82 FR 16733 - Waivers From Requirements of the Sanitary Transportation of Human and Animal Food Rule
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 65 (April 6, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 65 (April 6, 2017)
| Page Range | 16733-16735 | |
| FR Document | 2017-06854 |
[Federal Register Volume 82, Number 65 (Thursday, April 6, 2017)] [Rules and Regulations] [Pages 16733-16735] From the Federal Register Online [www.thefederalregister.org] [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, [email protected]. 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: http://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
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Country Listed person and address Federal Register citation and date of publication
* * * * * * *
HONG KONG * * * * *
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.
* * * * * * *
Ling Ao Electronic Technology Co. Ltd., a.k.a. Voyage 80 FR 4779, January 29, 2015.
Technology (HK) Co. Ltd., a.k.a. Xuan Qi Technology 80 FR 60529, October 7, 2015.
Co., Ltd. 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–
713 Nathan Road, Mongkok, Kowloon, Hong Kong;
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,
Kwun Tong, Kowloon, Hong Kong.
* * * * * * *
LEBANON ............................ Al Ghayth Trade and Transport, 1st Floor, Bohsali 82 FR [INSERT Federal Register PAGE NUMBER]
Bldg., Beirut Port Street, Beirut, Lebanon. April 6, 2017.
* * * * * * *
UNITED ARAB EMIRATES * * * * *
Blue Wing General Trading, Damas Tower #506, Al 82 FR [INSERT Federal Register PAGE NUMBER]
Maktoum Road, Dubai, UAE. April 6, 2017.
* * * * * * *
Dated: March 29, 2017. Federal Food, Drug, and Cosmetic Act respect to the following classes of
Matthew S. Borman, (FD&C Act). persons:
Deputy Assistant Secretary for Export DATES: The waivers are effective as of • Shippers, carriers, and receivers
Administration. April 6, 2017. who hold valid permits and are
[FR Doc. 2017–06857 Filed 4–5–17; 8:45 am] FOR FURTHER INFORMATION CONTACT:
inspected under the National
BILLING CODE 3510–33–P Michael Kashtock, Center for Food Conference on Interstate Milk
Safety and Applied Nutrition, Food and Shipments Grade ‘‘A’’ Milk Safety
Drug Administration, 5001 Campus Dr., Program, only when engaged in
DEPARTMENT OF HEALTH AND College Park, MD 20740, 240–402–2022, transportation operations involving
HUMAN SERVICES Michael.Kashtock@fda.hhs.gov. Grade ‘‘A’’ milk and milk products and
• Food establishments holding valid
SUPPLEMENTARY INFORMATION: permits, only when engaged in
Food and Drug Administration
I. Background transportation operations as receivers,
21 CFR Part 1 or as shippers and carriers in operations
In a proposed rule published on
in which food is relinquished to
[Docket No. FDA–2013–N–0013] February 5, 2014 (79 FR 7006), entitled
consumers after transportation from the
‘‘Sanitary Transportation of Human and
establishment.
Waivers From Requirements of the Animal Food,’’ the Agency announced We requested comment regarding
Sanitary Transportation of Human and that it had tentatively determined that, whether these proposed waivers could
Animal Food Rule in accordance with the provisions of result in the transportation of food
section 416 (21 U.S.C. 350e) of the under conditions that would be unsafe
AGENCY: Food and Drug Administration,
FD&C Act,1 it would be appropriate to for human or animal health, or could be
HHS.
waive the applicable provisions of the contrary to the public interest. We did
ACTION: Notification. rule, if finalized as proposed, with not receive any comments with
SUMMARY: The Food and Drug information indicating that these
mstockstill on DSK3G9T082PROD with RULES
1 Section 416(d) of the FD&C Act states that the
Administration (FDA, Agency, or we) is Secretary of Health and Human Services may waive
waivers would lead to these outcomes.
publishing three waivers from the any requirement under this section, with respect to We published the final rule on April 6,
requirements of the Sanitary any class of persons, vehicles, food, or nonfood 2016 (81 FR 20091), and established an
Transportation of Human and Animal products, if the Secretary determines that the effective date of June 6, 2016, but did
waiver will not result in the transportation of food
Food (the Sanitary Transportation rule). under conditions that would be unsafe for human
not finalize the proposed waivers at that
The Agency is taking this action in or animal health; and will not be contrary to the time, stating that we intended to do so
accord with the requirements of the public interest. prior to the rule’s initial compliance
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![Federal Register / Vol. 82, No. 65 / Thursday, April 6, 2017 / Rules and Regulations 16735
receivers, loaders, and carriers engaged Connecticut. This deviation is necessary In accordance with 33 CFR 117.35(e),
in transportation operations without to complete electrical repairs, install the drawbridge must return to its regular
impairing our ability to ensure the new rebar and concrete, repair/replace operating schedule immediately at the
safety of food. The waivers will remove structural steel, and retrofit navigation end of the effective period of this
certain classes of persons from having to lighting. This deviation allows the temporary deviation. This deviation
comply with the requirements of part 1, bridge to remain fully closed for two from the operating regulations is
subpart O. weeks followed by a two-week period authorized under 33 CFR 117.35.
during which the bridge will open for Dated: March 31, 2017.
II. References
vessels upon 72 hours of advance C.J. Bisignano,
The following references are on notice.
Supervisory Bridge Management Specialist,
display in the Division of Dockets
DATES: This deviation is effective from First Coast Guard District.
Management (HFA–305), Food and Drug
12:01 a.m. on April 1, 2017 to 12:01 a.m. [FR Doc. 2017–06818 Filed 4–5–17; 8:45 am]
Administration, 5630 Fishers Lane, Rm.
on May 1, 2017. BILLING CODE 9110–04–P
1061, Rockville, MD 20852, and are
available for viewing by interested ADDRESSES: The docket for this
persons between 9 a.m. and 4 p.m., deviation, USCG–2017–0147, is
available at http://www.regulations.gov. DEPARTMENT OF HOMELAND
Monday through Friday; they are also
Type the docket number in the SECURITY
available electronically at https://
www.regulations.gov. FDA has verified ‘‘SEARCH’’ box and click ‘‘SEARCH’’.
Coast Guard
the Web site addresses, as of the date Click on Open Docket Folder on the line
this document publishes in the Federal associated with this deviation.
33 CFR Part 117
Register, but Web sites are subject to FOR FURTHER INFORMATION CONTACT: If
change over time. you have questions on this temporary [Docket No. USCG–2017–0048]
1. Food and Drug Administration deviation, call or email James M. Moore,
Center for Food Safety and Applied Drawbridge Operation Regulation;
Bridge Management Specialist, First
Nutrition Analysis of Comments Atlantic Beach Bridge, Reynolds
District Bridge Branch, U.S. Coast
Submitted to Docket FDA 2013–N–0013 Channel, Lawrence, NY
Guard; telephone 212–514–4334, email
Regarding Waivers from the james.m.moore2@uscg.mil. AGENCY: Coast Guard, DHS.
Requirements of 21 CFR part 1, subpart SUPPLEMENTARY INFORMATION: The ACTION:Notice of deviation from
O—Sanitary Transportation of Human Connecticut Department of drawbridge regulation.
and Animal Food, March 2017. Transportation, the owner of the bridge,
Available also at https://www.fda.gov/ requested a temporary deviation to SUMMARY: The Coast Guard has issued a
Food/GuidanceRegulation/FSMA/ facilitate rehabilitation of the bridge and temporary deviation from the operating
ucm383763.htm. bascule leaves. The Stratford Avenue schedule that governs the Atlantic
2. ‘‘National Shellfish Sanitation Bridge, across Yellow Mill Channel, Beach Bridge across Reynolds Channel,
Program (NSSP) Guide for the Control of mile 0.3 at Bridgeport, Connecticut is a mile 0.4 at Lawrence, New York. This
Molluscan Shellfish 2015 Revision’’, double-leaf bascule bridge offering action is necessary to recoat the
available at: http://www.fda.gov/ mariners a vertical clearance of 11 feet superstructure and reconstruct the
downloads/Food/GuidanceRegulation/ at mean high water and 17 feet at mean double-leaf bascule spans in three
FederalStateFoodPrograms/ low water in the closed position. The sequential two month stages within six
UCM505093.pdf. existing drawbridge operating months. The deviation will allow the
regulations are listed at 33 CFR 117.225. bridge to open only one bascule span at
Dated: April 3, 2017.
The bulk of traffic utilizing the a time in order to provide passage for
Leslie Kux,
waterway is recreational in nature, vessels that require an opening.
Associate Commissioner for Policy.
requiring only occasional openings of DATES: This deviation is effective from
[FR Doc. 2017–06854 Filed 4–5–17; 8:45 am]
the bridge in order to proceed. 12:01 a.m. on April 17, 2017 to 11:59
BILLING CODE 4164–01–P p.m. on October 13, 2017.
Under this temporary deviation, the
Stratford Avenue Bridge shall remain in ADDRESSES: The docket for this
the closed position from April 1, 2017 deviation, USCG–2017–0048 is available
DEPARTMENT OF HOMELAND at http://www.regulations.gov. Type the
to April 15, 2017. Between April 15,
SECURITY docket number in the ‘‘SEARCH’’ box
2017 and May 1, 2017, the span will
open for the passage of vessels requiring and click ‘‘SEARCH’’. Click on Open
Coast Guard
an opening provided 72 hours of Docket Folder on the line associated
advance notice is furnished to the with this deviation.
33 CFR Part 117
owner of the bridge. FOR FURTHER INFORMATION CONTACT: If
[Docket No. USCG–2017–0147] Vessels that can pass under the bridge you have questions on this temporary
without an opening may do so at all deviation, call or email James M. Moore,
Drawbridge Operation Regulation; Bridge Management Specialist, First
times. The bridge will not be able to
Yellow Mill Channel, Bridgeport, CT District Bridge Branch, U.S. Coast
open for emergencies. There is no
AGENCY: Coast Guard, DHS. alternate route for vessels to pass. Guard; telephone 212–514–4334, email
ACTION:Notice of deviation from The Coast Guard will also inform the james.m.moore2@uscg.mil.
mstockstill on DSK3G9T082PROD with RULES
drawbridge regulation. users of the waterways through our SUPPLEMENTARY INFORMATION: The
Local and Broadcast Notices to Mariners Nassau County Bridge Authority, the
SUMMARY: The Coast Guard has issued a of the change in operating schedule for owner of the bridge, requested a
temporary deviation from the operating the bridge so that vessel operators can temporary deviation in order to
schedule that governs the Stratford arrange their transits to minimize any facilitate reconstruction of the bascule
Avenue Bridge across Yellow Mill impact caused by the temporary leaves. The Atlantic Beach Bridge across
Channel, mile 0.3 at Bridgeport, deviation. Reynolds Channel, mile 0.4 at
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Document Created: 2017-04-06 01:46:31
Document Modified: 2017-04-06 01:46:31
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Notification. | |
| Dates | The waivers are effective as of April 6, 2017. | |
| Contact | Michael Kashtock, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2022, [email protected] | |
| FR Citation | 82 FR 16733 |
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