BIOTECHNOLOGY REGULATIONS - endrikawidyastuti 18, 2015 · Specific GMO Regulations 1. In the US,...

Copyright © 2009 Pearson Education, Inc.

PowerPoint Lectures for

Introduction to Biotechnology, Second EditionWilliam J.Thieman and Michael A.Palladino

Lectures by Lara Dowland

BIOTECHNOLOGY REGULATIONS


Government Oversight

EU

APHIS EPA

FDA

USDA

Regulatory

Agencies


Regulatory Agencies

1. United States Department of Agriculture

(USDA)

• Responsible for oversight on nearly all genetically

modified organisms

• Sets most policy regarding genetically modified

organisms.


Regulatory Agencies

2. Food & Drug Administration (FDA)

– US regulatory agency responsible for ensuring the safety

of genetically modified foods.

• Genetically modified foods DO NOT need to be labeled in

the US- as long as they are not SIGNIFICANTLY different

than traditional foods.

• Agrimedicines produced in GMO’s (through the process

of pharming) fall under the same regulations as

traditional medicines.


Regulatory Agencies

3. Animal & Plant Health Inspection Service

(APHIS)

– Responsible for ensuring the safety of introducing a

new genetically modified organism to the

environment and existing populations.

• Specifically monitor all field trials for genetically

modified organisms.


Regulatory Agencies

4. Environmental Protection Agency (EPA)

– Plays varying roles in monitoring the use of

genetically modified organisms.

• Monitors the use of GMO’s in pest management and

environmental science.


Regulatory Agencies

5. European Union

– forms legislation governing the regulation of

genetically modified foods and biotechnology

techniques in western Europe


Regulatory Issues

1. Unexpected results from the release of

genetically modified organisms have been

extremely rare.

– A recent study indicated that monarch butterflies

were being killed by pollen from Bt corn. – The study

upon reexamination was proven FALSE.


Regulatory Issues

2. In 2004, 56 genetically engineered products

were approved for human consumption in the

United States.

– The number has been increasing each year, though

Bt corn and Bt soybeans are by far the most

common.


Regulatory Issues

3. The successful development of a genetically

modified organism usually takes between 6-12

years and costs between $50-$300 million

dollars.


Regulatory Issues

4. Bans on GMO foods in many foreign countries (particularly in Europe and Africa).– African nations have even declined or destroyed

food aid during crises rather than allow consumption of GMO’s.

– Though economics could be a sub context, food safety is the primary concern.


Specific GMO Regulations

1. In the US, GMO foods must only be labeled if

they are NOT SUBSTANTIALLY EQUIVILANT to

normal products.

2. Any GMO can be certified organic in North

Carolina and many other states.


Safety issues over “GMO”

• Classic toxicity testing

• Substantial equivalence

• Pre-cautionary principal vs risk

benefit

• Identity preservation

• labeling


Poisonous or Deleterious Substances

• general toxicity

• carcinogens

• mutagens

• teratogens


Food Drug and Cosmetic Act

• 402(a)(1) - a food is adulterated if it contains

any poisonous or deleterious substance

which may render the food injurious to health






– Microbial example : pathogens such as E. coli

O157:H7






– Chemical examples : lead,

PCBs, dioxin, mercury,

– radio-nucleotides, pesticides






– Relates to unapproved substances added by man

intentionally or non-intentionally



• 402(a)(1) - however if not added*, the

food is not adulterated if the quantity

would not ordinarily render injurious to

health

example - solanine in potatoes

– New level of consumption

– More susceptible population

* meaning naturally present

So could apply to a GMO


GMO analytical Needs

• Problems in evaluating %GMO

–On farm or at commercial silo

–Mixing in transport

–Cost of test

–Time to do

–Sample size and reliability


Allergen analysis failure

Problems

extraction

denaturation +/-

need for specific ELISA

not available for most allergens

except peanuts and egg (Neogen)


Starlink Corn

Starlink corn with Cry9C based Bt toxin protein

63FR28258 Bacillus Thuringiensis Subspecies tolworthi Cry9C

Protein and the Genetic Material Necessary for its Production in

Corn;

Exemption from the Requirement of a Tolerance May 22, 1998


EPA allergenicity evaluation http://www.environmentaldefense.org/pubs/Filings/cry9c.html

• 1. Homology - EPA says no known homology of the 8 amino acid

sequence - but not all known

• 2. Cry9c is resistant to digestion

• 3. Cry9c is stable to thermal processing

• 4. MW (68 kD) is in upper range for allergens

• Thus EPA warned in approval that may be linked to allergens

• Other EPA arguments to allow approval

– Abundance of protein low but patent argues high toxicity

– Low environmental exposure but what about corn dust


Elisa Test Developed

http://www.agdia.com/cgi_bin/catalog.cgi/05600


Starlink Corn problem

• Starlink corn produced by Adventis Corp (Research Triangle NC ) with Cry9c Bt toxin protein

• Approval given by EPA in 1998 but restricted to animal feed as noted by potential for allergenic response in humans based on four criteria

• September 2000 Consumer group (FOE) analyzes taco shells and finds Cry9c Bt protein. Sept 11, 2000 calls on EPA to remove

• Taco Bell begins recall of tacos from supermarkets,

as does Safeway product made by Kraft


Seeds of Dissent

• The next step : Wednesday, October 11,

2000 4:48 PM EST • WASHINGTON (Reuters) - A biotech corn variety found last month in Taco Bell taco shells and intended

only for use as a livestock feed has been detected in a second human food product, a consumer

advocacy group said on Wednesday.

• Genetically Engineered Food Alert, a coalition of health,

consumer and environmental groups, said it would

announce the product at a news conference on Thursday.• ``It'll be a product that people have heard about,'' said Matt Rand, biotechnology specialist for the

National Environmental Trust and co-coordinator of the GE Food Alert campaign.

• The group's announcement last month that Taco Bell taco shells sold in grocery stores contained the

Starlink corn variety prompted manufacturer Kraft Foods, a unit of Philip Morris Cos. Inc. (MO.N), to

announce a voluntary recall.

• Starlink corn, which is made by Aventis SA (AVEP.PA), has been approved for animal feed but not for

use in human food because of concerns about the potential for allergic reactions.

• The U.S. Agriculture Department has said it would buy all of the estimated 45 million bushels of Starlink

corn produced this year to get it off the market. Aventis will reimburse the department for the expected

$90 to $100 million cost of that action.


Starlink Corn problem

• Kellogg’s shuts down corn flakes cereal plant ( 10/18/2000) as precaution against potential for allergenic response

• 10/19/00 Adventis says problem is farmers co-mingled corn into human food destined corn. Of 260 grain elevators, about 106 sent out to food processors which is 12% of Starlink

corn or 9 million bushels


Millers and Grocers Reuters 10/10/00

Kroger and Albertsons remove cereal and tacos

Mission Foods recalls all Tacos (largest US

maker)

Azteca Milling will take back all yellow 2 corn

flour

ConAgra stops operations at Kansas corn flour

mill - will not disclose customers

Nov 3 FDA announces over 300 products

with potential risk


FDA Regulation of GMO’s


CASE STUDY

• Examine ethical issues concerning the use of

genetic manipulation to improve the agricultural

productivity of living organisms.

* Frankenfoods ???


Labeling - Informed Consentbasis the consumer’s right to know so they can

protect themselves from harm

• Voluntary serious warnings

– allergens


Labeling - Informed Consent

basis the consumer’s right to know so they can

have a freedom of choice

• Voluntary warnings

– Non-GMO


Chapter Contents

• 12.1 The Regulatory Framework

• 12.2 U.S. Department of Agriculture

• 12.3 The Environmental Protection Agency

• 12.4 Food and Drug Administration

• 12.5 Legislation and Regulation: The Ongoing Role of Government

• 12.6 Introduction to Patents

• 12.7 Biotechnology Products in the Global Marketplace


12.1 The Regulatory Framework

• NIH was the first federal agency to assume regulatory responsibility over biotechnology– In 1974, NIH published research guidelines for recombinant

DNA techniques

– Continued monitoring until 1984

• Government published the “Coordinated Framework for Regulation of Biotechnology”– Joint responsibility of the NIH, the USDA (United stated

Department of Agriculture), and the EPA (Environmental Protection Agency)

– Established as formal policy in 1986

– Biotechnology products would not pose regulatory and scientific issues that are substantially different from those posed by traditional products


12.1 The Regulatory Framework


12.2 U.S. Department of Agriculture

• Created in 1862

• Advancement and Regulations of Agriculture

– Regulating plant pests, plants, and veterinary biologics

• Biologics – any medical preparation made from living

organisms or their products



• Animal and Plant Health Inspection Service

(APHIS)

– Branch of USDA responsible for protecting agriculture

from pests and diseases

– Genetically engineered plants and insects are potentially

invasive so are treated as plant pests



• Permitting Process

– Requires several years of field trials to investigate

everything about the plant

• Disease resistance, drought tolerance, reproductive rates

– Precautions must be taken to prevent accidental cross-

pollination



• Ultimate objective for grower is to harvest a

marketable product

– Petition APHIS for deregulated status

– Three broad areas to evaluate the petition

• Plant pest consequences

• Risks to other organisms

• Weed consequences



• Alternative system to fast-track some new agricultural

products called notification– Six criteria must be met

• The new agricultural product must be one of only a limited number of eligible plant species

• The new genetic material must be confined to the nucleus of the new plant

• The function of the genes being introduced must be known

• If to be used for food, the new genes cannot cause the production of a toxin, an infectious disease, or any substance used medically

• If the gene is derived from a plant virus, it cannot have the potential to create a new virus

• The new genetic material must not be derived from animal or human viruses


12.3 The Environmental Protection Agency

• Established in 1970 with responsibilities including

– Protecting endangered species

– Establishing emission standards for cars

– Regulating pesticides and herbicides

• Regulates any plant that is genetically engineered to

express proteins that provide pest control

– Supervising the use of herbicide-tolerant plants



• Experimental Use Permits

If field test will involve 10 acres or more of land

or 1 acre or more of water, then need an

experimental use permit (EUP)

First EUP issued in July 1985 to Advanced

Genetic Sciences for use of two genetically

altered strains of naturally occurring bacteria that

could potentially protect crops from frost damage



• Deregulation and Commercialization

– EPA spends about one year reviewing the data collected,

concentrating on four areas of concern:

• Source of gene, how it is expressed, and the nature of the

pesticide-protein produced

• Health effects of the bioengineered plant

• The environmental fate of the pesticide protein

• The effects on nontarget species


12.4 Food and Drug Administration

• Charged with making sure that the foods we eat and

the medicines we use are safe and effective

• Food and Food Additives

– FDA serves as a consultant

– Studies focus on

• Unexpected or undesirable effects

• Evaluation of the protein to see if it is substantially the

same as naturally occurring proteins in food

– If food additive poses no foreseeable threat, FDA can grant

generally-recognized-as-safe (GRAS) status



• The Drug Approval Process

– Investigational new drug (IND) application

• FDA considers results of previous experiments, the nature

of the substance itself, and the plans for additional testing

• Good Laboratory Practice (GLP) and Good

Manufacturing Practice (GMP)

– Regulations instituted by FDA to govern animal studies of

pharmaceutical products

• Follow written protocols, have adequate facilities, provide

proper animal care, record data properly, and conduct valid

toxicity tests



• Phase Testing of Drugs

– Phase I (safety) – between 20 and 80 healthy volunteers

take the medicine

– Phase II (efficacy) – test new treatment on 100-300

patients who actually have the illness

– Phase III (comparative benefit to other current drugs)

– testing on 1,000-3,000 patients in double-blinded tests

• FDA approval as an NDA (new drug authorization)



• Biotech company will file for a Biological License

Agreement (BLA)

– If seeking approval of a biologically derived product such

as a viral therapy, blood compound, vaccine, or protein

derived from animals

• FDA reviews information that goes on label and

inspects the facilities where drug will be

manufactured as part of approval process



• Exceptions to Phase Testing Procedure

– FDA allows approval of drugs and vaccines intended to

counter biological, chemical, and nuclear terrorism

without first proving their safety and worth in Phase II and

Phase III trials

– Also true for orphan drugs – drugs with a small number

of beneficiaries but with great benefit


12.5 Legislation and Regulation: The

Ongoing Role of Government

• Regulation of biotechnology, like other industries, is

a matter of politics as well as science

– Stem cells

– Labeling of foods that contain GMOs


12.5 Legislation and Regulation: The

Ongoing Role of Government


12.6 Introduction to Patents

• A patent gives an inventor or researcher exclusive

rights to a product and prohibits others from making,

using, or selling the product for a certain number of

years

• Regulated by the U.S. Patent and Trademark Office

(USPTO)

– 1980 first patent for a bacterium with a unique gene sequence

– 2,000 patents granted since for plant, animal, and human

genes



• To win a patent, discovery

– Must be novel

– Must be nonobvious

– Must have some utility

• Patents are enforced for up to 20 years from

earliest date of filing

• Must file an application that

– Adequately describes the product

– Discloses the best use of the product



• Patenting DNA Sequences

– Applicants must assert a utility for the claimed invention

that is specific, substantial, and credible

• Specific utility – must know exactly what the DNA

sequence does

• Substantial utility – defines a real-world use

• Credible utility – must convince the patent office that the

application is backed by sound science


12.7 Biotechnology Products in the Global

Marketplace

• Biotechnology Is a Global Enterprise

– World community is still in preliminary negotiations about

the regulation of biotechnology products

• As a model, the European Union (EU) has created

the European Agency for the Evaluation of

Medicinal Products (EMEA)

– Once a product is approved, can be marketed in all 15

countries in the EU


PowerPoint Lectures for

Introduction to Biotechnology, Second EditionWilliam J.Thieman and Michael A.Palladino

Lectures by Lara Dowland

ETHNICS and BIOTECHNOLOGY


Chapter Contents

• 13.1 What Is Ethics?

• 13.2 Biotechnology and Nature

• 13.3 Economics, The Role of Science, and

Communication


Defining Ethics

1. Ethics are a theory or system of moral values

and principles that govern interactions in

society.

– Vary between cultures and religious groups - often

conflicting in the US.

– Many times ethical decisions are not absolutely right

or wrong, but somewhere in the middle.


Defining Ethics

2. Ethic is the discipline dealing with what is good

and bad and with moral duty and obligation.


Ethical Examples

1. The use of embryonic stem cells in research.

– Positives- because of the ability of stem cells to

differentiate, research could result in tremendous medical

breakthroughs.

• Producing spare organs, skin for grafts, and other

biological products for medical treatments.

– Negatives- requires the destruction of developing human

embryos for the collection of genetic information.


Ethical Examples

2. The process of cloning.

– Occurs naturally in many varieties of plants through

processes like layering, rhizomes and division.

– Usually (the exception is identical twins) requires

human intervention in animals.

• Often damages embryos, resulting in the death of

developing baby- highly objectionable in animals and

humans.


Ethical Examples

3. MOST BIOTECHNOLOGY TECHNIQUES &

PRODUCTS DO NOT POSE AN ETHICAL DILLEMNA

FOR A MAJORITY OF PEOPLE IN DEVELOPED

NATIONS.

– Ethical objections remain the most common objection for

the use of biotechnology in agriculture especially for

uninformed.

– Despite concerns over food safety, increasing use of

biotechnology has occurred as a result of demands for

increased production.


3. MOST BIOTECHNOLOGY TECHNIQUES & PRODUCTS…

continued

– Objections are centered more around the human element as to who makes decisions that life is expendable in one case and not in another.

– Misuse is at the center of ethical objections.

– Objections to products focus on the uncertainty as to what long-term effects the use of genetically modified materials might have in the absence of long-term records.

• Will genetically modified foods have a chronic effect on the animals that consume them?

• Will Bt crops create “super pests” that adapt over a period of time?

• Will Bt products lose their effectiveness over time?


13.1 What Is Ethics?

• Ethics identifies a code of values for our actions

• Bioethics – area of ethics that deals with the

implications of biological research and

biotechnological applications, especially regarding

medicine

– Ask “Should this be done?” not “Can this be done?”



• Approaches to Ethical Decision Making

– Two main viewpoints

• Utilitarian approach – states that something is good if it is

useful, and an action is moral if it maximizes pleasure

among humans; “greatest good for the greatest number”

• Deontological approach (Kantian approach or duty

ethics) – focuses on certain imperatives, or absolute

principles, which we should follow out of a sense of duty

and which should dictate our actions



• Modern Bioethics

– Primarily the work of two ethicists in the 1970s

• Joseph Fletcher and Paul Ramsey

• Refined the utilitarian and deontological approaches


13.2 Biotechnology and Nature

• Scientists met at conference in Asilomar, CA, in

1975 to discuss the safety and possible

consequences of recombinant DNA techniques

– Established guidelines for different levels of biosafety

containment



• Cells and Products

– Issues of safety

– Issue of efficacy (effectiveness)

– Humane treatment of animals



• GM Crops: Are You What You Eat?

– Several areas of concern

• The plant itself (species integrity)

• Possible effect of altered plants on the ecosystem and on

overall biodiversity

– Effects on nontarget species

• How will the crop be used? Is it safe to feed to animals? Is

it safe for humans?

• Consideration of other genes or products present in the

GM crop



• GM Crops: Are You What You Eat?

– Social and economic questions arise

• Statistical Probability

– The likelihood of an event; what chance exists for a “bad”

event to happen

• Risk Assessment

– Considers the likelihood that something harmful or

unintended will happen in making a decision



• Animal Husbandry or Animal Tinkering

– Raises same ethical questions as genetic modification of plants

• The Human Question

– Informed consent – patients have the right to be informed fully of

the potential effects of the experimental treatment, both good and

bad

– Placebos – a safe but non-effective treatment

• Double-blind trials: An experimental procedure in which neither

the subjects of the experiment nor the persons administering the

experiment know In a double-blind experiment, neither the

individuals nor the researchers know who belongs to the control

group and the experimental group ; "a double-blind procedure is

used to guard against both experimenter bias and placebo

effects"



• What Does It Mean to Be Human?

– Many ethical debates revolve around the moral status of

the human embryo

• Is it ethical to destroy early-stage human embryos for

research that may potentially treat thousands of patients?

– Personhood – used to define an entity that qualifies for

protection based not on an intrinsic value but rather on

certain attributes, such as self-awareness



• Spare Embryos for Research Versus Creating

Embryos for Research

– Primary source of embryos for research is excess

embryos from in vitro fertilization

– Another potential source is the creation of embryos for

research purposes



• Cloning

– Raises many of the same questions, with the added

complexity of the technique and the potential identity of

the clone

– Is creating a cloned embryo with the intent of initiating a

pregnancy another type of assisted reproductive

technology?



• Cloning

– Ethical considerations of a human clone include

• How lack of relatedness to one parent might change

kinship and family relationships

• Expectations put on a clone once born to “live a better life”

than the person who was cloned

• Expectation to live up to a legacy achieved by the donor of

the genetic material

• When someone creates a clone from a dead dear one….



• Cloning

– Creation of human embryos could lead to matched

embryonic cells for patients

• Could this lead to human commercialization, making

human life a commodity to be bought, sold, and used?



• Patient Rights and Biological Materials

– Physicians do have a duty to disclose the physician’s

personal interest in research and potential economic

matters unrelated to patient treatment

– Courts have ruled that donors of cells and other

biological materials do not have ownership rights of their

biological materials



• Regulations in Flux– August 9, 2001, ban on using federal funds for embryo

creation or destruction

– Some states have enacted their own laws

– 2009: The Government approved the use of embryonic cells for research (In particular stem cells research) (Embryos from in vitro fertilization only)

– Stem cells: Un programmed cells that can continue dividing forever and can change into other types of cells (bone, muscle, cartilage, etc), so they have the potential to treat many diseases, including Parkinson's, Alzheimer's, diabetes and cancer, and repairing damage in other organs - such as the liver, kidneys, heart, etc



• Your Genes, Your Self

– Concern over the privacy of DNA information

• How genetic information could be used negatively by

employers, insurance companies, governmental agencies,

or through perceptions by the general public

• 2008, the Genetic Information Nondiscrimination Act was

passed into law

– Prohibits discrimination based on genetics and the

improper use of genetic information in health insurance

and employment



• More or Less Human?

– Ethical considerations of gene therapy

• Informed consent, safety, and efficacy

• What about treatment of the possibility of genetic disease?


13.3 Economics, The Role of Science, and

Communication

• Money plays a major role in research decisions

• Patenting of intellectual property may be lucrative, but

may also pose ethical and scientific problems

– Limited scientific access to gene for other researchers

• Should scientists have unlimited freedom for research?

• Accurate, honest communication is vital to the success

of science


What Are the Public Concerns?

Economics

Are we changing the economics on the farm?

Environmental

Are we irreversibly modifying the environment?

Globalization

Is technology becoming centralized in too few hands?

Social

Will we develop a class of genetic outcasts?

Religious

Are we playing God?


• Microbial Biotechnology

• Plant Biotechnology

• Animal Biotechnology

• Aquatic Biotechnology

• Medical Biotechnology

BIOTECHNOLOGY REGULATIONS - endrikawidyastuti 18, 2015 · Specific GMO Regulations 1. In the US,...

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