOR METHYL ISOBUTYL KETONE Docket No. OPPTS 42205B TABLE OF CONTENTS I. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 II. Chemical Subject to the ECA . . . . . . . . . . . . . . . . . . . . . . . . 1 III. Obligation of Signatory Companies and Role of the Ketones Panel of the Chemical Manufacturers Association ( CMA) . . . . . . . . . . . . . . . . . . . . . 1 IV. Purpose and Scope of the Testing Program . . . . . . . . . . . . . . .2 V. Standards for Conducting Testing . . . . . . . . . . . . . . . . . . . . . . 2 VI. Submission of Study Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 VII. Modifications to the Enforceable Consent Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . . . . . 3 VIII. Failure to Comply with the Enforceable Consent Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 IX. EPA Monitoring of Enforceable Consent Agreement Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 X. Submission of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 XI. Publication and Disclosure of Test Results . . . . . . . . . . . . . . . 4 XII. Confidentiality of Information . . . . . . . . . . . . . . . . . . . . . . . . . 4  i

XIII. Responsibilities of the Companies . . . . . . . . . . . . . . . . . . . . . . 5 XIV. Severability of Enforceable Consent Agreement Provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 XV. Final Agency Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 XVI. Public Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 XVII. Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 XVIII. Rights of the Companies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 XIX. Identity of the Companies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 XX. Signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 TABLE 1: Required Testing, Test Standards, Reporting and Other Requirements for Methyl Isobutyl Ketone . . . . . . . . . . . . . . . . 12 Appendix 1: Protocol: An Inhalation Two Generation Reproductive Toxicity Study of Methyl Isobutyl Ketone ( MIBK) in Rats ( WIL Study No: WIL 186007)

 ii 1 I. INTRODUCTION Under the authority of section 4 of the Toxic Substances Control Act ( TSCA), 15 U. S. C. 2603, the United States Environmental Protection Agency ( EPA), Eastman Chemical Company, Celanese, Ltd., Shell Chemical Company, and Union Carbide Corporation ( hereinafter collectively " the Companies") enter into the following enforceable consent agreement ( ECA). This ECA takes effect on the date of publication of the notice in the Federal Register announcing the issuance of the testing consent order ( Order) that incorporates this ECA.

In EPA's proposed test rule for hazardous air pollutants ( HAPs) published on June 26, 1996 ( 61 FR 33178), amended on December 24, 1997 ( 62 FR 67466) and on April 21, 1998 ( 63 FR 19694), EPA invited the submission of alternative testing proposals for HAP chemicals that would provide the data needs identified by EPA in the proposed HAPs rulemaking via an ECA process. This ECA resulted from negotiations conducted as a part of an ECA process for the HAPs chemical methyl isobutyl ketone ( 63 FR 32656). The official record for this ECA Action, including the public version, is established under EPA docket control number OPPTS 42205B. The procedures for ECA negotiations are described at 40 CFR 790.22( b).

II. CHEMICAL SUBJECT TO THE ECA The subject of this ECA is the chemical substance methyl isobutyl ketone, CAS No. 108 10 1. The methyl isobutyl ketone to be tested shall be as pure as can be reasonably attained, but shall be at least 99 percent pure.

III. OBLIGATION OF SIGNATORY COMPANIES AND ROLE OF THE KETONES PANEL OF THE CHEMICAL MANUFACTURERS ASSOCIATION( CMA)

A. Testing shall be sponsored by the Companies, which are responsible for complying with this ECA.

B. The Companies recognize that to implement this ECA, EPA will issue and publish in the Federal Register an Order under section 4 of TSCA that incorporates the terms of this ECA. The Companies agree that all terms of this ECA shall take effect on the date of publication of the notice in the Federal Register announcing the issuance of the Order that incorporates this ECA, and all applicable time periods shall be treated as beginning on that publication date.

C. The Companies are members of the Ketones Panel of the Chemical Manufacturers Association ( hereinafter, referred to as the CMA Ketones Panel) which is an association of manufacturers and processors of methyl isobutyl ketone. The CMA Ketones Panel shall be responsible for coordinating and administering testing under this ECA and communicating with EPA about study plans, protocols, test standards, and other aspects of the testing program. In performing these functions, the CMA Ketones Panel will be acting as the agent of the 2 Companies for purposes of compliance and communication with EPA. EPA and the Companies recognize that, except for its role as agent as specified in this ECA, the CMA Ketones Panel has no legal responsibility for complying with this ECA. Responsibility for complying with the ECA rests at all times with the Companies as individual entities.

IV. PURPOSE AND SCOPE OF THE TESTING PROGRAM A. The purpose of the testing program specified in this ECA is to supplement available information and to further characterize the potential for reproductive effects of methyl isobutyl ketone from inhalation exposures.

B. EPA believes that the studies specified in Table 1 and described in Appendix 1 to this ECA, will generate data needed by EPA to determine whether methyl isobutyl ketone presents an unreasonable risk of injury to human health from inhalation exposures.

C. The Companies, through the CMA Ketones Panel, shall jointly conduct or provide for the performance of the testing program specified in this ECA. This testing program shall consist of: 1) conducting the reproductive effects testing by inhalation exposure listed in Table 1 in accordance with the test standards specified in Table 1 and described in Appendix 1 (" Test Standards"); and 2) submitting the reports and documents specified in Table 1 in accordance with the deadlines set forth in Table 1.

D. EPA will not finalize the testing requirements for reproductive effects for methyl isobutyl ketone as specified in the proposed HAPs test rule, as amended, because such testing will be conducted under this ECA. However, EPA will continue the process to finalize the proposed HAPs test rule for the other studies specified for methyl isobutyl ketone, viz.: acute inhalation testing, including pulmonary alveolar macrophage function testing, and immunotoxicity testing. Prior to finalizing the HAPs rulemaking, EPA will take into consideration the public comments received regarding the proposed testing requirements for methyl isobutyl ketone that are not included in this ECA.

V. STANDARDS FOR CONDUCTING TESTING A. Testing shall be conducted in accordance with the Test Standards listed in Table 1 and described in Appendix 1 to this ECA.

Certain provisions of the Test Standards are considered to be mandatory and are referred to as " requirements." These requirements are identified by the use of the word " shall" in the text of the Test Standard. Provisions that are not mandatory, and are therefore only recommended, are identified by the use of " should" statements. In the event such " should" provisions are not followed, the Companies will not be deemed by EPA to be in violation of this ECA and will not be subject to penalties or other enforcement actions, as described in Part X. of this ECA. EPA 3 will use its professional judgment to determine the scientific adequacy and validity of the test results, and any repeat testing that is determined by EPA to be necessary will be required either under a subsequent ECA or pursuant to a rule promulgated under section 4( a) of TSCA, 15 U. S. C. 2603( a). In addition, for the purpose of this ECA, the words " will" and " must," if they appear in the Test Standards, are considered equivalent to the word " shall" and therefore delineate a test requirement to be followed or met.

B. The Companies, through the CMA Ketones Panel, and EPA will consult in a good faith effort to consider the need for Test Standard modifications if either EPA or the Companies desire such modifications. Modifications to this ECA shall be governed by 40 CFR 790.68 ( see Part IX. of this ECA).

C. All testing required by this ECA shall be conducted in accordance with the EPA Good Laboratory Practice ( GLP) Standards contained in 40 CFR part 792.

D. All final reports must be submitted by the Companies to EPA by the dates specified in Table 1 unless otherwise authorized by EPA pursuant to 40 CFR 790.68. Interim status reports for testing shall be submitted by the Companies to EPA every six months beginning six months from the effective date of this ECA, until the final report is submitted.

VI. SUBMISSION OF STUDY PLANS The Companies, through the CMA Ketones Panel, shall submit a study plan to EPA for each test conducted pursuant to this ECA in accordance with 40 CFR 790.62. The principal sponsor of the testing ( as defined in 40 CFR 790.3) must submit a study plan prior to the initiation of testing. The study plan must be submitted prior to initiating testing, but does not need to be submitted 45 days prior to the initiation of testing as specified at 40 CFR 790.62( a). The initiation of testing is the date on which the administration of the test substance begins in accordance with the protocol. The content of the study plan submitted to EPA shall comply with 40 CFR 790.62( b). Modifications to the study plan shall be governed by the procedures of 40 CFR 790.62( c). The study plan shall become part of the official record ( Docket Control Number OPPTS 42205B).

VII. MODIFICATIONS TO ENFORCEABLE CONSENT AGREEMENT Modifications to this ECA, if any, shall be made according to the procedures contained in 40 CFR 790.68. 4 VIII. FAILURE TO COMPLY WITH THE ENFORCEABLE CONSENT AGREEMENT The Companies acknowledge that a violation of the requirements of this ECA shall constitute a " prohibited act" under section 15( 1) of TSCA, 15 U. S. C. 2614( 1), and shall trigger all provisions applicable to a section 15 violation. In addition, noncompliance with any term of this ECA by any Company shall constitute conduct " in violation of this Act" under section 20( a)( 1) of TSCA, 15 U. S. C. 2619( a)( 1), and could result in a citizen's civil action.

Under the penalty provisions of section 16 of TSCA, 15 U. S. C. 2615, and the Federal Civil Penalties Inflation Adjustment Act of 1990, 28 U. S. C. 2461 note, as amended by the Debt Collection Improvement Act of 1996, 31 U. S. C. 3701 note, as implemented by 61 FR 69360 ( December 31, 1996), a non complying Company could be subject to a civil penalty of up to $ 27,500 per violation, with each day in violation potentially constituting a separate violation under section 15. Knowing or willful violations may lead to the imposition of criminal penalties or a fine of not more than $ 27,500 for each day of violation, or to imprisonment for up to 1 year, or both. In addition, EPA could enforce this ECA pursuant to section 17 of TSCA, 15 U. S. C. 2616, by seeking an injunction to compel adherence to the requirements of this ECA.

IX. EPA MONITORING OF ENFORCEABLE CONSENT AGREEMENT TESTING EPA may monitor the testing conducted under this ECA, including laboratory inspections and study audits, as permitted under section 11 of TSCA, 15 U. S. C. 2610.

X. SUBMISSION OF DATA All data submitted to EPA under this ECA shall be identified by the Docket Number: OPPTS 42205B, the name: methyl isobutyl ketone, and the CAS Number: 108 10 1. Six ( 6) copies of all submissions under this ECA shall be provided to EPA at the address specified in 40 CFR 790.5( b).

XI. PUBLICATION AND DISCLOSURE OF TEST RESULTS All results of testing conducted pursuant to this ECA will be announced to the public by EPA in accordance with the procedures specified in section 4( d) of TSCA, 15 U. S. C. 2603( d). Disclosure by EPA of data generated by such testing will be governed by section 14 of TSCA, 15 U. S. C. 2613( b), and 40 CFR part 2.

XII. CONFIDENTIALITY OF INFORMATION Any claims of confidentiality for information submitted under this ECA shall be made under the terms of 40 CFR 790.7. If no claim of confidentiality is made by the submitter of the information at the time of submission, the information will be deemed by EPA, in accordance with 40 CFR 790.7, to be public, and may be made available to the public without further notice 5 to the submitter. Information claimed as confidential will be treated in accordance with the procedures in 40 CFR part 2 established pursuant to section 14 of TSCA, 15 U. S. C. 2613.

XIII. RESPONSIBILITIES OF THE COMPANIES A. The Companies are bound by the terms of this ECA and the provisions of 40 CFR 790.62 and 790.65.

B. As indicated in Part II of the ECA, the subject of this ECA is methyl isobutyl ketone. The Companies shall comply with the notification requirements of section 12( b)( 1) of TSCA, 15 U. S. C. 2611( b)( 1), and 40 CFR part 707, subpart D, if they export or intend to export methyl isobutyl ketone. Any other person who exports or intends to export methyl isobutyl ketone will be subject to these export notification requirements upon promulgation of an export notification rule for methyl isobutyl ketone under section 12( b)( 1) of TSCA.

C. If methyl isobutyl ketone becomes subject to a rule promulgated under TSCA section 5( a)( 2), 15 U. S. C. 2604( a)( 2), governing significant new uses of methyl isobutyl ketone, then the Companies shall be subject to the data submission requirements imposed by section 5( b)( 1)( A) of TSCA, 15 U. S. C. 2604( b)( 1)( A), as if the testing under this ECA had been required by a TSCA section 4 test rule.

XIV. SEVERABILITY OF ENFORCEABLE CONSENT AGREEMENT PROVISIONS In the event that one or more provisions of this ECA are determined by a court decision to be unenforceable, the remaining provisions of this ECA will not be presumed to be valid, and EPA will either initiate a rulemaking proceeding to require testing or publish in the Federal Register the reasons for not initiating such a proceeding.

XV. FINAL AGENCY ACTION Issuance of this ECA by EPA constitutes final EPA action for purposes of 5 U. S. C. 704.

XVI. PUBLIC RECORD EPA has established a public record which will contain this ECA, the Order that incorporates this ECA, the Federal Register notice announcing issuance of the Order incorporating this ECA, and any and all relevant information, subject to the confidentiality provisions of section 14( b) of TSCA and 40 CFR part 2. The official record for this ECA, including the public version, which does not include any information claimed as CBI, has been established under docket control number OPPTS 42205B. 6 XVII. EFFECTIVENESS This ECA may be signed in separate counterparts. This ECA shall not be effective unless signed by each of the Companies and by EPA. This ECA shall take effect on the date of publication of the Federal Register notice announcing the issuance of the Order that incorporates this ECA.

XVIII. RIGHTS OF THE COMPANIES By signing this ECA, the Companies waive their right to challenge EPA's authority to assess penalties for violations of the terms of this ECA. This waiver does not affect any other rights that the Companies may have under TSCA, including the right to dispute the amount of any penalty or to dispute factually whether a violation of the terms of this ECA has occurred.

XIX. IDENTITY OF THE COMPANIES The Companies subject to this ECA are:

Eastman Chemical Company Celanese, Ltd.

Shell Chemical Company Union Carbide Corporation 7 XX. SIGNATURE TEST SPONSOR Eastman Chemical Company Date: Marc G. Schurger Director of Product Safety and Stewardship Eastman Chemical Company 200 South Wilcox Drive P. O. Box 431 Building 280W Kingsport, TN 37662 5280 8 XX. SIGNATURE TEST SPONSOR Celanese, Ltd.

Date: Debra B. Phillips Coordinator, Product Stewardship Celanese, Ltd. 1601 West LBJ Freeway Dallas, TX 75234 9 XX. SIGNATURE TEST SPONSOR Shell Chemical Company Date: Don Roche Business Manager, Americas One Shell Plaza Room 1780 P. O. Box 4320 Houston, TX 77252 10 XX. SIGNATURE TEST SPONSOR Union Carbide Corporation Date: Neal A. Wyhs Business Director, Solvents and Intermediates 39 Old Ridgebury Road Danbury, CT 06817 0001 11 XX. SIGNATURE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Date: Lynn R. Goldman, M. D., Assistant Administrator Office of Prevention, Pesticides, and Toxic Substances U. S. Environmental Protection Agency 401 M Street SW Washington, DC 20460 1 Number of months after the effective date of the testing consent order that incorporates this ECA.

2 This column shows the number of interim reports required. Interim reports are required every 6 months from the effective date of this ECA.

12 Table 1. REQUIRED TESTING, TEST STANDARDS, REPORTING AND OTHER REQUIREMENTS FOR METHYL ISOBUTYL KETONE HAPs Testing Test Standard Deadline for Final Report1 ( Months) Interim Reports2 Required ( Number)

Reproductive effects testing by inhalation ( rats) § 799.9380 ( as modified in Appendix 1) 29 4