[Federal Register Volume 79, Number 140 (Tuesday, July 22, 2014)]
[Notices]
[Page 42509]
[FR Doc No: 2014-17199]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP14-1090-000.
    Applicants: Cimarron River Pipeline, LLC.
    Description: Withdraw of Noncontiguous Filing.
    Filed Date: 7/14/14.
    Accession Number: 20140714-5138.
    Comments Due: 5 p.m. ET 7/28/14.

    Docket Numbers: RP14-1101-000.
    Applicants: WBI Energy Transmission, Inc.
    Description: Negotiated & Non-Conforming Agreements--Devon to be
effective 7/18/2014.
    Filed Date: 7/14/14.
    Accession Number: 20140714-5079.
    Comments Due: 5 p.m. ET 7/28/14.

    Docket Numbers: RP14-1102-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Housekeeping 2014-07-14 Contact Info on Title Page to
be effective 8/14/2014.
    Filed Date: 7/14/14.
    Accession Number: 20140714-5080.
    Comments Due: 5 p.m. ET 7/28/14.

    Docket Numbers: RP14-1103-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: 2014-07-14 Title Page Contact Information to be
effective 8/14/2014.
    Filed Date: 7/14/14.
    Accession Number: 20140714-5081.
    Comments Due: 5 p.m. ET 7/28/14.

    Docket Numbers: RP14-1104-000.
    Applicants: Tallgrass Interstate Gas Transmission, L.
    Description: Housekeeping to change contact name on title page to
be effective 8/14/2014.
    Filed Date: 7/14/14.
    Accession Number: 20140714-5082.
    Comments Due: 5 p.m. ET 7/28/14.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR Sec.  385.211 and Sec.  385.214) on or
before 5:00 p.m. Eastern time on the specified comment date. Protests
may be considered, but intervention is necessary to become a party to
the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 15, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-17199 Filed 7-21-14; 8:45 am]
BILLING CODE 6717-01-P


Generic Clearance for Participatory Science and Crowdsourcing Projects

1.	Circumstances Making the Collection of Information Necessary

Participatory science and crowdsourcing: Innovative research methods that engage the public

Participatory science and crowdsourcing are tools that engage, educate, and empower the public to apply their curiosity and contribute their talents to a wide range of scientific and societal issues. Participatory science is a form of open collaboration where the public can participate actively in the scientific process through methods that include asking research questions, collecting and analyzing data, interpreting results, or engaging in problem solving. Crowdsourcing is a process where individuals or organizations submit an open call for contributions of information from a large group of individuals ("the crowd"). Participatory science is EPA's all-embracing term that is inclusive of diverse community engagement models, academic disciplines, project scope, and/or methodology in which members of the public participate. Note that the term citizen science is used in statutes and regulations referred to throughout this document.

EPA's mission to protect human health and the environment

The mission of EPA is to protect human health and the environment. Participatory science and crowdsourcing can support EPA's mission and purpose, ensuring that national efforts to reduce environmental and public health risks are based on the best available scientific information and that all parts of society  -  communities, individuals, businesses, and state, local and Tribal governments  -  have access to accurate information sufficient to effectively participate in managing human health and environmental risks. To meet these goals, EPA fosters the use of science and technology, conducts leading-edge research, and funds community-driven projects. Likewise, the Agency conducts educational activities to increase the public's knowledge and understanding of environmental issues so that they can make appropriate decisions.

Benefits of using participatory science and crowdsourcing approaches at EPA

Participatory science and crowdsourcing can create engaging opportunities for the public to experience their environment, contribute environmental data at a more local level, and provide opportunities to analyze large environmental datasets. These methods give people the ability to easily share data they encounter in their communities and environments. Whether it is an individual photographing an endangered species they come across on their walk, someone at home adding descriptions to online aerial photographs taken at a disaster site, or owners of personal monitors documenting their daily activities, crowdsourcing and participatory science provide people a fun and accessible way to contribute to science or foster a greater appreciation of their natural environment and community. In addition, participatory science and crowdsourcing projects promote greater openness in the scientific process by actively encouraging participation in various aspects of research. Researchers using participatory science and crowdsourcing are committed to the dissemination of data and results back to the public.

Many federal and non-federal organizations are already using innovative participatory science and crowdsourcing tools to advance their missions. These tools are especially valuable where data are distributed across space and time or when projects rely on large datasets. Successful participatory science and crowdsourcing projects usually result from iterations of the design based on feedback from the participants.

The growth and success of participatory science and crowdsourcing is tied closely with advances in technology. Enhanced tools and methods are constantly making participatory science and crowdsourcing more feasible and effective.

Federal support for participatory science and crowdsourcing

In the 2017 American Innovation and Competitiveness Act, Congress authorized agencies to harness the ingenuity of the public by using open innovation methods such as participatory science and crowdsourcing. Participatory science and crowdsourcing are in line with the Paperwork Reduction Act's intent to "ensure the greatest possible public benefit from and maximize the utility of information created, collected, maintained, used, shared, and disseminated by or for the Federal Government."

Design principles for participatory science and crowdsourcing projects

Participatory science and crowdsourcing projects under this generic ICR will include the following design principles:

 Participants have a meaningful role in the research project and can act as contributors or collaborators.
 Projects have a genuine scientific question or goal.
 Projects are low-burden for participants.
 Projects include active management of data and data quality, including a data quality assurance plan and ongoing evaluation of data quality and data management.
 Projects are opt-in and participants have full control over the extent that they participate.
 The data gathered and/or analyzed are shared with participants and generally made publicly available, unless there are security or privacy concerns that prevent this.
 Participants receive feedback on how their contribution adds to the project.
 Project leads evaluate scientific output, data quality, and the impact on participants.
 Projects are designed to contribute to research and science, not to inform Agency regulations or policies.

EPA participatory science research will have clear linkages to community problems and concerns, and this participatory, "translational science approach" differentiates participatory science research from EPA's traditional research activities. The objective of a participatory science project under this ICR is to use a rigorous research approach  -  and then apply findings to real-world problems.

2.	Purpose and Use of the Information Collection

EPA relies on scientific information. Participatory science and crowdsourcing techniques allow the Agency to collect qualitative and quantitative data that might help inform scientific research, assessments, or environmental screening; validate environmental models or tools; or enhance the quantity and quality of data collected across the country's diverse communities and ecosystems to support the Agency's mission. Information gathered under this generic clearance will be used by the Agency to support the activities listed above and might provide unprecedented avenues for conducting breakthrough research.

Collections will be from participants who actively seek to participate on their own initiative through an open and transparent process (the Agency does not select participants or require participation); the collections will be low-burden for participants; collections will be low-cost for both the participants and the Federal Government; and data will be available to support the scientific research (including assessments, environmental screening, tools, models, etc.) of the Agency, states, Tribal or local entities where data collection occurs. EPA may, by virtue of collaborating with non-federal entities, sponsor the collection of this type of information in connection with participatory science projects.

Collection of health symptoms, illnesses, and human biological samples (e.g., blood, urine, hair) is outside the scope of this generic clearance.

All such collections will accord with Agency policies and regulations related to human subjects research as described in EPA Order 1000.17A (Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research). Each project under this generic ICR will be classified as either not human subjects research (NHSR) or human subjects research (HSR). All HSR must be reviewed and approved by the EPA Human Subjects Research Review Official (HSRRO). To obtain approval by the HSRRO, researchers must submit the Institutional Review Board (IRB)-approved research package including documentation of the approval or determination of exemption by the IRB or the institution's Human Research Protection Program (HRPP), evidence of a Federal wide Assurance (FWA) on file with the U.S. Department of Health and Human Services, or other assurance in accordance with 40 CFR 26.103(a). Human Subjects Officers (HSOs) will review NHSR projects, and ensure the project is submitted to the EPA HSRRO for approval. Finally, personally identifiable information (PII) will only be collected when necessary and in accordance with applicable federal procedures and policies. If a new collection is not within the parameters of this generic ICR, the Agency will submit a separate information collection request to OMB for approval.

The methods used for collecting information can vary greatly across projects, including the use of apps, questionnaires or monitoring devices. All participatory science and crowdsourcing activities under this ICR will be consistent with the citizen science definition in Section 3 of the Citizen Science and Crowdsourcing Act of 2017. All projects conducted by EPA will be reviewed and approved by the EPA participatory science coordinator to ensure compliance with the parameters in this ICR as well as compliance with all other legal and administrative requirements. In addition, all projects submitted under this ICR will manage PII according to the Federal regulations. As with any scientific endeavor at EPA, participatory science and crowdsourcing projects will have approved data quality and data management plans as part of their project design before implementation. EPA provides employees resources for developing data quality and data management plans.

The popularity and application of participatory science and crowdsourcing methods continues to grow with new and low-cost portable technologies. Therefore, the modes of data collection under this generic clearance may include: paper or digital questionnaires, data forms, surveys, focus groups or interviews; new and existing online collaboration tools; fields in a cell or smart phone applications (apps); online web-based forms or interactive computer interfaces that elicit information; social media platforms; text or SMS messages; readings from sensors (personal, mobile, stationary or portable) or other mobile, portable or stationary instruments -  readings either sent back to the Agency in real-time, through an online data collection site, or through another acceptable mode listed here; analog or digital audio or video recordings; digital or analog photographs; and information collected automatically through an app, computer, the metadata accompanying a digital photograph, or a mobile sensor.
Information may be actively collected and actively submitted information (such as descriptions, measurements, photographs, etc.) as well as passively submitted information, such as the metadata accompanying actively submitted information (date, time, and location stamps automatically included with apps and digital photographs).
Participatory science and crowdsourcing collections submitted under this generic clearance can be stand-alone projects or the methods may be incorporated into an existing or new project, including, but not limited to, projects in the following typology:
 Data gathering projects. These projects may include 1) observation, characterization and documentation of natural phenomena or general environmental observations, opinions, or preferences, or 2) surveying participants or screening environmental conditions, including using specialized equipment provided by project leaders to record and submit data, or submitting samples plus descriptors for testing. Data may be collected using technologies mentioned above, through structured data forms, surveys, focus groups or interviews, submitting photographs or other media, surveys or questionnaires, or providing written observations.
 Classification/problem solving projects. Participants' tasks may include: 1) observation of recorded materials provided by project organizers (images, video, etc.) through structured data submission forms, surveys or questionnaires in an online or computer program, clicking boxes, highlighting parts of text or image, and providing comments and/or annotations; 2) classification of images or sounds using structured data submission forms or clicking boxes in an online or computer program; 3) transcribing information, by typing handwritten logs or notes; 4) performing a function meant to generate human behavior data; or 5) problem-solving or manipulation of data. Tasks 1-5 may be conducted via structured actions or instructions or through the use of a "human-based computational game" or a "game with a purpose", a human-based computational technique in which a computational process performs its function by presenting certain steps to humans in an entertaining way.
Data gathering and classification/problem solving projects may include participants providing information, opinions or observations about a research subject's environmental surroundings.
Participatory science and crowdsourcing collections under this generic clearance may include the following types of questions or requests of participants:

 Profile/Preference information. Projects may request a username and/or password as well as user preference information to facilitate or customize the user experience. Participants may be asked to submit an email address, name, and zip code, as well as acknowledge a privacy policy or terms agreement. Participants may also be presented with an opportunity to be placed on a mailing list for the project. This includes projects administered through a web form or mobile application.
 Personal and Contact Information. Participatory science and crowdsourcing projects may solicit contact information. This information may be necessary to organize and analyze data (i.e., it may be necessary to know which data points are from the same observer). Projects may request contact information to provide participants with project updates and share data. Participants would be made aware that the publicly available data on contact information will be anonymized and aggregated, for example, by census tract, zip code, or city.
 Experience and Expertise. For data quality purposes, participatory science and crowdsourcing projects may request information to evaluate the skill level of the participant by asking about their experience with the project topic. Questions may be about a person's age range, level or topic of education, participation in organizations, or professional experience.
 Information about Observations. Projects may request accompanying information, such as the date and time of the activity, the location (e.g., GPS coordinates, address, zip code, etc.), the weather (e.g., temperature, precipitation, wind, humidity, visibility, etc.), and a description or characterization of the location (e.g., vegetation type, type of water body, environmental condition, etc.) or personal senses (e.g. smell, visual cues, sound, etc.).
 Project Evaluation. Participatory science and crowdsourcing projects may collect information on the participant's experience for project evaluation and development. This may include questions on how the participant found out about the project, the amount of time spent, distance traveled, how difficult the task was for the participant, whether the participant enjoyed the experience, and if they will participate again. Projects may also request information to evaluate participant outcomes, such as changes in the participant's understanding of the scientific process or project topic, through survey questions before and after participation.
 Training. Participatory science and crowdsourcing projects may need to train participants for the purpose of soliciting quality data and increasing participant benefits including education and engagement. Participants may be asked to read materials, watch training videos, or attend training sessions in-person or virtually via a webinar. To ensure that participants understand the training, they may be assessed through testing instruments like a questionnaire or survey, which may be administered online or through a computer program, on paper, in cell a phone app, or in-person.
3. 	Consideration Given to Information Technology

Participatory science and crowdsourcing efforts often utilize information technology that is already available to potential participants (cell phones, personal computers, tablets, etc.). Projects submitted under this generic clearance may collect information electronically through new and existing online collaboration tools, cell phone applications (apps) or SMS, web-based forms, online computer programs or forms, social media platforms, or sensors (personal, mobile, stationary or portable).
4.	 Duplication of Information
No similar data are gathered or maintained by the Agency or are available from other sources known to the Agency. Participatory science projects will collect new information that is not already available (e.g. local water and air quality).
5.	Reducing the Burden on Small Entities
Participants in the crowdsourcing and participatory science projects under this generic clearance will be individuals, not small businesses or other small entities.
6.	Consequences of not Conducting Collection
If unable to collect information through participatory science or crowdsourcing methods under a generic ICR, the Agency would be unable to adapt and utilize these innovative tools in a timely manner to engage the public in EPA science. With these methods, EPA benefits from the public's knowledge, expertise, and willingness to contribute to scientific endeavors that rely on large and geographically comprehensive datasets. The public and other organizations are beginning to capture and organize data with smartphones and portable sensors; the Agency's involvement will allow for publicly-generated data to effectively support EPA research, including initiating data collection, developing innovative methods for data processing, and managing data quality. The ability of EPA researchers to have access to the newest technologies affords EPA the opportunity to contribute meaningfully to low-cost sensor testing and use. Moreover, members of the public enjoy participating in participatory science and crowdsourcing projects, which are fun, educational, engaging, and will allow for more open communication between EPA and the public. Participatory science projects at other agencies have gathered millions of data points contributed by hundreds of thousands of interested individuals. These projects are always voluntary, low-burden, and rely on the interest and self-motivation of the participants. Finally, projects under this generic clearance will allow Agency researchers to test ideas more quickly, respond to the project's needs as they evolve, and incorporate feedback from participants for flexible, innovative research methods that involves the public in a variety of aspects of scientific research.
7. 	Special Circumstances
There are no special circumstances.
8.	Consultations with Persons outside the Agency
In accordance with 5 CFR 1320.8(d), a 60-day and 30-day notice for public comment will be published in the Federal Register. The Agency consulted with representatives from USGS, HHS and USDA on participatory science and crowdsourcing efforts. These federal representatives are associated with the Federal Community of Practice on Crowdsourcing and Citizen Science (FCPCCS). Representatives reviewed a draft of this generic clearance. This document reflects the feedback and comments from this community.
9.	Payment of Gift
The Agency will not provide payment or other forms of remuneration to participants.
10. 	Confidentiality
If a confidentiality pledge is deemed useful and feasible, the Agency will only include a pledge of confidentiality that is supported by authority established in statute or regulation, that is supported by disclosure and data security policies that are consistent with the pledge, and that does not unnecessarily impede sharing of data with other agencies for compatible confidential use. If the agency includes a pledge of confidentiality, it will include a citation for the statute or regulation supporting the pledge.

11. 	Sensitive Nature
No questions will be asked that are of a personal or sensitive nature as defined by OMB.
12.	Burden of Information Collection
A variety of platforms and media will be used to collect information from respondents. We expect that there will be a range of burden hours depending on the details of the participatory science and crowdsourcing method employed. The total range of annual burden hours requested is 350,000 to 400,000 hours based on the number of collections we expect to conduct over the requested period for this clearance.

The total dollar value of the annual burden hours is based on the National Compensation Survey: Occupational Wages in the United States published by the Bureau of Labor Standards Occupation and Wages, May 2022 (http://www.bls.gov/oes/current/oes_nat.htm#00-0000). We use the value for All Occupations, average hourly wage of $29.76 multiplied by 1.4 to account for benefits, equal to $41.66.

 Data gathering projects: We estimate approximately 1,425 participants per year per data gathering collection project under this generic clearance. Under this generic clearance, we estimate 7 data gathering projects per year (10,000 registrants). We estimate the number of participants completing training will be 80% of registrants (8,000 participants). Training modules will vary by data collection; we estimate an average of four hours. For this estimate we assume that each trained participant will collect the same number of observations in the same amount of time. The estimated annual burden for 7 data gathering projects is 75,833 hours.

 Classification/problem-solving project: We estimate 3 clarification/problem-solving projects annually under this generic clearance. We estimate the number of participants completing training will be 80% of registrants. Training modules will vary by data collection; we estimate four hours. The estimated number of participants that will spend time on the website, app, or computer program engaged in the activities will vary, and it is difficult to predict. Participants will continue to engage with the site based on their interest and submit data until the task is complete. For this estimate, we assume data collection tasks (classification/problem solving) will be completed with 50% of the trained participants engaged by the sites for 8 hours per month or 96 hours per year. The estimated annual burden for 3 classification/problem solving projects is 313,250 hours.

Burden of information collection request table
                       Estimated Annual Reporting Burden
                              Type of Collection
                            Number of Participants
         Estimated Time per Participant (hours unless otherwise noted)
                           Total Annual Burden Hours

                          A. Data gathering projects
Participant registration, initial login & reading guidelines
                                    10,000
                                  13 minutes
                                  2,167 hours
Participant training (estimate 80% of those who register will undergo training)
                                     8,000
                                    4 hours
                                 32,000 hours
Participants contributing observations (estimate all "trained")
                                     8,000
              5.2 hours (500,000 observations at 5 minutes each)
                                    41,667
Total burden hours for data gathering projects

                                 75,833 hours
Total annual labor costs for data gathering projects

                    hourly rate including benefits = $41.66
                                  $3,159,203
                  B. Classification/problem-solving projects
                              Type of Collection
                            Number of Participants
                        Estimated Time per Participant
                           Total Annual Burden Hours

Participant registration, initial login & reading guidelines
                                     7,500
                                  10 minutes
                                  1,250 hours
Participant training
                                     6,000
                                    4 hours
                                 24,000 hours
Participants completing data collection tasks
                                     3,000
                           96 hours (8 hours/month)
                                 288,000 hours
Total burden hours for classification/problem-solving projects

                                 313,250 hours
Total annual labor costs for classification/problem-solving projects

                    hourly rate including benefits, $41.66
                                  $13,049,995
Total COMBINED ANNUAL burden hours

                                 389,083 hours
Total COMBINED ANNUAL labor costs

                                  $16,209,198
Total COMBINED 3 YEAR burden hours

                                   1,167,249
Total COMBINED 3 YEAR labor costs

                                  $48,627,593

13.	Costs to Respondents
There will not be fees associated with participation in the data collections under this generic clearance. Participants will not be required to purchase any equipment to collect data, but some low-cost sensors or other technical or low-tech supplies may be necessary to complete the data collection tasks. The costs to participants for materials will vary based on the data collection type (data gathering, classification/problem solving, or research subject participation) and medium (i.e., sensors, apps, or paper forms). The Agency does not expect participants to make purchases specifically for participatory science and crowdsourcing projects under this generic clearance. However, the table below reflects an annual 3-year estimate for Operations and Maintenance Costs (O&M) that participants might incur should they decide to purchase equipment to fully participate in a participatory science or crowdsourcing collection under this generic clearance. The estimate is based on the following assumptions: one eighth of the expected participants in the "data gathering projects" purchases low-tech equipment with a maximum cost of $25 per person (i.e., use of already owned internet or data plans; or purchase of low-technology equipment like water monitoring kits) and one eighth of the expected participants in the "data gathering projects" purchases high-tech equipment (i.e. personal monitors, portable/personal air sensors, or other higher-technology equipment) with a maximum cost of $500 per person.
Operations & Maintenance (O&M) Costs

Estimated maximum cost per participant
Estimated number of participants expected to use
O&M costs
Low-tech equipment
$25.00
1000
$25,000
Low-cost personal or portable technology
$500.00
1000
$500,000
Total annual non-hour burden cost
$525,000
O&M costs over 3 years
$1,575,000

14. 	Costs to Federal Government
The anticipated cost to the Federal Government is approximately $151,678 annually. These costs are comprised of project administration and estimated contractor payments. EPA person-costs are estimated using an hourly rate for a GS-14 (step 1) including an additional 60% for benefits based in Washington, DC. Time spent on each step may vary, as well as the GS-level of the employees involved. The estimate for project administration is based on 10 projects per year at 5% time given 2,087-hour divisor for an employee's annual rate of pay.

Task
Costs (and Person-hours) Per Project
Total Hours and Cost

EPA
($63.43/
Hour)
Estimated contractor costs
Total Cost/Year (estimated for 10 projects per year)
Project Administration
$132,378

$132,378

Contractor costs

$60,000
$60,000
Total

$192,378

15. 	Reason for Change
This three year renewal will allow EPA to continue its participatory science activities consistent with Congressional legislation (American Innovation and Competitiveness Act), a 2016 GAO report ("Practices to Engage Citizens and Effectively Implement Federal Initiatives"), a 2017 GAO Report ("Executive Branch Developed Resources to Support Implementation, but Guidance Could Better Reflect Leading Practices"), and a September 2018 EPA OIG report on improving management controls for EPA participatory science ("EPA Needs a Comprehensive Vision and Strategy for Citizen Science that Aligns with its Strategic Objectives on Public Participation"). The dollar figures have been updated to reflect current wages.
16. 	Tabulation of Results, Schedule, Analysis Plans
The tabulation, timeline, analysis, and publication of information collected under this generic clearance will vary by submission.

In accordance with the Presidential Memorandum on Transparency and Open Government, information collected under this generic clearance will disclose information rapidly in forms that the public can readily find and use and in compliance with the data policies outlined on Data.Gov.

Each project submitted under this generic clearance will specify the tabulation, timeline, and analysis of the information collection. The information collected is for Agency scientific purposes, thus a number of projects are likely to publish the results of analyzed data, in peer-reviewed scientific journals, white-papers, Agency reports, or Agency strategic research plans, which will be available for public consumption.

17.	Display of OMB Approval Date
Not applicable for this request.
18. 	Exceptions to Certification for Paperwork Reduction Act Submissions
These activities comply with the requirements in 5 CFR 1320.9.

B.	STATISTICAL METHODS
Data collection methods and procedures will vary; however, the primary purpose of these collections will be for qualitative and quantitative data collections that might help inform scientific research, assessments, or environmental screening; validate environmental models or tools; or enhance the quantity and quality of data collected across the country's diverse communities and ecosystems to support the Agency's mission.

 Universe and Respondent Selection

   Statistical methods will not be used in the selection of respondents. Participants in participatory science and crowdsourcing projects are self-selected. The method for soliciting participation will be described fully in each collection request, but participation may be advertised through targeted outreach and engagement methods like standard and social media outlets, collaborations with on-the-ground partners, public talks, and word-of-mouth.

   The number of participants will vary by project submitted under this generic clearance. The variation in participation is likely due to multiple factors like personal interests, accessibility, perceived burden, outreach by the Agency, and success over time.
   Results will not be used to directly inform Agency regulations or policies. Data also will not be generalized beyond the scope of the sample.

 Procedures for Collecting Information

   Data collection methods and procedures will vary and the specifics of these will be provided with each collection request. Each request under this generic collection will include details on the statistical methodology for stratification and sample selection (if applicable to the collection  -  this is not applicable to the selection of participants), estimation procedure, degree of accuracy needed for the research purpose described in the justification, unusual problems requiring specialized sampling procedures, and any use of periodic data collection cycles (less frequent than annual) to reduce burden.

 Methods to Maximize Response

   Participants will have complete control over their participation in participatory science or crowdsourcing projects. Participants will need to proactively seek out opportunities, respond to an email, or actively sign up for a project to participate. Outreach and advertising materials will provide information on how to participate but will not assume participation from anyone. Several existing participatory science and crowdsourcing projects employ engagement tactics to support continued participation, and reduce non-response including newsletters with appreciation, motivation and results delivered to participants, and optional bi-weekly reminders to observe. The collection requests under this generic clearance may utilize some of these techniques while acknowledging that participants have full control over whether to participate or not.

   Each collection request under this generic clearance will specify methods to track and increase response rates. Some collection requests will provide opportunities for participants to submit negative data, for example, information on the time and effort to attempt to obtain an observation in the event of no observation.

 Testing of Procedures

   Pretesting may be done with internal staff or a limited number of external colleagues (less than 10). If the number of pretest respondents exceeds nine members of the public, the Agency will submit the pretest instruments for review under this generic clearance.

 Contacts for Statistical Aspects and Data Collection

   Projects submitted under this generic clearance can consult with statisticians in the development, design, conduct, and analysis of the data collection. Statistical expertise is available from agency statisticians or contractors and the Agency will include the names and contact information of persons consulted in the specific information collection requests submitted under this generic clearance as needed.

C.	APPENDIX

EPA Statutory Authorities

 American Innovation and Competitiveness Act § 402 42 USC § 1861 authorizes Federal science agencies to "conduct projects designed to advance the mission of" the agency. It also authorizes an agency to work with outside organizations in these projects.
 Clean Air Act § 103, 42 U.S.C. § 7403, authorizes research into techniques for monitoring and controlling air pollution.
 Clean Water Act § 104, 33 U.S.C. § 1254, authorizes EPA to encourage, cooperate with and render technical services to individuals, including the general public, to promote the coordination and acceleration of demonstrations, studies and training relating to the causes, effects, prevention and elimination of water pollution.
 Solid Waste Disposal Act § 8001, 42 U.S.C. § 6981, authorizes EPA to encourage, cooperate with and render technical services to individuals as well as public and private sector entities to promote the coordination and acceleration of demonstrations, studies, training and public education programs relating to, among other things: adverse and welfare effects of the release of solid waste into the environment; operation and financing of solid waste management programs; planning and operation of resource recovery and conservation systems and hazardous waste management systems; production and marketing of recovered resources; reductions in the amount of solid and hazardous waste and unsalvageable waste materials; and, the development and application of improved methods of collecting and disposing of solid wastes to recover and market materials and energy from these wastes.
 Marine Protection, Research and Sanctuaries Act § 203, 33 U.S.C. § 1443, authorizes EPA to encourage, cooperate with, and render technical assistance to public and private sector entities, including individuals, to promote the coordination of demonstrations, studies and training to minimize dumping of materials into the ocean that may unreasonably degrade or endanger human health, welfare, or the marine environment and economic potential.
 Safe Drinking Water Act § 1442, 42 U.S.C. § 300j-1, authorizes the Administrator to conduct research, studies, and demonstrations relating to the causes, diagnosis, treatment, control, and prevention of risks to human health related to drinking water supply, and to share information and make recommendations based on this research and investigation.
 The National Environmental Education Act, § 4, 20 U.S.C. § 5503authorizes EPA to develop and support programs to increase environmental literacy.
 107-118 Comprehensive Environmental Response, Compensation and Liability Act § 311, 42 U.S.C. § 9660, authorizes EPA to conduct research, and provide training and technical assistance to individuals and organizations, to facilitate the inventory, assessment, preparation and remediation of brownfields sites, including associated community involvement.

Policy support
 EPA Vision and Principles for Participatory Science: https://www.epa.gov/participatory-science/epa-vision-participatory-science
 GAO Report GAO-17-507. Open Innovation: Executive Branch Developed Resources to Support Implementation, but Guidance Could Better Reflect Leading Practices. June 2017. This report identified key actions agencies and executive offices could do to encourage and expand the use of open innovation in government.
 EPA Office of Inspector General Report No. 18-P-0240. EPA Needs a Comprehensive Vision and Strategy for Citizen Science that Aligns with Its Strategic Objectives on Public Participation. September 5, 2018. This report evaluated whether EPA has developed controls to manage the use of citizen science results to meet the agency's mission.
 2013 Second Open Government National Action Plan - encourages Federal Agencies to harness the ingenuity of the public by accelerating and scaling the use of open innovation methods such as citizen science and crowdsourcing: https://www.whitehouse.gov/sites/default/files/docs/us_national_action_plan_6p.pdf
 OMB Memo M-11-07. Facilitating Scientific Research by Streamlining the Paperwork Reduction Act Process. December 9, 2010. Citizen science and crowdsourcing are in line with the Paperwork Reduction Act's intent to "ensure the greatest possible public benefit from and maximize the utility of information created, collected, maintained, used, shared, and disseminated by or for the Federal Government."
 OMB Memo M-10-06. Open Government Directive. December 8, 2009. Promotes open government and the use of new technologies.
 OMB Memo M-15-16. Multi-Agency Science and Technology Priorities for the FY 2017 Budget. July 9[th], 2015. "Agencies are encouraged to use approaches to foster innovation such as Grand Challenges, incentive prizes, citizen science, and collaboration with members of the Maker Movement."

Lesson Learned from EPA's First and Second Generic ICR for citizen science (2016-present)
Generic ICR #2080-0083

EPA used the generic ICR for participatory science to conduct twenty-four new projects. Some "lessons learned" are that well designed participatory science projects can 1) fill data gaps and provide another means of identifying potential environmental problems, 2) improve public understanding of environmental issues and actions that address them, 3) create a stronger, more inclusive and collaborative network of individuals and organizations dedicated to environmental problem solving, and 4) yield cost savings and efficiency in environmental monitoring and protection programs.

EPA benefitted from an Office of the Inspector General (OIG) self-initiated audit of EPA's participatory science conducted in 2017 and 2018. The final report was issued on September 5, 2018, titled "EPA Needs a Comprehensive Vision and Strategy for Citizen Science that Aligns with Its Strategic Objectives on Public Participation" (https://www.epa.gov/sites/production/files/2018-09/documents/_epaoig_20180905-18-p-0240.pdf). The report highlights as a noteworthy achievement the generic ICR to expedite the approval process for new citizen science projects.
  Selected Projects Included Under the Generic ICR #2080-0083 (from 2016-present)

 Bloomwatch and CyanoScope
 Date: 2016 to present
 Location: Primary geographic target was northeastern U.S. (EPA Regions 1 & 2), but there has been broad participation from across the country.
 Number of Participants: Over 300 organizations have participated so far.
 Project Summary:  Bloomwatch and CyanoScope are two tiers of a three-tiered program to identify, monitor, and manage harmful cyanobacteria blooms. BloomWatch is the first tier of the program that utilizes a phone app, allowing the public to photo document the occurrence of a suspected bloom. These images are immediately uploaded to a crowdsourced public facing data dashboard while notifications of the event are sent simultaneously to preselected email lists as established by the user. This allows for individuals/organizations in charge of managing blooms to be notified immediately and appropriate action to be taken. Cyanoscope is the second program tier and follows on Bloomwatch by enabling the participant to collect bloom samples after taking images and using consistent methods for microscopically confirming cyanobacteria populations within the waterbody and identifying potentially toxic genera within the sample. This step helps verify that the bloomWatch images are indeed cyanobacteria in origin and provides notice that potentially toxin producing cyanobacteria are present.
 Types of Data Collected: Image based documentation of harmful algal blooms, microscopic images of individual organisms, and fluorometric data
 How Results Were Disseminated or Used: This program has trained hundreds of individuals over the past few years and has been the catalyst for many local startup monitoring and education programs. It continues to be well received and participation continues to expand. There is also a great need for aggregating data across state lines in order to gain regional perspectives. EPA is developing data visualization and exploration tools.
 Types of Future Information Collection: Types of information that may be collected in the future include water quality data, biological information on the types of cyanobacteria present in specific waterbodies, cyanobacteria toxin data, and toxin accumulation in biota.

 Smoke Sense
 Date: 2017 - present
 Location: Nationwide
 Number of Participants: 90,000 (estimated)
 Project Summary: The overarching objective of the Smoke Sense project is to develop and maintain an interactive platform for building knowledge in communities about wildfire smoke, health impacts and protective actions to reduce exposure that can improve health outcomes. Central to the Smoke Sense project is the smart phone application through which participants can explore current and forecasted daily air quality, maps of fire locations, satellite images of smoke plumes, and learn about ways to protect our health from smoke and poor air quality.
 Types of Data Collected: Individual reports of smoke observations, health symptoms, and behavioral actions taken to reduce exposure.
 How Results Were Disseminated or Used: Results from this project will be used to promote public science literacy, provide education or training to the public, produce novel data, augment existing data, advance ongoing scientific research, provide data or tools to the public, inform agency planning, support community efforts and encourage community engagement. To date, the project has resulted in five manuscripts which provide an unprecedented advance in knowledge of individual level engagement with the issue of air quality as a health risk. Data is also available in the smart phone application and on the data visualization site on https://www.epa.gov/air-research/smoke-sense-study-citizen-science-project-using-mobile-app
 Types of Future Information Collection: Future collections will likely be the same as current.

 Smoke Ready Communities
 Date: 2021 - present
 Location: Combination of virtual and physical locations: Butte-Silver Bow, Montana & Garfield County, Colorado
 Number of Participants: approximately 60
 Project Summary:  This project is one way that EPA is working to protect public health during wildfire smoke events by improving smoke forecasting abilities, identifying and communicating when and where smoke events are occurring, building local capacity, and providing tools and resources for communities for health protection during smoke events. The purpose of this participatory research is to support local communities in developing a tailored strategy for how their community will respond to future wildfire smoke episodes and advance the state of the science on effective approaches to local collaborative planning processes that support community-defined outcomes related to local response and resilience to wildfire smoke episodes.
 Types of Data Collected: Experience and perspectives on the impacts of extreme wildland fire smoke events on communities and how communities respond; perceptions on health risks associated with smoke exposure; and input on ideas for community-level responses.
 How Results Were Disseminated or Used: Results will inform the broader conversation in the peer-reviewed literature on effective strategies for addressing complex social-environmental issues. Results will also inform EPA on how to approach community-led collaborative projects, and leverage insights for program and tool development and revision processes. Also, the county wildland fire smoke response plans will be used by local communities during future smoke events that require a public health response at the community level.
 Types of Future Information Collection: Future collection will likely be similar.

 EPA Sanitary Survey App for Marine and Fresh Waters
 Date: 2021 - present
 Location: Virtual
 Number of Participants: 105
 Project Summary: The EPA Sanitary Survey App for Marine and Fresh Waters allows users to gather sanitary survey data to identify sources of fecal contamination and potential harmful algal bloom (HAB) events affecting water quality. The App consists of surveys for both marine and fresh waters. The Sanitary Survey App can be used on any device in the field without the need for WiFi or Internet access. It includes photo storage, real time geolocation, links to websites such as the National Weather Service to access data, and free data storage.
 Types of Data Collected: Sanitary survey data to identify sources of fecal contamination and potential HAB events affecting water quality.
 How Results Were Disseminated or Used: Data collected could be used by states, territories, and tribes to understand sources of fecal contamination that are impacting a beach or waterbody. Data collected can also be used to develop predictive models for making same-day decisions on swimming advisories.
 Types of Future Information Collection: Future collection will likely be similar.


[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)]
[Notices]
[Pages 36655-36658]
[FR Doc No: 2018-16164]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83690; File No. SR-ICC-2018-004]

Self-Regulatory Organizations; ICE Clear Credit LLC; Order
Approving Proposed Rule Change Relating To Formalization of the ICC
Model Validation Framework

July 24, 2018.

I. Introduction

    On May 23, 2018, ICE Clear Credit LLC (``ICC'') 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 formalize the
ICC Model Validation Framework. The proposed rule change was published
in the Federal Register on June 12, 2018.\3\ The Commission has not
received any comments on the proposed rule change. For the reasons
discussed below, the Commission is approving the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 34-83386 (June 6, 2018),
83 FR 27360 (June 12, 2018) (SR-ICC-2018-004) (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    The proposed rule change would formalize the ICC Model Validation
Framework (``Framework''), which sets forth ICC's model validation
procedures.\4\ Through the use of these model validation procedures,
ICC determines the effectiveness of the risk models underpinning ICC's
risk management system, considers new components and enhancements to
existing components of the risk models, and monitors and validates on
an ongoing basis the risk models. The Framework also describes the
personnel responsible for, and the governance process associated with,
the successful operation and maintenance of the model validation
procedures. Specifically, the Framework designates ICC's Risk Oversight
Officer (``ROO'') as the Framework owner and makes the ROO responsible
to the ICC President for the successful operation and maintenance of
the Framework.\5\
---------------------------------------------------------------------------

    \4\ Notice, 83 FR at 27361. Capitalized terms used herein but
not otherwise defined have the meaning set forth in the Framework
and ICE Clear Europe rulebook, which is available at https://www.theice.com/clear-europe/regulation#rulebook.
    \5\ Notice, 83 FR at 27361.
---------------------------------------------------------------------------

    ICC has a proprietary risk management system that uses models to
assess the risk of the credit default swap-based portfolios that ICC
clears. ICC uses its risk management system to determine the
appropriate Initial Margin and Guaranty Fund requirements that offset
the risks of the credit default swap-based portfolios ICC clears. The
risk management system is composed of risk model components (``Model
Components''), which employ a combination of statistical analysis of
credit spread time series and stress test simulation scenarios to
address different sources of risk. These sources of risk addressed by
the Model Components constitute the foundation of total Initial Margin
and Guaranty Fund requirements for the credit default swap-based
portfolios that ICC clears.\6\
---------------------------------------------------------------------------

    \6\ Id.
---------------------------------------------------------------------------

    The Framework considers both new Model Components and enhancements
to existing Model Components (collectively, ``Model Change''). New
Model Components consider sources of risk that are not currently
included in the risk management system.\7\ Enhancements to existing
Model Components improve upon the methodologies already used by the
risk management system to consider a given source or sources of
risk.\8\ The Framework classifies Model Changes as either Materiality A
or Materiality B, depending on how substantially the Model Change
affects the risk management system's assessment of risk for the related
source or sources of risk.\9\ Materiality A Model Changes substantially
affect the risk management system's assessment of risk for the related
source or sources of risk. Materiality B Model Changes do not
substantially affect the risk management system's assessment of risk
for the related source or sources of risk. The Framework requires that
the ICC Chief Risk Officer (``CRO'') and the ROO review and determine
which enhancements to the risk management system qualify as Model
Changes and classify Model Changes as Materiality A or B.\10\ The
Framework requires that the ICC Risk Committee review the materiality
classifications and provide feedback as necessary.\11\ The Framework
also describes the Model Inventory which is maintained by the ICC Risk
Department and which contains key information about all Model
Components and Model Changes.\12\ The Framework requires that the ICC
ROO review the model

inventory at least quarterly to ensure that it contains accurate and up
to date information relating to Model Components and Model Changes.\13\
---------------------------------------------------------------------------

    \7\ Id.
    \8\ Notice, 83 FR at 27361.
    \9\ Id.
    \10\ Id.
    \11\ Id.
    \12\ Id.
    \13\ Id.
---------------------------------------------------------------------------

    To assure the effectiveness of ICC's risk management system, the
Framework employs four controls: Initial validation; ongoing monitoring
and validation; investigation; and independent periodic review.\14\
Before going live with any Model Change, the Framework requires an
initial validation of the conceptual soundness of the methodology and
the proposed ongoing monitoring and validation approach.\15\ In
addition, the Framework subjects Materiality A Model Changes to an
additional independent initial validation.\16\
---------------------------------------------------------------------------

    \14\ Notice, 83 FR at 27361.
    \15\ Id.
    \16\ Id.
---------------------------------------------------------------------------

    Ongoing monitoring and validation provides assurances that ICC has
appropriately configured and calibrated the risk management system,
including any recent Model Change, and that the risk management system
is achieving the desired level of performance.\17\ Ongoing monitoring
and validation consists of three areas: Parameter setting, execution
monitoring, and outcome analysis.\18\ Through execution monitoring ICC
reviews on a daily basis the changes generated by its risk management
system and explains them in relation to known changes in cleared
portfolios, prices, and market conditions.
---------------------------------------------------------------------------

    \17\ Id.
    \18\ Id.
---------------------------------------------------------------------------

    If ongoing monitoring and validation identifies features of the
risk management system that might indicate weakness in a Model
Component, the Framework requires ICC to investigate and identify the
root cause.\19\ If weakness in a Model Component is discovered during
investigation, the Framework requires the ICC CRO to inform the ICC
Risk Committee of the results of the investigation.\20\ ICC must then
remediate the identified weakness through an appropriate Model Change,
which passes through the required steps of the Framework starting with
an Initial validation.\21\
---------------------------------------------------------------------------

    \19\ Notice, 83 FR at 27361.
    \20\ Id.
    \21\ Id.
---------------------------------------------------------------------------

    The Framework sets forth the process for selecting independent
validators and describes the independent validator criteria, including
technical expertise and independence requirements. The Framework
requires that the ICC CRO provide support and information to allow the
independent validators to perform periodic reviews of all Model
Components and related practices at least once in every calendar
year.\22\ At ICC's choosing, the scope of an independent periodic
review may cover all Model Components used by the risk management
system, or a subset of Model Components, as long as all Model
Components are included in one or more independent periodic reviews
each year.\23\ The independent periodic review must demonstrate that
the Model Components remain fit for purpose; that the assumptions
associated with the Model Components are still valid; that ICC has
adequately addressed any open items of medium priority \24\ from Model
Change initial validations and any other implementation conditions; and
that ICC has been complying with its ongoing monitoring and validation
requirements and the Model Components are performing without any
significant weakness.\25\ The ICC CRO must present the periodic review
to the ICC Risk Committee and describe ICC's plans in relation to any
open high or medium priority items in the report.\26\
---------------------------------------------------------------------------

    \22\ Id.
    \23\ Id.
    \24\ The Framework defines as medium priority those items that
reflect deficiencies in the Model Components, assumptions, usage, or
compliance with stated procedures that create risks that ICC can
mitigate with viable workarounds until it remediates them fully,
within a reasonable timeframe agreed with the Risk Committee.
    \25\ Notice, 83 FR at 27361.
    \26\ Id.
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act directs the Commission to approve a
proposed rule change of a self-regulatory organization if it finds that
such proposed rule change is consistent with the requirements of the
Act and the rules and regulations thereunder applicable to such
organization.\27\ For the reasons given below, the Commission finds
that the proposal is consistent with Section 17A(b)(3)(F) of the Act
\28\ and Rules 17Ad-22(b)(2), 17Ad-22(b)(3), 17Ad-22(b)(4), and 17Ad-
22(d)(8) thereunder.\29\
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 78s(b)(2)(C).
    \28\ 15 U.S.C. 78q-1(b)(3)(F).
    \29\ 17 CFR 240.17Ad-22(b)(2)-(4), (d)(8).
---------------------------------------------------------------------------

A. Consistency With Section 17A(b)(3)(F) of the Act

    Section 17A(b)(3)(F) of the Act requires, among other things, that
the rules of ICC be designed to promote the prompt and accurate
clearance and settlement of securities transactions and, to the extent
applicable, derivative agreements, contracts, and transactions, as well
as to assure the safeguarding of securities and funds which are in the
custody or control of ICC or for which it is responsible, and, in
general, to protect investors and the public interest.\30\
---------------------------------------------------------------------------

    \30\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    As described above, the Framework would provide a process for
reviewing and enhancing ICC's risk management system. The Framework
would also designate the personnel responsible for, and the governance
process associated with, the successful operation and maintenance of
the model validation procedures and would set forth the process and
criteria for selecting independent validators.
    Taken together, the Commission believes these aspects of the
Framework would help ensure that ICC's risk management system
appropriately and effectively addresses the risks associated with
clearing security based swap-related portfolios by providing ICC a
means for reviewing and enhancing the risk management system as needed.
In providing for independent validators, the Commission believes the
Framework would help ensure that ICC receives unbiased and objective
views regarding its risk management system, which would improve such
review and enhancement. The Commission believes that both of these
aspects of the Framework would improve the effectiveness of ICC's risk
management system, thereby improving ICC's ability to manage the risks
associated with clearing security based swap-related portfolios. Given
that mismanagement of the risks associated with clearing security based
swap-related portfolios could cause ICC to realize losses on such
portfolios and disrupt ICC's ability to promptly and accurately clear
security based swap transactions, the Commission believes that the
Framework would promote the prompt and accurate clearance and
settlement of securities transactions. Similarly, given that
mismanagement of the risks associated with clearing security based
swap-related portfolios could cause ICC to realize losses on such
portfolios and threaten ICC's ability to operate, thereby threatening
access to securities and funds in ICC's control, the Commission
believes that the Framework would help assure the safeguarding of
securities and funds which are in the custody or control of the ICC or
for which it is responsible. Finally, for both of these reasons, the
Commission believes the Framework would, in general, protect investors
and the public interest.
    Therefore, the Commission finds that the proposed rule change would
promote the prompt and accurate

clearance and settlement of securities transactions, assure the
safeguarding of securities and funds in ICC's custody and control, and,
in general, protect investors and the public interest, consistent with
the Section 17A(b)(3)(F) of the Act.\31\
---------------------------------------------------------------------------

    \31\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

B. Consistency With Rule 17Ad-22(b)(2)

    Rule 17Ad-22(b)(2) requires that ICC establish, implement, maintain
and enforce written policies and procedures reasonably designed to use
margin requirements to limit its credit exposures to participants under
normal market conditions and use risk-based models and parameters to
set margin requirements and review such margin requirements and the
related risk-based models and parameters at least monthly.\32\
---------------------------------------------------------------------------

    \32\ 17 CFR 240.17Ad-22(b)(2).
---------------------------------------------------------------------------

    As described above, the Framework would describe how ICC would
review and enhance its risk management system, including the selection
and use of independent validators. In doing so, the Commission believes
that the Framework would help ensure that ICC's risk management system
is appropriate and effective for dealing with the risks associated with
clearing security based swap-related portfolios. The Commission
believes that the Framework would also enable ICC to improve its margin
requirements by allowing ICC to review and improve the models that
generate such margin requirements. The Commission believes that these
aspects of the Framework would improve ICC's use of margin requirements
to limit its credit exposures to participants under normal market
conditions and ICC's use of risk-based models and parameters to set
margin requirements.
    In addition, the Framework would describe ICC's process for
execution monitoring, whereby ICC would review on a daily basis the
changes generated by its risk management system and would explain those
changes in relation to known changes in cleared portfolios, prices, and
market conditions. The Framework would require ICC to then investigate
any anomalies identified. In reviewing such changes and anomalies, the
Commission believes ICC would review its margin requirements and the
models that generate such requirements. Thus, the Commission believes
the Framework would enable ICC to review its margin requirements and
the models that generate such requirements on a daily basis.
    Therefore, for the above reasons the Commission finds that the
proposed rule change is consistent with Rule 17Ad-22(b)(2).\33\
---------------------------------------------------------------------------

    \33\ 17 CFR 240.17Ad-22(b)(2).
---------------------------------------------------------------------------

C. Consistency With Rule 17Ad-22(b)(3)

    Rule 17Ad-22(b)(3) requires that ICC establish, implement, maintain
and enforce written policies and procedures reasonably designed to
maintain sufficient financial resources to withstand, at a minimum, a
default by the two participant families to which it has the largest
exposures in extreme but plausible market conditions, in its capacity
as a central counterparty for security-based swaps.\34\
---------------------------------------------------------------------------

    \34\ 17 CFR 240.17Ad-22(b)(3).
---------------------------------------------------------------------------

    As described above, the Framework would provide a process for
reviewing and enhancing ICC's risk management system and would set
forth the process and criteria for selecting independent validators. In
doing so, the Commission believes that the Framework would help ensure
that ICC's risk management system appropriately and effectively deals
with the risks associated with clearing security based swap-related
portfolios, including the risk associated with the default by the two
participant families to which ICC has the largest exposures in extreme
but plausible market conditions. The Commission believes that the
Framework would also help ICC improve its guaranty fund requirements by
allowing ICC to review and improve the models that generate such
requirements. The Commission believes that these aspects of the
Framework would help ensure that ICC effectively establishes and
maintains financial resources sufficient to withstand, at a minimum, a
default by the two participant families to which ICC has the largest
exposures in extreme but plausible market conditions.
    Therefore, for the above reasons the Commission finds that the
proposed rule change is consistent with Rule 17Ad-22(b)(3).\35\
---------------------------------------------------------------------------

    \35\ 17 CFR 240.17Ad-22(b)(3).
---------------------------------------------------------------------------

D. Consistency With Rule 17Ad-22(b)(4)

    Rule 17Ad-22(b)(4) requires that ICC establish, implement, maintain
and enforce written policies and procedures reasonably designed to
provide for an annual model validation consisting of evaluating the
performance of its margin models and the related parameters and
assumptions associated with such models by a qualified person who is
free from influence from the persons responsible for the development or
operation of the models being validated.\36\
---------------------------------------------------------------------------

    \36\ 17 CFR 240.17Ad-22(b)(4).
---------------------------------------------------------------------------

    As discussed above, the Framework would require the ICC CRO to
provide support and information to allow independent validators to
perform periodic reviews of all Model Components and related practices
at least once in every calendar year. The Framework would further
provide that the scope of an independent periodic review may cover all
Model Components used by the risk management system, or a subset of
Model Components, as long as all Model Components are included in one
or more independent periodic reviews each year. The Framework would
also provide the process and criteria (including independence) for
selecting independent validators. Finally, the Framework would describe
the required components of an independent review and the documentation
required to be produced by the independent validators.
    The Commission believes these aspects of the Framework would enable
ICC to validate the models underpinning its risk management system on
an annual basis including the related parameters and assumptions
associated with such models. The Commission also believes that by
setting out the process and criteria (including independence) for
selecting independent validators, the Framework would help ensure that
such validations are performed by qualified persons free from influence
from the persons responsible for the development or operation of the
models being validated.
    Therefore, for the reasons described above the Commission finds
that the proposed rule change is consistent with Rule 17Ad-
22(b)(4).\37\
---------------------------------------------------------------------------

    \37\ 17 CFR 240.17Ad-22(b)(4).
---------------------------------------------------------------------------

E. Consistency With Rule 17Ad-22(d)(8)

    Rule 17Ad-22(d)(8) requires that ICC establish, implement, maintain
and enforce written policies and procedures reasonably designed to have
governance arrangements that are clear and transparent to fulfill the
public interest requirements in Section 17A of the Act \38\ applicable
to clearing agencies, to support the objectives of owners and
participants, and to promote the effectiveness of the clearing agency's
risk management procedures.\39\
---------------------------------------------------------------------------

    \38\ 15 U.S.C. 78q-1.
    \39\ 17 CFR 240.17Ad-22(d)(8).
---------------------------------------------------------------------------

    As discussed above, the Framework would describe the personnel
responsible for, and the governance process associated with, the
successful operation and maintenance of the model validation
procedures. Specifically, the Framework would designate ICC's ROO

as the Framework owner and would make the ROO responsible to the ICC
President for the successful operation and maintenance of the
Framework. The Framework would also designate certain responsibilities
to ICC's CRO and the Risk Committee. The Commission believes that in
doing so the Framework would allow ICC to establish clear and
transparent arrangements for governing the Framework and its model
validation procedures. The Commission further believes that these same
arrangements would contribute to ICC's fulfilling the public interest
requirements in Section 17A of the Act \40\ applicable to clearing
agencies, and the objectives of owners and participants. Finally, the
Commission believes that these procedures and arrangements would
promote the effectiveness of ICC's risk management procedures by
clarifying the process for, and responsibilities associated with, using
the Framework to improve ICC's risk management system.
---------------------------------------------------------------------------

    \40\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    Therefore, for the above reasons the Commission finds that the
proposed rule change is consistent with Rule 17Ad-22(d)(8).\41\
---------------------------------------------------------------------------

    \41\ 17 CFR 240.17Ad-22(d)(8).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act, and in
particular, with the requirements of Section 17A(b)(3)(F) of the Act
\42\ and Rules 17Ad-22(b)(2), 17Ad-22(b)(3), 17Ad-22(b)(4), and 17Ad-
22(d)(8) thereunder.\43\
---------------------------------------------------------------------------

    \42\ 15 U.S.C. 78q-1(b)(3)(F).
    \43\ 17 CFR 240.17Ad-22(b)(2)-(4), (d)(8).
---------------------------------------------------------------------------

    It is therefore ordered pursuant to Section 19(b)(2) of the Act
\44\ that the proposed rule change (SR-ICC-2018-004) be, and hereby is,
approved.\45\
---------------------------------------------------------------------------

    \44\ 15 U.S.C. 78s(b)(2).
    \45\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\46\
---------------------------------------------------------------------------

    \46\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-16164 Filed 7-27-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: April 9, 2008 (Volume 73, Number 69)]
[Notices]
[Page 19278]
[DOCID:fr09ap08-99]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Opportunity for Public Comment on Surplus Property
Release at Mobile Downtown Airport, Mobile, AL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of intent to rule on land release request.

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SUMMARY: Under the provisions of Title 49, U.S.C. Section 47153(c),
notice is being given that the FAA is considering a request from the
Mobile Airport Authority to waive the requirement that a 46.75-acre
parcel of surplus property, located at the Mobile Downtown Airport, be
used for aeronautical purposes.

DATES: Comments must be received on or before May 9, 2008.

ADDRESSES: Comments on this notice may be mailed or delivered in
triplicate to the FAA at the following address: Jackson Airports
District Office, 100 West Cross Street, Suite B, Jackson, MS 39208-
2307.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Mr. Thomas Hughes, Airport Director, at the
following address: P.O. Box 88004, Mobile, Alabama 36608-0004.

FOR FURTHER INFORMATION CONTACT: William Schuller, Program Manager,
Jackson Airports District Office, 100 West Cross Street, Suite B,
Jackson, MS 39208-2307,<PHONE_NUMBER>. The land release request may be
reviewed in person at this same location.

SUPPLEMENTARY INFORMATION: The FAA is reviewing a request by the Mobile
Airport Authority to release 46.75 acres of surplus property at the
Mobile Downtown Airport. The property will be exchanged within the
Mobile Airport Authority for non-obligated land better suited for
aeronautical purposes. The property will be held by the Mobile Airport
Authority and sold in part or in whole to commercial or industrial
users. The property is located along Mobile Bay and is separated from
airside operations by existing, non-aeronautical development. The
airport will realize equivalent fair market value in the exchange of
this property.
    Any person may inspect the request in person at the FAA office
listed above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may, upon request, inspect the request,
notice and other documents germane to the request in person at the
offices of the Mobile Airport Authority, Mobile, Alabama.

    Issued in Jackson, Mississippi on April 1, 2008.
Rans D. Black,
Manager, Jackson Airports District Office, Southern Region.
 [FR Doc. E8-7244 Filed 4-8-08; 8:45 am]

BILLING CODE 4910-13-M


<EPA Registration Division contact: Sidney Jackson,<PHONE_NUMBER>>

Docket ID:  EPA-HQ-OPP-2007-0940

<Interregional Research Project No. 4 (IR-4)>

<PP#: 7E7234>

	EPA has received a pesticide petition (PP) [7E7234] from the IR-4
Project Headquarters, 500 College Road East, Suite 201 W, Princeton, NJ
08540 proposing, pursuant to section 408(d) of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part
180.516 by establishing a tolerance for residues of

the fungicide fludioxonil 4-(2,
2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile in or on the
raw agricultural commodities: tomato at 0.4 parts per million (ppm),
tomatillo at 0.4 ppm, tomato, paste at 1.0 ppm, avocado at 0.45 ppm,
black sapote at 0.45 ppm, canistel at 0.45 ppm, mamey sapote at 0.45
ppm, mango at 0.45 ppm, papaya at 0.45 ppm, sapodilla at 0.45 ppm, star
apple at 0.45 ppm, herb subgroup 19A, fresh at 13 ppm, herb subgroup
19A, dried at 55 ppm, leaves of root and tuber vegetables at 40 ppm,
root vegetables, except sugar beet subgroup at 0.5 ppm, lemon at 0.25
ppm, lime at 0.25 ppm, cucurbits at 0.6 ppm, tuberous and corm
vegetables, except potato subgroup at 4.0 ppm.

Upon approval of the aforementioned tolerances, it is proposed that 40
CFR 180.516 be amended to remove the established tolerances for the
residues of fludioxonil:  4-(2,
2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile in or on the
raw agricultural commodities: herb subgroup 19A, fresh at 10 ppm, herb
subgroup 19A, dried at 65 ppm, and carrot at 0.75 ppm, turnip, greens at
10 ppm.

EPA has determined that the petition contains data or information
regarding the elements set forth in section 408 (d)(2) of  FDDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the petition.
Additional data may be needed before EPA rules on the petition.

<A. Residue Chemistry>

<1. Plant metabolism.  The metabolism of fludioxonil is adequately
understood for the purpose of the proposed tolerances.

>

<2. Analytical method. Syngenta has developed and validated analytical
methodology for enforcement purposes. This method (Syngenta Crop
Protection Method AG-597B) has passed an Agency petition method
validation for several commodities, and is currently the enforcement
method for fludioxonil. This method has also been forwarded to the Food
and Drug Administration for inclusion into PAM II. An extensive database
of method validation data using this method on various crop commodities
is available.    >

<3. Magnitude of residues. Complete residue data to support the
requested tolerances have been submitted. The requested tolerances are
adequately supported.

>

In support of the requested tolerances, IR-4 conducted the following
trials:  Tomato trials were conducted in the field in Maryland, New
York, Florida (two trials), North Carolina, California (five trials),
New Mexico (two trials), Washington, and Wisconsin; greenhouse trials
were conducted in New Jersey, Texas, Tennessee, and Colorado.  Avocado
field trials were conducted in Florida (Region 3), Texas (Region 6), and
four trials in California (Region 10).  Parsley trials were conducted in
Florida (Region 3), California (Region 10), Ohio (Region 5), and Oregon
(Region 12).  In the radish study, magnitude of residue data were
collected from New York (Region 1), two trials in Florida (Region 3),
Ohio (Region 5), California (Region 10), and Washington (Region 11).  In
the lemon study, five trials were conducted in California (Region 10).
In the sweet potato study, a post-harvest trial was conducted in
California (Region 10) and North Carolina (Region 2).  In the cucurbit,
Group 9, trials, 18 field trials were conducted in 10 states:  five
trials in California (Region 10), two trials in Florida (Region 3), two
trials in Georgia (Region 2), two trials in Illinois (Region 5), one
trial in Michigan (Region 5), one trial in New York (Region 1), one
trial in North Carolina (Region 2), one trial in South Carolina (Region
2), two trials in Texas (Region 6), and one trial in Wisconsin (Region
5).

<B. Toxicological Profile

>

An assessment of toxic effects caused by fludioxonil is discussed in
Unit III. A. and Unit III. B. of the Federal Register published by EPA
dated August 2, 2002 (67 FR 50354) (FRL-7188-7) and is repeated in part
below.

Carcinogenic and Other Toxicity

<>

Study Type             	Results

Carcino-genicity rats      	NOAEL = 590 mg/kg/day (M) and 715 mg/kg/day
(F). LOAEL: 851 mg/kg/day (M) and 1,008 mg/kg/ day (F) based on reduced
survival (F), decreased body weights (M), bile duct hyperplasia (M) and
severe nephropathy(both sexes). No evidence of carcinogenicity.

In vivo Rat hepatocyte micronucleus assay                	Male rats were
orally dosed at 50, 250, and 1,250 mg/kg and hepatocytes were harvested.
There was no evidence of a significant increase in micronucleated
hepatocytes in treated groups in comparison to controls.

Unscheduled DNA synthesis assay  	There was no evidence that unscheduled
DNA synthesis, as determined by nuclear silver grain counts, was induced
in hepatocyte cultures obtained from male rats dosed at 2,500 or 5,000
mg/kg.

Summary of Toxicological Dose and Endpoints for Fludioxonil for Use in
Human Risk Assessment

Exposure Scenario       	Dose Used in Risk Assessment, UF
      	FQPA SF and Level of Concern for Risk Assessment     	Study and
Toxicological Effects

Acute Dietary females 13-50 years of age
                            	NOAEL = 100 mg/kg/day

UF = 100

Acute RfD = 1.0 mg/kg/day.                         	FQPA SF = 1X

aPAD = acute RfD ÷ FQPA

SF = 1.0 mg/kg/day.                           	Developmental Toxicity
Study – rat

Developmental LOAEL =1,000 mg/kg/day based on increased incidence of
fetuses and litters dilated renal pelvis and with dilated ureter

Chronic Dietary all populations
                                                         	NOAEL= 3.3
mg/kg/day UF = 100

Chronic RfD = 0.03 mg/ kg/day.
                                             	FQPA SF = 1X

cPAD = chronic RfD FQPA SF = 0.03 mg/kg/day.

1 year chronic toxicity study – dog

LOAEL = 35.5 mg/kg/day based on decreased weight gain in female dogs

Incidental Oral, Short-Term
                                                       	NOAEL = 10
mg/kg/day
                             	LOC for MOE = 100	Rabbit developmental
study

LOAEL = 100 mg/kg/day based on decreased weight gain during gestation

Incidental Oral, Intermediate-Term
                                                     	NOAEL = 3.3
mg/kg/day    	LOC for MOE = 100        	1 year chronic toxicity study -
dog

LOAEL = 35.5 mg/kg/day based on decreased weight gain in female dogs

Short-and Intermediate Term Dermal (1-30 days and 1-6 months)
(Residential)                                        	None
      	No systemic toxicity      was seen at the limit dose (1,000
mg/kg/day) in the 28-day dermal toxicity study in rats  	Endpoint was
not selected

Long-Term (several months-lifetime) Dermal (Residential)

Oral study

NOAEL = 3.3 mg/kg/day (dermal penetration =  40%).

        	LOC for MOE = 100 (Occupational)

LOC for MOE = 100 (Residential).                         	1 year chronic
toxicity study - dog

LOAEL = 35.5 mg/kg/day based on decreased weight gain in female dogs

Short-Term (1-30 Days) Inhalation (Residential)
                                                              	Oral
NOAEL = 10 mg/kg/ day (inhalation absorption rate = 100%)
            	LOC for MOE = 100 (Occupational)

LOC for MOE = 100(Residential).                        	Rabbit
developmental study

LOAEL = 100 mg/kg/day based on decreased weight gain during gestation

Intermediate-term (1 month - 6 months) Inhalation (Residential)	Oral
NOAEL = 3.3 mg/kg/ day (inhalation absorption rate = 100%)
          	LOC for MOE = 100                        (Occupational)

LOC for MOE = 100(Residential).                            	 1 year
chronic toxicity study - dog                                     LOAEL =
35.5 mg/kg/day based on decreased weight gain in female dogs

Long-Term (several months-lifetime) Inhalation (Residential)   	Oral
NOAEL = 3.3 mg/kg/day (inhalation absorption rate = 100%)         	LOC
for MOE = 100(Occupational)  LOC for MOE = 100(Residential).
                       	1 year chronic toxicity study – dog

LOAEL = 35.5 mg/kg/day based on decreased weight gain in female dogs

<>

<6. Animal metabolism. The metabolism of fludioxonil in rats is
adequately understood.

                                                        >

<7. Metabolite toxicology. The residue of concern for tolerance setting
purposes is the parent compound. Consequently, there is no additional
concern for toxicity of metabolites.

>

<8. Endocrine disruption. Fludioxonil does not belong to a class of
chemicals known for having adverse effects on the endocrine system. No
estrogenic effects have been observed in the various short- and
long-term studies conducted with various mammalian species.

C. Aggregate Exposure>

<1. Dietary exposure.  Tier III acute and chronic dietary exposure
evaluations were performed for fludioxinil using the Dietary Exposure
Evaluation Model (DEEM-FCIDTM, version 2.14) from Exponent.  Empirically
derived processing factors for apple juice (0.09X), apple pomace
(6.77X), tomato puree (0.34X), tomato paste (1.1X), and citrus oil (50X)
were used in these assessments.  The apple juice processing factor was
used as a surrogate for pear juice.  All other processing factors used
the DEEMTM defaults.  All consumption data for these assessments was
taken from the USDA’s Continuing Survey of Food Intake by individuals
(CSFII) with the 1994-96 consumption database and the Supplemental CSFII
children’s survey (1998) consumption database.  These exposure
assessments included all current and proposed new uses for fludioxinil
including tomato, tomatillo, avocado, black sapote, canistel, mamey
sapote, mango, papaya, sapodilla, star apple, fresh and dried herbs
(Crop Group 19A), root vegetables (Crop Group 1B), leaves of root and
tuber vegetables (Crop Group 2), lemon and lime.  These assessments
utilized residue data from field trials where fludioxonil was applied at
the maximum intended use rate and samples were harvested at the minimum
pre-harvest interval (PHI) to obtain maximum residues.  Percent of crop
treated values were estimated based upon economic, pest and competitive
pressures.  Secondary residues in animal commodities were estimated
based on theoretical worst-case, yet nutritionally adequate animal diets
and transfer information from feeding studies.>

<i. Food.  Acute exposure.  The acute dietary (food only) risk
assessment for females 13 to 49 years old (the only population subgroup
for which an acute toxicological endpoint has been established) was
performed using an acute reference dose (aRfD) of 1.0 mg/kg-bw/day,
based upon a rat teratology study with a no observable adverse effect
level (NOAEL) of 100 mg/kg/day and an uncertainty factor (UF) of 100X
for intra- and inter-species variations; no additional FQPA safety
factor was applied.  For the purpose of the aggregate risk assessment,
the exposure value was expressed in terms of margin of exposure (MOE),
which was calculated by dividing the no observable adverse effect level
(NOAEL) by the exposure for each population subgroup.  In addition,
exposure was expressed as a percent of the acute reference dose (%aRfD).
 Acute exposure to the females 13-49 years subpopulation resulted in a
MOE of 1,940 (5.2% of the acute RfD of 1.0 mg/kg-bw/day).  Since the
Benchmark MOE for this assessment was 100 and since EPA generally has no
concern for exposures below 100% of the RfD, Syngenta believes that
there is a reasonable certainty that no harm will result from dietary
(food) exposure to residues arising from the current and proposed uses
for fludioxonil.

Chronic exposure.  The chronic reference dose (RfD) for fludioxonil is
0.033 mg/kg-bw/day, based upon a one-year study in dogs with a NOAEL of
3.3 mg/kg-bw/day and an uncertainly factor of 100X; no additional FQPA
safety factor was applied.  For the purpose of the aggregate risk
assessment, the exposure values were expressed in terms of margin of
exposure (MOE), which was calculated by dividing the no observable
adverse effect level (NOAEL) by the exposure for each population
subgroup.  In addition, exposure was expressed as a percent of the
reference dose (%RfD).  Chronic exposure to the most exposed
sub-population (children 1 and 2 years old) resulted in a MOE of 732
(13.7% of the chronic RfD of 0.033 mg/kg-bw/day).  Since the Benchmark
MOE for this assessment was 100 and since EPA generally has no concern
for exposures below 100% of the RfD, Syngenta believes that there is a
reasonable certainty that no harm will result from dietary (food)
exposure to residues arising from the current and proposed uses for
fludioxonil.

>

<ii. Drinking water. Estimated Drinking Water Concentrations (EDWCs) for
fludioxonil were determined using Tier 1 screening models, FIRST which
estimates pesticide concentration in surface water and SCI-GROW which
estimates pesticide concentration in ground water.  The modeling was
conducted using chosen environmental fate data applying EPA’s guidance
for selecting inputs and the current highest labeled use rate for
fludioxonil.  The professional turf use pattern of 0.68 lb a.i./A with
three applications at 14 day intervals was used.  The FIRST model
calculated EDWCs of 72.291 ppb and 30.325 ppb for acute and chronic
surface water, respectively.  The SCI-GROW model calculated an EDWC
level of 2.00E-01 ppb for ground water.  Since the surface water EDWCs
exceed the ground water EDWC, the FIRST surface water values were used
for risk assessment purposes and will be considered protective for any
ground water concentration concerns.

 into the DEEM-FCID™ software to obtain acute dietary (food and water)
exposures.  Drinking water exposures at the 99.9th percentile to
fludioxinil for females 13-49 years old (the only population subgroup
for which an acute toxicological endpoint has been established) resulted
in a MOE of 61,920 (0.2% of the aRfD of 1.0 mg/kg-bw/day).  Since the
Benchmark MOE for this assessment was 100, and since the EPA generally
has no concern for exposures below 100% of the aRfD, Syngenta believes
that there is a reasonable certainty that no harm will result from acute
drinking water exposure to residues arising from all current and
proposed uses of fludioxinil.

Chronic Exposure from Drinking Water:  The chronic EDWC of 30.325 ppb
(0.030325 ppm) was incorporated with food residues as “water, direct
and indirect, all sources” directly into the DEEM-FCID™ software to
obtain chronic dietary (food and water) exposures.  Chronic drinking
water exposure to the U.S. population resulted in a MOE of 5,164 (1.9%
of the cRfD of 0.033 mg/kg-bw/day).  The most exposed sub-population was
children 1-2 years old, with a MOE of 3,477 (2.8% of the cRfD of 0.033
mg/kg-bw/day).  Since the Benchmark MOE for this assessment was 100 and
since the EPA generally has no concern for exposures below 100% of the
cRfD, Syngenta believes that there is a reasonable certainty that no
harm will result from chronic drinking water exposure to residues
arising from all current and proposed uses of fludioxinil.

Cancer.  A chronic cancer exposure analysis was not performed, since
there is no evidence of human carcinogenic potential for fludioxinil.

	>

<2. Non-dietary exposure.  There is a potential residential
post-application exposure to adults and children entering residential
areas treated with fludioxonil.  Fludioxonil is currently registered for
professionally applied uses on turf grass and ornamentals in residential
landscapes.  No residential handler exposures are anticipated, however,
short- and intermediate-term dermal (adults and children) and incidental
oral ingestion (children) post-application residential exposures are
anticipated based on the use pattern for turf grass.  In a recent
fludioxonil aggregate EPA risk assessment, short- and intermediate-term
dermal endpoints were not selected due to the NOAEL of 1,000 mg/kg/day
(highest dose tested) in the 28-day dermal toxicity study in rats and
also since there were no developmental concerns.  The Agency concluded
that there were no significant post-application exposures anticipated
from treated landscape ornamentals and limited their residential risk
assessment to incidental oral ingestion by children following
residential lawn applications.  The Syngenta short- and
intermediate-term residential risk assessments were based on the maximum
Medallion® label rate for turf grass of 0.68 lb a.i./A (0.50 oz
product/1000ft2) with a maximum of three applications allowed per year
(0.68 lb a.i./A x 3 apps = 2 lb a.i./A/year).  In these residential risk
assessments, a short-term NOAEL of 10 mg/kg-bw/day from a rabbit
developmental study and an intermediate-term NOAEL of 3.3 mg/kg/day from
a one year chronic toxicity study were selected.  The residential risk
assessments were limited to children since the only route of exposure
was incidental oral ingestion via hand-to-mouth activity and
object-to-mouth (grass and soil ingestion).  The combined short-term MOE
for children 1-6 years was 785, and the combined intermediate-term MOE
for children 1-6 years was 259; both are above the Benchmark MOE of 100
for these assessments.

>

<D. Cumulative Effects>

<Cumulative Exposure to Substances with a Common Mechanism of Toxicity.
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether
to establish, modify, or revoke a tolerance, the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide’s residues and “other substances that have a
common mechanism of toxicity.”  Unlike other pesticides for which EPA
has followed a cumulative risk approach based on a common mechanism of
toxicity, EPA has not made a common mechanism of toxicity finding as to
fludioxinil and any other substances, and fludioxinil does not appear to
produce a toxic metabolite produced by other substances.  For the
purposes of this tolerance action, the EPA has not assumed that
fludioxinil has a common mechanism of toxicity with other substances.

>

<E. Safety Determination>

<	1. U.S. population. An acute toxicological endpoint has not been
established for the U.S. population, so an acute exposure assessment was
not performed for the U.S. population.  The chronic aggregate exposure
analysis showed that exposure from all current and proposed fludioxinil
uses resulted in a MOE of 1,772 (5.6% of the cRfD of 0.033 mg/kg-bw/day)
for the U.S. population, which exceeds the Benchmark MOE of 100.  A
cancer exposure analysis was not performed, since there is no evidence
of human carcinogenic potential for fludioxinil.  The short- and
intermediate term aggregate assessments resulted in MOEs of 2,301 and
1,771, respectively, for the U.S. population, both of which exceed the
Benchmark MOE of 100.  Based on the completeness and reliability of the
toxicity data supporting these petitions, Syngenta believes that there
is a reasonable certainty that no harm will result from aggregate
exposure from all current and proposed uses of fludioxinil.

>

<2. Infants and children. An acute toxicological endpoint has not been
established for infants and children, so an acute exposure assessment
was not performed for infants and children.  The chronic aggregate
exposure analysis showed that exposure from all established and proposed
fludioxinil uses resulted in a MOE of 605 (16.5% of the cRfD of 0.033
mg/kg-bw/day) for children 1-2 years old, which exceeds the Benchmark
MOE of 100.  A cancer exposure analysis was not performed, since there
is no evidence of human carcinogenic potential for fludioxinil.  The
short- and intermediate term aggregate assessments resulted in MOEs of
366 and 191, respectively, for children 1-2 years old, both of which
exceed the Benchmark MOE of 100.  Based on the completeness and
reliability of the toxicity data supporting these petitions, Syngenta
believes that there is a reasonable certainty that no harm will result
from aggregate exposure from all current and proposed uses of
fludioxinil.

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sis was not performed, since there is no evidence of human carcinogenic
potential for fludioxinil.  The short- and intermediate term aggregate
assessments resulted in MOEs of 3,108 and 2,260, respectively, for
females 13-49 years old, both of which exceed the Benchmark MOE of 100.
Based on the completeness and reliability of the toxicity data
supporting these petitions, Syngenta believes that there is a reasonable
certainty that no harm will result from aggregate exposure from all
current and proposed uses of fludioxinil.

>

<F. International Tolerances>

	There are no Codex maximum residue levels established for fludioxonil.

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