Waivers From Requirements of the Sanitary Transportation of Human and Animal Food Rule, 16733-16735 [2017-06854]
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16733
Federal Register / Vol. 82, No. 65 / Thursday, April 6, 2017 / Rules and Regulations
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HONG KONG
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Brilliance Technology Ltd, a.k.a., Brilliance Technology 79 FR 34220, June 16, 2014. 82 FR [INSERT Federal
Group, Flat A, 11/F, Adolfo Mansion, 114–116 Austin
Register PAGE NUMBER] April 6, 2017.
Road, Tsim Sha Tsui, Yau Tsim Mong, Hong Kong;
and Rm. 1203, 12/F, Hip Kwan Commercial Bldg., 38
Pitt Street, Yau Ma Tei, Yau Tsim Mong, Hong Kong.
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Ling Ao Electronic Technology Co. Ltd., a.k.a. Voyage
Technology (HK) Co. Ltd., a.k.a. Xuan Qi Technology
Co., Ltd.
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80 FR 4779, January 29, 2015.
80 FR 60529, October 7, 2015.
82 FR [INSERT Federal Register PAGE NUMBER]
April 6, 2017.
Room 17, 7/F, Metro Centre Phase 1, No. 32 Lam Hing
St., Kowloon Bay, Kwun Tong, Hong Kong; and
15B, 15/F, Cheuk Nang Plaza, 250 Hennessy Road,
Wanchai, Hong Kong; and
Flat C, 11/F, Block No. 2, Camelpaint Bldg. 62 Hoi
Yuen Street, Kwun Tong, Kowloon, Hong Kong; and
Room C1–D, 6/F, Wing Hing Industrial Building 14 Hing
Yip Street, Kwun Tong, Kowloon, Hong Kong; and
Flat/Rm. A30, 9/F Silvercorp International Tower, 707–
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and
Room, 912A, 9/F. Witty Commercial Building, 1A–1L
Tung Choi Street, Mongkok, Kowloon, Hong Kong;
and
Unit A, 7/F, King Yip Factory Bldg., 59 King Yip Street,
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LEBANON ............................ Al Ghayth Trade and Transport, 1st Floor, Bohsali
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UNITED ARAB EMIRATES
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82 FR [INSERT Federal Register PAGE NUMBER]
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Blue Wing General Trading, Damas Tower #506, Al 82 FR [INSERT Federal Register PAGE NUMBER]
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Dated: March 29, 2017.
Matthew S. Borman,
Deputy Assistant Secretary for Export
Administration.
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Federal Food, Drug, and Cosmetic Act
(FD&C Act).
DATES: The waivers are effective as of
April 6, 2017.
FOR FURTHER INFORMATION CONTACT:
Michael Kashtock, Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2022,
Michael.Kashtock@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2017–06857 Filed 4–5–17; 8:45 am]
BILLING CODE 3510–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
I. Background
21 CFR Part 1
[Docket No. FDA–2013–N–0013]
Waivers From Requirements of the
Sanitary Transportation of Human and
Animal Food Rule
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK3G9T082PROD with RULES
ACTION:
Notification.
The Food and Drug
Administration (FDA, Agency, or we) is
publishing three waivers from the
requirements of the Sanitary
Transportation of Human and Animal
Food (the Sanitary Transportation rule).
The Agency is taking this action in
accord with the requirements of the
SUMMARY:
VerDate Sep<11>2014
18:09 Apr 05, 2017
Jkt 241001
In a proposed rule published on
February 5, 2014 (79 FR 7006), entitled
‘‘Sanitary Transportation of Human and
Animal Food,’’ the Agency announced
that it had tentatively determined that,
in accordance with the provisions of
section 416 (21 U.S.C. 350e) of the
FD&C Act,1 it would be appropriate to
waive the applicable provisions of the
rule, if finalized as proposed, with
1 Section 416(d) of the FD&C Act states that the
Secretary of Health and Human Services may waive
any requirement under this section, with respect to
any class of persons, vehicles, food, or nonfood
products, if the Secretary determines that the
waiver will not result in the transportation of food
under conditions that would be unsafe for human
or animal health; and will not be contrary to the
public interest.
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
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*
respect to the following classes of
persons:
• Shippers, carriers, and receivers
who hold valid permits and are
inspected under the National
Conference on Interstate Milk
Shipments Grade ‘‘A’’ Milk Safety
Program, only when engaged in
transportation operations involving
Grade ‘‘A’’ milk and milk products and
• Food establishments holding valid
permits, only when engaged in
transportation operations as receivers,
or as shippers and carriers in operations
in which food is relinquished to
consumers after transportation from the
establishment.
We requested comment regarding
whether these proposed waivers could
result in the transportation of food
under conditions that would be unsafe
for human or animal health, or could be
contrary to the public interest. We did
not receive any comments with
information indicating that these
waivers would lead to these outcomes.
We published the final rule on April 6,
2016 (81 FR 20091), and established an
effective date of June 6, 2016, but did
not finalize the proposed waivers at that
time, stating that we intended to do so
prior to the rule’s initial compliance
E:\FR\FM\06APR1.SGM
06APR1
mstockstill on DSK3G9T082PROD with RULES
16734
Federal Register / Vol. 82, No. 65 / Thursday, April 6, 2017 / Rules and Regulations
date of April 6, 2017 (81 FR 20091 at
20106). We are finalizing these waivers
through this notification. These waivers
are effective upon publication of this
notification. In the final rule, we also
stated that we would discuss, in a
subsequent notice, our thinking on
comments we received asking us to
consider publishing an additional
waiver for transportation operations for
molluscan shellfish for entities that hold
valid State permits under the National
Shellfish Sanitation Program (NSSP) (81
FR 20091 at 20106).
In response to the proposed rule, we
did receive comments requesting that
we modify or expand the scope of these
waivers beyond that which we
discussed in the proposed rule. We
received information from an
organization representing institutional
foodservice establishments that
provided details about the operational
practices of these establishments
relevant to the scope of the proposed
waiver.
We have evaluated the comments and
information that we received to
determine whether we should modify
any of the waivers. We have modified
the language of the waivers to clarify
their applicability only to businesses
subject to the requirements of 21 CFR
part 1, subpart O. We have made a
clarification to the Grade ‘‘A’’ milk
waiver to specify that it applies to the
transportation of bulk and finished
Grade ‘‘A’’ milk products. We have also
made clarifications to the food
establishment waiver to better express
the types of businesses within its scope,
and to incorporate established
definitions in 21 CFR 1.227 to describe
the food establishments for which this
waiver is available. We have also
revised the language of this waiver to
make clear that it applies to receiving
and delivery operations of a food
establishment that are part of the normal
business operations of the
establishment. In addition, we have
modified the language of the food
establishment waiver to recognize that
State or local authorities may vary in the
methods they use to authorize
establishments to operate. We have
included our analysis of these
comments as a reference to this notice
(Ref. 1). We also are making this
document available at https://
www.fda.gov/Food/
GuidanceRegulation/FSMA/
ucm383763.htm.
In addition, we have evaluated
comments we received asking us to
consider publishing an additional
waiver for certain transportation
operations for molluscan shellfish
performed by persons that hold valid
VerDate Sep<11>2014
18:09 Apr 05, 2017
Jkt 241001
State permits (meaning that they are
appropriately certified) under the NSSP.
Participants in the NSSP include
agencies from shellfish producing and
non-producing States, FDA, the
Environmental Protection Agency, the
National Oceanic and Atmospheric
Administration, and the shellfish
industry. Under international
agreements with FDA, foreign
governments also participate in the
NSSP. The purpose of the program is to
promote and improve the sanitation of
shellfish (oysters, clams, mussels, and
scallops) moving in interstate commerce
through Federal/State cooperation and
uniformity of State shellfish programs.
The NSSP uses as its basic standard the
Guide for the Control of Molluscan
Shellfish (GCMS), which incorporates a
Model Ordinance and related materials
(Ref. 2). The Model Ordinance provides
readily adoptable standards and
administrative practices necessary for
the sanitary control of molluscan
shellfish. Provisions of the GCMS and
the NSSP address several aspects of the
transportation of molluscan shellfish in
interstate commerce including
requirements for conveyances,
containers used for holding product
during transportation, sanitation and
temperature control. Through their
participation in the NSSP and
membership in the Interstate Shellfish
Sanitation Conference, states have
agreed to enforce the Model Ordinance
as the requirements which are
minimally necessary for the sanitary
control of molluscan shellfish.
The GCMS, and the state regulations
modeled after it, specify that every
shellstock shipper, i.e., a dealer who
grows, harvests, buys, or repacks and
sells shellstock (live molluscan shellfish
in the shell) shall be certified by a State
shellfish control authority or its
designated agents. Furthermore, when
any requirement of the NSSP is violated,
the shipper could be subject to
decertification.
We have determined that waiving the
requirements of part 1, subpart O, with
respect to shippers, loaders, carriers,
and receivers who are appropriately
certified and inspected under the NSSP,
would not result in the transportation of
food under conditions that would be
unsafe for human or animal health and
would not be contrary to the public
interest. Specifically, we have
determined that shippers, loaders,
carriers, and receivers who are
appropriately certified and are
inspected under the NSSP, and
transport molluscan shellfish in
vehicles that are permitted, or otherwise
appropriately licensed by the State
NSSP certification authority, by
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
complying with requirements that are
based upon those set forth in the GCMS,
are using sanitary transportation
practices to ensure that molluscan
shellfish are not transported under
conditions that may render such
products unsafe.
In accordance with the requirements
of section 416 of the FD&C Act, by this
notice we are waiving the following
persons from the applicable
requirements of the Sanitary
Transportation rule:
• Businesses subject to the
requirements of part 1, subpart O, that
hold valid permits and are inspected
under the National Conference on
Interstate Milk Shipments’ Grade ‘‘A’’
Milk Safety Program, only when
engaged in transportation operations
involving bulk and finished Grade ‘‘A’’
milk and milk products.
• Businesses subject to the
requirements of part 1, subpart O, that
are permitted or otherwise authorized
by the regulatory authority to operate a
food establishment that provides food
directly to consumers (i.e., restaurants,
retail food establishments, and
nonprofit food establishments as
defined in 21 CFR 1.227), only when
engaged in transportation operations as:
Æ Receivers, whether the food is
received at the establishment itself or at
a location where the authorized
establishment receives and immediately
transports the food to the food
establishment;
Æ shippers and carriers in operations
in which food is transported from the
establishment as part of the normal
business operations of a retail
establishment, such as:
• Delivery of the food directly to the
consumer(s) by the authorized
establishment or a third-party delivery
service or;
• delivery of the food to another
location operated by the authorized
establishment or an affiliated
establishment where the food is to be
sold or served directly to the
consumer(s).
• Businesses subject to the
requirements of part 1, subpart O, that
are appropriately certified and are
inspected under the requirements
established by the Interstate Shellfish
Sanitation Conference’s NSSP, only
when engaged in transportation
operations involving molluscan
shellfish in vehicles that are permitted
by the State NSSP certification
authority.
These waivers are effective upon
publication of this notification. The
issuance of these waivers is
deregulatory in nature because they
lessen the burden imposed on shippers,
E:\FR\FM\06APR1.SGM
06APR1
Federal Register / Vol. 82, No. 65 / Thursday, April 6, 2017 / Rules and Regulations
receivers, loaders, and carriers engaged
in transportation operations without
impairing our ability to ensure the
safety of food. The waivers will remove
certain classes of persons from having to
comply with the requirements of part 1,
subpart O.
II. References
The following references are on
display in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 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 Web site addresses, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
1. Food and Drug Administration
Center for Food Safety and Applied
Nutrition Analysis of Comments
Submitted to Docket FDA 2013–N–0013
Regarding Waivers from the
Requirements of 21 CFR part 1, subpart
O—Sanitary Transportation of Human
and Animal Food, March 2017.
Available also at https://www.fda.gov/
Food/GuidanceRegulation/FSMA/
ucm383763.htm.
2. ‘‘National Shellfish Sanitation
Program (NSSP) Guide for the Control of
Molluscan Shellfish 2015 Revision’’,
available at: https://www.fda.gov/
downloads/Food/GuidanceRegulation/
FederalStateFoodPrograms/
UCM505093.pdf.
Dated: April 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–06854 Filed 4–5–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2017–0147]
Drawbridge Operation Regulation;
Yellow Mill Channel, Bridgeport, CT
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation.
mstockstill on DSK3G9T082PROD with RULES
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
schedule that governs the Stratford
Avenue Bridge across Yellow Mill
Channel, mile 0.3 at Bridgeport,
SUMMARY:
VerDate Sep<11>2014
18:09 Apr 05, 2017
Jkt 241001
Connecticut. This deviation is necessary
to complete electrical repairs, install
new rebar and concrete, repair/replace
structural steel, and retrofit navigation
lighting. This deviation allows the
bridge to remain fully closed for two
weeks followed by a two-week period
during which the bridge will open for
vessels upon 72 hours of advance
notice.
This deviation is effective from
12:01 a.m. on April 1, 2017 to 12:01 a.m.
on May 1, 2017.
ADDRESSES: The docket for this
deviation, USCG–2017–0147, is
available at https://www.regulations.gov.
Type the docket number in the
‘‘SEARCH’’ box and click ‘‘SEARCH’’.
Click on Open Docket Folder on the line
associated with this deviation.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
deviation, call or email James M. Moore,
Bridge Management Specialist, First
District Bridge Branch, U.S. Coast
Guard; telephone 212–514–4334, email
james.m.moore2@uscg.mil.
SUPPLEMENTARY INFORMATION: The
Connecticut Department of
Transportation, the owner of the bridge,
requested a temporary deviation to
facilitate rehabilitation of the bridge and
bascule leaves. The Stratford Avenue
Bridge, across Yellow Mill Channel,
mile 0.3 at Bridgeport, Connecticut is a
double-leaf bascule bridge offering
mariners a vertical clearance of 11 feet
at mean high water and 17 feet at mean
low water in the closed position. The
existing drawbridge operating
regulations are listed at 33 CFR 117.225.
The bulk of traffic utilizing the
waterway is recreational in nature,
requiring only occasional openings of
the bridge in order to proceed.
Under this temporary deviation, the
Stratford Avenue Bridge shall remain in
the closed position from April 1, 2017
to April 15, 2017. Between April 15,
2017 and May 1, 2017, the span will
open for the passage of vessels requiring
an opening provided 72 hours of
advance notice is furnished to the
owner of the bridge.
Vessels that can pass under the bridge
without an opening may do so at all
times. The bridge will not be able to
open for emergencies. There is no
alternate route for vessels to pass.
The Coast Guard will also inform the
users of the waterways through our
Local and Broadcast Notices to Mariners
of the change in operating schedule for
the bridge so that vessel operators can
arrange their transits to minimize any
impact caused by the temporary
deviation.
DATES:
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Fmt 4700
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16735
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the effective period of this
temporary deviation. This deviation
from the operating regulations is
authorized under 33 CFR 117.35.
Dated: March 31, 2017.
C.J. Bisignano,
Supervisory Bridge Management Specialist,
First Coast Guard District.
[FR Doc. 2017–06818 Filed 4–5–17; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2017–0048]
Drawbridge Operation Regulation;
Atlantic Beach Bridge, Reynolds
Channel, Lawrence, NY
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
schedule that governs the Atlantic
Beach Bridge across Reynolds Channel,
mile 0.4 at Lawrence, New York. This
action is necessary to recoat the
superstructure and reconstruct the
double-leaf bascule spans in three
sequential two month stages within six
months. The deviation will allow the
bridge to open only one bascule span at
a time in order to provide passage for
vessels that require an opening.
DATES: This deviation is effective from
12:01 a.m. on April 17, 2017 to 11:59
p.m. on October 13, 2017.
ADDRESSES: The docket for this
deviation, USCG–2017–0048 is available
at https://www.regulations.gov. Type the
docket number in the ‘‘SEARCH’’ box
and click ‘‘SEARCH’’. Click on Open
Docket Folder on the line associated
with this deviation.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
deviation, call or email James M. Moore,
Bridge Management Specialist, First
District Bridge Branch, U.S. Coast
Guard; telephone 212–514–4334, email
james.m.moore2@uscg.mil.
SUPPLEMENTARY INFORMATION: The
Nassau County Bridge Authority, the
owner of the bridge, requested a
temporary deviation in order to
facilitate reconstruction of the bascule
leaves. The Atlantic Beach Bridge across
Reynolds Channel, mile 0.4 at
SUMMARY:
E:\FR\FM\06APR1.SGM
06APR1
Agencies
[Federal Register Volume 82, Number 65 (Thursday, April 6, 2017)]
[Rules and Regulations]
[Pages 16733-16735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06854]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. FDA-2013-N-0013]
Waivers From Requirements of the Sanitary Transportation of Human
and Animal Food Rule
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
publishing three waivers from the requirements of the Sanitary
Transportation of Human and Animal Food (the Sanitary Transportation
rule). The Agency is taking this action in accord with the requirements
of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: The waivers are effective as of April 6, 2017.
FOR FURTHER INFORMATION CONTACT: Michael Kashtock, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-2022,
Michael.Kashtock@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In a proposed rule published on February 5, 2014 (79 FR 7006),
entitled ``Sanitary Transportation of Human and Animal Food,'' the
Agency announced that it had tentatively determined that, in accordance
with the provisions of section 416 (21 U.S.C. 350e) of the FD&C Act,\1\
it would be appropriate to waive the applicable provisions of the rule,
if finalized as proposed, with respect to the following classes of
persons:
---------------------------------------------------------------------------
\1\ Section 416(d) of the FD&C Act states that the Secretary of
Health and Human Services may waive any requirement under this
section, with respect to any class of persons, vehicles, food, or
nonfood products, if the Secretary determines that the waiver will
not result in the transportation of food under conditions that would
be unsafe for human or animal health; and will not be contrary to
the public interest.
---------------------------------------------------------------------------
Shippers, carriers, and receivers who hold valid permits
and are inspected under the National Conference on Interstate Milk
Shipments Grade ``A'' Milk Safety Program, only when engaged in
transportation operations involving Grade ``A'' milk and milk products
and
Food establishments holding valid permits, only when
engaged in transportation operations as receivers, or as shippers and
carriers in operations in which food is relinquished to consumers after
transportation from the establishment.
We requested comment regarding whether these proposed waivers could
result in the transportation of food under conditions that would be
unsafe for human or animal health, or could be contrary to the public
interest. We did not receive any comments with information indicating
that these waivers would lead to these outcomes. We published the final
rule on April 6, 2016 (81 FR 20091), and established an effective date
of June 6, 2016, but did not finalize the proposed waivers at that
time, stating that we intended to do so prior to the rule's initial
compliance
[[Page 16734]]
date of April 6, 2017 (81 FR 20091 at 20106). We are finalizing these
waivers through this notification. These waivers are effective upon
publication of this notification. In the final rule, we also stated
that we would discuss, in a subsequent notice, our thinking on comments
we received asking us to consider publishing an additional waiver for
transportation operations for molluscan shellfish for entities that
hold valid State permits under the National Shellfish Sanitation
Program (NSSP) (81 FR 20091 at 20106).
In response to the proposed rule, we did receive comments
requesting that we modify or expand the scope of these waivers beyond
that which we discussed in the proposed rule. We received information
from an organization representing institutional foodservice
establishments that provided details about the operational practices of
these establishments relevant to the scope of the proposed waiver.
We have evaluated the comments and information that we received to
determine whether we should modify any of the waivers. We have modified
the language of the waivers to clarify their applicability only to
businesses subject to the requirements of 21 CFR part 1, subpart O. We
have made a clarification to the Grade ``A'' milk waiver to specify
that it applies to the transportation of bulk and finished Grade ``A''
milk products. We have also made clarifications to the food
establishment waiver to better express the types of businesses within
its scope, and to incorporate established definitions in 21 CFR 1.227
to describe the food establishments for which this waiver is available.
We have also revised the language of this waiver to make clear that it
applies to receiving and delivery operations of a food establishment
that are part of the normal business operations of the establishment.
In addition, we have modified the language of the food establishment
waiver to recognize that State or local authorities may vary in the
methods they use to authorize establishments to operate. We have
included our analysis of these comments as a reference to this notice
(Ref. 1). We also are making this document available at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm383763.htm.
In addition, we have evaluated comments we received asking us to
consider publishing an additional waiver for certain transportation
operations for molluscan shellfish performed by persons that hold valid
State permits (meaning that they are appropriately certified) under the
NSSP.
Participants in the NSSP include agencies from shellfish producing
and non-producing States, FDA, the Environmental Protection Agency, the
National Oceanic and Atmospheric Administration, and the shellfish
industry. Under international agreements with FDA, foreign governments
also participate in the NSSP. The purpose of the program is to promote
and improve the sanitation of shellfish (oysters, clams, mussels, and
scallops) moving in interstate commerce through Federal/State
cooperation and uniformity of State shellfish programs. The NSSP uses
as its basic standard the Guide for the Control of Molluscan Shellfish
(GCMS), which incorporates a Model Ordinance and related materials
(Ref. 2). The Model Ordinance provides readily adoptable standards and
administrative practices necessary for the sanitary control of
molluscan shellfish. Provisions of the GCMS and the NSSP address
several aspects of the transportation of molluscan shellfish in
interstate commerce including requirements for conveyances, containers
used for holding product during transportation, sanitation and
temperature control. Through their participation in the NSSP and
membership in the Interstate Shellfish Sanitation Conference, states
have agreed to enforce the Model Ordinance as the requirements which
are minimally necessary for the sanitary control of molluscan
shellfish.
The GCMS, and the state regulations modeled after it, specify that
every shellstock shipper, i.e., a dealer who grows, harvests, buys, or
repacks and sells shellstock (live molluscan shellfish in the shell)
shall be certified by a State shellfish control authority or its
designated agents. Furthermore, when any requirement of the NSSP is
violated, the shipper could be subject to decertification.
We have determined that waiving the requirements of part 1, subpart
O, with respect to shippers, loaders, carriers, and receivers who are
appropriately certified and inspected under the NSSP, would not result
in the transportation of food under conditions that would be unsafe for
human or animal health and would not be contrary to the public
interest. Specifically, we have determined that shippers, loaders,
carriers, and receivers who are appropriately certified and are
inspected under the NSSP, and transport molluscan shellfish in vehicles
that are permitted, or otherwise appropriately licensed by the State
NSSP certification authority, by complying with requirements that are
based upon those set forth in the GCMS, are using sanitary
transportation practices to ensure that molluscan shellfish are not
transported under conditions that may render such products unsafe.
In accordance with the requirements of section 416 of the FD&C Act,
by this notice we are waiving the following persons from the applicable
requirements of the Sanitary Transportation rule:
Businesses subject to the requirements of part 1, subpart
O, that hold valid permits and are inspected under the National
Conference on Interstate Milk Shipments' Grade ``A'' Milk Safety
Program, only when engaged in transportation operations involving bulk
and finished Grade ``A'' milk and milk products.
Businesses subject to the requirements of part 1, subpart
O, that are permitted or otherwise authorized by the regulatory
authority to operate a food establishment that provides food directly
to consumers (i.e., restaurants, retail food establishments, and
nonprofit food establishments as defined in 21 CFR 1.227), only when
engaged in transportation operations as:
[cir] Receivers, whether the food is received at the establishment
itself or at a location where the authorized establishment receives and
immediately transports the food to the food establishment;
[cir] shippers and carriers in operations in which food is
transported from the establishment as part of the normal business
operations of a retail establishment, such as:
Delivery of the food directly to the consumer(s) by the
authorized establishment or a third-party delivery service or;
delivery of the food to another location operated by the
authorized establishment or an affiliated establishment where the food
is to be sold or served directly to the consumer(s).
Businesses subject to the requirements of part 1, subpart
O, that are appropriately certified and are inspected under the
requirements established by the Interstate Shellfish Sanitation
Conference's NSSP, only when engaged in transportation operations
involving molluscan shellfish in vehicles that are permitted by the
State NSSP certification authority.
These waivers are effective upon publication of this notification.
The issuance of these waivers is deregulatory in nature because they
lessen the burden imposed on shippers,
[[Page 16735]]
receivers, loaders, and carriers engaged in transportation operations
without impairing our ability to ensure the safety of food. The waivers
will remove certain classes of persons from having to comply with the
requirements of part 1, subpart O.
II. References
The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 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 Web site addresses, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.
1. Food and Drug Administration Center for Food Safety and Applied
Nutrition Analysis of Comments Submitted to Docket FDA 2013-N-0013
Regarding Waivers from the Requirements of 21 CFR part 1, subpart O--
Sanitary Transportation of Human and Animal Food, March 2017. Available
also at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm383763.htm.
2. ``National Shellfish Sanitation Program (NSSP) Guide for the
Control of Molluscan Shellfish 2015 Revision'', available at: https://www.fda.gov/downloads/Food/GuidanceRegulation/FederalStateFoodPrograms/UCM505093.pdf.
Dated: April 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-06854 Filed 4-5-17; 8:45 am]
BILLING CODE 4164-01-P