Markets and Politics

Markets and Politics
TO: Upper Management
FROM: Assistant Genetic Engineer
DATE: February 1, 2018
SUBJECT: Directive on Regulation of Intentionally Altered Genomic DNA in Animals
Background of the Regulation
Following the revision of Regulation No. 187 on Internationally Altered Genomic DNA
in animals by the Food and Drug Administration (FDA) on January 2017, it is imperative to for
firm to understand the mechanics and provisions of guidance. The guidance aims at clarifying
FDA's requirements and recommendations for both developers and producers of animals with
intentionally modified genomic DNA using modern molecular technologies. The directive
applies to both the founder animals as well as the entire subsequent lineage of animals containing
genomic alteration stemming from the use traditional techniques to most recent such as clustered
regulatory interspersed short palindromic repeats (CRISPR) to new ones yet to be developed
(FDA, 2017). The FDA revised the 2009 Regulation following emergence of new technologies
to alter the DNA of animals that were not covered in the previous version. The Regulation is
aimed to help the industries and forms involved to understand the regulations and statutory
requirements in their endeavors of application the DNA modification practices on the animals.
The Regulation 187 is just guidance and does not have binding obligation unless cited under
respective statutory
Industries and Companies Affected
The guidance affects all the industries, firms and research organizations that develop and
produce genetically modified animals through either genetic engineering or genome editing
techniques. These firms include those producing substances and materials to be used as or in
biologics, drugs, or devices for use in humans and those producing substances used as or in
veterinary biologics and all research institution involved in biotechnology.
Guidance Recommendations
There are diverse guidelines outlined in the guidance. First, under the Investigation New
Animal Drug (INAD) recommends, that producer and developers of animals with intentionally
modified genome should ensure that investigational animals and/or their products are used only
for research purposes in order to prevent release of unsafe animals and their products into the
market. Second, there is need to ensure all shipments of investigational animals and/or their
products must be labeled correctly indicating edible products from the animal and those that
require certification and authorization of FDA to warrant consumption. In addition, proper
labeling materials of particular animals with modified DNA must be sort from the FDA to ensure
the animals are seed for the intended purpose.
The third recommendation is to ensure non-edible foods from animals with intentionally
modified genome are not supplied to the market without FDAs approval to ascertain the safety,
genotypic and phenotypic stability of the animals. Approval of Investigational Food Use
Authorization must be sort before introducing any investigational animals and products into the
food market and an environmental assessment should be conducted as per the set regulations on
the implication of introducing the investigational animals and products in the environment to
ascertain the potential health, animal environmental risks. Fourth, ensure surplus investigational
animals and/or their products are buried or incinerated and ensure proper storage of appropriate
identification and deposition documentation.
Regarding operation and activities of producers and developers of animals with the
intentionally altered genome, the guidance recommends that the firms’ management must
register the name and location of their business and identify facilities endeavored in testing or
producing animals with altered genome as a listing responsibility. Furthermore, it is
commendable to establish and maintain a well and succinctly indexed records comprising of all
the information concerning the effectiveness or safety of the animals and products under
question to ensure easy follow-ups, retrieval and tracking of activities undertaken by the firm.
Records and reports alongside any other relevant information pertaining the organization’s
experience with animals with intentional altered DNA must be submitted to the FDA Division of
Surveillance after every six months. Finally, ensure data and information on the phenotypic and
genotypic durability of the animals and products is collected, analyzed and documented annually
using the standard operating procedures to allow effective auditing of operations and promote
Status of Compliance
As per the public interest comment on revised Guidance 187 by FDA by Lutter and
Lewis (2017) notes that the effectiveness of the guidance is under question and debate. Lutter
and Lewis discredit the regulation arguing that it is inconclusive and lacks cogent scientific basis
as well as inconsistent with the FDA’s regulation of genetically modified plants. Nonetheless,
the direction is not binding hence the management can refer to it in cases that it sees the best fits
the mission of protecting and promoting public health.
FDA. (2017, Jan). Guidance No. 187 for Industry on Regulation of Genetically Engineered
Animals (Draft Guidance). Food and Drug Administration. Retrieved Feb 1, 2018, from
Lutter, R., & Lewis, L. (2017). Public Interest Comment on The Food and Drug
Administration’s Draft Guidance for Industry #187 “Regulation of Intentionally Altered
Genomic DNA in Animals": How to Regulate Genome Edited Animals? A Comment on
FDA’s Proposed Guidance (ID No. FDA-2008-D-0394). Washington, DC: George
Washington University. Retrieved Feb 1, 2018, from

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