EPA-730-N-97-002
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
4/18/97
OFFICE OF
PREVENTION, PESTICIDES, AND
TOXIC SUBSTANCES
Pesticide Registration (PR) Notice 97-2
NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS AND
REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION:
SUBJECT:
Persons Responsible for Registration of Pesticide Products
New Chemical, New Use, EUP, Non-Fast Track Amendments and Inert
Ingredient Registration Priorities for Conventional Pesticides
This notice describes policies and procedures that will help hi the prioritization and
scheduling of applications for new chemical, new use, experimental use permits (EUP), non- /
Fast Track (NFT) Amendments (i.e., amendments that require science division reviews) and
inert ingredient registration actions for conventional pesticides handled by the Registration
Division (RD). Submissions to the Biopesticides and Pollution Prevention Division (BPPD)
and to the new Antimicrobial Division (AD) are not covered by this notice. Submissions made
to BPPD include microbial pesticides (bacteria, fungi, protozoans and viruses used to control
pests), plant-pesticides (pesticidal substances introduced into plants along with the genetic
material necessary for the production of the substances within the plants themselves) and
biochemical pesticides (naturally occurring compounds that have a non-toxic mode of action)
and certain other naturally occurring or essentially like naturally occurring compounds of low
risk that have been approved by OPP for review in BPPD. Submissions made to AD include '
sanitizers, disinfectants, antifoulants, water filters, algicides, microbiocides, wood
preservatives, phenols, inorganic halides and mineral acids. Methyl Bromide replacements are.
covered by this notice, unless they are subject to action by BPPD.
I.
BACKGROUND
While pesticide registration productivity hi OPP has increased hi recent years, these
gains have not been sufficient to offset the increased applications and requests made by
registrants as well as the new requirements imposed by the Food Quality Protection Act
(FQPA) of 1996. Since all the requests made on the Office of Pesticide Programs (OPP) '
cannot be met simultaneously, it is important that OPP address its customers' highest priorities
in an efficient and equitable manner. For this reason all parties with applications pending hi
RD for the registration of new active ingredients, new uses, EUPs, NFT amendments and inert
Recycled/Recyclable • Printed with Vegetable Oil Based Inks on 100% Recycled Paper (40% Postconsumer)
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ingredients for conventional pesticides should submit in ranked order requests for their next
top five priority actions by June 30, 1997. Submitter's ranked ordering should be consistent
with the ordering specified in this PR Notice. OPP will combine these externally identified
priorities with its own internal priorities (methyl bromide replacements, IR-4, etc.) and
develop a schedule of when each action should be completed.
H. KF.GTSTRATTON DTVTSTON (RD) GOALS
RD has the following registration goals:
(1) Ensure that the nation's food supply continues to be safe, plentiful, and nutritious and
strive to make it safer;
(2) Ensure that the nation's food production system continues to be safe and strive to make
it safer;
(3) Reduce the potential risks that pesticides pose to human health (especially to infants and
children) including:
(a) reducing potential dietary risks (both food and drinking water) to consumers;
(b) reducing potential risks to homeowners and others as a result of pesticide use hi
residential and other nonagricultural settings, and
(c) reducing risks to workers who may be exposed to pesticides used hi agriculture.
(4) Reduce the potential risks that pesticides pose to the earth's ozone layer, groundwater,
aquatic organisms and wildlife;
(5) Increase the acreage subject to Integrated Pest Management (IPM) practices;
(6) Improve pest resistance management practices; and
(7) Reduce trade barriers, where consistent with U.S. health and environmental protection
standards.
To meet these goals and the requirements of the Food Quality Protection Act, RD will
prioritize its registration actions in the following order:
(a) methyl bromide alternatives
(b) reduced risk candidates
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(c) USDA-EPA identified potentially vulnerable crops
(d) minor use priorities
(e) non-minor use priorities
(f) addressing trade irritants
Submitter's should explain how their priorities address RD's registration goals and are
consistent with the above priorities.
HI. METHYL BROMIDE ALTERNATIVES
If a registrant intends to submit a Methyl Bromide alternative, it does not have to be
one of theu: five priorities. It becomes an EPA priority, and the Agency will attempt to meet
the tune frames specified in PR Notice 95^4 to the maximum extent possible. Expediting the
availability of alternatives for the pesticide methyl bromide, which is scheduled to be phased-
out under the Clean Air Act due to its ozone depleting potential, is one of EPA's highest
priorities.
IV. REDUCED RISK CANDIDATES
If a registrant intends to submit or already has submitted a new chemical as a reduced
risk candidate or a new use of a chemical already determined to be reduced risk by EPA, it
must be one of theu: top five priorities. If the chemical is determined by OPP to be a reduced
risk candidate, then KD will expedite the review and any resubmission that may be necessary
can come in at any time, and the Agency will endeavor to review it at the earliest possible
tune. If the new active ingredient has been determined to be a reduced risk candidate by OPP,
and if the submitter is simultaneously seeking registration in Canada, and if the application has
been determined by Canada to be complete, the action can qualify for work-sharing between
the two countries. While this work-sharing program is still in the "pilot" stage, it could result
in reduced review times and greater harmonization.
V. USDA-EPA TDENTTETED VULNERABLE CROPS
The United States Department of Agriculture (USDA) and the Environmental
Protection Agency (EPA) entered into a Memorandum of Understanding (MOU) on August
15, 1994. This MOU was amended on April 18, 1996. One of the purposes of this MOU was
to establish a coordinated framework for collaborative efforts to develop pest management
alternatives to a list of crop/pest combinations that are identified as potentially vulnerable (i.e.
for which producers have only one or a limited number of efficacious alternatives or where
pest resistance limits effective pest management or where regulatory action would result hi
pest management problems.)
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The following crop/pest combinations have been identified by the USDA and EPA
through interaction with State Agricultural Experiment Station research and extension faculty
via the National Agricultural Pesticide Impact Assessment Program and state and regional
Integrated Pest Management programs. In addition, commodity groups and producers were
involved. The identified, potentially vulnerable crop/pest combinations are: ,
(1) alfalfa/aphids
(2) apples/mites
(3) apricots/mites
(4) artichokes/aphids
(5) blackberry, raspberry/pear psylla, rhizopus, rust
(6) cabbage/thrips, mites
(7) carrot/dodder, mites, fungal leaf diseases
(8) cole crops/aphids
(9) collards/alternaria, anthracnose, cercospora
(10) cranberry/mites
(11) cruciferous greens/alternaria, white rust
(12) grape/grape philoxera, black vine weevil
(13) leafy greens/aphids
(14) leek shallot/alternaria, borrytis, downy mildew
(15) lemon tangerine/pale color
(16) lettuce/aphids
(17) millet/annual grasses
(18) peaches/mites
(19) pecans/yellow pecan aphid
(20) peppermint, spearmint/weeds
(21) plums, prunes/mites, brown rot
(22) pumpkin/pigweed, nightshade
(23) radicchio/aphids
(24) rice/rice water weevil
(25) sorghum/cinch bug, broadleaf weeds
(26) spinach/fungal leaf diseases
(27) sugar cane/aphids, weeds
(28) sweet potato/weeds
If a registrant intends to submit an action that specifically addresses one or more of the
crop/pest combinations listed above, it does not have to be one of their five priorities. It will
become an Agency priority.
VI. . MTNDK TTSF. PKTORTTTRS
A minor use priority is defined as any of the following:
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(1) A single pesticide petition (for a new AI or new use) covering one or several major (and
possibly minor) uses (as defined in section VII) and. a single pesticide petition (for a new AI or
new use) covering one or several minor uses. The two petitions may or may not be for the
same pesticide.
(2) A single pesticide petition (for a new AI or new use) covering a major use and.up to three
pesticide petitions totaling up to three minor uses (as defined in section VQ) where all petitions
are for the same pesticide.
(3) Up to three pesticide petitions (for a new minor use AI or a new minor use) on up to three
different pesticides totaling up to three minor uses (as defined in section VII). The petitions
may or may not be for the same pesticide.
(4) Experimental use permits (EUP) with or without a temporary tolerance on up to three
minor uses (as defined in section VII) all for the same pesticide.
(5) A new non-food use chemical or a new use for a non-food use chemical that meets the
definition for minor use (as defined hi section VII).
(6) A full resubmission of a prior priority action where OPP required studies/data to be
upgraded or repeated. A "full" submission requires that the registrant address alLof the
deficiencies identified hi the Health Effects Division (HED) reviews or all of the deficiencies
identified in the Environmental Fate and Ecological Effects (EFED) reviews. Partial
resubmissions (i.e. residue chemistry deficiencies addressed but not toxicology issues) will not
be scheduled. Full resubmissions are required since both HED and EFED are being
reorganized with interdisciplinary branches to do these reviews.
(7) A non-fast track amendment (i.e. an amendment that requires science review) which
impacts at least one minor use (as defined in section VII).
(8) An inert ingredient which impacts at least one minor use (as defined in section VET).
VH. MINOR USE DEFINITION
For the purpose of addressing the Food Quality Protection Act in this PR notice, the
legislation defines "minor use" to mean the use of a pesticide on an animal, on a commercial
agricultural crop or site, or for the protection of public health where—
(1) the total United States acreage for the crop is less than 300,000 acres, as determined by
the Secretary of Agriculture; or.
(2) the use does not provide sufficient economic incentive to support the initial registration or
continuing registration of a pesticide for such use and. —
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(A) there are insufficient efficacious alternative registered pesticides available for
the use; or
(B) the alternatives to the pesticide use pose greater risks to the environment or
human health; or
(C) the minor use pesticide plays or will play a significant part in managing pest
resistance; or
(D) the minor use pesticide plays or will play a significant part in an integrated pest
management program.
The Food Quality Protection Act defines "minor use" of a pesticide on an animal, a
commercial agricultural crop or site, or for public health purposes in two different ways. The
first definition identifies minor use crops as those with less than 300,000 total U.S. acres. The
second definition requires an economic determination that a registrant does not have the
market revenues or sufficient economic incentive to support pesticide registration for a use
site.
MINOR USE CROPS
A pesticide use on a crop with less than 300,000 acres of total U.S. production is a
minor use. This definition applies to numerous fruits, vegetables, spices, and horticulture and
nursery crops. As an alternative to listing all minor use crops, a list of crops with more than
300,000 acres of U.S. production is provided below. Pesticide uses on commercial
agricultural crops that do not appear on the list will automatically be considered minor uses.
Because the first definition applies only to crop uses of less than 300,000 acres, non-crop uses
or sites (such as animal uses, aquatic weed control, and rights-of-ways) are not evaluated
under the first definition.
Agricultural Crops Grown on More Than 300,000 Acres
Almonds
Apples
Barley
Beans, dry
Beans, snap
Canola
Corn (sweet & field)
Cotton
Cottonseed
Grapes
Hay (alfalfa & other)
Pecans
Popcorn
Potatoes
Rice
Rye
Sod Farms
Sorghum
Soybeans
Sugarbeets
Sugarcane
Sunflower-
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Oats
Oranges
Peanuts
Tobacco
Tomatoes
Turf
Wheat
MINOR USE ECONOMIC DEFINITION
A pesticide use on an agricultural crop grown on more than 300,000 acres or on a non-
agricultural site may quality as a minor use, provided the registrant can demonstrate that the
use does not provide sufficient economic incentive to support registration. For purposes of
this PR notice this economic determination can be made by using the equation:
(a) costs ^. gross revenues for 1 year for the specific site.
where:
Costs = incremental costs to register the site which are the costs of the additional data
requirements to register the specific site. If registration costs are shared by more than
one registrant, the costs should represent the registrant's share of the data
requirement.
Revenues = registrant's gross sales which are the additional sales projected at full
market potential for the specific site. EPA, in consultation with USDA, will make this
determination based on the following information provided by the registrant:
Registrants that choose to submit priorities based on the economic definition for a
minor use must provide the following:
1 . A list of the registration data requirements and the estimated cost to generate the data
for the specific site.
2. The Annual Domestic Sales or Revenues for the Specific Site: Provide the actual,
annual value and quantity of domestic sales of the pesticide for the specific site. This
value should be calculated as the average of the most recent 3 years. For the
registration of a new site, annual revenues should be projected on the basis of full
market potential.
3. A written summary addressing at least one of the criteria described in section VTI
For a minor use priority that is determined to be a minor use as a result of the
economic criteria specified above, the one year time frame for completion of reviews does not
begin until after the economic determination has been completed.
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IR-4 will be given an unlimited number of priorities for their minor use submissions.
[For further information on minor uses, contact Hoyt Jamerson, Registration Division
(7505C), Office of Pesticide Programs, EPA, 401 M St., S.W., Washington, D.C. 20460,
(703) 308-8783, Fax (703) 308-6547, E-Mail -jamerson.hoyt@epamail.epa.gov. Also,
registrants wishing to coordinate with USDA's IR-4 minor use program concerning minor crop
registrations should contact: National Director; IR-4 Project Headquarters; New Jersey
Agricultural Experiment Station; P.O. Box 231; New Brunswick, NJ 08903-0231; Phone
(908) 932-9575; FAX (908) 932-8481; e-mail guest@aesop.rutgers.edu.
NON-MTNOR USSR PRTORTTTRS
A non-minor use priority can be defined as any of the following:
A single pesticide petition (for a new AI or new use) covering one or several major use
agricultural crops (as defined in section W).
An EUP with or without a temporary tolerance on a major use crop (as defined in
section VII).
A new non-food use chemical or a new use for a non-food use chemical that does nol
meet the criteria for minor use in section VTL
(1)
(2)
(3)
(4) A non-fast track amendment which impacts only major uses (as defined hi section VII).
(5) An inert ingredient which impacts only major uses (as defined in section VII).
Non-minor use priorities as defined hi this section must be prioritized by all submitters
after their minor use priorities as defined hi Section VI.
DL TRADE TRRTTANTS
OPP recognizes that national differences hi tolerances/Maximum Residue Limits
(MRLs) for pesticide residues hi food may impede international trade hi agricultural goods.
Resolving these differences may be a high priority for growers trading partners, or others.
Submitters pursuing international marketing strategies (especially hi Canada and Mexico) for
their pesticides, or who can reasonably anticipate that crops treated with their pesticides hi
other countries will be exported to the United States, are advised to consider the need to place
a priority on seeking appropriate U.S. registrations and/or tolerances, to reduce the likelihood
of adulterated food entering the U.S. and to avoid placing then: customers at risk of regulatory
action by U.S. authorities. To the extent that standards can be harmonized among countries
engaged hi agricultural trade, without lowering the level of protection standards, compliance
and enforcement will be simplified and as a result, consumers, growers and the pesticide
industry will benefit from greater consistency. If a tolerance or registration action that falls
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into this category is not one of the submitter's priorities, OPP reserves the right to substitute
the new action for one of the submitter's identified priorities. OPP does not anticipate taking
such an action except in exceptional cases.
Also, as explained in PR Notice 97-1, FQPA requires EPA to consider international
standards in its tolerance setting decisions. Therefore, the Agency has requested .information
on international Maximum Residue Limits be included in tolerance petitions to facilitate
reviews.
X. OPP PRIORITIES AND RESPONSIBILITIES
OPP reserves the right to insert its own priorities (i.e., new uses for repeat section 18s
and other actions that OPP decides warrant priority attention) into the scheduling cycle.
OPP will schedule each priority action to the greatest extent feasible. OPP will
complete each priority action or complete as much of the reviews and risk assessment as
possible. Once OPP has completed its review, that priority action is considered completed.
Any follow-up work that involves the need for further OPP scientific review of data will have
to be reprioritized and rescheduled in a subsequent scheduling cycle.
XI. COMPLETE SUBMISSION
The data package to be reviewed for a given priority should be complete and submitted
to OPP prior to the initiation of the scheduling cycle (June 30, 1997). This is necessary so
that the scientists can estimate how long it will take to complete the work for each priority.
Where data packages are not complete, the priority will not be scheduled until all the data are
submitted regardless of the priority given by the submitter.
XH. SUBSTITUTIONS
Once priorities have been submitted, OPP strongly prefers that no changes or
substitutions be made because even a single substitution can require a complex series of
reassignments of science reviewers and changes in completion dates across multiple actions.
However, if a party wishes to withdraw one of its priority actions and substitute another one
for it, one such substitution will be permitted per party per scheduling cycle provided that (a)
work on the existing priority has not already begun and (b) the new priority will be scheduled
at the end of the priority list regardless of the priority of the action it is replacing.
Xm. Coordination with Tolerance Reassessment
The FQPA requires the Agency to reassess all tolerances and exemptions that predate
the act to ensure that existing tolerances are consistent with the requirements of section 408 of
the Federal Food, Drug and Cosmetic Act (FFDCA) as amended. For some pesticides
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scheduled for reassessment in the next two years, EPA may be unable to approve an
application for a proposed new use or new tolerance until it completes the reassessment
process for the pesticide. The reassessment process should not, however, delay evaluation and
action on applications for "me-too" registrations issued pursuant to section 3(c)(7)(A) of
FJJFRA.
XIV. INFORMATION ON PRTOKTTTRS TO RF. STTRMTTTF.D
For each priority the following information should be included:
1. Chemical name (ANSI Name and Trade Name)
2. Type of action (new chemical, new use, EUP, resubmission, etc.)
3. Site(s) (crops, non-crops)
4. Identification - REG#, CAS #, petition #, EUP #, file symbol (if known)
5. When data was submitted
6. What work needs to be done
7. Product manager assigned to chemical
8. All submissions must conform with the requirements of FQPA as specified in PR
Notice 97-1.
XV. MATT .TNG ADDKRSS
Priorities should be submitted no later than June 30, 1997 to:
U.S. Postal Service
Peter Caulkins, Deputy Director
Registration Division (7505C)
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460-0001
Personal/Courier Service Deliveries
Peter Caulkins, Deputy Director
Registration Division (7505C)
Office of Pesticide Programs
U. S. Environmental Protection Agency
Room 713, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
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FAX
Peter Caulkins
(703) 305-6920
XI. FOK FURTHER INFORMATION
If you have questions regarding this notice, contact Peter Caulkins, Deputy Director,
Registration Division at (703) 305-6550.
Stephen JEX Johpsao; Director
tegistratioV,Divi£ion
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