Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 4495 

EPA-APPROVED NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES IN THE NEW MEXICO SIP 

Name of SIP provision 

Applicable geographic or nonattainment area 

State submittal/ 

effective date EPA approval date Explanation 

* * * * * * * 

New Mexico Visibility Protection Plan for Phase I, Part I of the 

Federal Visibility Requirements, August 8, 1986.

Statewide .......... 08/21/86 01/27/06 [Insert FR 

page number where 

document begins].

New Mexico Visibility Protection Plan for Phase I, Part II of the 

Federal Visibility Requirements, September 9, 1992.

Statewide .......... 10/08/92 01/27/06 [Insert FR 

page number where 

document begins].

§ 52.1636 [Removed and Reserved] 

■ 3. Section 52.1636 is removed and 

reserved. 

[FR Doc. 06–760 Filed 1–26–06; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 166 

[EPA–HQ–OPP–2004–0038; FRL–7749–3] 

RIN 2070–AD36 

Pesticides; Emergency Exemption 

Process Revisions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This action revises the 

regulations governing emergency 

exemptions that allow unregistered uses 

of pesticides to address emergency pest 

conditions for a limited time. One 

change provides applicants for certain 

repeat exemptions a simple way to recertify that the emergency conditions 

that qualified for an exemption in a 

previous year continue to exist. Another 

change revises the criteria for 

determining when a potential 

emergency condition is expected to 

cause a significant economic loss and 

revises the data requirements for 

documenting the loss. These revisions 

streamline and improve the application 

and review process by reducing the 

burden to both applicants and the 

Environmental Protection Agency (EPA, 

or ‘‘the Agency’’), allowing for 

potentially quicker decisions by the 

Agency, and providing for consistent 

and equitable determinations of 

‘‘significant economic loss‘‘ as the basis 

for an emergency. This action also 

includes several minor revisions to the 

regulations. None of these various 

improvements compromise protections 

for human health and the environment. 

DATES: This final rule is effective on 

March 28, 2006. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2004–0038. All documents in the 

docket are listed on the 

www.regulations.gov web site. 

(EDOCKET, EPA’s electronic public 

docket and comment system was 

replaced on November 25, 2005, by an 

enhanced federal-wide electronic docket 

management and comment system 

located at http://www.regulations.gov/). 

Follow the on-line instructions. 

Although listed in the index, some 

information is not publicly available, 

i.e., CBI or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically in 

EDOCKET or in hard copy at the Public 

Information and Records Integrity 

Branch (PIRIB), Rm. 119, Crystal Mall 

#2, 1801 S. Bell St., Arlington, VA, 

Monday through Friday, excluding legal 

holidays. The Docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Joseph Hogue, Field and External 

Affairs Division (7506C), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001; telephone number: (703) 308–

9072; fax number: (703) 305–5884; email address: hogue.joe@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are a federal, State, or 

territorial government agency that 

petitions EPA for an emergency use 

authorization under section 18 of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA). Potentially 

affected entities may include, but are 

not limited to: 

• Federal Government (NAICS Code 

9241), i.e., Federal Agencies that 

petition EPA for section 18 use 

authorization. 

• State or Territorial governments 

(NAICS Code 9241), i.e., States, as 

defined in FIFRA section 2(aa), that 

petition EPA for section 18 use 

authorization. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the summary of the 

applicability provisions as found in 

Unit III. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information? 

In addition to using EDOCKET (http:// 

www.epa.gov/edocket/), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. An 

electronic version of 40 CFR part 166 is 

available at E-CFR Beta Site Two at 

http://www.gpoaccess.gov/ecfr/. 

II. Purpose 

The primary purpose of this 

rulemaking is to simplify the process of 

applying for emergency exemptions, 

and allow for potentially quicker 

responses to emergency pest conditions, 

without affecting current protections for 

human health and the environment. 

This action revises the regulations at 40 

CFR part 166, to make a variety of 

improvements to the pesticide 


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4496 Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 

emergency exemption program and 

process. The two most significant of the 

revised requirements are streamlining 

provisions intended to reduce the 

burden to both applicants and the 

Agency and to expedite decisions on 

some exemption requests. The first of 

these revisions expressly authorizes 

applicants for certain repeat exemptions 

to re-certify that an emergency 

condition continues in subsequent 

years, and to incorporate by reference 

all information submitted in a previous 

application rather than annually resubmit complete but perhaps redundant 

applications. 

The second change revises the 

approach to determining when a 

potential emergency condition is 

expected to cause a ‘‘significant 

economic loss’’ (SEL). In addition to 

reducing the application and review 

burden, the new economic assessment 

approach will result in consistent and 

equitable determinations of whether a 

significant economic loss is expected. 

These two streamlining approaches 

have been tested in limited pilot 

projects since 2003. 

In addition, EPA is making a number 

of revisions to correct or update minor 

administrative aspects of the emergency 

exemption regulations. The reason for 

each of these minor administrative 

revisions falls into one of the following 

categories: Conformance with statutory 

requirements arising from the Food 

Quality Protection Act of 1996 (FQPA); 

codification of improved practices that 

have been voluntary but widely 

followed by applicants; and correction 

of typographical or administrative 

errors. Also, the Agency is adding 

specific language to the regulations to 

clarify that treatment of ‘‘invasive 

species’’ is a valid basis for issuing a 

quarantine exemption. 

III. Statutory Authority 

EPA regulates the use of pesticides 

under the authority of two federal 

statutes: FIFRA and the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

FIFRA provides the basis for 

regulation, sale, distribution, and use of 

pesticides in the United States. FIFRA 

generally prohibits the sale and 

distribution of any pesticide product, 

unless it has been registered by EPA in 

accordance with section 3. (7 U.S.C. 

136a). Section 18 of FIFRA gives the 

Administrator of EPA broad authority to 

exempt any federal or State agency from 

any provision of FIFRA if the 

Administrator determines that 

emergency conditions exist that require 

such an exemption. (7 U.S.C. 136p). 

Under section 2(aa) of FIFRA, the term 

‘‘State’’ is defined to include a ‘‘State, 

the District of Columbia, the 

Commonwealth of Puerto Rico, the 

Virgin Islands, Guam, the Trust 

Territory of the Pacific Islands, and 

America Samoa.’’ (7 U.S.C. 136(aa)). 

Section 408 of FFDCA authorizes EPA 

to set maximum residue levels, or 

tolerances, for pesticides used in or on 

foods or animal feed, or to exempt a 

pesticide from the requirement of a 

tolerance, if warranted. (21 USC 346a). 

Section 408(l)(6) provides that where 

EPA grants an emergency exemption 

under FIFRA section 18, the Agency 

must establish a time-limited tolerance 

or exemption from the requirement of a 

tolerance for any residues of the 

pesticide chemical in food or feed. 

IV. Background 

A. April 2003 Notice Initiating Pilot for 

Two Primary Revisions now being 

Codified 

EPA published a Notice in the 

Federal Register on April 24, 2003 (68 

FR 20145) (FRL–7293–6), announcing 

the initiation of a limited pilot program 

to test two potential improvements to 

the emergency exemption process. The 

pilot continued through the end of 2005, 

but has not been extended for 2006 as 

it is superceded by this final rule. The 

two potential improvements included in 

the pilot were: (1) Allowing applicants 

for certain repeat exemptions to recertify that the emergency condition 

still exists in the second and third years, 

and to incorporate by reference all 

information submitted in a previous 

application rather than annually resubmit to EPA complete new 

applications and, (2) a new approach to 

documenting an SEL that focuses on the 

significance of the potential loss relative 

to yields and/or revenues without the 

emergency rather than a comparison to 

historical profit variation. The April 

2003 notice also discussed whether 

exemptions for the purpose of pest 

resistance management might be 

allowed. Finally, the notice solicited 

public comment on all three potential 

changes and announced EPA’s plan to 

issue a proposed rule addressing them. 

The two revised practices included in 

the pilot are also included in this final 

rule, with modification. Today’s final 

rule expands the application to all 

pesticides, beyond the restriction to 

reduced-risk pesticides under the 

limited terms of the pilot. 

Anyone interested in the background 

leading up to the pilot program, or other 

related documents, may wish to review 

the announcement of the pilot, and the 

related documents. EPA considers the 

comments on the pilot program to be 

part of the administrative record for this 

rulemaking. A public docket was 

established for that announcement 

under docket ID number EPA–HQ–

OPP–2002–0231. Interested parties 

should follow instructions under 

ADDRESSES for accessing the docket, but 

should use docket ID number EPA–HQ–

OPP–2002–0231 to access the docket for 

the April 24, 2003, announcement. 

B. September 2004 Proposed Rule 

EPA published a proposed rule on 

September 3, 2004 (69 FR 53866) (FRL–

7371–3). The proposed rule included 

proposals for the two revised practices 

in the pilot program, but without the 

limitation to reduced-risk pesticides, as 

well as a number of minor 

administrative revisions. Key public 

comments and Agency responses are 

briefly summarized in Unit V. of this 

document and, more completely, in a 

separate Response to Comments 

document available in the public 

docket. 

Those interested in seeing the 

proposed rule, related documents, and 

public comments submitted may access 

them in the docket. A public docket was 

established for this rulemaking under 

docket ID number EPA–HQ–OPP–2004–

0038. Interested parties should follow 

instructions under ADDRESSES for 

accessing the docket. 

C. Summary of Pilot Experience 

The pilot was started on April 24, 

2003, and will not be extended for the 

2006 growing season as it is being 

superceded by today’s final rule. 

Applicability of the pilot was restricted 

to ‘‘reduced-risk’’ pesticides in order to 

limit the scope and effectively add an 

additional margin of safety while the 

new procedures were tested. Although 

participation in the pilot was limited, 

the process worked well for both 

applicants and EPA. 

For the 2003 growing season, 16 

exemptions were identified by EPA as 

eligible for re-certification, of which 7 

submitted re-certification applications. 

In 2004, 12 exemptions were eligible, of 

which 4 applied by re-certification, 

while in 2005, 10 exemptions were 

eligible for re-certification and 6 used 

the process. EPA made expedited 

decisions on re-certification requests 

under the pilot in an average of 9 days 

in 2003, 14 days in 2004, and 8 days in 

2005, counted from receipt of the 

request until the decision was made. Of 

the exemptions that were eligible but for 

which no re-certification was submitted, 

some were for pesticide uses that had 

obtained federal registration under 

FIFRA section 3 since the previous 

year’s exemption, some were not 

requested at all (indicating that the 


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emergency ended), and the others were 

requested using conventional exemption 

requests. 

The revised approach to determining 

an SEL applied to any new exemption 

request, as long as the requested 

chemical was designated as reducedrisk. However, for all 3 years of the 

pilot, EPA voluntarily conducted 

economic evaluations of exemption 

requests using both the current 

approach of historical 5–year data, as 

well as the proposed new loss-based 

(tiered) approach. This experience 

indicates that the new approach will not 

cause EPA to find SEL more commonly, 

nor expand the definition of emergency. 

A retrospective analysis to develop the 

loss-based approach, covering 2000 

through 2003, showed that 

approximately the same number of 

requests would result in an SEL finding 

using the new, loss-based approach as 

actually occurred under the existing 

approach. The new criteria will, in most 

cases, reduce applicants’ data burden 

and thereby streamline the exemption 

process. 

V. Public Comments, EPA Responses, 

and Modifications for Final Rule 

This unit briefly discusses the major 

public comments received on the 

proposed rule, EPA’s responses to those 

comments, and changes made in the 

final rule as a result. All comments 

leading to modifications to the proposed 

revisions for the final rule are included 

here, as are opposing comments on the 

same issues, and comments opposed to 

proposed revisions for which 

modifications were not made. A more 

detailed, complete summary of public 

comments and Agency responses is 

available in a separate document in the 

public docket for this rule. That 

document also addresses comments and 

responses on the April 2003 document 

that announced the pilot program. 

A total of 28 submissions of public 

comments on the proposed rule were 

received. A total of 41 commenters were 

represented by these comments, as some 

were submitted jointly by multiple 

parties. For ease of discussion and a 

better understanding of the sources of 

the various comments, commenters are 

grouped according to the type of 

organization or interest. The number of 

comment submissions on the proposed 

rule, by type of commenter are: Two by 

education/research groups; 3 by 

agriculture/food industry groups; 1 by 

environmental/public interest groups 

(joint submission by 13 groups); 12 by 

grower groups; 2 by pesticide industry/ 

registrants; 1 by a private citizen; and, 

10 by States (9 State lead pesticide 

regulatory agencies and 1 by the 

American Association of Pesticide 

Control Officials, which represents the 

States in pesticide regulatory matters). 

Generally, all except for the 

environmental/public interest groups 

and the private citizen favored both of 

the two primary proposals, although a 

few only commented on one of the two, 

and some suggested modifications. The 

13 environmental/public interest groups 

and the private citizen were opposed to 

both of the primary revisions, but the 

environmental/public interest groups 

also suggested some modifications to 

the proposals. 

All changes made in the final rule 

relative to the proposed rule are 

explained in this unit, while a summary 

of all provisions of the final rule is in 

Unit VI. EPA decided to make these 

changes to the proposed revisions after 

considering public comments on the 

proposed rule. Each substantive 

comment is briefly paraphrased, 

followed by EPA’s response to that 

comment. Where multiple commenters 

made a substantially similar comment, 

it is stated once, with an indication of 

how many made the comment and the 

types of organizations the commenters 

represent. 

This unit is organized into separate 

sections for the two main provisions of 

the final rule, a section on all other 

aspects of the rule, and a section on 

miscellaneous comments not covered in 

the first three sections. Within each 

section, one or more issues raised by 

commenters is addressed. For each 

issue, all applicable comments are 

presented, followed by EPA’s response, 

including the resulting modification to 

the proposed revision, if any, and the 

rationale for making the change or not. 

A. Re-certification of Emergency 

Condition by Applicants 

EPA has significantly reorganized 

§ 166.20(b)(5) for improved clarity, but 

no substantive changes relative to the 

proposed rule are intended, except as 

discussed below. 

1. Commenter Issue: Allow recertification beyond third year—(a) 

Comments requesting modification to 

proposal. The proposed rule would 

have allowed re-certification 

applications only in the second and 

third years of an exemption for an 

applicant, assuming the exemption met 

the eligibility criteria (e.g., type of 

emergency condition that could 

reasonably be expected to continue). 

Many commenters stated that eligibility 

to use a streamlined re-certification 

application for repeat requests should 

not be limited to the second and third 

years of an exemption, but rather be 

longer or indefinite, as there is no 

compelling reason to limit it to 3 years. 

These commenters argued that recertification is specifically and solely 

for the purpose of determining the 

existence of an emergency condition, 

and that EPA could still decline a valid 

re-certification application based on 

new risk information, availability of 

new alternative controls, or insufficient 

progress toward registration of the 

requested use. 

In addition, full registration of a 

pesticide product often takes longer 

than 3 years, particularly for minor uses, 

even when States move expeditiously to 

identify the need. The commenters felt 

that States and affected growers should 

not be penalized when registration 

actions take more than 3 years. 

Commenters who supported allowing 

re-certification beyond the third year 

suggested various alternative 

limitations, including no limit. These 

general comments were made by 22 

commenters (9 grower groups, 7 State 

lead agencies, 2 education/research 

groups, 2 agriculture/food industry 

groups, and 2 pesticide industry/ 

registrants). 

(b) Opposing comments. Other 

commenters felt that applicants should 

not be allowed to re-certify emergency 

conditions at all. They stated that repeat 

conditions are routine, and therefore not 

an emergency, as defined in the 

regulations. These commenters believe 

that repeat requests reflect poor 

management by growers and that repeat 

exemptions should be more difficult, 

not easier, to obtain. They contend that 

EPA already grants too many repeat 

exemptions and ignores progresstoward-registration requirements. 

Allowing applicants to re-certify 

emergency conditions would only make 

matters worse. These comments were 

made by 13 environmental/public 

interest groups in a joint submission, 

and by one private citizen. 

(c) EPA Response, including decision 

on re-certification limits. EPA has 

carefully considered the comments 

summarized above concerning whether, 

and how long, to allow re-certification 

applications. The Agency is convinced 

not only that the re-certification process 

will provide the intended benefits of 

reduced burden and potentially quicker 

emergency response without negative 

consequences, but also that it would 

afford the same benefits in subsequent 

years as it would in the second and 

third years. Therefore, benefits would 

increase with the greater applicability of 

this improved process. Any specific 

limit to the number of years of eligibility 

for re-certification would be arbitrary. 

Therefore, in the final rule EPA has 

chosen to remove the applicability 


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restriction for re-certification that would 

have limited it to the second and third 

years. 

However this modification to the 

proposed 40 CFR 166.20(b)(5) includes 

the authority for EPA to declare an 

exemption ineligible for re-certification 

at any time, on a case-by-case basis. In 

determining whether to end eligibility 

for re-certification, the Agency will 

consider the continued validity of the 

information, generally from the original 

application, that documents the 

projected losses, as well as whether any 

of the other information needs to be 

updated. If EPA decides that updating 

the documentation of an SEL is likely to 

significantly improve the projected loss 

estimates, or, if any other information 

casts doubt on whether the initial 

conditions still exist, then the Agency 

may declare the exemption ineligible for 

re-certification. The applicant for any 

exemption that is ineligible for recertification may use a standard, full 

application format. 

In response to comments questioning 

whether re-certification, or any repeat 

exemption requests, should be allowed 

at all, EPA has recognized for many 

years that an emergency may continue 

for multiple years when the emergency 

condition continues relative to the 

routine situation prior to the first 

occurrence of the emergency. This most 

commonly occurs when a pesticide, 

formerly relied upon by growers, 

becomes unavailable for use or loses 

effectiveness and no other effective 

means of pest control is available. Such 

a situation would generally continue 

until an alternative control becomes 

available, e.g., an effective alternative 

pesticide becomes registered for the use 

(often the chemical requested for the 

exemption), or an effective alternative 

non-chemical control becomes 

available. 

The ability to indefinitely re-certify 

emergency conditions is not expected to 

increase the number of exemption 

requests submitted or the number of 

exemptions granted. EPA expects that 

when an emergency condition continues 

in a subsequent year, States would 

submit a repeat application regardless of 

whether a streamlined or full 

application were required. This rule 

reduces the burden in such situations. 

EPA believes that the reduced burden 

afforded by this rule would not induce 

applicants to make a repeat request. 

Re-certification that an emergency 

condition continues to exist, for a 

previously granted exemption, would be 

part of a streamlined application for an 

emergency exemption. If the same 

emergency condition exists in a 

subsequent year that existed for the first 

year of an exemption, then EPA would 

generally again find that the emergency 

condition exists, regardless of whether a 

full application or a re-certification 

application were submitted. A recertification application would simply 

reduce the burden on the applicant and 

help the Agency make the emergency 

determination more quickly. However, a 

determination by EPA that an 

emergency condition exists is not 

sufficient basis for an exemption to be 

approved. A re-certification application 

is no more likely to be approved than 

a full application for the same repeat 

request. Like a full application, a recertification application would also be 

reviewed for, and could be denied 

owing to any of the following: New risk 

information; availability of new, 

effective alternative controls; or 

insufficient progress toward registration 

of the requested pesticide use. 

Some commenters believe EPA grants 

too many repeat exemptions and that 

some exemptions are repeated for too 

many years. EPA would like to limit the 

number and length of long-running 

exemptions, and is pursuing new 

opportunities for minimizing such 

outcomes. Each year, EPA makes 

registration decisions on a large number 

of pesticide uses sought separately by 

State applicants under the emergency 

exemption program. For the fiscal years 

2001 through 2004, EPA transitioned 

313 uses to federal labels that had been 

requested under the section 18 

exemption program, thereby precluding 

further repeat exemptions for those 

uses. These products are registered after 

a comprehensive analysis of the risks 

posed by these uses. 

In addition, the Pesticide Registration 

Improvement Act (PRIA), enacted in 

early 2004, established time limits for 

EPA to make decisions on registration 

actions under section 3 of FIFRA which 

should further accelerate the pace of 

registration decision-making for all 

actions. Because of the emphasis within 

PRIA on review schedules, EPA is 

processing registration decisions more 

quickly than in the past. Pesticide uses 

that are requested for repeat exemptions 

will either gain registration more 

quickly than in the past, or their 

registration application could be not 

granted or denied in the same 

timeframe. The congressionally 

mandated review schedules under PRIA 

all become shorter and more 

compressed in upcoming years. For 

instance, the Agency’s available review 

period for a new food use for a 

conventional pesticide goes from 38 

months in FY 2004 to 22 months in FY 

2006. Similarly, the review schedule for 

each type of registration action becomes 

shorter in later implementation years of 

the law. Although PRIA shortens the 

timeframe for registration decisions, the 

law also provides more resources 

through registrant fees and does not 

compromise the rigorous, 

comprehensive nature of the risk 

analysis necessary to support each 

registration decision. In this manner, 

EPA expects that each registration 

action will be evaluated within the 

context of PRIA. Under the previous 

priority planning scheme, certain 

actions did not receive priority due to 

resource and policy considerations. 

Additionally, EPA is mandated to 

complete re-registration of older 

pesticides by the end of 2006. 

Remaining decisions on eligibility to reregister pesticide products are also 

expected to affect repeat exemptions, 

leading to the denial of some and paving 

the way for the registration of others. 

The Interregional Research Project No. 

4 (IR-4) program is a highly successful 

cooperative effort and partnership of the 

State land grant universities, industry, 

the U.S. Department of Agriculture 

(USDA), and EPA, to address the 

chronic shortage of pest control options 

for minor crops. In many cases, the crop 

protection industry lacks economic 

incentive to pursue registrations on 

minor crops because of low acreage and 

limited sales potential. IR-4 generates 

and supplies research data needed by 

EPA in order to register compounds for 

use on minor crops. The IR-4 process 

continues to improve, and registrations 

for repeat exemptions are among the 

highest priorities in the IR-4 queue. In 

1999, IR-4 initiated a streamlined 

project schedule of 30 months for its 

highest priority clearance projects. Pest 

management gaps associated with 

section 18 applications qualify for this 

highest priority schedule of 30 months. 

IR-4 is also increasingly performing 

research on pesticides which are 

presumed to pose less hazard than 

traditional synthetic chemicals. Over 

three quarters of the pesticides IR-4 

evaluates and then submits for review to 

EPA are classified as reduced-risk 

materials under the Agency’s programs 

for supporting transition to lower 

toxicity and sustainable means of pest 

management. Additionally, the review 

schedule under PRIA also favors and 

places a bias in support of submissions 

involving reduced-risk pesticides. For 

instance, the Agency’s review time 

period under PRIA for a new use of a 

conventional pesticide in FY 2006 is 22 

months whereas the review period for a 

reduced-risk pesticide in FY 2006 is 20 

months. These incentives could help IR4 and its collaborators realize a large 


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number of clearances. EPA anticipates 

that the processes discussed above will 

further enhance recent successes in 

registering repeat uses faster, as well as 

ensure that regulatory evaluations for 

any pending registration actions 

associated with a section 18 use will 

take place efficiently. 

EPA has authority under § 166.32 to 

revoke any exemption during its active 

use period, if the Agency learns that the 

emergency no longer exists, the risks are 

unacceptable, the use is not effective, or 

users are not complying with the terms 

and conditions of the exemption. When 

necessary and appropriate, this provides 

another means to end long-running 

exemptions quickly, without waiting for 

an exemption to expire. 

2. Commenter Issue: Make voluntarily 

canceled pesticides ineligible for recertification—(a) Comments requesting 

modification to proposal. Some 

commenters felt that voluntarily 

canceled pesticides should be added to 

the list of pesticide categories for which, 

when requested for an exemption, the 

applicant is not eligible to use a recertification application. The proposal 

already lists several categories of 

pesticides (e.g., new active ingredient, 

first food use, canceled pesticides) that 

warrant heightened review and public 

notice, and are therefore not eligible for 

re-certification. These commenters 

contended that EPA should not allow 

re-certification for voluntarily canceled 

pesticides. This comment was made by 

13 environmental/public interest groups 

in a joint submission. 

(b) Opposing comments. No other 

comments were received on the issue of 

pesticide categories ineligible for recertification. 

(c) EPA Response, including decision 

on modification. The proposed rule 

listed several categories of pesticides as 

ineligible for re-certification. 

Specifically, the existing regulations at 

40 CFR 166.24(a) identify a number of 

situations where, upon receipt of an 

application for an emergency 

exemption, the regulatory status of a 

pesticide product calls for public notice 

and comment. EPA believes there is a 

legitimate need for heightened review 

and awareness of exemption requests 

with the listed regulatory statuses. Both 

the notice-and-comment requirements 

as well as the need for heightened 

review would preclude the benefit of an 

expedited review that would otherwise 

be expected from a re-certification 

application. The categories proposed as 

ineligible for re-certification include 

new pesticide active ingredients, first 

food uses, canceled or suspended 

pesticides, and pesticides that have 

been the subject of a Special Review. 

Because a pesticide that has been 

voluntarily canceled by its registrant 

may be similar to these other categories 

of pesticides, the Agency agrees with 

this comment and believes this category 

of pesticide uses should also be 

ineligible for re-certification. Therefore, 

the proposed 40 CFR 166.20(b)(5) is 

modified accordingly in the final rule. 

Also, EPA is expanding the provision 

for 40 CFR 166.24 to add this category 

of pesticide uses to those for which EPA 

will issue a Notice of Receipt. Therefore, 

a Notice of Receipt will be published in 

connection with the submission of 

emergency exemption uses that involve 

pesticide uses which have been 

voluntarily canceled. Therefore, while 

applicants may still request exemptions 

for a voluntarily canceled pesticide, the 

streamlined re-certification application 

process will not be allowed for such 

uses. 

3. Commenter Issue: Add to 

documentation requirements for repeat 

exemptions—(a) Comments requesting 

modification to proposal. Some 

commenters suggested that repeat 

applicants should be required to 

document at least: 

(i) What effect the exemption had on 

the emergency condition during the first 

year, 

(ii) Why the exemption continues to 

be necessary, 

(iii) That there are no feasible nonchemical alternatives, and, 

(iv) That the original predictions of 

economic harm are legitimate. This 

comment was made by 13 

environmental/public interest groups in 

a joint submission. 

(b) Opposing comments. No other 

comments were received on the issue of 

modifying the documentation 

requirements for repeat exemption 

requests. 

(c) EPA Response, including decision 

on modification. EPA’s responses below 

correspond to the lettered list of the 

commenters’ suggested documentation 

requirements for repeat requests: 

(i) Annually, in a post-exemption 

report per § 166.32, and with any repeat 

application per § 166.20(a)(11), 

applicants will still be required to 

include a description of the effect the 

exemption had on the emergency 

condition. 

(ii) A re-certification application must 

contain a certification that the same 

emergency condition previously 

documented continues and is the reason 

the exemption continues to be 

necessary. 

(iii) EPA believes that the applicant is 

in a better position than the Agency to 

identify availability of a non-chemical 

alternative, i.e., cultural practice, for the 

specific use in their State. EPA agrees 

that it would be appropriate to have 

applicants (which are primarily State 

agencies) for repeat exemptions 

document availability and effectiveness 

of new non-chemical controls identified 

since the previous year’s application, or 

to certify that none are known. 

Therefore, in the final rule EPA has 

added a requirement, at 

§ 166.20(b)(5)(v)(E), that applicants 

certify that they are not aware of any 

alternative non-chemical practice that 

may offer a meaningful level of pest 

control, or else provide documentation 

that each such known practice does not 

provide adequate control or is not 

economically or environmentally 

feasible. In situations where such 

effective and feasible cultural practices 

are available, EPA would not grant the 

exemption because there would not be 

an emergency condition, by definition. 

(iv) One way to validate the 

reasonableness of the estimated losses 

would be to allow them to happen, i.e., 

to grow the crop under the emergency 

condition without use of the requested 

pesticide. EPA already has the 

discretion to grant a repeat exemption 

subject to the condition that some 

research areas be grown under the 

emergency condition without use of the 

requested pesticide, although such 

validation has generally not been 

required. Occasionally, confirmatory 

data, such as comparative product 

performance studies, are required on 

repeat requests. The re-certification 

program would not alter this practice. 

Furthermore, re-certification requires 

that other economic factors that result in 

a projection of an SEL (e.g. cost of 

alternative, crop prices) have not 

changed substantially, and that there is 

no new information about pest damage. 

B. Determining and Documenting 

‘‘Significant Economic Loss’’ (SEL) 

1. Commenter Issue: Lower 

quantitative thresholds for SEL, add 

flexibility—(a) Comments requesting 

modification to proposal. Some 

commenters said that the thresholds for 

the three tiers for determining SEL 

should be lower, as the proposed 

thresholds require total elimination of 

net income to qualify. Also, EPA should 

be allowed flexibility to use judgement 

to make an SEL finding for situations 

not meeting any of the thresholds. 

Commenters argued that total 

elimination of annual net income is too 

severe a threshold, and that some lesser 

loss constitutes a significant economic 

loss. These commenters feel the three 

tiers should be screens to identify 

obvious emergencies, and that 

flexibility, which does not clearly exist 


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in the proposed rule, should be added 

to identify the less obvious emergencies. 

No commenter suggested an alternative 

level for any threshold, or a basis on 

which to develop one. This general 

comment was made by 17 commenters 

(9 grower groups, 4 State lead agencies, 

2 agriculture/food industry groups, and 

2 pesticide industry/registrants). 

(b) Opposing comments. Other 

commenters felt that the proposed 

quantitative thresholds for determining 

SEL are already too low. They stated 

that the proposed tiered approach to 

document an SEL with the selected 

thresholds would unreasonably expand 

the definition of emergency and make it 

easier to find that an emergency exists. 

These commenters felt that the 

proposed method allows prohibited 

pesticide uses for profit. They assert that 

the proposed new approach together 

with the quantitative thresholds for the 

three tiers are unlawful, arbitrary and 

capricious, and contrary to 

congressional intent. This comment was 

made by 13 environmental/public 

interest groups in a joint submission. 

(c) EPA Response, including decision 

on modification. After considering all 

comments, EPA believes that the 

proposed thresholds are appropriate and 

should not be relaxed, but that 

flexibility should be available to allow 

EPA to use judgement to make an SEL 

finding where projected losses are 

particularly difficult to quantify or other 

factors warrant an emergency 

exemption. Some commenters 

concluded that the proposal provided 

no flexibility for EPA to use judgement 

to determine an SEL for situations not 

meeting any threshold, regardless of 

how close to a threshold quantitative 

loss projections may come. To the 

extent that this comment reflects a 

concern that EPA would consider only 

quantitative data in determining 

whether the loss thresholds are met, 

EPA notes that it interprets the language 

of both the proposed and final rule to 

allow for consideration of estimates 

based on qualitative information, either 

alone or in addition to quantitative 

information, in determining whether 

losses under the emergency condition 

would exceed the thresholds for SEL. 

However, EPA intends to limit the use 

of qualitative information to document 

projected losses, relying on such 

information only in cases where 

credible quantitative information is not 

available. 

In response to the concern that the 

quantitative loss thresholds of 

§ 166.3(h)(1) may not apply to all pest 

activity primarily affecting the current 

growing season, EPA has expanded 

§ 166.3(h)(2) so that EPA may use its 

broader criteria wherever they are more 

appropriate. The proposed rule 

provided a loss-based approach with 

quantitative thresholds applicable to 

pest activity primarily affecting the 

current growing season under 

§ 166.3(h)(1), and ‘‘for all other pest 

activity’’ included in a provision at 

§ 166.3(h)(2) to determine an SEL for 

situations where the loss-based 

approach does not adequately address 

the expected loss, similar to a provision 

in the existing regulations. Such losses 

include those not confined to the 

current year or those that impact capital 

assets rather than productive activities. 

This change to § 166.3(h)(2) will allow 

the flexibility to apply an appropriate 

methodology for assessing the 

consequences of an emergency, and 

help ensure that any of the widely 

variable situations potentially causing 

an SEL can be adequately addressed. 

Although no commenter addressed 

the issue, EPA has corrected the scope 

of the proposed SEL definition. The SEL 

criteria under the proposed § 166.3(h)(1) 

would have applied to ‘‘pest activity 

that primarily affects the current crop.’’

For the final rule ‘‘or other output’’ is 

added after ‘‘current crop,’’ so that noncrop productive activities (e.g., dairy 

production) may also be assessed under 

the loss-based, tiered approach. For the 

same reason, EPA has removed the word 

‘‘crop’’ from §§ 166.3(h)(1)(i) and 

166.20(b)(4)(i). 

As explained above, some 

commenters believe that the proposed 

thresholds for SEL are too high, arguing 

that these thresholds effectively require 

total elimination of net income to 

qualify. Other commenters believe that 

the proposed thresholds make it easier 

to find that an emergency exists, 

allowing unregistered pesticide uses for 

profit. Actually, the selected thresholds 

neither raise nor lower the standard for 

SEL. EPA’s retrospective analysis of past 

exemption requests, discussed in the 

Economic Analysis available in the 

public docket for this final rule, shows 

that the new approach would not make 

SEL findings any more common and 

would not otherwise expand the 

definition of emergency. The analysis 

indicates that virtually the same number 

of requests would result in an SEL 

finding using the new approach as 

actually occurred under the current 

approach, although different findings 

(in both directions) may occur in some 

individual cases. 

Although the new tiered approach for 

determining SEL maintains the same 

overall standard to qualify, its fixed, 

quantitative thresholds intentionally 

make the standard consistent, in 

contrast to the current variable standard. 

However, the fixed SEL standard allows 

an easy comparison of the quantitative 

thresholds to farm income statistics. It is 

true that, according to USDA statistics, 

the new thresholds for SEL are roughly 

equivalent to elimination of net farm 

income from the affected crop, if fixed 

costs are also considered. Because the 

new SEL standard is comparable to the 

average of the current standard, for the 

first time it is apparent that the current 

standard is approximately equivalent to 

elimination of net farm income. 

However, when the States 

recommended revising the approach to 

determining SEL, their stated reason 

was to establish a fixed standard that is 

more equitable and easier to document. 

EPA had extensive interaction with 

stakeholders during the development of 

this rule, but received no input saying 

that the existing standard for SEL was 

too high. 

EPA acknowledges that economic 

terms such as ‘‘net revenue’’ and ‘‘net 

farm income’’ may be confusing and are 

not always used the same way by all 

parties. Although the proposed 

threshold for the third tier for SEL is 

50% of ‘‘net revenues,’’ as defined in 

the preamble to the proposed rule, this 

is not equivalent to ‘‘profits’’ because it 

does not include fixed costs. For the 

purpose of this rule, EPA defines net 

revenue as gross revenue less variable 

operating costs. A calculation of 

‘‘profit’’ would typically subtract fixed 

costs from this amount. In this case, 

‘‘profit’’ is roughly equivalent to the 

gross pay of a typical salaried employee 

and is essentially the return to the 

farmer’s labor and managerial skills. 

This is also referred to as ‘‘net farm 

income.’’ If typical fixed costs were 

included in the consideration of impacts 

on income, a loss of 50% of net 

revenues (Tier 3 threshold) would, 

according to USDA statistics, result in 

approximate elimination of net farm 

income. With this as the context for the 

SEL thresholds, EPA believes that there 

is no basis for concern that farmers 

might unduly profit from emergency 

exemptions. 

Section 18 of FIFRA provides broad 

discretion for EPA to define and 

determine, by regulation, when an 

emergency exists. The Agency believes 

that the new approach and thresholds 

are not arbitrary or capricious, as they 

are essentially refinements to make the 

standard that has been used for years 

more uniform and equitable, without 

raising or lowering it. Furthermore, 

while this standard may seem severe to 

some, the standard for SEL was always 

intended to identify and avert true 

economic emergencies, and was not 

intended to maintain farm income at or 


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near a certain level. EPA believes that 

there should be a high standard for 

allowing an exemption from the 

requirements of registration. Even if 

EPA were to consider a lower standard, 

the Agency is not aware of a basis for 

selecting a lower standard that would 

not be arbitrary. 

C. Other Regulatory Provisions 

1. Commenter Issue: Confirm efficacy 

and economics of non-chemical 

alternatives—(a) Comments requesting 

modification to proposal. Commenters 

stated that EPA should use section 18 to 

promote Integrated Pest Management 

(IPM) by confirming the efficacy and 

economics of non-chemical alternatives 

for pesticide uses requested for an 

emergency exemption. This comment 

was made by 13 environmental/public 

interest groups in a joint submission. 

(b) Opposing comments. No other 

comments were received on this issue. 

(c) EPA Response, including decision 

on modification. The existing 

§ 166.20(a)(4)(ii) already requires 

applicants to explain why alternative 

practices would not provide adequate 

control or would not be economically or 

environmentally feasible. Some time 

after this final rule is issued, EPA plans 

to provide new guidance for applicants 

to improve the quality and consistency 

of information submitted on nonchemical alternatives. Although EPA 

supports and encourages IPM and use of 

risk-reducing, alternative, non-chemical 

controls, as evidenced by the Agency’s 

voluntary Pesticide Environmental 

Stewardship Program, the Agency does 

not directly regulate cultural practices. 

For this reason and because applicants 

are typically State agricultural agencies, 

EPA believes that the applicant is in a 

better position than the Agency to 

identify availability of a non-chemical 

alternative practice for the specific use 

in their State, and to assess its 

effectiveness and feasibility. In this final 

rule, a new provision has been added at 

§ 166.20(b)(5)(v)(E) to require that 

applicants using the re-certification 

process separately certify that they are 

not aware of any available chemical 

alternatives or reasonable non-chemical 

alternative practices, or if they know of 

any such practice that they include with 

the application documentation 

demonstrating that the chemical or 

practice does not provide adequate 

control or is not economically or 

environmentally feasible. 

2. Commenter Issue: Clarify or 

improve notification/confirmation for 

crisis exemptions—(a) Comments 

requesting modification to proposal. 

Commenters stated that for crisis 

exemptions, the proposal to have 

applicants notify EPA and receive 

verbal confirmation from the Agency of 

no risk-based objections before using the 

crisis provisions needs clarification and 

possible revision. The proposal says that 

EPA will attempt to provide such 

confirmation as quickly as possible, and 

within 36 hours. Commenters stated 

that they may not be able to reach the 

appropriate EPA contact on a Friday, a 

weekend, or a holiday, which could 

delay confirmation and use of the crisis 

exemption until 36 hours after the 

beginning of the next work day. They 

suggest that EPA make someone 

available at all times, or, add a provision 

that notification can be made by 

voicemail, and a consent by default 

would be assumed after 36 hours if the 

applicant has not heard back from EPA 

by that time. One commenter also 

suggested that EPA should make 

exceptions to the 36–hour waiting 

period for EPA confirmation for some 

uses, including public health crises, 

bioterrorism attacks, and non-food uses. 

This comment was made by two State 

lead agencies. 

(b) Opposing comments. No other 

comments were received on this issue. 

(c) EPA Response, including decision 

on modification. The reason for this 

revision is to replace the current 

ambiguous language at 40 CFR 

166.43(a), which allows for the 

possibility of a State or federal agency 

notifying EPA after beginning use of the 

crisis provisions. The revision will 

codify a process that has been widely 

practiced and accepted by applicants, 

and that has become more necessary 

after enactment of FQPA. FQPA 

expressly required that time-limited 

tolerances be established for emergency 

exemption uses that may result in 

residues in food. EPA maintains that it 

is in the best interest of all parties 

(including States, EPA, users of 

pesticides under section 18, the food 

processing and marketing industries, 

etc.) that there is some assurance before 

the use begins that EPA will be able to 

establish a ‘‘safe’’ tolerance for a 

pesticide to be used under a crisis 

exemption. Without that assurance, 

users run the risk of producing an 

adulterated crop that results in unsafe 

pesticide residues and would be illegal 

to sell. It is also important that EPA be 

given the opportunity to voice other 

objections to a use being considered for 

a crisis exemption. The Agency may be 

aware of risk issues unknown to the 

applicant, and has the authority to deny 

crisis provisions for a particular 

pesticide use, under § 166.41(a). 

EPA is keenly aware of the timesensitivity of emergency situations for 

which crisis exemptions are needed. 

The Agency will continue to make every 

effort to receive and quickly respond to 

notifications of intent to declare a crisis. 

EPA believes that the concerns raised by 

these commenters can be adequately 

addressed in the same manner that EPA 

has managed these issues since 

enactment of FQPA. It is true that EPA 

staff are not available at all times, such 

as at night or during weekends, to 

receive notification of a State’s intent to 

declare a crisis. However, EPA believes 

that applicants generally first become 

aware of the need for a crisis exemption 

at least a few days before notifying EPA 

of its intent to issue a crisis exemption. 

If an applicant notifies the Agency of 

their intent to declare a crisis as soon as 

possible, even before they have gathered 

all of the necessary information, EPA 

should be able to provide confirmation 

before use of the pesticide is needed. 

The Agency believes that the existing 

confirmation process now being 

codified has not caused significant 

delays to use of crisis exemptions in the 

past. In fact, there have been cases 

where EPA staff have worked with 

applicants during weekends in order to 

provide timely confirmation, and in 

extraordinary circumstances EPA will 

continue to do this in the future. A 

default presumption of no EPA 

objection to a crisis exemption, in cases 

when the Agency cannot be 

immediately reached, would provide 

neither the necessary assurances for 

users of the pesticide, nor proper 

protections for human health and the 

environment. 

EPA is not taking the commenter’s 

suggestion that an exception to the need 

for EPA confirmation be made in cases 

of non-food uses, or public health or 

bioterrorism threats. For non-food uses, 

EPA can generally provide confirmation 

more quickly than for food uses, but 

must still be allowed the opportunity to 

identify other unacceptable risks. In the 

case of major public health threats or 

bioterrorism, a national emergency 

network and system is in place that will 

enable applicants to contact EPA at any 

time, and EPA will quickly respond. 

Through the National Infrastructure 

Protection Plan, as part of a network of 

federal, State, and local governments, 

agencies can quickly contact EPA 

whenever a public health threat arises, 

including terrorism. In such cases, the 

Agency expects to be able to act very 

quickly and at any time. For certain 

listed biological threats, there is an 

expedited process in place whereby, 

once notified of the emergency need for 

an unregistered pesticide or use, EPA 

would evaluate the applicant’s remedial 

action plan and, after considering the 


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safety and efficacy of such use, would 

decide whether to issue a crisis 

decision. 

The Agency has modified the 

proposed language at § 166.43(a) for the 

final rule, to remove references to EPA’s 

confirmation and the 36–hour time 

period, as it is not appropriate in this 

paragraph for notification by applicants 

to EPA. EPA will strive to provide the 

confirmation as quickly as possible and 

within the customary 36 hours, and will 

attempt to match the urgency of 

decision-making with the urgency of the 

situation. This final rule does not 

attempt to change the timeframe in 

which EPA provides confirmation. The 

Agency’s practice will continue that the 

36–hour clock does not start until EPA 

actually receives and acknowledges the 

notice, and only applies to business 

days. The lack of a response in 36 hours 

should not be interpreted as approval of 

the crisis exemption; this final rule does 

not include decision by default. The 

language in the proposed § 166.40(c) is 

modified for this final rule to allow EPA 

to withhold confirmation due to any 

objection, not just risk-based objections. 

D. Miscellaneous Comments 

Protections for endangered species 

under the emergency exemption 

program and pest resistance 

management issues are discussed in 

Unit VIII. These are important issues 

that were discussed in the preamble to 

the proposed rule, but for which no 

regulatory revisions were proposed. 

Some comments received on these 

issues are addressed in Unit VIII, while 

other significant miscellaneous 

comments are included below. 

1. Commenter Issue: The section 18 

pilot violates the Administrative 

Procedure Act—(a) Comment summary. 

Commenters stated that the section 18 

pilot violates the Administrative 

Procedure Act (APA) as a binding 

regulation without notice and comment. 

These commenters went on to say that 

EPA solicited public comment on the 

pilot provisions in the Federal Register 

Notice that initiated the pilot, but failed 

to respond to those comments. This 

comment was made by 13 

environmental/public interest groups in 

a joint submission. 

(b) Opposing comments. No other 

comments were received on this issue. 

(c) EPA Response. The comment that 

the pilot violated the APA is not 

relevant to the proposed or final rule 

and to whatever extent it might have 

been relevant to the pilot program, the 

issue is moot because EPA has ended 

the pilot program. EPA disagrees with 

the comment because the section 18 

pilot program was not a binding 

regulation and did not require notice 

and comment rulemaking under section 

553 of the APA. EPA believes that 

participants in the section 18 pilot 

program conformed to the requirements 

of the Agency’s existing regulations 

pertaining to emergency exemption 

requests at 40 CFR part 166. The 

purpose of the pilot was to gain 

experience and gather information for 

the rulemaking on improvements to the 

section 18 process. The pilot was 

intentionally limited in scope. During 

the course of the pilot, less than 5% of 

all applications received were eligible 

for the pilot and utilized its provisions. 

No applicant was required to use the 

pilot. EPA is confident that the pilot’s 

standard for an emergency finding was 

no higher or lower than the current 

standard. The risk side of the 

assessment and decision process was 

not changed for the pilot. Furthermore, 

an additional safety margin was 

essentially added to the pilot by limiting 

application to ‘‘reduced-risk’’

pesticides. 

During development of the proposed 

rule, EPA carefully considered public 

comments received on the Federal 

Register Notice that initiated the pilot. 

Those comments and EPA responses are 

summarized in the separate response-tocomments document that also addressed 

comments on the proposed rule and is 

available in the public docket. 

2. Commenter Issue: Documentation 

for endangered species needs 

clarification—(a) Comment summary. 

Commenters stated that documentation 

requirements for endangered species 

concerns in emergency exemption 

requests need clarification and further 

guidance. They also said that EPA, the 

U.S. Fish and Wildlife Service and the 

National Marine Fisheries Service have 

data on endangered species that States 

do not have, and these federal agencies 

should either provide such data, or 

make it readily available to States. One 

commenter suggested that when 

measures are necessary to protect 

endangered species, EPA should involve 

the State early (before decision). This 

comment was made by three State lead 

agencies and by AAPCO. 

(b) Opposing comments. No other 

comments were received on this issue. 

(c) EPA Response: EPA believes that 

an important aspect of assuring 

protections of endangered and 

threatened species in the 

implementation of the emergency 

exemption program is to have available 

good information on the potential 

exposure and risk of a requested use to 

a listed species and its habitat. Some 

time after promulgation of this final 

rule, EPA plans to issue improved 

guidance on what information regarding 

threatened and endangered species 

should be included with an application. 

EPA will continue to involve applicants 

in the discussion of possible mitigation 

measures whenever it appears that 

threatened or endangered species may 

be at risk. 

VI. Final Rule Revisions to Emergency 

Exemption Process 

While Unit V. summarizes changes in 

the regulatory provisions of the final 

rule from those in the proposed rule, 

Unit VI. summarizes how this final rule 

revises the existing regulations at 40 

CFR part 166 that govern the emergency 

exemption process. 

A. Re-certification of Emergency 

Condition by Applicants 

1. How the re-certification process will 

work. This final rule adds a new 

paragraph (b)(5) to 40 CFR 166.20 that 

allows applicants for eligible repeat 

exemptions to submit streamlined ‘‘recertification’’ applications. The recertification application process applies 

only to specific exemptions, and is not 

available to applicants for quarantine 

exemptions, public health exemptions, 

or crisis exemptions. In addition, recertification can only be used if the 

same exemption was approved for the 

same applicant the previous year, or use 

period, and meets other eligibility 

criteria discussed below. Subject to 

limitations specified in § 166.20(b)(5) 

and discussed below, where an 

emergency condition that originally 

qualified for an emergency exemption 

continues in a subsequent year, eligible 

applicants may re-certify that the same 

emergency condition continues and rely 

on the preceding year’s submission to 

document the economic impact of the 

pest emergency. This re-certification 

approach allows applicants to 

incorporate by reference all information 

submitted in a previous application, 

instead of submitting a complete new 

application and supporting 

documentation. The re-certification of 

the emergency condition by the 

applicant combined with other 

information available to EPA will serve 

as the basis for EPA’s determination as 

to whether an emergency condition 

continues to exist. 

While a re-certification application 

may allow for speedier preparation of 

exemption requests and quicker 

determinations by EPA that an 

emergency condition exists, it will not 

result in automatic granting of an 

emergency exemption. In addition to an 

emergency finding, before granting an 

exemption EPA must also determine 

that, among other things, there are no 


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effective registered alternatives to the 

requested pesticide use, no feasible 

alternative practices that provide 

adequate control are available, the 

requested pesticide use will not cause 

unreasonable adverse effects on human 

health or the environment, and there 

has been sufficient progress towards 

registration of the requested use. If an 

effective product has been registered for 

the requested use since the previous 

exemption was approved, an emergency 

condition may no longer exist. If the 

Agency has received new risk 

information since approving the 

previous exemption, then the risk will 

be re-evaluated. Likewise, if the request 

includes any change in the conditions of 

use that may increase exposure, such as 

application rate, number of 

applications, type of application, preharvest interval, re-entry interval, total 

number of acres, or change in the 

geographic area proposed for treatment, 

then the risk will also be re-evaluated. 

EPA may determine that sufficient 

progress towards registration has not 

been made for a requested pesticide use. 

The risk evaluation process for repeat 

requests is not changed by this rule. 

Not all repeat exemption requests will 

be eligible for re-certification. Upon 

approval of any specific exemption, 

EPA intends to make an initial 

assessment regarding potential 

eligibility for a streamlined recertification application the following 

year, in the event that the applicant 

reapplies the next year. EPA will 

consider the following in determining 

potential eligibility to use a streamlined 

re-certification application: 

1. Whether the emergency situation 

could reasonably be expected to 

continue for longer than 1 year. An 

emergency situation could reasonably 

be expected to continue where, for 

example, a registered product relied 

upon by growers becomes permanently 

unavailable, a pest expands its range, or 

a registered product ceases to be 

effective against a pest. Situations that 

would not be expected to continue, and 

therefore not be eligible for recertification, would include a temporary 

supply problem of a registered product, 

an isolated weather event, or a sporadic 

pest outbreak. 

2. Whether the pesticide product, 

owing to its regulatory status, warrants 

heightened review before any additional 

use is approved. EPA will rely primarily 

on the same criteria used in the existing 

regulations at 40 CFR 166.24(a), which 

identifies a number of different 

situations where, upon receipt of an 

application for an emergency 

exemption, the regulatory status of a 

pesticide product calls for public notice 

and comment. The first five categories 

listed below are from the existing 40 

CFR 166.24(a), while the sixth is a 

similar category, added for the final 

rule, as discussed in Unit V.A.2. An 

applicant will be ineligible to use a recertification application when the 

following categories of pesticides are 

requested for an exemption: 

(a) A new chemical; 

(b) The first food use of an active 

ingredient; 

(c) Any use of a pesticide if the 

pesticide has been subject to a 

suspension notice under section 6(c) of 

the Act; 

(d) A pesticide which: 

(i) Was the subject of a notice under 

section 6(b) of the Act and was 

subsequently canceled, and 

(ii) Is intended for a use that poses a 

risk similar to the risk posed by any use 

of the pesticide which was the subject 

of the notice under section 6(b); 

(e) A pesticide which: 

(i) Contains an active ingredient 

which is or has been the subject of a 

Special Review, and 

(ii) Is intended for a use that could 

pose a risk similar to the risk posed by 

any use of the pesticide which is or has 

been the subject of the Special Review; 

(f) A pesticide which: 

(i) Contains an active ingredient 

which was contained in a pesticide 

product that was voluntarily canceled 

by its registrant, and 

(ii) Is intended for a use that could 

pose a risk similar to the risk posed by 

any use of the pesticide which was 

voluntarily canceled by its registrant. 

Furthermore, EPA may declare that an 

exemption that was previously eligible 

for re-certification is no longer eligible. 

In determining whether to end 

eligibility for re-certification, the 

Agency will consider the continued 

validity of the information, generally 

from the original application, that 

documents the projected losses, as well 

as whether any of the other information 

needs to be updated. If EPA decides that 

updating the documentation of an SEL 

is likely to significantly improve the 

projected loss estimates, or, if any other 

information casts doubt on whether the 

initial conditions still exist, then the 

Agency may declare the exemption 

ineligible for re-certification. The 

applicant for any exemption that is 

ineligible for re-certification may use a 

standard application. 

In instances where EPA determines 

that an exemption is potentially eligible 

for re-certification, EPA will advise the 

successful applicant that, should it 

reapply the following year, they appear 

eligible to use a re-certification 

application. EPA anticipates that this 

advice will be included in the notice of 

approval of the current year’s 

application. However, if an exemption 

is not classified as a candidate for recertification in the approval notice, and 

an applicant believes that subsequent 

information would make it eligible, the 

applicant may contact the Agency to 

request an eligibility determination. In 

some instances, EPA may determine 

that an emergency condition exists, and 

that the exemption appears eligible for 

a re-certification application the 

following year, yet conclude that 

additional information should be 

gathered in order to support approval in 

future years. In such instances, EPA 

may indicate in the approval notice that 

the exemption appears eligible for recertification provided the applicant 

submits the specified information. 

Finally, EPA reserves the authority to 

declare an emergency exemption 

ineligible for re-certification where, in 

the Agency’s sole discretion, it 

determines that a complete application 

is necessary. 

An acceptable re-certification 

application must include not only the 

applicant’s re-certification that the 

emergency condition continues, but also 

its certification to several other specific 

facts, or be accompanied by additional 

information. An eligible re-certification 

applicant will be exempted from the 

information requirements of 

§ 166.20(a)(1) through (a)(10), and of the 

existing § 166.20(b), where the applicant 

certifies that: 

(i) The emergency condition 

described in the preceding year’s 

application continues to exist; 

(ii) Except as expressly identified, all 

information submitted in the preceding 

year’s application is still accurate; 

(iii) Except as expressly identified, the 

proposed conditions of use are identical 

to the conditions of use EPA approved 

for the preceding year; 

(iv) Any conditions or limitations on 

the eligibility for re-certification 

identified in the preceding year’s notice 

of approval of the emergency exemption 

have been satisfied; 

(v) The applicant is not aware of any 

alternative chemical or non-chemical 

practice that may offer a meaningful 

level of pest control, or, if any, has 

provided documentation that each such 

known practice does not provide 

adequate control or is not economically 

or environmentally feasible. 

Applicants meeting the requirements 

of § 166.20(b)(5), as discussed above, 

would not need to submit new, updated 

documentation that the emergency 

condition continues or the data 

elements otherwise required under 40 

CFR 166.20, except that the interim 


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4504 Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 

report specified in § 166.20(a)(11) would 

still be required where a re-certification 

is filed before the final report on the 

previous exemption is available. 

2. Rationale for new re-certification 

process. Allowing applicants for eligible 

exemption requests to recertify the 

existence of an ongoing emergency 

condition and to incorporate by 

reference all information submitted in a 

previous application is expected to 

reduce the burden to both applicants 

and EPA as well as allow for potentially 

quicker decisions. When an applicant 

certifies the continuation of the 

emergency condition and incorporates 

previously submitted materials by 

reference, a complete new application 

sufficient to characterize the situation in 

accordance with 40 CFR 166.20 will not 

be required. This will save applicants 

time and effort in gathering data and 

preparing their submissions. The 

Agency will save time and resources by 

not having to annually repeat each 

administrative step of its review of the 

documents supporting the exemption 

requests. If no pesticides that could 

avert the emergency have been newly 

registered, no new non-chemical 

controls have been developed, and 

nothing has changed to affect the 

assessment of risk, then re-certification 

of an emergency will lead to 

significantly shorter Agency review. 

For repeat exemption requests where 

the emergency situation has not 

changed, EPA’s experience with full, 

annual applications indicates that 

projected yield and revenue losses are 

generally comparable to those found the 

first year and a significant economic 

loss is again found. This is reasonable 

since applicable losses are those 

resulting from the emergency situation 

relative to the situation prior to the first 

occurrence of the emergency. Therefore, 

with the applicant’s certification that 

the emergency condition continues and 

that all information in the earlier 

application is still accurate, reliance on 

the previously submitted data and other 

supporting information should be 

adequate to support an emergency 

finding. Re-certification only alters the 

process for an emergency finding, 

whereas determinations of acceptable 

risk, availability of alternative controls, 

and progress toward registration are not 

changed by this final rule. With a recertification application, the applicant 

and Agency must still address these 

other areas necessary to approve or deny 

the request, just as with a full 

application. Furthermore, the final rule 

provides that EPA may declare an 

exemption ineligible for re-certification 

at any time, should the Agency decide 

that a full application is more 

appropriate. For the reasons discussed 

above, EPA believes that the recertification process will provide the 

benefits of reduced burden and quicker 

emergency response, without 

compromising either the quality of 

decisions or protections for human 

health and the environment. 

B. Determining and Documenting 

‘‘Significant Economic Loss’’

1. How determination of significant 

economic loss (SEL) will work. This rule 

re-defines ‘‘significant economic loss’’ at 

40 CFR 166.3(h). Under the new 

definition, the method for determining 

the amount of the projected loss due to 

the emergency condition will not 

change, although the calculation will be 

done in steps (tiers) and sometimes the 

later steps will be unnecessary. 

However, the new definition of SEL 

changes how EPA will determine 

whether the loss is considered 

‘‘significant.’’ The revised approach 

provides standard criteria for 

determining the significance of the 

projected loss, rather than comparing 

losses to past variations in revenue or 

profit. The goal of the criteria is to 

compare losses to farm or firm income 

in the absence of the emergency in a 

manner that can be easily and 

consistently measured. Successive 

screening levels (tiers) have been chosen 

that permit situations that clearly 

qualify to be resolved quickly, with a 

minimum of data. Each tier has a 

quantitative loss threshold that 

generally applies to all eligible 

emergency exemption applications. If 

the pest situation does not appear likely 

to result in a significant economic loss 

based on the first tier analysis, it might 

qualify based on further analysis in 

succeeding tiers. Each additional tier 

requires more data and involves more 

analysis on how the emergency affects 

revenues. 

Tier 1: Yield Loss - Tier 1 is based on 

quantity loss, i.e., crop yield or other 

output loss. If the projected yield loss 

due to the emergency condition is 

sufficiently large, EPA would conclude 

that a significant economic loss will 

occur, due to the magnitude of the 

expected revenue loss. The yield loss 

threshold in Tier 1 is 20% for all 

situations. This threshold is set at a 

sufficiently high level such that a loss 

that exceeded the threshold would also 

meet the thresholds in Tiers 2 and 3, if 

the additional economic data were 

submitted and analyzed. Therefore, for 

such large yield losses it is not 

necessary to separately estimate 

economic loss, which would require 

detailed economic data. 

Tier 2: Economic Loss as a Percentage 

of Gross Revenues - A quantity or yield 

loss that does not satisfy the threshold 

in Tier 1 may nonetheless cause a 

significant economic loss because such 

loss alone may not reflect all economic 

losses. Quality losses may result in 

reductions in prices received and/or 

there may be changes in production 

costs, such as pest control costs and 

harvesting costs. For situations with 

yield or output losses that do not meet 

the significant economic loss criterion 

for Tier 1, EPA would evaluate 

estimates of economic loss as a percent 

of gross revenue in Tier 2, to determine 

if the loss meets that threshold for a 

significant economic loss. The economic 

loss threshold in Tier 2 is 20% of gross 

revenue for all situations. Again, this 

threshold in Tier 2 is set with the 

intention that losses exceeding the 

threshold would also meet the threshold 

in Tier 3, if the additional Tier 3 

analysis were performed. 

Tier 3: Economic Loss as a Percentage 

of Net Revenues - If neither quantity nor 

economic losses are above the 

thresholds in Tiers 1 and 2, EPA will 

compare impacts to net revenues. Net 

revenues are defined for the purposes of 

this rule as gross revenues minus 

operating costs. The loss threshold in 

Tier 3 is 50% of net revenues for all 

situations. Emergency conditions that 

fall short of the thresholds in Tiers 1 

and 2 may qualify as a significant 

economic loss in Tier 3, particularly for 

enterprises with high costs of 

production relative to gross revenue. 

Applicants should first determine 

whether their projected loss meets the 

Tier 1 yield loss threshold of 40 CFR 

166.3(h)(1)(i), analytically the least 

burdensome criterion. The associated 

data requirements appear in 

§ 166.20(b)(4)(i). If the projected loss 

does not meet this threshold, applicants 

should determine whether their 

projected loss meets the Tier 2 gross 

revenue threshold of § 166.3(h)(1)(ii), 

providing additional data as noted in 

§ 166 20(b)(4)(ii). Failing to meet that 

threshold, applicants should submit the 

data to perform the analysis necessary 

for the Tier 3 net revenue threshold of 

§ 166.3(h)(1)(iii) as given in 

§ 166.20(b)(4)(iii). The three tiers 

established in § 166.3(h)(1)(i), (ii), and 

(iii) are designed such that when an 

emergency condition qualifies for 

significant economic loss under a lower 

tier, data for higher tiers are not 

required, and the burden and cost of 

preparing the emergency exemption 

application are reduced. Each 

successive tier builds upon the previous 

one. That is, the information required 

for estimating a lower tier is also 


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Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 4505 

necessary in estimating each higher tier. 

This allows an applicant to collect data, 

and build a case for significant 

economic loss, as needed and 

determined by the conditions, without 

requiring additional data. Applicants 

will continue to submit data to 

demonstrate the emergency nature of 

the pest outbreak including the basis for 

expected losses in quantity, and 

sometimes quality and/or additional 

production costs. However, applicants 

no longer need to submit historical 

economic data demonstrating variations 

in revenues, although historical data 

may be appropriate to define the 

baseline, routine, or ‘‘without 

emergency’’ scenario. The new guidance 

document that EPA is issuing in 

conjunction with this final rule includes 

a description of information that EPA 

expects applicants to submit in order to 

demonstrate an SEL. 

This loss-based approach is designed 

to capture the economic impact of pest 

activity as it affects the current 

production season, which will be 

sufficient for most emergency 

exemption applications. Although 

§ 166.3(h)(1) applies the loss-based 

approach to pest activity primarily 

affecting the current growing season, 

EPA has reserved the authority to use a 

case-by-case approach in the new 

§ 166.3(h)(2). Where EPA determines 

that the loss-based approach of 

§ 166.3(h)(1) would not adequately 

describe the expected loss, for example 

long-term losses in orchard crops, the 

Agency would continue to make its 

significant economic loss 

determinations based on other criteria 

(i.e., a substantial loss or impairment of 

capital assets, or a loss that would affect 

the long-term financial viability 

expected from the productive activity) 

where the applicant demonstrates 

significant losses that would not be 

recognized under § 166.3(h)(1). 

2. Rationale for revised SEL approach. 

The revised methodology for 

determining an SEL is intended to 

streamline the data and analytical 

requirements for emergency exemption 

requests, and allow for potentially 

quicker decisions by EPA. In addition, 

the methodology is designed to reflect 

more accurately the significance of an 

anticipated economic loss. Specifically, 

this approach makes a more direct 

comparison between the losses 

anticipated owing to the emergency 

situation and the yield and/or revenues 

without the pest emergency, rather than 

a comparison to the historical range of 

profit variability. Year-to-year profit 

variability often reflects market forces 

entirely unrelated to pest pressure. 

Although EPA has attempted to make 

allowances for crops’ differing profit 

variability when determining the 

economic significance of losses under 

the current approach, EPA believes that 

the loss-based approach better and more 

directly permits EPA to evaluate the 

significance of economic losses. 

An analysis of past emergency 

exemption requests suggests that this 

revised approach will not cause a 

significant change in the overall 

likelihood of an SEL finding, although 

findings may differ in individual cases. 

The results of this analysis are 

discussed in the Economic Analysis of 

the final rule, available in the public 

docket. The analysis shows that in many 

cases an SEL can be adequately 

demonstrated with less data and 

without loss of reliability or flexibility 

through the revised methodology. The 

new approach is expected to lead to 

savings to both applicants and EPA from 

reduced data and analytical burdens. 

Under the new procedure, applicants 

may elect to submit the minimum 

amount of data necessary to 

demonstrate a significant economic loss 

in one of three increasingly refined tiers. 

If the first tier is sufficient, the burden 

is reduced most significantly, as it 

identifies the most obvious emergencies 

with less data. The loss-based approach 

requires less data from applicants in 

cases that qualify under Tier 1, where 

the same conclusion of a significant 

economic loss would be made with the 

additional data and analysis under the 

higher tiers. Even in the highest tier, the 

burden may be reduced relative to the 

current approach as the analysis focuses 

on the current year rather than historical 

data. Like re-certification of 

emergencies, this approach is expected 

to save applicants time and resources in 

gathering data and preparing 

submissions. The Agency’s burden 

should be reduced due to the simplified 

approach and clear, consistent 

thresholds. 

Because the loss-based approach in 

today’s final rule shifts the focus from 

annual price variability to actual pestrelated losses, it is expected to lead to 

more consistent and transparent 

findings of the significance of economic 

losses. Under the current approach, 

producers of crops that have very wide 

fluctuations in net revenues, even if due 

to price variability, may experience a 

large economic loss due to non-routine 

pest-related conditions, without a 

significant economic loss finding by 

EPA under strict adherence to the 

current approach. Other crops and cases 

may have very little variation in 

historical net revenues, which could 

lead to a small economic loss being 

found significant under the current 

approach. Again, the new, loss-based 

approach is designed so that it would 

not cause a significant change in the 

overall likelihood of a significant 

economic loss finding, but it may 

change the findings in individual cases 

so that determinations of significance 

are more accurate, appropriate, and 

equitable. 

C. Specifying Invasive Species as 

Targets under Quarantine Exemptions 

Existing regulations describe four 

types of emergency exemptions, one of 

which is a quarantine exemption. The 

purpose of a quarantine exemption is 

stated in 40 CFR 166.2(b) as follows: 

(b) Quarantine exemption. A quarantine 

exemption may be authorized in an 

emergency condition to control the 

introduction or spread of any pest new to or 

not theretofore known to be widely prevalent 

or distributed within and throughout the 

United States and its territories. 

Quarantine exemptions are not 

necessarily for the purpose of, or 

approved on the basis of, averting a 

significant economic loss, although they 

may ultimately help prevent large 

economic losses. In addition to being for 

the control of pests that are not widely 

prevalent or distributed in the U.S., 

quarantine exemptions are intended to 

control recently-introduced, non-native 

species. In recent years such species 

have come to be commonly known as 

‘‘invasive species.’’ Because of the 

potentially widespread and devastating 

impacts of invasive species to 

ecosystems, the environment, and the 

economy, the challenge of preventing 

their introduction, and when necessary 

controlling them, has garnered 

increasing attention in recent years. 

Although invasive species implicitly fall 

within the scope of quarantine 

exemptions, the now widely-recognized 

term does not appear in the existing 

regulations, probably because it was not 

widely used at the time 40 CFR part 166 

was promulgated. This final rule adds 

the term ‘‘invasive species’’ to § 166.2(b) 

and to § 166.3(d)(3)(i), to clarify that the 

intent of making quarantine exemptions 

available includes the control of 

invasive species. The rule also adds, at 

§ 166.3(k), a definition of ‘‘invasive 

species’’ that is derived from that used 

in Executive Order 13112 (64 FR 6183, 

February 3, 1999). 

D. Updating Administrative and 

Communication Processes 

A number of minor revisions to 40 

CFR part 166 are made with this final 

rule to correct errors or update 

administrative aspects of the emergency 

exemption regulations, particularly in 

light of the fact that the Food Quality 


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4506 Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 

Protection Act (FQPA), which amended 

FIFRA and the FFDCA, was enacted 

since the regulations under part 166 

were last revised. Each of these 

revisions is made for one of the 

following reasons: (1) To correct 

typographical or administrative errors or 

inaccuracies, (2) to bring the regulations 

into agreement with current 

requirements put in place by the FQPA, 

or (3) to reflect improvements to the 

process that have been identified since 

40 CFR part 166 was last revised, and 

that have been voluntarily practiced by 

applicants. Each of these revisions are 

non-substantive or reflect minor 

changes to the regulatory requirements, 

but all correct, improve, or update the 

regulations. The corrections of 

typographical or administrative errors or 

inaccuracies are self-explanatory. The 

revisions for the other reasons are 

discussed below. 

Under FFDCA section 408(l)(6), as 

amended by FQPA, EPA is required to 

establish time-limited tolerances, or 

exemptions from the requirement of a 

tolerance, for pesticide residues in food 

or feed resulting from uses under 

emergency exemptions. The existing 

regulations predate FQPA and therefore 

do not reflect this requirement. Four 

revisions are made to bring 40 CFR part 

166 into agreement with current 

practices as required by the FFDCA. 

Inasmuch as FFDCA section 408(l)(6) 

applies to all food-use emergency 

exemptions, regardless of whether its 

requirements are reflected in 40 CFR 

part 166, these changes to 40 CFR part 

166 do not substantively change the 

applicable law. For ease of discussion, 

below, ‘‘tolerance’’ is used to refer to a 

tolerance or exemption from the 

requirement of a tolerance. 

First, this rule amends § 166.3(e) to 

revise the definition of ‘‘first food use.’’

The existing definition includes an 

explanation that no permanent tolerance 

or food additive regulation has been 

established for such a use. The word 

‘‘permanent’’ is removed in the revised 

definition so that any tolerance would 

be included, and the reference to ‘‘food 

additive regulation’’ is removed 

because, owing to the FQPA 

amendments, EPA no longer issues food 

additive regulations. 

Second, under § 166.25--Agency 

Review, the regulations state that the 

review enables EPA to make a 

determination with respect to several 

items, including the level of residues in 

or on all food resulting from the 

proposed use. The final rule revises 

§ 166.25(a)(2) to add the establishment 

of a time-limited tolerance for such 

residues, where necessary. 

The third revision made necessary by 

FQPA is to add, under § 166.40, an 

additional limitation to the authority of 

a State or federal agency to issue a crisis 

exemption, namely, that they may issue 

a crisis exemption for a food use only 

where a tolerance or exemption is 

already in effect, or where EPA has 

provided verbal confirmation that a 

time-limited tolerance for the proposed 

use can be established in a timely 

manner. It is in the best interests of 

applicants and potential users of the 

pesticide under the crisis exemption 

that there is some assurance that an 

exemption can be established in a 

timely manner before use of the 

pesticide begins. This revision at 

§ 166.40(c) also stipulates that all crisis 

exemptions be conditioned upon EPA 

confirming that it has no other objection 

to the use of the pesticide under the 

crisis provisions. 

The fourth change is to remove from 

§ 166.30(b) and § 166.47 the nowsuperfluous requirement that EPA 

directly notify the U.S. Food and Drug 

Administration (FDA), USDA, and State 

health officials. The original purpose of 

this requirement was to notify these 

agencies of levels of pesticides that may 

occur in food and feed items as a result 

of an emergency exemption use. Prior to 

FQPA, EPA did not routinely establish 

tolerances for food use pesticides 

applied under an emergency exemption 

program. This notification provision 

served to advise other agencies of the 

exemption and to support field 

enforcement activities. Now, however, 

with the FQPA requirement that timelimited tolerances be established in 

accordance with FFDCA section 

408(l)(6), such levels are published in 

the Federal Register, along with 

detailed background regarding safety of 

these tolerances, as well as incorporated 

into 40 CFR part 180. Therefore, EPA 

considers providing separate 

notification to the other regulatory 

organizations (FDA, USDA, and State 

health officials) on an individual basis 

redundant to the Federal Register notice 

and incorporation of the regulatory 

decision in the appropriate section of 40 

CFR part 180. 

Several revisions are made in this 

final rule to codify minor improvements 

to the process that have been identified 

since the existing regulations became 

effective. Applicants have been 

generally following these practices, in 

most cases for several years, and EPA 

believes that the public will generally 

agree that these are improvements to the 

regulatory requirements. First, under 

§ 166.20, ‘‘Application for a specific, 

quarantine, or public health 

exemption,’’ paragraph (a)(2)(i)(A) is 

revised so that an application must 

include a copy of the EPA-approved 

label for each specific pesticide product 

requested, instead of the existing 

requirement to include the registration 

number and name of the product. This 

will facilitate the review of applications. 

Next, under § 166.20(a)(3), the final 

rule adds a new item, and revises 

several of the others, to specify that the 

conditions of use requested in an 

application must include the maximum 

number of applications, the period of 

time for which the use is proposed, and 

the earliest possible harvest dates of the 

treated crop. Such information is clearly 

necessary for both risk assessment and 

tolerance setting, and in those rare 

occasions in the past where it was not 

apparent from the application, EPA had 

to contact the applicant to obtain the 

information. Expressly requiring this 

information in § 166.20(a)(3) will 

expedite review of applications and 

allow tolerances to be established in an 

orderly fashion. 

Additionally, this rule revises 

§ 166.20(a)(9) to specify that in addition 

to the registrant or manufacturer being 

notified of the application submission, 

the application must also include a 

statement of support from the registrant 

or manufacturer, and the expectation 

that supplies of the requested material 

will be adequate to meet the needs 

under the proposed emergency use. 

The existing regulations establish a 

measure of whether adequate progress 

toward the registration of a repeat 

requested use is being made. Existing 

regulations suggest that the lack of a 

request for registration within 3 years of 

an emergency exemption first being 

requested for the use suggests that 

adequate progress is not being made. 

This final rule revises § 166.24(a)(6)(i) 

and § 166.25(b)(2)(ii) to relax this 

presumption for repeat emergency 

exemption applications for uses being 

supported by IR-4. The IR-4 program is 

a cooperative effort of the state land 

grant universities, USDA and EPA, to 

address the chronic shortage of pest 

control options for minor crops. In 

many cases, the crop protection 

industry lacks economic incentive to 

pursue registrations on minor crops 

because of low acreage. IR-4 generates 

and supplies research data needed by 

EPA in order to register compounds for 

use on minor crops. Owing to the 

limited pest control options available 

for minor use crops, the significance of 

the need evidenced by IR-4 action, and 

the limits on IR-4 resources, a somewhat 

slower rate of progress towards 

registration is reasonable for emergency 

exemptions for uses being supported by 

the IR-4 program. Accordingly, this rule 


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revises § 166.24(a)(7)(i) and 

§ 166.25(b)(2)(ii) so that the 

presumption against adequate progress 

toward registration of repeat emergency 

exemptions for uses being supported by 

the IR-4 program would begin after 5 

years, 2 years more than allowed for 

uses supported by other, typically 

commercial, parties. For uses supported 

by parties other than IR-4, the 3-year 

presumption in the existing regulations 

remains in effect. 

This rule revises § 166.30(a)(1) to 

reflect that EPA will not process 

incomplete applications, and that action 

on such submissions will be halted until 

required additional information is 

submitted. 

The rule clarifies § 166.32(b) to ensure 

that applicants submit interim use 

reports for exemptions when requesting 

a repeated emergency exemption prior 

to the due date of the final report. 

This rule also clarifies the authority of 

an applicant to issue a crisis exemption 

by specifying in § 166.40(a) that crisis 

exemptions are to be used only for 

unpredictable emergency conditions. 

This change is strictly for purposes of 

clarification, as the term 

‘‘unpredictable’’ already appears in the 

introductory language of § 166.40, and 

does not represent any intention by EPA 

to change the criteria for crisis 

exemptions. This rule also adds a 

paragraph (c) under § 166.40, so that the 

state’s authority to exercise the crisis 

exemption is stayed pending verbal 

confirmation by EPA that a tolerance 

can be established in a timely manner 

and that the Agency has no other 

objections. 

This final rule also revises 

§ 166.43(a)(1) to improve the 

notification process for crisis 

exemptions, reflect the standard 

practice of the state agencies, and 

provide for advance notice so that EPA 

may make a determination of whether a 

tolerance may be supported in 

accordance with FFDCA section 408 

requirements. Section 166.43(a)(1) is 

revised to require advance notification 

for crisis exemptions by applicants. This 

replaces the currently ambiguous 

requirement that notification must be 

made at least 36 hours in advance, or no 

later than 24 hours after the decision of 

a state to avail itself of a crisis 

exemption. Notification after the crisis 

has been declared does not allow EPA 

to evaluate whether a crisis use can be 

supported with a section 408 safety 

finding, or whether other potential risks 

are unacceptable, before use of the 

pesticide begins. In any case, EPA will 

continue to provide the necessary verbal 

confirmations as quickly as possible, 

thereby often allowing use of the crisis 

exemption in less than 36 hours. This 

final rule does not attempt to change the 

customary 36–hour timeframe for 

Agency response to notification. The 

Agency recognizes that speed is 

important for all crisis exemptions, and 

that certain situations may be 

particularly urgent, including, but not 

necessarily limited to, national security 

threats and some requests under 

USDA’s Animal and Plant Health 

Inspection Service quarantine program. 

EPA believes that these requests can be 

reviewed in a timely manner through 

the appropriate use of OPP resources. 

To clarify necessary information for a 

crisis exemption, this rule revises 

§ 166.43(b)(1) and (b)(4), to specify 

submission of the registered label(s) for 

the pesticide product(s) proposed for 

crisis use, as well as proposed use 

directions specific to the crisis use, and 

the timeframe for the anticipated use, 

including end date. 

To bring the reporting requirements 

for crisis exemption requests into 

agreement with those for specific, 

quarantine, and public health 

exemption requests, this rule revises 

§ 166.49(a)(1) through (a)(4) and deletes 

§ 166.49(a)(5), to clarify information 

requirements, such as applicant, 

product used, site treated, and contact 

information. 

VII. Implementation of Final Rule 

This final rule becomes effective 

March 28, 2006. Applicants submitting 

exemption requests that are received by 

the Agency after publication of the final 

rule, but before the effective date, will 

have the option of using the revised 

approaches for re-certification or 

documenting an SEL, or using the 

outgoing application method and 

approach. Applications received by EPA 

after the effective date will be processed 

under the approach described in today’s 

final rule. However, applicants for 

exemptions eligible to use a streamlined 

re-certification request may still submit 

a full application, even after the 

effective date. EPA recognizes that 

persons who have previously obtained 

emergency exemptions have not yet 

been advised whether those emergency 

exemptions are eligible for the recertification program. The Agency will 

use submissions received in fiscal year 

2005 as the baseline year for evaluating 

whether emergency exemptions are 

eligible for the new re-certification 

program. As soon as possible, and 

before the effective date of this final 

rule, EPA intends to share with 

applicants and post on its web page a 

list of candidate exemptions that appear 

to Agency reviewers to be eligible for 

the re-certification program. Applicants 

that believe an exemption is eligible for 

re-certification may submit a recertification application prior to EPA’s 

release of the eligibility list. However, 

upon receipt, the Agency must agree 

that it was eligible for re-certification in 

order to process the request in that 

fashion. 

Applications that have already been 

received by EPA as of today’s 

publication date, January 27, 2006, will 

be processed and reviewed in the 

context of the existing framework and 

authorities, unless the applicant submits 

a replacement request under the 

provisions of the final rule. The section 

18 pilot program is terminated as a 

result of the promulgation of this final 

rule. 

Mindful that this national program 

has many stakeholders, EPA plans to 

provide training on how this final rule 

affects the application, review, and 

approval process for emergency 

exemptions. EPA intends to hold public 

meetings and develop information 

materials to help applicants comply 

with this final rule and help others 

understand its new provisions. A 

guidance document concerning the recertification process and the new, lossbased approach for determining and 

documenting an SEL is being issued in 

conjunction with this final rule. EPA 

plans to issue new guidance on other 

aspects of the final rule, or revised 

guidance on other areas, in the future as 

it is needed and available. 

VIII. Related Issues and Emergency 

Exemption Program Context 

A. Pest Resistance Management 

The April 24, 2003 Federal Register 

Notice, that initiated the pilot to test the 

re-certification and revised SEL 

processes, indicated that EPA was 

considering addressing pest resistance 

management (RM) in this rulemaking. 

However, after carefully considering 

public comments on that Notice and reconsidering the possibility of emergency 

exemptions for the purpose of resistance 

management, EPA decided not to 

include such a change in the proposed 

rule. Additional comments on this issue 

were received in response to the 

proposed rule and considered by the 

Agency. EPA believes that section 18 is 

an inappropriate avenue for addressing 

the worthy goal of managing pest 

resistance, for several reasons. 

Some who commented on the 

proposed rule also stated that 

exemptions for the purpose of RM 

should be allowed. Some commenters 

said that although the recently enacted 

Pesticide Registration Improvement Act 

(PRIA) may help bring more RM tools to 


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market sooner, it will not be sufficient 

to address the lack of RM tools, 

particularly for minor crops. While 

these commenters recognize the need to 

prevent abuse of RM exemptions, and 

the difficulty in developing clear criteria 

for approval of an exemption for RM, 

they believe that there is ample middle 

ground between liberally allowing RM 

exemptions and allowing no such 

exemptions. This general comment was 

made by 19 commenters (nine grower 

groups, four State lead agencies, two 

education/research groups, two 

agriculture/food industry groups, and 

two pesticide industry/ registrants). 

Virtually all commenters that 

addressed RM agree with EPA that any 

potentially successful approach for RM 

exemptions would be proactive, 

allowing exemptions before resistance 

has occurred for a particular use in the 

field. Most also agree that predicting 

and documenting a case of resistance 

would be highly variable and complex. 

The Agency believes that the burden to 

applicants of preparing a request for an 

RM exemption that included such 

documentation would be substantially 

higher than the burden of preparing 

other requests. EPA believes such costly 

and complex burden is contrary to the 

purpose of this rulemaking. Likewise, 

the burden to EPA of reviewing and 

deciding on such a request would be 

high, diverting resources from other 

priorities. EPA feels that such a burden 

is not the best use of Agency resources, 

and that other means of dealing with 

RM would be both more efficient and 

more appropriate. Furthermore, a need 

for an RM tool to address a future 

problem arguably does not fit within a 

conventional interpretation of 

‘‘emergency.’’

EPA understands the importance of 

pest resistance management and 

continues to explore how to best use its 

regulatory and non-regulatory 

authorities to support and facilitate 

effective RM. The Agency believes that 

RM capabilities will be improved 

through a multi-faceted approach 

involving incorporating RM 

considerations into pesticide labeling 

(i.e., Pesticide Registration Notice 2001–

5), registering more pesticides for minor 

crops, resistance management education 

programs, crop management and 

stewardship programs, further crop 

grouping for tolerance setting, and 

outreach efforts with stakeholders. 

Under PRIA, EPA is making more timely 

decisions and accelerating the 

registration of many products expected 

to be useful for RM. EPA’s process for 

classifying a pesticide product as 

‘‘reduced-risk’’ considers RM as an 

important factor. New products that 

would address significant RM needs 

would reach the market sooner, thereby 

providing a strong incentive to 

registrants to incorporate RM in their 

registration submissions. Also, the IR-4 

process has continued to improve in 

recent years, identifying priority 

pesticide needs for minor crops and 

facilitating quicker registrations, 

including many useful RM tools. 

B. Endangered Species Considerations 

The existing emergency exemption 

regulations include information 

requirements for applicants and review 

requirements for EPA concerning 

threatened and endangered species. In 

the proposed rule, EPA did not propose 

to revise these requirements. However, 

a discussion of plans for improving the 

process for ensuring that pesticides used 

under emergency exemptions do not 

affect threatened and endangered 

species was included in the preamble. 

One comment submission on the 

proposed rule claimed that EPA’s 

section 18 activities routinely violate 

the Endangered Species Act (ESA). 

These commenters said that the 

streamlining proposals would make 

matters worse. The commenters said 

that EPA does not list a single example 

of consultation with the U.S. Fish and 

Wildlife Service (FWS) or the National 

Marine Fisheries Service (NMFS) in the 

course of a section 18 review. They also 

cite a recent letter from FWS to EPA 

Region 2 stating that the section 18 

process insufficiently addresses EPA’s 

consultation obligations under ESA. 

This comment was made by 13 

environmental/public interest groups in 

a joint submission, and no other 

comments were received on this issue. 

EPA disagrees that this final rule in 

any way lessens protections for 

threatened and endangered species. As 

noted, the regulatory provisions 

regarding submission and consideration 

of information relating to listed species 

have not been altered by the rule nor 

have EPA’s obligations under the ESA 

been altered. EPA also disagrees that its 

plans for improving its processes will 

make matters worse. Indeed, EPA plans, 

as discussed in the proposal, explain 

that the Agency and FWS and NMFS 

(the Services) have developed 

mechanisms to provide increased and 

more expeditious scrutiny to these 

issues than the Agency has in the past. 

The Services, in collaboration with 

EPA and USDA, have developed a 

counterpart regulation (50 CFR part 

402), that would make the process of 

consultation about EPA actions 

involving pesticides - including any 

necessary consultations for emergency 

exemptions under section 18 - more 

efficient, effective, and timely, thereby 

strengthening the protections for 

endangered and threatened species. As 

part of the work supporting the 

counterpart rule, the Services and EPA 

reviewed the Agency’s approach to the 

assessment of potential risks to listed 

species resulting from pesticide use. 

The Services agreed that EPA’s 

approach to ecological risk assessment 

‘‘will produce effects determinations 

that reliably assess the effects of 

pesticides on listed species and critical 

habitat pursuant to section 7 of the ESA 

and implementing regulations.’’ (69 FR 

at 47735). 

EPA looks closely at potential 

ecological risks of pesticide use in 

connection with decisions on requests 

for emergency exemptions. As a result 

of the Services’ acceptance of the 

Agency’s ecological risk assessment 

process, the Agency intends to provide 

new guidance and to work closely with 

applicants for emergency exemptions, to 

improve the information submitted 

concerning threatened and endangered 

species and possible effects on them of 

the requested use. EPA anticipates that 

these measures will fall within existing 

requirements but should increase the 

availability of essential information 

needed to make a timely and 

substantive determination of the 

potential impact to endangered and 

threatened species. As EPA develops 

this new guidance, EPA will look for 

opportunities to enhance consideration 

of these impacts in its emergency 

exemption decision process, including 

any need to consult with FWS and 

NMFS. 

C. Improving Transparency in Decisions 

One of the ongoing challenges for EPA 

in relation to the emergency exemption 

program is to ensure that State agencies 

and interested stakeholders have useful, 

accurate, and timely information on the 

status of applications they are interested 

in as well as other key information that 

could help clarify pesticide use 

directions and facilitate observance of 

necessary safety restrictions that have 

been placed on the exempted use 

pattern. Along these lines, EPA is 

striving to upgrade the quality of the 

information available to States, 

pesticides users, extension agents and 

other key stakeholders under the section 

18 program and also to enhance the 

transparency of this program in general. 

One activity that the Agency has 

developed in this area is a searchable 

section 18 data system that is supported 

on the Office of Pesticide Programs’ web 

page. This data system, located at http:// 

cfpub1.epa.gov/oppref/section18/ 

search.cfm permits basic queries of 


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submissions and overall status 

information for emergency exemption 

applications. EPA also publishes 

information notices in the Federal 

Register in accordance with 40 CFR 

166.30. These are retrospective 

summaries of the section 18 activity 

sorted and presented on the basis of the 

requesting agency. 

EPA is also exploring other means of 

providing useful status and regulatory 

information for emergency exemptions 

that involve pest management concerns 

of national significance. For instance, in 

connection with the response to the 

newly identified select agent that causes 

the plant disease soybean rust, EPA has 

developed a special web page (http:// 

www.epa.gov/oppfod01/cb/csblpage/ 

updates/soybeanlrust.htm) that 

provides the public with a 

comprehensive listing of all of the 

products that have claims for control of 

the soybean rust pathogen. Soybean rust 

is a serious disease of soybean crops and 

has been identified as a select agent 

under the Agricultural Bioterrorism 

Control Act. Due to the national scope 

of the soybean industry, there has been 

significant interest on the part of the 

public in learning which pesticides 

have regulatory clearances for this pest. 

Finally, EPA is exploring another 

initiative for sharing information on the 

section 18 program more extensively. 

Specifically, EPA is investigating ways 

to post more comprehensively its 

decision documents under this program. 

Section 18 decision letters are public 

documents which the Agency transmits 

to the requesting state agency. However, 

certain stakeholders have requested 

copies of these materials directly. To 

this end, EPA has plans for posting its 

decision documents under section 18 on 

the Agency’s web page. 

IX. FIFRA Review Requirements 

In accordance with FIFRA section 

25(a), this final rule was submitted to 

the FIFRA Science Advisory Panel 

(SAP), the Secretary of Agriculture 

(USDA), and appropriate congressional 

committees. The SAP has waived its 

review of this final rule, and no 

comments were received from any of the 

congressional committees or USDA. 

X. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

Under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993), 

the Office of Management and Budget 

(OMB) has determined that this final 

rule is not a ‘‘significant regulatory 

action’’ under section 3(f) of the 

Executive Order. 

In addition, EPA has prepared an 

economic analysis, entitled Economic 

Analysis of the Pesticides Emergency 

Exemption Process Revisions, of the 

potential regulatory impacts of this final 

action on those affected. A copy of this 

Economic Analysis is available in the 

public docket for this action and is 

briefly summarized here. 

This action is not expected to cause 

any significant adverse economic 

impacts. There are no direct impacts on 

local governments or small entities, 

because this action directly affects only 

Federal and State agencies that petition 

EPA for section 18 use authorization, 

neither of which qualify as a small 

entity under the Regulatory Flexibility 

Act (RFA). The only substantive impacts 

expected are burden reductions to 

applicants for emergency exemptions, 

and to EPA in the review process, as 

well as quicker responses to emergency 

conditions. As detailed in the Economic 

Analysis prepared for this final rule, 

based on predicted future applications 

affected by the regulatory revisions, EPA 

estimates the annual combined savings 

for applicants and EPA of around $1.5 

million; nearly $1.2 million from recertification, and over $0.3 million from 

changing to the loss-based method of 

determining SEL. 

B. Paperwork Reduction Act (PRA) 

This action does not impose any new 

information collection burden that 

would require additional approval by 

OMB under the Paperwork Reduction 

Act (PRA), 44 USC 3501 et seq. This 

rule is expected to reduce the existing 

burden that is approved under OMB 

Control No. 2070–0032 (EPA ICR No. 

596), which covers the information 

collection activities contained in the 

existing regulations at 40 CFR part 166, 

and under the pilot program announced 

April 23, 2003 (68 FR 20145). 

The annual respondent burden for the 

collection of information currently 

approved by OMB is estimated to 

average 99 hours per application. A 

copy of the OMB approved Information 

Collection Request (ICR) has been 

placed in the public docket for this 

rulemaking, and the Agency’s estimated 

burden reduction is presented in the 

Economic Analysis that has been 

prepared for this rule. 

Under the PRA, ‘‘burden’’ means the 

total time, effort, or financial resources 

expended by persons to generate, 

maintain, retain, or disclose or provide 

information to or for a federal agency. 

This includes the time needed to review 

instructions; develop, acquire, install, 

and utilize technology and systems for 

the purposes of collecting, validating, 

and verifying information, processing 

and maintaining information, and 

disclosing and providing information; 

adjust the existing ways to comply with 

any previously applicable instructions 

and requirements; train personnel to be 

able to respond to a collection of 

information; search data sources; 

complete and review the collection of 

information; and transmit or otherwise 

disclose the information. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to an information collection 

request unless it displays a currently 

valid OMB control number. The OMB 

control number assigned to this final 

rule (No. 2070–0032) will be listed in 40 

CFR part 9. 

C. Regulatory Flexibility Act 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA), 5 

U.S.C. 601 et seq., the Agency hereby 

certifies that this rulemaking will not 

have a significant adverse economic 

impact on a substantial number of small 

entities. This action will only directly 

impact State and Federal agencies, 

neither of which qualify as a small 

entity under the RFA. This final rule 

does not have any direct adverse 

impacts on small businesses, small nonprofit organizations, or small local 

governments. Section 18 only applies to 

Federal and State governments. 

D. Unfunded Mandates Reform Act 

Under Title II of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

(Public Law 104–4), EPA has 

determined that this action does not 

contain a Federal mandate that may 

result in expenditures of $100 million or 

more for State, local, and tribal 

governments, in the aggregate, or the 

private sector in any 1 year. This final 

rule only applies to Federal and State 

government agencies, the only entities 

that can petition the EPA under FIFRA 

section 18. As such, this action will not 

impact local or tribal governments or 

the private sector, and will not 

significantly or uniquely affect small 

governments. In addition, as described 

in Unit X.A., this final rule is expected 

to result in an overall reduction of 

existing costs for applicants and EPA of 

around $1.5 million. Accordingly, this 

rule is not subject to the requirements 

of sections 202 and 205 of UMRA. 

E. Executive Order 13132 

Pursuant to Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999), EPA has determined 

that this final rule does not have 

‘‘federalism implications,’’ because it 


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will not have substantial direct effects 

on the states, on the relationship 

between the national government and 

the states, or on the distribution of 

power and responsibilities among the 

various levels of government, as 

specified in the Order. As indicated 

above, this final rule is expected to 

reduce burden on Federal and State 

government agencies that petition EPA 

under FIFRA section 18, and on EPA in 

processing the applications. Thus, 

Executive Order 13132 does not apply 

to this final rule. In the spirit of the 

Order, and consistent with EPA policy 

to promote communications between 

the Agency and State governments, EPA 

specifically solicited comment from 

State officials on the proposed rule. 

F. Executive Order 13175 

As required by Executive Order 

13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

6, 2000), EPA has determined that this 

final rule does not have tribal 

implications because it will not have 

any effect on tribal governments, on the 

relationship between the Federal 

government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

government and Indian tribes, as 

specified in the Order. As indicated 

above, this rule only applies to State 

and Federal government agencies. 

FIFRA section 18 does not apply to 

tribal governments. Thus, Executive 

Order 13175 does not apply to this final 

rule. 

G. Executive Order 13211 

This final rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) because it is not designated as 

an ‘‘economically significant’’

regulatory action as defined by 

Executive Order 12866 (see Unit X.A.), 

nor is it likely to have any significant 

adverse effect on the supply, 

distribution, or use of energy. 

H. Executive Order 13045 

Executive Order 13045, entitled 

Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997) does 

not apply to this final rule because this 

action is not designated as an 

‘‘economically significant’’ regulatory 

action as defined by Executive Order 

12866 (see Unit X.A.), nor does it 

establish an environmental standard, or 

otherwise have a disproportionate effect 

on children. 

I. National Technology Transfer and 

Advancement Act 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (NTTAA), (15 U.S.C. 272 

note) directs EPA to use voluntary 

consensus standards in its regulatory 

activities unless to do so would be 

inconsistent with applicable law or 

impractical. Voluntary consensus 

standards are technical standards (e.g., 

materials specifications, test methods, 

sampling procedures) that are 

developed or adopted by voluntary 

consensus standards bodies. This final 

rule does not impose any technical 

standards that would require EPA to 

consider any voluntary consensus 

standards. 

J. Executive Order 12898 

This final rule does not have an 

adverse impact on the environmental 

and health conditions in low-income 

and minority communities. Therefore, 

under Executive Order 12898, entitled 

Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994), the Agency has not considered 

environmental justice-related issues. 

XI. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

Agency promulgating the rule must 

submit a rule report that includes a copy 

of the rule to each House of the 

Congress and the Comptroller General of 

the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. This rule is not a 

‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 166 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 13, 2006. 

Stephen L. Johnson, 

Administrator. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 166—[AMENDED] 

■ 1. The authority citation for part 166 

continues to read as follows: 

Authority: 7 U.S.C. 136–136y. 

■ 2. Section 166.2 is amended by 

revising paragraph (b) to read as follows: 

§ 166.2 Types of exemptions. 

* * * * * 

(b) Quarantine exemption. A 

quarantine exemption may be 

authorized in an emergency condition to 

control the introduction or spread of 

any pest that is an invasive species, or 

is otherwise new to or not theretofore 

known to be widely prevalent or 

distributed within and throughout the 

United States and its territories. 

* * * * * 

■ 3. Section 166.3 is amended by 

revising paragraphs (a), (d)(3)(i), (e), (h), 

and adding paragraphs (k) and (l) to 

read as follows: 

§ 166.3 Definitions. 

* * * * * 

(a) The term the Act means the 

Federal Insecticide, Fungicide, and 

Rodenticide Act, as amended, 7 U.S.C. 

136 et seq. 

* * * * * 

(d) * * * 

(3) * * * 

(i) Involves the introduction or 

dissemination of an invasive species or 

a pest new to or not theretofore known 

to be widely prevalent or distributed 

within or throughout the United States 

and its territories; or 

* * * * * 

(e) The term first food use refers to the 

use of a pesticide on a food or in a 

manner which otherwise would be 

expected to result in residues in a food, 

if no tolerance or exemption from the 

requirement of a tolerance for residues 

of the pesticide on any food has been 

established for the pesticide under 

section 408(b)(2) and (c)(2) of the 

Federal Food, Drug, and Cosmetic Act. 

* * * * * 

(h) The term significant economic loss 

means that, compared to the situation 

without the pest emergency and despite 

the best efforts of the affected persons, 

the emergency conditions at the specific 

use site identified in the application are 

reasonably expected to cause losses 

meeting any of the following criteria: 

(1) For pest activity that primarily 

affects the current crop or other output, 

one or more of the following: 

(i) Yield loss greater than or equal to 

20%; 

(ii) Economic loss, including revenue 

losses and cost increases, greater than or 

equal to 20% of gross revenues; 

(iii) Economic loss, including revenue 

losses and cost increases, greater than or 

equal to 50% of net revenues; 

(2) For any pest activity where EPA 

determines that the criteria in paragraph 


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(h)(1) would not adequately describe the 

expected loss, substantial loss or 

impairment of capital assets, or a loss 

that would affect the long-term financial 

viability expected from the productive 

activity. 

* * * * * 

(k) The term invasive species means, 

with respect to a particular ecosystem, 

any species that is not native to that 

ecosystem, and whose introduction does 

or is likely to cause economic or 

environmental harm or harm to human 

health. 

(l) The term IR-4 program means the 

Interregional Research Project No. 4, a 

cooperative effort of the state land grant 

universities, the U.S. Department of 

Agriculture and EPA, to address the 

chronic shortage of pest control options 

for minor crops, which are generally of 

too small an acreage to provide 

economic incentive for registration by 

the crop protection industry. 

■ 4. Section 166.20 is amended by 

revising paragraphs (a)(2)(i)(A), (a)(3), 

(a)(9), (b)(4), and adding paragraph 

(b)(5) to read as follows: 

§ 166.20 Application for a specific, 

quarantine, or public health exemption. 

(a) * * * 

(2) * * * 

(i) * * * 

(A) A copy of the label(s) if a specific 

product(s) is/are requested; or the 

formulation(s) requested if a specific 

product is not requested; and 

* * * * * 

(3) Description of the proposed use. 

The application shall identify all of the 

following: 

(i) Sites to be treated, including their 

locations within the State; 

(ii) The method of application; 

(iii) The rate of application in terms 

of active ingredient and product; 

(iv) The maximum number of 

applications; 

(v) The total acreage or other 

appropriate unit proposed to be treated; 

(vi) The total amount of pesticide 

proposed to be used in terms of both 

active ingredient and product; 

(vii) All applicable restrictions and 

requirements concerning the proposed 

use which may not appear on labeling; 

(viii) The duration of the proposed 

use; and 

(ix) Earliest possible harvest dates. 

* * * * * 

(9) Acknowledgment by registrant. 

The application shall contain a 

statement by the registrants of all 

pesticide products proposed for use 

acknowledging that a request has been 

made to the Agency for use of the 

pesticide under this section. This 

acknowledgment shall include a 

statement of support for the requested 

use, including the expected availability 

of adequate quantities of the requested 

product under the use scenario 

proposed by the applicant(s); and the 

status of the registration in regard to the 

requested use including appropriate 

petition numbers, or of the registrant’s 

intentions regarding the registration of 

the use. 

* * * * * 

(b) * * * 

(4) A discussion of the anticipated 

significant economic loss, together with 

data and other information supporting 

the discussion, that addresses one or 

more of the following, as appropriate: 

(i) Yield or utilized yield reasonably 

anticipated in the absence of the 

emergency and expected losses in 

quantity due to the emergency; 

(ii) The information in paragraph 

(b)(4)(i) of this section plus prices 

reasonably anticipated in the absence of 

the emergency and changes in prices 

and/or production costs due to the 

emergency; 

(iii) The information in paragraph 

(b)(4)(ii) of this section plus operating 

costs reasonably anticipated in the 

absence of the emergency; 

(iv) Any other information explaining 

the economic consequences of the 

emergency. 

(5) Re-certification of an emergency 

condition. Applicants for specific 

exemptions may submit re-certification 

applications relying on previously 

submitted information to satisfy the 

information requirements of paragraphs 

(a)(1) through (a)(10) of this section, and 

of paragraphs (b)(1) through (b)(4) of 

this section, where all of the following 

conditions are met: 

(i) An exemption was granted for the 

same pesticide at the same site to the 

same applicant the previous year; 

(ii) The emergency condition could 

reasonably be expected to continue for 

longer than 1 year; 

(iii) EPA has not declared the use 

ineligible for re-certification; 

(iv) The use is not subject to public 

notice pursuant to § 166.24(a)(1) 

through (a)(6); 

(v) The applicant certifies that all of 

the following are true: 

(A) The emergency condition 

described in the preceding year’s 

application continues to exist; 

(B) Except as expressly identified, all 

information submitted in the preceding 

year’s application is still accurate; 

(C) Except as expressly identified, the 

proposed conditions of use are identical 

to the conditions of use EPA approved 

for the preceding year; 

(D) Any conditions or limitations on 

the eligibility for re-certification 

identified in the preceding year’s notice 

of approval of the emergency exemption 

have been satisfied; 

(E) The applicant is not aware of any 

alternative chemical or non-chemical 

practice that may offer a meaningful 

level of pest control, or has provided 

documentation that each such known 

practice does not provide adequate 

control or is not economically or 

environmentally feasible. 

* * * * * 

■ 5. Section 166.24 is amended by 

revising the introductory text of 

paragraph (a), redesignating paragraphs 

(a)(6) and (a)(7) as paragraphs (a)(7) and 

(a)(8) respectively, adding a new 

paragraph (a)(6), and revising newly 

redesignated paragraph (a)(7)(i) to read 

as follows: 

§ 166.24 Public notice of receipt of 

application and opportunity for public 

comment. 

(a) Publication requirement. The 

Administrator shall issue a notice of 

receipt in the Federal Register for a 

specific, quarantine, or public health 

exemption and request public comment 

when any one of the following criteria 

is met: 

* * * * * 

(6) The application proposes use of a 

pesticide which: 

(i) Was voluntarily canceled under 

section 6(f) of the Act, and 

(ii) Is intended for a use that poses a 

risk similar to the risk posed by any use 

of the pesticide which was voluntarily 

canceled under section 6(f); 

(7) * * * 

(i) An emergency exemption has been 

requested or approved for that use in 

any 3 previous years, or any 5 previous 

years if the use is supported by the IR4 program, and 

* * * * * 

■ 6. Section 166.25 is amended by 

revising paragraphs (a)(2), (a)(4), and 

(b)(2)(ii) to read as follows: 

§ 166.25 Agency review. 

(a) * * * 

(2) The Agency’s ability and intention 

to establish a time-limited tolerance(s) 

or exemption(s) from the requirement of 

a tolerance for any pesticide residues 

resulting from the authorized use, 

identifying the level of permissible 

residues in or on food or feed resulting 

from the proposed use; 

* * * * * 

(4) The potential risks to human 

health, endangered or threatened 

species, beneficial organisms, and the 

environment from the proposed use. 


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(b) * * * 

(2) * * * 

(ii) The progress which has been 

made toward registration of the 

proposed use, if a repeated specific or 

public health exemption is sought. It 

shall be presumed that if a complete 

application for registration of a use, 

which has been under a specific or 

public health exemption for any 3 

previous years, or any 5 previous years 

if the use is supported for registration by 

the IR-4 program, has not been 

submitted, reasonable progress towards 

registration has not been made. 

■ 7. Section 166.30 is amended by 

revising paragraph (a)(1), removing 

paragraph (b), and redesignating 

paragraph (c) as paragraph (b). 

§ 166.30 Notice of Agency decision. 

(a) * * * 

(1) Incomplete applications. The 

Agency may discontinue the processing 

of any application that does not address 

all of the requirements of § 166.20 until 

such time the additional information is 

submitted by the applicant. 

* * * * * 

■ 8. Section 166.32 is amended by 

revising the introductory text of 

paragraph (b) to read as follows: 

§ 166.32 Reporting and recordkeeping 

requirements for specific, quarantine, and 

public health exemptions. 

* * * * * 

(b) Interim and final reports. A final 

report summarizing the results of 

pesticide use under any specific, 

quarantine, or public health exemption 

must be submitted to the Agency within 

6 months from the expiration of the 

exemption unless otherwise specified 

by the Agency. For quarantine 

exemptions granted for longer than 1 

year, interim reports must be submitted 

annually. When an application for 

renewal of the exemption is submitted 

before the expiration of the exemption 

or before submission of the final report, 

an interim report must be submitted 

with the application. The information in 

interim and final reports shall include 

all of the following: 

* * * * * 

■ 9. Section 166.40 is amended by 

revising paragraph (a), removing the 

period at the end of paragraph (b) and 

adding a semi-colon and the word 

‘‘and’’ at the end of paragraph (b), and 

adding paragraph (c) to read as follows: 

§ 166.40 Authorization. 

* * * * * 

(a) An unpredictable emergency 

condition exists; 

* * * * * 

(c) EPA has provided verbal 

confirmation that, for food uses, a 

tolerance or exemption from the 

requirement of a tolerance can be 

established in a timely manner, 

responsive to the projected timeframe of 

use of the chemical and harvest of the 

commodity, and that, for any use, the 

Agency has no other objection. 

■ 10. Section 166.43 is amended by 

revising paragraphs (a)(1) and (b) to read 

as follows: 

§ 166.43 Notice to EPA and registrants or 

basic manufacturers. 

(a) * * * 

(1) The State or Federal Agency 

issuing the crisis exemption must notify 

the Administrator in advance of 

utilization of the crisis provisions. 

* * * * * 

(b) Contents of notice. Information 

required to be provided in notices shall 

include all of the following: 

(1) The name of the product and 

active ingredient authorized for use, 

along with the common name and CAS 

number if available, including a copy of 

the EPA registered label and use 

directions appropriate to the authorized 

use; 

(2) The site on which the pesticide is 

to be used or is being used; 

(3) The use pattern; 

(4) The date on which the pesticide 

use is to begin and the date when the 

use will end; 

(5) An estimate of the level of residues 

of the pesticide expected to result from 

use under the crisis exemption; 

(6) Earliest anticipated harvest date of 

the treated commodity; 

(7) Description of the emergency 

situation; and 

(8) Any other pertinent information 

available at the time. 

§ 166.47 [Removed] 

■ 11. Section 166.47 is removed. 

■ 12. Section 166.49 is amended by 

revising paragraph (a) to read as follows: 

§ 166.49 Public notice of crisis 

exemptions. 

(a) Periodic notices. At least quarterly, 

the Administrator shall issue a notice in 

the Federal Register announcing 

issuance of crisis exemptions. The 

notice shall contain all of the following: 

(1) The name of the applicant; 

(2) The pesticide authorized for use; 

(3) The crop or site to be treated; and 

(4) The name, address, and telephone 

number of a person in the Agency who 

can provide further information. 

* * * * * 

[FR Doc. 06–743 Filed 1–26–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0515; FRL–7757–2] 

Sorbitol Octanoate; Exemption from 

the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the biochemical 

sorbitol octanoate on all food 

commodities when applied/used in 

accordance with label directions. AVA 

Chemical Ventures, L. L. C. submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA), requesting an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of sorbitol 

octanoate. 

DATES: This regulation is effective 

January 27, 2006. Objections and 

requests for hearings must be received 

on or before March 28, 2006. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VIII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number EPA–HQ–

OPP–2005–0515. All documents in the 

docket are listed on the 

www.regulations.gov website. 

(EDOCKET, EPA’s electronic public 

docket and comment system was 

replaced on November 25, 2005, by an 

enhanced federal-wide electronic docket 

management and comment system 

located at http://www.regulations.gov/. 

Follow the online instructions.) 

Although listed in the index, some 

information is not publicly available, 

i.e., CBI or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically in 

EDOCKET or in hard copy at the Public 

Information and Records Integrity 

Branch (PIRIB), Rm. 119, Crystal Mall 

#2, 1801 S. Bell St., Arlington, VA. This 

docket facility is open from 8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays. The docket 

telephone number is (703) 305–5805. 


rmajette on PROD1PC67 with RULES