Biotechnology Laws and Regulations in USA

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The use of biological sciences to develop products, conventional plant and animal breeding techniques being held since the beginning of civilization, falls under biotechnology. Biotechnology refers to newly-developed scientific methods to make products by changing the genetic makeup of organisms and creating unique individuals or qualities that are not easily attained through conventional breeding techniques. 


These products are stated to as transgenic, bioengineered, or genetically modified since they comprise foreign genetic material.  Agriculture is one of the first industries fundamentally affected by this new technology on both a fundamental production level and a legal level.

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A huge collection of products resulting from biotechnology affect agriculture in numerous means.  Livestock hormones shaped in bacteria are used to upsurge milk production in dairy cows. 


Plants planned to yield massive amounts of specific proteins endure herbicide application that kills unchanged plants of the same species.  Tomatoes changed to fight staining throughout consignment are allowable to develop on the vine. 


Corn plants that yield the precursors of plastics cut the need for petroleum in the plastics industry.  Rice reformed to yield high levels of vitamin A may allow third-world countries to stop loss of sight in children.  Biotechnology companies specify that it is only the start and that the prospects are restricted only by resourcefulness.


Nevertheless, consumer acceptance of these products differs across the globe.  The comparatively new growth of this technology has obtainable original legal issues for private parties and governments as the law efforts to keep pace with scientific development through regulation, assignment of liability, protection of intellectual property rights, and international dispute resolution. 


The unlimited possibilities and interesting amalgamations of organisms pose an extraordinary challenge for law and policy creators.




Under the policy statement confined in the Coordinated Framework for Regulation of Biotechnology, regulation of biotechnology products in the United States is controlled by three agencies: the Food and Drug Administration (FDA), the United States Department of Agriculture (USDA), and the Environmental Protection Agency (EPA). 


Since federal policy takes the position that biotechnology itself has no inherent risks, biotechnology products are controlled under current laws in the same manner as non-biotechnology products, with no particular regulatory law or agency having only authority over biotechnology. 


The regulatory liability falls on a specific agency based on the product’s planned use and chemical composition.  Due to their original combination of traits, some products may need regulation under numerous agencies. Both the transgenic organism and the products formed from it may be controlled.


The FDA is accountable for the regulation of food, feed, human drugs, and animal drugs; the EPA controls pesticides and toxic substances; and the USDA supervises meat, poultry, and egg products, plant pests, and noxious weeds, and animal biologics.  Under this regulatory arrangement, transgenic plants may be controlled by the USDA as possible plant pests and may be controlled by the EPA if they yield pesticides or possibly toxic chemicals. 


Transgenic animals may be controlled by the FDA under the philosophy that genetic manipulation is an animal drug, and if the genetic change produces either a drug, food or biologic, then that product may also be controlled by the FDA.  If the transgenic animal produces meat, poultry, or egg product, the product will likewise be controlled by the USDA.


The likelihood for EPA regulation moreover exists if the transgenic animal produces possibly toxic chemicals.  The EPA also has the skill to control microorganisms under their ability to control toxic materials.


The directive of products resulting from transgenic organisms offers other means for agencies to control biotechnology.  Whole foods, food additives, dietary supplements, and drugs obtained from transgenic plants are controlled by the FDA. 


Foods resulting from transgenic animals may be controlled by the FDA under the theory that the genetic material is an animal drug; transgenic meat, poultry, and egg restriction falls to the USDA; pesticide and chemical commodities will be governed by the EPA.


United States directive of biotechnology is a multifaceted structure in which three agencies work together to control technology that did not occur when existing regulatory laws were passed.  Considerably the existing controlling framework is uncertified and will last to change as new transgenic organisms and products are transported to market.



Federally, the FDA and USDA have controlled genetically adapted product labels. In cooperation, FDA and USDA agencies inspect whether a label is incorrect or deceptive, which is termed misbranding. The FDA is accountable for bioengineered human and animal food, drugs, and cosmetic products, and cannot pre-approve labels of these products.


The USDA is accountable for reviewing labels of genetically modified meat, poultry, and egg products, verifying all labels are not disingenuous. The USDA has pre-marketing authority on labels and needs producers to submit labels for authorization before the product comes into trade.


Labelling products adapted by biotechnology was intentional until lately when Congress passed an Act necessitating the mandatory labeling of bioengineered foods.


This Act required the USDA to generate the National Bioengineered Foods Disclosure Standard (the Standard) to create a national standard for bioengineered foods and pre-empt fluctuating state laws on the issue.


Under the Act, a bioengineered food is a food

“(A) that comprises genetic material that has been changed through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and (B) for which the modification could not then be got through conventional breeding or found in nature.”


Fundamentally, bioengineered foods are modified using rDNA techniques that cannot be attained through conventional breeding or in a natural setting. Built on this definition, the Standard creates labelling and record-keeping necessities for bioengineered foods.



Liability for biotechnology damages usually surveys traditional common law actions, as no exclusive actions have developed only for damage from transgenic products.  Damage from the use of biotechnology generally contains contamination of non-genetically modified organisms by genetically modified ones.


One probable theory for liability may be in an action for trespass.  When transgenic pollen moves from the field where it is produced against another’s property, a physical invasion may follow.  If this invasion results in damage, then an action for trespass may be a suitable choice.


Strict liability may also be an opportunity for the recovery of damages if a farmer is damaged by a neighbor’s transgenic crop.  First, increasing transgenic crops must be chosen as an oddly dangerous activity.


Then, the injured party can recover notwithstanding precautions taken by the other party.  Though, representing that raising transgenic crops is an abnormally dangerous activity is becoming more problematic with the extensive use of such crops.


Negligence is also a probable method of establishing liability by requiring that biotechnology companies and farmers using transgenic crops use reasonable precautions to prevent damage to other parties.  Forces that neglect to reasonably safeguards others from the threats related to transgenic organisms may encounter penalties in the shape of negligence actions.


A private nuisance is also a theory that can be used to discuss liability onto users of biotechnology.  Liability may arise if it can be shown that the use of transgenic organisms unreasonably interfered with the quiet use and enjoyment of a neighbor’s land and caused significant harm.


Public nuisance authorizes a private individual or group to reclaim damages and to avoid additional damage to the public.  There is no law of specific damage to land ownership.  To recover, the necessary damage is a display of excessive interference to the right of the people. 


To recover, the individual who pursues the action must have been damaged in a special manner distinct from the harm suffered by the general public and must demonstrate that cultivating a specific transgenic harvest infringed on freedom available to the general public.



Intellectual Property


Intellectual property rights provide incentives for the development of novel products by recompensing inventors or developers with protections such as special rights for the production, using, and selling of the novel product.  Biotechnology investigation is costly, and its commodities are lucrative. 


Though, the technology itself is easily noticed by scientific tests.  These factors are leading to the rapid development of intellectual property rights in biotechnology, and in turn, the development of intellectual property rights fuels the scientific advancement of biotechnology.


Until the Plant Patent Act of 1930 (“PPA”), living organisms were deemed unpatentable as they are creations of nature and likely did not satisfy the prerequisites of utility patents.  The PPA authorizes creators of recent and different plants to curb the asexual duplication, exchange, and practice of patented plants.  It does not safeguard sexually generated plants.



The Plant Variety Protection Act of 1970 (PVPA) provides protections to breeders who make new and distinct varieties of sexually formed plants.  It stops the unauthorized sale or growing of a protected plant.  The protection comprises both the plant and its seeds and lasts for twenty years.  The PVPA moreover includes immunity for farmers who conserve seed for their usage and immunity for analysis through the excused plant.

Our team of advanced patent attorneys assists clients with patent searches, drafting patent applications, and patent (intellectual property) agreements, including licensing and non-disclosure agreements. Advocate Rahul Dev is a Patent Attorney & International Business Lawyer practicing Technology, Intellectual Property & Corporate Laws. He is reachable at rd (at) patentbusinesslawyer (dot) com & @rdpatentlawyer on Twitter.

Quoted in and contributed to 50+ national & international publications (Bloomberg, FirstPost, SwissInfo, Outlook Money, Yahoo News, Times of India, Economic Times, Business Standard, Quartz, Global Legal Post, International Bar Association, LawAsia, BioSpectrum Asia, Digital News Asia, e27, Leaders Speak, Entrepreneur India, VCCircle, AutoTech).

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