United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7510W)
EPA739-R-97-001
October 1997
&EPA
Streamlining Registration
of Antimicrobial Pesticides
1997 EPA Progress Report
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STREAMLINING REGISTRATION
of
ANTIMICROBIAL PESTICIDES
1997 EPA PROGRESS REPORT
Antimicrobials Division
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, DC
October 1997
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This report was prepared by the Antimicrobials Division, Office of Pesticide Programs,
U.S. Environmental Protection Agency.
To contact the Antimicrobials Division:
Phone: 703-308-6411
Fax: 703-308-6466
e-mail: last name.firstname@epamail.epa.gov
Mailing address
Name of Person
Antimicrobials Division (7510W)
EPA
401 M Street, SW
Washington, DC 20460
Division Director: Frank Sanders
Associate Division Director: William Jordan
Ombudsman: Yvette Hopkins (ph: 703-308-6214)
Communications Specialist: Barbara Mandula (ph: 703-308-7378)
To obtain additional copies of this report (Pub # 739-R-97-001)
National Center for Environmental Publications and Information (NCEPI)
ph: 1-800-490-9198
fax: 513-489-8695
e-mail: http://www.epa.gov/epahome/publicat.htm (all lower case)
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CONTENTS
EXECUTIVE SUMMARY
I. INTRODUCTION 1
Uses of Antimicrobial Pesticides , 1
Amounts of Antimicrobial Pesticides Used in the United States 2
Creation and Structure of Antimicrobials Division 2
II. MEETING NEW REGISTRATION DEADLINES t 5
Review Periods Under the 1096 Amendments to FIFRA 5
Types of Submissions ..., 6
Registration . . .., 5
Amendments 7
What is a Fast Track Submission? 7
III. MEASURES TAKEN TO REDUCE BACKLOG 8
IV. STREAMLINING ACTIVITIES 9
Processes 9
Expedited Review Team 9
Other Process Changes : 10
Policies , 10
Minor Changes in Labels or Formulations 10
Proposed Procedural Rule and Data Requirements 12
V. OUTREACH 14
First National Antimicrobial Workshop-January 1997 14
Stakeholder Meetings 15
National Antimicrobial Information Network 16
VI. OTHER RESPONSIBILITIES OF THE ANTIMICROBIALS DIVISION 16
Reregistration Eligibility Decisions (REDs) , 16
Setting Tolerances 17
Ensuring Efficacy of Public Health Antimicrobial Pesticides 18
Efficacy Testing 18
Laboratory Accreditation (Certification) 18
Self Certification of Data 19
VII. SUMMARY AND RECOMMENDATIONS 19
ATTACHMENTS
A. 1996 Amendments to FIFRA Specifically Related to Antimicrobial Pesticides
B. Antimicrobials Division Organization Chart
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EXECUTIVE SUMMARY
On August 3, 1996, President Clinton signed the landmark Food Quality Protection Act,
which amends the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug, and Cosmetic Act (FFDCA). Section 3(h)(4) of the amended FIFRA requires EPA
to prepare an annual report to two Congressional committees explaining what measures the
Agency has taken to reduce the antimicrobial registration backlog, its progress in achieving
antimicrobial process reforms, and what further registration-related changes it recommends. This
report responds to the three topics mentioned in Section 3(h)(4) of FIFRA, but goes much further
in describing the far-reaching changes the Agency is making to streamline antimicrobial
registrations.
A turning point in improving antimicrobial pesticide registrations occurred with creation
of a self-contained Antimicrobials Division in the Office of Pesticide Programs. This new
division provides "one-stop shopping" for all antimicrobial regulatory services. After this
reorganization, EPA reduced the antimicrobials registration backlog from 388 at the end of
December 1996 to 90 by June 30,1997, a decrease of 77%. EPA's goal is to eliminate the
antimicrobial backlog during 1998. At the same time as reducing the backlog, EPA has met all
the fast track review goals mandated by the amended FIFRA. (Fast track actions are those that
need to be completed within 90 days.) These accomplishments were possible largely because the
new division can control its own workflow, and because it created a dedicated Expedited Review
Team that ensures that fast track actions and certain other activities are completed on time. In
addition to meeting the new FIFRA review goals, EPA has fulfilled all its other regulatory
responsibilities related to antimicrobial pesticides.
To continue its streamlining activities, EPA is meeting regularly with antimicrobial
pesticide stakeholders to obtain their suggestions for lessening the registration burden both on
EPA and on registrants, while ensuring the continued safely and efficacy of registered pesticides.
EPA and registrants are working together to develop standardized reporting forms for various
types of submissions. In the antimicrobial rule—developed with extensive input from
stakeholders—EPA is proposing to streamline certain registration steps and to develop a tiered
system of required tests so that the results of initial tiers determine the need for additional tests.
In the near future, EPA hopes to approve faster and more dependable efficacy tests for public
health antimicrobial pesticides.
With many successful streamlining activities in progress, it would be premature for EPA
to make recommendations for further improving antimicrobial pesticide registration at this time.
The Agency expects to include such recommendations in its 1998 progress report, after it has had
more experience with ongoing changes.
ill
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STREAMLINING REGISTRATION
of ANTIMICROBIAL PESTICIDES:
1997 EPA PROGRESS REPORT
I. INTRODUCTION
The landmark Food Quality Protection Act of 1996 (FQPA), Public Law 104-170, was
signed on August 3, 1996 by President Bill Clinton. Its major goals were to better protect the
public—especially children—from exposure to harmful pesticides in foods and to improve
registration processes related to non-food pesticides. The FQPA provisions became amendments
to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug,
and Cosmetic Act (FFDCA). Section 3(h) of the amended FIFRA (see Attachment A) addresses
Antimicrobial Pesticide Registration Reform and requires EPA to submit an annual progress
report to the Committee on Agriculture of the House of Representatives and the Committee on
Agriculture, Nutrition, and Forestry of the Senate that covers three topics related to registration
of antimicrobial pesticides. The yearly reports, required until specified statutory goals are
achieved, "shall include a description of—
"(I) measures taken to reduce the backlog of pending registration applications;
"(ii) progress toward achieving reforms under this subsection [subsection describes
new review deadline goals and types of streamlining processes EPA should consider to speed up
antimicrobial pesticide registration decisions]; and
"(in) recommendations to improve the activities of the Agency pertaining to
antimicrobial registrations."
This EPA report describes the Agency's recent activities in the three areas identified
above. But the report goes further, by showing how EPA is responding to both the statutory
requirements and the spirit of the law. Since the FQPA was passed, significant changes have
occurred in the way EPA manages antimicrobial registration activities. A new Antimicrobials
Division was formed to provide the structure and staff needed to respond to the law. Under the
new division, the backlog of applications for registration activities has been greatly reduced; fast-
track statutory deadlines are being met; registration submissions are being processed more
quickly than in the past; and outreach activities are involving stakeholders in an ongoing
dialogue about the best ways to protect human health and the environment while streamlining
registration procedures.
Uses of Antimicrobial Pesticides
According to the new FIFRA amendments, an antimicrobial pesticide is a pesticide that is
intended to "(i) disinfect, sanitize, reduce, or mitigate growth or development of microbiological
organisms; or (ii) protect inanimate objects, industrial processes or systems, surfaces, water, or
other chemical substances from contamination, fouling, or deterioration caused by bacteria,
viruses, fungi, protozoa, algae, or slime." This category does not include certain pesticides
intended for food use, but does encompass pesticides with a wide array of other uses. For
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example, antimicrobial pesticides act as preserving agents in paints, metalworking fluids, wood
supports, and many other products to prevent their deterioration.
Antimicrobials are especially important because many are public health pesticides. They
help to control microorganisms (viruses, bacteria, and other microorganisms) that can cause
human disease. Antimicrobial public health pesticides are used as disinfectants in medical
settings, where they are present in products used in cleaning cabinets, floors, walls, toilets, and
other surfaces. Proper use of these disinfectants is an important part of infection control
activities employed by hospitals and other medical establishments. According to the most recent
data available from the Centers for Disease Control, more than 2,000,000 infections per year
occur when individuals are in a hospital rather than at home or elsewhere. A substantial decrease
in that number would be a significant public health accomplishment. EPA also registers many
consumer products as disinfectants, which consumers use to decrease the number of microbes on
surfaces such as toilet bowls or sinks. Because microbes are invisible and users cannot
determine if the disinfectant is working, EPA reviews public health pesticides for efficacy as
well as safety.
Amounts of Antimicrobial Pesticides Used in the United States
The approximately 5,000 antimicrobial pesticide products registered with EPA contain
one or more of 256 active ingredients. The Antimicrobials Division (AD) of the Office of
Pesticide Programs (OPP) is responsible for regulating these ingredients and products. Table 1
shows the current share of responsibility for pesticide registration held by the Antimicrobials
Division compared with the responsibilities of the entire Office of Pesticide Programs.
Creation and Structure of Antimicrobials Division.
EPA has created an Antimicrobials Division (AD) in the Office of Pesticide Programs
that allows "one-stop shopping" for regulation of antimicrobial pesticides. For pesticides under
its jurisdiction, the division carries out the full range of regulatory activities, including
registration, reregistration, notifications, tolerance-setting, experimental use permits, and
oversight of State-registered products. When fully staffed, it will have the needed personnel and
expertise to conduct and manage virtually all reviews within the division, thus helping to ensure
that AD meets its deadlines and quickly responds to the needs of stakeholders. The division
consists of two Regulatory Management Branches, each with a projected ceiling of 13 people,
and a Risk Assessment and Science Support Branch with more than 20 technical staff (see Figure
1 and Attachment B). The Regulatory Management Branches manage all aspects of the review,
technical integration, and decision-making related to submissions. The technical branch reviews
all incoming data related to AD registration actions. It includes experts in the fields of
microbiology, toxicology, biology, chemistry, ecology, and risk assessment.
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Table 1. Portion of Total EPA Pesticide Registration Activities Managed by
Antimicrobials Division
Category
Active ingredients
registered
(number)*
Active products
registered
(number)*
Active ingredients
used per year in
U.S. (pounds)**
Antimicrobials
Division
256
5,000
Total: 3.3 billion
pounds.
2.3 billion
pounds
hypochlorite/
chlorine chemicals
for disinfecting
water, including
drinking water.
0.7 billion pounds
wood preservatives.
*** 0.3 billion
pounds "other,"
including public
health pesticides
such as
disinfectants and
sanitizers used in
medical facilities
and swimming
pools; preservatives
for metalworking
fluids, paints, and
coatings.
Office of Pesticide
Programs, Total
883
21,000
Total: 4.5 billion
pounds
1.0 billion pounds
conventional
pesticides used in
agriculture or on
lawns, gardens, etc.
0.2 billion
pounds "other."
3.3 billion pounds
antimicrobials
% Antimicrobials
Division
29%
24%
73%
** Data for 1995
*** Excludes water treatment chemicals with hypochlorite/chlorine
In addition to the Division Director and Associate Division Director, the Immediate
Office consists of nine people, four of them constituting an administrative team. Others in the
immediate office are a senior advisor, two special assistants, a communications specialist, and an
ombudsman. The ombudsman role is especially crucial in AD, where many applicants are small
companies that lack in-house expertise or that have limited experience with registration of
antimicrobial pesticides. Because the ombudsman is available to solve problems and to answer
a variety of questions, remaining AD staff can focus on completing registration actions assigned
to them.
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Figure 1.
Antimicrobials Division
Office of Pesticide Programs
U.S. Environmental Protection Agency
Associate
Director
Regulatory
Management
Branch I
1 Branch Chief
2 Product Managers
1 Senior Registration
Specialist
9 Registration
Specialists
Director
Regulatory
Management
Branch II
1 Branch Chief
2 Product Managers
1 Senior Registration
Specialist
9 Registration
Specialists
Immediate
Office Staff
Risk Assessment
& Science Support
Branch
1 Branch Chief
5 Team Leaders/
Senior Scientists
5 Efficacy Specialists
3 Hazard Assessors
4 Exposure Assessors
3 Ecological Fate &
Effects Assessors
3 Chemists
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Total AD staff is 60 full time employees (FTEs) (October 1997). Depending on the
workload, the division may add a second risk assessment and science support branch.
II. MEETING NEW REGISTRATION DEADLINES
Review Periods Under the 1996 Amendments to FIFRA
A major goal of the 1996 amendments to FIFRA is to ensure that pesticide registration
actions occur in a timely manner. Section 3(h) of the amended FIFRA establishes goals for the
length of time EPA can take to review and reach decisions on different types of pesticide
applications. These new review periods are months to years shorter than the length of time often
taken in the past (see Tables 2a and 2b). Except as explained below, EPA is required to meet
these new review times for submissions received after implementing regulations are in place
(21 months after enactment of the Act, or May 1998).
However, two shortened review periods for antimicrobials registration activities are
already in effect. The first shortened review period concerns Notifications for labeling changes
unrelated to pesticidal claims; a 30-day review period for disapproval of notifications became
operable the day the Food Quality Protection Act became law. The second is the 90-day review
period for expedited ("fast-track") submissions.
Although the review period goals of longer than 90 days are not yet in effect under the
provisions of FQPA, AD is processing applications received after November 1,1996 as though
all the review goals already apply. Under this self-imposed standard, AD has met all FQPA
review times for submissions received since FQPA was enacted, and expects to continue to do
so. Meeting these goals has required significant changes in the way AD processes different types
of submissions. Some administative changes, such as creation of an Expedited Review Team,
have been crucial in ensuring that AD meets the shortened time goals for reviewing and making
decisions on applications.
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Table 2a. Registering Antimicrobial Pesticides: Comparison of Historical Elapsed Times with
New Review Time Goals under FIFRA Amendments
Type of Registration
Application
A. Product with a new active
ingredient
B. Product with new use
C. Product identical or
substantially similar to one
already registered
D. Other new product
Historical Elapsed Time
(months)
36-84
24-36
Not Available
18-36
Review Time Goals under
New Amendments to
FIFRA (months)
18
9
3
4
Table 2b. Acting on Amendments for Antimicrobial Pesticides: Comparison of Historical
Elapsed Times with New Review Time Goals under FIFRA Amendments
Type of Amendment
E. New use (significant
amount of data review)
F. Amendment (no data
review except product
chemistry)
G. Other amendment (some
data review)
Historical Elapsed Time
(months)
6-30
Not Available
Not Available
Review Time Goals under
New Amendments to
FIFRA (months)
9
3
3-6
Types of Submissions
Registration
As shown by Tables 2a and 2b, several types of applications come to the Antimicrobials
Division. Below is a brief description of the categories of submissions, with review time goals
specified by FIFRA amendments in parentheses.
A. New active ingredient (18 months (540 days) ): Application for registration of a new
product containing any active ingredient not contained in a currently registered product.
B. Product with major new use (9 months (270 days)): Application for new registration that
also proposes a "major new use."
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D.
Substantially similar product (3 months (90 days)): An application for new registration
that meets the following three criteria: 1) the product formulation contains the same
active ingredients as, and is substantially similar in composition to, a cited currently
registered product; 2) the proposed uses are substantially similar to the uses on the label
of the cited substantially similar products; 3) the application relies solely on data already
submitted, with the exception of certain product chemistry data, and does not require
submission or citation of efficacy data.
Identical product (3 months (90 days)): Application for registration where 1) the
formulation is identical in composition to a cited currently registered formulation.
Typically a product is being repackaged or being produced by a different entity; 2) the
proposed uses are identical to those on the cited product.
Other new product (4 months (120 days)): Application for new registration that does not
fit into any of the categories already described. These products usually require
submission of data.
Amendments
The three categories of amendments, which are changes to a product's existing
registration, are described below:
E. Major new use (9 months (270 days)): An application for amended registration to add a
major new use that is not currently registered for one or more of the active ingredients in
the product. Data review required.
F. Minor amendment (3 months (90 days)): An amendment to an existing registration that
does not require scientific review of any type, and does not contain any new data that
need to be reviewed.
G. Other amendment (3-6 months (90-180 days)); A substantive amendment that is not a
major new use, and that requires scientific review, often of more than efficacy data.
What is a Fast Track Submission?
A fast track submission is the name that EPA has given to submissions that FIFRA
section 3(c)(3)(B) specifies must be reviewed and a decision made within 90 days of EPA's
receiving a complete application. The following three types of applications are fast track
applications:
1) Registration of an end use product that is identical or substantially similar in
composition and labeling to a currently registered product, and that does not require scientific
review of data other than product chemistry data (Item C in Table 2a);
2) Registration of an end use product that differs from a currently registered product in
composition and labeling only hi ways that do not substantially increase the risk of unreasonable
adverse effects on the environment (Item C in Table 2a);
3) Amended registration of an end use product that does not require scientific review of
data other than product chemistry data (Item F in Table 2b).
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. MEASURES TAKEN TO REDUCE BACKLOG
The Antimicrobials Division has made substantial progress in reducing its backlog. This
backlog reduction occurred while AD met all of the new FIFRA review time goals for
applications submitted after FQPA took effect. Thus, the antimicrobials backlog consists of the
following two categories of applications:
1) applications submitted before FQPA took effect and which were not completed under
EPA's self-imposed deadlines, and
2) applications received after FQPA took effect in categories for which FQPA does not
set review time goals; most of these applications are for antimicrobial pesticides with
food uses.
For categories B-G in Table 3 (next page), which encompass more than 95% of
antimicrobials registration actions, EPA reduced the backlog between December 1996 and July
1997 by almost 80%. The backlog in Category A, new active ingredients, is decreasing more
slowly for two reasons. First, these are the most complicated applications to review, and EPA's
self-imposed deadlines were exceeded. EPA has not completed the reviews for these backlogged
submissions since FQPA was passed. Second, the number of items in the backlog in category A
increased slightly (from 11 to 14) during early 1997 because that is when EPA's self-imposed
deadlines were exceeded.
Table 3 shows the numerical reductions in individual backlog categories from January to
June 1997. Amendments that are fast track, which have accounted for the largest share of the
backlog, were reduced by 85% during the January-to-June period. Fast track new products were
reduced by a similar percentage.
The Antimicrobials Division took specific actions to reduce the backlog. It created an
Expedited Review Team to process the majority of fast track submissions, thus giving other
reviewers time to work on the backlog. In some cases it consolidated multiple actions on the
same product. To ensure that new submissions do not enter the backlog, AD has strengthened its
tracking system so that submissions move quickly from one stage to the next and staff can
readily identify approaching deadlines. Additional staff who can help reduce the backlog have
recently joined the division. AD's goal is to eliminate the backlog for categories C, D, F, and G
by the end of December 1997, and to eliminate the backlog for categories A, B, and E during
1998. The division plans to continue making timely decisions on all incoming submissions so
that no new actions enter the backlog.
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Table 3. Number of Items in Antimicrobials Division Backlog at End of Various Months
Month Ending
December 1996
January 1997
February 1997
March 1997
April 1997
May 1997
June 1997
New active
ingredient
[A]
10
10
11
14
14
12
12
New use
[B][E]
16
17
16
12
9
8
8
New
product,
fast
track
[C]
69
52
44
26
15
11
7
New
product,
not fast
track
[D]
50
37
37
34
30
23
20
Amend-
ment,
fast track
[F]
178
127
114
94"
69
35
25
Amend-
ment,
not fast
track [G]
60
49
49
47
26
20
17
TOTAL*
388
297
276
232
167
112
90
NOTE: "Fast track" refers to submissions for amendments or new products for which FIFRA requires a decision
within 90 days (C and F). "Not fast track" refers to similar submissions with longer FQPA review periods or not
subject to FQPA (D and G).
* Total for each month includes up to 5 backlog items in a miscellaneous category.
[ ] Bracketed capital letters refer to categories in tables 2a and 2b.
IV. STREAMLINING ACTIVITIES
To meet the statutory goals for decision-making based on the review period goals in the
FQPA amendments to FIFRA, the Antimicrobials Division needs to ensure that it uses efficient
processes and that it clearly lays out its policies in new rules and guidelines. The division has
made significant progress in improving its processes and in developing a new antimicrobial rule.
Processes
Expedited Review Team
The Expedited Review Team is one of the innovations that AD introduced to streamline
its activities and meet the new FIFRA review goals while maintaining high standards for
decision-making. This dedicated team handles registration actions that need to be completed
within 90 days, as well as Notifications, for which the Agency is required to make a disapproval
finding within 30 days of receiving the proposed labeling modifications. Although the statute
only requires a written response in the case of disapprovals, AD decided that it would be more
efficient to respond to all notifications—approvals as well as disapprovals—within the 30-day
timeframe. The Expedited Review team also processes minor formulation changes (45-day
review period goal as established by PR Notice 95-2), although this deadline is not part of the
FIFRA review goals. This committed team has helped AD meet all of the FQPA 90-day
registration deadlines for submissions filed after November 1,1996, and also has processed all
notifications and minor formulation changes within the FIFRA-established time goals.
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Registrants have been pleased with turnaround times as short as two weeks for simple actions
such as minor label changes.
In addition, by lessening the burden on other staff, the Expedited Review Team has
allowed AD to reduce its backlog of registration actions. Another advantage, from AD's
perspective, is that new members of the division can begin learning about the division's activities
by starting with the relatively simple fast track actions. Thus, they can contribute significantly to
the division's work soon after joining the staff, a result that is beneficial both to the new
individual and to the division as a whole.
Other Process Changes.
Many of the suggestions for process change have come from registrants, including
members of trade associations such as CMA (Chemical Manufacturers Association); CSMA
(Chemical Specialties Manufacturers Association); and ISSA (International Sanitary Supply
Association), whose member companies tend to be relatively small compared to most members
of the larger trade associations. To help applicants submit complete, correct applications the first
time, the trade associations have suggested that the Antimicrobials Division develop standard
forms for submitting different types of applications, and for submitting toxicity, efficacy, and
other types of data. EPA is developing appropriate forms and guidance. In addition, EPA is
considering organizing and publicizing periodic registration training sessions for registrants and
potential registrants.
As a related activity, registrants have suggested that AD develop more standard forms for
some of AD's activities, such as reviewer summaries, decision documents, and certain types of
registrant communications. Such increased standardization would help EPA and registrants
avoid misunderstandings regarding what registrants need to do to correct inadequacies and move
their applications forward.
AD has developed performance measures so that it can track improvements in making
decisions on tune and can identify bottlenecks where more staff training or improved processes
could enhance performance. A training program has been developed to orient the many new
staff who are joining AD.
In the mid-to-long term, AD plans to expand its use of electronic technology to improve
its performance, for example, by continuing to computerize and automate the registration
process. Meanwhile, AD will make increased use of electronic communications wherever
feasible. An antimicrobial registration handbook is being developed, which will be available in
both paper and electronic forms.
Policies
Minor Changes in Labels or Formulations
In 1995, EPA issued a Pesticide Registration Notice [PR Notice 95-2] designed to
streamline certain registration actions. The Notice allowed EPA to process minor, low-risk
registration amendments quickly through notification, non-notification, or as accelerated
amendments, rather than through the usual amendment process. The Notice addressed policies
related to: a) Notifications; b) Minor Formulation Changes.
Notifications. The portion on notifications described the type of labeling changes
and product chemistry changes for which registrants could use the notification process. Only
proposed changes that did not affect pesticidal claims or activity were allowed. Registrants
could add or delete such label claims as "Cleans faster;" Package recyclable;" "Prevents odors;"
"Stays fresh longer" using a notification. Registrants also could use a notification if they were
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changing the source of active or inert ingredients, or the composition of the product so long as it
remained within specified limits and none of the changes altered pesticidal activity. No review
period was mentioned in PR Notice 95-2.
The FQPA amendments to FIFRA set a 30-day review period deadline for EPA to
disapprove notifications, measured from the date EPA received the notification. However, the
amendments limit this expedited notification process to non-pesticidal label changes for
antimicrobial pesticides only (i.e., the statutory provisions do not apply to other types of
pesticides). The notification process also applies to changes in antimicrobial product chemistry
that do not relate to any pesticidal claim or activity. The Antimicrobials Division has met this
30-day deadline for all notifications it has received since passage of the FQPA on August 3,
1996, with an average review time of 24 days for all notification actions. Tables 4 and 5 provide
more detailed analyses for the notifications received and processed between November 1, 1996
and June 30, 1997.
Table 4. Numbers of Decisions Made by the Antimicrobials Division on Notifications and
Minor Formulation Changes Submitted and Completed between November 1, 1996 and June 30,
1997.
Category of
Submission
Notification (labels
and product
chemistry)
Minor formulation
change
TOTAL
Number Accepted
236
78
314
Number Rejected
59
28
87
TOTAL
295
106
401
Table 5. Average Staff Time (in Minutes) Required to Review Notifications and Minor
Formulation Changes Completed by the Antimicrobials Division between November 1, 1996 and
June 30, 1997.
Category of Submission
Notification— requires label
review
Notification—does not require
label review
Minor formulation change
Change Accepted
40 minutes
20 minutes
240 minutes
Change Rejected
240 minutes
20 minutes
240 minutes
Minor Formulation Changes. The second part of PR Notice 95-2 provided that
EPA would have a 45-day target review period goal for registration amendments concerning
certain types of minor formulation changes. Although this part of PR Notice 95-2 was not
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reflected in the provisions of the Food Quality Protection Act amendments to FIFRA, OPP has
decided, on its own initiative, to process minor formulation change amendments in 45 days
whenever possible. The Antimicrobials Division has met the 45-day target for the 106 minor
formulation change submissions it received and completed between August 3,1996 and March
31,1997, with an average review tune of 36 days.
As part of its streamlining effort, AD is looking closely at suggestions from registrants
that would help them to prepare successful applications the first time, thereby saving themselves
and EPA many hours per year. As noted in Tables 4 and 5, the Antimicrobials Divison fails to
approve almost 30 % of total submissions of notifications and minor formulation changes. AD
staff spend 240 minutes (4 hours) to review a label that is eventually disapproved, compared with
40 minutes for a label that is approved. Following a disapproval, both registrants and EPA need
to spend additional tune on the resubmission.
Because the notification process has proven so successful, an OPP-wide team is exploring
additional areas where notifications might replace the more cumbersome amendment process.
Stakeholders are active participants in these discussions. Expanding the use of notifications
would allow registrants to implement changes more rapidly in product characteristics that do not
relate to any pesticidal claim or activity and would free EPA staff to focus on activities that are
critical to protecting public health and the environment.
Proposed Procedural Rule and Data Requirements
Under the FQPA amendments, EPA must issue a rule to aid in streamlining the
registration process for antimicrobial pesticides. This streamlining is necessary for EPA to meet
the new shorter statutory review and decision deadlines specified for different types of
registration actions. In cooperation with other parts of the Office of Pesticide Programs, and in a
process that includes ongoing consultation with stakeholders, the Antimicrobials Division is
developing two rules to help meet the streamlining requirement: a procedural rule (40 CFR 152)
and a data requirements rule (40 CFR 158).
40 CFR 152 (Procedural Rule). A new part 152 will lay out a variety of
procedural requirements for applications to register antimicrobial products, although some
provisions will apply to all pesticides. The major contents of Subpart W, which is being
developed, are:
• General (introductory material);
• Applicability;
• Consultations with EPA (required in certain instances, encouraged in others);
• Types of applications (new chemicals, identical, new product with new use, etc);
• Contents of application (describes what constitutes a complete application);
• Action on applications (describes what EPA will do with an incomplete application, and
the approval and denial responses. A basic premise, designed to help registrants, is that
the Agency may stop the clock in the midst of the review period to allow time for an
applicant to remedy easily correctable deficiencies; if the applicant can respond quickly,
the clock restarts close to where it stopped and the Agency's decision should come sooner
than if the application had to begin the review process again or encounter rejection.)
• Time frames for response to applications (contains the time frames identified as statutory
goals).
40 CFR 158 (Data Requirements). Part 158 currently contains data requirements
for all types of pesticides. Because many of the issues related to registering antimicrobial
pesticides are different from those for agricultural pesticides, the Agency has decided to develop
-12-
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a new subpart of 158 that is specific to uses of antimicrobial pesticides. The current draft
organizes these new data requirements of Part 158 into the following 12 antimicrobial use sites:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Agricultural premises and equipment (e.g., stalls, barns, shovels, halters, feeders,
troughs, and milking equipment);
Food handling/storage establishments premises and equipment (e.g., food
processing plants; restaurants and cafeterias; food shipping and storage
containers; food stores).
Commercial, institutional and industrial premises and equipment (e.g., ceilings,
stairs, woodwork and light fixtures in hotels, theaters, airports, factories, schools,
offices, auditoriums).
Residential and public access premises (e.g., homes, shelters, public buildings and
public areas).
Medical Premises and Equipment (includes premises and non-critical equipment
in hospital or medical environments such as clinics and nursing homes; non-
critical medical equipment includes items such as furniture, carts, bedpans, and
other items that do not contact the patient or generally contact only the patient's
intact skin).
Human drinking water systems (e.g., public water systems, individual water
systems, water purifier systems).
Materials preservatives (e.g., industrial process intermediate materials such as
dispersions, and emulsions, as well as the resulting products including paints,
coatings, textiles, paper).
Industrial processes and water systems (includes antimicrobials applied to
freshwater supplies for commercial and industrial systems and processes, and
similar specialized applications such as cooling towers, heat exchangers,
wastewater systems, and photo processing wash water).
Antifouling coatings for submerged structures and objects (e.g., boat hulls, crab
and lobster pots, and underwater structures or equipment).
Wood preservatives (includes products used on newly cut wood surfaces, kiln
dried wood, milled wood, and other building materials, which are then used in
playground equipment, lawn furniture, dwellings, containers, fences, and many
other products).
Swimming pools (encompasses swimming pools, Jacuzzis, hot tubs, and other
such structures that are lined with impermeable materials and do not connect
directly with environmental bodies of water).
-13-
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12. Aquatic areas (encompasses use sites that are mostly outdoors, including lakes,
ponds, reservoirs, and irrigation systems).
Testing requirements for antimicrobials are generally arranged in tiers so that the results
of earlier tiers determine the need for additional testing. Especially in the areas of human health
and exposure, a registrant must provide sufficient data for EPA to evaluate the safety of the
product in its intended use, but EPA can still minimize the testing burden on registrants. To
further protect public health and the environment, AD not only plans to specify exposure
measurement testing under conditions of pesticide application, but also is identifying situations
where post-application exposure testing should be done. For example, AD is concerned about
the level of exposure of swimmers, as well as applicators, to swimming pool disinfectants.
Drafts of 40 CFR 152 and 158 have been made available to stakeholders and others
through meetings and a public docket, and are undergoing pre-proposal discussions with
stakeholders. AD expects to issue a proposed rule for Part 152 in the first half of 1998. The data
requirements proposal is more complex and may take somewhat longer.
V. OUTREACH
As the Antimicrobials Division develops improved rules for registering antimicrobial
pesticides, it is maintaining an open dialogue with stakeholders. Industry is making helpful
suggestions for revising the rules, and will be able to submit better applications because they will
understand how the rules were developed. A non-adversarial relationship with industry will
enable AD to use its limited resources most efficiently in making timely decisions while
continuing to protect human health and the environment. In addition to pesticide registrants,
other stakeholders include consumer, environmental, and public health groups. To show how
important AD considers communications and outreach, the division includes a full-time
communications specialist to inform registrants and the rest of the public about AD activities and
about ways to use antimicrobial products safely and effectively.
First National Antimicrobial Workshop-January 1997
On January 8 and 9,1997, the Antimicrobials Division held the first National
Antimicrobials Workshop on the Regulation of Antimicrobial Pesticides. The workshop was set
up to provide registrants with an overview of OPP's new Antimicrobials Division and to discuss
the requirements and potential impacts of the 1996 Food Quality Protection Act on registration
of antimicrobial pesticides. More than 300 people attended.
The workshop was also the first step in opening an ongoing cooperative dialogue between
registrants and the Antimicrobials Division. Industry representatives helped develop the agenda
for the workshop. They presented their suggestions for how EPA could handle antimicrobial
registration actions more quickly at lower cost. In her opening speech, Dr. Lynn Goldman, EPA
Assistant Administrator for the Office of Prevention, Pesticides and Toxic Substances,
emphasized the importance of antimicrobial pesticides to public health and the need to ensure
that they were efficacious as well as safe..
Frank Sanders, Director of the Antimicrobials Division, set the participatory tone for the
workshop as he made the following points:
• Industry is AD's partner-not an adversary.
• We prefer compliance to enforcement, and will work to help industry comply.
-14-
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• We will be responsive to inquiries and will work to keep registrants informed about the
status of registration packages.
• We will listen to industry and work with them to streamline registration actions and meet
deadlines.
• We understand that industry needs credible information from EPA about when decisions
will be made.
• Standard Operating Procedures (SOP's) will be developed and implemented quickly to
help ease uncertainty for industry.
Plenary and breakout sessions covered such topics as:
Applying for a Registration
Reinventing the Registration Process
Data Requirements
Self-certification of Data
Harmonization with States and the International Community
Participants indicated that they were especially pleased with the opportunity to meet EPA
staff and to participate in informal discussions. More than 97% of attendees who responded to
an anonymous evaluation survey indicated that the workshop had met their needs and that they
would find a similar workshop useful in the future.
As a followup to the successful workshop, the Antimicrobials Division and the workshop
attendees arranged to set up regular stakeholder meetings, which have been held approximately
monthly since February 1997. Participants at stakeholder meetings represent several diverse
groups besides pesticide registrants. These meetings are providing stakeholders with an
opportunity to make their views known as OPP develops the antimicrobial rule and puts new
procedures in place.
Stakeholder Meetings
The Antimicrobials Division is holding meetings with stakeholders every three to four
weeks to address the issues that most concern registrants and others. Their input has been useful
in shaping the direction that AD is taking on the procedural rule and on development of Part 158
(data requirements). Invitees to these meetings have included members from diverse groups such
as industry trade associations (Chemical Manufacturers Association; Chemical Specialties
Manufacturers Association; International Sanitary Supply Association), user groups (Association
for Professionals in Infection Control) and environmental and consumer groups (Natural
Resources Defense Council; National Coalition Against Misuse of Pesticides). The agenda for
each meeting is based primarily on suggestions made by participants at the previous meeting.
Draft language for developing section 152 (procedural rule related to registration) and section
158 (data requirements for various antimicrobial site uses) have been distributed for discussion
and comment. Stakeholder input at this early, pre-proposal stage has been helpful to AD as it
proceeds to develop an effective new antimicrobial rule.
EPA has taken several steps to help publicize these meetings and make associated
documents widely accessible. EPA has opened a docket (OPP #00473) that contains information
about these meetings and development of the antimicrobial rule. The meetings are announced in
the Federal Register, and summaries of the meetings and copies of materials handed out are
distributed electronically.
-15-
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National Antimicrobial Information Network
of the National Pesticide Telecommunications Network
Under a cooperative agreement with Oregon State University, the Antimicrobials
Division supports a telecommunications information service called the National Antimicrobial
Information Network (NAIN), which is part of the National Pesticide Telecommunications
Network. Until recently NAIN was known as the Antimicrobials Complaint System, although
almost all of the 700+ phone calls it received in 1996 requested information about how to use
antimicrobial products safely and whether specific antimicrobial substances were registered with
EPA. Therefore, in early 1997 the network's name was changed to NAIN to reflect its
information role. NAIN responded to more than 800 calls in the first six months of 1997. To
help satisfy the public's need for reliable information, NAIN is developing fact sheets to answer
the most common questions it receives. (NAIN can be contacted in the following ways: phone
800-447-6349; fax 541-737-0761; e-mail nain@ace.orst.edu; website
http://ace.orst.edu/info/nain/
VL OTHER RESPONSIBILITIES OF THE
ANTIMICROBIALS DIVISION
Earlier sections of this report described short-term activities that the Antimicrobials
Division is undertaking to comply with FEFRA as amended by the Food Quality Protection Act.
AD has put special effort into finding ways to streamline registration processes and to make
decisions within the new review period goals. AD has met all statutory review deadline goals for
applications received after November 1,1996, and plans to continue meeting all statutory and
self-imposed deadlines. However, AD performs many activities in addition to those already
described. Although AD can continue functioning in the short-run without giving these other
items needed attention, for the longer term AD will need to devote a significant share of its
resources to fulfilling its responsibilities for reregistrations, tolerance setting, and efficacy
testing, as well as considering possible new initiatives on laboratory accreditation and self-
certification for submitted data.
Reregistration Eligibility Decisions (REDs)
Many older pesticides were registered when scientific knowledge and testing for safety
were less advanced than now. Under FEFRA, EPA is required to undertake a comprehensive
review of pesticides containing active ingredients registered before November 1,1984 to ensure
that they meet current safety standards. Reregistration is a two-step process. The first involves a
Reregistration Eligibility Decision (RED) for the active ingredient, in which EPA thoroughly
reviews all the data associated with the ingredient and identifies changes in the registration
requirements that would better protect public health and the environment. The second step
involves issuing the reregistration for specific products containing that active ingredient. Some
active ingredients cannot meet current standards, and products containing them cannot be
reregistered.
EPA is organizing its reregistration review to give priority to the active ingredients that
potentially present the greatest risk to human health or the environment. The FQPA amendments
to FEFRA provide funding for EPA to complete review of these pre-1984 active ingredients in
the next few years. The Antimicrobials Division is responsible for issuing Reregistration
-16-
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Eligibility Decisions by the year 2002 on 45 active ingredients or classes of active ingredients
registered before November 1, 1984.
The new FIFRA amendments carry the review of registered pesticides a step further than
the 1988 FIFRA amendments. The new amendments make provision for ongoing review of
pesticide registrations every 15 years, beginning with review in the year 1999 of pesticides
registered in 1984. The following year EPA would review pesticides registered in 1985, and so
on. However, there are no special funds authorized for this new activity.
Setting Tolerances
A tolerance is the maximum legal residue of a pesticide chemical that is allowed to
remain in or on a human or animal food. EPA and FDA have shared responsibility for setting
residue limits that ensure that the U. S. food supply is safe, with each agency responsible for
certain categories of substances. FDA has sole responsibility for enforcing the tolerances, that
is, for monitoring the amounts of pesticides and other selected substances in food and for taking
action to prevent unsafe foods from reaching consumers. EPA will not register a pesticide
intended for use on food or expected to enter the food supply unless it has a tolerance or has been
exempted from the need for a tolerance.
Setting a tolerance is resource intensive, requiring expert review of large amounts of data.
When a manufacturer wants to register a pesticide that may leave residues in food, the
manufacturer submits a petition containing data that allows EPA to determine whether a
tolerance is needed and what a safe tolerance will be, taking into account amounts of food people
eat, concentrations of pesticide residue, toxicity of the residue, and other factors. The FQPA
amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA) require that tolerances be
examined more closely than in the past, for example, by requiring EPA specifically to consider
exposures and other factors that may make children and other identified groups more vulnerable
to potential adverse effects of food pesticides. The amended FFDCA also requires that the
approximately 9,000 existing pesticide tolerances be reviewed within the next 10 years to ensure
that they meet the new safety standards.
Under the new amendments to FIFRA, the Antimicrobials Division will be assuming
additional responsibilities for setting tolerances. Prior to FQPA, EPA was responsible for setting
food tolerances only for pesticide residues that appeared in raw agricultural commodities, or that
had been used on raw agricultural commodities and were still present after the food had been
processed. For example, if EPA set a tolerance for a pesticide in raw apples, it was also
responsible for setting a tolerance for the pesticide in applesauce, if pesticide residue from the
raw apples would become more concentrated in the processed food.
EPA and FDA are discussing how to divide jurisdiction for antimicrobials used in or on
food contact articles to satisfy the FFDCA amendments. Although final agreement has not been
reached, recent discussions suggest that FDA will be responsible for antimicrobials in or on food
packaging materials and for antimicrobials intended to exert an antimicrobial effect in processed
food. Under the current discussions, EPA would retain jurisdiction over antimicrobials intended
to exert an antimicrobial effect in or on raw agricultural commodities (RACs). EPA would
become responsible for setting tolerances for antimicrobials intended to exert an antimicrobial
effect in or on finished articles or surfaces, such as cutting boards and conveyor belts, that are in
contact with food; previously, FDA was responsible for regulating these residues.
FDA and the Antimicrobials Division of EPA are working together to ensure that the
changes in responsibility occur smoothly, and that there is minimal delay for tolerance petitions
now with FDA. Where possible, EPA will use existing FDA data evaluations in reviewing new
-17-
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petitions. AD will carefully monitor the resources that these new tolerance responsibilities take
to ensure that other goals and activities stay on schedule.
Ensuring Efficacy of Public Health Antimicrobial Pesticides
Most public health pesticides are designed to help limit human disease by preventing the
spread of infectious organisms found on inanimate surfaces. Because the user generally cannot
tell if the pesticide is working as claimed, and there are potentially serious public health
consequences if a product does not work, EPA reviews data demonstrating the efficacy as well as
the safety of these pesticides before it registers them for public health uses. It also has a program
to evaluate the efficacy of products after registration. Obtaining dependable efficacy data
depends largely on the validity of the tests and the ability of laboratories to carry out the tests.
Efficacy Testing.
The new FEFRA amendments address ways that EPA could better ensure the efficacy of
antimicrobial public health pesticides. The law requires EPA to "ensure that the registration
process is sufficient to maintain antimicrobial pesticide efficacy and that antimicrobial pesticide
products continue to meet product performance standards and effectiveness" after they are
registered.
Since the early 1990s, EPA has taken steps to ensure that public health pesticides are
efficacious as well as safe. In particular, the Agency has funded multi-year research studies to
develop better and faster tests for determining the activity of public health antimicrobial agents
against spores, viruses, and the tuberculosis bacterium. This research has led to better tests,
which EPA expects to make part of standard test method guidelines in the near future.
To ensure that products remain efficacious after they are registered, EPA is in the process
of testing more than 800 hospital disinfectants on the market, including the 150 hospital
disinfectants with tuberculocide claims. As of October 1997, efficacy evaluations have been
completed for a total of 26 of the 38 high priority hospital disinfectant products chosen for early
evaluation. Preliminary results indicate that 19 of the 26 products with hospital disinfection
claims passed the efficacy testing and 7 failed. Of the 16 hospital disinfectants that also made
tuberculocide claims, 12 passed the efficacy testing and 4 failed. EPA is reviewing the results to
determine appropriate regulatory and enforcement responses for the products that failed the
efficacy tests.
laboratory Accreditation (Certification)
EPA is examining proposals to establish laboratory accreditation programs to improve the
scientific integrity, reliability, and accuracy of antimicrobial efficacy data developed to support
public health claims. FQPA amendments mention that use of certified laboratories might help
EPA speed up the review process. This outcome could occur in several ways. Data from
accredited laboratories might not need as rigorous review as data from other laboratories.
Registrants might prefer to have accredited laboratories perform their efficacy testing because
they believe the results might be reviewed more quickly if the laboratories have a good track
record with EPA. If use of accredited laboratories made reviews less time-consuming for EPA
staff, then EPA would have additional resources for other activities. EPA is working with
industry to see whether accreditation could help streamline registration activities for
antimicrobial pesticides.
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Self Certification of Data
To streamline its registration processes, the Antimicrobials Division is also considering
industry proposals to examine areas where, with appropriate safeguards and minimal risk, it
could allow applicants to certify both the results and regulatory consequences of certain required
toxicology or studies. As usually conceived, self-certification would allow EPA to make a
decision on an application before reviewing selected data that the applicant has submitted.
However, such data might be reviewed after registration to "spot check" compliance] AD is
approaching this possibility cautiously, however, since it is concerned with maintaining the
scientific integrity of submitted data and decisions based on those data.
VH. SUMMARY AND RECOMMENDATIONS
While continuing its ongoing activities, the Antimicrobials Division of the Office of
Pesticide Programs, EPA, has made significant progress in meeting the new requirements
imposed by the Food Quality Protection Act. The Antimicrobials Division has a structure
designed to function efficiently and to be responsive to registrant needs while protecting public
health and the environment. The division is maintaining a dialogue with stakeholders, who
include public health users and environmental groups as well as pesticide registants. It is
streamlining its operations, one of its most successful innovations being creation of a dedicated
Expedited Review Team to ensure that fast-track registration actions are completed within 90
days. During the first six months of 1997, the division met the review time goals set by new
FIFRA amendments while it reduced its backlog by almost 80%.
This report has described actions that EPA is taking to streamline antimicrobial
registration activities and to reduce the backlog of antimicrobial pesticide actions. With many
regulatory activities undergoing change, it would be premature to make recommendations for
further improvement in antimicrobial registration activities. The Antimicrobials Division is
beginning to implement important new streamlining and process changes while continuing to
explore and develop others. It is facing many new challenges as it attempts to integrate its
streamh'ning activities with new responsibilities for addressing reregistration, reexamining
existing tolerances, and upgrading the scientific foundation of its regulatory programs. After the
Agency has had experience with these ongoing and new activities, it expects to be in a position to
develop useful recommendations for its next antimicrobials progress report.
-19-
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-------
Attachment A. 1996 FIFRA AMENDMENTS RELATED TO
ANTIMICROBIAL PESTICIDES
33
FIFRA
Sec. 3
TiciDEs.-EGISTRATI°N
(1) EVALUATION OF PROCESS.— To the maximum
FOR ANTIMICROBIAL PES-
would reduce review periods existing £ of the daS of enac?
££»«« subsection for antimicrobial pesticide product reg-
istration applications and applications for amended registrl-
tion of antimicrobial pesticide products, including- reSlstra'
(A) new antimicrobial active ingredients;
(B) new antimicrobial end-use products-
ticid£;
tions(D) amendments to antimicrobial pesticide registra-
goal of reducing the review period
of a
? a
pestidde5«gfs?at£n a
antimicrobial active ingredient
n?T, ^timicrobial product;
Substantlally similar or iSenticai
9°daysjfor an amendment to an antimicrobial ree-
that does not require scientific review of dall;
( )
(F) 90 to 180 days for an amendment
^88fa?m2m **"* requires scientific
nerWl3e de8Cribed i
to
an
(A) PROPOSED RULEMAKING —
(i) ISSUANCE.— Not later than 270 days after the
date of enactment of this subsection, the Adniinis!
trator shall pubhsh in the Federal Register proposed
regulations to accelerate and improve the review of
antimicrobial pesticide products designed to imple-
° h(|)extent Practicable, the goals set forthPin
A-l
-------
Sec. 3
FIFRA
34
(I) define the various classes of antimicrobial
use patterns, including household, industrial, and
institutional disinfectants and sanitizing pes-
ticides, preservatives, water treatment, and pulp
and paper mill additives, and other such products
intended to disinfect, sanitize, reduce, or mitigate
growth or development of microbiological orga-
nisms, or protect inanimate objects, industrial
processes or systems, surfaces, water, or other
chemical substances from contamination, fouling,
or deterioration caused by bacteria,'viruses, fungi,
protozoa, algae, or slime;
(II) differentiate the types of review under-
taken for antimicrobial pesticides;
(III) conform the degree and type of review to
the risks and benefits presented by antimicrobial
pesticides and the function of review under this
Act, considering the use patterns of the product,
toxicity, expected exposure, and product type;
(IV) ensure that the registration process is
sufficient to maintain antimicrobial pesticide effi-
cacy and that antimicrobial pesticide products
continue to meet product performance standards
and effectiveness levels for each type of label
claim made; and
(V) implement effective and reliable deadlines
for process management.
(iii) COMMENTS.—In developing the proposed regu-
lations, the Administrator shall solicit the views from
registrants and other affected parties to maximize the
effectiveness of the rule development process.
(B) FINAL REGULATIONS.—
(i) ISSUANCE.—The Administrator shall issue final
regulations not later than 240 days after the close of
the comment period for the proposed regulations.
(ii) FAILURE TO MEET GOAL.—If a goal described in
paragraph (2) is not met by the final regulations, the
Administrator shall identify the goal, explain why the
goal was not attained, describe the element of the reg-
ulations included instead, and identify future steps to
attain the goal.
(iii) REQUIREMENTS.—In issuing final regulations,
the Administrator shall—
(I) consider the establishment of a certifi-
cation process for regulatory actions involving
risks that can be responsibly managed, consistent
with the degree of risk, in the most cost-efficient
manner;
(II) consider the establishment of a certifi-
cation process by approved laboratories as an ad-
junct to the review process;
(III) use all appropriate and cost-effective re-
view mechanisms, including—
A-2
-------
35
F1FRA
Sec. 3
(aa) expanded use of notification and non-
notification procedures;
(bb) revised procedures for application re-
view; and
(cc) allocation of appropriate resources to
ensure streamlined management of
antimicrobial pesticide registrations; and
(IV) clarify criteria for determination of the
completeness of an application.
(C) EXPEDITED REVIEW.—This subsection does not af-
fect the requirements or extend the deadlines or review pe-
riods contained in subsection (c)(3).
(D) ALTERNATIVE REVIEW PERIODS.—If the final regula-
tions to carry out this paragraph are not effective 630 days
after the date of enactment of this subsection, until the
final regulations become effective, the review period, be-
ginning on the date of receipt by the Agency of a complete
application, shall be—
(i) 2 years for a new antimicrobial active ingredi-
ent pesticide registration;
(ii) 1 year for a new antimicrobial use of a reg-
istered active ingredient;
(iii) 180 days for any other new antimicrobial
product;
(iv) 90 days for a substantially similar or identical
antimicrobial product;
(v) 90 days for an amendment to an antimicrobial
registration that does not require scientific review of
data; and
(vi) 240 days for an amendment to an
antimicrobial registration that requires scientific re-
view of data and that is not otherwise described in
this subparagraph.
(E) WOOD PRESERVATIVES.—An application for the reg-
istration, or for an amendment to the registration, of a
wood preservative product for which a claim of pesticidal
activity listed in section 2(mm) is made (regardless of any
other pesticidal claim that is made with respect to the
product) shall be reviewed by the Administrator within the
same period as that established under this paragraph for
an antimicrobial pesticide product application, consistent
with the degree of risk posed by the use of the wood pre-
servative product, if the application requires the applicant
to satisfy the same data requirements as are required to
support an application for a wood preservative product
that is an antimicrobial pesticide.
(F) NOTIFICATION.—
(i) IN GENERAL.—Subject to clause (iii), the Admin-
istrator shall notify an applicant whether an applica-
tion has been granted or denied not later than the
final day of the appropriate review period under this
paragraph, unless the applicant and the Administrator
agree to a later date.
A-3
-------
Sec. 4
FIFRA
36
(ii) FINAL DECISION.—If the Administrator fails to
notify an applicant within the period of time required
under clause (i), the failure shall be considered an
agency action unlawfully withheld or unreasonably de-
layed for purposes of judicial review under chapter 7
of title 5, United States Code.
(iii) EXEMPTION.—This subparagraph does not
apply to an application for an antimicrobial pesticide
that is filed under subsection (c)(3)(B) prior to 90 days
after the date of enactment of this subsection.
(4) ANNUAL REPORT.—
(A) SUBMISSION.—Beginning on the date of enactment
of this subsection and ending on the date that the goals
under paragraph (2) are achieved, the Administrator shall,
not later than March 1 of each year, prepare and submit
an annual report to the Committee on Agriculture of the
House of Representatives and the Committee on Agri-
culture, Nutrition, and Forestry of the Senate.
(B) REQUIREMENTS.—A report submitted under sub-
paragraph (A) shall include a description of—
(i) measures taken to reduce the backlog of pend-
ing registration applications;
(ii) progress toward achieving reforms under this
subsection; and
(iii) recommendations to improve the activities of
the Agency pertaining to antimicrobial registrations.
A-4
-------
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United States
Environmental Protection Agency
(7510W)
Washington, DC 20460
Official Business
Penalty for Private Use
S300
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