S6370 CONGRESSIONAL RECORD — SENATE September 13, 2012 

authorized to meet during the session 

of the Senate on September 13, 2012, at 

10 a.m., to conduct a hearing entitled 

‘‘Holding the CFPB Accountable: Review of Semi-Annual Report to Congress.’’ 

The PRESIDING OFFICER. Without 

objection, it is so ordered. 

f 

PRIVILEGES OF THE FLOOR 

Mr. HARKIN. Mr. President, I ask 

unanimous consent that Michael 

Mederos and Alexis Florczak of my 

staff be granted floor privileges for the 

duration of today’s proceedings. 

The PRESIDING OFFICER. Without 

objection, it is so ordered. 

Mr. TESTER. Mr. President, I ask 

unanimous consent that Nick Artuso, 

an intern in the office of Senator 

BLUMENTHAL, be granted the privilege 

of the floor for the duration of this 

afternoon’s session. 

The PRESIDING OFFICER. Without 

objection, it is so ordered. 

f 

THE PESTICIDE REGISTRATION IMPROVEMENT EXTENSION ACT OF 

2012 

Mr. DURBIN. Mr. President, I ask 

unanimous consent the Senate proceed 

to the consideration of S. 3552, introduced earlier today. 

The PRESIDING OFFICER. The 

clerk will report the bill by title. 

The bill clerk read as follows: 

A bill (S. 3552) to reauthorize the Federal 

Insecticide, Fungicide, and Rodenticide Act. 

There being no objection, the Senate 

proceeded to consider the bill. 

Mr. DURBIN. Mr. President, I ask 

unanimous consent the bill be read 

three times and passed, the motion to 

reconsider be laid upon the table, with 

no intervening action or debate, and 

any related statements be printed in 

the RECORD. 

The PRESIDING OFFICER. Without 

objection, it is so ordered. 

The bill (S. 3552) was ordered to be 

engrossed for a third reading, was read 

the third time, and passed, as follows: 

S. 3552 

Be it enacted by the Senate and House of Representatives of the United States of America in 

Congress assembled, 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Pesticide 

Registration Improvement Extension Act of 

2012’’. 

SEC. 2. PESTICIDE REGISTRATION IMPROVEMENT. 

(a) MAINTENANCE FEES.— 

(1) FEES.—Section 4(i) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 

U.S.C. 136a–1(i)) is amended— 

(A) in paragraph (5)— 

(i) in subparagraph (C), by striking ‘‘aggregate amount of’’ and all that follows through 

the end of the subparagraph and inserting 

‘‘aggregate amount of $27,800,000 for each of 

fiscal years 2013 through 2017.’’; 

(ii) in subparagraph (D)— 

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

all that follows through the semicolon and 

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

years 2013 through 2017;’’; and 

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

and all that follows through the period and 

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

years 2013 through 2017.’’; 

(iii) in subparagraph (E)(i)— 

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

and all that follows through the semicolon 

and inserting ‘‘shall be $70,600 for each of fiscal years 2013 through 2017;’’; and 

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

and all that follows through the period and 

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

years 2013 through 2017.’’; 

(iv) in subparagraph (F)— 

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

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

‘‘Human’’; 

(v) by redesignating subparagraphs (F) 

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

respectively; 

(vi) by inserting after subparagraph (E) the 

following: 

‘‘(F) FEE REDUCTION FOR CERTAIN SMALL

BUSINESSES.— 

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

term ‘qualified small business entity’ means 

a corporation, partnership, or unincorporated business that— 

‘‘(I) has 500 or fewer employees; 

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

most recent maintenance fee billing cycle, 

had an average annual global gross revenue 

from all sources that did not exceed 

$10,000,000; and 

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

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

(iii), the Administrator shall waive 25 percent of the fee under this paragraph applicable to the first registration of any qualified 

small business entity under this paragraph. 

‘‘(iii) LIMITATION.—The Administrator 

shall not grant a waiver under clause (ii) to 

a qualified small business entity if the Administrator determines that the entity has 

been formed or manipulated primarily for 

the purpose of qualifying for the waiver.’’; 

and 

(vii) in subparagraph (I) (as redesignated 

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

(B) in paragraph (6)— 

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

and 

(ii) by striking ‘‘paragraphs (1) through 

(5)’’ and inserting ‘‘paragraph (1)’’; 

(C) by striking paragraphs (1), (2), (3), (4), 

and (7); and 

(D) by redesignating paragraphs (5) and (6) 

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

(2) CONFORMING AMENDMENTS.— 

(A) Section 4 of the Federal Insecticide, 

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

136a–1) is amended— 

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

section’’; 

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

(i)(1)’’; and 

(iii) in subsection (k)(5)— 

(I) in the first sentence, by striking ‘‘subsection (i)(5)(C)(ii)’’ and inserting ‘‘subsection (i)(1)(C)(ii)’’; and 

(II) in the third and sixth sentences, by 

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

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

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

U.S.C. 136w–8(b)(7)(F)) is amended— 

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

place it appears in clauses (i), (ii)(I), and 

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

(ii) by striking ‘‘section 

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

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

(iii) in clause (iv)(II)— 

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

‘‘applicable’’; and 

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

‘‘revenue’’. 

(3) EXTENSION OF PROHIBITION ON TOLERANCE

FEES.—Section 408(m)(3) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 346a(m)(3)) 

is amended by striking ‘‘September 30, 2012’’ 

and inserting ‘‘September 30, 2017’’. 

(4) REREGISTRATION AND EXPEDITED PROCESSING FUND.— 

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

the Federal Insecticide, Fungicide, and 

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

amended— 

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

tracking of pesticide registration decisions,’’ 

after ‘‘paragraph (3)’’ each place it appears; 

and 

(ii) in clause (i)— 

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

of reregistration’’; and 

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

(B) EXPEDITED PROCESSING OF SIMILAR APPLICATIONS.—Section 4(k)(3)(A) of the Federal Insecticide, Fungicide, and Rodenticide 

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

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

striking ‘‘2008 through 2012, between 1⁄8 and 1⁄7’’ and inserting ‘‘2013 through 2017, between 1⁄9 and 1⁄8’’; 

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

(iii) in clause (ii), by striking ‘‘any application’’ and all that follows through ‘‘that—’’ 

and inserting ‘‘any application that—’’. 

(C) ENHANCEMENTS OF INFORMATION TECHNOLOGY SYSTEMS FOR IMPROVEMENT IN REVIEW

OF PESTICIDE APPLICATIONS.—Section 4(k) of 

the Federal Insecticide, Fungicide, and 

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

amended— 

(i) by redesignating paragraphs (4) and (5) 

as paragraphs (5) and (6), respectively; 

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

‘‘(4) ENHANCEMENTS OF INFORMATION TECHNOLOGY SYSTEMS FOR IMPROVEMENT IN REVIEW

OF PESTICIDE APPLICATIONS.— 

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

2013 through 2017, the Administrator shall 

use not more than $800,000 of the amounts 

made available to the Administrator in the 

Reregistration and Expedited Processing 

Fund for the activities described in subparagraph (B). 

‘‘(B) ACTIVITIES.—The Administrator shall 

use amounts made available from the Reregistration and Expedited Processing Fund to 

improve the information systems capabilities for the Office of Pesticide Programs to 

enhance tracking of pesticide registration 

decisions, which shall include— 

‘‘(i) the electronic tracking of— 

‘‘(I) registration submissions; and 

‘‘(II) the status of conditional registrations; 

‘‘(ii) enhancing the database for information regarding endangered species assessments for registration review; 

‘‘(iii) implementing the capability to electronically review labels submitted with registration actions; and 

‘‘(iv) acquiring and implementing the capability to electronically assess and evaluate 

confidential statements of formula submitted with registration actions.’’; and 

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

(as redesignated by clause (i)), by striking 

‘‘to carry out the goals established under 

subsection (l)’’ and inserting ‘‘for the purposes described in paragraphs (2), (3), and (4) 

and to carry out the goals established under 

subsection (l)’’. 

(b) PESTICIDE REGISTRATION SERVICE

FEES.— 

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September 13, 2012 CONGRESSIONAL RECORD — SENATE S6371 

(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 

R060 4 New Active Ingredient, Non-food use; outdoor (2) (3) 21 395,467 

R070 5 New Active Ingredient, Non-food use; outdoor; reduced risk (2) (3) 16 395,467 

R090 6 New Active Ingredient, Non-food use; outdoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient (3) 

16 293,596 

R110 7 New Active Ingredient, Non-food use; indoor (2) (3) 20 219,949 

R120 8 New Active Ingredient, Non-food use; indoor; reduced risk (2) (3) 14 219,949 

R121 9 New Active Ingredient, Non-food use; indoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows 

(3) 

18 165,375 

R122 10 Enriched isomer(s) of registered mixed-isomer active ingredient (2) (3) 18 287,643 

R123 11 New Active Ingredient, Seed treatment only; includes agricultural 

and non-agricultural seeds; residues not expected in raw agricultural commodities (2) (3) 

18 427,991 

R125 

New 

12 New Active Ingredient, Seed treatment; Experimental Use Permit application; submitted before application for registration; credit 45% 

of fee toward new active ingredient application that follows (3) 

16 293,596 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

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

by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active 

ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers 

a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in 

the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first 

food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed 

a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case 

of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be 

subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the 

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

fee for the new active ingredient or first food use application. (3) Where the action involves approval of a new or amended label, on or before 

the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by 

the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify 

the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and 

requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted 

label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice 

for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 

calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the 

terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agencystamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the 

Agency. 

‘‘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 

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S6372 CONGRESSIONAL RECORD — SENATE September 13, 2012 

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

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review Time 

(Months) (1) 

Registration 

Service 

Fee 

($) 

R170 17 Additional food use (3) (4) 15 59,976 

R175 

New 

18 Additional food uses covered within a crop group resulting from the 

conversion of existing approved crop group(s) to one or more revised 

crop groups. (3) (4) 

10 59,976 

R180 19 Additional food use; reduced risk (3) (4) 10 59,976 

R190 20 Additional food uses; 6 or more submitted in one application (3) (4) 15 359,856 

R200 21 Additional food uses; 6 or more submitted in one application; reduced 

risk (3) (4) 

10 359,856 

R210 22 Additional food use; Experimental Use Permit application; establish 

temporary tolerance; no credit toward new use registration (3) (4) 

12 44,431 

R220 23 Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration (3) (4) 6 17,993 

R230 24 Additional use; non-food; outdoor (3) (4) 15 23,969 

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

R250 26 Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration (3) (4) 6 17,993 

R251 

New 

27 Experimental Use Permit application which requires no changes to 

the tolerance(s); non-crop destruct basis (3) 

8 17,993 

R260 28 New use; non-food; indoor (3) (4) 12 11,577 

R270 29 New use; non-food; indoor; reduced risk (3) (4) 9 11,577 

R271 30 New use; non-food; indoor; Experimental Use Permit application; no 

credit toward new use registration (3) (4) 

6 8,820 

R273 31 Additional use; seed treatment; limited uptake into raw agricultural 

commodities; includes crops with established tolerances (e.g., for 

soil or foliar application); includes food or non-food uses (3) (4) 

12 45,754 

R274 32 Additional uses; seed treatment only; 6 or more submitted in one application; limited uptake into raw agricultural commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food and/or non-food uses (3) (4) 

12 274,523 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

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

by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active 

ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers 

a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in 

the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first 

food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed 

a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case 

of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be 

subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the 

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

fee for the new active ingredient or first food use application. 

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall 

provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label 

and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the 

terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agencystamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the 

Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including 

upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business 

days following the registrant’s written or electronic confirmation of agreement to the Agency. 

(4) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in 

the covered application must be submitted together in one package. Each application for an additional new product registration and new 

inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new 

inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in 

the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. 

Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, 

must be assessed 25% of the full registration service fee for the new use application. 

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September 13, 2012 CONGRESSIONAL RECORD — SENATE S6373 

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

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review Time 

(Months) (1) 

Registration 

Service 

Fee 

($) 

R280 33 Establish import tolerance; new active ingredient or first food use (2) 21 289,407 

R290 34 Establish import tolerance; additional food use 15 57,882 

R291 35 Establish import tolerances; additional food uses; 6 or more crops 

submitted in one petition 

15 347,288 

R292 36 Amend an established tolerance (e.g., decrease or increase); domestic 

or import; applicant-initiated 

11 41,124 

R293 37 Establish tolerance(s) for inadvertent residues in one crop; applicantinitiated 12 48,510 

R294 38 Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated 12 291,060 

R295 39 Establish tolerance(s) for residues in one rotational crop in response 

to a specific rotational crop application; applicant-initiated 

15 59,976 

R296 40 Establish tolerances for residues in rotational crops in response to a 

specific rotational crop petition; 6 or more crops submitted in one 

application; applicant-initiated 

15 359,856 

R297 

New 

41 Amend 6 or more established tolerances (e.g., decrease or increase) in 

one petition; domestic or import; 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. 

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

by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active 

ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers 

a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in 

the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first 

food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed 

a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case 

of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be 

subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the 

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

fee for the new active ingredient or first food use application. (3) Where the action involves approval of a new or amended label, on or before 

the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by 

the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify 

the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and 

requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted 

label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice 

for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 

calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the 

terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agencystamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the 

Agency. 

‘‘TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review Time 

(Months) (1) 

Registration 

Service 

Fee 

($) 

R300 44 New product; or similar combination product (already registered) to 

an identical or substantially similar in composition and use to a 

registered product; registered source of active ingredient; no data 

review on acute toxicity, efficacy or CRP – only product chemistry 

data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package 

of registered end-use or manufacturing-use product that requires no 

data submission nor data matrix. (2) (3) 

4 1,434 

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S6374 CONGRESSIONAL RECORD — SENATE September 13, 2012 

‘‘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 

R310 46 New end-use or manufacturing-use product with registered source(s) 

of active ingredient(s); includes products containing two or more 

registered active ingredients previously combined in other registered products; requires review of data package within RD only; 

includes data and/or waivers of data for only: 

∑ product chemistry and/or 

∑ acute toxicity and/or 

∑ public health pest efficacy and/or 

∑ child resistant packaging. (2) (3) 

7 4,807 

R314 

New 

47 New end use product containing two or more registered active ingredients never before registered as this combination in a formulated 

product; new product label is identical or substantially similar to 

the labels of currently registered products which separately contain 

the respective component active ingredients; requires review of 

data package within RD only; includes data and/or waivers of data 

for only: 

∑ product chemistry and/or 

∑ acute toxicity and/or 

∑ public health pest efficacy and/or 

∑ child resistant packaging. (2) (3) 

8 6,009 

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 

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 

R334 

New 

53 New product; MUP or End use product with unregistered source of the 

active ingredient; requires science data review; new physical form; 

etc. Selective data citation. (2) (3) 

11 17,993 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

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

pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient. (3) 

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

relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the 

terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agencystamped 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. 

mmaher on DSK4SPTVN1PROD with CONG-REC-ONLINE

September 13, 2012 CONGRESSIONAL RECORD — SENATE S6375 

‘‘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 

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 

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall 

provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label 

and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the 

terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agencystamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the 

Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including 

upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business 

days following the registrant’s written or electronic confirmation of agreement to the Agency. 

‘‘TABLE 6. — REGISTRATION DIVISION — OTHER ACTIONS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review Time 

(Months) (1) 

Registration 

Service 

Fee 

($) 

R124 60 Conditional Ruling on Preapplication Study Waivers; applicant-initiated 6 2,294 

R272 61 Review of Study Protocol applicant-initiated; excludes DART, preregistration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review 

3 2,294 

R275 

New 

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

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

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

‘‘TABLE 7. — ANTIMICROBIALS DIVISION — NEW ACTIVE INGREDIENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review Time 

(Months) (1) 

Registration 

Service 

Fee 

($) 

A380 64 Food use; establish tolerance exemption (2) (3) 24 104,187 

A390 65 Food use; establish tolerance (2) (3) 24 173,644 

A400 66 Non-food use; outdoor; FIFRA §2(mm) uses (2) (3) 18 86,823 

A410 67 Non-food use; outdoor; uses other than FIFRA §2(mm) (2) (3) 21 173,644 

A420 68 Non-food use; indoor; FIFRA §2(mm) uses (2) (3) 18 57,882 

A430 69 Non-food use; indoor; uses other than FIFRA §2(mm) (2) (3) 20 86,823 

mmaher on DSK4SPTVN1PROD with CONG-REC-ONLINE

S6376 CONGRESSIONAL RECORD — SENATE September 13, 2012 

‘‘TABLE 7. — ANTIMICROBIALS DIVISION — NEW ACTIVE INGREDIENTS—Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review Time 

(Months) (1) 

Registration 

Service 

Fee 

($) 

A431 70 Non-food use; indoor; low-risk, low-toxicity food-grade active ingredient(s); efficacy testing for public health claims required under 

GLP and following DIS/TSS or AD-approved study protocol (2) (3) 

12 60,638 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

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

by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active 

ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers 

a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in 

the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first 

food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed 

a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case 

of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be 

subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the 

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

fee for the new active ingredient or first food use application. 

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall 

provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label 

and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the 

terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agencystamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the 

Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including 

upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business 

days following the registrant’s written or electronic confirmation of agreement to the Agency. 

‘‘TABLE 8. — ANTIMICROBIALS DIVISION — NEW USES 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review Time 

(Months) (1) 

Registration 

Service 

Fee 

($) 

A440 71 First food use; establish tolerance exemption (2) (3) (4) 21 28,942 

A450 72 First food use; establish tolerance (2) (3) (4) 21 86,823 

A460 73 Additional food use; establish tolerance exemption (3) (4) (5) 15 11,577 

A470 74 Additional food use; establish tolerance (3) (4) (5) 15 28,942 

A471 

New 

75 Additional food uses; establish tolerances; 6 or more submitted in one 

application (3) (4) (5) 

15 173,652 

A480 76 Additional use; non-food; outdoor; FIFRA §2(mm) uses (4) (5) 9 17,365 

A481 

New 

77 Additional non-food outdoor uses; FIFRA §2(mm) uses; 6 or more submitted in one application (4) (5) 9 104,190 

A490 78 Additional use; non-food; outdoor; uses other than FIFRA §2(mm) (4) 

(5) 

15 28,942 

A491 

New 

79 Additional non-food; outdoor; uses other than FIFRA §2(mm); 6 or 

more submitted in one application (4) (5) 

15 173,652 

A500 80 Additional use; non-food, indoor, FIFRA §2(mm) uses (4) (5) 9 11,577 

A501 

New 

81 Additional non-food; indoor; FIFRA §2(mm) uses; 6 or more submitted 

in one application (4) (5) 

9 69,462 

A510 82 Additional use; non-food; indoor; uses other than FIFRA §2(mm) (4) (5) 12 11,577 

A511 

New 

83 Additional non-food; indoor; uses other than FIFRA §2(mm); 6 or more 

submitted in one application (4) (5) 

12 69,462 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

mmaher on DSK4SPTVN1PROD with CONG-REC-ONLINE

September 13, 2012 CONGRESSIONAL RECORD — SENATE S6377 

(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 applicant-submitted label 

and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the 

terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agencystamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the 

Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including 

upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business 

days following the registrant’s written or electronic confirmation of agreement to the Agency. 

(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in 

the covered application must be submitted together in one package. Each application for an additional new product registration and new 

inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new 

inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in 

the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. 

Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, 

must be assessed 25% of the full registration service fee for the new use application. 

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

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review Time 

(Months) (1) 

Registration 

Service 

Fee 

($) 

A530 84 New product; identical or substantially similar in composition and 

use to a registered product; no data review or only product chemistry data; cite-all data citation, or selective data citation when applicant owns all required data, or applicant submits specific authorization letter for data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. (2) (3) 

4 1,159 

A531 85 New product; identical or substantially similar in composition and 

use to a registered product; registered source of active ingredient: 

selective data citation only for data on product chemistry and/or 

acute toxicity and/or public health pest efficacy, where applicant 

does not own all required data and does not have a specific authorization letter from data owner. (2) (3) 

4 1,654 

A532 86 New product; identical or substantially similar in composition and 

use to a registered product; registered active ingredient; unregistered source of active ingredient; cite-all data citation except for 

product chemistry; product chemistry data submitted (2) (3) 

5 4,631 

A540 87 New end use product; FIFRA §2(mm) uses only (2) (3) 5 4,631 

A550 88 New end-use product; uses other than FIFRA §2(mm); non-FQPA product (2) (3) 7 4,631 

A560 89 New manufacturing-use product; registered active ingredient; selective data citation (2) (3) 12 17,365 

A570 90 Label amendment requiring data review (3) (4) 4 3,474 

A572 

New 

91 New Product or amendment requiring data review for risk assessment 

by Science Branch (e.g., changes to REI, or PPE, or use rate) (2) (3) 

(4) 

9 11,996 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

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

pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient. 

mmaher on DSK4SPTVN1PROD with CONG-REC-ONLINE

S6378 CONGRESSIONAL RECORD — SENATE September 13, 2012 

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall 

provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label 

and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the 

terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agencystamped 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, Non-Food Use (2) 9 5,789 

A521 93 Review of public health efficacy study protocol within AD, per AD Internal Guidance for the Efficacy Protocol Review Process; Code will 

also include review of public health efficacy study protocol and data 

review for devices making pesticidal claims; applicant-initiated; 

Tier 1 

3 2,250 

A522 94 Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; Code will also 

include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 

2 

12 11,025 

A524 

New 

95 New Active Ingredient, Experimental Use Permit application; Food 

Use Requires Tolerance. Credit 45% of fee toward new active ingredient application that follows. (2) 

18 138,916 

A525 

New 

96 New Active Ingredient, Experimental Use Permit application; Food 

Use Requires Tolerance Exemption. Credit 45% of fee toward new 

active ingredient application that follows. (2) 

18 83,594 

A526 

New 

97 New Active Ingredient, Experimental Use Permit application; NonFood, 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; NonFood, Indoor Use. Credit 45% of fee toward new active ingredient 

application that follows. (2) 

15 58,000 

A528 

New 

99 Experimental Use Permit application, Food Use; Requires Tolerance 

or Tolerance Exemption (2) 

15 20,260 

A529 

New 

100 Amendment to Experimental Use Permit; requires data review or risk 

assessment (2) 

9 10,365 

A523 

New 

101 Review of protocol other than a public health efficacy study (i.e., 

Toxicology or Exposure Protocols) 

9 11,025 

A571 

New 

102 Science reassessment: Cancer risk, refined ecological risk, and/or endangered species; applicant-initiated 18 86,823 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

(2) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall 

provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label 

and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the 

terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agencystamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the 

Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including 

upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business 

days following the registrant’s written or electronic confirmation of agreement to the Agency. 

‘‘TABLE 11. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND 

BIOCHEMICAL PESTICIDES; NEW ACTIVE INGREDIENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review Time 

(Months) (1) 

Registration 

Service 

Fee 

($) 

B580 103 New active ingredient; food use; petition to establish a tolerance (2) 19 46,305 

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September 13, 2012 CONGRESSIONAL RECORD — SENATE S6379 

‘‘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 

($) 

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 

B613 

New 

109 New active ingredient; petition to convert a temporary tolerance or a 

temporary tolerance exemption to a permanent tolerance or tolerance exemption (2) 

11 15,918 

B620 110 New active ingredient; Experimental Use Permit application; nonfood 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. 

‘‘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. 

(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. 

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S6380 CONGRESSIONAL RECORD — SENATE September 13, 2012 

(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. 

‘‘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 

B660 119 New product; registered source of active ingredient(s); identical or 

substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. 

No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required 

data or authorization from data owner is demonstrated. Category 

includes 100% re-package of registered end-use or manufacturinguse product that requires no data submission or data matrix. For 

microbial pesticides, the active ingredient(s) must not be re-isolated. (2) 

4 1,159 

B670 120 New product; registered source of active ingredient(s); no change in 

an established tolerance or tolerance exemption; requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or 

other relevant information that addresses the data requirement; or 

5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data 

requirement does not apply. (2) 

7 4,631 

B671 121 New product; unregistered source of active ingredient(s); requires a 

petition to amend an established tolerance or tolerance exemption; 

requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of 

data generated at government expense; or 4) submission or citation 

of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to 

be waived supported by a scientifically-sound rationale explaining 

why the data requirement does not apply. (2) 

17 11,577 

B672 122 New product; unregistered source of active ingredient(s); non-food use 

or food use with a tolerance or tolerance exemption previously established for the active ingredient(s); requires: 1) submission of 

product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientificallysound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported 

by a scientifically-sound rationale explaining why the data requirement does not apply. (2) 

13 8,269 

B673 

New 

123 New product MUP/EP; unregistered source of active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously 

reviewed and accepted by the Agency. Requires an Agency determination that the cited data supports the new product. (2) 

10 4,631 

B674 

New 

124 New product MUP; Repack of identical registered end-use product as 

a 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 

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September 13, 2012 CONGRESSIONAL RECORD — SENATE S6381 

‘‘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 

B677 

New 

127 New end-use non-food animal product with submission of two or more 

target animal safety studies; includes data and/or waivers of data 

for only: 

∑ product chemistry and/or 

∑ acute toxicity and/or 

∑ public health pest efficacy and/or 

∑ animal safety studies and/or 

∑ child resistant packaging (2) 

10 8,000 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

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

pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient. 

‘‘TABLE 14. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND 

BIOCHEMICAL PESTICIDES; AMENDMENTS 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review Time 

(Months) (1) 

Registration 

Service 

Fee 

($) 

B621 128 Amendment; Experimental Use Permit; no change to an established 

temporary tolerance or tolerance exemption. 

7 4,631 

B622 

New 

129 Amendment; Experimental Use Permit; petition to amend an established or temporary tolerance or tolerance exemption. 11 11,577 

B641 130 Amendment of an established tolerance or tolerance exemption. 13 11,577 

B680 131 Amendment; registered source of active ingredient(s); no new use(s); 

no changes to an established tolerance or tolerance exemption. Requires data submission. (2) 

5 4,631 

B681 132 Amendment; unregistered source of active ingredient(s). Requires 

data submission. (2) 

7 5,513 

B683 

New 

133 Label amendment; requires review/update of previous risk assessment(s) without data submission (e.g., labeling changes to REI, 

PPE, PHI). (2) 

6 4,631 

B684 

New 

134 Amending non-food animal product that includes submission of target 

animal safety data; previously registered (2) 

8 8,000 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be 

completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated 

fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) 

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

PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees. 

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

CHAIN LEPIDOPTERAN PHEROMONES(SCLPS) 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review Time 

(Months) (1) 

Registration 

Service 

Fee 

($) 

B690 135 New active ingredient; food or non-food use. (2) 7 2,316 

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 

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S6382 CONGRESSIONAL RECORD — SENATE September 13, 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% re-package of registered end-use or manufacturinguse product that requires no data submission or data matrix. (3) 

4 1,159 

B720 139 New product; registered source of active ingredient(s); requires: 1) 

submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or 

other relevant information that addresses the data requirement; or 

5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data 

requirement does not apply. (3) 

5 1,159 

B721 140 New product; unregistered source of active ingredient. (3) 7 2,426 

B722 141 New use and/or amendment; petition to establish a tolerance or tolerance exemption. (4) (5) 7 2,246 

B730 142 Label amendment requiring data submission. (4) 5 1,159 

(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. 

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

pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient. 

(4) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be 

completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated 

fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) 

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

PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees. 

(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in 

the covered application must be submitted together in one package. Each application for an additional new product registration and new 

inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new 

inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in 

the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. 

Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, 

must be assessed 25% of the full registration service fee for the new use application. 

‘‘TABLE 16. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — OTHER ACT 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review Time 

(Months) (1) 

Registration 

Service 

Fee 

($) 

B614 

New 

143 Conditional Ruling on Preapplication Study Waivers; applicant-initiated 3 2,294 

B615 

New 

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

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September 13, 2012 CONGRESSIONAL RECORD — SENATE S6383 

‘‘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 

B750 147 Experimental Use Permit application; with a petition to establish a 

temporary or permanent tolerance/tolerance exemption for the active ingredient. Includes new food/feed use for a registered (3) PIP. 

(4) 

9 115,763 

B770 148 Experimental Use Permit application; new (2) PIP; with petition to 

establish a temporary tolerance/tolerance exemption for the active 

ingredient; credit 75% of B771 fee toward registration application 

for a new active ingredient that follows; SAP review. (5) 

15 173,644 

B771 149 Experimental Use Permit application; new (2) PIP; with petition to 

establish a temporary tolerance/tolerance exemption for the active 

ingredient; credit 75% of B771 fee toward registration application 

for a new active ingredient that follows. 

10 115,763 

B772 150 Application to amend or extend an Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected. 

3 11,577 

B773 151 Application to amend or extend an Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the 

active ingredient. 

5 28,942 

B780 152 Registration application; new (2) PIP; non-food/feed. 12 144,704 

B790 153 Registration application; new (2) PIP; non-food/feed; SAP review. (5) 18 202,585 

B800 154 Registration application; new (2) PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient 

based on an existing temporary tolerance/tolerance exemption. 

12 231,585 

B810 155 Registration application; new (2) PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient 

based on an existing temporary tolerance/tolerance exemption. SAP 

review. (5) 

18 289,407 

B820 156 Registration application; new (2) PIP; with petition to establish or 

amend a permanent tolerance/tolerance exemption of an active ingredient. 

15 289,407 

B840 157 Registration application; new (2) PIP; with petition to establish or 

amend a permanent tolerance/tolerance exemption of an active ingredient. SAP review. (5) 

21 347,288 

B851 158 Registration application; new event of a previously registered PIP active ingredient(s); no petition since permanent tolerance/tolerance 

exemption is already established for the active ingredient(s). 

9 115,763 

B870 159 Registration application; registered (3) PIP; new product; new use; no 

petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (4) 

9 34,729 

B880 160 Registration application; registered (3) PIP; new product or new 

terms of registration; additional data submitted; no petition since a 

permanent tolerance/tolerance exemption is already established for 

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

9 28,942 

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S6384 CONGRESSIONAL RECORD — SENATE September 13, 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 

B884 

New 

163 Registration application; new (2) PIP, seed increase with negotiated 

acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient. (8) 

12 144,704 

B885 

New 

164 Registration application; registered (3) PIP, seed increase; breeding 

stack of previously approved PIPs, same crop; no petition since a 

permanent tolerance/tolerance exemption is already established for 

the active ingredient(s). (9) 

9 86,823 

B890 165 Application to amend a seed increase registration; converts registration to commercial registration; no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s). 

9 57,882 

B891 166 Application to amend a seed increase registration; converts registration to a commercial registration; no petition since a permanent 

tolerance/tolerance exemption already established for the active ingredient(s); SAP review. (5) 

15 115,763 

B900 167 Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. (10) (11) 

6 11,577 

B901 168 Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. SAP review. (10) (11) 

12 69,458 

B902 169 PIP protocol review 3 5,789 

B903 170 Inert ingredient tolerance exemption; e.g., a marker such as NPT II; 

reviewed in BPPD. 

6 57,882 

B904 171 Import tolerance or tolerance exemption; processed commodities/food 

only (inert or active ingredient). 

9 115,763 

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. 

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

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

(4) Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to sweet corn. 

(5) The scientific data involved in this category are complex. EPA often seeks technical advice from the Scientific Advisory Panel on risks 

that pesticides pose to wildlife, farm workers, pesticide applicators, non-target species, as well as insect resistance, and novel scientific 

issues surrounding new technologies. The scientists of the SAP neither make nor recommend policy decisions. They provide advice on the 

science used to make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the environment from risks 

posed by pesticides. Due to the time it takes to schedule and prepare for meetings with the SAP, additional time and costs are needed. 

(6) Registered PIPs stacked through conventional breeding. 

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

(8) The negotiated acreage cap will depend upon EPA’s determination of the potential environmental exposure, risk(s) to non-target organisms, and the risk of targeted pest developing resistance to the pesticidal substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type of non-target organism data submitted and the lack of insect resistance management data, 

which is usually not required for seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission of a registration application in this category. 

(9) Application can be submitted prior to or concurrently with an application for commercial registration. 

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

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

‘‘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 

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September 13, 2012 CONGRESSIONAL RECORD — SENATE S6385 

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

Continued 

EPA 

No. 

New 

CR 

No. 

Action 

Decision 

Review Time 

(Months) (1) 

Registration 

Service 

Fee 

($) 

I003 

New 

174 Amend currently approved inert ingredient tolerance or exemption 

from tolerance; no new data (2) 

8 3,000 

I004 

New 

175 Approval of new non-food use inert ingredient (2) 8 10,000 

I005 

New 

176 Amend currently approved non-food use inert ingredient with new use 

pattern; new data (2) 

8 5,000 

I006 

New 

177 Amend currently approved non-food use inert ingredient with new use 

pattern; no new data (2) 

6 3,000 

I007 

New 

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

original inert is compositionally similar with similar use pattern 

(2) 

4 1,500 

I008 

New 

179 Approval of new polymer inert ingredient, food use (2) 5 3,400 

I009 

New 

180 Approval of new polymer inert ingredient, non food use (2) 4 2,800 

I010 

New 

181 Petition to amend a tolerance exemption descriptor to add one or 

more CASRNs; no new data (2) 

6 1,500 

M001 

New 

182 Study protocol requiring Human Studies Review Board review as defined in 40 CFR 26 in support of an active ingredient (4) 9 7,200 

M002 

New 

183 Completed study requiring Human Studies Review Board review as 

defined in 40 CFR 26 in support of an active ingredient (4) 

9 7,200 

M003 

New 

184 External technical peer review of new active ingredient, product, or 

amendment (e.g., consultation with FIFRA Scientific Advisory 

Panel) for an action with a decision timeframe of less than 12 

months. Applicant initiated request based on a requirement of the 

Administrator, as defined by FIFRA § 25(d), in support of a novel active ingredient, or unique use pattern or application technology. 

Excludes PIP active ingredients. (5) 

12 58,000 

M004 

New 

185 External technical peer review of new active ingredient, product, or 

amendment (e.g., consultation with FIFRA Scientific Advisory 

Panel) for an action with a decision timeframe of greater than 12 

months. Applicant initiated request based on a requirement of the 

Administrator, as defined by FIFRA § 25(d), in support of a novel active ingredient, or unique use pattern or application technology. 

Excludes PIP active ingredients. (5) 

18 58,000 

M005 

New 

186 New Product: Combination, Contains a combination of active ingredients from a registered and/or unregistered source; conventional, 

antimicrobial and/or biopesticide. Requires coordination with other 

regulatory divisions to conduct review of data, label and/or verify 

the validity of existing data as cited. Only existing uses for each active ingredient in the combination product. (6) (7) 

9 20,000 

M006 

New 

187 Request for up to 5 letters of certification (Gold Seal) for one actively 

registered product. 

1 250 

M007 

New 

188 Request to extend Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(ii) 12 5,000 

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. 

mmaher on DSK4SPTVN1PROD with CONG-REC-ONLINE

S6386 CONGRESSIONAL RECORD — SENATE September 13, 2012 

(2) If another covered application is associated with and dependent upon a pending application for an inert ingredient action, each application will be subject to its respective registration service fee. The decision review time for the other associated covered application will be 

extended to match the PRIA due date of the pending inert ingredient action, unless the PRIA due date for the other associated covered action is further out, in which case it will be subject to its own decision review time. If the application covers multiple ingredients grouped by 

EPA into one chemical class, a single registration service fee will be assessed for approval of those ingredients. 

(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an antimicrobial product 

where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule. 

(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to its separate registration 

service fee. The decision review times for the associated actions run concurrently, but will end at the date of the latest review time. 

(5) Any other covered application that is associated with and dependent on the SAP review will be subject to its separate registration 

service fee. The decision review time for the associated action will be extended by the decision review time for the SAP review. (6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application 

pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient. 

(7) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall 

provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label 

and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the 

terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agencystamped 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’’; 

(B) by striking paragraph (4); and 

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

(4) REFORMS TO REDUCE DECISION TIME REVIEW PERIODS.—Section 33(e) of the Federal 

Insecticide, Fungicide, and Rodenticide Act 

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

‘‘Pesticide Registration Improvement Act of 

2003’’ and inserting ‘‘Pesticide Registration 

Improvement Extension Act of 2012’’. 

(5) DECISION TIME REVIEW PERIODS.—Section 

33(f) of the Federal Insecticide, Fungicide, 

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

amended— 

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

Registration Improvement Renewal Act, the 

Administrator shall publish in the Federal 

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

Administrator shall make publicly available’’; 

(B) in paragraph (2), by striking ‘‘appearing in the Congressional Record on pages 

S10409’’ and all that follows through the period and inserting ‘‘provided under subsection (b)(3).’’; and 

(C) in paragraph (4)— 

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

fee’’ before the period; and 

(ii) in subparagraph (B)— 

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

later’’ in clause (i) and inserting the following: 

‘‘(B) INITIAL CONTENT AND PRELIMINARY

TECHNICAL SCREENINGS.— 

‘‘(i) SCREENINGS.— 

‘‘(I) INITIAL CONTENT.—Not later’’; 

(II) in clause (i) (as so designated) by adding at the end the following: 

‘‘(II) PRELIMINARY TECHNICAL SCREENING.— 

After conducting the initial content screening described in subclause (I) and in accordance with clause (iv), the Administrator 

shall conduct a preliminary technical 

screening— 

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

on which the decision time review period begins (for applications with decision time review periods of not more than 180 days); and 

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

on which the decision time review period begins (for applications with decision time review periods greater than 180 days).’’; 

(III) by striking clause (ii) and inserting 

the following: 

‘‘(ii) REJECTION.— 

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

screening under clause (i)(II) that the application failed the initial content or preliminary technical screening and the applicant 

does not correct the failure before the date 

that is 10 business days after the applicant 

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

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

written notification of a rejection under subclause (I) during the 10-day period that begins on the date the Administrator completes the preliminary technical screening.’’; 

(IV) in clause (iii)— 

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

CONTENT’’ before ‘‘SCREENING’’ ; 

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

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

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

and 

(V) by adding at the end the following: 

‘‘(iv) REQUIREMENTS OF PRELIMINARY TECHNICAL SCREENING.—In conducting a preliminary technical screening of an application, 

the Administrator shall determine if— 

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

accurate and complete; and 

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

are consistent with the proposed labeling 

and any proposal for a tolerance or exemption from the requirement for a tolerance 

under section 408 of the Federal Food, Drug, 

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

such that, subject to full review under the 

standards of this Act, could result in the 

granting of the application.’’. 

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

Insecticide, Fungicide, and Rodenticide Act 

(7 U.S.C. 136w–8(k)) is amended— 

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

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

(B) in paragraph (2)— 

(i) in subparagraph (A)— 

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

the end; 

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

the end; and 

(III) by adding at the end the following: 

‘‘(viii) the number of extensions of decision 

time review periods agreed to under subsection (f)(5) along with a description of the 

reason that the Administrator was unable to 

make a decision within the initial decision 

time review period;’’; 

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

at the end; 

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

period and inserting a semicolon; and 

(iv) by adding at the end the following: 

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

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

amounts from the Reregistration and Expedited Processing Fund used for the purposes 

described in that section; 

‘‘(ii) implementing systems for the electronic tracking of registration submissions 

by December 31, 2013; 

‘‘(iii) implementing a system for tracking 

the status of conditional registrations, including making nonconfidential information 

related to the conditional registrations publicly available by December 31, 2013; 

‘‘(iv) implementing enhancements to the 

endangered species knowledge database, including making nonconfidential information 

related to the database publicly available; 

‘‘(v) implementing the capability to electronically submit and review labels submitted with registration actions; 

‘‘(vi) acquiring and implementing the capability to electronically assess and evaluate 

confidential statements of formula submitted with registration actions by December 31, 2014; and 

‘‘(vii) facilitating public participation in 

certain registration actions and the registration review process by providing electronic 

notification to interested parties of additions to the public docket; 

‘‘(H) the number of applications rejected 

by the Administrator under the initial content and preliminary technical screening 

conducted under subsection (f)(4); 

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September 13, 2012 CONGRESSIONAL RECORD — SENATE S6387 

‘‘(I) a review of the progress made in updating the Pesticide Incident Data System, 

including progress toward making the information contained in the System available to 

the public (as the Administrator determines 

is appropriate); and 

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

and 

(C) by adding at the end the following: 

‘‘(4) OTHER REPORT.— 

‘‘(A) SCOPE.—In addition to the annual report described in paragraph (1), not later 

than October 1, 2016, the Administrator shall 

submit to the Committee on Agriculture of 

the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report that includes an 

analysis of the impact of maintenance fees 

on small businesses that have— 

‘‘(i) 10 or fewer employees; and 

‘‘(ii) annual global gross revenue that does 

not exceed $2,000,000. 

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

and include in the report under that subparagraph, information on— 

‘‘(i) the number of small businesses described in subparagraph (A) that are paying 

maintenance fees; and 

‘‘(ii) the number of registrations each company holds.’’. 

(7) TERMINATION OF EFFECTIVENESS.—Section 33(m) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w– 

8(m)) is amended— 

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

inserting ‘‘2017’’; and 

(B) in paragraph (2)— 

(i) in subparagraph (A)— 

(I) in the heading, by striking ‘‘2013’’ and inserting ‘‘2018’’; 

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

‘‘2018,’’; and 

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

inserting ‘‘September 30, 2017’’; 

(ii) in subparagraph (B)— 

(I) in the heading, by striking ‘‘2014’’ and inserting ‘‘2019’’; 

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

‘‘2019,’’; and 

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

inserting ‘‘September 30, 2017’’; 

(iii) in subparagraph (C)— 

(I) in the heading, by striking ‘‘2014’’ and inserting ‘‘2019’’; and 

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

inserting ‘‘September 30, 2019’’; and 

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

each place it appears and inserting ‘‘2017’’. 

(c) EFFECTIVE DATE.—This section and the 

amendments made by this section take effect on October 1, 2012. 

(d) RELATIONSHIP TO OTHER LAW.—In the 

case of any conflict between this section (including the amendments made by this section) and a joint resolution making continuing appropriations for fiscal year 2013 

(including any amendments made by such a 

joint resolution), this section and the 

amendments made by this section shall control. 

f 

STATE AND PROVINCE EMERGENCY MANAGEMENT ASSISTANCE MEMORANDUM OF UNDERSTANDING 

Mr. DURBIN. Mr. President, I ask 

unanimous consent that the Senate 

proceed to the immediate consideration of S.J. Res. 44. 

The PRESIDING OFFICER. The 

clerk will report the joint resolution 

by title. 

The bill clerk read as follows: 

A joint resolution (S.J. Res. 44) granting 

the consent of Congress to the State and 

Province Emergency Management Assistance Memorandum of Understanding. 

There being no objection, the Senate 

proceeded to consider the joint resolution. 

Mr. DURBIN. Mr. President, I ask 

unanimous consent that the joint resolution be read a third time and passed, 

the motion to reconsider be laid upon 

the table, with no intervening action 

or debate, and any statements related 

to the joint resolution be printed in the 

RECORD. 

The PRESIDING OFFICER. Without 

objection, it is so ordered. 

The joint resolution (S.J. Res. 44) 

was ordered to be engrossed for a third 

reading, was read the third time, and 

passed, as follows: 

S.J. RES. 44 

Resolved by the Senate and House of Representatives of the United States of America in 

Congress assembled, 

SECTION 1. CONGRESSIONAL CONSENT. 

Congress consents to the State and Province Emergency Management Assistance 

Memorandum of Understanding entered into 

between States of Illinois, Indiana, Ohio, 

Michigan, Minnesota, Montana, North Dakota, Pennsylvania, New York, and Wisconsin, and the Canadian Provinces of Alberta, Manitoba, Ontario, and Saskatchewan. The compact is substantially as follows: 

‘‘ARTICLE I—PURPOSE AND AUTHORITIES

‘‘The State and Province Emergency Management Assistance Memorandum of Understanding, hereinafter referred to as the ‘compact’, is made and entered into by and 

among such of the jurisdictions as shall 

enact or adopt this compact, hereinafter referred to as ‘participating jurisdictions’. For 

the purposes of this compact, the term ‘jurisdictions’ may include any or all of the States 

of Illinois, Indiana, Ohio, Michigan, Minnesota, Montana, North Dakota, Pennsylvania, New York, and Wisconsin, and the Canadian Provinces of Alberta, Manitoba, Ontario, and Saskatchewan, and such other 

States and provinces as may hereafter become a party to this compact. The term 

‘States’ means the several States, the Commonwealth of Puerto Rico, the District of 

Columbia, and all territorial possessions of 

the United States. The term ‘Province’ 

means the 10 political units of government 

within Canada. 

‘‘The purpose of this compact is to provide 

for the possibility of mutual assistance 

among the participating jurisdictions in 

managing any emergency or disaster when 

the affected jurisdiction or jurisdictions ask 

for assistance, whether arising from natural 

disaster, technological hazard, manmade disaster or civil emergency aspects of resources 

shortages. 

‘‘This compact also provides for the process of planning mechanisms among the agencies responsible and for mutual cooperation, 

including civil emergency preparedness exercises, testing, or other training activities 

using equipment and personnel simulating 

performance of any aspect of the giving and 

receiving of aid by participating jurisdictions or subdivisions of participating jurisdictions during emergencies, with such actions occurring outside emergency periods. 

‘‘ARTICLE II—GENERAL IMPLEMENTATION

‘‘Each participating jurisdiction entering 

into this compact recognizes that many 

emergencies may exceed the capabilities of a 

participating jurisdiction and that intergovernmental cooperation is essential in such 

circumstances. Each participating jurisdiction further recognizes that there will be 

emergencies that may require immediate access and present procedures to apply outside 

resources to make a prompt and effective response to such an emergency because few, if 

any, individual jurisdictions have all the resources they need in all types of emergencies 

or the capability of delivering resources to 

areas where emergencies exist. 

‘‘On behalf of the participating jurisdictions in the compact, the legally designated 

official who is assigned responsibility for 

emergency management is responsible for 

formulation of the appropriate inter-jurisdictional mutual aid plans and procedures 

necessary to implement this compact, and 

for recommendations to the participating jurisdiction concerned with respect to the 

amendment of any statutes, regulations, or 

ordinances required for that purpose. 

‘‘ARTICLE III—PARTICIPATING JURISDICTION

RESPONSIBILITIES

‘‘(a) FORMULATE PLANS AND PROGRAMS.—It 

is the responsibility of each participating jurisdiction to formulate procedural plans and 

programs for inter-jurisdictional cooperation 

in the performance of the responsibilities 

listed in this section. In formulating and implementing such plans and programs the participating jurisdictions, to the extent practical, may— 

‘‘(1) share and review individual jurisdiction hazards analyses that are available and 

determine all those potential emergencies 

the participating jurisdictions might jointly 

suffer, whether due to natural disaster, technological hazard, man-made disaster or 

emergency aspects of resource shortages; 

‘‘(2) share emergency operations plans, procedures, and protocols established by each of 

the participating jurisdictions before entering into this compact; 

‘‘(3) share policies and procedures for resource mobilization, tracking, demobilization, and reimbursement; 

‘‘(4) consider joint planning, training, and 

exercises; 

‘‘(5) assist with alerts, notifications, and 

warnings for communities adjacent to or 

crossing participating jurisdiction boundaries; 

‘‘(6) consider procedures to facilitate the 

movement of evacuees, refugees, civil emergency personnel, equipment, or other resources into or across boundaries, or to a 

designated staging area when it is agreed 

that such movement or staging will facilitate civil emergency operations by the affected or participating jurisdictions; and 

‘‘(7) provide, to the extent authorized by 

law, for temporary suspension of any statutes or ordinances that impeded the implementation of responsibilities described in 

this section. 

‘‘(b) REQUEST ASSISTANCE.—The authorized 

representative of a participating jurisdiction 

may request assistance of another participating jurisdiction by contacting the authorized representative of that jurisdiction. 

These provisions only apply to requests for 

assistance made by and to authorized representatives. Requests may be verbal or in 

writing. If verbal, the request must be confirmed in writing within 15 days of the verbal 

request. Requests must provide the following 

information: 

‘‘(1) A description of the emergency service 

function for which assistance is needed and 

of the mission or missions, including but not 

limited to fire services, emergency medical, 

transportation, communications, public 

works and engineering, building inspection, 

planning and information assistance, mass 

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