[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Notices]
[Pages 6564-6566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00840]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-4389]
Genome Editing in New Plant Varieties Used for Foods; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification; establishment of docket; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
establishment of a docket to receive comments on the use of genome
editing techniques to produce new plant varieties that are used for
human or animal food. We invite comment on specific questions contained
in this document related to foods derived from such genome edited plant
varieties. FDA is taking this action to help inform our thinking about
foods derived from new plant varieties produced using genome editing
techniques.
DATES: Submit either electronic or written comments by April 19, 2017.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-N-4389 for ``Genome Editing in New Plant Varieties Used For
Foods; Request for Comments.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Division of Dockets Management. If you do not wish your
name and contact information to be made publicly available, you can
provide this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments
[[Page 6565]]
received, go to https://www.regulations.gov and insert the docket
number, found in brackets in the heading of this document, into the
``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Regarding human food issues: Jason
Dietz, Center for Food Safety and Applied Nutrition (HFS-205), Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2282. Regarding animal food issues: Kathleen Jones, Center for
Veterinary Medicine (HFV-220), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-402-5938.
SUPPLEMENTARY INFORMATION:
I. Background
Use of Genome Editing Techniques To Produce New Plant Varieties Used
for Human or Animal Food
Recently, new technologies have emerged that are intended to alter
the genomes of various organisms, including plants. FDA is aware that
these technologies make it easier for plant developers to produce new
plant varieties with targeted genetic modifications. Using
deoxyribonucleic acid (DNA) sequence information from a plant, plant
breeders can make targeted changes to a plant's DNA sequence to alter
expression of traits in the plant. These new methods include processes
using targeted nucleases (clustered regulatory interspersed short
palindromic repeat associated nucleases, zinc-finger nucleases,
meganucleases, and transcription activator-like effector nucleases or
targeted oligonucleotides (oligonucleotide-directed mutagenesis)
intended to modify a plant's DNA sequence by insertion, deletion, or
substitution of nucleotides at a specific site in a plant's genome. The
process of producing these targeted DNA sequence alterations is often
referred to as ``genome editing.''
In the National Strategy for Modernizing the Regulatory System for
Biotechnology Products (the Strategy; released by the White House
Office of Science and Technology Policy on September 16, 2016),\1\ FDA
noted its intent to clarify its policy for the regulation of products
derived from genome editing techniques, including, as appropriate,
identifying and/or updating relevant existing guidance documents.
Consistent with this commitment in the Strategy document, FDA is
opening this docket to inform its thinking on foods derived from plants
produced using genome editing techniques. FDA also looks forward to
receiving the results from the study being conducted by the National
Academies of Sciences, Engineering, and Medicine entitled ``Future
Biotechnology Products and Opportunities to Enhance Capabilities of the
Biotechnology Regulatory System'' commissioned under the Update to the
Coordinated Framework for Regulation of Biotechnology, available at
http://nas-sites.org/biotech/ biotech/. As we consider this issue, we intend
for our actions to be guided by the principles for the regulation of
biotechnology products articulated in the 2017 Update to the
Coordinated Framework (https://www.whitehouse.gov/sites/default/files/microsites/ostp/2017_coordinated_framework_update.pdf) and the goals
and objectives of the July 2015 EOP memorandum (https://www.whitehouse.gov/sites/default/files/microsites/ostp/modernizing_the_reg_system_for_biotech_products_memo_final.pdf).
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\1\ https://www.whitehouse.gov/sites/default/files/microsites/ostp/biotech_national_strategy_final.pdf.
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Producers of foods from plant varieties developed using genome
editing techniques, like all food producers, have an obligation under
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to ensure that
the foods they offer consumers are safe and in compliance with
applicable legal requirements (57 FR 22984 at 22985), available at
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Biotechnology/ucm096095.htm. The
FD&C Act gives FDA broad authority to initiate legal action against a
food that is adulterated or misbranded within the meaning of the
statute (id.). In 1992, FDA issued a statement of policy (57 FR 22984)
that discussed scientific issues and provided guidance relevant to the
safety assessment of foods derived from new plant varieties derived by
traditional methods, tissue culture methods, and recombinant DNA
methods (57 FR 22984 at 22991). The guidance provided in the 1992
policy has helped to ensure that developers of new plant varieties make
market entry decisions consistent with the FD&C Act. FDA also explained
that we have long regarded it to be a prudent practice for producers of
foods using new technologies to work cooperatively with us to ensure
that the new products are safe and comply with applicable legal
requirements (57 FR 22984 at 22991). Over the past 20 years, developers
have routinely consulted FDA about the safety and legality of foods
from new genetically engineered plant varieties prior to marketing.
These consultations have relied on the objective characteristics of
foods to consider their safety and legality prior to marketing. This
process has worked well and has helped developers ensure that all
safety and other legal issues are satisfactorily addressed prior to
market entry of foods derived from these new varieties. FDA intends to
continue offering consultations for developers of new plant varieties,
including those produced using genome editing, in order to help
developers ensure that applicable safety and legal questions are
resolved prior to market. In addition to the information we anticipate
gathering from developers in the course of consultations, we recognize
that developers, researchers, and other stakeholders may have valuable
factual information and data about foods derived from new plant
varieties produced using genome editing, which can help inform FDA's
thinking for these specific products. Therefore, we invite comment in
this notice.
II. Additional Issues for Consideration and Invitation for Comment:
Genome Editing in Plants
To help inform our thinking on foods derived from new plant
varieties produced using genome editing, we invite comment on the
following questions:
1. In what ways are the food safety risks associated with human and
animal foods from genome edited plants the same as or different from
those associated with other plant development methods (e.g.,
hybridization, chemical or radiation-induced mutagenesis and non-
targeted genetic modifications using in vitro recombinant DNA
technologies)? Please provide data and/or information to support your
view.
To what extent is the scientific knowledge of and
experience with current new plant varieties (such as those developed
with in vitro recombinant DNA technologies that have gone through the
voluntary consultation process) relevant to the safety assessment and
regulatory status of food from new plant varieties produced using
genome editing? Is there additional scientific knowledge that would be
relevant specifically to the safety assessment and regulatory status of
new plant varieties produced using genome editing? Please provide data
and/or information to support your view.
[[Page 6566]]
2. Are there categories of genome edited plant varieties for which
there are scientific bases to conclude that foods from such categories
are unlikely to present food safety risks different from or greater
than those for traditional plant breeding? Similarly, are there
categories of genome edited plant varieties for which the regulatory
status of the food derived from such plant varieties can be said to be
no different from that of traditionally-bred plants? If there are such
categories, is there a basis upon which to determine that there would
be no reason to include them in any voluntary premarket consultation
process? If so, please describe the characteristics of such categories
(including, for example, information about the types of phenotypes and
modifications (insertions, deletions or substitutions) achieved through
genome editing) and provide data and/or information for why plant
varieties in these categories are unlikely to present food safety risks
or regulatory status questions. Regulatory status questions may
include, for example, whether food from the new plant variety contains
an unapproved food or color additive such that premarket review and
approval is required (see sections 409 and 721 of the FD&C Act). As
another example, if food from the new plant variety has a different
nutritional profile from food from traditionally-bred plants, then
certain labeling may be required to disclose a material change in the
food.
a. If such categories exist, how do plant developers ensure the
safety of foods from new plant varieties in these categories? For
example, how are safety assessments of foods from these varieties
accomplished, and what data and information are or should be considered
in such assessments?
b. If certain categories of genome edited plants do not raise
questions of safety or regulatory status, should there nevertheless be
a mechanism separate from the voluntary premarket consultation process
through which plant developers may voluntarily notify FDA about their
intent to market a food derived from a genome edited new plant variety
that falls within these categories? If so, what process should plant
developers use to notify FDA? What kind of information should be
included in such a notification to FDA?
c. Given that genome editing techniques can give rise to a broad
range of plant modifications, from simple gene deletions to totally
novel genes, and that some such modifications can be achieved through
traditional breeding, please discuss the basis upon which to determine
that there would or would not be a reason to include, in any voluntary
premarket consultation process, foods from genome edited crops with
modifications that could have been achieved through traditional
breeding.
3. Are there categories of genome edited plant varieties for which
there are scientific bases to conclude that foods from these categories
are more likely than traditionally-bred plants to present food safety
risks? If so, please describe the characteristics of these categories
(including, for example, information about the types of phenotypes and
modifications (insertions, deletions or substitutions) achieved through
genome editing) and provide data and/or information to support why
plant varieties in these categories are more likely to present food
safety risks than traditionally-bred plants.
4. What steps can we take to help small firms, including those who
may be considering using genome editing to produce new plant varieties
for use in human or animal food, to engage with FDA about any questions
related to food safety or the regulatory status of foods from their new
plant varieties? Please provide supporting data and other information
to support your comments and responses to this question.
Dated: January 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00840 Filed 1-18-17; 8:45 am]
BILLING CODE 4164-01-P