[Congressional Record (Bound Edition), Volume 153 (2007), Part 16]
[Senate]
[Pages 21624-21626]
[From the U.S. Government Publishing Office, www.gpo.gov]




            PRESTICIDE REGISTRATION IMPROVEMENT RENEWAL ACT

  Mr. HARKIN. Mr. President, I ask unanimous consent that the following 
chart be printed in the Record. It is a chart related to the Pesticide 
Registration Improvement Renewal Act, a bill that Senator Chambliss and 
I plan to introduce shortly.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

----------------------------------------------------------------------------------------------------------------
                                                                 Decision time (months), PRIA
                                                                              II:                 Registration
 EPA  No.   New  No.                    Action                  ------------------------------  Service  Fee ($)
                                                                   FY #1     FY #2     FY #3
----------------------------------------------------------------------------------------------------------------
                             TABLE 1.--REGISTRATION DIVISION--NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
R1                 1  Food use (\1\)...........................        24        24        24            516,300
R2                 2  Food use; reduced risk (\1\).............        18        18        18            516,300
R3                 3  Food use; Experimental Use Permit                24        24        24            570,700
                       application submitted simultaneously
                       with application for registration;
                       decision time for Experimental Use
                       Permit and temporary tolerance same as
                       #R4 (\1\).
R4                 4  Food use; Experimental Use Permit                18        18        18            380,500
                       application; establish temporary
                       tolerance; submitted before application
                       for registration; credit $326,025 toward
                       new active ingredient application that
                       follows.
R5                 5  Food use; application submitted after            14        14        14            190,300
                       Experimental Use Permit application;
                       decision time begins after Experimental
                       Use Permit and temporary tolerance are
                       granted (\1\).
R6                 6  Non-food use; outdoor (\1\)..............        21        21        21            358,700
R7                 7  Non-food use; outdoor; reduced risk (\1\)        16        16        16            358,700
R8                 8  Non-food use; outdoor; Experimental Use          21        21        21            396,800
                       Permit application submitted
                       simultaneously with application for
                       registration; decision time for
                       Experimental Use Permit same as #R9
                       (\1\).
R9                 9  Non-food use; outdoor; Experimental Use          16        16        16            266,300
                       Permit application submitted before
                       application for registration; credit
                       $228,225 toward new active ingredient
                       application that follows.
R10               10  Non-food use; outdoor; submitted after           12        12        12            130,500
                       Experimental Use Permit application;
                       decision time begins after Experimental
                       Use Permit is granted (\1\).
R11               11  Non-food use; indoor (\1\)...............        20        20        20            199,500
R12               12  Non-food use; indoor; reduced risk (\1\).        14        14        14            199,500
new               13  Non-food use; indoor; Experimental Use           18        18        18            150,000
                       Permit application submitted before
                       application for registration; credit
                       $100,000 toward new active ingredient
                       application that follows.
R36               14  Enriched isomer(s) of registered mixed-          18        18        18            260,900
                       isomer active ingredient (\1\).
new               15  Seed treatment only; includes non-food           18        18        18            388,200
                       and food uses; limited uptake into Raw
                       Agricultural Commodities (\1\).
new               16  Conditional Ruling on Preapplication              6         6         6              2,080
                       Study Waivers; applicant-initiated.
----------------------------------------------------------------------------------------------------------------
                                    TABLE 2.--REGISTRATION DIVISION--NEW USES
----------------------------------------------------------------------------------------------------------------
R13               17  First food use; indoor; food/food                21        21        21            157,500
                       handling (\1\).
R14               18  Additional food use; indoor; food/food           15        15        15             36,750
                       handling.
R15               19  First food use (\1\).....................        21        21        21            217,400
R16               20  First food use; reduced risk (\1\).......        16        16        16            217,400
R17               21  Additional food use......................        15        15        15             54,400
R18               22  Additional food use; reduced risk........        10        10        10             54,400
R19               23  Additional food uses; 6 or more submitted        15        15        15            326,400
                       in one application.
R20               24  Additional food uses; 6 or more submitted        10        10        10            326,400
                       in one application; reduced risk.
R21               25  Additional food use; Experimental Use            12        12        12             40,300
                       Permit application; establish temporary
                       tolerance; no credit toward new use
                       registration.
R22               26  Additional food use; Experimental Use             6         6         6             16,320
                       Permit application; crop destruct basis;
                       no credit toward new use registration.
R23               27  Additional use; non-food; outdoor........        15        15        15             21,740
R24               28  Additional use; non-food; outdoor;               10        10        10             21,740
                       reduced risk.
R25               29  Additional use; non-food; outdoor;                6         6         6             16,320
                       Experimental Use Permit application; no
                       credit toward new use registration.
R26               30  New use; non-food; indoor................        12        12        12             10,500
R27               31  New use; non-food; indoor; reduced risk..         9         9         9             10,500
new               32  New use; non-food; indoor; Experimental           6         6         6              8,000
                       Use Permit application; no credit toward
                       new use registration.
new               33  Review of Study Protocol; applicant-              3         3         3              2,080
                       initiated; excludes DART, pre-
                       registration conferences, Rapid Response
                       review, DNT protocol review, protocols
                       needing HSRB review.
new               34  Additional use; seed treatment; limited          12        12        12             41,500
                       uptake into Raw Agricultural
                       Commodities; includes crops with
                       established tolerances (e.g., for soil
                       or foliar application); includes food or
                       non-food uses.
new               35  Additional uses; seed treatment only; 6          12        12        12            249,000
                       or more submitted in one application;
                       limited uptake into Raw Agricultural
                       Commodities; includes crops with
                       established tolerances (e.g., for soil
                       or foliar application); includes food
                       and/or non-food uses.
----------------------------------------------------------------------------------------------------------------
                          TABLE 3.--REGISTRATION DIVISION--IMPORT AND OTHER TOLERANCES
----------------------------------------------------------------------------------------------------------------
R28               36  Establish import tolerance; new active           21        21        21            262,500
                       ingredient or first food use\1\.
R29               37  Establish import tolerance; additional           15        15        15             52,500
                       food use.
new               38  Establish import tolerances; additional          15        15        15            315,000
                       food uses; 6 or more crops submitted in
                       one petition.

[[Page 21625]]

 
new               39  Amend an established tolerance (e.g.,            10        10        10             37,300
                       decrease or increase); domestic or
                       import; applicant-initiated.
new               40  Establish tolerance(s) for inadvertent           12        12        12             44,000
                       residues in one crop; applicant-
                       initiated.
new               41  Establish tolerances for inadvertent             12        12        12            264,000
                       residues; 6 or more crops submitted in
                       one application; applicant-initiated.
new               42  Establish tolerance(s) for residues in           15        15        15             54,400
                       one rotational crop in response to a
                       specific rotational crop application;
                       applicant-initiated.
new               43  Establish tolerances for residues in             15        15        15            326,400
                       rotational crops in response to a
                       specific rotational crop petition; 6 or
                       more crops submitted in one application;
                       applicant-initiated.
----------------------------------------------------------------------------------------------------------------
                                  TABLE 4.--REGISTRATION DIVISION--NEW PRODUCTS
----------------------------------------------------------------------------------------------------------------
R30               44  New product; identical or substantially           3         3         3              1,300
                       similar in composition and use to a
                       registered product; no data review or
                       only product chemistry data; cite-all
                       data citation, or selective data
                       citation where applicant owns all
                       required data, or applicant submits
                       specific authorization letter from data
                       owner. Category also includes 100% re-
                       package of registered end-use or
                       manufacturing-use product that requires
                       no data submission nor data matrix..
new               45  New product; identical or substantially           4         4         4              1,560
                       similar in composition and use to a
                       registered product; registered source of
                       active ingredient; selective data
                       citation only for data on product
                       chemistry and/or acute toxicity and/or
                       public health pest efficacy, where
                       applicant does not own all required data
                       and does not have a specific
                       authorization letter from data owner..
R31               46  New end-use or manufacturing-use product;         6         6         6              4,360
                       requires review of data package within
                       RD; includes reviews and/or waivers of
                       data for only:.
                      product chemistry and/or acute toxicity
                       and/or public health pest efficacy.
R32               47  New product; new physical form; requires         12        12  ........             10,880
                       data review in science divisions.
R33               48  New manufacturing-use product; registered        12        12        12             16,320
                       active ingredient; selective data
                       citation.
new               49  New product; requires approval of new            12        12        12             15,540
                       food-use inert; applicant-initiated;
                       excludes approval of safeners.
new               50  New product; requires approval of new non-        6         6         6              8,300
                       food-use inert; applicant-initiated.
new               51  New product; requires amendment to               10        10        10             11,420
                       existing inert tolerance exemption
                       (e.g., adding post-harvest use);
                       applicant-initiated.
new               52  New product; repack of identical                  3         3         3              2,080
                       registered end-use product as a
                       manufacturing-use product; same
                       registered uses only.
new               53  New manufacturing-use product; registered        24        24        24            233,000
                       active ingredient; unregistered source
                       of active ingredient; submission of
                       completely new generic data package;
                       registered uses only.
----------------------------------------------------------------------------------------------------------------
                           TABLE 5.--REGISTRATION DIVISION--AMENDMENTS TO REGISTRATION
----------------------------------------------------------------------------------------------------------------
R34               54  Amendment requiring data review within RD         4         4         4              3,280
                       (e.g., changes to precautionary label
                       statements, or source changes to an
                       unregistered source of active
                       ingredient) \2\.
R35               55  Amendment requiring data review in                8         8         8             10,880
                       science divisions (e.g., changes to REI,
                       or PPE, or PHI, or use rate, or number
                       of applications; or add aerial
                       application; or modify GW/SW advisory
                       statement) \2\.
R37               56  Cancer reassessment; applicant-initiated.        18        18        18            163,100
new               57  Amendment to Experimental Use Permit;             6         6         6              8,300
                       requires data review/risk assessment.
new               58  Refined ecological and/or endangered             18        18        12            155,300
                       species assessment; applicant-initiated.
----------------------------------------------------------------------------------------------------------------
                            TABLE 6.--ANTIMICROBIALS DIVISION--NEW ACTIVE INGREDIENTS
----------------------------------------------------------------------------------------------------------------
A38               59  Food use; establish tolerance exemption          24        24        24             94,500
                       \1\.
A39               60   Food use; establish tolerance \1\.......        24        24        24            157,500
A40               61  Sec. 2(mm) uses \1\......................        18        18        18             78,750
A41               62  Non-food use; outdoor; uses other than           21        21        21            157,500
                       FIFRA Sec. 2(mm) \1\.
A42               63  Non-food use; indoor; FIFRA Sec. 2(mm)           18        18        18             52,500
                       uses (\1\).
A43               64  Non-food use; indoor; uses other than            20        20        20             78,750
                       FIFRA Sec. 2(mm) (\1\).
new               65  Non-food use; indoor; low-risk and low-          12        12        12             55,000
                       toxicity foodgrade active ingredient(s);
                       efficacy testing for public health
                       claims required under GLP and following
                       DIS/TSS or AD-approved study protocol.
----------------------------------------------------------------------------------------------------------------
                                   TABLE 7.--ANTIMICROBIALS DIVISION--NEW USES
----------------------------------------------------------------------------------------------------------------
A44               66  First food use; establish tolerance              21        21        21             26,250
                       exemption \1\.
A45               67  First food use; establish tolerance \1\..        21        21        21             78,750
A46               68  Additional food use; establish tolerance         15        15        15             10,500
                       exemption.
A47               69  Additional food use; establish tolerance.        15        15        15             26,250
A48               70  Additional use; non-food; outdoor; FIFRA          9         9         9             15,750
                       Sec. 2(mm) uses.
A49               71  Additional use; non-food; outdoor; uses          15        15        15             26,250
                       other than FIFRA Sec. 2(mm).
A50               72  Additional use; non-food; indoor; FIFRA           9         9         9             10,500
                       Sec. 2(mm) uses.
A51               73  Additional use; non-food; indoor; uses           12        12        12             10,500
                       other than FIFRA Sec. 2(mm).
A52               74  Experimental Use Permit application......         9         9         9              5,250
new               75  Review of public health efficacy study            6         4         3              2,000
                       protocol within AD; per AD Internal
                       Guidance for the Efficacy Protocol
                       Review Process; applicant-initiated;
                       Tier 1.
new               76  Review of public health efficacy study           18        15        12             10,000
                       protocol outside AD by members of AD
                       Efficacy Protocol Review Expert Panel;
                       applicant-initiated; Tier 2.
----------------------------------------------------------------------------------------------------------------
                          TABLE 8.--ANTIMICROBIALS DIVISION--NEW PRODUCTS & AMENDMENTS
----------------------------------------------------------------------------------------------------------------
A53               77  New product; identical or substantially           3         3         3              1,050
                       similar in composition and use to a
                       registered product; no data review or
                       only product chemistry data; cite-all
                       data citation, or selective data
                       citation where applicant owns all
                       required data, or applicant submits
                       specific authorization letter from data
                       owner. Category also includes 100% re-
                       package of registered end-use or
                       manufacturing-use product that requires
                       no data submission nor data matrix..
new               78  New product; identical or substantially           4         4         4              1,500
                       similar in composition and use to a
                       registered product; registered source of
                       active ingredient; selective data
                       citation only for data on product
                       chemistry and/or acute toxicity and/or
                       public health pest efficacy, where
                       applicant does not own all required data
                       and does not have a specific
                       authorization letter from data owner..
A54               79  New end use product; FIFRA Sec. 2(mm)             4         4         4              4,200
                       uses only.
A55               80  New end-use product; uses other than              6         6         6              4,200
                       FIFRA Sec. 2(mm); non-FQPA product.
A56               81  New manufacturing-use product; registered        12        12        12             15,750
                       active ingredient; selective data
                       citation.
A57               82  Label amendment requiring data submission         4         4         4              3,150
                       (2).
New               83  Cancer reassessment; applicant-initiated.        18        18        18             78,750
New               84  Refined ecological risk and/or endangered        18        18        12             75,000
                       species assessment; applicant-initiated.
New               85  New product; identical or substantially           4         4         4              4,200
                       similar in composition and use to a
                       registered product; registered active
                       ingredient; unregistered source of
                       active ingredient; cite-all data
                       citation except for product chemistry;
                       product chemistry data submitted.
----------------------------------------------------------------------------------------------------------------
  TABLE 9.--BIOPESTICIDE & POLLUTION PREVENTION DIVISION--MICROBIAL & BIOCHEMICAL PESTICIDES; NEW PRODUCTIONS &
                                                   AMENDMENTS
----------------------------------------------------------------------------------------------------------------
B58               86  New active ingredient; food use;                 18        18        18             42,000
                       establish tolerance\1\.
B59               87  New active ingredient; food use;                 16        16        16             26,250
                       establish tolerance exemption\1\.
B60               88  New active ingredient; non-food use\1\...        12        12        12             15,750
B61               89  Food use; Experimental Use Permit                 9         9         9             10,500
                       application; establish temporary
                       tolerance exemption.
B62               90  Non-food use; Experimental Use Permit             6         6         6              5,250
                       application.
new               91  Extend or amend Experimental Use Permit..         6         6         6              4,200
B63               92  First food use; establish tolerance              12        12        12             10,500
                       exemption.
new               93  Amend established tolerance exemption....         9         9         9             10,500
B64               94  First food use; establish tolerance(\1\).        18        18        18             15,750
new               95  Amend established tolerance (e.g.,               12        12        12             10,500
                       decrease or increase).
B65               96  New use; non-food........................         6         6         6              5,250
B66               97  New product; identical or substantially           3         3         3              1,050
                       similar in composition and use to a
                       registered product; no data review or
                       only product chemistry data; cite-all
                       data citation, or selective data
                       citation where applicant owns all
                       required data, or applicant submits
                       specific authorization letter from data
                       owner. Category also includes 100% re-
                       package of registered end-use or
                       manufacturing-use product that requires
                       no data submission nor data matrix.
B67               98  New product; registered source of active          6         6         6              4,200
                       ingredient; all Tier I data for product
                       chemistry, toxicology, non-target
                       organisms, and product performance must
                       be addressed with product specific data
                       or with request for data waivers
                       supported by scientific rationales.
new               99  New product; food use; unregistered              16        16        16             10,500
                       source of active ingredient; requires
                       amendment of established tolerance or
                       tolerance exemption; all Tier I data
                       requirements for product chemistry,
                       toxicology, nontarget organisms, and
                       product performance must be addressed
                       with product-specific data or with
                       request for data waivers supported by
                       scientific rationales.
new              100  New product; non-food use or food use            12        12        12              7,500
                       having established tolerance or
                       tolerance exemption; unregistered source
                       of active ingredient; no data
                       compensation issues; all Tier I data
                       requirements for product chemistry,
                       toxicology, non-target organisms, and
                       product performance must be addressed
                       with product-specific data or with
                       request for data waivers supported by
                       scientific rationales.
B68              101  Label amendment requiring data                    4         4         4              4,200
                       submission(\2\).
new              102  Label amendment; unregistered source of           6         6         6              5,000
                       active ingredient; supporting data
                       require scientific review.
new              103  Protocol review; applicant-initiated;             3         3         3              2,000
                       excludes time for HSRB review (pre
                       application).
----------------------------------------------------------------------------------------------------------------

[[Page 21626]]

 
     TABLE 10.--BIOPESTICIDE & POLLUTION PREVENTION DIVISION--STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES (SCLPs)
----------------------------------------------------------------------------------------------------------------
B69              104  New active ingredient; food or non-food           6         6         6              2,100
                       use (\1\).
B70              105  Experimental Use Permit application; new          6         6         6              1,050
                       active ingredient or new use.
new              106  Extend or amend Experimental Use Permit..         3         3         3              1,050
B71              107  New product; identical or substantially           3         3         3              1,050
                       similar in composition and use to a
                       registered product; no data review or
                       only product chemistry data; cite-all
                       data citation, or selective data
                       citation where applicant owns all
                       required data, or applicant submits
                       specific authorization letter from data
                       owner. Category also includes 100% re-
                       package of registered end-use or
                       manufacturing-use product that requires
                       no data submission nor data matrix..
B72              108  New product; registered source of active          4         4         4              1,050
                       ingredient; all Tier I data for product
                       chemistry, toxicology, non-target
                       organisms, and product performance must
                       be addressed with product specific data
                       or with request for data waivers
                       supported by scientific rationales.
new              109  New product; unregistered source of               6         6         6              2,200
                       active ingredient.
new              110  New use and/or amendment to tolerance or          6         6         6              2,200
                       tolerance exemption.
B73              111  Label amendment requiring data submission         4         4         4              1,050
                       (\2\).
----------------------------------------------------------------------------------------------------------------
         TABLE 11.--BIOPESTICIDE & POLLUTION PREVENTION DIVISION--PLANT INCORPORATED PROTECTANTS (PIPs)
----------------------------------------------------------------------------------------------------------------
B74              112  Experimental Use Permit application;              6         6         6             78,750
                       registered active ingredient; non-food/
                       feed or crop destruct basis; no SAP
                       review required (\3\).
B75              113  Experimental Use Permit application;              9         9         9            105,000
                       registered active ingredient; establish
                       temporary tolerance or tolerance
                       exemption; no SAP review required (\3\).
B76              114  Experimental Use Permit application; new         12        12        12            131,250
                       active ingredient; non-food/feed or crop
                       destruct basis; SAP review required;
                       credit $78,750 toward new active
                       ingredient application that follows.
new              115  Experimental Use Permit application; new          7         7         7             78,750
                       active ingredient; non-food/feed or crop
                       destruct; no SAP review required; credit
                       $78,750 toward new active ingredient
                       application that follows.
B77              116  Experimental Use Permit application; new         15        15        15            157,500
                       active ingredient; establish temporary
                       tolerance or tolerance exemption; SAP
                       review required; credit $105,000 toward
                       new active ingredient application that
                       follows.
new              117  Experimental Use Permit application; new         10        10        10            105,000
                       active ingredient; establish temporary
                       tolerance or tolerance exemption; no SAP
                       review required; credit $105,000 toward
                       new active ingredient application that
                       follows.
new              118  Amend or extend Experimental Use Permit;          3         3         3             10,500
                       minor changes to experimental design;
                       established temporary tolerance or
                       tolerance exemption is unaffected.
new              119  Amend or extend existing Experimental Use         5         5         5             26,250
                       Permit; minor changes to experimental
                       design; extend established temporary
                       tolerance or tolerance exemption.
B86              120  Amend Experimental Use Permit; first food         6         6         6             10,500
                       use or major revision of experimental
                       design.
B78              121  New active ingredient; non-food/feed; no         12        12        12            131,250
                       SAP review required(\4\).
B79              122  New active ingredient; Non-food/feed; SAP        18        18        18            183,750
                       review required(\4\).
B80              123  New active ingredient; establish                 12        12        12            210,000
                       permanent tolerance or tolerance
                       exemption based on temporary tolerance
                       or tolerance exemption; no SAP review
                       required(\4\).
B81              124  New active ingredient; establish                 18        18        18            262,500
                       permanent tolerance or tolerance
                       exemption based on temporary tolerance
                       or tolerance exemption; SAP review
                       required(\4\).
B82              125  New active ingredient; establish                 15        15        15            262,500
                       tolerance or tolerance exemption; no SAP
                       review required(\4\).
B84              126  New active ingredient; establish                 21        21        21            315,000
                       tolerance or tolerance exemption; SAP
                       review required(\4\).
B83              127  New active ingredient; Experimental Use          15        15        15            315,000
                       Permit application submitted
                       simultaneously; establish tolerance or
                       tolerance exemption; no SAP review
                       required(\4\).
B85              128  New active ingredient; Experimental Use          21        21        21            367,500
                       Permit requested simultaneously;
                       establish tolerance or tolerance
                       exemption; SAP review required(\4\).
new              129  New active ingredient; different genetic          9         9         9            105,000
                       event of a previously approved active
                       ingredient; same crop; no tolerance
                       action required; no SAP review required.
new              130  New active ingredient; different genetic          9         9         9            157,500
                       event of a previously approved active
                       ingredient; same crop; no tolerance
                       action required; SAP review required.
B87              131  New use(\3\).............................         9         9         9             31,500
B88              132  New product; no SAP review required(\5\).         9         9         9             26,250
new              133  New product; SAP review required(\5\)....        15        15        15            278,250
B89              134  Amendment; seed production to commercial          9         9         9             52,500
                       registration; no SAP review required.
new              135  Amendment; seed production to commercial         15        15        15            105,000
                       registration; SAP review required.
B90              136  Amendment (except #B89); No SAP review            6         6         6             10,500
                       required; (e.g., new IRM requirements
                       that are applicant initiated; or
                       amending a conditional registration to
                       extend the registration expiration date
                       with additional data submitted) (2).
new              137  Amendment (except #B89); SAP review              12        12        12             63,000
                       required (2).
new              138  PIP Protocol review......................         3         3         3              5,250
new              139  Inert ingredient tolerance exemption;             6         6         6             52,500
                       e.g., a marker such as NPT II; reviewed
                       in BPPD.
new              140  Import tolerance or tolerance exemption;          9         9         9           105,000
                       processed commodities/food only.
----------------------------------------------------------------------------------------------------------------
\1\All uses (food and/or non-food) included in any original application or petition for a new active ingredient
  or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for
  that application.
\2\EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials
  Division are to be completed within the FIFRA stated timelines listed in Section 3(h) and are not subject to
  PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95-2 and PR Notice
  98-10, continue under PR Notice timelines and are not subject to PRIA fees.
\3\Example: Transfer existing PIP trait by traditional breeding, such as from field corn to sweet corn.
\4\May be either a registration for seed increase or a full commercial registration. If a seed increase
  registration is granted first, full commercial registration is obtained using B89 or New 134.
\5\Example: Stacking PIP traits within a crop using traditional breeding techniques.




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