112TH CONGRESS 

2D SESSION S. 3552 

AN ACT 

To reauthorize the Federal Insecticide, Fungicide, and 

Rodenticide Act. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
2 

†S 3552 ES

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Pesticide Registration 

3 Improvement Extension Act of 2012’’. 

4 SEC. 2. PESTICIDE REGISTRATION IMPROVEMENT. 

5 (a) MAINTENANCE FEES.— 

6 (1) FEES.—Section 4(i) of the Federal Insecti7 cide, Fungicide, and Rodenticide Act (7 U.S.C. 

8 136a–1(i)) is amended— 

9 (A) in paragraph (5)— 

10 (i) in subparagraph (C), by striking 

11 ‘‘aggregate amount of’’ and all that follows 

12 through the end of the subparagraph and 

13 inserting ‘‘aggregate amount of 

14 $27,800,000 for each of fiscal years 2013 

15 through 2017.’’; 

16 (ii) in subparagraph (D)— 

17 (I) in clause (i), by striking 

18 ‘‘shall be’’ and all that follows 

19 through the semicolon and inserting 

20 ‘‘shall be $115,500 for each of fiscal 

21 years 2013 through 2017;’’; and 

22 (II) in clause (ii), by striking 

23 ‘‘shall be’’ and all that follows 

24 through the period and inserting 

25 ‘‘shall be $184,800 for each of fiscal 

26 years 2013 through 2017.’’; 
3 

†S 3552 ES

1 (iii) in subparagraph (E)(i)— 

2 (I) in subclause (I), by striking 

3 ‘‘shall be’’ and all that follows 

4 through the semicolon and inserting 

5 ‘‘shall be $70,600 for each of fiscal 

6 years 2013 through 2017;’’; and 

7 (II) in subclause (II), by striking 

8 ‘‘shall be’’ and all that follows 

9 through the period and inserting 

10 ‘‘shall be $122,100 for each of fiscal 

11 years 2013 through 2017.’’; 

12 (iv) in subparagraph (F)— 

13 (I) by striking ‘‘paragraph (3)’’ 

14 and inserting ‘‘this paragraph’’; and 

15 (II) by striking ‘‘Humans’’ and 

16 inserting ‘‘Human’’; 

17 (v) by redesignating subparagraphs 

18 (F) through (H) as subparagraphs (G) 

19 through (I), respectively; 

20 (vi) by inserting after subparagraph 

21 (E) the following: 

22 ‘‘(F) FEE REDUCTION FOR CERTAIN

23 SMALL BUSINESSES.— 

24 ‘‘(i) DEFINITION.—In this subpara25 graph, the term ‘qualified small business 
4 

†S 3552 ES

1 entity’ means a corporation, partnership, 

2 or unincorporated business that— 

3 ‘‘(I) has 500 or fewer employees; 

4 ‘‘(II) during the 3-year period 

5 prior to the most recent maintenance 

6 fee billing cycle, had an average an7 nual global gross revenue from all 

8 sources that did not exceed 

9 $10,000,000; and 

10 ‘‘(III) holds not more than 5 pes11 ticide registrations under this para12 graph. 

13 ‘‘(ii) WAIVER.—Except as provided in 

14 clause (iii), the Administrator shall waive 

15 25 percent of the fee under this paragraph 

16 applicable to the first registration of any 

17 qualified small business entity under this 

18 paragraph. 

19 ‘‘(iii) LIMITATION.—The Adminis20 trator shall not grant a waiver under 

21 clause (ii) to a qualified small business en22 tity if the Administrator determines that 

23 the entity has been formed or manipulated 

24 primarily for the purpose of qualifying for 

25 the waiver.’’; and 
5 

†S 3552 ES

1 (vii) in subparagraph (I) (as redesig2 nated by clause (v)), by striking ‘‘2012’’ 

3 and inserting ‘‘2017’’; 

4 (B) in paragraph (6)— 

5 (i) by striking ‘‘2014’’ and inserting 

6 ‘‘2019’’; and 

7 (ii) by striking ‘‘paragraphs (1) 

8 through (5)’’ and inserting ‘‘paragraph 

9 (1)’’; 

10 (C) by striking paragraphs (1), (2), (3), 

11 (4), and (7); and 

12 (D) by redesignating paragraphs (5) and 

13 (6) as paragraphs (1) and (2), respectively. 

14 (2) CONFORMING AMENDMENTS.— 

15 (A) Section 4 of the Federal Insecticide, 

16 Fungicide, and Rodenticide Act (7 U.S.C. 

17 136a–1) is amended— 

18 (i) in subsection (d)(5)(B)(ii)(III), by 

19 striking ‘‘subsection (i)(1)’’ and inserting 

20 ‘‘this section’’; 

21 (ii) in subsection (j), by striking ‘‘sub22 section (i)(5)’’ and inserting ‘‘subsection 

23 (i)(1)’’; and 

24 (iii) in subsection (k)(5)— 
6 

†S 3552 ES

1 (I) in the first sentence, by strik2 ing ‘‘subsection (i)(5)(C)(ii)’’ and in3 serting ‘‘subsection (i)(1)(C)(ii)’’; and 

4 (II) in the third and sixth sen5 tences, by striking ‘‘subsection 

6 (i)(5)(C)’’ each place it appears and 

7 inserting ‘‘subsection (i)(1)(C)’’. 

8 (B) Section 33(b)(7)(F) of the Federal In9 secticide, Fungicide, and Rodenticide Act (7 

10 U.S.C. 136w–8(b)(7)(F)) is amended— 

11 (i) by striking ‘‘section 4(i)(5)(E)(ii)’’ 

12 each place it appears in clauses (i), (ii)(I), 

13 and (iv)(I) and inserting ‘‘section 

14 4(i)(1)(E)(ii)’’; 

15 (ii) by striking ‘‘section 

16 4(i)(5)(E)(ii)(I)(bb)’’ each place it appears 

17 in clauses (ii)(II) and (iv)(II) and inserting 

18 ‘‘section 4(i)(1)(E)(ii)(I)(bb)’’; and 

19 (iii) in clause (iv)(II)— 

20 (I) by striking ‘‘applicable.’’ and 

21 inserting ‘‘applicable’’; and 

22 (II) by striking ‘‘revenues’’ and 

23 inserting ‘‘revenue’’. 

24 (3) EXTENSION OF PROHIBITION ON TOLER25 ANCE FEES.—Section 408(m)(3) of the Federal 
7 

†S 3552 ES

1 Food, Drug, and Cosmetic Act (21 U.S.C. 

2 346a(m)(3)) is amended by striking ‘‘September 30, 

3 2012’’ and inserting ‘‘September 30, 2017’’. 

4 (4) REREGISTRATION AND EXPEDITED PROC5 ESSING FUND.— 

6 (A) SOURCE AND USE.—Section 4(k)(2)(A) 

7 of the Federal Insecticide, Fungicide, and 

8 Rodenticide Act (7 U.S.C. 136a–1(k)(2)(A)) is 

9 amended— 

10 (i) by inserting ‘‘, to enhance the in11 formation systems capabilities to improve 

12 the tracking of pesticide registration deci13 sions,’’ after ‘‘paragraph (3)’’ each place it 

14 appears; and 

15 (ii) in clause (i)— 

16 (I) by inserting ‘‘offset’’ before 

17 ‘‘the costs of reregistration’’; and 

18 (II) by striking ‘‘in the same por19 tion as appropriated funds’’. 

20 (B) EXPEDITED PROCESSING OF SIMILAR

21 APPLICATIONS.—Section 4(k)(3)(A) of the Fed22 eral Insecticide, Fungicide, and Rodenticide Act 

23 (7 U.S.C. 136a–1(k)(3)(A)) is amended— 

24 (i) in the matter preceding clause (i), 

25 by striking ‘‘2008 through 2012, between 
8 

†S 3552 ES

1⁄8 and 1 1 ⁄7’’ and inserting ‘‘2013 through 

2017, between 1⁄9 and 1 2 ⁄8’’; 

3 (ii) in clause (i), by striking ‘‘new’’; 

4 and 

5 (iii) in clause (ii), by striking ‘‘any ap6 plication’’ and all that follows through 

7 ‘‘that—’’ and inserting ‘‘any application 

8 that—’’. 

9 (C) ENHANCEMENTS OF INFORMATION

10 TECHNOLOGY SYSTEMS FOR IMPROVEMENT IN

11 REVIEW OF PESTICIDE APPLICATIONS.—Section 

12 4(k) of the Federal Insecticide, Fungicide, and 

13 Rodenticide Act (7 U.S.C. 136a–1(k)) is 

14 amended— 

15 (i) by redesignating paragraphs (4) 

16 and (5) as paragraphs (5) and (6), respec17 tively; 

18 (ii) by inserting after paragraph (3) 

19 the following: 

20 ‘‘(4) ENHANCEMENTS OF INFORMATION TECH21 NOLOGY SYSTEMS FOR IMPROVEMENT IN REVIEW OF

22 PESTICIDE APPLICATIONS.— 

23 ‘‘(A) IN GENERAL.—For each of fiscal 

24 years 2013 through 2017, the Administrator 

25 shall use not more than $800,000 of the 
9 

†S 3552 ES

1 amounts made available to the Administrator in 

2 the Reregistration and Expedited Processing 

3 Fund for the activities described in subpara4 graph (B). 

5 ‘‘(B) ACTIVITIES.—The Administrator 

6 shall use amounts made available from the Re7 registration and Expedited Processing Fund to 

8 improve the information systems capabilities for 

9 the Office of Pesticide Programs to enhance 

10 tracking of pesticide registration decisions, 

11 which shall include— 

12 ‘‘(i) the electronic tracking of— 

13 ‘‘(I) registration submissions; 

14 and 

15 ‘‘(II) the status of conditional 

16 registrations; 

17 ‘‘(ii) enhancing the database for infor18 mation regarding endangered species as19 sessments for registration review; 

20 ‘‘(iii) implementing the capability to 

21 electronically review labels submitted with 

22 registration actions; and 

23 ‘‘(iv) acquiring and implementing the 

24 capability to electronically assess and 
10 

†S 3552 ES

1 evaluate confidential statements of formula 

2 submitted with registration actions.’’; and 

3 (iii) in the first sentence of paragraph 

4 (6) (as redesignated by clause (i)), by 

5 striking ‘‘to carry out the goals established 

6 under subsection (l)’’ and inserting ‘‘for 

7 the purposes described in paragraphs (2), 

8 (3), and (4) and to carry out the goals es9 tablished under subsection (l)’’. 

10 (b) PESTICIDE REGISTRATION SERVICE FEES.— 

11 (1) AMOUNT OF FEES.—Section 33(b) of the 

12 Federal Insecticide, Fungicide, and Rodenticide Act 

13 (7 U.S.C. 136w–8(b)) is amended— 

14 (A) by striking paragraph (3) and insert15 ing the following: 

16 ‘‘(3) SCHEDULE OF COVERED APPLICATIONS

17 AND REGISTRATION SERVICE FEES.—Subject to 

18 paragraph (6), the schedule of covered pesticide reg19 istration applications and corresponding registration 

20 service fees shall be as follows: 

‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 

INGREDIENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

R010 1 New Active Ingredient, Food 

use (2) (3) 

24 569,221 
11 

†S 3552 ES

‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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, Nonfood use; outdoor (2) (3) 21 395,467 

R070 5 New Active Ingredient, Nonfood use; outdoor; reduced 

risk (2) (3) 

16 395,467 

R090 6 New Active Ingredient, Nonfood 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, Nonfood use; indoor (2) (3) 20 219,949 

R120 8 New Active Ingredient, Nonfood use; indoor; reduced 

risk (2) (3) 

14 219,949 

R121 9 New Active Ingredient, Nonfood 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 
12 

†S 3552 ES

‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 
13 

†S 3552 ES

‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

R125 

New 

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 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee 

for that new active ingredient or first food use application and retain the same 

decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base 

fee for the category covers a maximum of five new products. Each application 

for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new 

inert approval. All such associated applications that are submitted together will 

be subject to the new active ingredient or first food use decision review time. In 

the case of a new active ingredient application, until that new active ingredient 

is approved, any subsequent application for another new product containing the 

same active ingredient or an amendment to the proposed labeling will be deemed 

a new active ingredient application, subject to the registration service fee and 

decision review time for a new active ingredient. In the case of a first food use 

application, until that first food use is approved, any subsequent application for 

an additional new food use or uses will be subject to the registration service fee 

and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant 

at the applicant’s initiative to support the application after completion of the 

technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active 

ingredient or first food use application. 

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that 

differ from the applicant-submitted label and relevant supporting data reviewed 

by the Agency. The applicant will notify the Agency that the applicant either (a) 

agrees to all of the terms associated with the draft accepted label as amended by 

the Agency and requests that it be issued as the accepted final Agency-stamped 

label; or (b) does not agree to one or more of the terms of the draft accepted 

label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon 

resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. 
14 

†S 3552 ES

‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 

R175 

New 

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 
15 

†S 3552 ES

‘‘TABLE 2. — REGISTRATION DIVISION — NEW USES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 

R251 

New 

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 nonfood 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 nonfood uses (3) (4) 

12 274,523 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 
16 

†S 3552 ES

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee 

for that new active ingredient or first food use application and retain the same 

decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base 

fee for the category covers a maximum of five new products. Each application 

for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new 

inert approval. All such associated applications that are submitted together will 

be subject to the new active ingredient or first food use decision review time. In 

the case of a new active ingredient application, until that new active ingredient 

is approved, any subsequent application for another new product containing the 

same active ingredient or an amendment to the proposed labeling will be deemed 

a new active ingredient application, subject to the registration service fee and 

decision review time for a new active ingredient. In the case of a first food use 

application, until that first food use is approved, any subsequent application for 

an additional new food use or uses will be subject to the registration service fee 

and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant 

at the applicant’s initiative to support the application after completion of the 

technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active 

ingredient or first food use application. 

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that 

differ from the applicant-submitted label and relevant supporting data reviewed 

by the Agency. The applicant will notify the Agency that the applicant either (a) 

agrees to all of the terms associated with the draft accepted label as amended by 

the Agency and requests that it be issued as the accepted final Agency-stamped 

label; or (b) does not agree to one or more of the terms of the draft accepted 

label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon 

resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. 

(4) Amendment applications to add the new use(s) to registered product labels 

are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in 

the new use application package is subject to the registration service fee for a 

new product or a new inert approval. However, if a new use application only 

proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered 

by the new use fee. All such associated applications that are submitted together 

will be subject to the new use decision review time. Any application for a new 

product or an amendment to the proposed labeling (a) submitted subsequent to 

submission of the new use application and (b) prior to conclusion of its decision 

review time and (c) containing the same new uses, will be deemed a separate 

new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee 

is due for each type of new use and the longest decision review time applies to 

all of the new uses requested in the application. Any information that (a) was 

neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of 

the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use 

application. 
17 

†S 3552 ES

‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND OTHER 

TOLERANCES 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 

R297 

New 

41 Amend 6 or more established 

tolerances (e.g., decrease or 

increase) in one petition; domestic or import; applicantinitiated 

11 246,744 
18 

†S 3552 ES

‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND OTHER 

TOLERANCES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

R298 

New 

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 
19 

†S 3552 ES

‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND OTHER 

TOLERANCES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

R299 

New 

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 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee 

for that new active ingredient or first food use application and retain the same 

decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base 

fee for the category covers a maximum of five new products. Each application 

for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new 

inert approval. All such associated applications that are submitted together will 

be subject to the new active ingredient or first food use decision review time. In 

the case of a new active ingredient application, until that new active ingredient 

is approved, any subsequent application for another new product containing the 

same active ingredient or an amendment to the proposed labeling will be deemed 

a new active ingredient application, subject to the registration service fee and 

decision review time for a new active ingredient. In the case of a first food use 

application, until that first food use is approved, any subsequent application for 

an additional new food use or uses will be subject to the registration service fee 

and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant 

at the applicant’s initiative to support the application after completion of the 

technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active 

ingredient or first food use application. 

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that 

differ from the applicant-submitted label and relevant supporting data reviewed 

by the Agency. The applicant will notify the Agency that the applicant either (a) 

agrees to all of the terms associated with the draft accepted label as amended by 

the Agency and requests that it be issued as the accepted final Agency-stamped 

label; or (b) does not agree to one or more of the terms of the draft accepted 

label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon 

resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. 
20 

†S 3552 ES

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service 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 
21 

†S 3552 ES

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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: 

∑ product chemistry and/or 

∑ acute toxicity and/or 

∑ public health pest efficacy 

and/or 

∑ child resistant packaging. 

(2) (3) 

7 4,807 

R314 

New 

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: 

∑ product chemistry and/or 

∑ acute toxicity and/or 

∑ public health pest efficacy 

and/or 

∑ child resistant packaging. 

(2) (3) 

8 6,009 
22 

†S 3552 ES

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

R315 

New 

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: 

∑ product chemistry and/or 

∑ acute toxicity and/or 

∑ public health pest efficacy 

and/or 

∑ animal safety studies and/or 

∑ 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 manufacturinguse 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 

R333 

New 

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 
23 

†S 3552 ES

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

R334 

New 

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 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 

(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the 

Agency for review, will be considered an application for a new product with an 

unregistered source of active ingredient. 

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that 

differ from the applicant-submitted label and relevant supporting data reviewed 

by the Agency. The applicant will notify the Agency that the applicant either (a) 

agrees to all of the terms associated with the draft accepted label as amended by 

the Agency and requests that it be issued as the accepted final Agency-stamped 

label; or (b) does not agree to one or more of the terms of the draft accepted 

label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon 

resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. 

‘‘TABLE 5. — REGISTRATION DIVISION — AMENDMENTS TO 

REGISTRATION 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

R340 54 Amendment requiring data review within RD (e.g., 

changes to precautionary 

label statements) (2) (3) 

4 3,617 

R345 

New 

55 Amending non-food animal 

product that includes submission of target animal 

safety data; previously registered (2) (3) 

7 8,000 
24 

†S 3552 ES

‘‘TABLE 5. — REGISTRATION DIVISION — AMENDMENTS TO 

REGISTRATION—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 

R351 

New 

57 Amendment adding a new unregistered source of active 

ingredient. (2) (3) 

8 11,996 

R352 

New 

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 
25 

†S 3552 ES

‘‘TABLE 5. — REGISTRATION DIVISION — AMENDMENTS TO 

REGISTRATION—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

R371 59 Amendment to Experimental 

Use Permit; (does not include extending a permit’s 

time period) (3) 

6 9,151 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 

(2) (a) EPA-initiated amendments shall not be charged registration service 

fees. (b) Registrant-initiated fast-track amendments are to be completed within 

the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by 

the Antimicrobials Division are to be completed within the timelines specified in 

FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such 

as PR Notice 98–10, continue under PR Notice timelines and are not subject to 

registration service fees. (e) Submissions with data and requiring data review 

are subject to registration service fees. 

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that 

differ from the applicant-submitted label and relevant supporting data reviewed 

by the Agency. The applicant will notify the Agency that the applicant either (a) 

agrees to all of the terms associated with the draft accepted label as amended by 

the Agency and requests that it be issued as the accepted final Agency-stamped 

label; or (b) does not agree to one or more of the terms of the draft accepted 

label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon 

resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. 

‘‘TABLE 6. — REGISTRATION DIVISION — OTHER ACTIONS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

R124 60 Conditional Ruling on 

Preapplication Study Waivers; applicant-initiated 

6 2,294 
26 

†S 3552 ES

‘‘TABLE 6. — REGISTRATION DIVISION — OTHER ACTIONS— 

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 

R275 

New 

62 Rebuttal of agency reviewed 

protocol, applicant initiated 

3 2,294 

R370 63 Cancer reassessment; applicant-initiated 18 179,818 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 

‘‘TABLE 7. — ANTIMICROBIALS DIVISION — NEW ACTIVE 

INGREDIENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 
27 

†S 3552 ES

‘‘TABLE 7. — ANTIMICROBIALS DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee 

for that new active ingredient or first food use application and retain the same 

decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base 

fee for the category covers a maximum of five new products. Each application 

for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new 

inert approval. All such associated applications that are submitted together will 

be subject to the new active ingredient or first food use decision review time. In 

the case of a new active ingredient application, until that new active ingredient 

is approved, any subsequent application for another new product containing the 

same active ingredient or an amendment to the proposed labeling will be deemed 

a new active ingredient application, subject to the registration service fee and 

decision review time for a new active ingredient. In the case of a first food use 

application, until that first food use is approved, any subsequent application for 

an additional new food use or uses will be subject to the registration service fee 

and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant 

at the applicant’s initiative to support the application after completion of the 

technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active 

ingredient or first food use application. 

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that 

differ from the applicant-submitted label and relevant supporting data reviewed 

by the Agency. The applicant will notify the Agency that the applicant either (a) 

agrees to all of the terms associated with the draft accepted label as amended by 

the Agency and requests that it be issued as the accepted final Agency-stamped 

label; or (b) does not agree to one or more of the terms of the draft accepted 

label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon 

resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. 
28 

†S 3552 ES

‘‘TABLE 8. — ANTIMICROBIALS DIVISION — NEW USES 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 

A471 

New 

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 

A481 

New 

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 

A491 

New 

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 

A501 

New 

81 Additional non-food; indoor; 

FIFRA §2(mm) uses; 6 or 

more submitted in one application (4) (5) 

9 69,462 
29 

†S 3552 ES

‘‘TABLE 8. — ANTIMICROBIALS DIVISION — NEW USES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

A510 82 Additional use; non-food; indoor; uses other than 

FIFRA §2(mm) (4) (5) 

12 11,577 

A511 

New 

83 Additional non-food; indoor; 

uses other than FIFRA 

§2(mm); 6 or more submitted in one application 

(4) (5) 

12 69,462 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee 

for that new active ingredient or first food use application and retain the same 

decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base 

fee for the category covers a maximum of five new products. Each application 

for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new 

inert approval. All such associated applications that are submitted together will 

be subject to the new active ingredient or first food use decision review time. In 

the case of a new active ingredient application, until that new active ingredient 

is approved, any subsequent application for another new product containing the 

same active ingredient or an amendment to the proposed labeling will be deemed 

a new active ingredient application, subject to the registration service fee and 

decision review time for a new active ingredient. In the case of a first food use 

application, until that first food use is approved, any subsequent application for 

an additional new food use or uses will be subject to the registration service fee 

and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant 

at the applicant’s initiative to support the application after completion of the 

technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active 

ingredient or first food use application. 

(3) If EPA data rules are amended to newly require clearance under section 

408 of the FFDCA for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data 

for such clearance of such product is not subject to a registration service fee for 

the tolerance action for two years from the effective date of the rule. 
30 

†S 3552 ES

(4) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that 

differ from the applicant-submitted label and relevant supporting data reviewed 

by the Agency. The applicant will notify the Agency that the applicant either (a) 

agrees to all of the terms associated with the draft accepted label as amended by 

the Agency and requests that it be issued as the accepted final Agency-stamped 

label; or (b) does not agree to one or more of the terms of the draft accepted 

label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon 

resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. 

(5) Amendment applications to add the new use(s) to registered product labels 

are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in 

the new use application package is subject to the registration service fee for a 

new product or a new inert approval. However, if a new use application only 

proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered 

by the new use fee. All such associated applications that are submitted together 

will be subject to the new use decision review time. Any application for a new 

product or an amendment to the proposed labeling (a) submitted subsequent to 

submission of the new use application and (b) prior to conclusion of its decision 

review time and (c) containing the same new uses, will be deemed a separate 

new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee 

is due for each type of new use and the longest decision review time applies to 

all of the new uses requested in the application. Any information that (a) was 

neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of 

the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use 

application. 
31 

†S 3552 ES

‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS AND 

AMENDMENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service 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 
32 

†S 3552 ES

‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS AND 

AMENDMENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 

A572 

New 

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 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 

(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the 

Agency for review, will be considered an application for a new product with an 

unregistered source of active ingredient. 

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that 

differ from the applicant-submitted label and relevant supporting data reviewed 

by the Agency. The applicant will notify the Agency that the applicant either (a) 

agrees to all of the terms associated with the draft accepted label as amended by 

the Agency and requests that it be issued as the accepted final Agency-stamped 

label; or (b) does not agree to one or more of the terms of the draft accepted 

label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon 

resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. 

(4) (a) EPA-initiated amendments shall not be charged registration service 

fees. (b) Registrant-initiated fast-track amendments are to be completed within 

the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by 

the Antimicrobials Division are to be completed within the timelines specified in 

FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such 

as PR Notice 98–10, continue under PR Notice timelines and are not subject to 

registration service fees. (e) Submissions with data and requiring data review 

are subject to registration service fees. 
33 

†S 3552 ES

‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE 

PERMITS AND OTHER TYPE OF ACTIONS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service 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 

A524 

New 

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 

A525 

New 

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 
34 

†S 3552 ES

‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE 

PERMITS AND OTHER TYPE OF ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

A526 

New 

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 

A527 

New 

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 

A528 

New 

99 Experimental Use Permit application, Food Use; Requires Tolerance or Tolerance Exemption (2) 15 20,260 

A529 

New 

100 Amendment to Experimental 

Use Permit; requires data 

review or risk assessment 

(2) 

9 10,365 

A523 

New 

101 Review of protocol other than 

a public health efficacy 

study (i.e., Toxicology or 

Exposure Protocols) 

9 11,025 
35 

†S 3552 ES

‘‘TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE 

PERMITS AND OTHER TYPE OF ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

A571 

New 

102 Science reassessment: Cancer 

risk, refined ecological risk, 

and/or endangered species; 

applicant-initiated 

18 86,823 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 

(2) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that 

differ from the applicant-submitted label and relevant supporting data reviewed 

by the Agency. The applicant will notify the Agency that the applicant either (a) 

agrees to all of the terms associated with the draft accepted label as amended by 

the Agency and requests that it be issued as the accepted final Agency-stamped 

label; or (b) does not agree to one or more of the terms of the draft accepted 

label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon 

resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. 

‘‘TABLE 11. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW ACTIVE INGREDIENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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; nonfood 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 
36 

†S 3552 ES

‘‘TABLE 11. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW ACTIVE INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

B611 

New 

107 New active ingredient; Experimental Use Permit application; petition to establish 

permanent tolerance exemption 

12 11,577 

B612 

New 

108 New active ingredient; no 

change to a permanent tolerance exemption (2) 

10 15,918 

B613 

New 

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 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee 

for that new active ingredient or first food use application and retain the same 

decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base 

fee for the category covers a maximum of five new products. Each application 

for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new 

inert approval. All such associated applications that are submitted together will 

be subject to the new active ingredient or first food use decision review time, except where the new inert approval decision review time is greater than that for 

the new active ingredient, in which case the associated new active ingredient will 

be subject to the new inert approval decision review time. In the case of a new 

active ingredient application, until that new active ingredient is approved, any 

subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active 

ingredient application, subject to the registration service fee and decision review 

time for a new active ingredient. In the case of a first food use application, until 

that first food use is approved, any subsequent application for an additional new 

food use or uses will be subject to the registration service fee and decision review 

time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s 

initiative to support the application after completion of the technical deficiency 

screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or 

first food use application. 
37 

†S 3552 ES

‘‘TABLE 12. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW USES 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service 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 

B643 

New 

114 New Food use; petition to 

amend tolerance exemption 

(3) 

10 11,577 

B642 

New 

115 First food use; indoor; food/ 

food handling (2) 

12 28,942 

B644 

New 

116 New use, no change to an established tolerance or tolerance exemption (3) 8 11,577 
38 

†S 3552 ES

‘‘TABLE 12. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW 

USES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

B650 117 New use; non-food (3) 7 5,789 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee 

for that new active ingredient or first food use application and retain the same 

decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base 

fee for the category covers a maximum of five new products. Each application 

for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new 

inert approval. All such associated applications that are submitted together will 

be subject to the new active ingredient or first food use decision review time. In 

the case of a new active ingredient application, until that new active ingredient 

is approved, any subsequent application for another new product containing the 

same active ingredient or an amendment to the proposed labeling will be deemed 

a new active ingredient application, subject to the registration service fee and 

decision review time for a new active ingredient. In the case of a first food use 

application, until that first food use is approved, any subsequent application for 

an additional new food use or uses will be subject to the registration service fee 

and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant 

at the applicant’s initiative to support the application after completion of the 

technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active 

ingredient or first food use application. 

(3) Amendment applications to add the new use(s) to registered product labels 

are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in 

the new use application package is subject to the registration service fee for a 

new product or a new inert approval. However, if a new use application only 

proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered 

by the new use fee. All such associated applications that are submitted together 

will be subject to the new use decision review time. Any application for a new 

product or an amendment to the proposed labeling (a) submitted subsequent to 

submission of the new use application and (b) prior to conclusion of its decision 

review time and (c) containing the same new uses, will be deemed a separate 

new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee 

is due for each type of new use and the longest decision review time applies to 

all of the new uses requested in the application. Any information that (a) was 

neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of 

the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use 

application. 
39 

†S 3552 ES

‘‘TABLE 13. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

B652 

New 

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 
40 

†S 3552 ES

‘‘TABLE 13. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 reisolated. (2) 

4 1,159 
41 

†S 3552 ES

‘‘TABLE 13. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 
42 

†S 3552 ES

‘‘TABLE 13. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 
43 

†S 3552 ES

‘‘TABLE 13. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 

B673 

New 

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 

B674 

New 

124 New product MUP; Repack of 

identical registered end-use 

product as a manufacturinguse product; same registered 

uses only (2) 

4 1,159 
44 

†S 3552 ES

‘‘TABLE 13. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

B675 

New 

125 New Product MUP; registered 

source of active ingredient; 

submission of completely 

new generic data package; 

registered uses only. (2) 

10 8,269 

B676 

New 

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 
45 

†S 3552 ES

‘‘TABLE 13. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

B677 

New 

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: 

∑ product chemistry and/or 

∑ acute toxicity and/or 

∑ public health pest efficacy 

and/or 

∑ animal safety studies and/or 

∑ child resistant packaging (2) 

10 8,000 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 

(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the 

Agency for review, will be considered an application for a new product with an 

unregistered source of active ingredient. 

‘‘TABLE 14. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; AMENDMENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

B621 128 Amendment; Experimental 

Use Permit; no change to 

an established temporary 

tolerance or tolerance exemption. 

7 4,631 

B622 

New 

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 
46 

†S 3552 ES

‘‘TABLE 14. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; AMENDMENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 

B683 

New 

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 

B684 

New 

134 Amending non-food animal 

product that includes submission of target animal 

safety data; previously registered (2) 

8 8,000 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 

(2) (a) EPA-initiated amendments shall not be charged registration service 

fees. (b) Registrant-initiated fast-track amendments are to be completed within 

the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by 

the Antimicrobials Division are to be completed within the timelines specified in 

FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such 

as PR Notice 98–10, continue under PR Notice timelines and are not subject to 

registration service fees. (e) Submissions with data and requiring data review 

are subject to registration service fees. 

‘‘TABLE 15. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES(SCLPS) 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

B690 135 New active ingredient; food or 

non-food use. (2) 

7 2,316 
47 

†S 3552 ES

‘‘TABLE 15. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — STRAIGHT CHAIN LEPIDOPTERAN 

PHEROMONES(SCLPS)—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 
48 

†S 3552 ES

‘‘TABLE 15. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — STRAIGHT CHAIN LEPIDOPTERAN 

PHEROMONES(SCLPS)—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 
49 

†S 3552 ES

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee 

for that new active ingredient or first food use application and retain the same 

decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base 

fee for the category covers a maximum of five new products. Each application 

for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new 

inert approval. All such associated applications that are submitted together will 

be subject to the new active ingredient or first food use decision review time, except where the new inert approval decision review time is greater than that for 

the new active ingredient, in which case the associated new active ingredient will 

be subject to the new inert approval decision review time. In the case of a new 

active ingredient application, until that new active ingredient is approved, any 

subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active 

ingredient application, subject to the registration service fee and decision review 

time for a new active ingredient. In the case of a first food use application, until 

that first food use is approved, any subsequent application for an additional new 

food use or uses will be subject to the registration service fee and decision review 

time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s 

initiative to support the application after completion of the technical deficiency 

screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or 

first food use application. 

(3) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the 

Agency for review, will be considered an application for a new product with an 

unregistered source of active ingredient. 

(4) (a) EPA-initiated amendments shall not be charged registration service 

fees. (b) Registrant-initiated fast-track amendments are to be completed within 

the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by 

the Antimicrobials Division are to be completed within the timelines specified in 

FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such 

as PR Notice 98–10, continue under PR Notice timelines and are not subject to 

registration service fees. (e) Submissions with data and requiring data review 

are subject to registration service fees. 

(5) Amendment applications to add the new use(s) to registered product labels 

are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in 

the new use application package is subject to the registration service fee for a 

new product or a new inert approval. However, if a new use application only 

proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered 

by the new use fee. All such associated applications that are submitted together 

will be subject to the new use decision review time. Any application for a new 

product or an amendment to the proposed labeling (a) submitted subsequent to 

submission of the new use application and (b) prior to conclusion of its decision 

review time and (c) containing the same new uses, will be deemed a separate 

new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee 

is due for each type of new use and the longest decision review time applies to 

all of the new uses requested in the application. Any information that (a) was 

neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of 

the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use 

application. 
50 

†S 3552 ES

‘‘TABLE 16. — BIOPESTICIDES AND POLLUTION PREVENTION 

DIVISION — OTHER ACT 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

B614 

New 

143 Conditional Ruling on 

Preapplication Study Waivers; applicant-initiated 

3 2,294 

B615 

New 

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 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 

‘‘TABLE 17. — BIOPESTICIDES AND POLLUTION PREVENTION 

DIVISION — PLANT INCORPORATED PROTECTANTS (PIPS) 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service 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 
51 

†S 3552 ES

‘‘TABLE 17. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — PLANT INCORPORATED PROTECTANTS (PIPS)—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 
52 

†S 3552 ES

‘‘TABLE 17. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — PLANT INCORPORATED PROTECTANTS (PIPS)—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 
53 

†S 3552 ES

‘‘TABLE 17. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — PLANT INCORPORATED PROTECTANTS (PIPS)—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 

B883 

New 

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 
54 

†S 3552 ES

‘‘TABLE 17. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — PLANT INCORPORATED PROTECTANTS (PIPS)—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

B884 

New 

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 

B885 

New 

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 
55 

†S 3552 ES

‘‘TABLE 17. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — PLANT INCORPORATED PROTECTANTS (PIPS)—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 

(2) New PIP = a PIP with an active ingredient that has not been registered. 

(3) Registered PIP = a PIP with an active ingredient that is currently registered. 

(4) Transfer registered PIP through conventional breeding for new food/feed 

use, such as from field corn to sweet corn. 

(5) The scientific data involved in this category are complex. EPA often seeks 

technical advice from the Scientific Advisory Panel on risks that pesticides pose 

to wildlife, farm workers, pesticide applicators, non-target species, as well as insect resistance, and novel scientific issues surrounding new technologies. The scientists of the SAP neither make nor recommend policy decisions. They provide 

advice on the science used to make these decisions. Their advice is invaluable to 

the EPA as it strives to protect humans and the environment from risks posed 

by pesticides. Due to the time it takes to schedule and prepare for meetings with 

the SAP, additional time and costs are needed. 

(6) Registered PIPs stacked through conventional breeding. 

(7) Deployment of a registered PIP with a different IRM plan (e.g., seed 

blend). 

(8) The negotiated acreage cap will depend upon EPA’s determination of the 

potential environmental exposure, risk(s) to non-target organisms, and the risk 

of targeted pest developing resistance to the pesticidal substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity 

and type of non-target organism data submitted and the lack of insect resistance 

management data, which is usually not required for seed-increase registrations. 

Registrants are encouraged to consult with EPA prior to submission of a registration application in this category. 

(9) Application can be submitted prior to or concurrently with an application 

for commercial registration. 

(10) For example, IRM plan modifications that are applicant-initiated. 

(11) EPA-initiated amendments shall not be charged fees. 
56 

†S 3552 ES

‘‘TABLE 18. — INERT INGREDIENTS, EXTERNAL REVIEW AND 

MISCELLANEOUS ACTIONS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

I001 172 Approval of new food use inert 

ingredient (2) (3) 

12 18,000 

I002 

New 

173 Amend currently approved 

inert ingredient tolerance or 

exemption from tolerance; 

new data (2) 

10 5,000 

I003 

New 

174 Amend currently approved 

inert ingredient tolerance or 

exemption from tolerance; 

no new data (2) 

8 3,000 

I004 

New 

175 Approval of new non-food use 

inert ingredient (2) 

8 10,000 

I005 

New 

176 Amend currently approved 

non-food use inert ingredient with new use pattern; 

new data (2) 

8 5,000 

I006 

New 

177 Amend currently approved 

non-food use inert ingredient with new use pattern; 

no new data (2) 

6 3,000 

I007 

New 

178 Approval of substantially similar non-food use inert ingredients when original inert is 

compositionally similar with 

similar use pattern (2) 

4 1,500 

I008 

New 

179 Approval of new polymer inert 

ingredient, food use (2) 

5 3,400 

I009 

New 

180 Approval of new polymer inert 

ingredient, non food use (2) 

4 2,800 

I010 

New 

181 Petition to amend a tolerance 

exemption descriptor to add 

one or more CASRNs; no 

new data (2) 

6 1,500 
57 

†S 3552 ES

‘‘TABLE 18. — INERT INGREDIENTS, EXTERNAL REVIEW AND 

MISCELLANEOUS ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

M001 

New 

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 

M002 

New 

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 

M003 

New 

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 
58 

†S 3552 ES

‘‘TABLE 18. — INERT INGREDIENTS, EXTERNAL REVIEW AND 

MISCELLANEOUS ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

M004 

New 

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 

M005 

New 

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 

M006 

New 

187 Request for up to 5 letters of 

certification (Gold Seal) for 

one actively registered product. 

1 250 

M007 

New 

188 Request to extend Exclusive 

Use of data as provided by 

FIFRA Section 

3(c)(1)(F)(ii) 

12 5,000 
59 

†S 3552 ES

‘‘TABLE 18. — INERT INGREDIENTS, EXTERNAL REVIEW AND 

MISCELLANEOUS ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

M008 

New 

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 

(1) A decision review time that would otherwise end on a Saturday, Sunday, 

or federal holiday, will be extended to end on the next business day. 

(2) If another covered application is associated with and dependent upon a 

pending application for an inert ingredient action, each application will be subject to its respective registration service fee. The decision review time for the 

other associated covered application will be extended to match the PRIA due 

date of the pending inert ingredient action, unless the PRIA due date for the 

other associated covered action is further out, in which case it will be subject to 

its own decision review time. If the application covers multiple ingredients 

grouped by EPA into one chemical class, a single registration service fee will be 

assessed for approval of those ingredients. 

(3) If EPA data rules are amended to newly require clearance under section 

408 of the FFDCA for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data 

for such clearance of such product is not subject to a registration service fee for 

the tolerance action for two years from the effective date of the rule. 

(4) Any other covered application that is associated with and dependent on 

the HSRB review will be subject to its separate registration service fee. The decision review times for the associated actions run concurrently, but will end at 

the date of the latest review time. 

(5) Any other covered application that is associated with and dependent on 

the SAP review will be subject to its separate registration service fee. The decision review time for the associated action will be extended by the decision review 

time for the SAP review. 

(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the 

Agency for review, will be considered an application for a new product with an 

unregistered source of active ingredient. 

(7) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that 

differ from the applicant-submitted label and relevant supporting data reviewed 

by the Agency. The applicant will notify the Agency that the applicant either (a) 

agrees to all of the terms associated with the draft accepted label as amended by 

the Agency and requests that it be issued as the accepted final Agency-stamped 

label; or (b) does not agree to one or more of the terms of the draft accepted 

label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon 

resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.’’; 
60 

†S 3552 ES

1 (B) in paragraph (6)— 

2 (i) in subparagraph (A)— 

3 (I) by striking ‘‘October 1, 2008’’ 

4 and inserting ‘‘October 1, 2013’’; and 

5 (II) by striking ‘‘September 30, 

6 2010’’ and inserting ‘‘September 30, 

7 2015’’; and 

8 (ii) in subparagraph (B)— 

9 (I) by striking ‘‘October 1, 2010’’ 

10 and inserting ‘‘October 1, 2015’’; and 

11 (II) by striking ‘‘September 30, 

12 2010’’ and inserting ‘‘September 30, 

13 2015’’; and 

14 (C) in paragraph (8)(C)(ii)— 

15 (i) in subclause (I), by striking ‘‘or’’ 

16 at the end; 

17 (ii) in subclause (II), by striking the 

18 period at the end and inserting ‘‘; or’’; and 

19 (iii) by adding at the end the fol20 lowing: 

21 ‘‘(III) on the basis that the Ad22 ministrator rejected the application 

23 under subsection (f)(4)(B).’’. 

24 (2) PESTICIDE REGISTRATION FUND.—Section 

25 33(c)(3)(B) of the Federal Insecticide, Fungicide, 
61 

†S 3552 ES

1 and Rodenticide Act (7 U.S.C. 136w–8(c)(3)(B)) is 

2 amended— 

3 (A) in clause (i), by striking ‘‘2008 

4 through 2012’’ and inserting ‘‘2013 through 

5 2017’’; 

6 (B) in clause (ii), by striking ‘‘grants’’ and 

7 all that follows through the end of the clause 

8 and inserting ‘‘grants, for each of fiscal years 

9 2013 through 2017, $500,000.’’; and 

10 (C) in clause (iii), by striking ‘‘2008 

11 through 2012’’ and inserting ‘‘2013 through 

12 2017’’. 

13 (3) ASSESSMENT OF FEES.—Section 33(d) of 

14 the Federal Insecticide, Fungicide, and Rodenticide 

15 Act (7 U.S.C. 136w–8(d)) is amended— 

16 (A) in paragraph (2), by striking ‘‘2002’’ 

17 each place it appears and inserting ‘‘2012’’; 

18 (B) by striking paragraph (4); and 

19 (C) by redesignating paragraph (5) as 

20 paragraph (4). 

21 (4) REFORMS TO REDUCE DECISION TIME RE22 VIEW PERIODS.—Section 33(e) of the Federal Insec23 ticide, Fungicide, and Rodenticide Act (7 U.S.C. 

24 136w–8(e)) is amended by striking ‘‘Pesticide Reg25 istration Improvement Act of 2003’’ and inserting 
62 

†S 3552 ES

1 ‘‘Pesticide Registration Improvement Extension Act 

2 of 2012’’. 

3 (5) DECISION TIME REVIEW PERIODS.—Section 

4 33(f) of the Federal Insecticide, Fungicide, and 

5 Rodenticide Act (7 U.S.C. 136w–8(f)) is amended— 

6 (A) in paragraph (1), by striking ‘‘Pes7 ticide Registration Improvement Renewal Act, 

8 the Administrator shall publish in the Federal 

9 Register’’ and inserting ‘‘Pesticide Registration 

10 Improvement Extension Act of 2012, the Ad11 ministrator shall make publicly available’’; 

12 (B) in paragraph (2), by striking ‘‘appear13 ing in the Congressional Record on pages 

14 S10409’’ and all that follows through the pe15 riod and inserting ‘‘provided under subsection 

16 (b)(3).’’; and 

17 (C) in paragraph (4)— 

18 (i) in subparagraph (A), by inserting 

19 ‘‘and fee’’ before the period; and 

20 (ii) in subparagraph (B)— 

21 (I) by striking ‘‘(B) COMPLETE22 NESS OF APPLICATION’’ and all that 

23 follows through ‘‘Not later’’ in clause 

24 (i) and inserting the following: 
63 

†S 3552 ES

1 ‘‘(B) INITIAL CONTENT AND PRELIMINARY

2 TECHNICAL SCREENINGS.— 

3 ‘‘(i) SCREENINGS.— 

4 ‘‘(I) INITIAL CONTENT.—Not 

5 later’’; 

6 (II) in clause (i) (as so des7 ignated) by adding at the end the fol8 lowing: 

9 ‘‘(II) PRELIMINARY TECHNICAL

10 SCREENING.—After conducting the 

11 initial content screening described in 

12 subclause (I) and in accordance with 

13 clause (iv), the Administrator shall 

14 conduct a preliminary technical 

15 screening— 

16 ‘‘(aa) not later than 45 days 

17 after the date on which the deci18 sion time review period begins 

19 (for applications with decision 

20 time review periods of not more 

21 than 180 days); and 

22 ‘‘(bb) not later than 90 days 

23 after the date on which the deci24 sion time review period begins 

25 (for applications with decision 
64 

†S 3552 ES

1 time review periods greater than 

2 180 days).’’; 

3 (III) by striking clause (ii) and 

4 inserting the following: 

5 ‘‘(ii) REJECTION.— 

6 ‘‘(I) IN GENERAL.—If the Ad7 ministrator determines at any time 

8 before the Administrator completes 

9 the preliminary technical screening 

10 under clause (i)(II) that the applica11 tion failed the initial content or pre12 liminary technical screening and the 

13 applicant does not correct the failure 

14 before the date that is 10 business 

15 days after the applicant receives a no16 tification of the failure, the Adminis17 trator shall reject the application. 

18 ‘‘(II) WRITTEN NOTIFICATION.— 

19 The Administrator shall make every 

20 effort to provide a written notification 

21 of a rejection under subclause (I) dur22 ing the 10-day period that begins on 

23 the date the Administrator completes 

24 the preliminary technical screening.’’; 

25 (IV) in clause (iii)— 
65 

†S 3552 ES

1 (aa) in the heading, by in2 serting ‘‘INITIAL CONTENT’’ be3 fore ‘‘SCREENING’’ ; 

4 (bb) in the matter preceding 

5 subclause (I), by inserting ‘‘con6 tent’’ after ‘‘initial’’; and 

7 (cc) in subclause (II), by 

8 striking ‘‘contains’’ and inserting 

9 ‘‘appears to contain’’; and 

10 (V) by adding at the end the fol11 lowing: 

12 ‘‘(iv) REQUIREMENTS OF PRELIMI13 NARY TECHNICAL SCREENING.—In con14 ducting a preliminary technical screening 

15 of an application, the Administrator shall 

16 determine if— 

17 ‘‘(I) the application and the data 

18 and information submitted with the 

19 application are accurate and complete; 

20 and 

21 ‘‘(II) the application, data, and 

22 information are consistent with the 

23 proposed labeling and any proposal 

24 for a tolerance or exemption from the 

25 requirement for a tolerance under sec-
66 

†S 3552 ES

1 tion 408 of the Federal Food, Drug, 

2 and Cosmetic Act (21 U.S.C. 346a), 

3 and are such that, subject to full re4 view under the standards of this Act, 

5 could result in the granting of the ap6 plication.’’. 

7 (6) REPORTS.—Section 33(k) of the Federal 

8 Insecticide, Fungicide, and Rodenticide Act (7 

9 U.S.C. 136w–8(k)) is amended— 

10 (A) in paragraph (1), by striking ‘‘March 

11 1, 2014’’ and inserting ‘‘March 1, 2017’’; 

12 (B) in paragraph (2)— 

13 (i) in subparagraph (A)— 

14 (I) in clause (vi)(V), by striking 

15 ‘‘and’’ at the end; 

16 (II) in clause (vii)(II), by insert17 ing ‘‘and’’ at the end; and 

18 (III) by adding at the end the 

19 following: 

20 ‘‘(viii) the number of extensions of de21 cision time review periods agreed to under 

22 subsection (f)(5) along with a description 

23 of the reason that the Administrator was 

24 unable to make a decision within the initial 

25 decision time review period;’’; 
67 

†S 3552 ES

1 (ii) in subparagraph (E), by striking 

2 ‘‘and’’ at the end; 

3 (iii) in subparagraph (F), by striking 

4 the period and inserting a semicolon; and 

5 (iv) by adding at the end the fol6 lowing: 

7 ‘‘(G) a review of the progress made to8 ward— 

9 ‘‘(i) carrying out section 4(k)(4) and 

10 the amounts from the Reregistration and 

11 Expedited Processing Fund used for the 

12 purposes described in that section; 

13 ‘‘(ii) implementing systems for the 

14 electronic tracking of registration submis15 sions by December 31, 2013; 

16 ‘‘(iii) implementing a system for 

17 tracking the status of conditional registra18 tions, including making nonconfidential in19 formation related to the conditional reg20 istrations publicly available by December 

21 31, 2013; 

22 ‘‘(iv) implementing enhancements to 

23 the endangered species knowledge data24 base, including making nonconfidential in-
68 

†S 3552 ES

1 formation related to the database publicly 

2 available; 

3 ‘‘(v) implementing the capability to 

4 electronically submit and review labels sub5 mitted with registration actions; 

6 ‘‘(vi) acquiring and implementing the 

7 capability to electronically assess and 

8 evaluate confidential statements of formula 

9 submitted with registration actions by De10 cember 31, 2014; and 

11 ‘‘(vii) facilitating public participation 

12 in certain registration actions and the reg13 istration review process by providing elec14 tronic notification to interested parties of 

15 additions to the public docket; 

16 ‘‘(H) the number of applications rejected 

17 by the Administrator under the initial content 

18 and preliminary technical screening conducted 

19 under subsection (f)(4); 

20 ‘‘(I) a review of the progress made in up21 dating the Pesticide Incident Data System, in22 cluding progress toward making the information 

23 contained in the System available to the public 

24 (as the Administrator determines is appro25 priate); and 
69 

†S 3552 ES

1 ‘‘(J) an assessment of the public avail2 ability of summary pesticide usage data.’’; and 

3 (C) by adding at the end the following: 

4 ‘‘(4) OTHER REPORT.— 

5 ‘‘(A) SCOPE.—In addition to the annual 

6 report described in paragraph (1), not later 

7 than October 1, 2016, the Administrator shall 

8 submit to the Committee on Agriculture of the 

9 House of Representatives and the Committee 

10 on Agriculture, Nutrition, and Forestry of the 

11 Senate a report that includes an analysis of the 

12 impact of maintenance fees on small businesses 

13 that have— 

14 ‘‘(i) 10 or fewer employees; and 

15 ‘‘(ii) annual global gross revenue that 

16 does not exceed $2,000,000. 

17 ‘‘(B) INFORMATION REQUIRED.—In con18 ducting the analysis described in subparagraph 

19 (A), the Administrator shall collect, and include 

20 in the report under that subparagraph, infor21 mation on— 

22 ‘‘(i) the number of small businesses 

23 described in subparagraph (A) that are 

24 paying maintenance fees; and 
70 

†S 3552 ES

1 ‘‘(ii) the number of registrations each 

2 company holds.’’. 

3 (7) TERMINATION OF EFFECTIVENESS.—Sec4 tion 33(m) of the Federal Insecticide, Fungicide, 

5 and Rodenticide Act (7 U.S.C. 136w–8(m)) is 

6 amended— 

7 (A) in paragraph (1), by striking ‘‘2012’’ 

8 and inserting ‘‘2017’’; and 

9 (B) in paragraph (2)— 

10 (i) in subparagraph (A)— 

11 (I) in the heading, by striking 

12 ‘‘2013’’ and inserting ‘‘2018’’; 

13 (II) by striking ‘‘2013,’’ and in14 serting ‘‘2018,’’; and 

15 (III) by striking ‘‘September 30, 

16 2012’’ and inserting ‘‘September 30, 

17 2017’’; 

18 (ii) in subparagraph (B)— 

19 (I) in the heading, by striking 

20 ‘‘2014’’ and inserting ‘‘2019’’; 

21 (II) by striking ‘‘2014,’’ and in22 serting ‘‘2019,’’; and 

23 (III) by striking ‘‘September 30, 

24 2012’’ and inserting ‘‘September 30, 

25 2017’’; 
71 

†S 3552 ES

1 (iii) in subparagraph (C)— 

2 (I) in the heading, by striking 

3 ‘‘2014’’ and inserting ‘‘2019’’; and 

4 (II) by striking ‘‘September 30, 

5 2014’’ and inserting ‘‘September 30, 

6 2019’’; and 

7 (iv) in subparagraph (D), by striking 

8 ‘‘2012’’ each place it appears and inserting 

9 ‘‘2017’’. 

10 (c) EFFECTIVE DATE.—This section and the amend11 ments made by this section take effect on October 1, 2012. 

12 (d) RELATIONSHIP TO OTHER LAW.—In the case of 

13 any conflict between this section (including the amend14 ments made by this section) and a joint resolution making 

15 continuing appropriations for fiscal year 2013 (including 

16 any amendments made by such a joint resolution), this 

17 section and the amendments made by this section shall 

18 control. 

Passed the Senate September 13, 2012. 

Attest: 

Secretary. 
112TH CONGRESS 

2D SESSION S. 3552 

AN ACT 

To reauthorize the Federal Insecticide, Fungicide, 

and Rodenticide Act.