[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]


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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.

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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:
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    \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.
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     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