5 ms·

searching the page for the word "rule" hits 13 occurrences. The only real "meat" if you can call it that surrounding what that rule is was this: Next week (July

searching the page for the word "rule" hits 13 occurrences. The only real "meat" if you can call it that surrounding what that rule is was this: Next week (July 17), EPA will hold its only public hearing on the proposed rule called “Strengthening Transparency in Regulatory Science.” As far as I can see that's the only immediate information this article bothered to speak about the rule itself. Anybody see a summary on this rule to share with the crowd? Or did I miss something?

microcolonel 8y ago
It took me a while to find the actual document (which is actually about as much text as this article), which can be found at: https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-0001 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-0... Hope that helps.
mhneu 8y ago
From the article: EPA is proposing to eliminate consideration of scientific studies unless the raw study data are made publicly available — possibly including participants’ personal, confidential, and private information — data that may be subject to legal, ethical, and human subject research protections. This requirement would eliminate human health studies that use integral medical, lifestyle, and geographic data, as well as studies that include confidential business information, such as information from studies conducted by industry to demonstrate safety of a pesticide or other toxic chemical. It could also eliminate consideration of older studies for which data are no longer available or accessible, even if the data have been reanalyzed and the studies have been validated, replicated, reproduced, and undergone rigorous and independent peer review. Far from using the best available science for EPA decision-making, the proposal would severely limit the studies and scientific evidence the agency would use to fulfill is statutory mission to protect human health and the environment. This is not a new idea. It is the result of a decades-long campaign to undercut reliance on groundbreaking research...
- deleted 8y ago
  [deleted]
- refurb 8y ago
  Instead of quoting the article, how about we quote the actual proposed regulation? The proposed regulation provides that when EPA develops regulations, including regulations for which the public is likely to bear the cost of compliance, with regard to those scientific studies that are pivotal to the action being taken, EPA should ensure that the data underlying those are publicly available in a manner sufficient for independent validation.[1] Seem eminently reasonable to me. And seems aligned with the "open science" movement to me. And in terms of privacy... 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. Nothing in the proposed rule compels the disclosure of any confidential or private information in a manner that violates applicable legal and ethical protections. [1] 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...
  - Retric 8y ago
    Changing the rules after the fact is generally a terrible idea. Suppose zero studies that satisfy that criteria study lead. Should the EPA suddenly say lead must be safe in any concentration?
    - refurb 8y ago
      These standards are no different than any reputable scientific journal. Try and publish a paper in Nature and tell them “I can’t share the data”.
    - smsm42 8y ago
      Why would there be zero studies that study lead and have source data? What happened to those that studied lead - did they destroy their data for some reason? Are the data about lead somehow unique so that, unlike any other data, they can't be published? Did some weird catastrophe occur which erased all data regarding to lead studies, and nobody knows about it? What would be the reason that basic scientific norms would not be preserved in this case? I guess if it happened, we'd need to conduct new studies - and find people who screwed up the old ones and make sure they are not responsible for any new studies ever again, to avoid future screwups.
- swebs 8y ago
  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...
- nine_k 8y ago
  It sounds as if the requirement is to make the data available for anyone to reproduce the analysis. It's not a bad goal, though making data public is always a bit tricky when data collected from human beings is involved.
- smsm42 8y ago
  It's fascinating. EPA says "we won't consider your research unless it's done in open and reproducible fashion so that other people can verify your results and reproduce the conclusions" and people hear "we hate science and want to undercut research". Amazing.
throwawayjava 8y ago
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... The proposed regulation provides that, for the science pivotal to its significant regulatory actions, EPA will ensure that the data and models underlying the science is publicly available The public availability requirement sounds nice on paper, but in practice, it means ignoring a lot of science during rule-making because the original data can't be published due to genuine privacy concerns. There are some common-sense workarounds. For example, requiring an EPA or third-party audit of the original dataset and analysis. Or simply carving out exceptions for research whenever it can be demonstrated that an IRB (and therefore federal law) would not have allowed the research without restricting public access to data/analysis.
- microcolonel 8y ago
  > The public availability requirement sounds nice on paper, but in practice, it means ignoring a lot of science during rule-making because the original data can't be published due to genuine privacy concerns. It is more limited if you read the whole sentence, which goes on to qualify which data they are interested in (specifically "publicly available in a manner sufficient for validation and analysis.").
  - throwawayjava 8y ago
    which de facto excludes 90% of medical research because medical patients have privacy rights and researchers have legal obligations to respect those rights. These rules are a hot political topic that are years in the making. The people pushing them are not scientists and have never expressed genuine interest in reproducibility outside of this one issue. And scientists who have spent years fighting for reproducibility have publicly stated they oppose this rule. And all the major proponents have strong anti-regulatory preferences. These rules are not about reproducibility. This rule is an intentionally crafted Catch-22 designed to exclude medical research from consideration so it's easier to justify repealing or not implementing environmental regulations. Otherwise, the rules would find a middle ground; e.g., by allowing the EPA access to relevant scientific data and analysis without risking https://en.wikipedia.org/wiki/De-anonymization https://en.wikipedia.org/wiki/De-anonymization by posting sensitive medical information about thousands of patients on the public internet.

microcolonel 8y ago

It took me a while to find the actual document (which is actually about as much text as this article), which can be found at: https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-0001 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-0... Hope that helps.

mhneu 8y ago

From the article: EPA is proposing to eliminate consideration of scientific studies unless the raw study data are made publicly available — possibly including participants’ personal, confidential, and private information — data that may be subject to legal, ethical, and human subject research protections. This requirement would eliminate human health studies that use integral medical, lifestyle, and geographic data, as well as studies that include confidential business information, such as information from studies conducted by industry to demonstrate safety of a pesticide or other toxic chemical. It could also eliminate consideration of older studies for which data are no longer available or accessible, even if the data have been reanalyzed and the studies have been validated, replicated, reproduced, and undergone rigorous and independent peer review. Far from using the best available science for EPA decision-making, the proposal would severely limit the studies and scientific evidence the agency would use to fulfill is statutory mission to protect human health and the environment. This is not a new idea. It is the result of a decades-long campaign to undercut reliance on groundbreaking research...

deleted 8y ago
[deleted]
refurb 8y ago
Instead of quoting the article, how about we quote the actual proposed regulation? The proposed regulation provides that when EPA develops regulations, including regulations for which the public is likely to bear the cost of compliance, with regard to those scientific studies that are pivotal to the action being taken, EPA should ensure that the data underlying those are publicly available in a manner sufficient for independent validation.[1] Seem eminently reasonable to me. And seems aligned with the "open science" movement to me. And in terms of privacy... 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. Nothing in the proposed rule compels the disclosure of any confidential or private information in a manner that violates applicable legal and ethical protections. [1] 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...
- Retric 8y ago
  Changing the rules after the fact is generally a terrible idea. Suppose zero studies that satisfy that criteria study lead. Should the EPA suddenly say lead must be safe in any concentration?
  - refurb 8y ago
    These standards are no different than any reputable scientific journal. Try and publish a paper in Nature and tell them “I can’t share the data”.
  - smsm42 8y ago
    Why would there be zero studies that study lead and have source data? What happened to those that studied lead - did they destroy their data for some reason? Are the data about lead somehow unique so that, unlike any other data, they can't be published? Did some weird catastrophe occur which erased all data regarding to lead studies, and nobody knows about it? What would be the reason that basic scientific norms would not be preserved in this case? I guess if it happened, we'd need to conduct new studies - and find people who screwed up the old ones and make sure they are not responsible for any new studies ever again, to avoid future screwups.
swebs 8y ago
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...
nine_k 8y ago
It sounds as if the requirement is to make the data available for anyone to reproduce the analysis. It's not a bad goal, though making data public is always a bit tricky when data collected from human beings is involved.
smsm42 8y ago
It's fascinating. EPA says "we won't consider your research unless it's done in open and reproducible fashion so that other people can verify your results and reproduce the conclusions" and people hear "we hate science and want to undercut research". Amazing.

throwawayjava 8y ago

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... The proposed regulation provides that, for the science pivotal to its significant regulatory actions, EPA will ensure that the data and models underlying the science is publicly available The public availability requirement sounds nice on paper, but in practice, it means ignoring a lot of science during rule-making because the original data can't be published due to genuine privacy concerns. There are some common-sense workarounds. For example, requiring an EPA or third-party audit of the original dataset and analysis. Or simply carving out exceptions for research whenever it can be demonstrated that an IRB (and therefore federal law) would not have allowed the research without restricting public access to data/analysis.

microcolonel 8y ago
> The public availability requirement sounds nice on paper, but in practice, it means ignoring a lot of science during rule-making because the original data can't be published due to genuine privacy concerns. It is more limited if you read the whole sentence, which goes on to qualify which data they are interested in (specifically "publicly available in a manner sufficient for validation and analysis.").
- throwawayjava 8y ago
  which de facto excludes 90% of medical research because medical patients have privacy rights and researchers have legal obligations to respect those rights. These rules are a hot political topic that are years in the making. The people pushing them are not scientists and have never expressed genuine interest in reproducibility outside of this one issue. And scientists who have spent years fighting for reproducibility have publicly stated they oppose this rule. And all the major proponents have strong anti-regulatory preferences. These rules are not about reproducibility. This rule is an intentionally crafted Catch-22 designed to exclude medical research from consideration so it's easier to justify repealing or not implementing environmental regulations. Otherwise, the rules would find a middle ground; e.g., by allowing the EPA access to relevant scientific data and analysis without risking https://en.wikipedia.org/wiki/De-anonymization https://en.wikipedia.org/wiki/De-anonymization by posting sensitive medical information about thousands of patients on the public internet.