[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