Registration Division Progress Report: Fiscal Year 1995


REGISTRATION
   PROGRESS
      Registration Division
     Office of Pesticide Programs
Office of Prevention, Pesticides and Toxic Subsfcmces
        April, 1996

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FOREWORD I

The Registration Division (RD), Office of Pesticide Programs, is pleased
to pr<3sent its annual progress report for Fiscal Year (FY) 1995. The intent of
this report is to provide in-depth information about RD's performance not only
for FY95, but for preceding years as well for comparison. [

RD had a record-breaiang year hi FY95, exceeding its performance
targets in 9 out of 12 registration categories. For new chemicals, RD
completed 26 decisions compared to its target of 13. These decisions included
5 reduced risk chemicals, 16 conventional chemicals and 6 biochemicals. On
average, RD completed the conventional chemicals hi 38 months, reduced risk
chemicals hi 12 months and biochemicals in 9 months: These decisions were
made much faster than the 5 year average decision time for new;chemicals in
FY91. ,' . •;•.:,:.-" ' ' '• .'.. • ^ -.-'• ',. ' . ' •,
:•"•''.--'• •' ••- , . " ' • . ' , ;,, -f.- •-•.-..-..
m most of the other registration categories, RD greatly exceeded its
targets for numbers of decisions. In addition, RD exceeded the itafget number
of product reregistration decisions by about 33%. Numerous reinvention .
projects aimed at improving ithe speed and efficiency of registration were
completed or initiated. Finally, many other projects were undertaken or
finished which further demonstrate new and better ways that RDj conducted its
business. All of these accomplishments are summarized in Section I
(Highlights), while details are provided" graphically, numerically knd narratively
in the remaining-sections. . [ . .
'• - - • ' . - . . ' --'• . • " . •,. ,'u.., '. ' •-, '
' " '" ' ••'-•••", - "' • • • • T
RD's successes can be attributed to its highly dedicated, experienced and
hard-working staff. Their continuous efforts to work faster, smarter and more
efficiently are evident. They stand folly committed to serving RD's many
"customers"—the public, registrants, states, organizations and individuals—who.
request assistance or submit applications for approval. i .

We are confident fliat ED can continue to be highly productive and
innovative hi carrying out FIFRA's mandate to register pesticides while folly
protecting human health and the environment.
n, Director PefefHTauIBns, Depu^r Director
Division Registration Division!

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         REGISTRATION DIVISION PROGRESS REPORT
                        J1SCAL YEAR 1995          1

 1'    The Registration Division (RD) of the Office of Pesticide Programs
 (OPP), EPA is responsible for the registration of all non-biological
 pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act
 (FIFRA), as amended in 1988.  This report summarizes RD's
 accomplishments tor the period of October 1,  1994 to September 30, 1995
' as'follows:-•'  '•.."•'•'•.;••. '   ,'•."-.-. :• .  '. '"•'.   '••'• -''.-\ •   '.-''''•  •••''

 +    Section I provides highlights of RD's significant acconiplishments.

 >    Section n presents graphics of registration actions for FY95;  .

 + '••   Section HI provides the detailed information behind the graphics.

 > '.•  Section IV describes all of RD's projects.           j

 >    The glossary defines key terms.                   I

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                     I.  HIGHLIGHTS

 Registered 26 new pesticide active ingredients in FY l£95 consisting
.'oft  v -•;  -/"./•••;,;/;:;  ;    :   >      .-•.;>-. •.:[;''•"'•'....- V."  :

  5   Reduced Risk Chemicals                                   ;
 15   Regular Chemicals                           |
  6   Biochemicals   /      .':                      ;  •*•

 Exceeded annual registration targets in 9 out of 12 categories (see
 asterisked numbers in table below).                 I
CATEGORY
Old Chemicals (FT)
Old Chemicals (NFT)
Amendments (FT)
Amendments (NFT)
New Uses-
New Chemicals
EUPs ' ;.:•>•; •' :
Tolerances
Temporary Tolerances
Inerts
Emergency Exemption
Special Local Needs
TARGET DECISIONS
727
40
2,719
. . . • 72
• •'-••• : • '.92;-; .. • -,..
•/-'•• -. ^ ' : • : ;'
117
85
30
.'. ':. ' •"'••' -7 .•'• ^ •:.
320 ;
150
FINAL DECISIONS
524
206*
3,491*
182*
-• / 102*
-:•-• : ;.-,-26* .- :.- .'
86
116*
'-.. • 29
-. ' •;; $* • • •
400*
472* A '
4 Exceeded annual target for product reregistration decisions-405
decisions completed vs. target of 298. Cumulatively, 747 products
have been reregistered and 2,242 decisions have been made to date.
• • ' • •- • - " '•.-,. •• •- - - - . . •" . . • • r .'.••'.•'•
......... -. ; .... , , ' - . • , • • ... . ..;>••'. .-•..• • , • •

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Reinvented the registration process to make it faster and more
efficient while protecting human health and .the environment:
' V ' • ' ' ' . . '
• PR Notice 95-2--Notifications, non-notifications and
accelerated minor formulation amendments.

• Section 25(b) exemptions rule was proposed, public comments
were evaluated and a final rule is nearly ready. .

• - Entered into an agreement with California to share acute .
toxicity and certain label amendment reviews.

« PR Notice 94-8 allowed water soluble packaging to be included
Under the same registration number as other packaging.

« PR Notice 95-l--Exemption of small containers from effluent
discharge labeling statements.
r * , - . > '•').., • -' , 'i , • • • .. • •
• Explored ways to allow registrants to "self-certify" -acute
toxicity and product chemistry studies. .

Adopted new ways of doing business:

• Section 18 exemption for potatoes used European data.

• Section 18 on cotton permitted a use of a pesticide which was
"triggered" when a certain level of infestation occurred.

• Sec. 24c for carbofuran on canola was approved with a.
temporary tolerance based on Canadian data.

• A new chemical (tebufenozide) was jointly registered with
California and Canada (CUSTA).

• Section 18 regulations were revised to allow EPA and states
greater flexibility.

Other special projects are listed in Section IV of this report.

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••-.."'  •-^.;':V;:;' ''";;        n. VISUALS -;   /•. '•:  -   '

Registration Targets vs. Completions:  Actions and decisions (completed
vs. planned) in FY95.

Actions vs. Decisions: Ratio of 'actions'to decisions.
 Bacldogs:  Registration backlogs for ;FY95 vs. FY94.
                        '', i    ....      , -       ....     .. -;
   •'-•'-          •             > *~      •'.     i  ' . ' '
 Workload (Actions): Pending plus backlog actions awaitinj

 Workload (Decisions):  Estimated number of decisions (per
 backlogged) awaiting processing.
 Resources Spent vs. Planned:  Resources used vs. planned
      processing.
     ding plus
     inFY95.
 Total Resources Spent vs. Planned on Registrations:
 vs. planned across OPP in FY95 for processing registration
  Resources used
 Product Reregistration Sttatus:  Cumulative status of
 decisions as of October, 1
     actions.

current and future

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m.
New Active Ingredients Registered in FY95: New chemicals,
biocKemicals and reduced risk (chemical) active ingredients.
Actions and Decisions Completed: Numbers of completed
decisions for each registration category in FY95.
actions and
Workload: Pending and backlogg&I Actions for each registration category
at the end of FY95. • '.T •
Resources: Resources spent vs. planned by registration type
FY95. -•'..". ::/.'"--. ' 'V: '•--.• . :.'..•-.''•' '•••'-. •- -•••':- .'
during
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NEW PESTICIDE ACTIVE INGREDIENTS FY S 5
Pesticide Name
and CAS Reg-No-
Prallethirin
(23031-36-9)
Halosulfuron
(100784-20-1)
Potassium Bicarbonate
(298-14-6)
Sodium Bicarbonate
(144_53-8)
Pyridaben
(96489-71-3)
Resource (87546-18-7)
Rimsulfuron .
(122931-48-0)
Sodium
Carboxymethyl-
cellulose. (9004-32-4)
l,4Dimethyl-
napthalene
(571-58-4)
Fenbuconazole
(114369-43-6)
Sodium 5-Nitro-
.guaiacolate .
(67233-85-6)
Registrant
Sumitomo
Monsanto
Church &
DwightCo.
Church &
DwightCo.
Nissan
Chemical
Valent
DuPont
Creative
Services :fac. -
. D-I-l-41nc.
Rohm and
Haas
Company
Asahi .
Chemical
Manufacituring
Pesticide
Type
Insecticide
'"'.'! .
•5.!-" '".'
Herbicide
Fungicide
Fungicide
Insecticide
Miticide
Herbicide
Herbicide
Insecticide
Plant Growth
Regulator
Fungicide
Plant Growth,
Regulator
Use(s)
Non-food/fee.d
areas
Corn/ornamenta
Formulating
Uses
Formulating
Uses -..-'..
Non-
food/ornamental
Corn . .
Corn/Potatoes
•
Ornamental
•_,""' ; . ,;i "
Potatoes ; '
• -. •% . •• , '-
Pecans/Small
Fruits
Cotton/soybeans
rice
Active
Ingredient
Type
Chemical
Chemical ,
Biochemical
Biochemical
Chemical
/ - -
Reduced Risk
Chemical
Chemical
Biochemical
Biochemical
Chemical
Biochemical
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Diethyl Sulfide
(352-93-2) , .
AO-159 (58842-20-9)
Isobardac
Primisulfuron Methyl
(86209-51-0)
Difethialone
(104653-34-1)
Tebufenozide
(112410-23-8)
Methyl Anthranilate
(134-20-3)
Hymexazol
(10004-4^1)
Dioctyl Sodium
Sulfosuccinate
(1639-66-3)
Undecylenic Acid
(112-38-9)
Pyriproxyfen
(95737-68-1)
Maxim (13 1341-86-1)
Ghlorethoxyfos .
(54593-83-8)
Pyrithiobac-sodium
(123342-16-8)
Poly (N^N-dimethyl
diallyl ammonium
'chloride)
(26062-79-3)
Bear Country
Products
DuPont
Lonza,Inc.
Ciba-Geigy
LiphaTech,
Lie.
Rohm and
• Haas
Company
Dolphin Trust.
Sumitomo
Chemical
Safe and Sure
Products
Safe and Sure
Products
Mclaughlin
Gormley King
. Company
Ciba-Geigy
DuPont
DuPont
• Calgon
Bear
Deterrent
Insecticide s
Antimicrobial
Herbicide
Rodenticide
Insecticide
Bird
Repellent
Fungicide
f
Insecticide
Insecticide
Insecticide.
Fungicide
Insecticide
Herbicide
Aritifoulant
NonFood
Farm
Animals/Pets
Water treatment
Corn
Home
Walnuts
Small Fruits/
ornamental
Seed treatment
Dogs/Cats
Dogs/Cats
Dogs/Cats
Seed Treatment
Corn
Cotton
Water treatment
Chemical
Chemical
Chemical
Chemical
•f
Chemical
Reduced Risk
Chemical
Reduced Risk
Chemical
Reduced Risk
Chemical
Chemical
Chemical
Chemical
.*
Reduced Risk
Chemical
Chemical
Chemical
Chemical
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Following is a listing of UD projects with a brief status report on
each as to what has been accomplished to date. The projects are grouped
according to the branch or office having the lead, and then listed
alphabetically. f ,

FRONT OFFICE . '\ .-"- •..-.;• '.•''.' ' ' ,."'.' ,';.'', '....'j--'' ••'•.-.'-

EXEMPTION OF EFFLUENT DISCHARGE STATEMENTS FOR CERTAIN
PRODUCTS. On May 1, 1995, OPP issued;PR Notice 95-1 to exempt containers under five
gallons (liquid) or 50 pounds (dry weight) from bearing the effluent discharge labeling
statements specified in PR Notice 93-10. PR Notice 95-1 will reduce the burden which •
would have fallen on small container products because their labels lack space, but will
continue the effluent discharge statements for larger containers where the impact is minimal
and where users are in the industrial/commercial sector. ' ;

EXPEDITED REGISTRATION. RD is developing guidance for PM teams concerning how
to process "fast track" applications. The Fast Track Work. Group presentee!
recommendations to the RD Director and is working on a guidance document for the PM
. teams. This guidance is intended to speed up processing of fast track registrations through
standardizingand simplifying current procedures. I

NOTIFICATIONS^ NON-NOTIFICATIONS AND ACCELERATED REVIEW OF
MINOR FORMULATION AMISNDMENTS. PR Notice 95-2, issued on May 31, 1995^
expands the categories of low risk, minor amendments which may be accomplished by
notification (self-certification) or non-notification. In addition, the PR notiibe creates an
accelerated process for/reviewing minor formulation changes in 45 days instead of 90 days.
As msuiy as 10% (i.e., 500 annuaiUy) of current non-fast track amendments-may be done by
notification, saving about 1.2 FEE and eliminating the current 3-6 month wait for EPA
approval. The expedited process for minor formulation changes should reduce unit costs and
cut EPA's turnaround time in half (45 days vs. 90 days) for about 5% of fsist track
amendments (250 per year). EPA will make minor revisions to its regulations to be
consistent with the PR notice. : ^ ^

SECTION 25(b) EXEMPTIONS RULE. EPA issued a proposed rule on September 9,
1994, to exempt 3 i possible active ingredients from regulationunder FIFR^. These,
ingredients will only be exempted when used alone or in formulation with List 4A inerts.
Many of the comments.received were critical, but we believe they can be adequately
addreiised without major revisions in the final rule. The final rule should be promulgated at
the end of 1995. The Agency is 'considering proposing another 25(b) rule to deregulate a
number of additional chemicals and/or uses such as in the antimicrobial area, including
sodium hypochlorite, bacteriostatic water filters and products which control odor-causing
bacteria!. , .'
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SELF CERTIFICATION OF ME-TOO PRODUCTS. OPP is exploring the concept of
self certification of registration of fast track, me-too products. An issue paper-is being
drafted which develops and evaluates several options. The draft paper will be made available
for public comment and meetings may be held with stakeholders. After considering the
public inputs, OPP will decide whether to proceed witfii this concept.

VOLUNTARY REDUCED RISK PESTICIDE INITIATIVE. Since the introduction of
EPA's voluntary reduced risk pesticide initiative in July of 1993, Registration Division has
received twenty reduced risk pesticide applications. Of the 20 applications requesting reduced
risk status, nine candidates have been accepted, while six.of these candidates have been ' ,
registered. Seven candidates have been deniedj apd currently there are four applications
pending reduced risk status. RD is committed to" make a decision one year after the candidate
has been granted reduced risk status. OPP has also issued a draft PR Notice expanding the initial
voluntary reduced risk PR Notice to include new uses of those pesticides that have been granted
reduced risk status. This PR Notice should be finalized by December 1. The primary goal of
this PR Notice is to grant expedited reviews to those new use applications of reduced risk
pesticides. . . . .

WATER SOLUBLE PACKAGING (WSP): On September 27, 1994, PR Notice 94-8
allowed water soluble packaging to be included under the same registration number as other
packaging; this change may be done by notification. The notice streamlines and encourages
the approval of WSP, reduces risks for pesticide handlers and decreases the number of .
pesticide containers requiring .cleaning prior to disposal.

ANTIMICROBIAL PROGRAM BRANCH

STRATEGY TO IMPROVE THE ANTIMICROBIAL PROGRAM.

• • . 6 The benchwork has been completed on three of the five cooperative
. agreements which are conducting studies to improve or revise the existing test
methods used for registration of antimicrobial pesticides. The Sporicidal Coop
has completed itsTier 1 collaborative study. The Virucidal and
Tuberculocidal Coops are in the precess of preparing, for their collaborative
. • studies. The Howard University cooperative agreement, involved in
researching injury to bacterial cells, is in the final stages of its benchwork.
All of these coops are due to be completed between December .31, 1995 and;
. , the end of FY 96. The Statistical Cooperative is undergoing final negotiations
for conversion to a contract, This cooperative supports the research performed
by the other four by analyzing the data and assisting with the design for the
collaborative studies. The Statistical Coop/Contract will be completed
approximately one year, beyond the completion of the other coops.

o The Antimicrobial Complaint System (ACS) handles inquiries or complaints
• concerning EPA registered antimicrobial pesticides. This function was
, transferred from Texas Technical University, which handled over. 1074
inquiries during FY 95, to Oregon University during the second quarter of FY
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. , X-. 96. Oregon University is currently in the initial setup phase (hiring and
training personnel). r '-> j

. WATER PURIFIER PROTOCOL. \

o The Water Purifier Protocol has been: removed; from the regulatory agenda. It
was decided that a policy for handling water purifier claims cpuld be published
without going through the rule making process. OPP is currently awaiting
final advice from OGC on the most appropriate means for publication of the
• .' ', •• .;,-. policy.- - • .'": '• : ' '. • - •••••'• . • .':!.;,
• • ... . * * '' ' '•, " •'•.-' '• •'•.' . .?•.""' ' • . .•...'•'.
STRATEGY FOR TESTING ANTIMICROBIAL PRODUCTS. :

6 The FDA/EPA Interagency Agreement for testing EPA registered sterilant
products is in the process of final closeout procedures. All testing of sterilant
products was completed in September 1993. Products which failed to show
effectiveness as sterilants were referred to the Toxics and Pesticides
: Enforcement Division (TPED) for enforcement action. 1

. o The Disinfectant Testing Program was converted from an OKD contract to an
in-house OPP managed program in FY 95.. Staff from the Antimicrobial,
. Program Branch in RD and the Biological Analysis Branch ini BEAD are cd-
managing the testing program. BEAD/BAB laboratory technicians, at the EPA
OPP-Cincinnati MicrobiologyLaboratory, are currently in the process of
resuming testing of ttiberculocides and hospital disinfectants. Due to current
. resource constraints: (both budgetary..and personnel related) being faced by
many programs in OPP, the overall strategy for testing disinfectant products is
undergoing revisions so as to address the issue of removing inefficacious
products from the market in the most resource effective manner possible.

EPA/FDA MEMORANDUM OF UNDERSTANpING-25(B) STERILAIJJT
EXEMPTION. ..'".:,\ ' •-'••".' '.'•'•• i--. ' ~ -I.!.' '-• • .•.'•-• ','

o Under the EPA/FDA Memorandum of Understanding, as amended, for ,
regulation of liquid, chemical germicides used on medical devices/medical
equipment surfaces, efficacy data required for sterilant products is being
reviewed by FDA. All other antimicrobial pesticides which require efficacy
data, will continue to have their data submitted to and reviewied by EPA.

o As part of the EPA/FDA Memorandum of Understanding, «ich agency wiU be
responsible for their respective rule makings to eliminate the!dual regulation of
liquid chemical germicides. A draft proposed rule, exempting sterilant
products from registration under FIFRA section 25(b), is in ithe process of
undergoing revisions by the Office of General Counsel and tlie Antimicrobial
Program Branch. ."... |
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fGICIDE HERBICIDE
ACETOCHLOR NEGOTIATIONS. FHB/EFGW completed negotiations with the
Acetochlor Registration Partnership dealing with the 7A provisions of the March 8, 1994
conditional registration of acetochlor. . ; ,

AUTOMATION" OF CERTAIN PM TEAM DOCUMENTS. Three kinds of documents
are being put into electronic form to facilitate the work of the Product Manager Teams: (1)
electronic TAIS forms,. (2) FR tolerance documents and correspondence, and <3) standard
response letters. ' . ,

EXPERIMENTAL USE PERMITS.- Reviewed the regulations and recommended.that
unutilized reporting be dropped and the 10 acre limitation be increased to 250 acres.

MOU WITH CALIFORNIA DEPARTMENT OF PESTICIDE REGULATION (CDPR).
On may 7, 1995, OPP and CDPR agreed to conduct a pilot in which registrants submit
simple amendments to CDPR for review,: CDPR forwards the amendment and its review to
OPP, and OPP accepts CDPR's review .'and issues approvals to registrants. This pilot is in
progress. . •

METAM SODIUM SEWER LINE ROOT CONTROL MANUAL. As of March 1, 1996,
metam sodium products., used for sewer root control, will be reclassified as restricted use
pesticides. A manual is now in place to provide assistance to State education and regulatory
agencies in introducing sewer root control into their training and certification programs. The
manual is being distributed to the regions, state pesticide lead agencies, and state cooperative
extension offices. The manual was crucial to the negotiations between the Agency and'
Arrigation in conjunction with" the Notice of Intent 'to Cancel issued earlier this year,

PMAT (PM AUTOMATION TEAM). The purpose of the PMAT is to streamline the way
PM teams function by establishing new ways of conducting our day to day activities via pilot
projects and/or best available software. The PMAT assisted in the FHB TAIS pilot project.
By doing the TAIS forms electronically we have improved our accuracy by reducing the
number of errors normally reported. PMAT has also established macros and boilerplates
which allow RD personnel to easily pull up registration notices, fact sheets, federal register
notices, and other forms used regularly, saving us time and allowing us to perform more
efficiently. The PMAT is currently participating in two pilot projects, the automated
labeling project and the Lotus Notes Pilot Project.

REGISTRATION ELIGIBILITY DOCUMENT. As part of the living chemical pilot
project, RD issued .the first Registration Eligibility Document. This document is similar to a
Eejregistration Eligibility Decision (RED) document in that it contains a fact sheet, science
chapters, and a regulatory chapter. The living chemical document also functions the same as
a Living RED document in that it is updated as new regulatory decisions are made.

SECTION 24(c) GUIDANCE DOCUMENT. This document was drafted arid sent out for
public comment. The document should be issued in December 1995. .
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WORKER PROTECTIONSTANDARD LABELING. fR Notice 95-5 which provided
guidance to retailers and distributors of agricultural pesticides on how to bring
non-complying WPS products into compliance was issued. fV ,--,

INSECTICIDE RODENTIGIDE BRANCH T

CANADIAN-U.S. TRADE AGR1EEMENT (CUSTA). A parallel review cff tebufenozide -
was conducted by EPA and Canada. The goal was to identify,' through a reiil example, the
similarities and differences between the Canadian and U.S. pesticide regulatory systems.

RODENTICIDE PACKAGING PR NOTICE. A draft PR Notice will be issued for public
comment in the Fall of 1995 and issued final in FY 1996. A PR Notice will be proposed
which permits placepack products of different sizes; to be marketed under a single registration
number rather than under separate registrations for each size. This approach would give
registrants some relief from Federal and state fees and an opportunity to coordinate /
packaging of the various placepack sizes with the correct labels for the outer packages. The
policy change would be implemented via the amendment process under a "master label"
framework. The notice being drafted would delineate OPP's historical policies regarding the
consideration of rodenticide baits as distinct products and other administrative matters. This
document would also provide a "slxeamlining" benefit by enabling applicant!} to "get it right
the first time." , f

TERMTTICIDE LABELING PR NOTICE. A workgroup was formed in 1995 to finalize
the July 1994 Pesticide Regulation Notice on Termiticide Labeling. The workgroup includes
members from the Insecticide-Rodenticide Branch/RD, Occupational and Residential
Exposure Branch, HED, State and Regional Operations Branch and Certification and
Training Branch/FOD, the Office of Enforcement and Compliance Assurance, and the state
regulatory Association of Structural Pest Control Regulatory Officials. Thefpurpose of the
notice is to address a number of issues which have evolved over the years due'-to the highly
specialized nature of termiticides, including: use limitations, precautionary statements, use
directions, and longevity of termiticide treatments., In conjunction with thesp efforts a
one-day workshop was held at the headquarters of the National Pest Controlj Association in
Dunn Loring, Virginia: which included seminars on termite biology, .behavior and control
strategies, a field demonstration pi" a post-construction termiticide application and a video
demonstration of a pfe-eonstructibn termiticide application. The workgroup's goals is to
finalize the notice by December, 1995. [

REGISTRATION SUPPORT BRANCH (

ACUTE TOXICITY RELATED EFFORTS, OPP currently has a backlog of 357
submissions, down from 522 in December 1994. OPP receives approximately 900 new
submissions per year. A submission can be a single study, a six pack of studies, a rebuttal
to a previously rejected submission or any combination thereof. New submissions are about
equally divided between registration and reregistration. With current practicbs and resources,
OPP is; able to review about 70 submissions per month. Currentiy, without a change in
practices or resources, companies must wait upward of 12 months to receive a review of
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product specific acute .tox data. i

SHARE ACUTE TOXICITY REVIEWS WITH CDPR. OPP and CDPR have
determined that their review procedures are sufficiently harmonious to allow the
sharing of reviews and workload. To date, the MOU has not translated into
significant resource savings. We have received a handful of reviews from California
that we used for reregistration. However, we have begun a process that will lead to.
considerable savings. We have contacted registrants who have submitted acute
• ' toxicity data packages since October 1994 to determine if they plan to: register the
product in California and/or Canada. By the end of September 1995, we will
determine the overlapping data and distribute reviews equitably among the regulatory
agencies. Using an SOP developed by CDPR, we will then share the data packages
with CDPR (and Canada), with an agreed time frame for completion of the reviews.
We will then exchange reviews. EPA reviewers will dp a cursory review of the
CDPR reviews and labeling and the packages will be forwarded back to the PMs for
action. We expect that this will shorten the time in-house awaiting a review by at
least 25%. ... :
• " ' - * • '• ' "' •' L'••'•'•
SELF-CERTIFICATION OF ACUTE TOXICITY STUDIES. RD has created a
work group to explore the possibility of allowing registrants to self-certify product
specific acute toxicity test results. This work group consists of members of RD, .
SRRD, OECA, and OGC. The work group also has a subcommittee working on the
acceptance criteria for the six required studies.

COMPUTER SOFTWARE TO STANDARDIZE "PRECAUTIONARY"
LABELING. EPA has begun to develop a computer program which displays the
correct precautionary labeling statements for a product based on the results of the
acute toxieity. studies for that product. This system could be used by both EPA staff
and registrants to assure accurate and appropriate precautionary labeling for new or
existing products.. It would also enable registrants to submit correct labeling and help
EPA staff to assure that labeling is acceptable. -This program could result in a
reduction in review time and help unnecessary rejections of applications with incorrect
labeling. Computer software is anticipated to be produced and distributed in early
calendar year 1996. .

OTHER REINVENTIONPROCESS CHANGES FOR ACUTE TOXICITY.

Acceptance Criteria. The Precautionary Review Section (PRS) is now making
decisions about the acceptability of a study with respect to its acceptability for
•labeling. Previously, PRS decisions about acceptability were based on whether it
conformed with guidelines.

Reregistration. Studies accepted after 1989 (with two exceptions) will be considered
acceptable for registration purposes. If multiple products in a batch have studies
• ' .submitted as part of the 8 month response, PRS will perform a thorough review of
• ' one six pack and a cursory review of all other studies submitted in the same batch.
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LABELING.J Tib Labeling Unit (LU) AviU conduct a limited pilot project
to test the concept of electronically capturing, accessing and reviewing product labeling. The
•pilot will involve up to 25 products. The LU has done some preliminary work, has been
contacted by interested parties such as ACPA and intends to begin the pilot in the Fall 1995.
.Further activities in this area will be proposed for 1996 based on progress demonstrated in
'thepilot. ";'•".- . ;- ' '. • ••'" • • '•.••.•'•-••- , •' f ..'-• ' . ".-
_•,-..- ^ .-..•--•':.-. • : - •'-'-'••,•' .:'.- ''. ; ••..'..'•..'•• >•• V .'' ''..'' : •'•.
LABE1L AVAILABILITY. The LU is working closely with the Program Management
Support Division to .convert the compact label file to CD-ROM. This will streamline both
.RD and FOD by reducing requests for stamped, accepted labels and will vastly improve
service to OPP's customers including the state enforcement programs. The conversion is
also the first step toward making ilabel images available to PM reviewers through the LAN!
The conversion project has begun and will continue into FY 96. !

LABELING COORDINATION. RD has issued a draft PR Notice for comment which (1)
establishes an annual compliance date for implementing most EPA mandated labeling changes
and (2;).describes the LU's role in coordinating all labeling issues and related streamlining
efforts;. The LU reviewed, comments and has also met with several trade organizations
including ACPA, CMA, CSMA and CPDA. .Most comments have focused on the chahnels-
of-trade provisions specified in the Notice. LU currently reviewing the comments received
and our stocks in trade policy. . . P
""•'.,. • "" • '''""• ' • '''- '. ' ' • ,
LABEL REVIEW MANUAL: In December 1994, RD's Labeling Center for 'Excellence
(assisted by the Labeling Unit) completed ah extensive document to be used; by EPA staff in
reviewing and determining the acceptability of pesticide labeling. The Manual is on. OPP's
Local Area Network and is publicly available. •>• j

LABEL POLICY DIRECTORY: In October 1994, RD's LabeUng Center for Excellence
and the Labeling Unit initiated an electronic "on-line" Labeling Policy Directory that allows
GPP staff to quickly search and access labeling policy information via meirjcomputer. The
Directory is available on OPP's L,AN. Portions of the:policy directory will! be made
available to the public soon. . I
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• ;.w •••;;•;-,:,.•'• GLOSSARY ':'•;'>•';'•':'!; :.. .^v-v.

Action: Any application or correspondence submitted by a registrant is an
"action." Each submission is logged into the Pesticide Action Tracking System
.'.(PRAT$); upon completion of review, EPA issues a response, closes out the
action on PRATS and ends the "cycle" for that submission. !

Amendment: An application to change an existing registration (siuch as its
formula or labeling) is an "amendment." i

Amendment, Fast Track: An amendment which requires no data and qualifies
for expedited handling is a "fist track" amendment. j

Amendment, Non-Fast Track: An amendment application which requires
submission of data (such as exposure data to support a new method of
application) is a "non-fast track" amendment.

. Backlog: An action, which has been awaithig review longer than 'the target
turnaround time has reached "backlog" status. OPP has set target turnaround
times for reviewing/each type of registration. I _

Decision: When an application meets all requirements for approval, EPA
makes a registration decision by issuing either an approval or a denial. Such a
decision may occur after the first submission (one action) or after? 10
. submissions (10 actions), depending on when the entire application is
acceptable. ;.'•. '• . •;' • •• •"'.;.. .-. ,. " '•",'.. . ' "|';-:•.,;. . ..-. .''. ' .
' -' ' '' • •'•''• ' '' •"'•" •' •-''""" ' '• ' '••.'•„ " ' ' - '- -"i" " " '' ' ''
Emergency Exemption: Under Section 18 of FIFRA, .EPA may [approve a
state's; request to use an unregistered pesticide when no registered product is
available. This type of action is an "emergency exemption." !

Experimental Use Permit (EUP): A permit required to conduct field trials
(residue tests)^ to support the registration of a new .active ingredient:

Inert^;: All inert ingredients used in pesticide products must be cleared by EPA
before registration. To obtain approval for new inerts, the producers must
submit toxicology data to EPA for review. Such submissions are called
.."inerts. ",-..•.'-" .'• ' .;•.'' ',':'.. •,• '''•'•,:';• •'. •'. '•/ • •".••. •.}' .'"•.'..• ' . :
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,.• • - - • •..•-.•• . ••.
New Chemical: An application for registration of a product contaimng an ;
active ingredient (a.i.) not contained in a currently registered product is called a
"new chemical." .

New Use: An application for registration of a use not currently registered is
called a "new use." A new use is "significant" if additional data are required.

Old Chemical: Refers to an application for a new product which contains an
active ingredient (a.i.) contained hi a currently registered product. Hence, an
application for a new product similar to an existing, registered product is an
"old chemical.-" . .

Old Chemical, Fast Track: An application for a new product containing an
old chemical which requires no data review and qualifies for expedited handling
is an "old chemical, fast track."

Old Chemical,,Non-Fast Track: An application for a new product which
requires data review is an "old chemical, non-fast track."

Pending: An action which has been waiting for EPA review less than the
target turnaround time isi "pending." .

Tolerance: When a pesticide is used on.a food crop, a pesticide residue level
or "tolerance" that is safe must be established before a product maiy be
registered for that crop. .

Tolerance, Temporary: When an tinregistered pesticide is tested under an
EUP on a food crop, a temporary tolerance must be established if that crop will
be consumed. . . .

24(c): Under Section 24(c) of FIFRA, a state may issue a registration for an
unregistered use of a currently registered product within,that state-.when a
"speciallocal need" exists. .
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