PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1327 

Public Law 112–177 

112th Congress 

An Act 

To reauthorize the Federal Insecticide, Fungicide, and Rodenticide Act. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Pesticide Registration Improvement Extension Act of 2012’’. 

SEC. 2. PESTICIDE REGISTRATION IMPROVEMENT. 

(a) MAINTENANCE FEES.— 

(1) FEES.—Section 4(i) of the Federal Insecticide, Fungicide, 

and Rodenticide Act (7 U.S.C. 136a–1(i)) is amended— 

(A) in paragraph (5)— 

(i) in subparagraph (C), by striking ‘‘aggregate 

amount of’’ and all that follows through the end of 

the subparagraph and inserting ‘‘aggregate amount of 

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

2017.’’; 

(ii) in subparagraph (D)— 

(I) in clause (i), by striking ‘‘shall be’’ and 

all that follows through the semicolon and 

inserting ‘‘shall be $115,500 for each of fiscal years 

2013 through 2017;’’; and 

(II) in clause (ii), by striking ‘‘shall be’’ and 

all that follows through the period and inserting 

‘‘shall be $184,800 for each of fiscal years 2013 

through 2017.’’; 

(iii) in subparagraph (E)(i)— 

(I) in subclause (I), by striking ‘‘shall be’’ and 

all that follows through the semicolon and 

inserting ‘‘shall be $70,600 for each of fiscal years 

2013 through 2017;’’; and 

(II) in subclause (II), by striking ‘‘shall be’’ 

and all that follows through the period and 

inserting ‘‘shall be $122,100 for each of fiscal years 

2013 through 2017.’’; 

(iv) in subparagraph (F)— 

(I) by striking ‘‘paragraph (3)’’ and inserting 

‘‘this paragraph’’; and 

(II) by striking ‘‘Humans’’ and inserting 

‘‘Human’’; 

(v) by redesignating subparagraphs (F) through 

(H) as subparagraphs (G) through (I), respectively; 

Pesticide 

Registration 

Improvement 

Extension Act 

of 2012. 

7 USC 136 note. 

Sept. 28, 2012 

[S. 3552] 


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126 STAT. 1328 PUBLIC LAW 112–177—SEPT. 28, 2012 

(vi) by inserting after subparagraph (E) the following: 

‘‘(F) FEE REDUCTION FOR CERTAIN SMALL BUSINESSES.— 

‘‘(i) DEFINITION.—In this subparagraph, the term 

‘qualified small business entity’ means a corporation, 

partnership, or unincorporated business that— 

‘‘(I) has 500 or fewer employees; 

‘‘(II) during the 3-year period prior to the most 

recent maintenance fee billing cycle, had an average annual global gross revenue from all sources 

that did not exceed $10,000,000; and 

‘‘(III) holds not more than 5 pesticide registrations under this paragraph. 

‘‘(ii) WAIVER.—Except as provided in clause (iii), 

the Administrator shall waive 25 percent of the fee 

under this paragraph applicable to the first registration 

of any qualified small business entity under this paragraph. 

‘‘(iii) LIMITATION.—The Administrator shall not 

grant a waiver under clause (ii) to a qualified small 

business entity if the Administrator determines that 

the entity has been formed or manipulated primarily 

for the purpose of qualifying for the waiver.’’; and 

(vii) in subparagraph (I) (as redesignated by clause 

(v)), by striking ‘‘2012’’ and inserting ‘‘2017’’; 

(B) in paragraph (6)— 

(i) by striking ‘‘2014’’ and inserting ‘‘2019’’; and 

(ii) by striking ‘‘paragraphs (1) through (5)’’ and 

inserting ‘‘paragraph (1)’’; 

(C) by striking paragraphs (1), (2), (3), (4), and (7); 

and 

(D) by redesignating paragraphs (5) and (6) as paragraphs (1) and (2), respectively. 

(2) CONFORMING AMENDMENTS.— 

(A) Section 4 of the Federal Insecticide, Fungicide, 

and Rodenticide Act (7 U.S.C. 136a–1) is amended— 

(i) in subsection (d)(5)(B)(ii)(III), by striking ‘‘subsection (i)(1)’’ and inserting ‘‘this section’’; 

(ii) in subsection (j), by striking ‘‘subsection (i)(5)’’ 

and inserting ‘‘subsection (i)(1)’’; and 

(iii) in subsection (k)(5)— 

(I) in the first sentence, by striking ‘‘subsection 

(i)(5)(C)(ii)’’ and inserting ‘‘subsection (i)(1)(C)(ii)’’; 

and 

(II) in the third and sixth sentences, by 

striking ‘‘subsection (i)(5)(C)’’ each place it appears 

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

(B) Section 33(b)(7)(F) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)(7)(F)) is 

amended— 

(i) by striking ‘‘section 4(i)(5)(E)(ii)’’ each place it 

appears in clauses (i), (ii)(I), and (iv)(I) and inserting 

‘‘section 4(i)(1)(E)(ii)’’; 

(ii) by striking ‘‘section 4(i)(5)(E)(ii)(I)(bb)’’ each 

place it appears in clauses (ii)(II) and (iv)(II) and 

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

(iii) in clause (iv)(II)— 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1329 

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

‘‘applicable’’; and 

(II) by striking ‘‘revenues’’ and inserting ‘‘revenue’’. 

(3) EXTENSION OF PROHIBITION ON TOLERANCE FEES.—Section 408(m)(3) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 346a(m)(3)) is amended by striking ‘‘September 30, 

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

(4) REREGISTRATION AND EXPEDITED PROCESSING FUND.— (A) SOURCE AND USE.—Section 4(k)(2)(A) of the Federal 

Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a– 

1(k)(2)(A)) is amended— 

(i) by inserting ‘‘, to enhance the information systems capabilities to improve the tracking of pesticide 

registration decisions,’’ after ‘‘paragraph (3)’’ each place 

it appears; and 

(ii) in clause (i)— 

(I) by inserting ‘‘offset’’ before ‘‘the costs of 

reregistration’’; and 

(II) by striking ‘‘in the same portion as appropriated funds’’. 

(B) EXPEDITED PROCESSING OF SIMILAR APPLICATIONS.— 

Section 4(k)(3)(A) of the Federal Insecticide, Fungicide, and 

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

(i) in the matter preceding clause (i), by striking 

‘‘2008 through 2012, between 1⁄8 and 1⁄7’’ and inserting 

‘‘2013 through 2017, between 1⁄9 and 1⁄8’’; 

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

(iii) in clause (ii), by striking ‘‘any application’’ 

and all that follows through ‘‘that—’’ and inserting 

‘‘any application that—’’. 

(C) ENHANCEMENTS OF INFORMATION TECHNOLOGY SYSTEMS FOR IMPROVEMENT IN REVIEW OF PESTICIDE APPLICATIONS.—Section 4(k) of the Federal Insecticide, Fungicide, 

and Rodenticide Act (7 U.S.C. 136a–1(k)) is amended— 

(i) by redesignating paragraphs (4) and (5) as paragraphs (5) and (6), respectively; 

(ii) by inserting after paragraph (3) the following: 

‘‘(4) ENHANCEMENTS OF INFORMATION TECHNOLOGY SYSTEMS

FOR IMPROVEMENT IN REVIEW OF PESTICIDE APPLICATIONS.— 

‘‘(A) IN GENERAL.—For each of fiscal years 2013 

through 2017, the Administrator shall use not more than 

$800,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund 

for the activities described in subparagraph (B). 

‘‘(B) ACTIVITIES.—The Administrator shall use amounts 

made available from the Reregistration and Expedited 

Processing Fund to improve the information systems 

capabilities for the Office of Pesticide Programs to enhance 

tracking of pesticide registration decisions, which shall 

include— 

‘‘(i) the electronic tracking of— 

‘‘(I) registration submissions; and 

‘‘(II) the status of conditional registrations; 

‘‘(ii) enhancing the database for information 

regarding endangered species assessments for registration review; 


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126 STAT. 1330 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘(iii) implementing the capability to electronically 

review labels submitted with registration actions; and 

‘‘(iv) acquiring and implementing the capability 

to electronically assess and evaluate confidential statements of formula submitted with registration actions.’’; 

and 

(iii) in the first sentence of paragraph (6) (as 

redesignated by clause (i)), by striking ‘‘to carry out 

the goals established under subsection (l)’’ and 

inserting ‘‘for the purposes described in paragraphs 

(2), (3), and (4) and to carry out the goals established 

under subsection (l)’’. 

(b) PESTICIDE REGISTRATION SERVICE FEES.— 

(1) AMOUNT OF FEES.—Section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) is 

amended— 

(A) by striking paragraph (3) and inserting the following: 

‘‘(3) SCHEDULE OF COVERED APPLICATIONS AND REGISTRATION SERVICE FEES.—Subject to paragraph (6), the schedule 

of covered pesticide registration applications and corresponding 

registration service fees shall be as follows: 

‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 

INGREDIENTS 

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 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1331 

‘‘TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

R060 4 New Active Ingredient, 

Non-food use; outdoor 

(2) (3) 

21 395,467 

R070 5 New Active Ingredient, 

Non-food use; outdoor; reduced risk (2) 

(3) 

16 395,467 

R090 6 New Active Ingredient, 

Non-food use; outdoor; Experimental 

Use Permit application; submitted before application for 

registration; credit 

45% of fee toward 

new active ingredient 

(3) 

16 293,596 

R110 7 New Active Ingredient, 

Non-food use; indoor 

(2) (3) 

20 219,949 

R120 8 New Active Ingredient, 

Non-food use; indoor; 

reduced risk (2) (3) 

14 219,949 

R121 9 New Active Ingredient, 

Non-food use; indoor; 

Experimental Use 

Permit application; 

submitted before application for registration; credit 45% of fee 

toward new active ingredient application 

that follows (3) 

18 165,375 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1332 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 

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. 

Extension. 


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PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1333 

(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 applicantsubmitted 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. 

Notification. 

Labeling. 

Deadlines. 


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126 STAT. 1334 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 


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PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1335 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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; nonfood; outdoor (3) (4) 15 23,969 

R240 25 Additional use; nonfood; outdoor; reduced risk (3) (4) 10 23,969 

R250 26 Additional use; nonfood; 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 


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126 STAT. 1336 PUBLIC LAW 112–177—SEPT. 28, 2012 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 

non-food 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. 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1337 

(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 applicantsubmitted 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. 

Notification. 

Labeling. 

Deadlines. 


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126 STAT. 1338 PUBLIC LAW 112–177—SEPT. 28, 2012 

(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. 

‘‘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 


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PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1339 

‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 

OTHER TOLERANCES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1340 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘TABLE 3. — REGISTRATION DIVISION — IMPORT AND 

OTHER TOLERANCES—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

R297 

New 

41 Amend 6 or more established tolerances 

(e.g., decrease or increase) in one petition; domestic or import; applicant-initiated 

11 246,744 

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 

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. 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1341 

(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 applicantsubmitted 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. 

Labeling. 

Deadlines. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1342 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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% repackage of registered 

end-use or manufacturing-use product 

that requires no data 

submission nor data 

matrix. (2) (3) 

4 1,434 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1343 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1344 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1345 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1346 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 

manufacturing-use 

product; same registered uses only (2) 

(3) 

3 2,294 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1347 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1348 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 applicantsubmitted 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. 

Notification. 

Labeling. 

Deadlines. 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1349 

‘‘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 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1350 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 applicantsubmitted 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. 

Notification. 

Labeling. 

Deadlines. 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1351 

‘‘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; applicantinitiated 

6 2,294 

R272 61 Review of Study Protocol applicant-initiated; excludes DART, 

pre-registration conference, Rapid Response review, DNT 

protocol review, protocol needing HSRB 

review 

3 2,294 

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 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1352 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘TABLE 7. — ANTIMICROBIALS DIVISION — NEW ACTIVE 

INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

A400 66 Non-food use; outdoor; 

FIFRA §2(mm) uses 

(2) (3) 

18 86,823 

A410 67 Non-food use; outdoor; 

uses other than 

FIFRA §2(mm) (2) (3) 

21 173,644 

A420 68 Non-food use; indoor; 

FIFRA §2(mm) uses 

(2) (3) 

18 57,882 

A430 69 Non-food use; indoor; 

uses other than 

FIFRA §2(mm) (2) (3) 

20 86,823 

A431 70 Non-food use; indoor; 

low-risk, low-toxicity 

food-grade active ingredient(s); efficacy 

testing for public 

health claims required under GLP 

and following DIS/ 

TSS or AD-approved 

study protocol (2) (3) 

12 60,638 

(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. 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1353 

(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 applicantsubmitted 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. 

Labeling. 

Deadline. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1354 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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; nonfood; 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; nonfood; outdoor; uses 

other than FIFRA 

§2(mm) (4) (5) 

15 28,942 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1355 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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; nonfood, 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 

A510 82 Additional use; nonfood; 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. 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1356 PUBLIC LAW 112–177—SEPT. 28, 2012 

(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. 

(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 applicantsubmitted 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. 

Notification. 

Labeling. 

Deadlines. 

Time period. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1357 

(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. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1358 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1359 

‘‘TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS 

AND AMENDMENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1360 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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); nonFQPA 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. 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1361 

(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 applicantsubmitted 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. 

‘‘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, NonFood Use (2) 9 5,789 

Notification. 

Labeling. 

Deadlines. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1362 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 

($) 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1363 

‘‘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 

($) 

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 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1364 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 

($) 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1365 

‘‘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 applicantsubmitted 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. 

Notification. 

Labeling. 

Deadlines. 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1366 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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; 

non-food use (2) 

13 17,365 

B610 106 New active ingredient; 

Experimental Use 

Permit application; 

petition to establish a 

temporary tolerance 

or temporary tolerance exemption 

10 11,577 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1367 

‘‘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 

($) 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1368 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 

($) 

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. 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1369 

‘‘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 

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. 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1370 PUBLIC LAW 112–177—SEPT. 28, 2012 

(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. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1371 

‘‘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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1372 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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% repackage of registered 

end-use or manufacturing-use product 

that requires no data 

submission or data 

matrix. For microbial 

pesticides, the active 

ingredient(s) must 

not be re-isolated. (2) 

4 1,159 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1373 

‘‘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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1374 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1375 

‘‘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); nonfood 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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1376 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 

($) 

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 manufacturing-use product; 

same registered uses 

only (2) 

4 1,159 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1377 

‘‘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 

($) 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1378 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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. 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1379 

‘‘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 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1380 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 

($) 

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. 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1381 

‘‘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 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1382 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 

($) 

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% repackage of registered 

end-use or manufacturing-use product 

that requires no data 

submission or data 

matrix. (3) 

4 1,159 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1383 

‘‘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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1384 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 

($) 

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. 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1385 

(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. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1386 PUBLIC LAW 112–177—SEPT. 28, 2012 

(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. 

‘‘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; applicantinitiated 

3 2,294 

B615 

New 

144 Rebuttal of agency reviewed protocol, applicant initiated 3 2,294 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1387 

‘‘TABLE 16. — BIOPESTICIDES AND POLLUTION 

PREVENTION DIVISION — OTHER ACT—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1388 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 

($) 

B750 147 Experimental Use Permit application; with 

a petition to establish 

a temporary or permanent tolerance/tolerance exemption for 

the active ingredient. 

Includes new food/ 

feed use for a registered (3) PIP. (4) 

9 115,763 

B770 148 Experimental Use Permit application; new 

(2) PIP; with petition 

to establish a temporary tolerance/tolerance exemption for 

the active ingredient; 

credit 75% of B771 

fee toward registration application for a 

new active ingredient 

that follows; SAP review. (5) 

15 173,644 

B771 149 Experimental Use Permit application; new 

(2) PIP; with petition 

to establish a temporary tolerance/tolerance exemption for 

the active ingredient; 

credit 75% of B771 

fee toward registration application for a 

new active ingredient 

that follows. 

10 115,763 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1389 

‘‘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 

($) 

B772 150 Application to amend 

or extend an Experimental Use Permit; 

no petition since the 

established tolerance/ 

tolerance exemption 

for the active ingredient is unaffected. 

3 11,577 

B773 151 Application to amend 

or extend an Experimental Use Permit; 

with petition to extend a temporary tolerance/tolerance exemption for the active ingredient. 

5 28,942 

B780 152 Registration application; new (2) PIP; 

non-food/feed. 

12 144,704 

B790 153 Registration application; new (2) PIP; 

non-food/feed; SAP 

review. (5) 

18 202,585 

B800 154 Registration application; new (2) PIP; 

with petition to establish permanent 

tolerance/tolerance 

exemption for the active ingredient based 

on an existing temporary tolerance/tolerance exemption. 

12 231,585 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1390 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 

($) 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1391 

‘‘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 

($) 

B851 158 Registration application; new event of a 

previously registered 

PIP active ingredient(s); no petition 

since permanent tolerance/tolerance exemption is already 

established for the 

active ingredient(s). 

9 115,763 

B870 159 Registration application; registered (3) 

PIP; new product; 

new use; no petition 

since a permanent 

tolerance/tolerance 

exemption is already 

established for the 

active ingredient(s). 

(4) 

9 34,729 

B880 160 Registration application; registered (3) 

PIP; new product or 

new terms of registration; additional 

data submitted; no 

petition since a permanent tolerance/tolerance exemption is 

already established 

for the active ingredient(s). (6) (7) 

9 28,942 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1392 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 

($) 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1393 

‘‘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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1394 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 

($) 

B891 166 Application to amend a 

seed increase registration; converts 

registration to a commercial registration; 

no petition since a 

permanent tolerance/ 

tolerance exemption 

already established 

for the active ingredient(s); SAP review. 

(5) 

15 115,763 

B900 167 Application to amend a 

registration, including actions such as 

extending an expiration date, modifying 

an IRM plan, or adding an insect to be 

controlled. (10) (11) 

6 11,577 

B901 168 Application to amend a 

registration, including actions such as 

extending an expiration date, modifying 

an IRM plan, or adding an insect to be 

controlled. SAP review. (10) (11) 

12 69,458 

B902 169 PIP protocol review 3 5,789 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1395 

‘‘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 

($) 

B903 170 Inert ingredient tolerance exemption; e.g., 

a marker such as 

NPT II; reviewed in 

BPPD. 

6 57,882 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1396 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 

($) 

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 nontarget 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. 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1397 

‘‘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 nonfood 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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1398 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘TABLE 18. — INERT INGREDIENTS, EXTERNAL REVIEW 

AND MISCELLANEOUS ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

I007 

New 

178 Approval of substantially similar nonfood 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 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1399 

‘‘TABLE 18. — INERT INGREDIENTS, EXTERNAL REVIEW 

AND MISCELLANEOUS ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1400 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1401 

‘‘TABLE 18. — INERT INGREDIENTS, EXTERNAL REVIEW 

AND MISCELLANEOUS ACTIONS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review 

Time 

(Months) 

(1) 

Registration 

Service Fee 

($) 

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 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
126 STAT. 1402 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘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. 

Extension. 


dkrause on DSKHT7XVN1PROD with PUBLIC LAWS
PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1403 

(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 applicantsubmitted 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.’’; 

(B) in paragraph (6)— 

(i) in subparagraph (A)— 

(I) by striking ‘‘October 1, 2008’’ and inserting 

‘‘October 1, 2013’’; and 

(II) by striking ‘‘September 30, 2010’’ and 

inserting ‘‘September 30, 2015’’; and 

(ii) in subparagraph (B)— 

(I) by striking ‘‘October 1, 2010’’ and inserting 

‘‘October 1, 2015’’; and 

(II) by striking ‘‘September 30, 2010’’ and 

inserting ‘‘September 30, 2015’’; and 

(C) in paragraph (8)(C)(ii)— 

(i) in subclause (I), by striking ‘‘or’’ at the end; 

(ii) in subclause (II), by striking the period at 

the end and inserting ‘‘; or’’; and 

(iii) by adding at the end the following: 

‘‘(III) on the basis that the Administrator 

rejected the application under subsection 

(f)(4)(B).’’. 

(2) PESTICIDE REGISTRATION FUND.—Section 33(c)(3)(B) of 

the Federal Insecticide, Fungicide, and Rodenticide Act (7 

U.S.C. 136w–8(c)(3)(B)) is amended— 

(A) in clause (i), by striking ‘‘2008 through 2012’’ and 

inserting ‘‘2013 through 2017’’; 

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

follows through the end of the clause and inserting ‘‘grants, 

for each of fiscal years 2013 through 2017, $500,000.’’; 

and 

(C) in clause (iii), by striking ‘‘2008 through 2012’’ 

and inserting ‘‘2013 through 2017’’. 

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

Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w– 

8(d)) is amended— 

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

it appears and inserting ‘‘2012’’; 

Notification. 

Labeling. 

Deadlines. 


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126 STAT. 1404 PUBLIC LAW 112–177—SEPT. 28, 2012 

(B) by striking paragraph (4); and 

(C) by redesignating paragraph (5) as paragraph (4). 

(4) REFORMS TO REDUCE DECISION TIME REVIEW PERIODS.— 

Section 33(e) of the Federal Insecticide, Fungicide, and 

Rodenticide Act (7 U.S.C. 136w–8(e)) is amended by striking 

‘‘Pesticide Registration Improvement Act of 2003’’ and inserting 

‘‘Pesticide Registration Improvement Extension Act of 2012’’. 

(5) DECISION TIME REVIEW PERIODS.—Section 33(f) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 

136w–8(f)) is amended— 

(A) in paragraph (1), by striking ‘‘Pesticide Registration 

Improvement Renewal Act, the Administrator shall publish 

in the Federal Register’’ and inserting ‘‘Pesticide Registration Improvement Extension Act of 2012, the Administrator 

shall make publicly available’’; 

(B) in paragraph (2), by striking ‘‘appearing in the 

Congressional Record on pages S10409’’ and all that follows 

through the period and inserting ‘‘provided under subsection (b)(3).’’; and 

(C) in paragraph (4)— 

(i) in subparagraph (A), by inserting ‘‘and fee’’ 

before the period; and 

(ii) in subparagraph (B)— 

(I) by striking ‘‘(B) COMPLETENESS OF APPLICATION’’ and all that follows through ‘‘Not later’’ in 

clause (i) and inserting the following: 

‘‘(B) INITIAL CONTENT AND PRELIMINARY TECHNICAL

SCREENINGS.— 

‘‘(i) SCREENINGS.— 

‘‘(I) INITIAL CONTENT.—Not later’’; 

(II) in clause (i) (as so designated) by adding 

at the end the following: 

‘‘(II) PRELIMINARY TECHNICAL SCREENING.— 

After conducting the initial content screening 

described in subclause (I) and in accordance with 

clause (iv), the Administrator shall conduct a 

preliminary technical screening— 

‘‘(aa) not later than 45 days after the date 

on which the decision time review period 

begins (for applications with decision time 

review periods of not more than 180 days); 

and 

‘‘(bb) not later than 90 days after the date 

on which the decision time review period 

begins (for applications with decision time 

review periods greater than 180 days).’’; 

(III) by striking clause (ii) and inserting the 

following: 

‘‘(ii) REJECTION.— 

‘‘(I) IN GENERAL.—If the Administrator determines at any time before the Administrator completes the preliminary technical screening under 

clause (i)(II) that the application failed the initial 

content or preliminary technical screening and the 

applicant does not correct the failure before the 

date that is 10 business days after the applicant 

Determination. 

Deadlines. 


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PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1405 

receives a notification of the failure, the Administrator shall reject the application. 

‘‘(II) WRITTEN NOTIFICATION.—The Administrator shall make every effort to provide a written 

notification of a rejection under subclause (I) 

during the 10-day period that begins on the date 

the Administrator completes the preliminary technical screening.’’; 

(IV) in clause (iii)— 

(aa) in the heading, by inserting ‘‘INITIAL

CONTENT’’ before ‘‘SCREENING’’ ; 

(bb) in the matter preceding subclause (I), 

by inserting ‘‘content’’ after ‘‘initial’’; and 

(cc) in subclause (II), by striking ‘‘contains’’ and inserting ‘‘appears to contain’’; and 

(V) by adding at the end the following: 

‘‘(iv) REQUIREMENTS OF PRELIMINARY TECHNICAL

SCREENING.—In conducting a preliminary technical 

screening of an application, the Administrator shall 

determine if— 

‘‘(I) the application and the data and information submitted with the application are accurate 

and complete; and 

‘‘(II) the application, data, and information are 

consistent with the proposed labeling and any proposal for a tolerance or exemption from the 

requirement for a tolerance under section 408 of 

the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 346a), and are such that, subject to full 

review under the standards of this Act, could result 

in the granting of the application.’’. 

(6) REPORTS.—Section 33(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(k)) is amended— 

(A) in paragraph (1), by striking ‘‘March 1, 2014’’ and 

inserting ‘‘March 1, 2017’’; 

(B) in paragraph (2)— 

(i) in subparagraph (A)— 

(I) in clause (vi)(V), by striking ‘‘and’’ at the 

end; 

(II) in clause (vii)(II), by inserting ‘‘and’’ at 

the end; and 

(III) by adding at the end the following: 

‘‘(viii) the number of extensions of decision time 

review periods agreed to under subsection (f)(5) along 

with a description of the reason that the Administrator 

was unable to make a decision within the initial decision time review period;’’; 

(ii) in subparagraph (E), by striking ‘‘and’’ at the 

end; 

(iii) in subparagraph (F), by striking the period 

and inserting a semicolon; and 

(iv) by adding at the end the following: 

‘‘(G) a review of the progress made toward— 

‘‘(i) carrying out section 4(k)(4) and the amounts 

from the Reregistration and Expedited Processing 

Fund used for the purposes described in that section; 

Determination. 

Time period. 


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126 STAT. 1406 PUBLIC LAW 112–177—SEPT. 28, 2012 

‘‘(ii) implementing systems for the electronic 

tracking of registration submissions by December 31, 

2013; 

‘‘(iii) implementing a system for tracking the status 

of conditional registrations, including making nonconfidential information related to the conditional registrations publicly available by December 31, 2013; 

‘‘(iv) implementing enhancements to the endangered species knowledge database, including making 

nonconfidential information related to the database 

publicly available; 

‘‘(v) implementing the capability to electronically 

submit and review labels submitted with registration 

actions; 

‘‘(vi) acquiring and implementing the capability 

to electronically assess and evaluate confidential statements of formula submitted with registration actions 

by December 31, 2014; and 

‘‘(vii) facilitating public participation in certain registration actions and the registration review process 

by providing electronic notification to interested parties 

of additions to the public docket; 

‘‘(H) the number of applications rejected by the 

Administrator under the initial content and preliminary 

technical screening conducted under subsection (f)(4); 

‘‘(I) a review of the progress made in updating the 

Pesticide Incident Data System, including progress toward 

making the information contained in the System available 

to the public (as the Administrator determines is appropriate); and 

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

(C) by adding at the end the following: 

‘‘(4) OTHER REPORT.— 

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

in paragraph (1), not later than October 1, 2016, the 

Administrator shall submit to the Committee on Agriculture of the House of Representatives and the Committee 

on Agriculture, Nutrition, and Forestry of the Senate a 

report that includes an analysis of the impact of maintenance fees on small businesses that have— 

‘‘(i) 10 or fewer employees; and 

‘‘(ii) annual global gross revenue that does not 

exceed $2,000,000. 

‘‘(B) INFORMATION REQUIRED.—In conducting the analysis described in subparagraph (A), the Administrator shall 

collect, and include in the report under that subparagraph, 

information on— 

‘‘(i) the number of small businesses described in 

subparagraph (A) that are paying maintenance fees; 

and 

‘‘(ii) the number of registrations each company 

holds.’’. 

(7) TERMINATION OF EFFECTIVENESS.—Section 33(m) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 

136w–8(m)) is amended— 

Assessment. 

Review. 

Notification. 

Assessment. 

Evaluation. 

Deadline. 

Public 

information. 

Deadline. 


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PUBLIC LAW 112–177—SEPT. 28, 2012 126 STAT. 1407 

LEGISLATIVE HISTORY—S. 3552: 

CONGRESSIONAL RECORD, Vol. 158 (2012): 

Sept. 13, considered and passed Senate. 

Sept. 14, considered and passed House. 

Æ 

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

‘‘2017’’; and 

(B) in paragraph (2)— 

(i) in subparagraph (A)— 

(I) in the heading, by striking ‘‘2013’’ and 

inserting ‘‘2018’’; 

(II) by striking ‘‘2013,’’ and inserting ‘‘2018,’’; 

and 

(III) by striking ‘‘September 30, 2012’’ and 

inserting ‘‘September 30, 2017’’; 

(ii) in subparagraph (B)— 

(I) in the heading, by striking ‘‘2014’’ and 

inserting ‘‘2019’’; 

(II) by striking ‘‘2014,’’ and inserting ‘‘2019,’’; 

and 

(III) by striking ‘‘September 30, 2012’’ and 

inserting ‘‘September 30, 2017’’; 

(iii) in subparagraph (C)— 

(I) in the heading, by striking ‘‘2014’’ and 

inserting ‘‘2019’’; and 

(II) by striking ‘‘September 30, 2014’’ and 

inserting ‘‘September 30, 2019’’; and 

(iv) in subparagraph (D), by striking ‘‘2012’’ each 

place it appears and inserting ‘‘2017’’. 

(c) EFFECTIVE DATE.—This section and the amendments made 

by this section take effect on October 1, 2012. 

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

between this section (including the amendments made by this section) and a joint resolution making continuing appropriations for 

fiscal year 2013 (including any amendments made by such a joint 

resolution), this section and the amendments made by this section 

shall control. 

Approved September 28, 2012. 

7 USC 136a–1 

note. 

7 USC 136a–1 

note. 


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