[Federal Register Volume 85, Number 154 (Monday, August 10, 2020)]
[Proposed Rules]
[Pages 48124-48127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16800]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 112
[Docket No. FDA-2020-N-1119]
Request for Information and Comments on Consumption of Certain
Uncommon Produce Commodities in the United States; Establishment of a
Public Docket
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, the Agency, or we) is
opening a docket to receive information and comments related to certain
produce commodities with no or low reported consumption in the database
relied on to create the list of rarely consumed raw commodities that
are exempt from the Standards for the Growing, Harvesting, Packing, and
Holding of Produce for Human Consumption regulation. FDA intends to use
the information to consider whether any of these commodities should be
added to the rarely consumed raw list.
DATES: Submit either electronic or written comments by November 9,
2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be
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considered. Electronic comments must be submitted on or before November
9, 2020. The https://www.regulations.gov electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end of November 9,
2020. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is on or before that date.
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2020-N-1119 for ``Request for Information and Comments on
Consumption of Certain Uncommon Produce Commodities in the United
States.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
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.'' The Agency will
review this copy, including the claimed confidential information, in
its 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 Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Samir Assar, Center for Food Safety
and Applied Nutrition (HFS-317), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-1636.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November 27, 2015, we issued the final
rule, ``Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption'' (80 FR 74354), which established at 21
CFR part 112 science-based minimum standards for fruits and vegetables
grown for human consumption (produce safety regulation). The produce
safety regulation is one of the seven foundational regulations that we
issued as part of our implementation of the FDA Food Safety
Modernization Act (Pub. L. 111-353), which directs FDA to better
protect public health by, among other things, adopting a modern,
preventive, and risk-based approach to food safety.
Produce is subject to the produce safety regulation (i.e., is
``covered produce'') unless it is ``not covered'' because it is: (1)
Rarely consumed raw (RCR) (Sec. 112.2(a)(1) (21 CFR 112.2(a)(1))) (the
RCR exemption); (2) produced for personal or on-farm consumption (Sec.
112.2(a)(2)); or (3) not a raw agricultural commodity (Sec.
112.2(a)(3)). This request for information pertains to certain
commodities that were not categorized as RCR.
The RCR list is a list of produce commodities that we determined
are almost always consumed in the United States only after being
cooked. Cooking is a kill step that can be expected to adequately
reduce the presence of microorganisms of public health significance in
most cases. FDA concluded that it is not reasonably necessary to
subject RCR commodities to the produce safety regulation.
FDA's classification of produce as RCR was based on food
consumption patterns reported in a robust dataset: The National Health
and Nutritional Examination Survey/What We Eat in America (NHANES/
WWEIA) dataset (Ref. 1), which is the most comprehensive, robust, and
nationally representative dataset currently available on dietary intake
in the United States. We also used the U.S. Environmental Protection
Agency's Food Commodity Intake Database (Ref. 2), which is a recipe
database that identifies proportions of commodity ingredients in
NHANES/WWEIA codes, and also identifies the cooking status (uncooked or
cooked) and the food forms (e.g., fresh, frozen, canned) associated
with each commodity ingredient. We provided background information and
data analyses informing the inclusion of produce commodities in the RCR
list in a memorandum (the Produce RCR memorandum) that we made
available in the administrative record of the produce safety rulemaking
(Ref. 3).
Note that the identification of a commodity on the RCR list does
not mean the produce is never eaten raw or that it is not eaten raw,
typically or occasionally, in specific regions of the United States (or
among specific ethnic
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communities in the United States). The RCR list also does not reflect
the form in which these commodities are consumed by populations in
other countries.
Consumption patterns for a commodity had to meet three criteria
that were used to determine if a commodity qualified as rarely consumed
raw. First, the commodity had to be consumed uncooked by less than 0.1
percent of the United States population. Second, the commodity had to
be consumed uncooked on less than 0.1 percent of eating occasions.
Third, at least 1 percent of the weighted number of survey respondents
must have reported consuming the commodity in any form for the data to
provide a reasonable representation of how that commodity is consumed
by U.S. consumers. The purpose of the third criteria was to ensure that
we had sufficient data to provide a reasonable representation of how
the commodity is consumed in the United States for the purpose of
exempting commodities from the coverage of the produce safety
regulation (80 FR 74354 at 74388). For commodities not reported as
consumed by at least 1 percent of the weighted number of respondents,
we consider the overall reported rate to be too low to justify relying
on these data as a reasonable representation of consumption among all
U.S. consumers.
Commodities that failed to satisfy all three NHANES/WWEIA food
consumption criteria were not included in the RCR list. Several produce
commodities satisfied the first two NHANES/WWEIA food consumption
criteria for demonstrating that the commodities are almost always eaten
only after being cooked, but are covered by the produce safety
regulation because the 2003-2010 NHANES/WWEIA dataset did not
demonstrate consumption of the commodities in any form by at least 1
percent of survey respondents. (See Response to Comments 68 and 69, 80
FR 74354 at 74392 to 74394.) In the remainder of this document, we
refer to these commodities as ``produce commodities with low reported
consumption.'' The following is an exhaustive list \1\ of these produce
commodities with low reported consumption according to the methodology
used in developing the RCR list: Artichoke, globe[hyphen]type;
artichoke, Jerusalem; arugula; balsam pear; boysenberry; Brazil nut;
breadfruit; broccoli, Chinese; brussels sprouts; burdock; cabbage,
Chinese, bok choy; cabbage, Chinese, mustard; cabbage, Chinese, Napa;
cactus; celeriac; chayote fruit; chestnut; Chinese waxgourd;
chrysanthemum garland; citron; cress, garden; currant; dandelion
leaves; dasheen (taro) (leaves and corm); fennel, Florence; genip;
gooseberry; grape, leaves; guava; huckleberry; jicama; kale; kohlrabi;
kumquat; leek; lime; lotus root; lychee; macadamia nut; mulberry;
mustard greens; palm heart, leaves; parsnip; passion fruit; persimmon;
pine nut; plantain; pomegranate; quince; radish, oriental, roots;
rhubarb; rutabaga; shallot; soursop; soybean, sprouts; starfruit; swamp
cabbage; sweetsop; Swiss chard; turnip (roots and greens); and yam.
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\1\ The original analysis included amaranth, which we have not
included here because it is a grain, and grains are not ``produce''
as that term is defined by the produce safety regulation. See 21 CFR
112.3(c). We have also omitted from this list several pulse
commodities (e.g., dry pea) because that group of commodities is
under separate consideration. See the discussion related to pulses
in our guidance entitled ``Guidance for Industry: Enforcement Policy
for Entities Growing, Harvesting, Packing, or Holding Hops, Wine
Grapes, Pulse Crops, and Almonds;'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-enforcement-policy-entities-growing-harvesting-packing-or-holding-hops-wine-grapes.
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Some produce commodities did not appear in the NHANES/WWEIA at all;
a commodity is added to NHANES/WWEIA partly based on the number of
times the new food is reported and partly based on whether a new
reported food has nutrient contents that are very different from the
nutrient contents of a food that already exists in the database. In the
remainder of this document we refer to these commodities as ``produce
commodities with no reported consumption.'' Arrowroot and fiddleheads
are examples of produce commodities with no reported consumption.
As we stated when we issued the produce safety final rule, we will
consider updating the list of RCR commodities if new data become
available (80 FR 74354 at 74390). We therefore invite interested
persons to submit data, information, and/or comment to support whether
particular commodities with either no or low reported consumption in
NHANES/WWEIA should be categorized as RCR. We seek commodity-specific
data that would indicate whether that particular fruit or vegetable is
consumed cooked by almost all consumers across the United States at
this time. To be most useful, newly submitted data should be
quantitative data of U.S. consumption patterns that are sufficiently
robust such that we could draw from them scientifically valid
conclusions. The data should clearly indicate what proportion of the
population consumes the commodity in the uncooked form and/or how often
the commodity is consumed uncooked compared to the cooked form. Results
of a well-designed consumer survey would be one possible type of data
that may be submitted. Market data that closely parallels consumer
consumption data may also be helpful. Another type of data that could
be useful is data indicating that a commodity cannot safely be consumed
uncooked, e.g., because in its uncooked state it contains toxic
properties. We also request information on any kill steps other than
cooking (e.g., fermentation that adequately reduces microorganisms of
public health significance) that are always or almost always applied to
produce commodities with no or low reported consumption and data on the
extent to which this kill step is applied consistently across the
industry.
For this Request for Information, FDA is requesting data,
information, and comments from all interested parties, including, but
not limited to, academic and government researchers, industry, and any
other source. When submitting information, please include details about
how the data were collected, including information on the study design
and sample population, year(s) of data collection, a detailed summary
of the methods and measures used (e.g., any surveys utilized) and if
available, the survey results (i.e., raw data).
II. References
The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.
1. Center for Disease Control and Prevention, National Center for
Health Statistics. ``National Health and Nutrition Examination
Survey/What We Eat in America (NHANES/WWEIA).'' Available at https://www.cdc.gov/nchs/nhanes/wweia.htm. Last accessed July 23, 2020.
2. Environmental Protection Agency Office of Pesticide Programs and
University of Maryland Joint Institute for Food Safety and Applied
Nutrition. ``What We Eat in America--Food Commodity Intake Database,
2005-2010 (WWEIA-FCID 2005-10).'' Available at https://fcid.foodrisk.org/. Last accessed July 23, 2020.
3. Tijerina, M. J., J. Johanson, J. Spungen, and S. Briguglio,
``Memorandum to the File--Produce Rarely Consumed Raw,''
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October 2015. Available in Docket No. FDA-2011-N-0921 at https://www.regulations.gov.
Dated: July 28, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16800 Filed 8-5-20; 4:15 pm]
BILLING CODE 4164-01-P