20050503 40 Cfr Part 158 Proposed Rule Presentation

Karen E. Warkentien Compliance Services International 1

40 CFR Part 158Data Requirement Revisions

Long Overdue Codification of Existing Long Overdue Codification of Existing PracticePracticeOROR

Way More Than We Bargained ForWay More Than We Bargained For


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


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).


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.


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.


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)).


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).


Confidentiality Claim

Information claimed as confidential has been removed to a confidential attachment.


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.


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.


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).


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).


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.


Where to Find Information

EDOCKET Docket Control ID OPP-2004-0387 http://docket.epa.gov

20050503 40 Cfr Part 158 Proposed Rule Presentation

Documents

Transcript of 20050503 40 Cfr Part 158 Proposed Rule Presentation