2017-02760. Proposed Data Collection Submitted for Public Comment and Recommendations

AGENCY:

Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS).

ACTION:

Notice with comment period.

SUMMARY:

Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled “Characterization of Exposure Potential during Activities Conducted on Synthetic Turf with Crumb Rubber Infill.” The purpose of the proposed study is to evaluate and characterize human exposure potential to constituents in crumb rubber infill.

DATES:

Written comments must be received on or before April 11, 2017.

ADDRESSES:

You may submit comments, identified by Docket No. ATSDR-2017-0002 by any of the following methods:

• Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.
• Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

Please note: All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

Proposed Project

Characterization of Exposure Potential during Activities Conducted on Synthetic Turf with Crumb Rubber Infill—New—Agency for Toxic Substances and Disease Registry (ATSDR).

Background and Brief Description

Currently in the United States, there are more than 12,000 synthetic turf fields in use. While the Synthetic Turf Council has set guidelines for the content of crumb rubber used as infill in synthetic turf fields, manufacturing processes result in differences among types of crumb rubber. Additionally, the chemical composition may vary highly between different processes and source materials and may vary even within granules from the same origin.

In July, 2016, the Agency for Toxic Substances and Disease Registry (ATSDR) and the United States Environmental Protection Agency (USEPA) were granted an emergency Paperwork Reduction Act (PRA) clearance for a research study titled “Collections Related to Synthetic Turf Fields with Crumb Rubber Infill” (OMB Control No. 0923-0054, expiration date 01/31/2017). The research goals for the three activities in the protocol are pilot-level investigations to evaluate and characterize: (1) The chemical composition and use of crumb rubber infill in synthetic turf using a convenience sample of nine tire recycling manufacturing plants and 40 facilities that use synthetic turf fields (Activity 1); (2) the human exposure potential to constituents in crumb rubber infill among a convenience sample of 60 field users (Activity 2); and (3) collection of biological specimens (blood and urine) from 45 participants from Activity 2 (Activity 3).

By December, 2016, ATSDR and USEPA completed Activity 1 which was aimed at characterizing the chemical composition and use of synthetic turf fields with tire crumb rubber infill. The agencies successfully consented and sampled 40 synthetic turf fields with crumb rubber infill across the United States. The activities are reported in the “Status Report on the Federal Research Action Plan on Recycled Tire Crumb Used on Playing Fields and Playgrounds.” The Status Report was released on December 30, 2016.

During Activity 1, ATSDR and USEPA obtained permission to return to participating fields to complete the human exposure characterization. Due to the limited time constraints and field activity schedules, ATSDR and USEPA chose to begin Activity 2 data collection and Activity 3 specimen collection in 2017.

The agencies are requesting a new information collection request (ICR) for a two-year OMB clearance to complete Activity 2 and Activity 3, now subtitled “Characterization of Exposure Potential during Activities Conducted on Synthetic Turf with Crumb Rubber Infill.” This will be the first assessment of activities conducted on synthetic turf for the purpose of characterizing potential exposure patterns. The study will include persons who use synthetic turf with crumb rubber infill (e.g., facility users) and who routinely perform activities that would result in a high level of contact to crumb rubber. This will allow for evaluation of potential high-end exposures to constituents in synthetic turf among this group of users. The respondents will be administered a detailed questionnaire on activity patterns on synthetic turf with crumb rubber infill. This instrument, along with extant videography of persons engaged in activities of interest (see below), will be used to characterize exposure scenarios, including the nature and duration of potential exposures.

Additionally, we will conduct an exposure characterization sub-study among a subset of the respondents. We will use a subset of the facilities sampled in the first study to conduct activities for the exposure characterization of facility users. The exposure characterization sub-study will include field environment sampling, personal air monitoring, dermal sampling, and urine and blood collection. Video data collection of facility user activities will be performed for a subset of respondents. It is likely that some of the collection items will not be analyzed in the current project time frame but will be archived for future analysis.

The research study will screen a total of 75 participants for eligibility. The sample size for the exposure characterization study is 60 respondents and 45 respondents for the exposure measurements sub-study. The total burden hours for the research study is 174 hours among all of the 75 respondents. There is no cost to the respondents other than their time in the study.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Adult/Adolescent Field Users	Eligibility Screening Script	41	1	5/60	4
	Adult and Adolescent Questionnaire	36	1	30/60	18
	Exposure Measurement Form	27	1	3	81
	Phlebotomist Safety Exclusion Questions Form	27	1	2/60	1
Parents/Guardians of Youth/Child Field Users	Eligibility Screening Script	34	1	5/60	3
	Youth and Child Questionnaire	24	1	30/60	12
	Phlebotomist Safety Exclusion Questions Form	18	1	2/60	1
Youth/Child Field Users	Exposure Measurement Form	18	1	3	54
Total					174

Leroy A. Richardson,

Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.