1. 40 CFR Part 158
Data Requirement Revisions
Long Overdue Codification of Existing
Practice
OR
Way More Than We Bargained For
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2. Points for Discussion
 Financial Implications
 Registrants
 EPA
 Confidentiality Statements
 New Statements
 Release for Work Sharing
 Supplemental Claims
 Changes in Release of Information Procedures under
FOIA
 Codifying “Nonexistent” Guidelines
 Guideline Series 835: Environmental Fate
 Guideline Series 850: Ecological Effects
 Comments Filed in Response to Proposed Rule
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3. Financial Implications
 Registrants
 Direct Study Costs
 EPA estimates that study costs will increase
$50 million annually (approximately
$420,000 per firm).
 Need to look at EPA cost estimates to see if
they approximate “real-world” costs we
actually incur (see Appendix A of EPA Economic
Analysis document).
 Need to look at EPA’s estimates on how often
such “new” data are required (see Appendix B
of EPA Economic Analysis document).
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4. Financial Implications
 Registrants (Continued)
 Study Monitoring Costs
 EPA’s Economic Analysis does not take
these costs into account.
 New requirements, like developmental
neurotoxicity and immunotoxicity testing, will
require substantial internal resources to
develop and monitor.
 Existing requirements already account for
substantial expenses in study monitoring.
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5. Financial Implications
 EPA
 Appendix C of the Economic Analysis document
attempts to quantify Agency and Contractor
review time expenses.
 Total estimated costs are approximately $2
million annually.
 Review times (in hours) may not be accurate
(may be too low).
 Actual costs per hour may be inaccurate (based
on a GS-13, step 5 salary).
 May impact on PRIA fees and review times.
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6. Confidentiality Claims
 EPA proposes to change the confidentiality
statements currently outlined in PR Notice
86-5.
 Still includes only two statements: one for
confidentiality and one for no claims of
confidentiality.
 Also includes an optional statement that can be
added to allow EPA to release information to
state and foreign governments for data sharing
activities.
 Does not make any mention of supplemental
claims of confidentiality (claims other than those
under FIFRA §10(d)(1)(A), (B), or (C)).
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7. No Claim of Confidentiality
 No claim of confidentiality, on any basis
whatsoever, is made for any information
contained in this document. I acknowledge
that information not designated as within
the scope of FIFRA §10(d)(1)(A), (B), or
(C) and which pertains to a registered or
previously registered pesticide is not
entitled to confidential treatment and may
be released to the public, subject to the
provisions regarding disclosure to
multinational entities under FIFRA §10(g).
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8. Confidentiality Claim
 Information claimed as confidential
has been removed to a confidential
attachment.
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9. Optional Authorization to Release
Information
 I authorize the Environmental
Protection Agency to release any
information contained in this
document to State or foreign
governments, without relinquishing
proprietary rights or any
confidentiality claims asserted above.
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10. Changes in Release of Information
Under FOIA (40 CFR Part 2)
 Any information submitted on or after 4
May 1988 that has not previously been
claimed confidential under FIFRA §10(d)
may be disclosed without further notice to
the submitter.
 Any information deemed not entitled to
confidential protection under FIFRA §10(b),
40 CFR §158.33, and 40 CFR Part 2,
Subpart B, may be released to the public
without the Affirmation of Non-Multinational
Status so long as it does not include the full
methodology and complete test results.
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11. Codifying “Non-Existent”
Guidelines
 Guideline Series 835: Environmental Fate
 Guidelines issued in “Public Comment Draft”
form in 1998.
 Only guidelines that have been made final are
TSCA-specific.
 Guidelines proposed for codification in the
proposed rule are not final and, technically, are
not being used
 Still following old Pesticide Assessment
Guidelines, Subdivision N, Guidance (series 160
guidelines).
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12. Codifying “Non-Existent”
Guidelines
 Guideline Series 850: Terrestrial and
Aquatic Nontarget Organisms
 Guidelines issued in “Public Comment
Draft” form in 1998.
 Guidelines proposed for codification in
the proposed rule are not final and,
technically, are not being used
 Still following old Pesticide Assessment
Guidelines, Subdivisions E and L, Guidance
(series 70 and 140 guidelines).
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13. Comments Filed in Response to
Proposed Rule
 Comment on the proposed rule!!!
 Review the proposed rule and all the ancillary
documents in the docket.
 These changes affect each and every registrant,
large and small, in very real ways (financial,
time, and human resources).
 This rule does much more than codify existing
practice; it expands the scope greatly.
 New paradigms are in the works and it is
counterproductive to put additional data
requirements in place when they may fall out of
favor in the near future (remember mesocosm
studies????).
 Comment period closes on 9 June 2005.
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14. Where to Find Information
 EDOCKET
 Docket Control ID OPP-2004-0387
 http://docket.epa.gov
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