Agr oc he mic al

Reg is tr ati on
A G lo ba l V ie w
Dr. Arun Dhuri
 The Power of
Regulation

Regulatory forces have a more

pervasive influence on the pesticides
•industry than they do in most other
segments of the chemical industry.

A perpetual effort to replace more

environmentally damaging products with
more benign alternatives
 DATA REQUIREMENT
BROAD AREAS OF DATA NEEDS

- Chemistry: Phys-chem Properties, 5-Batch

Analysis, Equivalence.
- Efficacy.
- Safety -Toxicity and Environmental toxicity.
- Metabolism, Residue and E-fate.
- Manufacturing Plant Factory Registration
(USA, Argentina, etc.,).
- Packaging and Labeling.
- Trade Marks and Patents.
 Broad Categories of Countries
w.r.t Regulatory Complexity

1. EU, USA, & Japan-Highly Regulated, Complex &

Expensive
- up to 4 years.

2. Latin America, Australia & N. Zealand-Medium

Regulations, Less Complex- upto 2 years.

3. Small Countries of Africa, Asia, South Asian

Countries-Low Regulations & low cost (More
Competition)- up to 1 year.
 E.U.
The Plant Protection Products (PPP) Directive
91/414/EEC (adopted 15 July 1991, in force 26 July 1993)
1. To harmonize the overall arrangements for
authorization of plant protection products within
the European Union.
- Active Substances at a E.U. level by establishing
agreed criteria for considering the safety of
those products.
- Product authorization remains the responsibility
of individual Member States
2. The Directive provides for the establishment of a
positive list of active substances (Annex I), that
have been shown to be without unacceptable risk
to people or the environment
3. Member States can only authorize the marketing
 E.U. - Directive 91/414/EEC
Evaluation of existing* Active Substances (A.S.)
– Annex I
*907 active substances on the market @ 25 July 1993
1. Notification
2. Submission of the dossier to the Rapporteur Member State
(RMS)- consists of: Annex II dossier for the active
substance Minimum
Annex III dossier for 1 formulation
3. Rapporteur Member State evaluates & produces a Draft
Assessment Report (DAR) (previously known as draft
monograph).
4. Technical peer review of draft monograph by EFSA (from
Nov. 2003), the European Food Safety Authority
5. Discussed by European Commission Evaluation Group &
circulated all MS & stakeholders for comments - Proposal
for inclusion in Annex I
6. A vote by the Standing Committee on Food Chain and
 U.S.A. – E.P.A.
Integrated re-registration and tolerance
reassessment
• EPA is reviewing older pesticides (registered prior to Nov.
1984)
under the Federal Insecticide, Fungicide, and
Rodenticide Act
(FIFRA) to ensure that they meet current scientific and
regulatory
standards
• EPA
EPA also is reassessing
issues tolerances decision
a risk management (pesticidedocument
residue
limits
known in as
food)
a to
ensure that they
RED, an IRED, ormet the safety standard established by
a TRED.
the Food
• Quality
REDs (Re-registration
Protection ActEligibility
(FQPA) of Decisions)
1996
• IREDs (Interim Re-registration Eligibility Decisions)
• TREDs (Reports on FQPA Tolerance Reassessment Progress
and [Interim]
Risk Management Decisions)
EPA publishes Notices of Availability in the Federal Register.
 U.S.A. – E.P.A.
State Registration of Pesticides

States may register a new end use product, or an

additional use of a federally registered pesticide product
under the following conditions:
• Special Local Need* = an existing or imminent pest problem
within a state
for which an appropriate federally registered pesticide
product is not
sufficiently available (40 CFR 162.151 )
• The additional use is covered by necessary tolerances or
other clearances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
• The state submits a complete 24(c) notification package for
each
registration to the EPA
• EPA reviews individual 24(c) registrations & oversees the
states' 24(c) \
registration programs.
 NAFTA
Technical Working Group (TWG) on
Pesticides
NAFTA TWG regulatory agencies
• US EPA Office of Pesticide Programs (OPP)
• Canadian Pest Management Regulatory Agency (PMRA)
• a consortium of Mexican agencies (CICOPLAFEST)
Target : Harmonization of pesticide regulatory processes in
NAFTA
countries
• developing common data submissions for manufacturers –
electronic
harmonization
• providing greater co-ordination of approval processes for
pesticides - joint
reviews
• eliminating trade problems related to differences in maximum
residue limits
 Central America
OIRSA (“Organismo Internacional Regional
de
Sanidad Agropecuaria”)
Belize, Costa Rica, El Salvador, Honduras, Mexico,
Technical Regional
Nicaragua & Panama Pesticide
Working Group
• harmonized (OIRSA region) registration data and
labeling
requirements
• FAO specifications & Codex Alimentarius
• data exchange on efficacy within region
• minor use authorizations
 South America
Andean Community

• Bolivia, Colombia, Ecuador, Peru & Venezuela

• Common Pesticide Registration Manual (Jul. 2002) :
“ (Norma
Andina para el Registro y Control de Plaguicidas
Químicos de Uso
Agrícola - Decisión 436. Comisión Andina. Gaceta
Oficial del
Acuerdo de Cartagena. Año XIV - No. 347. Lima, 17
June 1998).”
• Mercosur: “Mercado Comun del Sur” (Southern
• Based on the principles established in the FAO's
Common Market)
"International
• Established in 1991 for
Code of Conduct : Argentina, Brazil, Paraguay
the Distribution and Use and
of
Uruguay
Pesticides" and
related guidelines of other international agencies.
 Asia - Pacific
Characterized by widely different regulatory
• systems
Developed regulatory system
• efforts in harmonization through the Regional Network
on
Pesticides in Asia and the Pacific (RENPAP)

P.R. China / Vietnam South East Asia

• Regulatory systems developed in some countries,
neonate in others
(Cambodia, Laos)
• Harmonization of MRLs
• Network for Pesticide Regulatory Authorities
• most elaborate, now largely in line with OECD
• undergone some significant changes by changing study
requirements,
grouping crops by type and revising the MRL regulation
• to be conducted in Japan: soil metabolism, photolysis
and hydrolysis
in natural water and (Japanese) soil, and residue
studies
• influenced the regulatory systems of Korea & Taiwan
Australia / New Zealand
• Regulatory systems well developed

• Like in E.U. , review of older chemicals & harmonization

efforts with
OECD & other international institutions
 Africa
Harmonization
• CILSS – regional grouping of 9 Sahel countries: Chad, Mali, Burkina
Faso, Niger, Mauritania, Senegal, Cape Verde, Gambia & Guiinea- Bissau

• CSP (Comité Sahelien des Pesticides) – located in Bamako - is the regional

registration authority for all the 9 countries

• SADC (Southern African Development

Community) 14 Countries: Angola,
Botswana, Congo (DR), Lesotho,
• Malawi, Mauritius, Mozambique, Namibia,
• Seychelles, South Africa, Swaziland, Tanzania,
Zambia & Zimbabwe.
• South Africa: Registrar Act 36/1947 & Agricultural
Remedies Registration Procedure Policy Document"
 Global Harmonization:
FAO
Pesticide Management Unit
• Prior Informed Consent (PIC) - Information on
Certain
Hazardous Pesticides and Industrial Chemicals in
International
Trade
• International Code of Conduct on the Distribution
and Use of
Pesticides
• FAO Pesticide Management Guidelines : incl
Guidelines Related to
the Development and Evaluation of Data Considered in
the Registration
Proces
• Joint FAO/WHO Meeting on Pesticide Residues
(JMPR)
 Global
Harmonization: WHO
WHO Pesticides Evaluation Scheme:
"WHOPES“
Public Health Impact of Pesticides & Public
Health Pesticides
• establishes and publishes specifications for technical
material
and related formulations of public health pesticides
• reviews efficacy & safety reports of public health
pesticides
• guidelines for laboratory and field evaluation of
insecticides and
repellents
• equipment and application manuals
WHO health criteria (EHC) monographs on chemicals /
pesticides
 O.E.C.D.
The OECD Pesticide Programme consists of six
programe
areas, aimed at achieving the following objectives
1. Registration, re-registration and work sharing : To share
the burden of
registration and re-registration of pesticides and to help
countries co-operate in the hazard assessment of
pesticides.
2. Data requirements : To promote international
harmonization of pesticide data requirements for
registration and use of pesticides
3. Test guidelines - To revise and develop OECD test
guidelines appropriate for pesticides in order to increase
the mutual acceptance among Member countries of data
used in pesticide assessment.
4. Hazard and risk assessment - To develop internationally
harmonized pesticide assessment methods.
 Global Harmonization: MRL
OECD/FAO Global Residue Zoning Project
 Global Harmonization:
MRL
OECD/FAO Global Residue Zoning
• Initial Project
Work Plan: Define geographic zones based on climate for
the purpose of extrapolating residues behaviour
• Validate the proposed zones using available JMPR residue data
• Variability of residues at harvest within climate zone as high
as
between climate zones
• Zoning based on climate maps or pre-harvest weather
conditions
cannot be validated
• Variations in residues at day zero can account for ≈ 70% of
residue
variability at harvest
• Contribution of climate is small ( < 10%)
•
 Global Harmonization: MRL

OECD/FAO Global Residue Zoning Project

• Less emphasis on climatic differences when assessing

residue data from comparable trials → Potential

advantage of being able to accept residue trials from
a
larger database of comparable trials
• Consider importance of factors contributing to zero-
day
variability (different GAP within regions)
 Global Harmonization
Electronic Submissions - Towards a Global Platform
CADDY : Computer Aided Dossier and Data Supply
Dedicated software: CADDY v. 2
• The Joint Data Transfer Steering Group was established June 1995 by EU
Member States, the European Commission and the European Crop Protection
Association (ECPA). - renamed Joint CADDY Steering Group in Nov. 1997
• In the E.U. from 2001 CADDY–only dossiers encouraged but other formats also
used
• From 1996 - 1999 the Canadian PMRA, the US EPA and ACPA joined the group.
• From 1999 : US – Canada harmonization under NAFTA, as other systems are
also being supported, including HTML, PDF and Word.
• Companies tend to have their own individual approach to structuring dossiers
which all differ in some respects. Many have company systems with interfaces to
CADDY.
• All systems to join into a global platform
• Present medium : CD ROM
 Minor Use Programmes

USA : NRSP-4 (IR-4)

• To obtain regulatory clearances for crop protection chemicals on
minor food crops when the economic incentives for the registrants
precluded private sector investment.
• IR-4 has been administered by the USDA and Cooperative State
Research Education and Extension Service (CSREES) since its
inception in 1963.
• Efficacy & residue field trials
• Can take up to 6 years to get the registration
 Minor Use
Programmes
Australia
• ~60% of uses are ‘off-label’, a significant proportion “minor
uses”.
• Minor Use Permits usually an extension of use of an
existing
registered product. Permits are time-limited, but in practice
they
New Zealand
are often extended.
• Data requirements
• Illegal for minor
to use pesticides in such use permits
a way that are reduced,
residues in
in food
some
crops
cases, only
exceed residue
any data
specific sufficient
MRLs or theinNZsupport of temporary
'default' MRL of 0.1
MRL.
mg/kg.
Japan
• This 'default' MRL has informally supported a number of 'off-
• Data
label'requirement relief:
or minor uses, 1 year data
particularly for(2herbicides
or 3 efficacy & 2

phytotoxicity trials, 2 residue trials. (Major crops: 2 years’

 Registration in India

COST OF DATA – REGISTRATION IN INDIA

The data on parameters of Chemistry, Toxicology,
Metabolism, Persistence, Efficacy, Residue &
Packaging is required to be generated at a cost of
Rs. 1.5 to Rs. 2.0 crores. And a time frame of 3 to
3.5 years.

Subsequently CIBRC takes 1 to 1.5 years to evaluate

the dossier and grant Registration.

Of late fixation of MRL by Ministry of Health adds

additional time of 6 months or more.
 INDIA

INDIAN REGULATORY ENVIRONMENT

1. Most stringent in Asia (Excepting Japan)

2. Very comprehensive and extensive data

requirements in all the areas-Chemistry, Safety,
Efficacy, Packaging/labeling etc.,

3. Indian Registration Data is generated on wide

variety of crops and agroclimatic environments.

4. Data generated for Indian Registration v/s Data

needs of most developing countries match very
well.
 INDIA

INDIAN STRENGTHS IN REGULATORY ISSUES

1. Strong and deep understanding of Regulatory

requirements
of different regions of the world.

2. Large pool of Regulatory Experts and others.

6. Fairly good infrastructure for data generation.

8. Acceptability of Indian data in most of the countries

of the world.

5. Very strong R & D capabilities.

 INDIA
INCREASING THE OPPORTUNITIES
- STRATEGIES FOR SUCCESS
1. Generate Data (esp. Tox. & Chem.) according to
Internationally agreed Tests, Procedures or
Guidelines (GLP).
2. Thus Data becomes acceptable by Regulatory
bodies worldwide.
3. Develop Data/Products jointly (Task Force concept
of EU) to reduce the burden of Data cost as well
as duplication.
4. Joint dossier Development efforts also helps in
pricing the products competitively .
5. All the above enhances the competitiveness of
Indian Manufacturers esp. against the Chinese
Thank you!