Earlier this week, the Agency for Toxic Substances and Disease Registry (“ATSDR”) issued a notice – “Proposed Data Collection Submitted for Public Comment and Recommendations”.
The notice was published in the Federal Register on January 11, 2023 by Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention (the “Notice”).
ATSDR is asking the general public and other federal agencies to comment on a continuing information collection as required by the Paperwork Reduction Act . This notice requests comment on a proposed information collection project entitled “Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS): A Multi-Site Cross-Sectional Study (the Multi-Site Study)”. The goal of the research is to develop and deploy sound study methods to better determine if and how drinking water exposure to PFAS is related to health outcomes.
ATSDR is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected;
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and
5. Assess information collection costs.
Per the Notice, ATSDR seeks to cumulatively enroll approximately 9,100 participants (7,000 adults and 2,100 children and their parents) from communities exposed to PFAS-contaminated drinking water. In total, each recipient will attempt to meet a target recruitment of 1,000 adults and 300 children. Annualized estimates are 3,033 participants (2,333 adults and 700 children). Over the first three years of the five-year cooperative agreement program, the recipients have enrolled over 3,000 adults and over 300 children (as of 11/17/2022). The enrollment of children has been especially challenging during and following major closures and access to schools and other educational facilities due to the COVID-19 pandemic.
Further, according to the Notice, the main goal of the cross-sectional study is to evaluate associations between measured and reconstructed historic serum levels of PFAS including PFOA, PFOS, and PFHxS, and selected health outcomes. The health outcomes of interest to the ADSDR include lipids, renal function and kidney disease, thyroid hormones and disease, liver function and disease, glycemic parameters and diabetes, as well as immune response and function in both children and adults. In addition, the study has been designed to investigate PFAS differences in sex hormones and sexual maturation, vaccine response, and neurobehavioral outcomes in children. In adults, additional outcomes of interest by the ATSDR include cardiovascular disease, osteoarthritis and osteoporosis, endometriosis, and autoimmune disease.
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7118; Email: email@example.com
If interested in the full text of the Notice, please see attached: http://www.gpo.gov/fdsys/pkg/FR-2023-01-11/html/2023-00333.htm
Duane Morris has an active PFAS Team to help organizations and individuals plan, respond to, and execute on your PFAS issues and initiatives. We would be happy to discussion your concerns and objectives and how new rules, regulations and rulings might apply to you. For more information or if you have any questions about this post, please contact Lindsay Brown, Brad A. Molotsky, Alyson Walker Lotman, Alice Shanahan, Seth Cooley, Sharon Caffrey or the attorney in the firm with whom you in regular contact or the attorney in the firm with whom you are regularly in contact.