[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

[[Page 48125]]

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