Genetically Engineered Crops: A USDA Inspector’s Perspective

Douglas W. Grant, Ph.D.Chief, Western Region Compliance Assurance Branch

USDA APHIS BRS

National Alliance of Independent Crop Consultants Annual Meeting

Fort Worth, TXJanuary 20, 2011

Overview of Biotechnology Regulation

The Historical Perspective- Federal Government 1970’s – The National Institute of Health (NIH)

develops the early protocols

1980’s- Federal Government adopts the ‘Coordinated Framework for Regulation of Biotechnology’ delegating responsibilities to:− USDA-APHIS: Coordinates efforts with State agriculture agencies and

inspects field trials− EPA: Evaluates the properties of insect and virus resistant crops− FDA: Assesses safety of food and animal feeds produced through

biotechnology

BRS Organizational StructureOffice of the Deputy Administrator

Michael Gregoire – Deputy AdministratorBeverly Simmons – Associate Deputy Administrator

Office of Science

Policy Coordination Program

Regulatory and Environmental Analysis Branch

Government Relations Branch

Communications Branch

Environmental Risk Analysis Program

Plants Branch

Plant Pests and Protectants Branch

Regulatory Operations Programs

Compliance Evaluation and Enforcement Branch

Permits and Program Services Branch

Resource Support Services Branch

Technical Services Branch

Office of NEPA Implementation

Resource Management Program

Eastern Region Compliance Assurance Branch

Western Region Compliance Assurance Branch

Compliance Assistance Branch

Eastern Region:Wendy.Jin@aphis.usda.gov

Western Region:Douglas.W.Grant@aphis.usda.gov

Fort Collins, CO

Raleigh, NC

Avg # of inspections/state (2005-2007)

7.0

CT 9.0DE 1.0MA 0.7MD 3.3NJ 2.3RI 0.3

18.3

8.0

27.3 15.0

26.0

9.0

13.7

7.3

9.7

27.0

6.05.7

28.0

19.74.3

7.3

10.0

0.3

WR 285 - ER 265

10.0 8.0

32.3

6.3

61.0

7.3

49.7

17.3

2.3

13.0

1.3

16.7

0.7

10.0

3.0

9.0

2.0

12.3

1.7

23.7

BRS Regulatory Operations Program Compliance Assurance Branches

Key Goals:Inspection management Management of planting report informationWork with industry regarding complianceFair, uniform, science-based enforcement

actionsCollaboration with Compliance Evaluation

and Enforcement Branch – manages self-reported incidents

BRS Regulatory Operations Program Promote compliance through proactive measures

to prevent compliance infractions Conduct educational and outreach activities for

stakeholders and the public

Communicate compliance best management practices, proactive compliance assistance

Ensure training and coordination with other APHIS units -Plant Protection and Quarantine (PPQ), Investigation and Enforcement Service (IES) - and State Departments of Agriculture− PPQ and States conduct most inspections

Types of Inspections Notifications (N) Permits (R, M or R/M)Standard Permits (single or multi-year)Pharmaceutical-Industrial Permit

− 5 inspections during growing season,− 2 the next year

Movement Permit (M) Facility Inspection− (Laboratories, Greenhouses, Storage Areas,

etc.)−Directed (incidents, self-reports, follow-up)

Inspection Basics Planting report information is received -

inspections are initiated through ePermits Inspection questions based on standard

worksheets - aligned with regulations Questions are customizable based on inspection

type Examples:Perennial tree trial questions differ from inspections for

annual plants Self-reported incidents may lead to directed

inspections to verify what company reports

Perennials Example – Poplar

Performance Standards for Introductions Under Notification

7 CFR 340.3 (c) Performance standards for introductions under the notification procedure must be met for any introductions under notification (paraphrased): If transported, must be shipped in such a way as to

prevent release into the environmentMust not be mixed with any non-regulated plant

material The identity of the plant material must be maintained

while in use, and contained or devitalized when no longer in use

There must be no viable vector agent associated with the regulated article

Performance Standards for Introductions Under Notification

7 CFR 340.3 (c) Performance standards must be met for any introductions under notification (paraphrased):The field trial is conducted such that:

− The article will not persist in the environment− No offspring produced can persist in the environment

Upon termination− No viable plant material may remain to volunteer…..

− Volunteer plants shall be managed to prevent persistence of the field test:

Overview of BiotechnologyRegulations - Permits

Standard Permit Conditions (340.4 (f) (1-11): The regulated article shall be maintained and disposed of

(when necessary) in a manner so as to prevent the dissemination and establishment of plant pests.

All packing material, shipping containers, and any other material accompanying the regulated article shall be treated or disposed of in such a manner so as to prevent the dissemination and establishment of plant pests.

The regulated article shall be kept separate from other organisms, except as specifically allowed in the permit;

The regulated article shall be maintained only in areas and premises specified in the permit;

Overview of BiotechnologyRegulations - Permits

Standard Permit Conditions cont. (paraphrased): Unauthorized release must be prevented Remedial measures may be taken Identity of regulated articles maintained (labeling) Inspector shall be allowed access to locations and records

related to introductions Applicant must submit a field test report 6 months after

termination of field test

APHIS notified immediately if: Accidental/unauthorized release occurs Unusual occurrence on non-target organisms (unintended

effects)

Overview of BiotechnologyRegulations (7 CFR 340)

Permits vs. Notifications - What’s the difference?For organisms (e.g. microbes, trees) or genes

not familiar to APHIS−Material considered to be higher risk

Must follow Standard Permit Conditions and Supplemental Permit Conditions (SPCs)Permits can be amended, not NotificationsNotifications only apply to plantsNotifications are only for single year trials

Inspection Frequency Permits – inspected at least once in each

state with a release each year Inspection conducted at any point during the

growing season, or may be after growing season

Inspection verifies compliance Permit ConditionsSPCs added by BRS are specific to each permit

Multiple inspections of pharmaceutical-industrial permits each year

Inspection Frequency Notifications – randomly selected from planting

report information Sites selected to provide broad oversight Inspection verifies compliance with Performance

Standards Design Protocols are implemented Winter nursery locations inspected more

frequently Large acreage trials inspected at a higher

frequency Facilities (M) inspected at request of Risk

Assessment

Regulations – Authority for Inspections

7 CFR 340.3(d)(6) - Notifications (6) Access shall be allowed for APHIS and State

regulatory officials to inspect facilities and/or the field test sites and any records necessary to evaluate compliance with the provisions of paragraphs (b) and (c) of this section.

7 CFR 340.4(f)(5) - Permits (5) An inspector shall be allowed access, during

regular business hours, to the place where the regulated article is located and to any records relating to the introduction of a regulated article;

USDA Inspectors Biotech inspectors receive in depth trainingClassroom training events – every 3 yearsAnnual Confidential Business Information (CBI) eLearning On the job (OJT) training

Inspectors use the BRS Inspection Manual a guidance and reference publication provides details about each different type of

inspection and worksheet questions

Guidance on Notification & Permit Inspections

Confidential Business Information (CBI)

Protection of CBI a priority for USDA Applicant decides what to consider CBI (e.g. Trade

Secrets) Information relating to the production process,

production data, formulas, and processes, and quality control tests and data as well as research methodology and data generated in development of the production process (i.e. intellectual property)

Such information must be (1) commercially valuable (2) used in one’s business (3) maintained in secrecy

Commercial/Financial or Personal Information

Steps During Inspection Gather names of all present Review documents and records

Including an up-to-date map

Ask questions about past activities and future plans Make observations Take measurements Is the cooperator aware of reporting requirements? GPS coordinates collected Photos taken

Additional photo documentation of any potential compliance issues

Row Crops Vegetables & Grains PerennialsCanola/Rapeseed Barley AlfalfaCorn Peas AppleCotton Rice Creeping bentgrassPotato Sorghum EucalyptusSafflower Sugarbeet GrapesSoybeans Tomato GrapefruitSugarcane Wheat PapayaTobacco Populus spp.

Most Common GE Field Trials in Western U.S. 2005-2009

Inspection Methods of Verification

Biotechnology Regulatory Services

USDA Animal and Plant Health Inspection Service

Methods of Verification New Worksheets – have methods of verification

indicated after each question

The methods indicated are to be used by the inspector to answer the question Methods of verification

− O-Observation, R=Records Review, I=Interview, M=Measure/Mapping

− When two verification methods are listed after a question, the first method should be used whenever possible, but the secondary verification method is acceptable. A combination of methods may be ideal.

Questions are posed to the inspector, not intended to be asked to the cooperator verbatim

Observations – what you see at the location being inspected

Examples –Physical inspection Identification, labelingAre conditions being met, such as reproductive

controls Isolation or separation zonesCompatible speciesSeeds or plant materials out of placeDevitalization and disposal

Methods of Verification

Methods of Verification Records review – review of

documentation and record keeping Examples – Permit Notification Design protocols or SOPs Training records Shipping logs/inventory Equipment cleaning records Monitoring records

Verify Equipment Cleaning

Methods of Verification Interview – question cooperator,

permit/notification holder Examples – Ask about containment during shipping How do they store regulated material Ask how they segregate regulated from non-

regulated How they plan to implement reproductive

controls How they monitor How they clean equipment When will they harvest

Methods of Verification Measure – use GPS, range finder,

measuring wheel, measuring tape Examples – Measure size of plot Count number of trees Accuracy of isolation/separation

distance Check maps Check GPS coordinates

Physical and Biological Isolation

Regulated Soybeans

BRS 1.0 Notification Inspection Worksheet Example

BRS 2.0 Permit Inspection Worksheet Example Questions

Maps for Inspection Report Map obtained from cooperator preferred GPS coordinates can be used to make

map Map notes locations of other regulated

trials in vicinity Map should include points of reference

(e.g. roads, buildings) Map required with each inspection

report

Map for Inspection Report –Made from GPS Coordinates

Regulated Corn – Hawaii

Volunteer Corn Plants

Sources of InformationCoordinated Framework

http://usbiotechreg.nbii.gov/

BRS – Biotechnology Regulatory Serviceshttp://www.aphis.usda.gov/brs/

ISB – Information Systems for Biotechnologyhttp://www.isb.vt.edu/

Sources of Information:

Inspection Goals Verify compliance with 7 CFR 340 Safeguarding American agriculture Keeping regulated material separate

from non-regulated materialOut of food and feed supply

Prevent instances of low level presence (LLP) Facilitate Research and Development

and trade

Final Thoughts Remember inspector does not make

final compliance determinationThat is done by BRS

Don’t ask inspector about inspection results or for copies of reportsReports (sans CBI) available only through

a FOIA requestApplicants receive letter on inspection

findings

Biotechnology Regulatory Services

If you have questions about obtaining a permit or inspection results contact BRSHeadquarters or Regional OfficesPermits or Compliance Staff

For more information go to our website:www.aphis.usda.gov/biotechnology/brs_main.shtml