S. 3552 (112th): Pesticide Registration Improvement Extension Act of 2012
112th Congress, 2011–2013. Text as of Sep 13, 2012 (Considered and Passed by the Senate).
Status & Summary | PDF | Source: GPO
S 3552 CPS
112th CONGRESS
2d Session
S. 3552
To reauthorize the Federal Insecticide, Fungicide, and Rodenticide Act.
IN THE SENATE OF THE UNITED STATES
September 13, 2012
September 13, 2012
Ms. STABENOW (for herself and Mr. ROBERTS) introduced the following bill; which was considered, read the third time, and passed
A BILL
To reauthorize the Federal Insecticide, Fungicide, and Rodenticide Act.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘Pesticide Registration Improvement Extension Act of 2012’.
SEC. 2. PESTICIDE REGISTRATION IMPROVEMENT.
(a) Maintenance Fees-
(1) FEES- Section 4(i) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)) is amended--
(A) in paragraph (5)--
(i) in subparagraph (C), by striking ‘aggregate amount of’ and all that follows through the end of the subparagraph and inserting ‘aggregate amount of $27,800,000 for each of fiscal years 2013 through 2017.’;
(ii) in subparagraph (D)--
(I) in clause (i), by striking ‘shall be’ and all that follows through the semicolon and inserting ‘shall be $115,500 for each of fiscal years 2013 through 2017;’; and
(II) in clause (ii), by striking ‘shall be’ and all that follows through the period and inserting ‘shall be $184,800 for each of fiscal years 2013 through 2017.’;
(iii) in subparagraph (E)(i)--
(I) in subclause (I), by striking ‘shall be’ and all that follows through the semicolon and inserting ‘shall be $70,600 for each of fiscal years 2013 through 2017;’; and
(II) in subclause (II), by striking ‘shall be’ and all that follows through the period and inserting ‘shall be $122,100 for each of fiscal years 2013 through 2017.’;
(iv) in subparagraph (F)--
(I) by striking ‘paragraph (3)’ and inserting ‘this paragraph’; and
(II) by striking ‘Humans’ and inserting ‘Human’;
(v) by redesignating subparagraphs (F) through (H) as subparagraphs (G) through (I), respectively;
(vi) by inserting after subparagraph (E) the following:
‘(F) FEE REDUCTION FOR CERTAIN SMALL BUSINESSES-
‘(i) DEFINITION- In this subparagraph, the term ‘qualified small business entity’ means a corporation, partnership, or unincorporated business that--
‘(I) has 500 or fewer employees;
‘(II) during the 3-year period prior to the most recent maintenance fee billing cycle, had an average annual global gross revenue from all sources that did not exceed $10,000,000; and
‘(III) holds not more than 5 pesticide registrations under this paragraph.
‘(ii) WAIVER- Except as provided in clause (iii), the Administrator shall waive 25 percent of the fee under this paragraph applicable to the first registration of any qualified small business entity under this paragraph.
‘(iii) LIMITATION- The Administrator shall not grant a waiver under clause (ii) to a qualified small business entity if the Administrator determines that the entity has been formed or manipulated primarily for the purpose of qualifying for the waiver.’; and
(vii) in subparagraph (I) (as redesignated by clause (v)), by striking ‘2012’ and inserting ‘2017’;
(B) in paragraph (6)--
(i) by striking ‘2014’ and inserting ‘2019’; and
(ii) by striking ‘paragraphs (1) through (5)’ and inserting ‘paragraph (1)’;
(C) by striking paragraphs (1), (2), (3), (4), and (7); and
(D) by redesignating paragraphs (5) and (6) as paragraphs (1) and (2), respectively.
(2) CONFORMING AMENDMENTS-
(A) Section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1) is amended--
(i) in subsection (d)(5)(B)(ii)(III), by striking ‘subsection (i)(1)’ and inserting ‘this section’;
(ii) in subsection (j), by striking ‘subsection (i)(5)’ and inserting ‘subsection (i)(1)’; and
(iii) in subsection (k)(5)--
(I) in the first sentence, by striking ‘subsection (i)(5)(C)(ii)’ and inserting ‘subsection (i)(1)(C)(ii)’; and
(II) in the third and sixth sentences, by striking ‘subsection (i)(5)(C)’ each place it appears and inserting ‘subsection (i)(1)(C)’.
(B) Section 33(b)(7)(F) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(b)(7)(F)) is amended--
(i) by striking ‘section 4(i)(5)(E)(ii)’ each place it appears in clauses (i), (ii)(I), and (iv)(I) and inserting ‘section 4(i)(1)(E)(ii)’;
(ii) by striking ‘section 4(i)(5)(E)(ii)(I)(bb)’ each place it appears in clauses (ii)(II) and (iv)(II) and inserting ‘section 4(i)(1)(E)(ii)(I)(bb)’; and
(iii) in clause (iv)(II)--
(I) by striking ‘applicable.’ and inserting ‘applicable’; and
(II) by striking ‘revenues’ and inserting ‘revenue’.
(3) EXTENSION OF PROHIBITION ON TOLERANCE FEES- Section 408(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(3)) is amended by striking ‘September 30, 2012’ and inserting ‘September 30, 2017’.
(4) REREGISTRATION AND EXPEDITED PROCESSING FUND-
(A) SOURCE AND USE- Section 4(k)(2)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)(2)(A)) is amended--
(i) by inserting ‘, to enhance the information systems capabilities to improve the tracking of pesticide registration decisions,’ after ‘paragraph (3)’ each place it appears; and
(ii) in clause (i)--
(I) by inserting ‘offset’ before ‘the costs of reregistration’; and
(II) by striking ‘in the same portion as appropriated funds’.
(B) EXPEDITED PROCESSING OF SIMILAR APPLICATIONS- Section 4(k)(3)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)(3)(A)) is amended--
(i) in the matter preceding clause (i), by striking ‘2008 through 2012, between 1/8 and 1/7 ’ and inserting ‘2013 through 2017, between 1/9 and 1/8 ’;
(ii) in clause (i), by striking ‘new’; and
(iii) in clause (ii), by striking ‘any application’ and all that follows through ‘that--’ and inserting ‘any application that--’.
(C) ENHANCEMENTS OF INFORMATION TECHNOLOGY SYSTEMS FOR IMPROVEMENT IN REVIEW OF PESTICIDE APPLICATIONS- Section 4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)) is amended--
(i) by redesignating paragraphs (4) and (5) as paragraphs (5) and (6), respectively;
(ii) by inserting after paragraph (3) the following:
‘(4) ENHANCEMENTS OF INFORMATION TECHNOLOGY SYSTEMS FOR IMPROVEMENT IN REVIEW OF PESTICIDE APPLICATIONS-
‘(A) IN GENERAL- For each of fiscal years 2013 through 2017, the Administrator shall use not more than $800,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund for the activities described in subparagraph (B).
‘(B) ACTIVITIES- The Administrator shall use amounts made available from the Reregistration and Expedited Processing Fund to improve the information systems capabilities for the Office of Pesticide Programs to enhance tracking of pesticide registration decisions, which shall include--
‘(i) the electronic tracking of--
‘(I) registration submissions; and
‘(II) the status of conditional registrations;
‘(ii) enhancing the database for information regarding endangered species assessments for registration review;
‘(iii) implementing the capability to electronically review labels submitted with registration actions; and
‘(iv) acquiring and implementing the capability to electronically assess and evaluate confidential statements of formula submitted with registration actions.’; and
(iii) in the first sentence of paragraph (6) (as redesignated by clause (i)), by striking ‘to carry out the goals established under subsection (l)’ and inserting ‘for the purposes described in paragraphs (2), (3), and (4) and to carry out the goals established under subsection (l)’.
(b) Pesticide Registration Service Fees-
(1) AMOUNT OF FEES- Section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(b)) is amended--
(A) by striking paragraph (3) and inserting the following:
‘(3) SCHEDULE OF COVERED APPLICATIONS AND REGISTRATION SERVICE FEES- Subject to paragraph (6), the schedule of covered pesticide registration applications and corresponding registration service fees shall be as follows:
‘TABLE 1. -- REGISTRATION DIVISION -- NEW ACTIVE INGREDIENTS
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EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
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R010 1 New Active Ingredient, Food use (2) (3) 24 569,221
R020 2 New Active Ingredient, Food use; reduced risk (2) (3) 18 569,221
R040 3 New Active Ingredient, Food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3) 18 419,502
R060 4 New Active Ingredient, Non-food use; outdoor (2) (3) 21 395,467
R070 5 New Active Ingredient, Non-food use; outdoor; reduced risk (2) (3) 16 395,467
R090 6 New Active Ingredient, Non-food use; outdoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient (3) 16 293,596
R110 7 New Active Ingredient, Non-food use; indoor (2) (3) 20 219,949
R120 8 New Active Ingredient, Non-food use; indoor; reduced risk (2) (3) 14 219,949
R121 9 New Active Ingredient, Non-food use; indoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3) 18 165,375
R122 10 Enriched isomer(s) of registered mixed-isomer active ingredient (2) (3) 18 287,643
R123 11 New Active Ingredient, Seed treatment only; includes agricultural and non-agricultural seeds; residues not expected in raw agricultural commodities (2) (3) 18 427,991
R125New 12 New Active Ingredient, Seed treatment; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3) 16 293,596
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‘TABLE 2. -- REGISTRATION DIVISION -- NEW USES
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EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
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R130 13 First food use; indoor; food/food handling (2) (3) 21 173,644
R140 14 Additional food use; Indoor; food/food handling (3) (4) 15 40,518
R150 15 First food use (2) (3) 21 239,684
R160 16 First food use; reduced risk (2) (3) 16 239,684
R170 17 Additional food use (3) (4) 15 59,976
R175New 18 Additional food uses covered within a crop group resulting from the conversion of existing approved crop group(s) to one or more revised crop groups. (3) (4) 10 59,976
R180 19 Additional food use; reduced risk (3) (4) 10 59,976
R190 20 Additional food uses; 6 or more submitted in one application (3) (4) 15 359,856
R200 21 Additional food uses; 6 or more submitted in one application; reduced risk (3) (4) 10 359,856
R210 22 Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration (3) (4) 12 44,431
R220 23 Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration (3) (4) 6 17,993
R230 24 Additional use; non-food; outdoor (3) (4) 15 23,969
R240 25 Additional use; non-food; outdoor; reduced risk (3) (4) 10 23,969
R250 26 Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration (3) (4) 6 17,993
R251New 27 Experimental Use Permit application which requires no changes to the tolerance(s); non-crop destruct basis (3) 8 17,993
R260 28 New use; non-food; indoor (3) (4) 12 11,577
R270 29 New use; non-food; indoor; reduced risk (3) (4) 9 11,577
R271 30 New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration (3) (4) 6 8,820
R273 31 Additional use; seed treatment; limited uptake into raw agricultural commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food or non-food uses (3) (4) 12 45,754
R274 32 Additional uses; seed treatment only; 6 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 (3) (4) 12 274,523
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‘TABLE 3. -- REGISTRATION DIVISION -- IMPORT AND OTHER TOLERANCES
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EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
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R280 33 Establish import tolerance; new active ingredient or first food use (2) 21 289,407
R290 34 Establish import tolerance; additional food use 15 57,882
R291 35 Establish import tolerances; additional food uses; 6 or more crops submitted in one petition 15 347,288
R292 36 Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated 11 41,124
R293 37 Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated 12 48,510
R294 38 Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated 12 291,060
R295 39 Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated 15 59,976
R296 40 Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; applicant-initiated 15 359,856
R297New 41 Amend 6 or more established tolerances (e.g., decrease or increase) in one petition; domestic or import; applicant-initiated 11 246,744
R298New 42 Amend an established tolerance (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated (3) 13 53,120
R299New 43 Amend 6 or more established tolerances (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated (3) 13 258,740
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‘TABLE 4. -- REGISTRATION DIVISION -- NEW PRODUCTS
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EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
R300 44 New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; no data review on acute toxicity, efficacy or CRP - 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. (2) (3) 4 1,434
R301 45 New product; or similar combination product (already registered) to an identical or substantially 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. (2) (3) 4 1,720
R310 46 New end-use or manufacturing-use product with registered source(s) of active ingredient(s); includes products containing two or more registered active ingredients previously combined in other registered products; requires review of data package within RD only; includes data and/or waivers of data for only: g product chemistry and/or g acute toxicity and/or g public health pest efficacy and/or g child resistant packaging. (2) (3) 7 4,807
R314New 47 New end use product containing two or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; requires review of data package within RD only; includes data and/or waivers of data for only: g product chemistry and/or g acute toxicity and/or g public health pest efficacy and/or g child resistant packaging. (2) (3) 8 6,009
R315New 48 New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only: g product chemistry and/or g acute toxicity and/or g public health pest efficacy and/or g animal safety studies and/or g child resistant packaging (2) (3) 9 8,000
R320 49 New product; new physical form; requires data review in science divisions (2) (3) 12 11,996
R331 50 New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only (2) (3) 3 2,294
R332 51 New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only; requires review in RD and science divisions (2) (3) 24 256,883
R333New 52 New product; MUP or End use product with unregistered source of active ingredient; requires science data review; new physical form; etc. Cite-all or selective data citation where applicant owns all required data. (2) (3) 10 17,993
R334New 53 New product; MUP or End use product with unregistered source of the active ingredient; requires science data review; new physical form; etc. Selective data citation. (2) (3) 11 17,993
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‘TABLE 5. -- REGISTRATION DIVISION -- AMENDMENTS TO REGISTRATION
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EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
R340 54 Amendment requiring data review within RD (e.g., changes to precautionary label statements) (2) (3) 4 3,617
R345New 55 Amending non-food animal product that includes submission of target animal safety data; previously registered (2) (3) 7 8,000
R350 56 Amendment requiring data review in 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) (3) 9 11,996
R351New 57 Amendment adding a new unregistered source of active ingredient. (2) (3) 8 11,996
R352New 58 Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data (2) (3) 8 11,996
R371 59 Amendment to Experimental Use Permit; (does not include extending a permit’s time period) (3) 6 9,151
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‘TABLE 6. -- REGISTRATION DIVISION -- OTHER ACTIONS
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EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
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R124 60 Conditional Ruling on Preapplication Study Waivers; applicant-initiated 6 2,294
R272 61 Review of Study Protocol applicant-initiated; excludes DART, pre-registration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review 3 2,294
R275New 62 Rebuttal of agency reviewed protocol, applicant initiated 3 2,294
R370 63 Cancer reassessment; applicant-initiated 18 179,818
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‘TABLE 7. -- ANTIMICROBIALS DIVISION -- NEW ACTIVE INGREDIENTS
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EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
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A380 64 Food use; establish tolerance exemption (2) (3) 24 104,187
A390 65 Food use; establish tolerance (2) (3) 24 173,644
A400 66 Non-food use; outdoor; FIFRA 2(mm) uses (2) (3) 18 86,823
A410 67 Non-food use; outdoor; uses other than FIFRA 2(mm) (2) (3) 21 173,644
A420 68 Non-food use; indoor; FIFRA 2(mm) uses (2) (3) 18 57,882
A430 69 Non-food use; indoor; uses other than FIFRA 2(mm) (2) (3) 20 86,823
A431 70 Non-food use; indoor; low-risk, low-toxicity food-grade active ingredient(s); efficacy testing for public health claims required under GLP and following DIS/TSS or AD-approved study protocol (2) (3) 12 60,638
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‘TABLE 8. -- ANTIMICROBIALS DIVISION -- NEW USES
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EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
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A440 71 First food use; establish tolerance exemption (2) (3) (4) 21 28,942
A450 72 First food use; establish tolerance (2) (3) (4) 21 86,823
A460 73 Additional food use; establish tolerance exemption (3) (4) (5) 15 11,577
A470 74 Additional food use; establish tolerance (3) (4) (5) 15 28,942
A471New 75 Additional food uses; establish tolerances; 6 or more submitted in one application (3) (4) (5) 15 173,652
A480 76 Additional use; non-food; outdoor; FIFRA 2(mm) uses (4) (5) 9 17,365
A481New 77 Additional non-food outdoor uses; FIFRA 2(mm) uses; 6 or more submitted in one application (4) (5) 9 104,190
A490 78 Additional use; non-food; outdoor; uses other than FIFRA 2(mm) (4) (5) 15 28,942
A491New 79 Additional non-food; outdoor; uses other than FIFRA 2(mm); 6 or more submitted in one application (4) (5) 15 173,652
A500 80 Additional use; non-food, indoor, FIFRA 2(mm) uses (4) (5) 9 11,577
A501New 81 Additional non-food; indoor; FIFRA 2(mm) uses; 6 or more submitted in one application (4) (5) 9 69,462
A510 82 Additional use; non-food; indoor; uses other than FIFRA 2(mm) (4) (5) 12 11,577
A511New 83 Additional non-food; indoor; uses other than FIFRA 2(mm); 6 or more submitted in one application (4) (5) 12 69,462
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‘TABLE 9. -- ANTIMICROBIALS DIVISION -- NEW PRODUCTS AND AMENDMENTS
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
A530 84 New product; identical or substantially 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 when applicant owns all required data, or applicant submits specific authorization letter for data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. (2) (3) 4 1,159
A531 85 New product; identical or substantially 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. (2) (3) 4 1,654
A532 86 New product; identical or substantially 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 (2) (3) 5 4,631
A540 87 New end use product; FIFRA 2(mm) uses only (2) (3) 5 4,631
A550 88 New end-use product; uses other than FIFRA 2(mm); non-FQPA product (2) (3) 7 4,631
A560 89 New manufacturing-use product; registered active ingredient; selective data citation (2) (3) 12 17,365
A570 90 Label amendment requiring data review (3) (4) 4 3,474
A572New 91 New Product or amendment requiring data review for risk assessment by Science Branch (e.g., changes to REI, or PPE, or use rate) (2) (3) (4) 9 11,996
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‘TABLE 10. -- ANTIMICROBIALS DIVISION -- EXPERIMENTAL USE PERMITS AND OTHER TYPE OF ACTIONS
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EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
A520 92 Experimental Use Permit application, Non-Food Use (2) 9 5,789
A521 93 Review of public health efficacy study protocol within AD, per AD Internal Guidance for the Efficacy Protocol Review Process; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 1 3 2,250
A522 94 Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 2 12 11,025
A524New 95 New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance. Credit 45% of fee toward new active ingredient application that follows. (2) 18 138,916
A525New 96 New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance Exemption. Credit 45% of fee toward new active ingredient application that follows. (2) 18 83,594
A526New 97 New Active Ingredient, Experimental Use Permit application; Non-Food, Outdoor Use. Credit 45% of fee toward new active ingredient application that follows. (2) 15 86,823
A527New 98 New Active Ingredient, Experimental Use Permit application; Non-Food, Indoor Use. Credit 45% of fee toward new active ingredient application that follows. (2) 15 58,000
A528New 99 Experimental Use Permit application, Food Use; Requires Tolerance or Tolerance Exemption (2) 15 20,260
A529New 100 Amendment to Experimental Use Permit; requires data review or risk assessment (2) 9 10,365
A523New 101 Review of protocol other than a public health efficacy study (i.e., Toxicology or Exposure Protocols) 9 11,025
A571New 102 Science reassessment: Cancer risk, refined ecological risk, and/or endangered species; applicant-initiated 18 86,823
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‘TABLE 11. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW ACTIVE INGREDIENTS
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EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
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B580 103 New active ingredient; food use; petition to establish a tolerance (2) 19 46,305
B590 104 New active ingredient; food use; petition to establish a tolerance exemption (2) 17 28,942
B600 105 New active ingredient; non-food use (2) 13 17,365
B610 106 New active ingredient; Experimental Use Permit application; petition to establish a temporary tolerance or temporary tolerance exemption 10 11,577
B611New 107 New active ingredient; Experimental Use Permit application; petition to establish permanent tolerance exemption 12 11,577
B612New 108 New active ingredient; no change to a permanent tolerance exemption (2) 10 15,918
B613New 109 New active ingredient; petition to convert a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption (2) 11 15,918
B620 110 New active ingredient; Experimental Use Permit application; non-food use including crop destruct 7 5,789
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‘TABLE 12. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW USES
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EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
------------------------------------------------------------------------------------------------------------------------------------------------------
B630 111 First food use; petition to establish a tolerance exemption (2) 13 11,577
B631 112 New food use; petition to amend an established tolerance (3) 12 11,577
B640 113 First food use; petition to establish a tolerance (2) 19 17,365
B643New 114 New Food use; petition to amend tolerance exemption (3) 10 11,577
B642New 115 First food use; indoor; food/food handling (2) 12 28,942
B644New 116 New use, no change to an established tolerance or tolerance exemption (3) 8 11,577
B650 117 New use; non-food (3) 7 5,789
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‘TABLE 13. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
B652New 118 New product; registered source of active ingredient; requires petition to amend established tolerance or tolerance exemption; requires 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply (2) 13 11,577
B660 119 New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. For microbial pesticides, the active ingredient(s) must not be re-isolated. (2) 4 1,159
B670 120 New product; registered source of active ingredient(s); no change in an established tolerance or tolerance exemption; requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2) 7 4,631
B671 121 New product; unregistered source of active ingredient(s); requires a petition to amend an established tolerance or tolerance exemption; requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2) 17 11,577
B672 122 New product; unregistered source of active ingredient(s); non-food use or food use with a tolerance or tolerance exemption previously established for the active ingredient(s); requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2) 13 8,269
B673New 123 New product MUP/EP; unregistered source of active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously reviewed and accepted by the Agency. Requires an Agency determination that the cited data supports the new product. (2) 10 4,631
B674New 124 New product MUP; Repack of identical registered end-use product as a manufacturing-use product; same registered uses only (2) 4 1,159
B675New 125 New Product MUP; registered source of active ingredient; submission of completely new generic data package; registered uses only. (2) 10 8,269
B676New 126 New product; more than one active ingredient where one active ingredient is an unregistered source; product chemistry data must be submitted; requires: 1) submission of product specific data, and 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2) 13 8,269
B677New 127 New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only: g product chemistry and/or g acute toxicity and/or g public health pest efficacy and/or g animal safety studies and/or g child resistant packaging (2) 10 8,000
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‘TABLE 14. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; AMENDMENTS
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
B621 128 Amendment; Experimental Use Permit; no change to an established temporary tolerance or tolerance exemption. 7 4,631
B622New 129 Amendment; Experimental Use Permit; petition to amend an established or temporary tolerance or tolerance exemption. 11 11,577
B641 130 Amendment of an established tolerance or tolerance exemption. 13 11,577
B680 131 Amendment; registered source of active ingredient(s); no new use(s); no changes to an established tolerance or tolerance exemption. Requires data submission. (2) 5 4,631
B681 132 Amendment; unregistered source of active ingredient(s). Requires data submission. (2) 7 5,513
B683New 133 Label amendment; requires review/update of previous risk assessment(s) without data submission (e.g., labeling changes to REI, PPE, PHI). (2) 6 4,631
B684New 134 Amending non-food animal product that includes submission of target animal safety data; previously registered (2) 8 8,000
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‘TABLE 15. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES(SCLPS)
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EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
B690 135 New active ingredient; food or non-food use. (2) 7 2,316
B700 136 Experimental Use Permit application; new active ingredient or new use. 7 1,159
B701 137 Extend or amend Experimental Use Permit. 4 1,159
B710 138 New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. (3) 4 1,159
B720 139 New product; registered source of active ingredient(s); requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (3) 5 1,159
B721 140 New product; unregistered source of active ingredient. (3) 7 2,426
B722 141 New use and/or amendment; petition to establish a tolerance or tolerance exemption. (4) (5) 7 2,246
B730 142 Label amendment requiring data submission. (4) 5 1,159
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‘TABLE 16. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- OTHER ACT
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EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
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B614New 143 Conditional Ruling on Preapplication Study Waivers; applicant-initiated 3 2,294
B615New 144 Rebuttal of agency reviewed protocol, applicant initiated 3 2,294
B682 145 Protocol review; applicant initiated; excludes time for HSRB review 3 2,205
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‘TABLE 17. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- PLANT INCORPORATED PROTECTANTS (PIPS)
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EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
B740 146 Experimental Use Permit application; no petition for tolerance/tolerance exemption. Includes: 1) non-food/feed use(s) for a new (2) or registered (3) PIP; 2) food/feed use(s) for a new or registered PIP with crop destruct; 3) food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exists for the intended use(s). (4) 6 86,823
B750 147 Experimental Use Permit application; with a petition to establish a temporary or permanent tolerance/tolerance exemption for the active ingredient. Includes new food/feed use for a registered (3) PIP. (4) 9 115,763
B770 148 Experimental Use Permit application; new (2) PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows; SAP review. (5) 15 173,644
B771 149 Experimental Use Permit application; new (2) PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows. 10 115,763
B772 150 Application to amend or extend an Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected. 3 11,577
B773 151 Application to amend or extend an Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient. 5 28,942
B780 152 Registration application; new (2) PIP; non-food/feed. 12 144,704
B790 153 Registration application; new (2) PIP; non-food/feed; SAP review. (5) 18 202,585
B800 154 Registration application; new (2) PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. 12 231,585
B810 155 Registration application; new (2) PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. SAP review. (5) 18 289,407
B820 156 Registration application; new (2) PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. 15 289,407
B840 157 Registration application; new (2) PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. SAP review. (5) 21 347,288
B851 158 Registration application; new event of a previously registered PIP active ingredient(s); no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s). 9 115,763
B870 159 Registration application; registered (3) PIP; new product; new use; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (4) 9 34,729
B880 160 Registration application; registered (3) PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (6) (7) 9 28,942
B881 161 Registration application; registered (3) PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). SAP review. (5) (6) (7) 15 86,823
B883New 162 Registration application; new (2) PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. (8) 9 115,763
B884New 163 Registration application; new (2) PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient. (8) 12 144,704
B885New 164 Registration application; registered (3) PIP, seed increase; breeding stack of previously approved PIPs, same crop; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (9) 9 86,823
B890 165 Application to amend a seed increase registration; converts registration to commercial registration; no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s). 9 57,882
B891 166 Application to amend a seed increase registration; converts registration to a commercial registration; no petition since a permanent tolerance/tolerance exemption already established for the active ingredient(s); SAP review. (5) 15 115,763
B900 167 Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. (10) (11) 6 11,577
B901 168 Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. SAP review. (10) (11) 12 69,458
B902 169 PIP protocol review 3 5,789
B903 170 Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD. 6 57,882
B904 171 Import tolerance or tolerance exemption; processed commodities/food only (inert or active ingredient). 9 115,763
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‘TABLE 18. -- INERT INGREDIENTS, EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS
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EPANo. NewCRNo. Action DecisionReview Time(Months) (1) RegistrationService Fee($)
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I001 172 Approval of new food use inert ingredient (2) (3) 12 18,000
I002New 173 Amend currently approved inert ingredient tolerance or exemption from tolerance; new data (2) 10 5,000
I003New 174 Amend currently approved inert ingredient tolerance or exemption from tolerance; no new data (2) 8 3,000
I004New 175 Approval of new non-food use inert ingredient (2) 8 10,000
I005New 176 Amend currently approved non-food use inert ingredient with new use pattern; new data (2) 8 5,000
I006New 177 Amend currently approved non-food use inert ingredient with new use pattern; no new data (2) 6 3,000
I007New 178 Approval of substantially similar non-food use inert ingredients when original inert is compositionally similar with similar use pattern (2) 4 1,500
I008New 179 Approval of new polymer inert ingredient, food use (2) 5 3,400
I009New 180 Approval of new polymer inert ingredient, non food use (2) 4 2,800
I010New 181 Petition to amend a tolerance exemption descriptor to add one or more CASRNs; no new data (2) 6 1,500
M001New 182 Study protocol requiring Human Studies Review Board review as defined in 40 CFR 26 in support of an active ingredient (4) 9 7,200
M002New 183 Completed study requiring Human Studies Review Board review as defined in 40 CFR 26 in support of an active ingredient (4) 9 7,200
M003New 184 External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of less than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. (5) 12 58,000
M004New 185 External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of greater than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. (5) 18 58,000
M005New 186 New Product: Combination, Contains a combination of active ingredients from a registered and/or unregistered source; conventional, antimicrobial and/or biopesticide. Requires coordination with other regulatory divisions to conduct review of data, label and/or verify the validity of existing data as cited. Only existing uses for each active ingredient in the combination product. (6) (7) 9 20,000
M006New 187 Request for up to 5 letters of certification (Gold Seal) for one actively registered product. 1 250
M007New 188 Request to extend Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(ii) 12 5,000
M008New 189 Request to grant Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(vi) for a minor use, when a FIFRA Section 2(ll)(2) determination is required 10 1,500
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(B) in paragraph (6)--
(i) in subparagraph (A)--
(I) by striking ‘October 1, 2008’ and inserting ‘October 1, 2013’; and
(II) by striking ‘September 30, 2010’ and inserting ‘September 30, 2015’; and
(ii) in subparagraph (B)--
(I) by striking ‘October 1, 2010’ and inserting ‘October 1, 2015’; and
(II) by striking ‘September 30, 2010’ and inserting ‘September 30, 2015’; and
(C) in paragraph (8)(C)(ii)--
(i) in subclause (I), by striking ‘or’ at the end;
(ii) in subclause (II), by striking the period at the end and inserting ‘; or’; and
(iii) by adding at the end the following:
‘(III) on the basis that the Administrator rejected the application under subsection (f)(4)(B).’.
(2) PESTICIDE REGISTRATION FUND- Section 33(c)(3)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(c)(3)(B)) is amended--
(A) in clause (i), by striking ‘2008 through 2012’ and inserting ‘2013 through 2017’;
(B) in clause (ii), by striking ‘grants’ and all that follows through the end of the clause and inserting ‘grants, for each of fiscal years 2013 through 2017, $500,000.’; and
(C) in clause (iii), by striking ‘2008 through 2012’ and inserting ‘2013 through 2017’.
(3) ASSESSMENT OF FEES- Section 33(d) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(d)) is amended--
(A) in paragraph (2), by striking ‘2002’ each place it appears and inserting ‘2012’;
(B) by striking paragraph (4); and
(C) by redesignating paragraph (5) as paragraph (4).
(4) REFORMS TO REDUCE DECISION TIME REVIEW PERIODS- Section 33(e) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(e)) is amended by striking ‘Pesticide Registration Improvement Act of 2003’ and inserting ‘Pesticide Registration Improvement Extension Act of 2012’.
(5) DECISION TIME REVIEW PERIODS- Section 33(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(f)) is amended--
(A) in paragraph (1), by striking ‘Pesticide Registration Improvement Renewal Act, the Administrator shall publish in the Federal Register’ and inserting ‘Pesticide Registration Improvement Extension Act of 2012, the Administrator shall make publicly available’;
(B) in paragraph (2), by striking ‘appearing in the Congressional Record on pages S10409’ and all that follows through the period and inserting ‘provided under subsection (b)(3).’; and
(C) in paragraph (4)--
(i) in subparagraph (A), by inserting ‘and fee’ before the period; and
(ii) in subparagraph (B)--
(I) by striking ‘(B) COMPLETENESS OF APPLICATION’ and all that follows through ‘Not later’ in clause (i) and inserting the following:
‘(B) INITIAL CONTENT AND PRELIMINARY TECHNICAL SCREENINGS-
‘(i) SCREENINGS-
‘(I) INITIAL CONTENT- Not later’;
(II) in clause (i) (as so designated) by adding at the end the following:
‘(II) PRELIMINARY TECHNICAL SCREENING- After conducting the initial content screening described in subclause (I) and in accordance with clause (iv), the Administrator shall conduct a preliminary technical screening--
‘(aa) not later than 45 days after the date on which the decision time review period begins (for applications with decision time review periods of not more than 180 days); and
‘(bb) not later than 90 days after the date on which the decision time review period begins (for applications with decision time review periods greater than 180 days).’;
(III) by striking clause (ii) and inserting the following:
‘(ii) REJECTION-
‘(I) IN GENERAL- If the Administrator determines at any time before the Administrator completes the preliminary technical screening under clause (i)(II) that the application failed the initial content or preliminary technical screening and the applicant does not correct the failure before the date that is 10 business days after the applicant receives a notification of the failure, the Administrator shall reject the application.
‘(II) WRITTEN NOTIFICATION- The Administrator shall make every effort to provide a written notification of a rejection under subclause (I) during the 10-day period that begins on the date the Administrator completes the preliminary technical screening.’;
(IV) in clause (iii)--
(aa) in the heading, by inserting ‘INITIAL CONTENT’ before ‘SCREENING’ ;
(bb) in the matter preceding subclause (I), by inserting ‘content’ after ‘initial’; and
(cc) in subclause (II), by striking ‘contains’ and inserting ‘appears to contain’; and
(V) by adding at the end the following:
‘(iv) REQUIREMENTS OF PRELIMINARY TECHNICAL SCREENING- In conducting a preliminary technical screening of an application, the Administrator shall determine if--
‘(I) the application and the data and information submitted with the application are accurate and complete; and
‘(II) the application, data, and information are consistent with the proposed labeling and any proposal for a tolerance or exemption from the requirement for a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), and are such that, subject to full review under the standards of this Act, could result in the granting of the application.’.
(6) REPORTS- Section 33(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(k)) is amended--
(A) in paragraph (1), by striking ‘March 1, 2014’ and inserting ‘March 1, 2017’;
(B) in paragraph (2)--
(i) in subparagraph (A)--
(I) in clause (vi)(V), by striking ‘and’ at the end;
(II) in clause (vii)(II), by inserting ‘and’ at the end; and
(III) by adding at the end the following:
‘(viii) the number of extensions of decision time review periods agreed to under subsection (f)(5) along with a description of the reason that the Administrator was unable to make a decision within the initial decision time review period;’;
(ii) in subparagraph (E), by striking ‘and’ at the end;
(iii) in subparagraph (F), by striking the period and inserting a semicolon; and
(iv) by adding at the end the following:
‘(G) a review of the progress made toward--
‘(i) carrying out section 4(k)(4) and the amounts from the Reregistration and Expedited Processing Fund used for the purposes described in that section;
‘(ii) implementing systems for the electronic tracking of registration submissions by December 31, 2013;
‘(iii) implementing a system for tracking the status of conditional registrations, including making nonconfidential information related to the conditional registrations publicly available by December 31, 2013;
‘(iv) implementing enhancements to the endangered species knowledge database, including making nonconfidential information related to the database publicly available;
‘(v) implementing the capability to electronically submit and review labels submitted with registration actions;
‘(vi) acquiring and implementing the capability to electronically assess and evaluate confidential statements of formula submitted with registration actions by December 31, 2014; and
‘(vii) facilitating public participation in certain registration actions and the registration review process by providing electronic notification to interested parties of additions to the public docket;
‘(H) the number of applications rejected by the Administrator under the initial content and preliminary technical screening conducted under subsection (f)(4);
‘(I) a review of the progress made in updating the Pesticide Incident Data System, including progress toward making the information contained in the System available to the public (as the Administrator determines is appropriate); and
‘(J) an assessment of the public availability of summary pesticide usage data.’; and
(C) by adding at the end the following:
‘(4) OTHER REPORT-
‘(A) SCOPE- In addition to the annual report described in paragraph (1), not later than October 1, 2016, the Administrator shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report that includes an analysis of the impact of maintenance fees on small businesses that have--
‘(i) 10 or fewer employees; and
‘(ii) annual global gross revenue that does not exceed $2,000,000.
‘(B) INFORMATION REQUIRED- In conducting the analysis described in subparagraph (A), the Administrator shall collect, and include in the report under that subparagraph, information on--
‘(i) the number of small businesses described in subparagraph (A) that are paying maintenance fees; and
‘(ii) the number of registrations each company holds.’.
(7) TERMINATION OF EFFECTIVENESS- Section 33(m) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(m)) is amended--
(A) in paragraph (1), by striking ‘2012’ and inserting ‘2017’; and
(B) in paragraph (2)--
(i) in subparagraph (A)--
(I) in the heading, by striking ‘2013’ and inserting ‘2018’;
(II) by striking ‘2013,’ and inserting ‘2018,’; and
(III) by striking ‘September 30, 2012’ and inserting ‘September 30, 2017’;
(ii) in subparagraph (B)--
(I) in the heading, by striking ‘2014’ and inserting ‘2019’;
(II) by striking ‘2014,’ and inserting ‘2019,’; and
(III) by striking ‘September 30, 2012’ and inserting ‘September 30, 2017’;
(iii) in subparagraph (C)--
(I) in the heading, by striking ‘2014’ and inserting ‘2019’; and
(II) by striking ‘September 30, 2014’ and inserting ‘September 30, 2019’; and
(iv) in subparagraph (D), by striking ‘2012’ each place it appears and inserting ‘2017’.
(c) Effective Date- This section and the amendments made by this section take effect on October 1, 2012.
(d) Relationship to Other Law- In the case of any conflict between this section (including the amendments made by this section) and a joint resolution making continuing appropriations for fiscal year 2013 (including any amendments made by such a joint resolution), this section and the amendments made by this section shall control.