[Federal Register Volume 64, Number 46 (Wednesday, March 10, 1999)]
[Notices]
[Pages 12064-12069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5966]
[[Page 12063]]
_______________________________________________________________________
Part V
Environmental Protection Agency
_______________________________________________________________________
Pesticides; Registration Division's Fiscal Year 1999 Work Plan; Notice
Federal Register / Vol. 64, No. 46 / Wednesday, March 10, 1999 /
Notices
[[Page 12064]]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00574; FRL-6051-3]
Pesticides; Notice of the Registration Division's Fiscal Year
1999 Work Plan
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is publishing the fiscal year 1999 (FY99) work plan for
the Office of Prevention, Pesticides, and Toxic Substances, Office of
Pesticide Programs, Registration Division (RD) in keeping with efforts
to improve the transparency and flexibility in the pesticide
registration process.
With the publication of this FY99 work plan, RD is placing a large
emphasis on new chemical, new use, and inert registration actions. In
no way, however, will RD neglect the many other actions (e.g., label
amendments, me-too actions, and emergency exemption requests) that are
currently pending or will soon be submitted to the Agency. This FY99
work plan represents our current list and schedules for these important
actions; however, the Agency has included room for flexibility in this
FY99 work plan to ensure a quick response should an emerging public
health or environmental issue arise. While forecasting such issues can
be difficult, the Agency is committed to working with all affected
parties to address their needs on an expeditious basis. Any submission
which creates a modification to the schedule will, of course, require
the appropriate justification and scientific data which will allow the
Agency to make a sound, health-based decision.
FOR FURTHER INFORMATION CONTACT: By mail: Steve Robbins (7505C), Office
of Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Rm. 732D,
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-
6439, fax: 703-305-6920, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: This Federal Register notice presents the
FY99 work plan for the Registration Division (RD) in the Office of
Prevention, Pesticides, and Toxic Substances (OPPTS) at the
Environmental Protection Agency (EPA). EPA is publishing RD's FY 99
work plan in order to improve the transparency and predictability of
the pesticide registration process, while maintaining sufficient
flexibility to address emerging needs as appropriate.
I. General Information
A. Does This Notice Apply to Me?
You may be particularly interested in this notice if you are a
producer or registrant of a pesticide product. Your interest in this
notice may depend upon your interest in the chemicals for which the
Registration Division plans on making a decision (new conventional
active ingredient and/or new tolerance petition) in fiscal year 1999.
B. How Can I Get Additional Information or Copies of This Document or
Other Documents?
1. Electronically. You may obtain electronic copies of this
document from the EPA internet Home Page at: http://www.epa.gov/
opprd001/workplan.
2. In person or by phone. If you have any questions or need
additional information about this action, you may contact the technical
person identified in the ``FOR FURTHER INFORMATION CONTACT'' section.
II. Background
Historically, the Agency has reviewed new registration applications
and tolerance petitions based upon a system of ``first received, first
reviewed.'' In 1993, the Agency switched its process for setting the
review queue to a points based system. Under this points based system
RD assigned priority points of differing values depending on the type
of action (e.g. Section 18s = 75 points, Experimental Use Permits = 15
points, New Active Ingredients = 10 points). Priority points were also
accrued for `aging,'' i.e., the longer a submission remained in the
Agency before being completed, the more priority points it accrued.
Actions with the highest number of priority points were generally the
first to be completed by each of the science review divisions.
Shortcomings of the point-based priority system have included:
difficulty in planning and predicting priorities; some registrant
priorities have not been completed in order; little perceived incentive
for the registrants to submit comprehensive submissions; and poor
reflection of Agency resources allocated toward registration progress.
Despite an increase in registration productivity, backlogs for some
critical registration actions remained. To address this concern and to
create a more efficient, predictable and equitable review queue, in
June of 1995 the Agency launched a pilot priority system limiting the
registrants to five (5) priorities of their choice. Using this method,
RD received approximately 170 priorities (designated #1-5) which were
blended with Agency identified priorities (mainly IR-4 and repeat
Section 18s) and placed into review. It was generally understood that
priority #1 would be reviewed before priority #2 and priority #2 before
#3, etc. PR Notice 95-6 (October 1995) officially announced the new
priority policy and procedures, and requested that registrants submit
their second round of five priorities (designated #6-10). This round of
priorities included new active ingredients, new uses, and experimental
use permits. The second round yielded 332 registrant priorities which
were blended with EPA priorities.
In April 1997, EPA issued PR Notice 97-2 requesting a third round
of 5 priorities (designated #11-15). The action eligibility for this
round was expanded to include inerts and non-fast track amendments,
including additional incentives to encourage more products for minor
uses, methyl bromide substitutes, and alternatives to certain
organophosphates. Registrants identified approximately 600 actions for
prioritization in response to PR Notice 97-2. Changes required in the
registration process by the Food Quality Protection Act have caused
delays in completing the reviews for priorities 1 - 10; and delays in
the scheduling of priorities 11 - 15.
Review of the registration process reveals a diversity of priority
needs: there are statutory priorities such as minor use, me-too, and
reduced risk actions; registrants frequently submit their top business
priorities; USDA submits priorities on the basis of crop/pest
combinations; priorities for grower groups are channeled directly to
EPA or revealed by trends in Section 18 requests; and priorities for
public interest groups are frequently related to contemporary issues,
such as identifying methyl bromide replacement chemicals and
alternatives to certain organophosphate pesticides. (Refer to Section C
for definitions)
By publishing this FY99 RD work plan, the Agency expects to extend
the transparency and predictability of the registration process. Based
upon resource allocations for FY99, RD expects to make decisions on
approximately 13 new conventional active ingredients, 75 (non Section
18) tolerance decisions and 23 food use inert ingredient decisions.
[[Page 12065]]
III. Overview
A. What are the Agency's Goals for This Work Plan?
By publishing this FY99 RD work plan, the Agency expects to extend
the transparency and predictability of the registration process, while
maintaining sufficient flexibility to address emerging needs as
appropriate. Based upon resource allocations for FY99, RD expects to
make decisions on approximately 13 new conventional active ingredients,
75 (non Section 18) tolerance decisions and 23 food use inert
ingredient decisions.
With the implementation of the Government Performance and Result
Act of 1993 (GPRA) OPP is tasked with doubling the annual number of
registrations for reduced-risk new chemicals and bio-pesticides by the
year 2005. To date RD has been averaging 2.5 new conventional reduced-
risk chemicals per year. All registration activities including
registration of new conventional chemicals, new uses, me-toos,
antimicrobials, etc. (Refer to Section C for definitions) will meet the
applicable standards mandated by law.
For fiscal year 1999, the Agency had originally anticipated being
able to issue registration decisions for 15 conventional pesticides.
However, in light of recent reductions in RD's operating plan, the
Agency has reassessed this goal to 13 registration decisions for
conventional pesticides. Resource reductions in FY99 have further
reduced expected outputs for FY2000.
B. What Information Does the Work Plan Include?
The Registration Division's FY99 work plan includes the following
information: (a) the quarter in which RD believes it can make a
decision (please note that a decision does not necessarily mean a
registration); (b) the chemical for which a registration action is
requested; (c) the Trade Name associated with the chemical's end-use
product for which the registration action is requested; (d) uses
associated with the requested registration action; (e) name of the
Registrant who has submitted the request; and (f) any relevant comments
associated with the requested action. The above information is for both
new conventional chemicals and conventional chemical new uses for which
RD has committed to making a decision in FY99. In addition to the new
conventional chemicals and conventional chemical new uses lists, RD has
included a list of food use inerts and safeners, which require Health
Effects Division review during FY99. Additional food-use inert
decisions (e.g., polymers) will also likely be made during FY99.
Furthermore, EPA expects to issue 60 non-food use inert clearance
decisions during FY99.
Once again, please note that RD is committing to decision dates and
is not committing to registration dates. RD, in conjunction with the
Health Effects Division and the Environmental Fate and Effects
Division, has considered the amount of data associated with each
requested actions in order to project a commitment date for decision
making. These commitment dates could change or be delayed because of
the following reasons: (a) data gaps; (b) significant risk issues; and
(c) protracted negotiations on risk mitigation. With the publication of
these commitment dates, RD is emphasizing new conventional chemicals,
conventional chemical new uses, inerts and safeners but will not
neglect the other actions (e.g., label amendments and me-too actions)
pending or recently submitted to the Agency. Moreover, emerging needs
will continue to be addressed as needed.
RD is posting the FY99 work plan on the EPA Internet web site
[http://www.epa.gov/opprd001/workplan]. This web site will be updated
periodically to provide current information on dates and other
pertinent information for completed registration decisions and/or
modified registration actions.
C. What are the Definitions of Certain Terms that are Used in the Work
Plan?
1. Active Ingredient: means any substance (or group of structurally
similar substances if specified by the Agency) that will prevent,
destroy, repel or mitigate any pest, or that functions as a plant
regulator, desiccant, or defoliant within the meaning of FIFRA sec.
2(a).
2. Conventional Pesticide: refers to any substance or mixture of
substances intended for: a. Preventing, destroying, repelling, or
mitigating any pest; b. Use as a plant regulator, defoliant, or
desiccant, and c. Use as nitrogen stabilizer.
This shall not include any antimicrobial, biological or plant
pesticides.
3. Experimental Use Permits: means a permit pursuant to section 5
of FIFRA, including permits requiring the establishment of a temporary
tolerance. The permit may be for a new active ingredient or for a new
use of an active ingredient contained in a registered product
4. Inert: means a non-pesticidal active component of a pesticide
product such as a surfactant or emulsifier.
5. IR-4: refers to the Inter-Regional Research Project Number 4
funded by USDA and generates data to support minor use registrations,
and coordinates the development of information on the clearance of
these pesticides.
6. Me-too: refers to an application for registration of a pesticide
product that is substantially similar or identical in its uses and
formulation to products that are currently registered.
7. Minor Uses: refers to the use of a pesticide on an animal, on a
commercial agricultural crop or site, or for the protection of public
health where;
(A) the total United States acreage for the crop is less than
300,000 acres, as determined by the Secretary of Agriculture; or
(B) the Administrator, in consultation with the Secretary of
Agriculture, determines that based on information provided by an
applicant for registration or a registrant, the use does not provide
sufficient economic incentive to support the registration or for
such use and:
(i) there are insufficient efficacious alternative registered
pesticides available for the use; and
(ii) the alternatives to the pesticide use pose greater risks to
the environment or human health; and
(iii) the minor use pesticide plays or will play a significant
part in managing pest resistance; or
(iv) the minor use pesticide plays or will play a significant
part in an integrated pest management program.
8. New Registration Application: means any new application
requiring Agency approval to register or amend a registration of a new
or old chemical and its associated products.
9. New Use: when used with respect to a product containing a
particular active ingredient, means:
a. Any proposed use pattern that would require the establishment
of, the increase in, or the exemption from the requirement of, a
tolerance or food additive regulation under section 408 of the Federal
Food, Drug and Cosmetic Act;
b. Any aquatic, terrestrial, outdoor, or forestry use pattern, if
no product containing the active ingredient is currently registered for
that use pattern; or
c. Any additional use pattern that would result in a significant
increase in the level of exposure, or a change in the route of
exposure, to the active ingredient of man or other organisms.
10. Non-fast Track Amendments: involve label amendments where an
active ingredient is registered for the use(s), but the product
formulation is sufficiently different from existing products that
product specific data are required to be submitted and reviewed. Data
to be reviewed may include acute toxicity, product chemistry, and
efficacy data.
[[Page 12066]]
11. Organophosphate (OP) Alternative: a non-organophosphate
conventional registration application request for either a new active
ingredient or new use for which the crop/pest combination provides a
reduced-risk (to human health and/or the environment) alternative to a
registered organophosphate.
12. Polymer: a macromolecule formed by the chemical union of five
or more identical combining units called monomers.
13. Reduced Risk: a conventional reduced risk pesticide use is
defined as one which: (1) reduces pesticide risks to human health; (2)
reduces pesticide risks to non-target organisms; (3) reduces the
potential for contamination of valued environmental resources; or (4)
broadens adoption of integrated pest management strategies, or makes
them more available or effective.
14. Safener: refers to an inert ingredient used to protect desired
crop from the effects of the active ingredient, typically a herbicide.
15. Section 18s: means any action submitted under Section 18 of
FIFRA which authorizes EPA to allow States to use a pesticide for an
unregistered use for a limited time if EPA determines that emergency
conditions exist.
16. Tolerance Petition: refers to a formal request to establish a
new tolerance or modify (raise, lower or revoke) existing maximum
residue levels.
IV. Registration Division's Fiscal Year 1999 Work Plan
A. New Chemical Registration Candidates
The Registration Division's FY 1999 Work Plan identifies 20 new
chemical candidates for decision-making during the fiscal year. Eight
(8) of these chemicals are for reduced-risk chemicals, include 4
potential alternatives for organophosphate insecticides. These 20
candidates cover approximately 31 crops. From these 20 candidates, the
Agency anticipates making 13 registration decisions.
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Quarter Chemical Trade Name Pesticide Type Uses Registrant Comments
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1st Quarter Tralkoxydim Achieve Herbicide Wheat, Barley Zeneca Registered
December 1998
2nd Quarter Emamectin Benzoate Proclaim Insecticide Cole Crops Novartis
2nd Quarter CGA-248757 Action Herbicide Soybeans Novartis
2nd Quarter..................... s-Dimethenamid BAS 656034 Herbicide All rac's BASF Reduced-Risk
currently Chemical
registered with
dimethenamid
2nd Quarter Sulfosulfuron MON 37500 Herbicide Wheat Monsanto
2nd Quarter Diflufenzopyr Distinct Herbicide Corn BASF Registered January
1999
Reduced-Risk
Chemical
Joint Review with
Canada
2nd Quarter Lithium P. Sulfotine Insecticide Wasp Bait Station SC Johnson
Sulfonate
2nd Quarter n- Expel Repellent Indoor Use Colgate-Palmolive
Methylneodecanami
de
2nd Quarter Bifenazate Floramite Insecticide Ornamentals Uniroyal Reduced-Risk
Chemical
OP Alternative
2nd Quarter Chlorfenapyr Pirate Insecticide Cotton American Cyanamid
3rd Quarter Propidine Repellent Insect Repellent Bayer
3rd Quarter Azafenidin Milestone Herbicide Citrus, Grape, DuPont
Sugarcane,
Vegetation
Management
3rd Quarter Fenhexamid Elevate Fungicide Grapes, Tomen Agro Reduced-Risk
Strawberries, Chemical
Ornamentals
Joint Review with
Canada
3rd Quarter Fenpyroximate Insecticide Import Tolerances Nihon Nohyaku
for Hops, Wine
Grapes
3rd Quarter Pymetrozine Rally/Fulfill Insecticide Cucurbits, Novartis Reduced-Risk
Fruiting Vegs, Chemical
Hops, Tobacco,
Cotton
OP Alternative
4th Quarter Trifloxystrobin Flint Fungicide Pome Fruit, Novartis Reduced-Risk
Grapes, Chemical
Cucurbits,
Peanuts, Turf,
Bananas
4th Quarter Methoxyfenozide Intrepid Insecticide Cotton, Pome Fruit Rohm & Haas Reduced-Risk
Chemical
OP Alternative
4th Quarter DPX-MP062 Insecticide Cotton, Tomato, DuPont Reduced-Risk
Pepper, Cole Chemical
Crops,
OP Alternative
4th Quarter Ethametsulfuron Muster Herbicide Canola DuPont
[[Page 12067]]
4th Quarter Gentamicin Agrigent Fungicide Pome Fruit Quimica Withdrawn December
1998
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B. New Use Candidates for Already-Registered Chemicals
The listing below identifies approximately 120 potential new uses
for 37 already-registered chemicals. Many of these new uses are for
compounds currently classified as ``reduced-risk pesticides.'' As
opportunities arise during the course of the fiscal year, additional
new use candidates may be added to this list for decision-making. Any
additions to this list will be subjected to the prioritization criteria
outlined in Pesticide Registration Notice 97-2. From these new use
candidates, the Agency anticipates issuing 100 new use decisions.
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Quarter Chemical Trade Name Pesticide Type Uses Registrant Comments
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1st Quarter Dicamba Banvel Herbicide Soybeans, Wheat, BASF Tolerance
Cotton, Barley, Published 01/06/
Asparagus 99
1st Quarter Picloram Tordon Herbicide Sorghum Dow Agrosciences Tolerance
Published 01/05/
99
1st Quarter Avermectin Insecticide Chili Peppers, Novartis
Grapes
1st Quarter Hexythiazox Savy Insecticide Hops Gowan Tolerance
Published 10/16/
98
1st Quarter Cymoxanil Curzate Fungicide Grapes, Tomatoes DuPont Tolerance
Published 02/10/
99
1st Quarter Tebuconazole Elite, Folicur Fungicide Grapes, Grasses Bayer Tolerance
Grown for Seed Published 01/08/
99
1st Quarter Tribasic Copper Fungicide Several Uses Premium
Sulfate, Copper Compounding,
Oxychloride, Griffin, Monterey
Copper Hydroxide, Chem. Co.
Copper salts of
fatty and rosin,
Cuprous Chloride,
Cuprous Oxide
1st Quarter Copper Inferno Fungicide Potato IR-4 Tolerance
Ethylenediamine Published 01/04/
99
2nd Quarter Azoxystrobin Heritage, Quadris Fungicide Canola, Peanut Zeneca Reduced-Risk
Hay, Pistachios, Chemical
Tree Fruits,
Wheat, Turf ,
Potatoes, Stone
Fruit, Cucurbits
2nd Quarter Triallate Fargo Herbicide Sugar Beets Monsanto
2nd Quarter Halosulfuron Permit Herbicide Sugarcane, Monsanto
Popcorn, Sweet
and Field Corn,
Cotton, Rice,
Grain Sorghum,
Tree Nuts
2nd Quarter Quinclorac Facet Herbicide Sorghum, Wheat BASF Sorghum is on the
USDA Vulnerable
Crops List
[[Page 12068]]
2nd Quarter Tebufenozide Confirm Insecticide Pome Fruit, Rohm & Haas Reduced-Risk
Cotton, Leafy Chemical
Vegetables, Cole
Crops, Sugarcane,
Fruiting
Vegetables,
Pecans, Forestry,
Ornamentals,
Cranberry,
Turnips,
Caneberry,
Canola, Mint,
Blueberry
2nd Quarter Pyriproxyfen Knack Insecticide Tree Crops, Valent Reduced-Risk
Apples, Pears, Chemical
Walnuts
2nd Quarter Fludioxanil Switch, Medallion Fungicide Grapes, Turf Novartis Reduced-Risk
Chemical
2nd Quarter Iprodione Rovral Fungicide Cottonseed Rhone-Poulenc
2nd Quarter Arsanilic Acid Fungicide Grapefruit Fleming
(EUP) Laboratories
2nd Quarter Clofentezine Apollo Insecticide Apples AgrEvo
3rd Quarter Cyfluthrin Insecticide Potato Bayer
3rd Quarter Fosetyl-al Aliette Fungicide Bananas, Grapes, Rhone-Poulenc
Macademia Nuts
3rd Quarter Spinosad Spintor Insecticide Tuberous and Corm Dow Agrosciences Reduced-Risk
Vegetables Chemical
3rd Quarter Pyriproxyfen Knack Insecticide Citrus, Fruiting Valent Reduced-Risk
Vegetables Chemical
3rd Quarter Imidacloprid Admire Insecticide Tuberous and Corm Bayer, IR-4
Vegetables
Subgroup,
Cucurbit,
Watercress
3rd Quarter Cyromazine Insecticide Bulb Vegetables, Novartis
Mango, Cotton,
Potato, Radish,
Sweet Corn
3rd Quarter Glufosinate Liberty Herbicide Canola, Potato, AgrEvo
Ammonium Sugar beet
4th Quarter Difenconazole Dividend Fungicide Bananas Novartis
4th Quarter Fenpropathrin Danitol Insecticide Melons, Citrus, Valent
Brassica
4th Quarter Dazomet Atlante Fumigant Strawberries, BASF
Tomatoes
4th Quarter Propazine Milo Pro Herbicide Sorghum Griffin Sorghum is on the
USDA Vulnerable
Crops List
4th Quarter Myclobutanil Rally/Nova Fungicide Asparagus, Snap Rohm-Haas, IR-4
Beans, Caneberry,
Gooseberry,
Currant, Mint,
Strawberry
4th Quarter Kresoxim-methyl Sovran Fungicide Grapes, Pecan, BASF
Pome Fruit
4th Quarter Spinosad Insecticide Cucurbits, Stone Dow Agrosciences Reduced-Risk
Fruit, Legume, Chemical
Corn, Sorghum,
Wheat
4th Quarter Glyphosate Roundup Herbicide Barley, Canola, Monsanto Reduced-Risk
Sugar Beet, Chemical
4th Quarter Bifenthrin Capture Insecticide Cucurbits, IR-4
Eggplant,
Legumes, Lima
Beans, Head and
Stem Brassica
Subgroup,
Artichoke, Canola
4th Quarter Chlorothalonil Bravo Fungicide Non-bell Peppers, IR-4 and GB
Almonds, Bioscience
Asparagus, Mango,
Pistachio
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[[Page 12069]]
C. Inert1 and Safener2 Registration Decisions
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Quarter Chemical Uses
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1st Quarter Rhodamine B Inert
2nd Quarter HOE 107892 Safener
2nd Quarter MON 4660 Safener
3rd Quarter MON 13900 Safener
3rd Quarter Dichlormid Safener
4th Quarter DMSO Inert
4th Quarter Isophorone Inert
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\1\Inert = non-pesticidal active component of a pesticide product such
as a surfactant or emulsifier.
\2\Safener = inert ingredient used to protect desired crop from the
effects of the active ingredient, typically a herbicide.
List of Subjects
Environmental protection, Pesticides, Tolerances.
Dated: March 2, 1999.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 99-5966 Filed 3-9-99; 8:45 am]
BILLING CODE 6560-50-F