From the actual document: >With this notice, EPA is soliciting public comment on a proposed regulation designed to provide a mechanism to increase access to do

From the actual document: >With this notice, EPA is soliciting public comment on a proposed regulation designed to provide a mechanism to increase access to dose response data and models underlying pivotal regulatory science in a manner consistent with statutory requirements for protection of privacy and confidentiality of research participants, protection of proprietary data and confidential business information, and other compelling interests. >The proposal takes comment on how to ensure that, over time, more of the data and models underlying the science that informs regulatory decisions (over and above the dose response data and models underlying “pivotal regulatory science”) is available to the public for validation [13] in a manner that honors legal and ethical obligations to reduce the risks of unauthorized disclosure and re-identification. >EPA believes that concerns about access to confidential or private information can, in many cases, be addressed through the application of solutions commonly in use across some parts of the Federal government.[16] Nothing in the proposed rule compels Start Printed Page 18771the disclosure of any confidential or private information in a manner that violates applicable legal and ethical protections. Other federal agencies have developed tools and methods to de-identify private information for a variety of disciplines.[17] The National Academies have noted that simple data masking, coding, and de-identification techniques have been developed over the last half century and that “Nothing in the past suggests that increasing access to research data without damage to privacy and confidentiality rights is beyond scientific reach.” [18] More recently, both the National Academies and the Bipartisan Commission on Evidence Based Policy [19] have discussed the challenges and opportunities for facilitating to secure access to confidential data for non-government analysts. >Considering the breadth of dose response data and models used in the development of significant EPA regulations, the requirements for availability may differ. These mechanisms may range from deposition in public data repositories, consistent with requirements for many scientific journals,[20] to, for certain types of information, controlled access in federal research data centers that facilitate secondary research use by the public.[21] EPA should collaborate with other federal agencies to identify strategies to protect confidential and private information in any circumstance in which it is making information publicly available. These strategies should be cost-effective and may also include: Requiring applications for access; restricting access to data for the purposes of replication, validation, and sensitivity evaluation; establishing physical controls on data storage; online training for researchers; and nondisclosure agreements.[22] https://www.federalregister.gov/documents/2018/04/30/2018-09078/strengthening-transparency-in-regulatory-science https://www.federalregister.gov/documents/2018/04/30/2018-09...