Documents
Horner Memo to R.J. Reynolds
Feb. 5, 2017
From : Christopher Horne r
To: Hyde, Timothy N .; Tompson, Randy
CC:
BCC :
Subject : Federal Agency Science
Date : 12/23/1996 1 :56 :01 P M
Attachments :
Gentlemen : The following is the document we discussed . Have a happy
holiday. CC H
MEMORANDU M
TO : Mr. Tim Hyde
Mr . Randy Johnso n
RJ Reynolds Tobacco Company
FROM : Mr. Christopher C . Horner
Bracewell & Patterson, L .L.P.
DATE : December 23, 1996
RE : Background and Proposed Program to Address Federal
Agency Scienc e
Per our earlier conversations, the following sets forth what needs to be
done to reform agency science, focusing on the need based upon your
interests, and how you are positioned to take a behind the scene s
leadership position . It provides an overview of the issues relevant to this
goal, and details a program taking advantage of the increasingly flagrant
way regulators have perverted the scientific process, hiding behind a
wall of selected scientists to essentially cow industry and Congress into
accepting fringe scientific conclusions .
Summary
We propose creating, beginning with congressional oversight and a goal
of enacting legislation, required review procedures which EPA and other
federal agencies must follow in developing "extra-judicial" documents
(i .e ., those documents produced as guidance, science or other
government products issued by regulatory agencies which are not
necessarily at time of publication ripe for judicial review) . This is
important to your organization because, at some point in the near future,
EPA will most likely be ordered to re-examine ETS . The only way to d o
RJR7028305
70090 0686
http://legacy.library.ucsf.edu/tid/rzb77a00/pdf
Source: http://industrydocuments.library.ucsf.edu/tobacco/docs/jfww0019
From : Christopher Horne r
To: Hyde, Timothy N .; Tompson, Randy
CC:
BCC :
Subject : Federal Agency Science
Date : 12/23/1996 1 :56 :01 P M
Attachments :
Gentlemen : The following is the document we discussed . Have a happy
holiday. CC H
MEMORANDU M
TO : Mr. Tim Hyde
Mr . Randy Johnso n
RJ Reynolds Tobacco Company
FROM : Mr. Christopher C . Horner
Bracewell & Patterson, L .L.P.
DATE : December 23, 1996
RE : Background and Proposed Program to Address Federal
Agency Scienc e
Per our earlier conversations, the following sets forth what needs to be
done to reform agency science, focusing on the need based upon your
interests, and how you are positioned to take a behind the scene s
leadership position . It provides an overview of the issues relevant to this
goal, and details a program taking advantage of the increasingly flagrant
way regulators have perverted the scientific process, hiding behind a
wall of selected scientists to essentially cow industry and Congress into
accepting fringe scientific conclusions .
Summary
We propose creating, beginning with congressional oversight and a goal
of enacting legislation, required review procedures which EPA and other
federal agencies must follow in developing "extra-judicial" documents
(i .e ., those documents produced as guidance, science or other
government products issued by regulatory agencies which are not
necessarily at time of publication ripe for judicial review) . This is
important to your organization because, at some point in the near future,
EPA will most likely be ordered to re-examine ETS . The only way to d o
RJR7028305
70090 0686
http://legacy.library.ucsf.edu/tid/rzb77a00/pdf
Source: http://industrydocuments.library.ucsf.edu/tobacco/docs/jfww0019
so on a level playing field is to construct explicit procedural hurdles the
Agency must follow in issuing scientific reports .
Because there is virtually no chance of affecting change on this issue if
the focus is ETS, our approach is one of addressing process a s
opposed to scientific substance, and global applicability to industry rather
than focusing on any single industrial sector . Thus the examples of
questionable science, to justify these standards . Congress must require
those examples serve as the test cases .
Background
On the surface, now appears an opportune moment for addressing
agency science head on, tackling the substance . This would seem the
case because the first run at legislative attempts to reform the regulatory
process failed and concerned Members are searching for a new
mechanism to control EPA and other regulatory bodies . The landscape
of the past year is littered with examples of persistent o r
newly-promoted "bad science," including the Mercury Report t o
Congress, MACT Hazardous Waste Combustion Rule, Methylene Chloride
and the Dioxin Reassessment . Regarding the latter example, as you are
likely aware, for the next round of EPA Science Advisory Board (SAB)
review of the Dioxin Reassessment the Agency has removed any SAB
members who were too vocal in their disagreement with the Agency .
There will still be SAB review, but it will be an already-transparent grou p
of "agreeable" scientists . So, in addition EPA is flagrantly "stacking the
deck" with those whose conclusions are predetermined and in the
Agency's favor .
Irrespective of this pattern, it is clear the 104th Congress was singularly
unsuccessful in managing the Agency on a chemical-by-chemical or
industry-by-industry basis . EPA actions demonstrate the it has taken
measure of its legislative and industry adversaries, and decided upon
aggressive campaigns on several of these issues to impose its
policy-driven will upon scientific conclusions . The Agency helps create,
and responds, to, the political winds, so you should anticipate no relief
on re-evaluating ETS . EPA has of late played its public relations card
very well, avoiding long news cycles for its proposals -- even timing
them around holidays when readership is at its nadir -- while engaging
the environmental press for the coming conflicts . EPA, helped by the
backlash of the generally "pro-environment" public to a poorly
implemented reg-reform agenda, has fostered an atmosphere where
"industry" are reluctant to match the Agency's hardball tactics out of fear
either that Congress would duck/mismanage the issue, or of Agency
retribution . Thus, through a lack of industry support and unfavorable
press, Congress has to date lacked the requisite support to effectively
use the oversight powers of the legislative branch .
RJR7028305
70090 0687
http://legacy.library.ucsf.edu/tid/rzb77a00/pdf
Source: http://industrydocuments.library.ucsf.edu/tobacco/docs/jfww0019
so on a level playing field is to construct explicit procedural hurdles the
Agency must follow in issuing scientific reports .
Because there is virtually no chance of affecting change on this issue if
the focus is ETS, our approach is one of addressing process a s
opposed to scientific substance, and global applicability to industry rather
than focusing on any single industrial sector . Thus the examples of
questionable science, to justify these standards . Congress must require
those examples serve as the test cases .
Background
On the surface, now appears an opportune moment for addressing
agency science head on, tackling the substance . This would seem the
case because the first run at legislative attempts to reform the regulatory
process failed and concerned Members are searching for a new
mechanism to control EPA and other regulatory bodies . The landscape
of the past year is littered with examples of persistent o r
newly-promoted "bad science," including the Mercury Report t o
Congress, MACT Hazardous Waste Combustion Rule, Methylene Chloride
and the Dioxin Reassessment . Regarding the latter example, as you are
likely aware, for the next round of EPA Science Advisory Board (SAB)
review of the Dioxin Reassessment the Agency has removed any SAB
members who were too vocal in their disagreement with the Agency .
There will still be SAB review, but it will be an already-transparent grou p
of "agreeable" scientists . So, in addition EPA is flagrantly "stacking the
deck" with those whose conclusions are predetermined and in the
Agency's favor .
Irrespective of this pattern, it is clear the 104th Congress was singularly
unsuccessful in managing the Agency on a chemical-by-chemical or
industry-by-industry basis . EPA actions demonstrate the it has taken
measure of its legislative and industry adversaries, and decided upon
aggressive campaigns on several of these issues to impose its
policy-driven will upon scientific conclusions . The Agency helps create,
and responds, to, the political winds, so you should anticipate no relief
on re-evaluating ETS . EPA has of late played its public relations card
very well, avoiding long news cycles for its proposals -- even timing
them around holidays when readership is at its nadir -- while engaging
the environmental press for the coming conflicts . EPA, helped by the
backlash of the generally "pro-environment" public to a poorly
implemented reg-reform agenda, has fostered an atmosphere where
"industry" are reluctant to match the Agency's hardball tactics out of fear
either that Congress would duck/mismanage the issue, or of Agency
retribution . Thus, through a lack of industry support and unfavorable
press, Congress has to date lacked the requisite support to effectively
use the oversight powers of the legislative branch .
RJR7028305
70090 0687
http://legacy.library.ucsf.edu/tid/rzb77a00/pdf
Source: http://industrydocuments.library.ucsf.edu/tobacco/docs/jfww0019
It is in this climate you will face a chastened but at least as aggressive
EPA on re-evaluating the ETS study .
Project Approac h
To improve the climate, and process, under which ETS and others are
reviewed, we recommend initiating reforms by playing a strong role in
molding and guiding Congress's oversight of EPA's latest Clean Air Act
initiative (on PM 2 .5/ozone) . Such an effort would work toward requiring
EPA to institute certain procedural changes to the pre-regulatory
process . These would serve as a set of checks and balances to ensure
a fair and equitable development and publication of scientific findings
(i .e ., reform the scientific process) . It is that process, which is beyond
the reach of the Administrative Procedure Act, which sets the stage for
the rulemaking process . These procedures could then be subject to
judicial review without the courts becoming involved in specific scientific
issues (i.e ., discern if EPA followed the requisite steps, rather than if it
achieved the "right" answer) .
When EPA announced its proposal to regulate particulate matter and
tropospheric ozone, despite their news cycle management, the set the
predicate for procedural change . These proposed regulations, based on
questionable science, are not focused on those industries that comprise
EPA's "usual suspects", but rather all industries including small
businesses . Congress is expected to conduct heavy oversight of this
process, with most leaders expressing that the actions are unnecessary
and unrealistic . EPA has already signaled a desire to compromise as the
process moves forward, and will start airing its options in the January
14-15 initial public hearings . It is critical to our overall goal that EPA not be
allowed to change the forum into an industry-by-industry examination .
Equally important, the process should not devolve into "outdoor air"
interest seeking to shift the focus to "indoor air" interests . Instead, the
efforts we envision focus on the process by which EPA arrived at its
scientific conclusions, avoiding to the extent possible specific scientific
issues, contaminants, or industries .
While some will approach these hearings as regulation-specific, as you
can appreciate, from our perspective the greater problem is EPA (and
OSHA) "science," encompassing all the scientific reports, studies,
guidance documents and procedures produced by the nonregulatory
offices of these agencies . None of these products are subject to timely
challenge . In some instances, industry must wait years before
regulations are promulgated, thus allowing industry to sue . Then, when
industry has that opportunity, the court is faced with the ramifications of
overturning years of EPA actions and policies based on this scientific
document . Moreover, industry face mindsets such as "how can a
RJ R7028305
70090 0688
http://legacy.library.ucsf.edu/tid/rzb77a00/pdf
Source: http://industrydocuments.library.ucsf.edu/tobacco/docs/jfww0019
It is in this climate you will face a chastened but at least as aggressive
EPA on re-evaluating the ETS study .
Project Approac h
To improve the climate, and process, under which ETS and others are
reviewed, we recommend initiating reforms by playing a strong role in
molding and guiding Congress's oversight of EPA's latest Clean Air Act
initiative (on PM 2 .5/ozone) . Such an effort would work toward requiring
EPA to institute certain procedural changes to the pre-regulatory
process . These would serve as a set of checks and balances to ensure
a fair and equitable development and publication of scientific findings
(i .e ., reform the scientific process) . It is that process, which is beyond
the reach of the Administrative Procedure Act, which sets the stage for
the rulemaking process . These procedures could then be subject to
judicial review without the courts becoming involved in specific scientific
issues (i.e ., discern if EPA followed the requisite steps, rather than if it
achieved the "right" answer) .
When EPA announced its proposal to regulate particulate matter and
tropospheric ozone, despite their news cycle management, the set the
predicate for procedural change . These proposed regulations, based on
questionable science, are not focused on those industries that comprise
EPA's "usual suspects", but rather all industries including small
businesses . Congress is expected to conduct heavy oversight of this
process, with most leaders expressing that the actions are unnecessary
and unrealistic . EPA has already signaled a desire to compromise as the
process moves forward, and will start airing its options in the January
14-15 initial public hearings . It is critical to our overall goal that EPA not be
allowed to change the forum into an industry-by-industry examination .
Equally important, the process should not devolve into "outdoor air"
interest seeking to shift the focus to "indoor air" interests . Instead, the
efforts we envision focus on the process by which EPA arrived at its
scientific conclusions, avoiding to the extent possible specific scientific
issues, contaminants, or industries .
While some will approach these hearings as regulation-specific, as you
can appreciate, from our perspective the greater problem is EPA (and
OSHA) "science," encompassing all the scientific reports, studies,
guidance documents and procedures produced by the nonregulatory
offices of these agencies . None of these products are subject to timely
challenge . In some instances, industry must wait years before
regulations are promulgated, thus allowing industry to sue . Then, when
industry has that opportunity, the court is faced with the ramifications of
overturning years of EPA actions and policies based on this scientific
document . Moreover, industry face mindsets such as "how can a
RJ R7028305
70090 0688
http://legacy.library.ucsf.edu/tid/rzb77a00/pdf
Source: http://industrydocuments.library.ucsf.edu/tobacco/docs/jfww0019
document which has been around for so long be wrong?" (the "historical
credibility" argument) . Finally, once industry's hands are tied in
Washington, EPA or OSHA has distributed the documents or guidance to
the press or states, forcing industry to face a public relations nightmare .
Thus, as we seek to create a regime where this cycle is a thing of the
past while highlighting problems with contemporary studies . These
studies will be the first "test cases" for the reformed process . This
requires developing (1) overall criteria for a "sound science" process,
and (2) a record, through congressional oversight, on how the Agency
typically does not meet those criteria .
To illustrate, criteria could be as follows :
"Sound Science" Criteria - any government scientific program must have
four components :
Inclusive - The scientific community, the public, Congress, and
other Executive Branch agencies are given fair and timely access
to review and affect change in the development of the
science/document .
Transparency - the public can follow the developmental process
the steps followed to develop the final science/document .
Able to be reproduced - Can the answer be reproduced from the
record ?
Algorithm - Given the set of all available scientific knowledge on
the subject would independent groups arrive at the same answer ?
[a possible fifth component which could be included as a deal
closer could be :
Not judicially reviewable - This may seem counterintuitive, but one
of the aspects of reg-reform which its opponents exploited t o
bring it down was the belief that everything would be litigated . Thus,
it may be possible to achieve reforms through the principle that the
scientific portions of a successful program should not be easily placed
before the courts. Instead, the courts should be able to easily look at
procedures followed (e .g ., did the Agency follow its ow n
procedures) .]
We envision these new steps being "field tested" on, e .g., the methylene
chloride study, ETS, etc . which, having been used as justification for
reform would be held and reviewed under the new procedures .
To ensure Agency compliance Congressional oversight is also required .
This at worst builds a record for judicial review and at best sets i n
RJ R7028305
70090 0689
http://legacy.library.ucsf.edu/tid/rzb77a00/pdf
Source: http://industrydocuments.library.ucsf.edu/tobacco/docs/jfww0019
document which has been around for so long be wrong?" (the "historical
credibility" argument) . Finally, once industry's hands are tied in
Washington, EPA or OSHA has distributed the documents or guidance to
the press or states, forcing industry to face a public relations nightmare .
Thus, as we seek to create a regime where this cycle is a thing of the
past while highlighting problems with contemporary studies . These
studies will be the first "test cases" for the reformed process . This
requires developing (1) overall criteria for a "sound science" process,
and (2) a record, through congressional oversight, on how the Agency
typically does not meet those criteria .
To illustrate, criteria could be as follows :
"Sound Science" Criteria - any government scientific program must have
four components :
Inclusive - The scientific community, the public, Congress, and
other Executive Branch agencies are given fair and timely access
to review and affect change in the development of the
science/document .
Transparency - the public can follow the developmental process
the steps followed to develop the final science/document .
Able to be reproduced - Can the answer be reproduced from the
record ?
Algorithm - Given the set of all available scientific knowledge on
the subject would independent groups arrive at the same answer ?
[a possible fifth component which could be included as a deal
closer could be :
Not judicially reviewable - This may seem counterintuitive, but one
of the aspects of reg-reform which its opponents exploited t o
bring it down was the belief that everything would be litigated . Thus,
it may be possible to achieve reforms through the principle that the
scientific portions of a successful program should not be easily placed
before the courts. Instead, the courts should be able to easily look at
procedures followed (e .g ., did the Agency follow its ow n
procedures) .]
We envision these new steps being "field tested" on, e .g., the methylene
chloride study, ETS, etc . which, having been used as justification for
reform would be held and reviewed under the new procedures .
To ensure Agency compliance Congressional oversight is also required .
This at worst builds a record for judicial review and at best sets i n
RJ R7028305
70090 0689
http://legacy.library.ucsf.edu/tid/rzb77a00/pdf
Source: http://industrydocuments.library.ucsf.edu/tobacco/docs/jfww0019
motion a set of enforceable procedures . We intend to develop for the Hill
a set of scientific and procedural questions on scientific issues which
different committees could then use . This requires :
Written Record - Submit lengthy, detailed questions to the agency
requiring written responses . This creates a written record which
the Agency often seeks to avoid, because it otherwise is permitted to
develop scientific documents without responding explicitly (unlike the
proposal/promulgation process) to public concerns .
Followup Hearings - Once the Agency has responded use this
record both within and across an issue in oversight on how th e
Agency develops science . (e .g., this is an ideal place to inquire into risk
assessment default values and risk criteria, which seem to change from
office to office) .
We envision the end results of the oversight hearings to be : (1) EPA
publication in the Federal Register of a formal process for handling
"extra-judicial" documents ; (2) new legislation ; and/or (3) inclusion in
environmental or regulatory reform legislation which appears moving in
the 105th Congress .
This approach merely ensures a fair hearing, but that is typically all the
situations require to avoid the skewed result the federal agency
prescribes . Critically, this approach also circumvents the tenuous
situation you otherwise likely will face, of seeking after-the-fact,
RJR-specific congressional support to undo the Agency's work .
What makes the National Association of Manufacturers a strong base for
the above work is NAM's broad, yet non-specific, business base . Its one
of a small handful, at best, of broad based associations not associated
with particular industries . Thus, their lead on this general issue will not
bog the hearings down in "anti-environmental," industry-specific rhetoric,
nor create an environment where specific industries can legitimately fear
Agency retaliation .
Conclusio n
We envision a program, using contemporary studies and reports to
illustrate how the Agency skews its results in the pre-regulation stage,
to create set, reviewable science procedures . That process and its
criteria will first be tested on those current examples of Agency
misfeasance, which obviously must be sent back to the Agency or
otherwise placed on hold in the interim . We need to meet again with you
to discuss this proposal and how to best implement it, specifically
beginning with the audiences with NAM and NFIB we discussed . We
need another meeting, to hammer out the presentation to the two
RJR7028305
70090 0690
http://legacy.library.ucsf.edu/tid/rzb77a00/pdf
Source: http://industrydocuments.library.ucsf.edu/tobacco/docs/jfww0019
motion a set of enforceable procedures . We intend to develop for the Hill
a set of scientific and procedural questions on scientific issues which
different committees could then use . This requires :
Written Record - Submit lengthy, detailed questions to the agency
requiring written responses . This creates a written record which
the Agency often seeks to avoid, because it otherwise is permitted to
develop scientific documents without responding explicitly (unlike the
proposal/promulgation process) to public concerns .
Followup Hearings - Once the Agency has responded use this
record both within and across an issue in oversight on how th e
Agency develops science . (e .g., this is an ideal place to inquire into risk
assessment default values and risk criteria, which seem to change from
office to office) .
We envision the end results of the oversight hearings to be : (1) EPA
publication in the Federal Register of a formal process for handling
"extra-judicial" documents ; (2) new legislation ; and/or (3) inclusion in
environmental or regulatory reform legislation which appears moving in
the 105th Congress .
This approach merely ensures a fair hearing, but that is typically all the
situations require to avoid the skewed result the federal agency
prescribes . Critically, this approach also circumvents the tenuous
situation you otherwise likely will face, of seeking after-the-fact,
RJR-specific congressional support to undo the Agency's work .
What makes the National Association of Manufacturers a strong base for
the above work is NAM's broad, yet non-specific, business base . Its one
of a small handful, at best, of broad based associations not associated
with particular industries . Thus, their lead on this general issue will not
bog the hearings down in "anti-environmental," industry-specific rhetoric,
nor create an environment where specific industries can legitimately fear
Agency retaliation .
Conclusio n
We envision a program, using contemporary studies and reports to
illustrate how the Agency skews its results in the pre-regulation stage,
to create set, reviewable science procedures . That process and its
criteria will first be tested on those current examples of Agency
misfeasance, which obviously must be sent back to the Agency or
otherwise placed on hold in the interim . We need to meet again with you
to discuss this proposal and how to best implement it, specifically
beginning with the audiences with NAM and NFIB we discussed . We
need another meeting, to hammer out the presentation to the two
RJR7028305
70090 0690
http://legacy.library.ucsf.edu/tid/rzb77a00/pdf
Source: http://industrydocuments.library.ucsf.edu/tobacco/docs/jfww0019
referenced audiences, and reach consensus with you on the issues and
approach we intend to pursue . Until we speak with you on this further,
Happy Holidays .
CC H
/cc h
RJR7028305
70090 0691
http://legacy.library.ucsf.edu/tid/rzb77a00/pdf
Source: http://industrydocuments.library.ucsf.edu/tobacco/docs/jfww0019
referenced audiences, and reach consensus with you on the issues and
approach we intend to pursue . Until we speak with you on this further,
Happy Holidays .
CC H
/cc h
RJR7028305
70090 0691
http://legacy.library.ucsf.edu/tid/rzb77a00/pdf
Source: http://industrydocuments.library.ucsf.edu/tobacco/docs/jfww0019