Request for Information and Comments on Consumption of Certain Uncommon Produce Commodities in the United States; Establishment of a Public Docket, 48124-48127 [2020-16800]
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Federal Register / Vol. 85, No. 154 / Monday, August 10, 2020 / Proposed Rules
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
The Proposed Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA proposes to amend 14 CFR part
39 as follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by
removing Airworthiness Directive (AD)
2016–25–29, Amendment 39–18755 (81
FR 94956, December 27, 2016), and
adding the following new AD:
■
The Boeing Company: Docket No. FAA–
2020–0680; Product Identifier 2020–
NM–079–AD.
(a) Comments Due Date
The FAA must receive comments on this
AD action by September 24, 2020.
(b) Affected ADs
This AD replaces AD 2016–25–29,
Amendment 39–18755 (81 FR 94956,
December 27, 2016) (‘‘AD 2016–25–29’’).
(c) Applicability
This AD applies to The Boeing Company
Model 767–200, –300, –300F, and –400ER
series airplanes, certificated in any category,
as identified in Boeing Special Attention
Service Bulletin 767–25–0550, Revision 1,
dated December 4, 2019.
(d) Subject
Air Transport Association (ATA) of
America Code 25, Equipment/furnishings.
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(e) Unsafe Condition
This AD was prompted by a report of a fire
in the bilge area of the cargo compartment
that burned through the insulation blankets
that were intended to prevent smoke from
migrating behind the cargo compartment
sidewall liners and upward into the main
cabin. The FAA is issuing this AD to address
a fire in the bilge area of the cargo
compartment, which if not contained could
lead to a possible smoke and fire event in the
passenger compartment.
(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
(g) Required Actions
Except as specified by paragraph (h) of this
AD: At the applicable times specified in
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paragraph 1.E., ‘‘Compliance,’’ of Boeing
Special Attention Service Bulletin 767–25–
0550, Revision 1, dated December 4, 2019, do
all applicable actions identified as ‘‘RC’’
(required for compliance) in, and in
accordance with, the Accomplishment
Instructions of Boeing Special Attention
Service Bulletin 767–25–0550, Revision 1,
dated December 4, 2019.
(h) Exception to Service Information
Specifications
Where Boeing Special Attention Service
Bulletin 767–25–0550, Revision 1, dated
December 4, 2019, uses the phrase ‘‘the
Revision 1 date of this service bulletin,’’ this
AD requires using ‘‘the effective date of this
AD.’’
(i) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, Seattle ACO Branch,
FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures
found in 14 CFR 39.19. In accordance with
14 CFR 39.19, send your request to your
principal inspector or local Flight Standards
District Office, as appropriate. If sending
information directly to the manager of the
certification office, send it to the attention of
the person identified in paragraph (j)(1) of
this AD. Information may be emailed to: 9ANM-Seattle-ACO-AMOC-Requests@faa.gov.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(3) An AMOC that provides an acceptable
level of safety may be used for any repair,
modification, or alteration required by this
AD if it is approved by The Boeing Company
Organization Designation Authorization
(ODA) that has been authorized by the
Manager, Seattle ACO Branch, FAA, to make
those findings. To be approved, the repair
method, modification deviation, or alteration
deviation must meet the certification basis of
the airplane, and the approval must
specifically refer to this AD.
(4) AMOCs approved previously for AD
2016–25–29 are approved as AMOCs for the
corresponding provisions of Boeing Special
Attention Service Bulletin 767–25–0550,
Revision 1, dated December 4, 2019, that are
required by paragraph (g) of this AD.
(5) For service information that contains
steps that are labeled as Required for
Compliance (RC), the provisions of
paragraphs (i)(5)(i) and (ii) of this AD apply.
(i) The steps labeled as RC, including
substeps under an RC step and any figures
identified in an RC step, must be done to
comply with the AD. If a step or substep is
labeled ‘‘RC Exempt,’’ then the RC
requirement is removed from that step or
substep. An AMOC is required for any
deviations to RC steps, including substeps
and identified figures.
(ii) Steps not labeled as RC may be
deviated from using accepted methods in
accordance with the operator’s maintenance
or inspection program without obtaining
approval of an AMOC, provided the RC steps,
including substeps and identified figures, can
still be done as specified, and the airplane
can be put back in an airworthy condition.
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(j) Related Information
(1) For more information about this AD,
contact Julie Linn, Aerospace Engineer,
Cabin Safety and Environmental Systems
Section, FAA, Seattle ACO Branch, 2200
South 216th St., Des Moines, WA 98198;
phone and fax: 206–231–3584; email:
Julie.Linn@faa.gov.
(2) For service information identified in
this AD, contact Boeing Commercial
Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd.,
MC 110–SK57, Seal Beach, CA 90740–5600;
telephone 562–797–1717; internet https://
www.myboeingfleet.com. You may view this
referenced service information at the FAA,
Airworthiness Products Section, Operational
Safety Branch, 2200 South 216th St., Des
Moines, WA. For information on the
availability of this material at the FAA, call
206–231–3195.
Issued on July 29, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives,
Compliance & Airworthiness Division,
Aircraft Certification Service.
[FR Doc. 2020–17362 Filed 8–7–20; 8:45 am]
BILLING CODE 4910–13–P
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.
Notification; establishment of
docket; request for comments.
ACTION:
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
SUMMARY:
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Federal Register / Vol. 85, No. 154 / Monday, August 10, 2020 / Proposed Rules
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.
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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
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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-201509-18/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
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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) (§ 112.2(a)(1) (21 CFR 112.2(a)(1)))
(the RCR exemption); (2) produced for
personal or on-farm consumption
(§ 112.2(a)(2)); or (3) not a raw
agricultural commodity (§ 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
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-
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produce commodities with low reported
consumption according to the
methodology used in developing the
RCR list: Artichoke, globe-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.
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
documents/guidance-industry-enforcement-policyentities-growing-harvesting-packing-or-holdinghops-wine-grapes.
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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
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R09–OAR–2020–0136; FRL–10012–
22–Region 9]
Air Plan Partial Approval and Partial
Disapproval; California; San Diego
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to partially
approve and partially disapprove
revisions to the San Diego Air Pollution
Control District (SDAPCD) portion of
the California State Implementation
Plan (SIP). These revisions concern the
District’s demonstration regarding
reasonably available control technology
(RACT) requirements and negative
declarations for the 2008 ozone national
ambient air quality standards (NAAQS
or ‘‘standards’’) in the San Diego ozone
SUMMARY:
nonattainment area (NAA) under the
jurisdiction of the SDAPCD. We are
taking comments on this proposal and
plan to follow with a final action.
DATES: Comments must be received on
or before September 9, 2020.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R09–
OAR–2020–0136 at https://
www.regulations.gov. For comments
submitted at Regulations.gov, follow the
online instructions for submitting
comments. Once submitted, comments
cannot be edited or removed from
Regulations.gov. The EPA may publish
any comment received to its public
docket. Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. Multimedia
submissions (audio, video, etc.) must be
accompanied by a written comment.
The written comment is considered the
official comment and should include
discussion of all points you wish to
make. The EPA will generally not
consider comments or comment
contents located outside of the primary
submission (i.e. on the web, cloud, or
other file sharing system). For
additional submission methods, please
contact the person identified in the FOR
FURTHER INFORMATION CONTACT section.
For the full EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
48127
making effective comments, please visit
https://www.epa.gov/dockets/
commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
Nancy Levin, EPA Region IX, 75
Hawthorne St., San Francisco, CA
94105. By phone: (415) 972–3848 or by
email at levin.nancy@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document, ‘‘we,’’ ‘‘us’’
and ‘‘our’’ refer to the EPA.
Table of Contents
I. The State’s Submittal
A. What document did the State submit?
B. Are there other versions of this
document?
C. What is the purpose of the submitted
document?
II. The EPA’s Evaluation and Action
A. How is the EPA evaluating the
submitted document?
B. Does the document meet the evaluation
criteria?
C. What are the deficiencies?
D. EPA Recommendations to Further
Improve the RACT SIP
E. Public Comment And Proposed Action
III. Statutory and Executive Order Reviews
I. The State’s Submittal
A. What document did the State submit?
Table 1 lists the document addressed
by this proposal with the date that it
was adopted by the local air agency and
submitted by the California Air
Resources Board (CARB).
TABLE 1—SUBMITTED DOCUMENT
Local agency
Document
Adopted
Submitted
SDAPCD ...........
2008 Eight-Hour Ozone Reasonably Available Control Technology Demonstration for San
Diego County (‘‘2016 RACT SIP’’).
12/14/16
4/12/2017
On October 12, 2017, the submittal for
the SDAPCD 2016 RACT SIP was
deemed by operation of law to meet the
completeness criteria in 40 CFR part 51
Appendix V, which must be met before
formal EPA review.
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B. Are there other versions of this
document?
There are no previous versions of the
RACT SIP and negative declarations in
the SDAPCD portion of the California
SIP for the 2008 ozone NAAQS.
C. What is the purpose of the submitted
document?
Emissions of volatile organic
compounds (VOCs) and oxides of
nitrogen (NOX) contribute to the
production of ground-level ozone, smog
and particulate matter (PM), which
harm human health and the
environment. Section 110(a) of the CAA
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requires states to submit regulations that
control VOC and NOX emissions.
Sections 182(b)(2) and (f) require that
SIPs for ozone NAAs classified as
Moderate or above implement RACT for
any source covered by a Control
Techniques Guidelines (CTG) document
and for any major source of VOCs or
NOX. The SDAPCD is subject to this
requirement as it regulates the San
Diego ozone NAA that was designated
and classified as a Moderate NAA for
the 2008 ozone NAAQS at the time of
submittal.1 Therefore, the SDAPCD
1 The EPA has since reclassified the San Diego
ozone nonattainment area to ‘‘Serious’’ because the
EPA determined that the area had not attained the
2008 ozone standard by the ‘‘Moderate’’ applicable
attainment date (July 20, 2018) and did not qualify
for a 1-year extension of the Moderate area
attainment date. 84 FR 44238 (August 23, 2019).
SDAPCD will be required to make a separate,
PO 00000
Frm 00006
Fmt 4702
Sfmt 4702
must, at a minimum, adopt RACT-level
controls for all sources covered by a
CTG document and for all major nonCTG sources of VOC or NOX emissions
within the ozone NAA that it regulates.
Any stationary source that emits or has
the potential to emit at least 100 tons
per year (tpy) of VOCs or NOX is a major
stationary source in a Moderate ozone
NAA (CAA section 182(b)(2), (f) and
302(j)).
Section III.D of the preamble to the
EPA’s final rule to implement the 2008
ozone NAAQS discusses RACT
requirements.2 It states, in part, that
RACT SIPs must contain adopted RACT
regulations, certifications where
appropriate that existing provisions are
RACT, and/or negative declarations that
updated RACT submittal based on this new
classification.
2 80 FR 12264, (March 6, 2015).
E:\FR\FM\10AUP1.SGM
10AUP1
]]>Agencies
[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
[[Page 48126]]
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,''
[[Page 48127]]
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
