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Comments on EPA’s Proposed 40 CFR Parts 152 and 156, Registration Requirements for Antimicrobial Pesticide Products

Date: Jan 21, 2000


Docket Control Number OPP-300890

Proposed 40 C.F.R. §152.447 -- Consulting with EPA

We oppose requiring consultation with EPA by rule. Current policiesand management practices within EPA's Antimicrobial Division make such meetings very counterproductive. Even if such policies and management practices are revised and beneficial consultations become possible, we see no practical advantage in codifying a requirement for consultation.

EPA's Antimicrobial Division (AD) is proposing to codify consultation with EPA and make it mandatory whenever an applicant intends to seek registration of a new active ingredient or major new use, or wishes to generate data using a new or modified protocol. AD has been requiring such meetings since the division wasformed, and, from the perspective of the applicant, the experience has generally been negative. It is valuable to examine what is done elsewhere in EPA's Office ofPesticide Programs (OPP) to determine what is missing in AD's proposal.

The practice is not new of meeting with EPA before preparing anapplication to register a new active ingredient and before initiating a study not covered by EPA regulations or guidelines. The practice has always been followed. It is informal, and it arose out of recognition that EPA's codified data requirements will always be approximations. EPA needs a myriad of complex data to determine if a new pesticide can be used safely. The codified data requirements were constructed only as a general guide to filling this need. Their design grew out of experience. They do not fit any pesticide exactly.

Years ago, EPA wisely recognized that no two pesticides are exactlyalike, and hence, as a practical matter, that the data required to register each newpesticide active ingredient or new use is always in some respect unique. Accordingly EPA built a flexibility into its data requirements that has served it well.
    • A majority of the codified data requirements, particularly requirements for expensive studies, were made conditional rather than mandatory;


    • Extensive footnotes were added to the data tables and text was added to testing guidelines explaining under what conditions each study was or was not required; and


    • EPA has in the past applied large measures of scientific judgement and regulatory discretion in making decisions regarding data requirements and protocols.

Because the process of defining data requirements has in the pastrelied heavily upon scientific judgement, pesticide registration applicants havetraditionally met with appropriate EPA managers and scientists at early stages in thegeneration of complex data packages, and before embarking on major non-routine studies. Such consultations with EPA are called preapplication conferences and can be characterized as open, non-adversarial exchanges of ideas, information and scientific thought. The meetings have traditionally been productive both for EPA and the applicant in that a consensus is reached on scientific and regulatory issues that need to be defined to proceed further. The applicant is then equipped to prepare an application that is focused, complete, and easy to review. Study protocols can be finely honed to address specialized EPA data needs. A small expenditure of effort produces winning results.

Shortly before each preapplication conference, the applicant generally provides EPA a briefing package. A few days after the meeting the applicant submits a letter to EPA summarizing the discussions. A couple of weeks after receiving thesummary letter, EPA generally provides in writing a confirmation letter, makingcorrections, if any, that seem appropriate. The entire process takes very little time and effort and is of great benefit both to EPA and the applicant.

In contrast, substantial lead time and extensive resources have beenrequired to schedule and prepare for such meetings with AD. The meetings themselves have not been open discussions for the purpose of reaching consensus. They generally have been lectures by AD, not dialogues. Even when the applicant provides an extensive briefing paper before the meeting and a written summary shortly after the meeting, AD takes six months to a year to respond back in writing, if it responds back at all. Rather than assisting in the preparation of an application or protocol, AD's required preapplication conferences delay the preparation of applications and cause confusion.

It has also been our experience to date that AD rarely concurs orprovides substantive written guidance when study protocols are the subject of theconsultation, thereby indefinitely delaying initiation of such studies.

A long period of uncertainty in terms of the data required forregistration is created by the AD's lack of responsiveness with regard to requiredconsultations. This period of uncertainty generally occurs at a critical point in thepreparation of an application, when efforts are being made to complete key protocols and testing programs. Furthermore, the act of meeting with AD to discuss data requirements creates the misleading expectation that AD's requirements are flexible and applied with scientific judgement, and that clear guidance is obtainable, when just the opposite is true.

It is AD's policy to apply data requirements across the boardequally to all products within a use category. AD has created a different and separate set of requirements (yet-to-be-proposed 40 C.F.R. Part 158, Subpart W) than the ones already codified and followed by the rest of OPP. AD's requirements have never been formally released nor proposed, but applicants must follow them. It is our experience that AD gives no consideration to individual differences between products in terms of chemical composition, method of application, toxicity or exposure. AD's data requirements seem intentionally designed and implemented without flexibility. In required consultations attended by the commentors, AD has contended that the requirements being imposed are mandated by the Food Quality Protection Act of 1996 (FQPA). It is our position that FQPA has in no way forced EPA to set aside the use of scientific judgement and regulatory discretion in defining data requirements.

It is both odd and damaging then for AD to propose mandatorypreapplication consultations when matters related to the design of applications orprotocols are considered by AD to be fixed by FQPA and its yet-to-be-proposed Part 158 regulations, rather than open for discussion.

It is obviously intentional that no mechanism is provided for makingadjustments in data requirements or study design -- a misplaced effort to improveefficiency. Applicants must knowingly follow ill-fitting requirements or AD returns theirapplications as incomplete. It is AD's firm policy that important scientific data andinformation showing a study is unnecessary, or that it needs modification, or that it isnot relevant, or that a different study is more appropriate, may not be considered during consultation with AD! In its written responses following preapplication conferences where scientific data and information have been provided, AD has repeatedly stated its policy that it will not consider such data or information unless it is contained in an application that is formally submitted and has been administratively determined by AD to be "complete", as defined by Subpart W. Gotcha! A perfect "Catch 22"!

FQPA Subtitle D -- Expedited Registration of Reduced Risk Pesticides

Discussion of FQPA Subtitle D requirements for expeditedregistration of reduced risk pesticides is conspicuously absent from EPA's preambleand from the proposed 40 CFR Part 152 sections establishing the review periods forapplications. In EPA's Pesticide Registration (PR) Notice 97-3, EPA has taken the position that antimicrobial pesticides are excluded from the requirements of Subtitle D. In private meetings with these commentors, EPA has expanded the exclusion to include any pesticides that are handled in AD, even those not falling within the Agency's definition of antimicrobial pesticide proposed as 40 C.F.R. § 152.3. It is also noteworthy that EPA's 40 C.F.R. § 152 proposal for implementation of the antimicrobial provisions of FQPA generously expands the scope of the new Subpart W to include many conventional pesticides, but without provisions for reduced risk treatment.

It is our position that all reduced risk pesticides handled by AD,including antimicrobial pesticides, qualify for expedited review under The Food QualityProtection Act of 1996 (FQPA), even though FQPA sets out a separate review time period reduction goal for antimicrobial pesticides. As a matter of law, EPA must provide for expedited review of all reduced risk pesticides -- NO EXCEPTIONS!

The sections of FQPA that are relevant to this issue are as follows:

(1) FQPA Section 221, DEFINITIONS, amends Section 2 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to define the term "antimicrobial pesticide" as follows:
(mm) ANTIMICROBIAL PESTICIDE-

(1) IN GENERAL - the term 'antimicrobial pesticide' means a pesticide that--
(A) is intended to--

(i) disinfect, sanitize, reduce, or mitigate growth or development of microbial organisms; or

(ii) protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and

(B) in the intended use is exempt from, or not otherwise subject to, a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a and 348) or a food additive regulation under section 409 of such Act.

(2) FQPA, Section 224, Registration Requirements For Antimicrobial Pesticides, amends FIFRA Section 3(h) to provide for the following evaluation process for antimicrobial pesticides:

(h) Registration Requirements For Antimicrobial Pesticides-

(1) Evaluation Process- To the maximum extent practicable consistent with the degrees of risk presented by an antimicrobial pesticide and the type of review appropriate to evaluate the risks, the Administrator shall identify and evaluate reforms to the antimicrobial registration process that would reduce review periods existing as of the date of enactment of this subsection for antimicrobial pesticide product registration applications and applications for amended registration of antimicrobial pesticide products, including--

(A) new active antimicrobial ingredients;
(B) new antimicrobial end-use products;
(C) substantially similar or identical antimicrobial pesticides; and
(D) amendments to antimicrobial pesticide registrations.

(2) Review Time Period Reduction Goal- Each reform identified under paragraph (1) shall be designated to achieve the goal of reducing the review period following submission of a complete application, consistent with the degree of risk, to a period of not more than--

(A) 540 days for a new antimicrobial active ingredient pesticide registration;

... .

(Emphasis added.)

(3) FQPA Section 250, Expedited Registration Of Pesticides, amends FIFRA Section 3(c)(10), as follows:

(10) Expedited Registration Of Pesticides-
        . . . .

(B) Any application for registration or an amendment, including biological and conventional pesticides, will be considered for expedited review under this paragraph. An application for registration or an amendment shall qualify for expedited review if use of the pesticide proposed by the application may reasonably be expected to accomplish 1 or more of the following:

(i) Reduce the risks of pesticides to human health.
(ii) Reduce the risks of the pesticides to nontarget organisms.
(iii) Reduce the potential for contamination of groundwater, surface water, or other valued environmental resources.
(iv) Broaden the adoption of integrated pest management strategies, or make such strategies more available or more effective.

(Emphasis added.)

PR Notice 97-3 and Interpretation of Relevant FQPA Sections

As indicated above, FQPA has amended FIFRA to adopt a definition of"antimicrobial pesticide" and a goal for expediting processing of antimicrobialpesticide registrations. In addition to these measures, FQPA requires that the review of reduced risk pesticide registrations must be expedited if the pesticides meet one of four listed criteria. Under FQPA, EPA is mandated to develop procedures and guidelines for expedited review of reduced risk pesticides within 1 year after enactment of FQPA (i.e.,by August 3, 1997).

EPA's Pesticide Registration (PR) Notice 97-3, published September4, 1997, provides guidelines for expedited review of reduced risk conventional pesticides and for biological pesticides. These guidelines supersede reduced risk criteria and guidelines for submissions for registration of reduced risk pesticides that were published in 1992 and 1993. The 1992 and 1993 guidelines were developed prior to the promulgation of FQPA as part of a Reduced-Risk effort to provide incentives for the development and registration of reduced risk pesticides. Under the reduced risk initiative, and prior to the passage of FQPA, the average total time for registration of reduced risk pesticides was 14 months. Since the passage of FQPA, at present the average time for registration of a reduced risk pesticide with a new active ingredient is still around 14 months C a period shorter than the time frame established for a new antimicrobial active ingredient registration (540 days).

PR Notice 97-3 states that, since the Agency is already expeditingreview of antimicrobial pesticides "pursuant to existing Agency programs, . . . it isnot necessary to include them in the review program established pursuant to FIFRA section 3(c)(10)." Thus, this PR Notice states that all types of applications forantimicrobial pesticides are outside its scope.

This exclusion of antimicrobial pesticides from the expeditedhandling required for reduced risk pesticides violates section 224 of FQPA.

There is no provision in FQPA that provides for the exclusion ofantimicrobial pesticides from expedited review as reduced risk pesticides. On thecontrary, as indicated above, FQPA Section 250 mandates expedited review of any application for a reduced risk pesticide, including, but not limited to, conventional pesticides and biological pesticides. Clearly, then, this provision applies to applications for reduced risk antimicrobial pesticides. If Congress had intended for the provision not to apply to certain types of pesticides, i.e., antimicrobial pesticides, then it would not have specifically stated that it applies to any application for a reduced risk pesticide. Likewise, if the provision were intended to apply only to what EPA now narrowly defines as "conventional" and biological pesticides, the provision would have been drafted specifically to limit expeditious treatment to, rather than specifically include, these types of pesticides.

Moreover, FQPA Section 224, while providing a maximum review timefor antimicrobial pesticides, makes clear that the review time should be reduced pursuant to FQPA consistent with the degrees of risk presented by an antimicrobial pesticide and the type of review appropriate to evaluate the risks. The precise language of this provision contemplates that certain antimicrobial pesticides will pose a lower degree of risk than others and, on this basis, should be reviewed on a more expedited basis.

It is clear that EPA reads this mandate quite differently. As partof its proposed Registration Requirements for Antimicrobial Pesticide Products and Other Pesticide Regulatory Changes, EPA makes quite explicit how little regard it has for the statutory mandate to expedite applications that pose reduced risk. 64 Fed. Reg. 50672 (Sept. 17, 1999). After properly quoting FIFRA section 3(h)(3)(A)(ii)(III) as requiring that EPA "conform the degree and type of review to the risks and benefits presented by antimicrobial pesticides and the function of review under this Act, considering the use patterns of the product, toxicity, expected exposure and product type," EPA asserts in its yet-to-be-released part 158 regulations, that the mandate is clearly implemented by defining use categories and data requirements that acknowledging that different use patterns have different exposures and risks. It explains that:

The data requirements for each use category are commensurate with the potential exposures and risks associated with that use pattern, and in some cases are tiered so that higher exposures or higher risks require a second level of data. The amount and types of data required in and of themselves dictate a review process that is more detailed, requiring a more complex assessment for these potentially higher exposures or higher toxicity. Therefore, in issuing part 158, EPA intends that the mandate to conform the degree and type of review to risks and benefits of use will be satisfied.

64 Fed. Reg. 50672, 50676. Noticeably absent from this discussion is any adjustment of data requirements for reduced risks that results from either or both reduction of exposure or reduced toxicity of the substance to which exposure occurs.

The mandate is clear; the reduced risk pesticide provisions must beinterpreted as written. EPA must expedite the review of applications forregistration of reduced risk antimicrobial pesticides notwithstanding the review goalsapplicable to all antimicrobial pesticides. When a legislative mandate is clear on itsface, it is inappropriate to refer to legislative history that might suggest somedifferent intent. Even if it were assumed that the mandate were ambiguous, however, the legislative history of FQPA, as summarized below, does not provide any support for the conclusion, or even a hint of support for the theory, that the above-cited provisions should be interpreted any differently from the precise way in which they are written.

Legislative History of FQPA

Relevant actions, for which published information is available, bythe House of Representatives and the Senate since May 12, 1995, the date of introduction of this legislation, are as follows:

 

(1) May 16, 1996, Hearing before the Subcommittee on Department Operations, Nutrition, and Foreign Agriculture of the Committee on Agriculture, House of Representatives (H. Hrg. 104-15);

 

(2) July 11, 1996, House Report No. 104-669 Part I (Agriculture Committee);

(3) July 17, 1996, Committee on Commerce , Subcommittee on Health and Environment, Notice of Action on H.R. 1627 (approval for Full Committee consideration by voice vote);

(4) July 23, 1996, House Report No. 104-669 Part II (Commerce Committee);

(5) July 23, 1996, House consideration and unanimous passage of H.R. 1627;

(6) July 24, 1996, Senate consideration and unanimous passage of H.R. 1627;

(7) July 25, 1997, Senate and House Enrolled Measures signed in;

(8) July 26, 1996, Presentation of Measure to President;

(9) President's signing statement (Public Law 104-170 signed August 3, 1996).

Upon careful review, none of the above-listed documents and have anyinformation that would support the conclusion that FQPA Section 250 setting forth therequirement for expedited review of reduced risk pesticides is intended to excludeantimicrobial pesticides.

The report of the May 16, 1996 Hearing before the Subcommittee onDepartment Operations, Nutrition, and Foreign Agriculture of the Committee on Agriculture, House of Representatives, discusses antimicrobials only in a few brief instances to support the reduction in review time for such pesticides. It does not mention the expedited review of reduced risk pesticides at all. The Hearing provides testimony almost entirely on the Delaney Clause issue. House Report No. 104-669, Parts I and II go through a section-by-section analysis of The Food Quality Protection Act of 1996. The discussions of Sections 221, 224, and 250 provide nothing more than a summary of the precise language of the sections. The Brief Explanation and Purpose and Need sections of this report simply indicate in one place that H.R. 1627 would amend FIFRA to provide for expedited registration procedures for antimicrobial pesticides, and in another that the bill wouldestablish an expedited review process for applications to register pesticides that areexpected to reduce pesticide risks. Nothing in any of these documents indicates that the two expedited review procedures must be mutually exclusive.

Having passed both the House and the Senate unanimously, there isessentially no record of a debate in either House, nor is there a Conference Committee Report for this bill. Virtually all the statements published in the Congressional Record are in support of the bill, and no statements go into any interpretation of the provisions of interest.

The Legislative History of the Senate versions, S. 1166 (FoodQuality Protection Act) and S. 1491 (Antimicrobial Pesticide Registration Reform Act of1995), which ultimately were incorporated into H.R. 1627, have also been reviewed and found to be lacking in any support for excluding antimicrobial pesticides from expedited review under FQPA, section 250. Specifically, hearings on S. 1166 and S. 1491 were held before the Committee on Agriculture, Nutrition, and Forestry, United States Senate, on June 12, 1996. The testimony from these hearings provides no indication that there ever was any intention to exclude applications for registration of antimicrobial pesticides from expedited review as reduced risk pesticides.

Because of the way the bills were drafted (i.e., a separatebill for antimicrobial pesticide registration reform), the issue of expedited review forantimicrobial pesticides is addressed in and of itself; there is no testimony on expedited review of reduced risk pesticides, per se. However, given that an entire bill was devoted to expediting review of antimicrobial pesticides, and that virtually every statement in the hearing testimony supports expedited review of these pesticides, it would be ludicrous to take the position that Congress intended for review of reduced risk antimicrobial pesticides to fall within a longer time frame for review than customarily required for reduced risk conventional pesticides and not to be entitled to any priority treatment over antimicrobial pesticides that did not qualify as reduced risk.

EPA's decision to exclude antimicrobial pesticides from PRNotice 97-3 can only be justified if, in fact, EPA could establish that all antimicrobialpesticides pose such uniform risks that it would be folly to try to discern differences.The data requirements that EPA has imposed for antimicrobials preclude any EPA attempt to argue that all antimicrobial pesticides are reduced risk. Indeed, EPA seems intent to impose more demanding data requirements on antimicrobials than are applicable to other pesticides, contrary to the legislative intent.

By its very name, reduced risk is a comparative property.Comparisons among antimicrobials are just as valid as among other pesticides. If something by its nature is a reduced risk pesticide chemical, what difference should it make what claims are made? The legislative mandate and intent are clear; EPA must implement a program for expedited review of reduced risk antimicrobial pesticides.

Proposed 152.3 -- Definitions: Antimicrobial pesticide, (ii) Afungicide for agricultural use.

We are very much opposed the extension of Subpart W to include abroad class of agricultural pesticides now regulated elsewhere in the Office of Pesticide Programs. In the section of the preamble to the proposed rule titled, "VI. What is an Antimicrobial Pesticide", EPA rationalizes this change by saying that:

&
FIFRA section 2(k) defines "fungus" broadly to include a variety of other microorganisms, including rust, smut, mildew, mold, yeast and bacteria, without specific reference to whether the microorganisms are pathogenic to plants or man and animals.

EPA intends the term "agricultural fungicide" to apply to all products applied in or on growing crops or to soil (i.e., pre-harvest application), regardless of the type of pest fungus. &

Under this interpretation, a product intended for post-harvest application against fungi (including bacteria) would not be an "agricultural fungicide". & All post-harvest use antimicrobial products would be subject to subpart W generally; however, not all would be "antimicrobial pesticides" eligible for the review periods in § 152.457.

EPA's interpretation is implemented in the definitions section of the proposedrule as follows:

(ii) A fungicide for agricultural use. A fungicide is considered to be for agricultural use if it is intended to be applied to soil or growing plants before harvest. A fungicide intended for post-harvest use is not considered to be for agricultural use. "Fungus," as defined in FIFRA, includes rust, smut, mildew, mold, yeast, and bacteria.

Such an expansion in the coverage of subpart W is unwarranted inthat the regulation of agricultural fungicides, most of which are used both before andafter harvest, is working smoothly under existing regulations and management. Suddenly transferring a portion of the jurisdiction over such products from the Registration Division and Biopesticides and Pollution Prevention Division to a different set of regulations, and presumably to management by the Antimicrobial Division, provides zero identifiable benefits to the public and has many drawbacks.

A broad class of important agricultural pesticides will suddenly beregulated under two distinctly different sets of data requirements by two differentdivisions. Each active ingredient will suddenly acquire a second product manager and be subject to two distinctly different sets of administrative procedures. Applicants wishing to add a new crop to their label will suddenly need to apply to different divisions for pre- and post-harvest uses. Presumably, also, separate tolerance petitions will be need for new pre- and post-harvest use. Paper data deficiencies will be created. Existing registrants will need to satisfy a new set of data requirements to maintain registration of both active ingredients and each end-use products, even if the active ingredients and all end-use products have already been reregistered. If reregistration is still underway, EPA and registrants will both suddenly find it inordinately complex to deal with dual jurisdiction and dual regulations governing data requirements, standards of review and labeling.

Congress clearly intended that antimicrobial reform, as specified inSubtitle B of FQPA, should simplify the antimicrobial regulatory process. Section 222 on Federal and state coordination provides that EPA should:

& coordinate data requirements, test protocols, timetables, and standards of review and reduce burdens and redundancy caused to the registrant by multiple requirements on the registrant.

It is unconscionable, then, that EPA should propose a change in the regulatory process that clearly will bring about the very outcome internally that Congress intended EPA to avoid in its external dealings, i.e., unnecessary redundancy and multiplicity of requirements!

Proposed 40 C.F.R. §152.458 -- Duration of registration, and §152.459-- Terms and Conditions of Registration

We are strongly opposed to Sections 152.458 and 152.459 in that EPApropose to provide itself unlimited authority to add conditions through registration and reregistration of pesticides for the purpose of cancellation without due process. EPA has no authority to propose regulations to remove the protections of due process contained in section 3(c)(6) and section 6 of FIFRA. There is no hint in FQPA, or its legislative history, that Congress intended EPA to have such authority.

EPA's current public health pesticide efficacy enforcementprogram is also accomplishing the objectives of the proposed "sunset provision"with much less burden.

Proposed 40 C.F.R. §152.455 -- Action on applications

FQPA imposes a strict statutory timeframe on the antimicrobialregistration process. In implementing these requirements, EPA has proposed certain reviews to determine completeness and procedures for computing time periods for registration for applications found to be incomplete. The proposed procedures are as described below.

Through a screening process, a preliminary determination can be madethat the application is administratively incomplete, i.e., in some respect thecontents of the application as defined in proposed §152.450 are administratively, nottechnically, unsatisfactory. In the preamble, EPA says the following about thisadministrative screening process:

EPA is likely to apply its completeness criteria very strictly, for several reasons. Strict application of completeness criteria appears to be consistent with the statutory direction to base enforceable deadlines on completeness determinations. Further, consistent treatment of applications is more likely if EPA established and adheres to relatively "bright line" criteria for completeness. & While refusing entry into review for a minor deficiency may appear inflexible, it is important to recognize that what is flexibility for one applicant may appear to be inconsistency or inequity to another.

If an application is found to be administratively incomplete, the applicant is notified and the time clock restarted from the beginning once the deficiency is cured.

Once an application is found to be administratively complete, it isplaced into "substantive Agency review", as EPA calls it in the preamble, whichmust be completed within the statutory timeframe. As studies and technical information in the application are reviewed, however, EPA may find other deficiencies not identified by the screen, for example, that a submitted study is unacceptable. In such a case, the time clock is stopped. In certain circumstances, if a "complete and timely" response is received from the applicant to cure the deficiency, the time clock for review may not be restarted from the beginning. A successful response to a technical deficiency is given the name "qualifying resubmission", and separate review periods are established for such resubmissions in §152.457(e).

If one could be certain that EPA would complete the preliminaryscreen in a reasonable time, say 30 days after submission of an application, EPA'sproposed approach, appears sensible. In practice, however, it does not work. Incommentors' experience, the preliminary screen is never completed expeditiously foran application with any complexity, i.e., an application to register a new activeingredient or new use. Rather, a majority of the statutory review period passes before EPA notifies the applicant of an administrative deficiency. Deficiencies are always found, and, in many instances, they are trivial, or matters of wording or presentation but not substance, and can be cured quickly. The identified deficiencies generally have no impact on the "substantive" review and yet EPA starts the time clock over from the beginning.

If EPA actually intends to complete its review of anything otherthan the simplest applications in the time allotted by the antimicrobial provisions inFQPA, the preliminary screen cannot consume most of the review time. It is horrendously unfair to make applicants start over after not hearing from EPA for 6 months to a year, while believing that substantive reviews are progressing without problems and nearing completion. It also makes one suspicious that administrative deficiencies are being invented simply to restart the clock when EPA fails to complete its substantive reviews within the allotted time.

It seems appropriate to propose that AD be required to complete thepreliminary screen within a suggested reasonable time period, say 30 days, as all other divisions in OPP do. Furthermore, we propose that credit be given for the time that passes beyond 30 days until notice is received of an administrative deficiency, if such a delay should occur. Such time credit should then be deducted from the statutory review period when the clock is restarted.

We would also like to comment that the "qualifyingresubmission" provisions proposed by EPA are of negligible value. Only thoseapplications that either contain no data to review (90 day review period) or only minimal data (120 day review period) are eligible under the proposed rule for classification as qualifying resubmissions. All applications likely to have technical deficiencies are excluded, specifically applications to register new uses (270 day review period) and new active ingredients (540 day review period).

We are not suggesting, however, that EPA make formal rules regardingthese more complex applications. Retaining flexibility within the review process, i.e., the option to think, is important.

Proposed 40 C.F.R. §156.441: Definitions: Equivalent

EPA discusses in the preamble and proposes in defining the term"equivalent," to require by rule that any test protocol or method for assessingproduct performance that deviates from EPA guidelines be validated by multiple laboratory studies. This requirement has already been informally implemented and is unquestionably onerous. It has already added unprecedented burdens and impenetrable roadblocks to the antimicrobial registration process.

In the normal operation of the pesticide regulatory process,EPA's health, safety and efficacy testing Guideline protocols are routinely amendedto fit the nature of the pesticide, the proposed uses and the anticipated exposures and risks. Special non-Guideline studies are frequently designed, completed and submitted to answer questions not addressed by the codified data requirements. As we commented earlier, in building its foundation "EPA wisely recognized that no two pesticides are exactly alike, and hence, as a practical matter, that the data required to register each new pesticide active ingredient or new use is in some respect always unique. Accordingly EPA built a flexibility into its data requirements that has served it well."

The requirement for validation removes all flexibility and the useof scientific judgement. EPA's pesticide regulatory program has a highly skilled andexperienced scientific staff that can readily judge the "equivalence" orvalidity of a test or study without needing to resort to multiple laboratory validation.Indeed, the reason for hiring highly skilled and experienced scientific staff is so thatsuch talent can be utilized. If EPA had always ignored the expertise of its staff toevaluate case by case customization of protocols to fit the demands of specificregistrations, few pesticides would ever have been registered and an effective regulatory process could never have been built. It can be observed even now that AD's informal imposition of the requirement has relegated many creative new products already in the pipeline to limbo, and that the flow of new applications to register innovative products for the protection of public health has practically stopped.