Scientific Issues Associated with E

Proposed Cancellation & Denial of C

Rodenticide Products

Goals and Objectives of the 

November 29 – December 1 

FIFRA Scientific Advisory Panel Revi

Steven Bradbury, Ph.D.Director, Office of Pesticide P
Background

• FIFRA (the Federal Insecticide, Fungicide a

Rodenticide Act) requires EPA to determine whether the uses of a pesticide generally p“unreasonable adverse effects on the environment.”

• EPA l i h i id EPA statutes also require that pesticides 

registered prior to 1984 be re-evaluated by to ensure continued use of these pesticides 

the statutory standards of human health anenvironmental protection.
FIFRA Risk/Benefit Paradigm

• To obtain or maintain a registration for a pe

To obtain or maintain

a registration for

a pe

under FIFRA, a registrant must demonstratthe pesticide satisfies the statutory standar

registration. That standard requires, amonthings, that the pesticide performs its intenfunction without causing unreasonable advfunction without causing unreasonable adv

effects on the environment.

• FIFRA defines an unreasonable adverse eff

th i t bl i k t the environmen

t as any unreasonable ris

k

t

or the environment, taking into account the economic, social, and environmental costs 

benefits of the use of the pesticide...
Notice of Intent to Cancel (NOIC) Pr

Under FIFRA section 6(b), the Agency may issNotice of Intent to Cancel the registration of a pesticide product whenever it appears either (1) A pesticide or its labeling or other materia

required to be submitted does not comply wrequired to be submitted does not comply w

FIFRA, or 

(2) When used in accordance with widespread 

commonly recognized practice, the pesticidgenerally causes unreasonable adverse effon the environment. on the environment.
FIFRA Requirements for a NO

• EPA is required to send the draft NOIC to U

EPA is required to send the draft NOIC to U

for comment on the impact of the decision agricultural economy.

• When a public health use is affected, EPA i

required to send the draft NOIC to HHS for comment on benefits or use.

• EPA is required to request the FIFRA SAP t

comment on the scientific bases of the humhealth and environmental assessments underlying the action proposed in a draft N

• EPA must evaluate and publish responses 

USDA HHS and USDA, HHS, and SAP reviews as part of the SAP reviews as part of the

Agency’s deliberations.
The Current NOIC

• EPA’s regulatory conclusions:

• 20 rodenticide products should be cance• 4 d ti id li ti f d t 4 ro

denti

cide applications 

for pro

duc

t

registration should be denied.

• EPA id d EPA provid

e

d th d ft NOIC th A ’ the 

draft NOIC, the 

Agency’s 

benefits analyses, and associated backgrodocuments to USDA and HHS.

• USDA and HHS reviews are progressing 

concurrentl

y S with the 

SAP review and its re
FIFRA Requirements for a N

Whil th SAP i h d t t i While the SAP is c

harge

d

to commen

t on scie

issues associated with the rodenticide risk assessments, there are certain topics that the 

i t s no

t ch d t idi t harge

d

to providing commen

t on w

hen 

reviewing a NOIC:• The impact of the draft NOIC on the a

gricul

economy and public health uses, i.e., the rodenticides benefits analyses.

• EPA s’ regulatory regulatory conclusions:

• Should these 20 products be cancelled.• Should the 4 product registration applica

b d id e 

denie

d. 
SAP Review: Goals and Object

Consistent with SAP reviews concerninNOICs:EPA is not asking advice on whether th

is not asking advice on whether th

scientific bases of the rodenticides risk assessments, the incident analyses, an

regulatory decision could benefit from t

could benefit from t

development of new scientific methodoor additional data.
SAP Review: Goals and Object

SAP Review: Review: Goals and Object

Object

EPA is re

qg p uestin

g the SAP 

provide 

comments on whether the Agency has reasonably assessed the nature and magnitude of risks to public health and environment posed by the use of certarodenticide products rodenticide products, given currently given currently

available information and accepted sci

methods.
SAP Review: Backg g round to Charge Qu

• EPA has identified scientific issues most c

to its decision to cancel and deny registrati

decision to cancel and deny registrati

that do not conform to the Risk Mitigation Decision for Ten Rodenticides.

• The issues primarily concern topics that ha

been py y reviously addressed by the SAP.
SAP Review: Background to Charge Qu

• EPA i i il ti EPA is primarily requesting a revi f th ew o

f the 

scientific elements that relate to EPA’s conclusions that the 20 rodenticide produc

cause unreasonable adverse effects cause unreasonable adverse effects.

• The general methodologies used to assess 

rodenticide ecolo

g y ical risks and to anal

yze 

human and pet incidents have been the subseveral previous SAP reviews.
SAP Review: Backg g round to Charge Que

• To provide adequate scientific peer review, S

responses to EPA’s charge questions are req

• While EPA’s charge questions must be addre

the SAP is not precluded from commenting oadditional scientific aspects of the rodenticidassessments and incident analyses associatethe draft NOIC.

• Any additional scientific issues that the SAP 

Any additional scientific issues that the SAP 

wish to address could be those raised by the or by individual SAP members.
Overview of Agenda

• Review of the regulatory history and Review of the regulatory history and the pr

the pr

EPA followed in preparing the draft NOIC.

• Presentations from scientists in OPP Presentations from scientists in OPP s’

Environmental Fate and Effects and Health Effects Divisions concerning the ecologica

assessments and incident analyses for non assessments and incident analyses for nontarget wildlife, human, and pets.

• A 

p y resentation on rodenticide efficac

y.

• Public Comment.• Charges to the Panel to the Panel.