Low-Level Presence (LLP):

USDA-APHIS

Experience and Policy

Sally McCammon

Biotechnology Regulatory Service

June 2013

Shared Regulation of Biotech Products in

Agriculture and the Environment

Regulation Under the

Coordinated Framework

• Department of Agriculture (USDA-APHIS) – Plant Protection Act (PPA): Protecting against

damage from plant pests and noxious weeds

• Environmental Protection Agency (EPA) – Federal Insecticide, Fungicide, and Rodenticide Act

(FIFRA): Regulating the safe use of pesticides

– Federal Food Drug and Cosmetic Act (FFDCA):

Tolerance actions for pesticide residues on food and

feed products

• Food and Drug Administration (FDA) – Federal Food, Drug and Cosmetics Act (FFDCA):

Safe use of GE organisms in food and feed products

Regulation in the Environment

• Department of Agriculture (USDA-APHIS) – Plant Protection Act (PPA): Protecting against

damage from plant pests and noxious weeds

– Oversight of field testing of regulated articles

• Environmental Protection Agency (EPA) – Federal Insecticide, Fungicide, and Rodenticide Act

(FIFRA): Regulating the safe use of pesticides

What Does APHIS-BRS Regulate?

• “Regulated articles” (7 CFR part 340)

• If the organism has been altered or

produced through genetic engineering, and

• If there is a possibility that the GE organism

could be a plant pest

• Donor, recipient, or vector organism is a plant

pest

• Plant pests are defined in the PPA as organisms

that can pose a direct or indirect risk to plants or

plant products.

Landmark Events

2001 – Industry notifies USG that canola seeds being brought into the U.S. may contain low levels (fraction of a percent) of GE varieties approved in Canada, but not approved in the U.S. The varieties were very similar, however, to varieties approved in U.S. Company submitted extension requests late 2001

New GE varieties de-regulated in 2002

2002 – OSTP publishes in the Federal Register an announcement of what actions the regulatory agencies of the USG would take to address LLP

Landmark Events

2003 – USDA-APHIS strengthens field testing oversight for pharmaceutical plants.

2004 – FDA proposes draft guidance for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use.

2007 – USDA-APHIS publishes in the Federal Register a policy to clarify when remedial actions may be needed in response to low levels of regulated material when it occur in commercial grains and seeds.

2008 – EPA publishes guidance on small-scale field testing and LLP of plant incorporated protectants.

Low Level Presence

USDA-APHIS present working definition of Low Level Presence (LLP) is derived from the 2002 OSTP policy statement:

“…low-levels of biotechnology-derived genes, and gene products occurring in commerce that have not gone through all applicable regulatory reviews.”

Our policy is not about approved GE varieties in organic or other non-GMO crops where they may be undesirable from a market standpoint (adventitious presence).

APHIS’ Current

Low Level Presence Policy

Principles of the 2007 Policy Based on plant pest risks. Describes when the agency is likely to take or not

take remedial action in response to LLP incidents. Agency retains discretion on need for remedial

action No specific threshold level for remedial action;

decisions are made on a case-by-case basis. Remedial action separate from compliance and

enforcement efforts. Violators are subject to penalties if regulations have been violated regardless of safety findings or requirements for remediation.

APHIS’ Current

Low Level Presence Policy

APHIS may not require remediation in two types of

situations:

• The first is when the GE plant from which the

material is derived is very similar to one which

has already been reviewed and deregulated by

the agency

• The second is when the plant is meets all of the

following criteria to indicate low plant pest risk:

APHIS’ Current

Low Level Presence Policy

Plant Pest Risk Criteria:

• The plant must not be listed on the Federal Noxious Weed list or be considered a weed in the area of proposed release.

• The introduced genetic material must be stably integrated, which means the introduced DNA must remain inside the living cell and replicate only with the plant DNA.

• The function of the introduced genetic material is known, and its presence in the regulated article does not result in a plant disease.

APHIS’ Current

Low Level Presence Policy

Plant Pest Risk Criteria (continued):

• The introduced genetic material does not cause the production of an infectious entity, produce substances that are known to be, or are likely to be, toxic to nontarget organisms, or produce products intended for pharmaceutical or industrial use.

• The introduced genetic sequences derived from plant viruses do not pose a significant risk of creating a new plant virus.

• The plant has not been modified to contain certain genetic material derived from animal or human pathogens. In addition, plants containing coding sequences whose products are known agents of diseases in humans or nontarget animals are not eligible.

Dow Event 32 Corn

Facts of the Case

• January 25, 2008 – Dow AgroSciences reports finding a regulated line of corn, known as “Event 32”, in its corn breeding and seed material. It was present at less than 1% in its seed products. – Cry34ab, PAT

• Event 32 was developed as a BT corn resistant to corn rootworm.

• Event 32 is not approved in any country.

Dow Event 32 Corn

Facts of the Case

• Event 32 contained exactly the same inserted sequences as another line known as Event 22 which had been de-regulated by APHIS and had all other approvals. The two differ only in site of insertion.

• Seeds containing Event 32 were planted in multiple states in 2006 and 2007. It is estimated that Event 32 constituted two seeds per million in the U.S. corn seed supply in 2007.

• Seeds with Event 32 were not sold in any other country.

• It is believed that the low levels were originally introduced into seed at a plant breeding location where Event 32 was being grown under notification and other corn seed lines were being produced using controlled pollination methodologies.

Dow Event 32 Corn

Facts of the Case

• Event 32 corn meets conditions in the policy so as to not require remedial action

– Low plant pest risk based on criteria

– High similarity to a de-regulated line

• EPA determines that the proteins in Event 32 corn are identical to those approved for Event 22 and therefore the previous tolerance exemption applies (Late February 08).

Dow Event 32 Corn

APHIS Actions

• BRS issued an Emergency Action Notification (EAN) to prevent the commercial distribution or planting of all affected hybrid corn seed

• February 22 - After gathering pertinent facts in the case USDA APHIS announces the incident publically on February 22.

• Rollout includes alerting overseas posts ahead of announcement, calling key foreign governments, states, NGOs, stakeholders, hill briefings, etc.

Dow Event 32 Corn

APHIS Actions

• April 29 - Original EAN repealed and

replaced with a new EAN to allow for

movement of affected seed for

incineration.

• Penalty assessment.

Position on

Low Level Presence

APHIS believes that it is prudent to have

an effective science-based LLP

incorporated into the regulatory text of the

rule.

Cotton

APHIS Actions

BQMS

• Biotechnology Quality Management

System

– Voluntary, audit based compliance assistance

– Assist universities, small and large business

– Sound management practices to proactively

enhance compliance; policies and Quality

Control practices

– Address potential issues before they arise.

– Human error

Summary

• USDA

– USDA_APHIS policy considers whether

mitigation is need to protect plant health and

the environment

• Criteria include type of plant, gene, environmental

exposure, and previous experience with similar GE

plants in APHIS reviews

– Even if LLP is safe, APHIS may levy fines or

other penalties for violations of the regulation

Summary

• EPA

– For PIPs, EPA policy considers

• Tolerance exemption for PIP

• Registration of PIP

• Even if LLP is safe, EPA may levy fines or other

penalties for violations of the pesticide regulations

• EPA has issued guidance on small-scale field

testing and LLP

Thank you