20051116 40 Cfr Part 158 For Cpda Registration 201

Karen E. Warkentien Compliance Services International 1

40 CFR Part 158: Proposed Data Requirement Revisions

What Does the Future Hold What Does the Future Hold and Where Do We Go From and Where Do We Go From

Here?Here?


Points for Discussion History of Part 158 What Has Been Proposed? 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

Other Items of Note Comments Filed in Response to Proposed Rule Summary


History of Part 158 Data requirements were formerly included

in Part 162, Subpart A. Included data requirements as well as testing

guidance, protocols, and the like. The subpart became too unwieldy as more and

more test guidance was codified. Current Part 158 was proposed in

November 1982 and finalized in October 1984. Sought to present a concise listing of data

requirements while removing the actual test guidance from the Code.

It has remained virtually unchanged ever since.


What Has Been Proposed? Sweeping reorganization of Part 158

Orders Part 158 into many subparts that generally correspond to the old Pesticide Assessment Guidelines Subdivisions.

Creates separate subparts for antimicrobials, biochemicals, microbials, and inert ingredients.

Reflects changes made to testing guidance documents New OPPTS harmonized guidelines are now

referenced. Includes guidelines that were never included in

Part 158 (e.g., worker exposure).


What Has Been Proposed?

“Codification of existing practice” EPA’s position is that the proposed rule

merely codifies what EPA is currently requiring for registration.

Many in industry do not agree with this assessment.

New data confidentiality statements New FOIA data release procedures


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 Registrants (Continued)

Analytical Support Costs EPA’s Economic Analysis does not take these

costs into account. Analytical methods development and analysis of

samples can be very costly. Apportioning Costs

EPA cost apportionment of $420,000 per registrant per year appears flawed. Based on averaging additional costs per year across

an average of 120 registrants. Each registrant will not be sharing these costs

equally.


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 Proposes changes to PR Notice 86-5

statements. 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).


Other Items of Note Minor Use Section (§158.60) Proposed

for Deletion Additional Avian Oral Test on

Passerine Species (Redwing Blackbird) Proposed

EPA Soliciting Comments on Endangered Species Requirements

Toxicology Data Requirements and the ILSI Tiered Approach


Comments Filed in Response to Proposed Rule

Almost 100 comments received from Trade associations Individual companies Environmental organizations Private citizens

EPA must now review and address these comments.


Summary The Agency has done an admirable job

tackling this long overdue revision of Part 158.

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????).


Where to Find Information

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

20051116 40 Cfr Part 158 For Cpda Registration 201

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