Follow Slashdot blog updates by subscribing to our blog RSS feed

 



Forgot your password?
typodupeerror
Businesses Government United States Science Politics

EPA Proposes Limits To Science Used In Rulemaking (reuters.com) 314

An anonymous reader quotes a report from Reuters: The U.S. Environmental Protection Agency proposed a rule on Tuesday that would limit the kinds of scientific research it can use in crafting regulations, an apparent concession to big business that has long requested such restrictions. Under the new proposals, the EPA will no longer be able to rely on scientific research that is underpinned by confidential medical and industry data. The measure was billed by EPA Administrator Scott Pruitt as a way to boost transparency for the benefit of the industries his agency regulates. But scientists and former EPA officials worry it will hamstring the agency's ability to protect public health by putting key data off limits.

The EPA has for decades relied on scientific research that is rooted in confidential medical and industry data as a basis for its air, water and chemicals rules. While it publishes enormous amounts of research and data to the public, the confidential material is held back. Business interests have argued the practice is tantamount to writing laws behind closed doors and unfairly prevents them from vetting the research underpinning the EPA's often costly regulatory requirements. They argue that if the data cannot be published, the rules should not be adopted. But ex-EPA officials say the practice is vital.

This discussion has been archived. No new comments can be posted.

EPA Proposes Limits To Science Used In Rulemaking

Comments Filter:
  • by aepervius ( 535155 ) on Tuesday April 24, 2018 @11:39PM (#56498163)
    I mean I usually suspect the industry to want to hamstring the EPA, after all it forces them to take into account externalities, which they could otherwise ignore and cut corner. But what sort of research would be private and have an impact ? Before deciding either way I would need example. I am no friend of "trust us we were told that XYZ is bad for you" (The only counter example I can think of is military research, but I guess that would be exempt).
    • by Anonymous Coward on Tuesday April 24, 2018 @11:55PM (#56498189)

      Medical research.

      The participants in a medical study generally are protected from having their medical histories exposed to the world.

      I suppose one could argue that knowing someone is 37, a non-smoker, takes over-the-counter asprin, and has high-blood pressure might not be enough to expose who they are. But in more detailed tests knowing someone had cancer in a timeframe or making their DNA public definitely could be invasive.

      • by kenh ( 9056 )

        You're talking about HIPPA regulations - have you ever read the HIPPA regulations? Ever worked in a HIPPA regulated field?

        HIPPA regulations require that patient identity be protected - I used to work in the clinical drug trial industry and we used six-digit patient numbers and three letter initials to identify patients in our studies, and the client research companies protected the key that mapped the six-digit IDs and initials to the actual consent forms and other personally-identifiable documents.

        Take you

        • by Rhipf ( 525263 )

          But it that identity is kept confidential at all the study couldn't be used by the EPA if this proposed rule is passed.

          the EPA will no longer be able to rely on scientific research that is underpinned by confidential medical and industry data

          • But it that identity is kept confidential at all the study couldn't be used by the EPA if this proposed rule is passed.

            the EPA will no longer be able to rely on scientific research that is underpinned by confidential medical and industry data

            I've never seen a medical study based on a person's name or social security number.

      • Wrong agency. FDA does medical, not EPA. Way to toss in a specious bunch of crap.
    • by Anonymous Coward on Wednesday April 25, 2018 @12:11AM (#56498219)

      But what sort of research would be private and have an impact ?

      Here's some of what the Union for Concerned Scientists had to say about attempted GOP legislation that tried to do the same thing:

      Agencies such as the EPA don’t make all this information publicly available for a number of very good reasons. Protecting individuals’ privacy is prime among them. For example, we’re all aware of the laws that protect the privacy of our medical records. The Secret Science bill appears to require the EPA to release such confidential personal health information about the participants in scientific studies if it wants to use health studies to make regulatory decisions—a direct violation of health privacy law. The bill also fails to protect intellectual property rights, another reason data often cannot be publicly released.

      Further, the bill would not compel companies and others to make their relevant data publicly available to the agency.

      The upshot is, if this bill became law, the EPA would not be able to use public health data protected by confidentiality agreements to enact science-based regulations. The result? The EPA would not be able to carry out its mission of protecting public health and the environment.

      What’s Wrong with Expecting the EPA to Make All of Its Data Available—Isn’t Complete Transparency a Good Thing? [ucsusa.org]

      • by Anonymous Coward on Wednesday April 25, 2018 @12:17AM (#56498229)

        Excerpt from a letter signed by 1000 scientists urging Pruitt not to do this: [amazonaws.com]

        Proponents for these radical restrictions purport to raise two sets of concerns: reproducibility and
        transparency. In reality, these are phony issues that weaponize ‘transparency’ to facilitate political
        interference in science-based decisionmaking, rather than genuinely address either. The result will be
        policies and practices that will ignore significant risks to the health of every American.

        First, many public health studies cannot be replicated, as doing so would require intentionally and
        unethically exposing people and the environment to harmful contaminants or recreating one-time events
        (such as the Deepwater Horizon oil spill).

        Second, there are multiple valid reasons why requiring the release of all data does not improve scientific
        integrity and could actually compromise research, including intellectual property, proprietary, and
        privacy concerns. Further, EPA has historically been transparent in demonstrating the scientific basis of
        its decisions, so the public can hold the agency accountable to establish evidence-based safeguards; any
        changes should be made with the full consultation with and support of the scientific community.

        • by Anonymous Coward on Wednesday April 25, 2018 @08:21AM (#56499241)

          Proponents for these radical restrictions purport to raise two sets of concerns: reproducibility and
          transparency. In reality, these are phony issues that weaponize ‘transparency’ to facilitate political
          interference in science-based decisionmaking, rather than genuinely address either.

          It is the same as pretty much everything else with them.

          1. Establish the desired outcome. Eliminate abortions, get more republicans elected, more tax cuts for high earners, etc.
          2. Determine what paths get that outcome ignoring ethics entirely or to a great degree.
          3. If necessary come up with "reasons" why you had to take those actions.
          4. Take those actions.

          With abortions, you have such things as requiring a 6 foot wide hallway. There have been no rational basis for why that is required beyond they wanted to shutdown more abortion clinics, but the stated reason was for the health of the people involved. In other words, they lied.

          In voting, you have protecting against fake voting as the stated reason. In practice their voting role purges, voter id requirements, etc, etc raise barriers to voting that tend to favour their side. In short, they lied again.

          With this you have the stated reason of protecting us from non verified info and such, but the outcome of gutting more of the EPA and making the planet dirtier. In short, they lied again.

          They elected someone known for lying and have established a pattern of lying continuously to get their way. None of this is new..

          Hell Trump just called the leader of North Korea "Very Honourable."

          Truth means nothing to these people. Only outcomes matter. It is all a means to the end.

        • Re: "Proponents for these radical restrictions purport to raise two sets of concerns: reproducibility and transparency. In reality, these are phony issues that weaponize ‘transparency’ to facilitate political interference in science-based decisionmaking, rather than genuinely address either."

          Centralized "big science" communities more likely generate non-replicable results [arxiv.org]

          "Abstract: Growing concern that most published results, including those widely agreed upon, may be false are rarely examin

          • I hear you and agree, but I doubt very much that you'll get any traction on /. with this observation, in spite of the fact that it actually has its own wikipedia page:

            https://en.wikipedia.org/wiki/... [wikipedia.org]

            Note that this is a crisis already in the realm of openly published research results and conclusions. There isn't any good reason to think that the numbers cited in the Nature study are going to be any smaller for studies conducted by parties with even stronger (monetary or sociopolitical) vested interests, wh

      • I was thinking of the result, but if the bill also require patient confidentiality to be broken then it is definitively intentional shenanigan from the industry parts. The points taken up by the UCS are very valid.
        • It's not necessarily shenanigan's even then, just a conflict of rules and goals, a very common thing in governing. It is actually quite rare when pushing one principle does not force compromises in others. Something always has to give. Here the conflict seems to be between making the rule making process transparent verses the privacy of the individuals in the studies. Both a things to strive for, but they are directly at odds here.
          • For an obscure law or regulation, sure, I'm willing to cut some slack. Patient confidentiality is a known entity, however. It's one of the most sacrosanct laws we have, imo. To claim it is unintentional to have these two potential laws at odds is... nonsense. Lawmakers are on a long trend of trying to use the law as a weapon instead of shield, especially when it comes to political hot buttons like EPA and abortion. Don't be naive.
            • So right and that is something just as much on the left as on the right. However, that doesn't mean any given policy when evaluated on it's own merits should be opposed simply because it comes from the side of the isle you don't stand on. To me if your data-sets aren't available for peer review, then basically no on can tell if you actually did science or just cooked the books and applied a convenient method. I don't see where 'confidentiality' should be a problem. It is easy enough to clean data and d

              • If the concern is that confidential health information needs to become public in order to confirm studies under this bill is accurate, then it's a law written in bad faith. That's the point. If you can reproduce findings in a study without the part of a record that ties an identity to the relevant medical data then there is no issue with the scientific method.

                Now, maybe, that's not what this bill is attempting to do, but I have yet to read anything on this that doesn't make me suspicious. And the histori

            • Patient confidentiality has little to do with the "confidential data" referred to. They're referring to data that is kept from other researchers not for patient confidentiality, but for trade secret, fuck you I'm not sharing my research, etc. type bullshit. They may claim patient confidentiality as the reason, but it's trivial to anonymize data or allow an audit or even just give them all of the data as long as they say they'll protect it.

              Here's how you comply with HIPAA:

              1) Get the other party to say they

      • by tomhath ( 637240 )

        if this bill became law, the EPA would not be able to use public health data protected by confidentiality agreements

        Almost all public health data can be used once it's de-identified. There will be some examples where an unusual combination of timing and medical conditions would mean it has to be kept confidential, but that's the exception and the number of cases will be small.

    • But what sort of research would be private and have an impact ?

      Cancer clusters vs. HIPAA.

    • by Humbubba ( 2443838 ) on Wednesday April 25, 2018 @03:22AM (#56498577)
      A statement is not scientific if it can't conceivably be proven wrong empirically. Testability is why I trust science to be the basis for EPA regulations and environmental laws.

      But instead of relying on science, our political system lets companies write the laws and regulations that govern them. As a result, we get abominations like polluted water in Flint MI, West Virginia, and North Carolina.

      Before releasing something into the water supply, samples should be tested for contaminants. And if those samples don't make the grade, those responsible need to be held accountable. Making discharge safe typically involves diluting it to approved contaminant levels before releasing it into the water supply. Simple, really. There are labs that can and do test discharge samples for a plethora of contaminants, acidity, color, dissolved oxygen, turbidity, etc. But they don't test for everything that might be dangerous - prescription drugs for example. These sort of things need to be put right before they are put in our water. But it won't happen if science doesn't make the rules and regulators don't enforce those rules.

      Because science and technology can verifiably be used to clean up the environment, whereas politics demonstratively won't, I propose replacing Scott Pruitt with AI. If AI is good enough for the CIA, it's gotta be better for the environment than a corrupt political lackey.

      --

      http://www.pbs.org/independentlens/videos/what-lies-upstream/ [pbs.org]

    • This is about someone publishing a graph that looks like a hockey stick and proclaiming global warming is real, but refusing to publish the original data to support that claim.
    • Potentially, there's very little that is impacted when it comes to the ability of the EPA to make sound and rational regulation decisions. The main reason that scientists and researchers are complaining about the rule change is because it shoulders them with the cost of first deanonymizing medical data in order to be able to present it for consideration in EPA rulemaking. They were not previously required to do this in which case they present research which the government in turn kept secret and consequentl

      • The main reason that scientists and researchers are complaining about the rule change is because it shoulders them with the cost of first deanonymizing medical data in order to be able to present it for consideration in EPA rulemaking.

        So what you are saying is that before people were sharing de-anonymoized medical data with federal agencies? HOLY SHIT. Why are we not screaming to the skies about that, since government traditionally has the worst security, and no overbite as to what employees are doing

  • by Jeremi ( 14640 ) on Tuesday April 24, 2018 @11:41PM (#56498169) Homepage

    Because this is how you end up watering your crops with Brawndo.

  • by ediron2 ( 246908 ) on Wednesday April 25, 2018 @12:21AM (#56498235) Journal

    Is this end-to-unattributed data going to have a fat, juicy exception written for fracking compounds? Asking for my grandkids.

  • Do you want the Trump Administration to make new environmental rules based on secret science?

    • by bankman ( 136859 )

      Do you want the Trump Administration to make new environmental rules based on secret science?

      I don't want the Trump Administration to make any new environmental rules because they can be trusted to protect anything and anyone but the environment and the public.

    • Re: (Score:2, Insightful)

      It's OK, folks--Kohath's merely asking a question [rationalwiki.org].

  • by rsilvergun ( 571051 ) on Wednesday April 25, 2018 @12:32AM (#56498259)
    in his administration. No joke, he didn't invite the press...
  • by KidSock ( 150684 ) on Wednesday April 25, 2018 @12:37AM (#56498269)

    Sounds like they need to further develop their hypothesis, conduct trials to collect data, establish a control group, analyze the data and present their findings for peer review to determine precisely how much Science should be permitted at the EPA.

  • by hey! ( 33014 ) on Wednesday April 25, 2018 @12:39AM (#56498277) Homepage Journal

    The intent may be to hobble the use of public health data, but it will may also force pesticide companies to publish trade secrets in order to have their products registered for legal use. At present this data is treated as confidential by the EPA.

    This will not only affect new pesticides, it could also affect already registered pesticides, even if you grandfathered in the original registration. That's because a new registration number needs to be issued whenever the manufacturer changes any of the inert ingredients in the formulation, or even makes changes to the the production processes.

    • by whoever57 ( 658626 ) on Wednesday April 25, 2018 @01:39AM (#56498387) Journal

      but it will may also force pesticide companies to publish trade secrets in order to have their products registered for legal use. At present this data is treated as confidential by the EPA.

      Very funny!

      No. Your prediction is wrong. Approvals for pesticides are not "rulemaking".

      Here is a hint: if you think that a change that the administration is making isn't intended to benefit large companies, you are almost certainly wrong.

  • Skeptical Science (Score:5, Insightful)

    by AlanObject ( 3603453 ) on Wednesday April 25, 2018 @12:47AM (#56498293)

    I am skeptical of any Trump associate (or even any guy Trump likes) proclaiming they are trying to make a government agency more transparent. Remember this is the guy who insisted on a bug sweep of his government office and also installed an expensive privacy phone booth, and insists on a security detail greater than that of most 3rd world dictators. He gets favors like cheap rent from industry lobbyists and then tries to lie about it.

    And, for good measure, freely uses taxpayer money for luxury travel so lavish that even Trump has to notice.

    So spare me protestations that this member of the Trump clown show is going to make anything better at the EPA for anyone except his industry executive friends and that any criticism is just anti-Trump bias. For someone to have faith in him doing the right thing they would have to be delusional, ignorant, partisan or any combination.

    • Re: (Score:2, Insightful)

      by Opportunist ( 166417 )

      Why single out Trump, you really think there is a single politician left who isn't just interested in lining his own pockets and would harvest and sell your organs if he thought he'd get away with it?

      • Re:Skeptical Science (Score:5, Interesting)

        by AlanObject ( 3603453 ) on Wednesday April 25, 2018 @08:45AM (#56499329)

        Why single out Trump, you really think there is a single politician left who isn't just interested in lining his own pockets and would harvest and sell your organs if he thought he'd get away with it?

        #1: The article was about a a Trump appointee and crony.

        #2: There are many politicians and even more career bureaucrats who are community minded, idealistic, and work hard from the common good. I am not going to name names here because I don't want to get into a shitstorm of denials and misinformation.

        #3: I will, however, point out that every time I see a statement like this, I remember there is one woman who has been investigated pretty much constantly for over a quarter of a century by the most nasty and mean legislators and political operatives using over $100M of taxpayer money to do so. A media network including Fox News, all right wing radio, and several print publications are fully dedicated to to defaming her. There has been no such thing as a crackpot theory or accusation that was too extreme to investigate. After all this she has not been indicted or convicted of one single crime.

  • by Applehu Akbar ( 2968043 ) on Wednesday April 25, 2018 @01:02AM (#56498323)

    Environmental regulations should be strictly based on science, but it should be on published research with publicly available, peer reviewable data.

    • Re: (Score:2, Funny)

      by Anonymous Coward

      That's fine. Please release the results of your latest colonoscopy to the public domain so we can use it to help formulate public policy.

    • by bankman ( 136859 ) on Wednesday April 25, 2018 @02:01AM (#56498441) Homepage

      Environmental regulations should be strictly based on science, but it should be on published research with publicly available, peer reviewable data.

      Absolutely! I would in fact propose a law that requires any company that challenges EPA regulation based on this argument to open all their own books and research in the interest of transparency.
       

    • by mvdwege ( 243851 )

      What, exactly, is stopping these corps to cough up the dough themselves for this data and do their replication? Oh yes. Fucking greed.

  • Reproducibility? (Score:5, Insightful)

    by mveloso ( 325617 ) on Wednesday April 25, 2018 @01:06AM (#56498335)

    Without data and methods, the study can't be reproduced, so the conclusions can't be challenged.

    That's not science.

    Anonymize the data. That's what everyone else does. Or compel data from the entities in question. Compelling data is only a rule change away.

    • Re: (Score:2, Insightful)

      by omnichad ( 1198475 )

      Anonymize the data. That's what everyone else does.

      That's specifically what this rule is proposed to prevent. That constitutes the confidential data that is not being disclosed, and thereby the entire research is excluded from EPA consideration. And due to HIPAA and the unlikelihood that patients will all sign a release for their medical information, that's exactly what would happen.

      • by Anonymous Coward on Wednesday April 25, 2018 @01:47AM (#56498403)

        That's not what the rule says. It bans research which is underpinned by confidential data. Now, nobody ever releases _all_ data regarding a research, any research. The question is whether _relevant_ data is held back. We don't need to know personal identification for a medical research to have validity (see: current standards in medical research), ergo this data is not underpinning an anonymized research and it can be consulted under the new rule while being HIPAA compatible.

        • You seem to know a lot about the wording of this rule. Did you find a source for the full text? Until then, I remain very skeptical - as my interpretation lines up with the current administrations goals very well.

    • by mvdwege ( 243851 )

      Or, maybe, just let the corps negotiate for that data themselves for their counterstudies?

  • by Anonymous Coward on Wednesday April 25, 2018 @02:48AM (#56498505)

    Environmental Pollution Agency?

  • What's worse for human beings.. No Regulation -OR- Biased crappy enforcement of industry-friendly regulations that institutionalize the ability to rape the environment without regards to its effect on people? What Protection does the EPA actually provide? None to people.
    • The EPA enforces the Clean Water Act and the Clean Air Act. Both have been enormous successes, and have been a boon to communities and individuals throughout the nation. You might not think the huge reductions of smog in major cities, or rivers that can now be home to fish that feed wildlife, or toxic sites that have been cleaned up and repurposed don't benefit people. I strongly disagree, and I think you'll find most people do as well.
  • In other words... (Score:3, Insightful)

    by kenh ( 9056 ) on Wednesday April 25, 2018 @08:13AM (#56499203) Homepage Journal

    This change will require environmental regulation decisions to be based on publicly-available data, rather than secret datasets - and the problem is what, exactly? Critics of this rule change apparently are forcing themselves to pretend medical data can't be annonimized and made public...

    What is fascinating is that the critics are ignoring how this regulation would protect their interests of a business-favoring administration tried to ram thru a regulation rolling back a clean water regulation ("I have secret medical data that shows humans have an incredible tolerance for less in their drinking water, we we are rolling back safe water regulations").

  • by kenh ( 9056 ) on Wednesday April 25, 2018 @08:30AM (#56499271) Homepage Journal

    Under the new proposals, the EPA will no longer be able to rely on scientific research that is underpinned by confidential medical and industry data.

    So the EPA proposes that the science used to determine public policy and environmental regulations be held to the same rigorous standard as your average sixth-grade science fair submission, and critics attack the proposal because... decisions based on secret data is the only way to protect the environment?

    • Confidential medical data is a standard thing. Under this rule, all sorts of data that would be normally confidential (especially identifying information of patients or subjects in studies) would need to be public for it to be used. This cannot for a whole host of reasons occur.
      • by kenh ( 9056 )

        You seem to think there is some HIPPA requirement that prevents publishing medical data for research purposes - take a look here [hhs.gov]:

        The HIPAA Privacy Rule establishes the conditions under which protected health information may be used or disclosed by covered entities for research purposes. Research is defined in the Privacy Rule as, “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” See 45 CFR 164.501. A covered entity may always use or disclose for research purposes health information which has been de-identified (in accordance with 45 CFR 164.502(d), and 164.514(a)-(c) of the Rule)

        De-identifying health information is as simple as removing patient name, birth date, and any other non-medically relevant identifier before publishing the data.

        • by rhazz ( 2853871 )
          You seem to think that making the de-identified information public is enough to satisfy the new rules. Given all the scientists decrying this change, do you think they didn't consider this?
  • As long as Corporations have full transparency, I'm game. No hiding behind, trade secrets.
  • by kenh ( 9056 ) on Wednesday April 25, 2018 @09:17AM (#56499455) Homepage Journal

    The HIPAA Privacy Rule establishes the conditions under which protected health information may be used or disclosed by covered entities for research purposes. Research is defined in the Privacy Rule as, “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” See 45 CFR 164.501. A covered entity may always use or disclose for research purposes health information which has been de-identified (in accordance with 45 CFR 164.502(d), and 164.514(a)-(c) of the Rule)

    Source: Health Information Privacy [hhs.gov]

    Ignorance of the HIPPA regulations is fueling much of the backlash this proposed federal regulation change is attracting.

    Once the data is "de-identified" it can be published, and removing identifying elements is trivial.

  • "The EPA has for decades relied on scientific research that is rooted in confidential medical and industry data "

    Am I reading this incorrectly? To me this means the EPA is relying on data that is not publicly available for peer review. How can you even call it science if you data-sets are not available for peer review?

Q: How many IBM CPU's does it take to execute a job? A: Four; three to hold it down, and one to rip its head off.

Working...