Introduction to Regulatory Affairs: Agencies and Permit Process Advanced Biotechnology (c)(8)(A)

Introduction toRegulatory Affairs:

Agencies and Permit ProcessAdvanced Biotechnology

(c)(8)(A)

ObjectivesToday you will be able to:

• Explain the role major regulatory agencies play in

biotechnology

• Apply the roles of the agencies to regulating specific biotech

products

• Explain the APHIS permit process including the notification

alternative criteria

Biosafety: Upmost Importance• Biosafety: Preserve biological integrity

through minimizing risks that biotechnology may pose to these systems.• Regulatory systems in place help achieve

this.

Major Players in Regulation

• Federal:• U.S. Department of Agriculture (USDA)

• Animal and Plant Health Inspection Service (APHIS)

• Environmental Protection Agency (EPA)• Food and Drug Administration (FDA)

• State:• States can regulate as they see fit. • Example:

• Florida requires a permit for the release of genetically modified organisms.

Agency Regulatory Oversight

PlantsPlant Pests

Veterinary Biologics

Microbial & plant pesticidesNew uses of existing pesticides

Novel microorganisms

FoodFeed

Food AdditivesDrugs

Medical Devices

USDA EPA FDA

• Split up into groups of three to four

• You will need a writing surface to present answers

• When I ask for answers, hold up your answer.

• If you answer correctly, you win a point.

• Group with the highest number of points wins

Agency Oversight Activity

Which agencies will review this product?

You engineered a sweet corn trait that is resistant to maize dwarf mosaic virus (MDMV). Which agencies

need to review your product, and for what purpose?



You engineered a sweet corn trait that is resistant to maize dwarf mosaic virus (MDMV). Which agencies

need to review your product, and for what purpose?

USDA (is it safe to grow?)EPA (is it safe for the environment?)

FDA (is it safe to eat?)



You engineered a soybean trait that is resistant to glufosinate herbicide. Which agencies need to review

your product, and for what purpose?



You engineered a soybean trait that is resistant to glufosinate herbicide. Which agencies need to review


USDA (is it safe to grow?)EPA (New use of companion herbicide)

FDA (is it safe to eat?)



You engineered a pine tree trait that is resistant to glyphosate herbicide. Which agencies need to review




You engineered a pine tree trait that is resistant to glyphosate herbicide. Which agencies need to review


USDA (is it safe to grow?)EPA (New use of companion herbicide)



You engineered a canola trait which produces a higher content of Vitamin E in the oil. Which agencies need to

review your product, and for what purpose?



You engineered a canola trait which produces a higher content of Vitamin E in the oil. Which agencies need to

review your product, and for what purpose?

USDA (is it safe to grow?)FDA (is it safe to eat?)



You engineered a trait in rose plants which produces bright blue color. Which agencies need to review this

product, and for what purpose?



You engineered a trait in rose plants which produces bright blue color. Which agencies need to review this

product, and for what purpose?

USDA (is it safe to grow?)



You engineered a soil bacteria which breaks down dioxins. Which agencies need to review this product,

and for what purpose?



You engineered a soil bacteria which breaks down dioxins. Which agencies need to review this product,

and for what purpose?

EPA (is it safe for the environment?)


• Animal and Plant Health Inspection Service

• Agency of the USDA

• Permit system with a notification alternative

• Must obtain permit, unless a notification or exemption applies, before moving or releasing a genetically engineered plant.

APHIS

• 3 types of permits:

• Permit for Movement and Importation

• Permit for Release into the Environment

• Courtesy Permit

• Before plant material can be sold, you must petition for USDA exemption from regulation. Once done, you no longer require permits for release or movement.

APHIS Permits

APHIS Permit Alternatives

• Process used for importation, interstate movement, and field testing of certain engineered organisms.

• Instead of applying for a permit, you can notify APHIS that a movement or release is planned.

• However, your plant must meet eligibility requirements and follow performance standards for release.

• Why would you prefer this over a permit?

APHIS Notification Eligibility Criteria

• Plant must not be listed as a Federal Noxious Weed, or considered a weed in the geographic area of release

• Genetic material must be stably integrated. DNA cannot exist outside the cell, and must replicate exclusively with plant DNA

• The function of the trait added is known, and does not result in plant disease

• The trait added does NOT:

• Produce an infectious entity

• Produce known or likely toxins to non-target organisms

• Produce products intended for pharmaceutical or industrial use

• Genetic sequences derived from plant viruses do not pose a significant risk to the creation of new plant viruses.

• The plant has not been modified to contain certain genetic material derived from an animal or human pathogen, nor use sequences which products are known agents of disease in humans or non-target animals

APHIS Notification Eligibility Criteria

APHIS Notification Performance Standards

• Must be shipped and maintained so there is no release

in environment. There cannot be regulated and non-

regulated mixing.

• Identity of all material must be known. At the

conclusion of tests, plant material must be contained or

devitalized.

• If transformation uses a live microorganism, the plant must be free of microorganism prior to movement or release.

• The regulated material and offspring cannot persist in the environment

• No viable plant material should remain that can germinate and create volunteers. Volunteers must be destroyed.

APHIS Notification Performance Standards

APHIS Petition Process

• Petition Process: request that a regulated plant should no longer be regulated

• This must always be done before commercialization of the transformed material.

• APHIS will grant non-regulated status to a new plant variety when it determines that this variety has no potential to pose a plant pest risks, and is safe to grow.

Environmental Protection Agency• Ensures safety of pesticides• Chemical and biological

• EPA sets tolerance limits for pesticides on and in food/feed, or develops an exemption from this tolerance requirement

• Develops tolerances for residues of herbicides used on novel herbicide-tolerant crops

Food and Drug Administration

• Requires that genetically modified food meet same rigorous safety

standards as other food.

• Three FDA Categories:

• Whole Foods – no changes in nutritional profile, no substance that may pose

health hazards

• Food Additives – significantly different in structure, function or amount than in

current food. Must receive pre-commercialization approval.

• Generally recognized as safe (GRAS) – consumed for long periods without hazards.

Scientifically found to have no undesirable effects on humans. Product is generally

the same as if it would be in nature.

Food and Drug Administration

• What Makes a Product Safe?

Not from a source with a history of toxicity or allergy

Does not resemble known toxins or allergens

Well understood functions

Gene expression is at low levels

Rapidly degraded in the stomach

Lack of adverse effects in mice at high levels of consumption

Animal feeding studies do not revel adverse effects.

Difference in Regulatory Processes

No Mandatory Testing

Product can be removed by USDA, FDA, or EPA if there is a question of safety for the

environment or consumers.

Product can be removed by USDA, FDA, or EPA if there is a question of safety for the environment or

consumers.

• Product characterization• Toxicity/Allergenicity• Crop safety• Food composition• Environmental safety

Transgenic Plant Conventionally Bred Plant

Summary• Fundamentally, biotech regulations serve to uphold

biosafety.

• USDA, FDA, EPA all play important roles in regulating applications of biotechnology

• APHIS has a permit process, and a notification alternative under specific criteria

• Transgenic plants are studied to ensure safety for all systems it may come in contact with

Evaluation• What role do the regulatory agencies play in

biotechnology?

• What purpose does the APHIS permit serve?

• What is the notification alternative?

• What is the criteria to use the notification alternative?

• What purpose does deregulation serve?

• How does the regulatory process differ between a transgenic plant and a conventionally bred one?

Introduction to Regulatory Affairs: Agencies and Permit Process Advanced Biotechnology (c)(8)(A)

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