International Agricultural Training and Regulatory ......International Agricultural Training and Regulatory Services: A Small Business Perspective Dr. Sue Cohen ... insect and biopesticide

International Agricultural Training

and Regulatory Services:

A Small Business Perspective

Dr. Sue Cohen

President

Center for Regulatory Research, LLC

www.regresearch.com

• Woman Owned Small Business

• Business Activities

• Contractor and Subcontractor Roles

•Industry Contracts

•Government Contracts

•University Contracts

Overview


• Woman Owned Small Business

Limited Liability Company A Limited Liability Company (LLC) is a business structure allowed by state statute.

LLCs are popular because, similar to a corporation, owners have limited personal

liability for the debts and actions of the LLC. Other features of LLCs are more like

a partnership, providing management flexibility and the benefit of pass-through taxation.

• Registered in Minnesota in 2005

• Registered as a Government Contractor

•Central Contractor Registrant Database

Company


• Business Activities

• Regulatory Services

• Risk Assessment Research

• Training

Company Activities


Regulatory Services

Center for Regulatory Research, LLC assists biotechnology and beneficial

insect and biopesticide companies with import/export permit applications.

• Permits require scientific literature reviews, knowledge of production

processes and knowledge of modes of transportation

• Evaluation of containment facilities and development of standard operating

procedures

• New product development, commercial feasibility and potential for product

export

Beneficial Insect: Cryptolaemus montrouzieri

that feeds on mealybugs

Biopesticide: Beauveria bassiana

fungus controls whiteflyGMO specialty crops

Risk Assessment Research

1) Risk Concepts

2) Species Distribution and Establishment

3) Climate Mapping and Analysis

Risk Concepts

• Risk = the likelihood and magnitude of an adverse event

• Risk Assessment = the estimation of risk

• Risk Management = the pragmatic decision making process concerned with what to do about the risk

• Risk Communication = the act or process of exchanging information concerning risk

• Risk Analysis = the process that includes risk assessment and risk management

• Pest = An organism whose undesired effects outweigh its beneficial effects as it relates to a specific time or place. (FAO definition) = Any species, strain or biotype of plant, animal or pathogen agent injurious to plants or plant products

• Source: Orr, R.L., Cohen, S.D., and Griffin, RL. 1993. Generic non-indigenous pest risk assessment process. USDA-APHIS report, November 22, 1993, 40 pp.

Risk assessment-Hazard identification

-Hazard characterization

-Exposure assessment

-Risk characterization

Risk management-Risk evaluation

-Option assessment

-Option implementation

-Monitoring and review

Risk communication

Structure of Risk Analysis

Pest Risk Assessment Model

Standard Risk Formula

Risk = Probability of

Establishment

Consequence of

Establishment

Elements of the Model

Risk =

Pest with

Host (Origin)

X

Entry Potential

X

Colonization Potential

X

Spread Potential

Economic Damage Potential

+

Environmental Damage Potential

+

Perceived Damage

(Social and Political)

X

Source: Orr, R. L., Cohen, S. D. and Griffin, R. L. 1993. Generic non-indigenous pest risk assessment process. USDA-APHIS

Report, 40 pp, November 22, 1993.

Risk Management

Hazard ID

Risk Characterization

Strategic and Operational Considerations

Operational and Economic Feasibility

Risk Reduction and Mitigation

Monitoring

RISK MATRIX FOR DECISION-MAKING

Impact Risk Management Actions

Significant Considerable

management

required

Must manage

and monitor risks

Extensive

management

essential

Moderate Risks may be

worth

Accepting with

monitoring

Management

effort

worthwhile

Management

effort

required

Minor Accept risks Accept but monitor

risks

Manage and

monitor risks

Low Medium High

Likelihood

Risk Assessment Guidelines

1) Ecological Risk Assessment: The process that evaluates

the likelihood that adverse ecological effects may occur or are

occurring as a result of exposure to one or more stressors.

[US Environmental Protection Agency Guidelines]

2) Microbial Risk Assessment: A process that evaluates the likelihood

Of human health effects occurring after exposure to a pathogenic

Microorganism or to a medium in which pathogens exist.

[ILSI, Revised Framework for Microbial Risk Assessment]

3) Pest Risk Assessment: Evaluation of the probability the introduction

And spread of a pest and the magnitude of the associated potential

Economic consequences. [FAO, IPPC, ISPM #5, 2010]

Risk Assessment Research

Climatic Mapping and Analysis are useful for risk and

environmental assessment processesSpecies distributions and establishment predicted by physiological responses

of growth and development to climate variables of temperature, rainfall,

soil moisture, dry conditions, and pest - host interactions.

Biome Analysis: Based on the presence or absence of species in an ecological

habitat described by climate and land type

Climate Matching: Presence or absence of species in one climate area of the world

is compared to other areas for eco-climatic similarity

Climate Analysis: One or more species physiological requirements based on

laboratory and/or field data are matched with existing monthly weather data

Biome

Analysis:

Risk

Assessment

Research

Risk

Assessment

Research

Climate Analysis:

International Agriculture Training

Center for Regulatory Research, LLC offers training to USDA Foreign

Agriculture Service programs through the company or will jointly provide

programs with university partners.

The company has offered training courses since 2006 and has hosted

participants from Ethiopia, Nigeria, Senegal, South Africa, Uganda, Yemen,

Egypt, Oman, Jordan, Peru, Viet Nam, Thailand, Philippines, and Indonesia.

Training courses on such topics as risk assessment, plant biotechnology,

food safety, animal health, SPS issues, plant quarantine, and plant inspection

have been offered by the company.

• International Agricultural Training Programs

• USDA Borlaug Program: a semester program

to take a course or learn research skills

• USDA Cochran Fellows Program: 1-3 week

program with lectures and field trips

• USDA Faculty Exchange Program: a semester

program designed for developing a course

and/or research skills

• U.S. Agency of International Development: 1- 5

year programs with company and/or university

partners

International Agriculture Training

• International Agricultural Training

•USDA Cochran Fellows Program

Senegal: USA Market Access



“ In 1984, Senator Cochran (Mississippi) had a vision for a new exchange program

to help developing countries improve their agricultural systems and

enhance trade links with the United States. He worked with the

U.S. Congress and the U.S. Department of Agriculture to implement this goal,

culminating in the creation of the Cochran Fellowship Program (CFP).”

Source: http://www.fas.usda.gov/icd/cochran/About.asp


USDA Cochran Fellowship Program

“Since 1984, the U.S. Congress has made funds available to the CFP for training

agriculturalists from middle-income countries, emerging markets and emerging

democracies. Training opportunities are for senior and mid-level specialists and

administrators working in agricultural trade, agribusiness development,

management, policy and marketing from the public and private sectors.”



USDA Cochran Fellows Program

“Since its inception in 1984, the Cochran Fellowship Program has provided

U.S.-based training for over 14,300 international participants from

123 countries worldwide.”




“(1) Assist eligible countries to develop agricultural systems necessary to

meet the food and fiber needs of their domestic populations; and

(2) Strengthen and enhance trade linkages between eligible countries and

agricultural interests in the United States.”





Center for Regulatory Research, LLC Training Programs


Cochran Fellows Program:

Market Access for Senegal

Trainers/Consultants: Steve Clarke, Sue Cohen, David Ragsdale,

Cindy Tong, Rob Venette

Program Focus: Export of Asparagus and Melons to the USA

Fellows: Minister of Agriculture, Plant Pathologist, Chief of Plant

Quarantine, Farm Producers

Senegal: Market Access


Senegal produces peanuts, millet, rice, corn,

sugarcane and fruits and vegetables for domestic

consumption. Green beans, cherry tomatoes,

mango and melons are exported to the European

Union.

Introduction

Senegal asked to be authorized to export asparagus to

the US. This presentation shows the procedure outlined

by APHIS for a pest risk assessment.

Stage 1: Initiation

Step 1: Document the Initiating

Event(s) for the PRA

In the outline:

The PRA explains that Senegal

requested authorization to export

Asparagus

In the Asparagus PRA:

Stage 2: Assessment

Step 2: Assess Weediness Potential

In the outline:

Weediness Potential?

YES

Could it become a new weed in US?

NO (already grows in US)


Step 3: Identify and Cite Previous Risk Assessments

In the outline:

Several PRAs from countries denying or

permitting importation are cited


Step 4a: Pest Categorization

List potential quarantine pests

occuring in export region

In the outline:

PRA presents a table with all potential

quarantine pests


Pest Geographic

Distribution

Plant Part

Affected

Quarant

ine Pest

Follow

Pathway

References

Arthropods

Acari: Tetranychidae

Tetranychus

urticae

Koch

Senegal, U.S. Leaves No No (Bolland et al.,

1998; CABI, 2004)

Coleoptera: Chrysomelidae

Crioceris

asparagi

(L.)

Senegal, U.S. Leaves and

shoot

No Yes (NCSU, 1997b;

Touré-Dieng, 1999)

Table from Guidelines for Pathway-Initiated Pest Risk Assessments, 2007

Step 4b: Identify Quarantine Pests Likely to Follow the Pathway

In the outline:

Seven pests need further analysis due to

association with asparagus shoots, the

part of the plant to be imported


Pests likely to follow pathway?

Proceed to Step Five

Yes No

STOP

Step 5: Assess Consequences of Introduction

In the outline:

Pests pose little economic risk to asparagus,

but most have high dispersal risk


Risk

Elements

Dispersal

pontentialHost range

Environmental

impact

Economic

impact

Climate-

host

interaction

Elements from Guidelines for Pathway-Initiated Pest Risk Assessments, 2007

Step 6: Assess Introduction Potential

In the outline:

Pests all score medium to high for

introduction potential


Risk

Elements

Survive

shipment?

Survive

Postharvest

Treatment?

Moved to area

with

environment

suitable for

survival

Not

detected at

port of

entry

Quantity

imported

annually


In contact

with host

material

suitable for

reproduction

Step 7: Conclusion and Pest Risk Potential

The PRA can comment on management options,

but full analysis is reserved for other documents

In the outline:

The PRA concludes that the current pest risk

is too high to import Asparagus and briefly

discusses management options.



Summary

(B)

Likelihood

of Introduction

(A)

Consequences

of Introduction

Pest Risk

Potential

(A)+(B)

The PRA includes a Pest Risk Potential

table, showing scores of the potential pests


Table from Importation of Fresh Asparagus…, 2007

Step 7: Conclusion and Pest Risk Potential (cont.)

Pest Consequences of

Introduction

(Cumulative Risk

Rating)

Likelihood of

Introduction

(Cumulative Risk

Rating)

Pest Risk

Potential

C.

pallescens

Medium (12) Medium (13) Medium

(25)

H.

armigera

High (15) High (17) High (32)

I.

aegyptiaca

Medium (10) Medium (13) Medium

(23)

L. villosa Medium (10) Medium (13) Medium

(23)

M. hirsutus High (14) Medium (14) High (28)

N. viridis High (14) Medium (14) High (28)

S. aurantii Medium (11) High (16) High (27)

S. dorsalis High (14) High (16) High (30)

S. littoralis High (14) High (16) High (30)

Example:

C. Pallescens scores 12

for Consequences and 13

for Likelihood. Its risk

potential:

12 + 13 = 25 (Medium)

Introduction

Senegal asked to be authorized to export asparagus to the

US. APHIS denied the request and gave suggestions for risk

management that could allow future importation.

Options for

Management

Monitoring

Pest-Free

Areas

Mitigation

Options

Certification

Inspections

Control

Program

White

Asparagus

Options available for Risk Managment

APHIS suggested the following types of management for Asparagus

Some Options Previously Detailed

Pest-Free Area

Control Program

Certification Inspections

Using chemical or

mechanical means

Mitigation Options Post-harvest and Prior to

Shipping

Options

Inspection

Wash

Pest-Free cratesCertification Inspections

Pest-free

packing house

Mitigation Options Post-harvest and Prior to

Shipping

Options

Quarantine Treatments

Sampling and

inspection

Pest-Free cratesIntact Packing Safeguards

Upon Arrival

Limits on Distribution and Transit

Options

Field Survey

And

Tracking

Pre-shipment

Program

Shipments

Traceable

to

Origin

Monitoring

•To identify shortcomings or

opportunities from improvement

•To be conducted under

supervision of APHIS and

Senegal NPPO personnel.

•Includes commodity cutting and

trapping

•Regular surveys to determine

presence of pests

•Growers receive certification

based on results

•Stems must be packed in

containers with identification

labels indicating origin

White Asparagus

Characteristics

Higher market

Price

Grown

under dirt

so many

pests

avoided

Admissible from

Several countries

Pests easy

to distinguish

on flesh

If white asparagus is exported to US,

APHIS will require the following:

• All stems show no green

•Certificate signed by Senegalese NPPO

declaring stems free of quarantine pests


USDA APHIS approved permit application and systems management

procedures for production of white asparagus and shipment of

white asparagus to the continental US on December 18, 2008.

Originally, a timeframe of 4 years was projected for final approval but

It took 9 years for regulatory approval.


Lessons Learned from Training:

1) Ask participants to fill out a form with special needs and interests

1) Interviewers who select participants some times do not have

the background to determine what participants need in the

way of training topics

2) Non-native speakers grasp information quicker with visual

illustrations, field trips and hands-on exercises

3) A mix of oral presentations and interactive computer exercises

reduce the fatigue of long hours working in a non-native language

4) Participants should fill out a one page evaluation form with

numerical ratings. The ratings system on the form should be stated

clearly to avoid misunderstandings.

Documents

International Agricultural Training and Regulatory ......International Agricultural Training and Regulatory Services: A Small Business Perspective Dr. Sue Cohen ... insect and biopesticide