information about the maintenance of temperature control to shippers.''
We again emphasized during the College Park public meeting that we
``tried to develop this recordkeeping provision in a way that minimizes
the burden but recognizes the accountability of the carrier to
demonstrate to shippers that they are transporting refrigerated foods
or bulk foods under conditions that comply with requirements of the
rule.'' Accordingly, these comments are correct in observing that the
records retention requirements of this rule do not require carriers or
shippers to maintain for our examination, records documenting
conditions, such as temperature conditions, for individual shipments.
Carriers may, however, choose to retain such information to provide to
shippers upon request in accordance with Sec.  1.908(e)(2)(i).
    These comments also are correct in stating that this rule differs
from other FSMA rules because this rule does not require the
maintenance of records of ongoing transportation operations in the same
way that some other FSMA rules require the retention of specific
operating records. This rule, for example, does not mandate that
persons covered by this rule must maintain monitoring records as does
the FSMA preventive controls rules. We will ensure that our
investigators are trained to understand the unique recordkeeping
requirements of this rule.
    Finally, there are no requirements in this rule concerning the
retention of individual shipment records for our examination related to
truck inspections, or precooling and temperature monitoring activities.
Shippers and carriers, however, may choose to retain such information
for business purposes.
    (Comment 168) One comment states that the proposed rule requires
carriers to demonstrate the temperature conditions that are maintained
during transport, but fails to specify how long a carrier must maintain
these temperature condition records.
    (Response 168) A carrier may, but is not required to, create
records of temperature conditions maintained during the transportation
of food to provide to a shipper or a receiver upon request pursuant to
Sec.  1.908(e)(2)(i). This rule does not establish any retention time
requirements for these optional temperature condition records.
    (Comment 169) Some comments state that the proposed requirements to
store records onsite are contrary to accepted and effective
recordkeeping practices. Some of these comments state that companies
frequently keep records of food safety activities, as well as
transportation, cleaning, and training records at their corporate
offices and not at operating facilities and asks us to allow this
practice to continue. These comments also state that there is little
practical difference between maintaining records onsite at food
transportation facilities versus maintaining them offsite, for example,
at corporate offices, provided that they can be provided to duly
authorized individuals promptly upon an oral or written request, that
is, within 24 hours.
    (Response 169) We agree with this comment. Therefore, we have
revised Sec.  1.912(h) of this final rule to allow offsite storage of
all records, except for the written procedures required by Sec.
1.908(e)(6)(i), provided that the records can be retrieved and made
available to us within 24 hours of a request for official review. As
proposed, we will continue to require that the written procedures
required by Sec.  1.908(e)(6)(i) remain onsite as long as the
procedures are in use in transportation operations. These written
procedures comprise cleaning, sanitizing and inspection procedures for

vehicles and equipment, and we believe that they would normally be kept
on site because they are used in operations at the site. We are not
requiring that carriers maintain records of their actual cleaning,
sanitizing and inspection operations they perform on vehicles and
equipment. We anticipate that many records will be stored
electronically and therefore will be accessible from an onsite food
transportation facility.
    (Comment 170) A few comments state that it may be difficult for
some carriers to promptly provide records, depending on what we mean by
the term ``promptly.'' The comment provided an example of a small
carrier such as a motor vehicle owner/driver who might own a single
motor vehicle used to transport food, who may not carry required
records (e.g., training records) while in transit and who might
maintain the required records in a private residence. One of these
comments asks us to apply reasonable and flexible records production
timeframes in these circumstances.
    (Response 170) We anticipate that, to the extent feasible, we will
carry out records examinations at a carrier's fixed business location.
If we were to determine for any reason that it is necessary to request
records for examination from a small carrier while the carrier is in
transit, we would not necessarily expect the carrier to have the
records in its immediate possession, and would provide the carrier with
a reasonable amount of time to provide the records. Similarly, if for
any reason we were to request records that a carrier maintains at a
private residence, we would take into account the circumstances of the
of the transportation operation as they may affect the carrier's
ability to produce the records promptly.
    (Comment 171) One comment states that the records requirements of
the proposed rule would be difficult to comply with because the
shipper, carrier and receiver roles are not always easily identifiable
when food is transported sequentially by more than one person between
its point of origin and final destination.
    (Response 171) We understand that the sequential shipment of food
by multiple persons might involve many persons such as brokers, rail
carriers, motor carriers, distributors, etc., and that the roles of
these persons may vary from one circumstance to another. Therefore, we
have revised this final rule to better define the persons who are
subject to the requirements of this rule. As we explained in our
response to Comment 70, we have revised the definition of the term
``shipper'' to clarify the scope of this definition. As we also
discussed in our response to Comment 53, we have revised the definition
of the term ``carrier'' to focus it more narrowly on the person who is
responsible for the sanitary condition of the vehicle or transportation
equipment used to transport food and to exclude from the definition, a
person who is solely responsible for the movement of the vehicle or
equipment. We believe the clarity we have added to the shipper, loader,
carrier and receiver roles will make recordkeeping easier.
    (Comment 172) Some comments state that written agreements assigning
duties in compliance with this rule to other persons, as discussed in
our response to Comment 16, should be subject to the record keeping
provisions of this rule.
    (Response 172) We agree. As we discussed in our response to Comment
16, we expect that the parties would have a written contract as proof
of their agreement. To enable us to determine which party has
responsibility to fulfill a duty assigned by this rule, we are
establishing in Sec.  1.912(b) that written agreements assigning duties
in compliance with this rule are subject to the record keeping
provisions of this rule.
    (Comment 173) Some comments express concern that this rule's
recordkeeping requirements will pose a burden on businesses. One of
these comments states that this rule adds to other FDA records
requirements. Another comment questioning the necessity of the records
requirements of this rule, states that food transportation vehicles are
pre-cooled and inspected before they are loaded and if they do not meet
the required sanitary standards, they are refused or sent to be washed
out and that this information is recorded in the shipping paperwork and
can be provided to shippers, receivers, and FDA if necessary. Another
comment acknowledges that it is important for a carrier to be able to
demonstrate that a process is in place for training, sanitizing and
cleaning, but asserts that retaining records that document these
activities for one year would not serve any meaningful food
transportation safety purpose.
    (Response 173) We have made several revisions to this final rule in
response to comments that we received on the proposed rule that will
lessen the recordkeeping requirements for persons who are subject to
the rule (see Comment 129, Comment 149, Comment 165, and Comment 169).
Section 7202(b) of the 2005 SFTA requires us to issue a regulation that
``require[s] shippers, carriers by motor vehicle or rail vehicle,
receivers, and other persons engaged in the transportation of food to
use sanitary transportation practices prescribed by the Secretary to
ensure that food is not transported under conditions that may render
the food adulterated.'' Section 7202(c) also states that we must
prescribe practices that we deem to be appropriate and necessary
relating to, among other things, recordkeeping. As we have explained
throughout the preamble to this final rule, we have determined that the
records provisions in this final rule are appropriate for this purpose
and required of us by our statutory mandate.
    (Comment 174) One comment asks us to codify all of the
recordkeeping requirements that apply to both the manufacture and
transportation of animal feed in one location for ease of accessibility
by the animal industry.
    (Response 174) We have issued this rule for the sanitary
transportation of human and animal food under the 2005 SFTA and the
preventive controls rule for animal food under the FSMA, which are two
separate grants of statutory authority given to us by Congress. These
rules and their records requirements have been codified in distinct
parts of Title 21 of the Code of Federal Regulations to reflect these
two different authorizing statutes. However, FDA maintains a Web site
dedicated to the FSMA, which can be found at http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm, from which industry can quickly
access information about this sanitary food transportation rule and the
other FSMA rules.
    (Comment 175) One comment notes that records that are required by
our seafood and juice HACCP rules are exempt from public disclosure
under the Freedom of Information Act (FOIA), and asks us to similarly
exempt the records required by this final rule from public disclosure.
The comment's concern is that the records required by this rule may
contain proprietary and confidential information (e.g., contracts
between carriers and shippers under proposed Sec.  1.908(d)(2)(ii)),
may contain information that could be used to compromise food safety
measures (e.g., carrier's written procedures for cleaning and
inspecting vehicles and transportation equipment), and could be
misunderstood if taken out of context.
    (Response 175) We first note that in the rulemaking for the seafood
and juice HACCP rules we did not state that records required by these
rules are exempt from public disclosure. In this regard, the Agency
concluded in the seafood HACCP final rule (60 FR 65096 at 65138), that
HACCP plans, as a general rule, meet the definition of trade

secret information, and thus, even if these plans are in Agency files,
they likely would not be available under FOIA. However, because FDA is
bound by FOIA and the Agency's implementing regulation in 21 CFR part
20, the Agency is unable to exclude categorically all HACCP records in
Agency files from public disclosure.
    We would determine whether records required by this rule that we
copy are either publicly disclosable or protected from public release
under the FOI Act on a case-by-case basis. We copy records on a case-
by-case basis as necessary and appropriate. We primarily intend to copy
such records if the preliminary assessment by our investigator during a
routine inspection is that regulatory followup may be appropriate
(e.g., if these records demonstrate that cleaning procedures to
maintain vehicles in appropriate sanitary condition are not being
followed in a food transportation operation). We may consider it
necessary to copy records when, for example, our investigators may need
assistance in reviewing a certain record from relevant experts in
headquarters. If we are unable to copy the records, we would have to
rely solely on our investigators' notes and reports when drawing
conclusions. In addition, copying records will facilitate followup
regulatory actions. Even in these circumstances, however, certain
information in the records could be considered confidential within the
scope of the FOI Act and would be redacted from any records that would
otherwise be publicly disclosable.

H. Waivers (Sec. Sec.  1.914-1.934)

    In table 11, we describe revisions to proposed Sec. Sec.  1.914 to
1.934 and following the table we respond to comments related to these
provisions.

                                  Table 11--Sec.  Sec.   1.914 to 1.934 Waivers
----------------------------------------------------------------------------------------------------------------
              Proposed section                           Description                        Revision
----------------------------------------------------------------------------------------------------------------
1.914(a) and (b)............................  Under what circumstances will     Replaced ``FDA'' with ``we''.
                                               FDA waive a requirement of this
                                               subpart?
1.916.......................................  When will FDA consider whether    Replaced ``FDA'' with ``we''.
                                               to waive a requirement of this
                                               subpart?
1.918(a) and (b)............................  What must be included in the      No change.
                                               Statement of Grounds in a
                                               petition requesting a waiver?
1.920.......................................  What information submitted in a   No change.
                                               petition requesting a waiver or
                                               submitted in comments on such a
                                               petition is publicly available?
1.922.......................................  Who will respond to a petition    No change.
                                               requesting a waiver?.
1.924(a)-(d)................................  What process applies to a         No change.
                                               petition requesting a waiver?.
1.926.......................................  Under what circumstances may FDA  Replaced ``FDA'' with ``we''.
                                               deny a petition requesting a
                                               waiver?
1.928.......................................  What process will FDA follow      Replaced ``FDA'' with ``we''.
                                               when waiving a requirement of     Replaced ``FDA'' with ``our''.
                                               this subpart on FDA's own
                                               initiative?
1.930.......................................  When will a waiver granted by     Replaced ``granted by FDA'' with
                                               FDA become effective.             ``that we grant''.
1.932.......................................  Under what circumstances may FDA  Replaced ``FDA'' with ``we''.
                                               modify or revoke a waiver?
1.934(a)-(c)................................  What procedures apply if FDA      Replaced ``FDA determines'' with
                                               determines that a waiver should   ``we determine''.
                                               be modified or revoked?
----------------------------------------------------------------------------------------------------------------

    (Comment 176) A comment asks that we clarify how we would waive
requirements if we determine that the waiver will not result in the
transportation of food under conditions that would be unsafe for human
or animal health and that is in the public interest, and how we would
communicate these waivers to state agencies.
    (Response 176) In Sec. Sec.  1.924 and 1.928 of the proposed rule,
we outlined the processes we will follow when waiving a requirement of
this subpart, depending on whether the waiver is granted in response to
a submitted petition or on our own initiative. In both cases, we will
publish a notice in the Federal Register setting forth the waiver and
the reasons for such waiver. We believe this explanation is clear;
therefore, we are retaining the language in Sec. Sec.  1.924 and 1.928
in this final rule. Additionally, publication in the Federal Register
provides notice to all interested parties, including State and Tribal
agencies.
    (Comment 177) Some comments support our proposal to include in the
final rule a petition process whereby we can grant a waiver from the
proposed requirements of this rule. Additionally, a few comments urge
us to not make such a petition too onerous or burdensome for
individuals, small shippers, and owner/operator carriers and to provide
lenience and guidance for such situations.
    (Response 177) We agree that we should allow a petition process to
grant waivers from the requirements of this rule. In Sec.  1.916 of the
proposed rule, we stated that we will consider whether to waive a
requirement of this rule on our own initiative or on a petition
submitted under 21 CFR 10.30. In proposed Sec.  1.918 we outlined what
must be included in the Statement of Grounds in the petition. And in
proposed Sec.  1.924 we outlined the process that will apply to a
petition requesting a waiver. We do not believe that the petition
described in Sec.  10.30, the Statement of Grounds described in Sec.
1.918, or the process described in Sec.  1.924 is onerous or burdensome
and, therefore, are retaining the language in these sections in the
final rule. We do not plan to publish guidance on the petition itself,
since it is explained in detail in 21 CFR 10.30.
    (Comment 178) A comment strongly urges that we issue public notice
of potential waivers and petitions for waivers in the Federal Register
and allow public comment on each proposed waiver. The comment states
that our proposed system of granting waivers for some sanitary
transportation requirements without first soliciting public comment is
inconsistent with the FD&C Act and the Administrative Procedures Act
(APA), since the FD&C Act requires the Secretary to publish waivers and
any reasons for the waiver in the Federal Register (21 U.S.C.
350e(d)(2)). The comment states that this demonstrates Congress's
intent to have the public involved in the waiver process and notes that
FDA itself recognized that public comment may be necessary to inform
its determination

whether to grant a waiver (79 FR 7006 at 7029).
    (Response 178) We will consider whether to waive a requirement of
this subpart in one of two ways: (1) On a petition submitted under 21
CFR 10.30 or (2) on our own initiative. For a filed petition, Sec.
1.924(b) states that we will publish a notice in the Federal Register
requesting information and views on the petition, including information
and views from persons who could be affected by the waiver if the
petition were to be granted. For waivers to be established on our own
initiative, Sec.  1.928 states that we will publish a notice in the
Federal Register setting forth the waiver and the reasons for such
waiver. We disagree that our system of granting waivers for some
sanitary transportation requirements without first soliciting public
comment is inconsistent with the FD&C Act and the APA. As we discussed
in the proposed rule (79 FR 7006 at 7028), when we have determined that
a waiver is appropriate in accordance with the standard set forth in
section 416(d)(1) of the FD&C Act and proposed Sec.  1.914, we may
grant a waiver without first soliciting public comment. We have
concluded that this process is sufficient for us granting a waiver on
our own initiative because it is the process set forth in section
416(d)(2) of the FD&C Act.
    (Comment 179) Some comments recommend that we expedite written
responses to waiver petitions and include in the final rule a timeframe
for our decision on a petition (e.g., 180 days) and steps to be taken
if the deadline is missed.
    (Response 179) We disagree with these comments. In proposed Sec.
1.924, we stated that the procedures set forth in 21 CFR 10.30 govern
our response to a petition requesting a waiver. 21 CFR 10.30 outlines
the petition process and states that we will respond to the petitioner
within 180 days of receipt of the petition. 21 CFR 10.30 does not
address steps to be taken if the 180-day timeframe is missed.
    (Comment 180) Some comments request that we establish a waiver
application process that resembles the process for granting a variance
under the proposed FSMA produce safety regulation and ensures
engagement with the applicant. One of the comments suggests that this
process provide an avenue for an industry or a person to request a
waiver without the involvement of a state or foreign government. These
comments also state that the process should include an opportunity to
re-obtain a revoked waiver after a period of time to incentivize long-
term commitments to food safety improvement.
    (Response 180) The process for granting a variance under the FSMA
produce safety rule is very similar to the waiver petition process
described in Sec. Sec.  1.914 to 1.934 of this final rule. Both require
the submission of a petition under 21 CFR 10.30, and both require that
we publish a notice in the Federal Register requesting information and
views on the filed petition. Also, in both cases, we will respond to
the petitioner in writing and also will make public a notice on our Web
site announcing our decision to either grant or deny the petition. Much
of the rest of the processes are similar, as well. Both ensure our
engagement with the applicant by requiring us to provide a written
response to the applicant. Additionally, the process in this final rule
does not require involvement of a state or foreign government. Finally,
while the waiver petition process doesn't specifically address the
opportunity to re-obtain a revoked waiver, it does not preclude an
interested party from reapplying for a revoked waiver using the
petition process described in this final rule.
    (Comment 181) Some comments request clarification regarding whether
a waiver can be revoked in whole or part from the group to which it was
granted. A few comments suggest that we develop a policy that would
allow us to revoke a waiver from a single ``bad actor,'' even when the
waiver has been granted to an entire industry. The comments state that
by doing so, each member of the industry still maintains individual
responsibility for ensuring compliance.
    (Response 181) We outlined the process we will follow for
modification and revocation of waivers in Sec. Sec.  1.932 and 1.934 of
the proposed rule. Specifically, we stated in Sec.  1.932 that we may
modify or revoke a waiver if we determine that the waiver could result
in the transportation of food under conditions that would be unsafe for
human or animal health or that the waiver could be contrary to the
public interest. We believe the language in Sec. Sec.  1.932 and 1.934
is clear and, therefore, are retaining it in the final rule. We do not
agree that we should establish a policy for revoking a waiver from a
single firm. The Sanitary Food Transportation Act of 2005 states that
``the Secretary may waive any requirement under this section, with
respect to any class of persons, vehicles, food, or nonfood products .
. . .'' Since the SFTA gives FDA the authority to issue waivers to
cover any class of persons, vehicles, food, or nonfood products, we
believe that revocation of a waiver must also cover that same class of
persons, vehicles, food, or nonfood products to which it was issued and
not a subset thereof. Nonetheless, FDA can take appropriate action
against an individual firm, such as described by this comment, if the
firm fails to comply with the requirements of this rule.
    (Comment 182) A comment urges us to adopt appropriate provisions in
the regulation governing waivers to protect against the disclosure of
confidential business information of shippers, carriers, and receivers.
    (Response 182) We have adopted appropriate provisions in this
regulation related to protection of confidential information. Proposed
Sec.  1.920 states that we will presume that information submitted in a
petition requesting a waiver and comments submitted on such a petition
does not contain information exempt from public disclosure under 21 CFR
part 20 and would be made public as part of the docket associated with
this request. As we stated in the proposed rule, we do not believe that
information exempt from disclosure under 21 CFR part 20 is the type of
information that we are requiring to be submitted in such a petition or
that would be relevant in any comments submitted on such a petition. We
will publicly disclose a petition for waiver or comments on such a
petition unless information in those documents falls within the
exemption for confidential commercial or trade secret information in 21
CFR part 20.
    (Comment 183) A few comments suggest that we provide a window of 60
days for industry to come into compliance with the regulation when a
waiver is revoked. The comments state that regulators could increase
food safety surveillance of the product or industry during this short
time.
    (Response 183) We disagree with these comments. In proposed Sec.
1.934(a)(2) we stated that we will publish a notice of our
determination that a waiver should be revoked in the Federal Register.
We believe that this will serve as a notification to the affected
industry that we are considering revocation of the waiver and will
allow affected parties to plan for changes, should the waiver, in fact,
be revoked. Therefore, we are retaining this language in the final
rule. After considering written comments on the revocation notice, we
will publish our decision in the Federal Register. The effective date
of the revocation will be the date of publication of the notice.

V. Effective and Compliance Dates

A. Effective and Compliance Dates for Part 1, Subpart O

    We proposed that any final rule based on proposed part 1, subpart O
become effective 60 days after its date of publication in the Federal
Register, with staggered compliance dates (79 FR 7006 at 7032).
Businesses other than small businesses would have 1 year from the date
of publication of the final rule to comply with the rule, whereas small
businesses would have 2 years to comply with the rule.
    After considering the following comments addressing the proposed
compliance dates for this rule, we are establishing the effective and
compliance dates as proposed.
    (Comment 184) One comment encourages us to allow a phased-in
timeframe for compliance with this rule because companies will need
time to develop written protocols and train company personnel. One
comment states that it is not reasonable to expect the industry to be
in compliance in 1 or 2 years, given the cultural changes required by
the proposed regulation. One comment states that the 2-year period for
compliance for small businesses seems overly generous because many, if
not most, of the requirements of this rule should already be in place
under existing rules and regulations. A comment states that it will be
difficult to implement phased-in compliance dates because inspectors
will not be able to determine a business' size when performing single
vehicle inspections. The comment recommends that we establish a single
compliance date that is possible for all businesses to meet.
    (Response 184) It is our general practice for this type of
rulemaking, which does not address a public health emergency or other
matter that would require a uniform compliance date for all businesses,
to consider business size in establishing timeframes for businesses to
come into compliance with the rule. After considering these comments,
we are retaining the proposed compliance dates for this rule, i.e., 1
year after the date of publication of the final rule for businesses
other than small businesses, and 2 years after the date of publication
of the final rule for small businesses, because we believe that they
are reasonable for businesses subject to this rule. We do expect that
questions, such as how would an inspector determine a business' size,
may arise during the implementation of this rule. We intend to work
closely with the food transportation industry, extension and education
organizations, and State, local, and tribal partners to facilitate
implementation of this rule. Furthermore, this rule is based upon
industry best practices already in place, which should minimize the
time for industry to come into compliance.

B. Effective Dates for Conforming Changes

    The conforming amendment to part 11 adds a reference to the scope
of part 11 that the records required under part 1, subpart O are not
subject to part 11. This conforming amendment is effective on June 6,
2016, the same date as the effective date of part 1, subpart O. We are
not establishing compliance dates for these conforming amendments. As a
practical matter, compliance dates will be determined by the dates for
compliance with part 1, subpart O.

VI. Executive Order 13175

    In accordance with Executive Order 13175, FDA has consulted with
tribal government officials. A Tribal Summary Impact Statement has been
prepared that includes a summary of tribal officials' concerns and how
FDA has addressed them (Ref. 31). Persons with access to the Internet
may obtain the Tribal Summary Impact Statement at http://www.fda.gov or
at http://www.regulations.gov. Copies of the Tribal Summary Impact
Statement also may be obtained by contacting the person listed under
FOR FURTHER INFORMATION CONTACT.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety effects, distributive impacts, and equity). We believe that
this final rule is a significant regulatory action as defined by
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. This final rule defines small business as one subject to this
rule employing fewer than 500 full-time equivalent employees except
that for carriers by motor vehicle that are not also shippers and/or
receivers, this term would mean a business subject to this rule having
less than $27,500,000 in annual receipts. The Agency concludes that the
final rule will have a significant economic impact on a substantial
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $144
million, using the most current (2014) Implicit Price Deflator for the
Gross Domestic Product. FDA expects this final rule to result in a 1-
year expenditure that would meet or exceed this amount.
    The final analysis conducted in accordance with these Executive
orders and statutes is available in the docket for this rulemaking
(Ref. 24) and at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses.

VIII. How does the Paperwork Reduction Act of 1995 apply to this final
rule?

    This final rule contains information collection requirements that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3521) (PRA). A description of these provisions is given
in the following paragraphs with an estimate of the annual
recordkeeping and reporting burdens. Included in the burden estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
    Title: Sanitary Transportation of Human and Animal Food.
    Description: This new collection of information will be performed
by shippers, receivers, loaders, and carriers of human and animal food.
The records requirements of this final rule include records pertaining
to: Sanitary specifications, temperature during transportation
operations, cleaning of bulk vehicles, training, and written
procedures. In addition, this final rule includes submission
requirements pertaining to waiver petitions, when appropriate.
    We have concluded that recordkeeping and submissions are necessary
for the success of the food transportation operation. Records of
actions taken due to each requirement are essential for manufacturers
to

implement this rule effectively. Further, records and reports are
essential for us to be able to determine whether a firm is in
compliance with the rule.

Analysis of Burden Estimates Resulting From This Final Rule

    Description of Respondents: Shippers, receivers, loaders, and
carriers of human and animal food.
    In the following paragraphs, we describe and respond to the
comments that we received on the PRA for our 2014 proposed rule. We
numbered each comment to help distinguish between different comments.
The number assigned to each comment is purely for organizational
purposes and does not signify the comment's value, importance, or the
order in which it was received.
    (Comment 185) We received many comments regarding the burden of
proposed Sec.  1.908(d)(2)(i), which required demonstration of
temperature conditions during a shipment. The comments stated that
these burdens can include adoption of a method of monitoring and
recording temperatures during shipment, purchase of equipment,
implementation of those systems, and the costs of downloading data. One
comment stated that, although most carriers have temperature data on
temperature-controlled shipments, this data is not readily available
and easily retrievable without incurring significant costs.
Furthermore, as another comment stated, if the proposed requirement
were finalized, far more than the 1 percent of industry estimated in
the economic analysis would have to incur these costs. Another comment
stated that, while ``reefer'' trailers are generally equipped with
thermometers, they do not ordinarily create any kind of permanent
printout record to be shown to the receiver. The comment emphasized
that any requirement to have this would put unnecessary burdens on
industry, particularly small firms. One comment stated that the current
practice is for such records to be provided only if there is an
indication of a problem (i.e., signs of temperature abuse) upon receipt
of the load.
    (Response 185) We acknowledge the lack of data available to us when
estimating the cost of this proposed requirement. However, as a result
of public comment, this requirement has been amended (final Sec.
1.908(e)(2)(i)) to require this demonstration of temperature conditions
only when the carrier has agreed by contract with the shipper to assume
this responsibility, and only if requested by the shipper or receiver
and in a way agreeable to the shipper and carrier, which can include
measurements of ambient temperature. We believe this is aligned with
current industry practices and is not estimated to represent new cost
to industry.
    (Comment 186) One commenter stated that proposed Sec.  1.908(d)(4),
requiring carriers offering bulk vehicles for food transportation to
provide written documentation to the shipper that identifies the three
previous cargoes transported in the vehicle, would be overly
burdensome. Another comment stated that the estimated burden of this
requirement did not include the cost of implementing industry-wide
software changes for railroads, as tracking this information is not
current industry practice.
    (Response 186) These comments did not provide any data to allow us
to calculate this burden, and we acknowledge the simplicity of our
assumptions in the estimations of the cost related to this provision.
However, in response to comments on the proposed rule, this provision
has been amended (final Sec.  1.908(e)(4)) to require carriers to
provide information identifying the last previous cargo only when they
have agreed by contract with the shipper to assume this responsibility,
and only if requested by the shipper. We believe this provision is
aligned with current industry practice. No new burden is estimated for
this information collection.
    (Comment 187) A commenter stated that proposed Sec.  1.908(d)(5),
which required carriers to provide information to shippers describing
the most recent cleaning of bulk vehicles, would be beyond the current
capabilities of railroads. The comment stated that compliance with this
requirement would likely require expensive investments to track this
information, as this is not current industry practice.
    (Response 187) This comment did not provide any data that would
allow us to estimate this burden. However, in response to comments on
the proposed rule, this provision has been amended (final Sec.
1.908(e)(5)) to require information describing the most recent cleaning
of bulk vehicles only when the carrier has agreed by contract with the
shipper to assume this responsibility, and only if requested by the
shipper. This provision is believed to be aligned with current industry
practice. No new burden is estimated for this information collection.
    (Comment 188) One commenter stated that requiring firms to retain
records for 1 year would not benefit those along the supply chain and
would be unnecessarily burdensome.
    (Response 188) This comment does not describe how the 12-month
retention requirement would be more burdensome. This final rule reduces
the total number of records related to sanitary food transport, which
will reduce new burden to industry. Furthermore, the codified provides
a wide range of options on how these records must be kept. We estimate
that firms will maintain electronic records, which further reduces
burden.
    (Comment 189) One comment expressed appreciation regarding the
ability of industry to diverge from certain proposed requirements, such
as those for bulk shipments, by contractual agreement. This comment
stated that reflects a practical understanding of the way business is
conducted and how flexibility is essential because of the highly
complex nature of the transportation chain. This comment went on to
state that FDA should permit flexibility to allow businesses to enter
into contractual agreements allocating the responsibilities for
shippers, carriers, and receivers to other parties.
    (Response 189) While this comment did not address the PRA of the
proposed rule specifically, it does allow us to estimate that
contractual agreements, such as those addressed in Sec.  1.908(b)(3),
are common business practice. No additional information collection
burden to industry is estimated for such agreements.
    FDA estimates the burden of this collection of information as
follows:
    The total one-time estimated burden imposed by this collection of
information is 254,923 hours (228,832 recordkeeping hours + 144
submission hours + 25,947 third-party disclosure hours). The total
annual estimated burden imposed by this collection of information is
120,342 hours (120,163 recordkeeping hours + 48 submission hours + 113
third-party disclosure hours). There are no capital costs or operating
and maintenance costs associated with this collection of information.
FDA estimates that firms will be able to fulfill recordkeeping
requirements with existing record systems; that is, FDA estimates that
it will not be necessary for firms involved in food transportation to
invest in new recordkeeping systems.
    One-time burdens are estimated for establishing written procedures
regarding integrated transportation operations, written procedures for
transportation operations with respect to sanitary condition of
vehicles and equipment, previous cargoes, and adequate temperature
control; written procedures for cleaning and sanitizing; procedures for
use of bulk vehicles; training; notification of operating temperature
and written sanitary

specifications, disclosure of information; and submission of waiver
petitions, when appropriate. Annual burdens are related to disclosure
of written sanitary specifications, operating temperatures, and
training records.
    First-year and annual burdens related to recordkeeping requirements
are presented in table 12. In the economic analysis of this final rule,
cost estimations were estimated based on a percentage of, for example,
shippers that may have to change behavior as a result of this final
rule, or shipments that would have new records associated with them.
Calculating percentages of firms or shipments often resulted in
fractions; these numbers were rounded to the nearest whole number to be
presented in the analysis. Therefore, any discrepancies in table 12 are
attributable to rounding.
    It is estimated that about 343 recordkeepers will each spend 2
hours (one-time) developing written procedures related to integrated
transportation operations, as required by Sec.  1.908(a)(4). Therefore,
343 x 2 = 686 (686.13) one-time hours, as presented in line 1.
    The one-time cost of developing written procedures to ensure
sanitary condition of vehicles and equipment, as required by Sec.
1.908(b)(3), is estimated at the shipper level. It is estimated that
these written procedures are relatively simple and easy to assemble,
and that one recordkeeper for about 4,483 firms will spend 0.5 hour
adjusting current practices with respect to this requirement.
Therefore, 0.5 hours x 4,483 = 2,242 (2,241.69) one-time hours for
Sec.  1.908(b)(3), as shown in line 2.
    The one-time cost of developing written procedures to ensure that
previous cargo does not make food unsafe, as required by Sec.
1.908(b)(4), is estimated at the shipper level. It is estimated that
these written procedures are relatively simple and easy to assemble,
and that one recordkeeper for about 4,483 firms will spend 0.5 hour
adjusting current practices with respect to this requirement.
Therefore, 0.5 hours x 4,483 = 2,242 (2,241.69) one-time hours for
Sec.  1.908(b)(4), as shown in line 3.
    The one-time cost of developing written procedures to ensure that
food is transported under adequate temperature control, as required by
Sec.  1.908(b)(5), is estimated at the shipper level. It is estimated
that these written procedures are relatively simple and easy to
assemble, and that one recordkeeper for about 4,483 firms will spend
0.5 hour aligning current practices with this requirement. Therefore,
0.5 hours x 4,483 = 2,242 (2,241.69) one-time hours for Sec.
1.908(b)(5), as shown in line 4.
    The one-time cost of development of written procedures related to
cleaning and sanitation, as required by Sec.  1.908(e)(6)(i), is
estimated at the carrier level. It is estimated that one recordkeeper
for about 37,249 firms will spend 2 hours developing written
procedures. Therefore, 2 hours x 37,249 = 74,498 (74,498.48) one-time
hours for Sec.  1.908(e)(6)(i), as shown in line 5.
    The one-time cost of development of written procedures related to
bulk vehicles, as required by Sec.  1.908(e)(6)(iii), is estimated at
the bulk carrier level. It is estimated that one recordkeeper for about
6,713 firms will spend 2 hours developing written procedures.
Therefore, 2 hours x 6,713 = 13,426 (13,426.48) one-time hours for
Sec.  1.908(e)(6)(iii), as shown in line 6.
    The one-time cost of establishing training records, as required by
Sec.  1.910(b), is estimated at the employee level. It is estimated
that one recordkeeper will establish a record for about 1,668,698
workers, and this will take 5 minutes (0.08 hours) for each worker.
Therefore, 0.08 hour x 1,668,698 = 133,496 (133,495.86) one-time hours
for Sec.  1.910(b), as shown in line 7.
    The total one-time hourly recordkeeping burden is 228,832
(228,832.02) hours.
    The annual cost of training records, as required by final Sec.
1.910(b), is estimated at the worker level. It is estimated that one
recordkeeper for each of about 1,502,032 workers will spend 5 minutes
(0.08 hour) minutes completing records related to annual training (the
time spent training is estimated separately and not included in this
PRA analysis). We believe recordkeeping will be very simple and can
consist of, for example, printing off a certificate of completion.
Therefore, 0.08 hour x 1,502,032 workers = 120,163 (120,162.59) annual
hours for Sec.  1.910(b), as shown in line 8. Therefore, the annual
hourly recordkeeping burden is 120,163 hours.

                           Table 12--First Year Only and Annual Recordkeeping Burdens
----------------------------------------------------------------------------------------------------------------
                                                    First year
         21 CFR section              Number of     frequency of    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeping                      record
----------------------------------------------------------------------------------------------------------------
                                          First Year Only Hourly Burden
----------------------------------------------------------------------------------------------------------------
1. Written Procedures for                    343               1             343               2             686
 Integrated Operations                                                                                (686.13)
 (1.908(a)(4))..................
2. Written procedures to ensure            4,483               1           4,483             0.5           2,242
 sanitary condition of vehicles                                                                       (2,241.69)
 (1.908(b)(3))..................
3. Written procedures to ensure            4,483               1           4,483             0.5           2,242
 that previous cargo does not                                                                         (2,241.69)
 make food unsafe (1.908(b)(4)).
4. Written procedures to ensure            4,483               1           4,483             0.5           2,242
 that food is transported under                                                                       (2,241.69)
 adequate temperature control
 (1.908(b)(5))..................
5. Written procedures, cleaning           37,249               1          37,249               2          74,498
 and sanitation (1.908(e)(6)(i))                                                                     (74,498.48)
6. Written procedures, bulk                6,713               1           6,713               2          13,426
 vehicles (1.908(e)(6)(iii))....                                                                     (13,426.48)
7. Training Records (1.910(b))..       1,668,698               1       1,668,698            0.08         133,496
                                                                                (133,495.86)
                                 -------------------------------------------------------------------------------
    First Year Only Hourly                                                                               228,832
     Recordkeeping Burden.......                                                                    (228,832.02)

----------------------------------------------------------------------------------------------------------------
                                                    First year
         21 CFR section              Number of     frequency of    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeping                      record
----------------------------------------------------------------------------------------------------------------
                                             Recurring Hourly Burden
----------------------------------------------------------------------------------------------------------------
8. Training Records (1.910(b))..       1,502,032               1       1,502,032            0.08         120,163
                                                                                (120,162.59)
                                 -------------------------------------------------------------------------------
    Annual Hourly Recordkeeping   ..............  ..............  ..............  ..............         120,163
     Burden.....................                                                                    (120,162.59)
----------------------------------------------------------------------------------------------------------------

    The one-time and annual hourly burdens related to submission of
waiver petitions (Sec.  1.914) are presented in table 13. This final
rule refers to previously approved collections of information found in
FDA regulations. These collections of information are subject to review
by OMB under the PRA. The collections of information in Sec.  10.30
have been approved under OMB control number 0910-0183 (General
Administrative Procedures: Citizen Petitions; Petition for
Reconsideration or Stay of Action; Advisory Opinions).
    In the first year, it is estimated that one recordkeeper from each
of a total of six firms will each spend 24 hours submitting a waiver
petition to FDA (per the estimate for the petition process in Sec.
10.30, approved and estimated under OMB control number 0910-0183 as 24
hours per submission). Therefore, 6 waiver petitions x 24 hours = 144
one-time hours for Sec.  1.914, as shown in line 1. Annually, it is
estimated that one recordkeeper from each of a total of two firms will
spend 24 hours submitting a waiver petition to FDA. Therefore, 2 waiver
petitions x 24 hours = 48 annual hours for Sec.  1.914, as shown in
line 2.

                                Table 13--First Year and Annual Submission Burden
----------------------------------------------------------------------------------------------------------------
                                                    First year
         21 CFR section              Number of     frequency of    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeping                      record
----------------------------------------------------------------------------------------------------------------
                                   Estimated First Year Only Submission Burden
----------------------------------------------------------------------------------------------------------------
1. Waiver Petitions (1.914).....               6               1               6              24             144
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                    First year
         21 CFR section              Number of     frequency of    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeping                      record
----------------------------------------------------------------------------------------------------------------
                                       Estimated Annual Submission Burden
----------------------------------------------------------------------------------------------------------------
2. Waiver Petitions (1.914).....               2               1               2              24              48
----------------------------------------------------------------------------------------------------------------

    The one-time and hourly burdens related to third-party disclosures
are presented in table 14. The one-time cost of developing written
sanitary specifications necessary for transportation, as required by
Sec.  1.908(b)(1), is estimated at the shipper level. It is estimated
that one recordkeeper for each of about 10,163 firms will spend 30
minutes developing written sanitary specifications. Therefore, 0.5 hour
x 10,163 firms = 5,082 (5,081.57) one-time hours for Sec.  1.908(b)(1),
as shown in line 1.
    The one-time cost of developing initial notifications of operating
temperature, as required by Sec.  1.908(b)(2), is estimated at the
shipper level. It is estimated that one recordkeeper for each of about
5,646 firms will spend 30 minutes (0.5 hour) developing these
notifications. Therefore, 0.5 hour x 5,646 firms = 2,823 (2,823.13)
hours, as shown in line 2.
    The one-time cost of establishing records pertaining to disclosure
of information, as required by Sec.  1.912(a), is estimated at the firm
level. It is estimated that one recordkeeper will establish a record at
a total of about 36,084 firms, and this will take 30 minutes (0.5 hour)
for each record. Therefore, 0.5 hour x 36,084 = 18,042 (18,041.88) one-
time hours for Sec.  1.912(a), as shown in line 3.
    The total one-time hourly third-party disclosure burden is 25,947
(25,946.57) hours.
    The annual cost of disclosing necessary sanitary specifications, as
required by Sec.  1.908(b)(1), is estimated at the firm level. It is
estimated that 1 recordkeeper for each of about 226 firms will spend 5
minutes disclosing sanitary specifications. Therefore, 0.08 hour x 226
shipments = 18 (18.07) annual hours for Sec.  1.908(b)(1), as shown in
line 4.
    The annual cost of disclosing operating temperature conditions, as
required by Sec.  1.908(b)(2), is estimated at the shipper level. It is
estimated that 1 recordkeeper for each of about 226 firms will spend 30
minutes (0.5 hour) disclosing necessary temperature conditions.
Therefore, 0.5 hour x 226 firms = 113 (112.93) annual hours for Sec.
1.908(b)(2), as shown in line 5.
    The total annual hourly third-party disclosure burden is 131
(130.99) hours.

                                     Table 14--Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
                                                    First year
         21 CFR section              Number of     frequency of    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeping                      record
----------------------------------------------------------------------------------------------------------------
                             Estimated First Year Only Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
1. Written Sanitary                       10,163               1          10,163             0.5           5,082
 Specifications (1.908(b)(1))...                                                                      (5,081.57)
2. Notification of operating               5,646               1           5,646             0.5           2,823
 temperature (1.908(b)(2))......                                                                      (2,823.13)
3. Records pertaining to                  36,084               1          36,084             0.5          18,042
 disclosure of information                                                                           (18,041.88)
 (1.912(a)).....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          25,947
                                                                                (25,946.57)
----------------------------------------------------------------------------------------------------------------
                                 Estimated Annual Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
4. Sanitary Specifications                   226               1             226            0.08              18
 (1.908(b)(1))..................                                                                         (18.07)
5. Operating temperature                     226               1             226             0.5             113
 conditions (1.908(b))(2).......                                                                        (112.93)
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             131
                                                                                (130.99)

    The information collection provisions of this final rule have been
submitted to OMB for review. Prior to the effective date of this final
rule, FDA will publish a notice in the Federal Register announcing
OMB's decision to approve, modify, or disapprove the information
collection provisions in this final rule. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

IX. What is the environmental impact of this rule?

    We have determined, under 21 CFR 25.30(j), that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment (Refs. 32 and 33). Therefore, neither
an environmental assessment nor an environmental impact statement is
required.

X. What are the federalism impacts of this rule?

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132 on federalism. We have examined the
effects of the requirements of this rule on the relationship between
the Federal Government and the States. We conclude that Federal
preemption of State or local rules that establish requirements for the
sanitary transportation of human and animal food such that: (1)
Complying with the requirements of the State or political subdivision
and with a requirement of section 416 of the FD&C Act, or with this
rule, is not possible; or (2) the requirements of the State or
political subdivision, as applied or enforced, is an obstacle to
accomplishing and carrying out section 416 of the FD&C Act or this
rule, is consistent with this Executive order. FDA has not incorporated
text in this rule to reflect this preemptive effect because section
416(e) of the FD&C Act expressly provides for this preemption.
    Section 3(b) of Executive Order 13132 recognizes that Federal
action limiting the policymaking discretion of States is appropriate
``where there is constitutional and statutory authority for the action
and the national activity is appropriate in light of the presence of a
problem of national significance.'' The constitutional basis for FDA's
authority to regulate food safety is well established. Section 4(a) of
Executive Order 13132 expressly contemplates preemption where the
exercise of State authority conflicts with the exercise of Federal
authority under a Federal statute. Moreover, section 4(b) of Executive
Order 13132 authorizes preemption of State law by rulemaking when the
exercise of State authority directly conflicts with the exercise of
Federal authority under the Federal statute, or there is clear evidence
to conclude that Congress intended the Agency to have the authority to
preempt State law.
    Section 4(e) of the Executive order provides that, ``when an agency
proposes to act through adjudication or rulemaking to preempt State
law, the agency shall provide all affected State and local officials
notice and an opportunity for appropriate participation in the
proceedings.'' As required by the Executive order, FDA provided the
States and local governments with an opportunity for appropriate
participation in this rulemaking when it sought input from all
stakeholders through publication of the proposed rule in the Federal
Register on February 5, 2014 (79 FR 7006). In the proposal, FDA
specifically described this preemptive effect. In addition, we held
three public meetings during the comment period for the proposed rule
to discuss the provisions of the rule, answer questions, and solicit
comments from stakeholders, including from State and local government
representatives. Meetings were held February 27, 2014, in Chicago, IL;
March 13, 2014, in Anaheim, CA; and March 20, 2014, in College Park,
MD.
    We received comments on the proposed rule from several State
government agencies. Most of these comments addressed matters in this
rulemaking other than the issue of preemption of State and local
requirements for the sanitary transportation of human and animal food.
One comment stated that the preemptive provision of section 416(e)(1)
or (2) of the FD&C Act could function to prevent States from developing
a unified sanitary transportation regulation that would address all
modes of transportation. However, a State law, including unified State
laws, should states wish to adopt such laws, concerning the sanitary
transportation of food by motor vehicle

or rail vehicle, is not preempted if such laws do not fall under either
section 416(e)(1) or (2) of the FD&C Act. Furthermore, it is highly
unlikely that any State law addressing transportation operations not
subject to the 2005 SFTA, e.g., barge transport, would fall within the
scope of the 2005 SFTA's preemption provision. In conclusion, we have
determined that the preemptive effects of this final rule are
consistent with Executive Order 13132.

XI. 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 http://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. Oxford Dictionary (2015). ``Definition of ``Best Practice,''
(http://www.oxforddictionaries.com/us/definition/american_english/best-practice), accessed and printed on December 16, 2015.
2. FDA Memorandum, ``FDA Memorandum to Dockets on Records of
Outreach,'' 2013. Available in Docket No. FDA-2011-N-0920.
3. FDA Memorandum, ``Memoranda of Outreach,'' 2015.
4. Hennessy. T.W., C.W. Hedberg, L. Slutsker, et al., ``A National
Outbreak of Salmonella Enteritidis Infections From Ice Cream,'' New
England Journal of Medicine, 334;1281-1286, 1996; available at
http://www.nejm.org/doi/full/10.1056/NEJM199605163342001, accessed
and printed on December 16, 2015.
5. FDA Memorandum, ``Feed RFRs Related to Transportation Problems,''
2012.
6. Wojtala, G., Interstate Food Transportation Assessment Project,
presented at the June 16 through 20, 2007, Conference of the
Association of Food and Drug Officials, available at http://www.michigan.gov/documents/mda/truckproj_224450_7.pdf, accessed and
printed on December 16, 2015.
7. Michigan Department of Agriculture, ``Food Truck Assessment
Project, April 18/19, 2006.''
8. Barfblog, ``200 Pounds of Contaminated Food Headed to Central
Indiana Restaurants in Semi Destroyed,'' (http://barfblog.com/2013/03/200-pounds-of-contaminated-food-headed-to-central-indiana-restaurants-in-semi-destroyed/), accessed and printed on December
16, 2015.
9. Caledonia Record, ``DMV Stops Truck, Finds Spoiled Food,'' August
18, 2012.
10. Courier Journal, ``Overheated Transport Trucks Spark Concerns
About Spoilage,'' August 10, 2012.
11. Motor Carrier Division, Michigan State Police, ``Commercial
Motor Vehicle Enforcement Quarterly,'' (http://www.michigan.gov/documents/msp/CMV_Quarterly_January_2007_205099_7.pdf), accessed and
printed on December, 16, 2015.
12. Eastern Research Group, Inc., 2009, Characteristics of Current
Food Transportation and Holding Practices for Food Commodities.
13. Tulsa World, ``Food Carriers Doubling as Garbage Trucks,'' June
11, 1989.
14. Philly.com, ``Food Trucks Can't Haul Waste in PA,'' March 14,
1990.
15. Los Angeles Times, ``Column One: Some Food Trucks Put Out Trash:
The same trucks that carry edibles to cities in the Northeast often
carry waste on the trip back, posing what regulators say is a
serious risk to health,'' October 20, 1989.
16. FDA, ``Guidance for Industry: Sanitary Transportation of Food,''
(http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/sanitationtransportation/ucm208199.htm), accessed and printed on December 16, 2015.
17. FDA, ``Guidance for Industry: Dairy Farms, Bulk Milk
Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors:
Food Security Preventive Measures Guidance,'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefense/ucm083049.htm), accessed and printed on December 17,
2015.
18. FDA, ``Guidance for Industry: Food Producers, Processors, and
Transporters: Food Security Preventive Measures Guide,'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefense/ucm083075.htm),
accessed and printed on December 17, 2015.
19. Memorandum of Understanding Between The Food Safety and
Inspection Service, United States Department of Agriculture, and The
Food and Drug Administration, United States Department of Health and
Human Services,'' (http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm117094.htm), accessed and printed on December 16,
2015.
20. ``Guidance for Industry: Questions and Answers Regarding
Establishment and Maintenance of Records By Persons Who Manufacture,
Process, Pack, Transport, Distribute, Receive, Hold, or Import Food
(Edition 5),'' (http://www.fda.gov/Food/GuidanceRegulation/ucm292746.htm), accessed and printed on December 16, 2015.
21. Consent Decree, Center for Food Safety v. Hamburg, No. 12-cv-
04529-PJH (N.D. Cal. February 20, 2014), (http://www.centerforfoodsafety.org/files/2014-2-20-dkt-82-1-joint-consent-decree_26503.pdf), accessed and printed on December 16, 2015.
22. United States. Office of Management and Budget. Office of
Information and Regulatory Affairs. ``Memorandum for the Heads of
Executive Departments and Agencies: Retrospective Analysis of
Existing Significant Regulations,'' 2011.
23. United States. Office of Management and Budget. Office of
Information and Regulatory Affairs. ``2013 Report to Congress on the
Benefits and Costs of Federal Regulations and Unfunded Mandates on
State, Local, and Tribal Entities,'' 2013.
24. FDA ``Sanitary Transportation of Human and Animal Food, Final
Regulatory Impact Analysis Final Regulatory Flexibility Analysis
Unfunded Mandates Reform Act Analysis,'' 2016.
25. S. Rep. No. 109-120, at 46 (2005) (https://www.gpo.gov/fdsys/pkg/CRPT-109srpt120/html/CRPT-109srpt120.htm), accessed and printed
on December 16, 2015.
26. ``National Shellfish Sanitation Program Guide for the Control of
Molluscan Shellfish, (2013 Revision),'' (http://www.fda.gov/downloads/Food/GuidanceRegulation/FederalStateFoodPrograms/UCM415522.pdf), accessed and printed on December 16, 2015.
27. ``Produce Transportation Best Practices, North American Produce
Transportation Working Group,'' (http://www.hortcouncil.ca/uploads/file/naptwg_produce_trans_best_practices.pdf), accessed and printed
on December 16, 2015.
28. FDA, ``Food Code 2009: Chapter 3--Food,'' 2013.
29. FDA Food Safety Modernization Act, February 27, 2014, (http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM392282.pdf),
accessed and printed on December 16, 2015.
30. FDA Food Safety Modernization Act (FSMA) Public Meeting, March
20, 2014, (http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM395355.pdf), accessed and printed on December 16, 2015.
31. FDA, Tribal Impact Summary Statement, 2016.
32. FDA Memorandum, ``Sanitary Transportation of Human and Animal
Food Regulation,'' 2011.
33. FDA Memorandum, ``Sanitary Transportation of Human and Animal
Food Final Rule,'' 2015.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 11

    Administrative practice and procedure, Computer technology,
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
1 and 11 are amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 is revised to read as
follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342i, 343,
350c, 350d, 350e, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362,
371, 373, 374, 381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241,
243, 262, 264.

0
2. Add subpart O, consisting of Sec. Sec.  1.900 through 1.934, to part
1 to read as follows:
Subpart O--Sanitary Transportation of Human and Animal Food

General Provisions

Sec.
1.900 Who is subject to this subpart?
1.902 How do the criteria and definitions in this subpart apply
under the Federal Food, Drug, and Cosmetic Act?
1.904 What definitions apply to this subpart?

Vehicles and Transportation Equipment

1.906 What requirements apply to vehicles and transportation
equipment?

Transportation Operations

1.908 What requirements apply to transportation operations?

Training

1.910 What training requirements apply to carriers engaged in
transportation operations?

Records

1.912 What record retention and other records requirements apply to
shippers, receivers, loaders, and carriers engaged in transportation
operations?

Waivers

1.914 Under what circumstances will we waive a requirement of this
subpart?
1.916 When will we consider whether to waive a requirement of this
subpart?
1.918 What must be included in the Statement of Grounds in a
petition requesting a waiver?
1.920 What information submitted in a petition requesting a waiver
or submitted in comments on such a petition is publicly available?
1.922 Who will respond to a petition requesting a waiver?
1.924 What process applies to a petition requesting a waiver?
1.926 Under what circumstances may we deny a petition requesting a
waiver?
1.928 What process will we follow when waiving a requirement of this
subpart on our own initiative?
1.930 When will a waiver that we grant become effective?
1.932 Under what circumstances may we modify or revoke a waiver?
1.934 What procedures apply if we determine that a waiver should be
modified or revoked?

Subpart O--Sanitary Transportation of Human and Animal Food

General Provisions

Sec.  1.900  Who is subject to this subpart?

    (a) Except for non-covered businesses as defined in Sec.  1.904 and
as provided for in paragraph (b) of this section, the requirements of
this subpart apply to shippers, receivers, loaders, and carriers
engaged in transportation operations whether or not the food is being
offered for or enters interstate commerce. The requirements of this
subpart apply in addition to any other requirements of this chapter
that are applicable to the transportation of food, e.g., in 21 CFR
parts 1, 117, 118, 225, 507, and 589.
    (b) The requirements of this subpart do not apply to shippers,
receivers, loaders, or carriers when they are engaged in transportation
operations:
    (1) Of food that is transshipped through the United States to
another country; or
    (2) Of food that is imported for future export, in accordance with
section 801(d)(3) of the Federal Food, Drug, and Cosmetic Act, and that
is neither consumed nor distributed in the United States; or
    (3) Of food when it is located in food facilities as defined in
Sec.  1.227 of this chapter, that are regulated exclusively, throughout
the entire facility, by the U.S. Department of Agriculture under the
Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products
Inspection Act (21 U.S.C. 1031 et seq.).

Sec.  1.902  How do the criteria and definitions in this subpart apply
under the Federal Food, Drug, and Cosmetic Act?

    (a) The criteria and definitions of this subpart apply in
determining whether food is adulterated within the meaning of section
402(i) of the Federal Food, Drug, and Cosmetic Act in that the food has
been transported or offered for transport by a shipper, carrier by
motor vehicle or rail vehicle, loader, or receiver engaged in
transportation operations under conditions that are not in compliance
with this subpart.
    (b) The failure by a shipper, carrier by motor vehicle or rail
vehicle, loader, or receiver engaged in transportation operations to
comply with the requirements of this subpart is a prohibited act under
section 301(hh) of the Federal Food, Drug, and Cosmetic Act.

Sec.  1.904  What definitions apply to this subpart?

    The definitions and interpretations of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act are applicable to such terms when
used in this part. The following definitions also apply:
    Adequate means that which is needed to accomplish the intended
purpose in keeping with good public health practice.
    Animal food means food for animals other than man, and includes pet
food, animal feed, and raw materials and ingredients.
    Bulk vehicle means a tank truck, hopper truck, rail tank car,
hopper car, cargo tank, portable tank, freight container, or hopper
bin, or any other vehicle in which food is shipped in bulk, with the
food coming into direct contact with the vehicle.
    Carrier means a person who physically moves food by rail or motor
vehicle in commerce within the United States. The term carrier does not
include any person who transports food while operating as a parcel
delivery service.
    Cross-contact means the unintentional incorporation of a food
allergen as defined in section 201(qq) of the Federal Food, Drug, and
Cosmetic Act into food, except animal food.
    Farm has the meaning given in Sec.  1.227 of this chapter.
    Food not completely enclosed by a container means any food that is
placed into a container in such a manner that it is partially open to
the surrounding environment. Examples of such containers include an
open wooden basket or crate, an open cardboard box, a vented cardboard
box with a top, or a vented plastic bag. This term does not include
food transported in a bulk vehicle as defined in this subpart.
    Full-time equivalent employee is a term used to represent the
number of employees of a business entity for the purpose of determining
whether the business is a small business. The number of full-time
equivalent employees is determined by dividing the total number of
hours of salary or wages paid directly to employees of the business
entity and of all of its affiliates and subsidiaries by the number of
hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52 weeks). If
the result is not a whole number, round down to the next lowest whole
number.
    Loader means a person that loads food onto a motor or rail vehicle
during transportation operations.
    Non-covered business means a shipper, loader, receiver, or carrier
engaged in transportation operations that has less than $500,000, as
adjusted

for inflation, in average annual revenues, calculated on a rolling
basis, during the 3-year period preceding the applicable calendar year.
For the purpose of determining an entity's 3-year average revenue
threshold as adjusted for inflation, the baseline year for calculating
the adjustment for inflation is 2011.
    Operating temperature means a temperature sufficient to ensure that
under foreseeable circumstances of temperature variation during
transport, e.g., seasonal conditions, refrigeration unit defrosting,
multiple vehicle loading and unloading stops, the operation will meet
the requirements of Sec.  1.908(a)(3).
    Pest means any objectionable animals or insects including birds,
rodents, flies, and larvae.
    Receiver means any person who receives food at a point in the
United States after transportation, whether or not that person
represents the final point of receipt for the food.
    Shipper means a person, e.g., the manufacturer or a freight broker,
who arranges for the transportation of food in the United States by a
carrier or multiple carriers sequentially.
    Small business means a business employing fewer than 500 full-time
equivalent employees except that for carriers by motor vehicle that are
not also shippers and/or receivers, this term would mean a business
subject to Sec.  1.900(a) having less than $27,500,000 in annual
receipts.
    Transportation means any movement of food in by motor vehicle or
rail vehicle in commerce within the United States.
    Transportation equipment means equipment used in food
transportation operations, e.g., bulk and non-bulk containers, bins,
totes, pallets, pumps, fittings, hoses, gaskets, loading systems, and
unloading systems. Transportation equipment also includes a railcar not
attached to a locomotive or a trailer not attached to a tractor.
    Transportation operations means all activities associated with food
transportation that may affect the sanitary condition of food including
cleaning, inspection, maintenance, loading and unloading, and operation
of vehicles and transportation equipment. Transportation operations do
not include any activities associated with the transportation of food
that is completely enclosed by a container except a food that requires
temperature control for safety, compressed food gases, food contact
substances as defined in section 409(h)(6) of the Federal Food, Drug,
and Cosmetic Act, human food byproducts transported for use as animal
food without further processing, or live food animals except molluscan
shellfish. In addition, transportation operations do not include any
transportation activities that are performed by a farm.
    Vehicle means a land conveyance that is motorized, e.g., a motor
vehicle, or that moves on rails, e.g., a railcar, which is used in
transportation operations.

Vehicles and Transportation Equipment

Sec.  1.906  What requirements apply to vehicles and transportation
equipment?

    (a) Vehicles and transportation equipment used in transportation
operations must be so designed and of such material and workmanship as
to be suitable and adequately cleanable for their intended use to
prevent the food they transport from becoming unsafe, i.e., adulterated
within the meaning of section 402(a)(1), (2), and (4) of the Federal
Food, Drug, and Cosmetic Act during transportation operations.
    (b) Vehicles and transportation equipment must be maintained in
such a sanitary condition for their intended use as to prevent the food
they transport from becoming unsafe during transportation operations.
    (c) Vehicles and transportation equipment used in transportation
operations for food requiring temperature control for safety must be
designed, maintained, and equipped as necessary to provide adequate
temperature control to prevent the food from becoming unsafe during
transportation operations.
    (d) Vehicles and transportation equipment must be stored in a
manner that prevents it from harboring pests or becoming contaminated
in any other manner that could result in food for which it will be used
becoming unsafe during transportation operations.

Transportation Operations

Sec.  1.908  What requirements apply to transportation operations?

    (a) General requirements. (1) Unless stated otherwise in this
section, the requirements of this section apply to all shippers,
carriers, loaders, and receivers engaged in transportation operations.
A person may be subject to these requirements in multiple capacities,
e.g., the shipper may also be the loader and the carrier, if the person
also performs the functions of those respective persons as defined in
this subpart. An entity subject to this subpart (shipper, loader,
carrier, or receiver) may reassign, in a written agreement, its
responsibilities under this subpart to another party subject to this
subpart. The written agreement is subject to the records requirements
of Sec.  1.912(d).
    (2) Responsibility for ensuring that transportation operations are
carried out in compliance with all requirements in this subpart must be
assigned to competent supervisory personnel.
    (3) All transportation operations must be conducted under such
conditions and controls necessary to prevent the food from becoming
unsafe during transportation operations including:
    (i) Taking effective measures such as segregation, isolation, or
the use of packaging to protect food from contamination by raw foods
and nonfood items in the same load.
    (ii) Taking effective measures such as segregation, isolation, or
other protective measures, such as hand washing, to protect food
transported in bulk vehicles or food not completely enclosed by a
container from contamination and cross-contact during transportation
operations.
    (iii) Taking effective measures to ensure that food that requires
temperature control for safety is transported under adequate
temperature control.
    (4) The type of food, e.g., animal feed, pet food, human food, and
its production stage, e.g., raw material, ingredient or finished food,
must be considered in determining the necessary conditions and controls
for the transportation operation.
    (5) Shippers, receivers, loaders, and carriers, which are under the
ownership or operational control of a single legal entity, as an
alternative to meeting the requirements of paragraphs (b), (d), and (e)
of this section may conduct transportation operations in conformance
with common, integrated written procedures that ensure the sanitary
transportation of food consistent with the requirements of this
section. The written procedures are subject to the records requirements
of Sec.  1.912(e).
    (6) If a shipper, loader, receiver, or carrier becomes aware of an
indication of a possible material failure of temperature control or
other conditions that may render the food unsafe during transportation,
the food shall not be sold or otherwise distributed, and these persons
must take appropriate action including, as necessary, communication
with other parties to ensure that the food is not sold or otherwise
distributed unless a determination is made by a qualified individual
that the temperature deviation or other condition did not render the
food unsafe.
    (b) Requirements applicable to shippers engaged in transportation

operations. (1) Unless the shipper takes other measures in accordance
with paragraph (b)(3) of this section to ensure that vehicles and
equipment used in its transportation operations are in appropriate
sanitary condition for the transportation of the food, i.e., that will
prevent the food from becoming unsafe, the shipper must specify to the
carrier and, when necessary, the loader, in writing, all necessary
sanitary specifications for the carrier's vehicle and transportation
equipment to achieve this purpose, including any specific design
specifications and cleaning procedures. One-time notification shall be
sufficient unless the design requirements and cleaning procedures
required for sanitary transport change based upon the type of food
being transported, in which case the shipper shall so notify the
carrier in writing before the shipment. The information submitted by
the shipper to the carrier is subject to the records requirements in
Sec.  1.912(a).
    (2) Unless the shipper takes other measures in accordance with
paragraph (b)(5) of this section to ensure that adequate temperature
control is provided during the transportation of food that requires
temperature control for safety under the conditions of shipment, a
shipper of such food must specify in writing to the carrier, except a
carrier who transports the food in a thermally insulated tank, and,
when necessary, the loader, an operating temperature for the
transportation operation including, if necessary, the pre-cooling
phase. One-time notification shall be sufficient unless a factor, e.g.,
the conditions of shipment, changes, necessitating a change in the
operating temperature, in which case the shipper shall so notify the
carrier in writing before the shipment. The information submitted by
the shipper to the carrier is subject to the records requirements in
Sec.  1.912(a).
    (3) A shipper must develop and implement written procedures,
subject to the records requirements of Sec.  1.912(a), adequate to
ensure that vehicles and equipment used in its transportation
operations are in appropriate sanitary condition for the transportation
of the food, i.e., will prevent the food from becoming unsafe during
the transportation operation. Measures to implement these procedures
may be accomplished by the shipper or by the carrier or another party
covered by this subpart under a written agreement subject to the
records requirements of Sec.  1.912(a).
    (4) A shipper of food transported in bulk must develop and
implement written procedures, subject to the records requirements of
Sec.  1.912(a), adequate to ensure that a previous cargo does not make
the food unsafe. Measures to ensure the safety of the food may be
accomplished by the shipper or by the carrier or another party covered
by this subpart under a written agreement subject to the records
requirements of Sec.  1.912(a).
    (5) The shipper of food that requires temperature control for
safety under the conditions of shipment must develop and implement
written procedures, subject to the records requirements of Sec.
1.912(a), to ensure that the food is transported under adequate
temperature control. Measures to ensure the safety of the food may be
accomplished by the shipper or by the carrier or another party covered
by this subpart under a written agreement subject to the records
requirements of Sec.  1.912(a) and must include measures equivalent to
those specified for carriers under paragraphs (e)(1) through (3) of
this section.
    (c) Requirements applicable to loaders engaged in transportation
operations. (1) Before loading food not completely enclosed by a
container onto a vehicle or into transportation equipment the loader
must determine, considering, as appropriate, specifications provided by
the shipper in accordance with paragraph (b)(1) of this section, that
the vehicle or transportation equipment is in appropriate sanitary
condition for the transport of the food, e.g., it is in adequate
physical condition, and free of visible evidence of pest infestation
and previous cargo that could cause the food to become unsafe during
transportation. This may be accomplished by any appropriate means.
    (2) Before loading food that requires temperature control for
safety, the loader must verify, considering, as appropriate,
specifications provided by the shipper in accordance with paragraph
(b)(2) of this section, that each mechanically refrigerated cold
storage compartment or container is adequately prepared for the
transportation of such food, including that it has been properly pre-
cooled, if necessary, and meets other sanitary conditions for food
transportation.
    (d) Requirements applicable to receivers engaged in transportation
operations. Upon receipt of food that requires temperature control for
safety under the conditions of shipment, the receiver must take steps
to adequately assess that the food was not subjected to significant
temperature abuse, such as determining the food's temperature, the
ambient temperature of the vehicle and its temperature setting, and
conducting a sensory inspection, e.g., for off-odors.
    (e) Requirements applicable to carriers engaged in transportation
operations. When the carrier and shipper have a written agreement that
the carrier is responsible, in whole or in part, for sanitary
conditions during the transportation operation, the carrier is
responsible for the following functions as applicable per the
agreement:
    (1) A carrier must ensure that vehicles and transportation
equipment meet the shipper's specifications and are otherwise
appropriate to prevent the food from becoming unsafe during the
transportation operation.
    (2) A carrier must, once the transportation operation is complete
and if requested by the receiver, provide the operating temperature
specified by the shipper in accordance with paragraph (b)(2) of this
section and, if requested by the shipper or receiver, demonstrate that
it has maintained temperature conditions during the transportation
operation consistent with the operating temperature specified by the
shipper in accordance with paragraph (b)(2) of this section. Such
demonstration may be accomplished by any appropriate means agreeable to
the carrier and shipper, such as the carrier presenting measurements of
the ambient temperature upon loading and unloading or time/temperature
data taken during the shipment.
    (3) Before offering a vehicle or transportation equipment with an
auxiliary refrigeration unit for use for the transportation of food
that requires temperature control for safety under the conditions of
the shipment during transportation, a carrier must pre-cool each
mechanically refrigerated cold storage compartment as specified by the
shipper in accordance with paragraph (b)(2) of this section.
    (4) If requested by the shipper, a carrier that offers a bulk
vehicle for food transportation must provide information to the shipper
that identifies the previous cargo transported in the vehicle.
    (5) If requested by the shipper, a carrier that offers a bulk
vehicle for food transportation must provide information to the shipper
that describes the most recent cleaning of the bulk vehicle.
    (6) A carrier must develop and implement written procedures subject
to the records requirements of Sec.  1.912(b) that:
    (i) Specify practices for cleaning, sanitizing if necessary, and
inspecting vehicles and transportation equipment that the carrier
provides for use in the transportation of food to maintain the vehicles
and the transportation equipment in appropriate sanitary condition as
required by Sec.  1.906(b);

    (ii) Describe how it will comply with the provisions for
temperature control in paragraph (e)(2) of this section, and;
    (iii) Describe how it will comply with the provisions for the use
of bulk vehicles in paragraphs (e)(4) and (5) of this section.

 Training

Sec.  1.910  What training requirements apply to carriers engaged in
transportation operations?

    (a) When the carrier and shipper have agreed in a written contract
that the carrier is responsible, in whole or in part, for the sanitary
conditions during transportation operations, the carrier must provide
adequate training to personnel engaged in transportation operations
that provides an awareness of potential food safety problems that may
occur during food transportation, basic sanitary transportation
practices to address those potential problems, and the responsibilities
of the carrier under this part. The training must be provided upon
hiring and as needed thereafter.
    (b) Carriers must establish and maintain records documenting the
training described in paragraph (a) of this section. Such records must
include the date of the training, the type of training, and the
person(s) trained. These records are subject to the records
requirements of Sec.  1.912(c).

Records

Sec.  1.912  What record retention and other records requirements apply
to shippers, receivers, loaders, and carriers engaged in transportation
operations?

    (a) Shippers must retain records:
    (1) That demonstrate that they provide specifications and operating
temperatures to carriers as required by Sec.  1.908(b)(1) and (2) as a
regular part of their transportation operations for a period of 12
months beyond the termination of the agreements with the carriers.
    (2) Of written agreements and the written procedures required by
Sec.  1.908(b)(3), (4), and (5), for a period of 12 months beyond when
the agreements and procedures are in use in their transportation
operations.
    (b) Carriers must retain records of the written procedures required
by Sec.  1.908(e)(6) for a period of 12 months beyond when the
agreements and procedures are in use in their transportation
operations.
    (c) Carriers must retain training records required by Sec.
1.910(b) for a period of 12 months beyond when the person identified in
any such records stops performing the duties for which the training was
provided.
    (d) Any person subject to this subpart must retain any other
written agreements assigning tasks in compliance with this subpart for
a period of 12 months beyond the termination of the agreements.
    (e) Shippers, receivers, loaders, and carriers, which operate under
the ownership or control of a single legal entity in accordance with
the provisions of Sec.  1.908(a)(5), must retain records of the written
procedures for a period of 12 months beyond when the procedures are in
use in their transportation operations.
    (f) Shippers, receivers, loaders, and carriers must make all
records required by this subpart available to a duly authorized
individual promptly upon oral or written request.
    (g) All records required by this subpart must be kept as original
records, true copies (such as photocopies, pictures, scanned copies,
microfilm, microfiche, or other accurate reproductions of the original
records), or electronic records.
    (h) Records that are established or maintained to satisfy the
requirements of this subpart and that meet the definition of electronic
records in Sec.  11.3(b)(6) of this chapter are exempt from the
requirements of part 11 of this chapter. Records that satisfy the
requirements of this subpart, but that also are required under other
applicable statutory provisions or regulations, remain subject to part
11 of this chapter.
    (i) Except for the written procedures required by Sec.
1.908(e)(6)(i), offsite storage of records is permitted if such records
can be retrieved and provided onsite within 24 hours of request for
official review. The written procedures required by Sec.
1.908(e)(6)(i) must remain onsite as long as the procedures are in use
in transportation operations. Electronic records are considered to be
onsite if they are accessible from an onsite location.
    (j) All records required by this subpart are subject to the
disclosure requirements under part 20 of this chapter.

Waivers

Sec.  1.914  Under what circumstances will we waive a requirement of
this subpart?

    We will waive any requirement of this subpart with respect to any
class of persons, vehicles, food, or nonfood products, when we
determine that:
    (a) The waiver will not result in the transportation of food under
conditions that would be unsafe for human or animal health; and
    (b) The waiver will not be contrary to the public interest.

Sec.  1.916  When will we consider whether to waive a requirement of
this subpart?

    We will consider whether to waive a requirement of this subpart on
our own initiative or on the petition submitted under Sec.  10.30 of
this chapter by any person who is subject to the requirements of this
subpart with respect to any class of persons, vehicles, food, or
nonfood products.

Sec.  1.918  What must be included in the Statement of Grounds in a
petition requesting a waiver?

    In addition to the requirements set forth in Sec.  10.30 of this
chapter, the Statement of Grounds in a petition requesting a waiver
must:
    (a) Describe with particularity the waiver requested, including the
persons, vehicles, food, or nonfood product(s) to which the waiver
would apply and the requirement(s) of this subpart to which the waiver
would apply; and
    (b) Present information demonstrating 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.

Sec.  1.920  What information submitted in a petition requesting a
waiver or submitted in comments on such a petition is publicly
available?

    We will presume that information submitted in a petition requesting
a waiver and comments submitted on such a petition does not contain
information exempt from public disclosure under part 20 of this chapter
and would be made public as part of the docket associated with this
request.

Sec.  1.922  Who will respond to a petition requesting a waiver?

    The Director or Deputy Directors of the Center for Food Safety and
Applied Nutrition (CFSAN) or the Center for Veterinary Medicine (CVM),
or the Director, Office of Compliance, CFSAN, or the Director, Office
of Surveillance and Compliance, CVM, will respond to a petition
requesting a waiver.

Sec.  1.924  What process applies to a petition requesting a waiver?

    (a) In general, the procedures set forth in Sec.  10.30 of this
chapter govern our response to a petition requesting a waiver.
    (b) Under Sec.  10.30(h)(3) of this chapter, we will publish a
notice in the Federal Register, requesting information and views on a
filed petition, including information and views from persons who could
be affected by the waiver if the petition were to be granted.
    (c) Under Sec.  10.30(e)(3) of this chapter, we will respond to the
petitioner in writing.

    (1) If we grant the petition, either in whole or in part, we will
publish a notice in the Federal Register setting forth any waiver and
the reasons for such waiver.
    (2) If we deny the petition (including partial denials), our
written response to the petitioner will explain the reason(s) for the
denial.
    (d) We will make readily accessible to the public, and periodically
update, a list of filed petitions requesting waivers, including the
status of each petition (for example, pending, granted, or denied).

Sec.  1.926  Under what circumstances may we deny a petition requesting
a waiver?

    We may deny a petition requesting a waiver if the petition does not
provide the information required under Sec.  1.918 (including the
requirements of Sec.  10.30 of this chapter), or if we determine that
the waiver could result in the transportation of food under conditions
that would be unsafe for human or animal health, or that the waiver
could be contrary to the public interest.

Sec.  1.928  What process will we follow when waiving a requirement of
this subpart on our own initiative?

    If we, on our own initiative, determine that a waiver is
appropriate, we will publish a notice in the Federal Register setting
forth the waiver and the reasons for such waiver.

Sec.  1.930  When will a waiver that we grant become effective?

    Any waiver that we grant will become effective on the date that
notice of the waiver is published in the Federal Register.

Sec.  1.932  Under what circumstances may we modify or revoke a waiver?

    We may modify or revoke a waiver if we determine that the waiver
could result in the transportation of food under conditions that would
be unsafe for human or animal health or that the waiver could be
contrary to the public interest.

Sec.  1.934  What procedures apply if we determine that a waiver should
be modified or revoked?

    (a) We will provide the following notifications:
    (1) We will notify the entity that initially requested the waiver,
in writing at the address identified in its petition, if we determine
that a waiver granted in response to its petition should be modified or
revoked.
    (2) We will publish a notice of our determination that a waiver
should be modified or revoked in the Federal Register. This notice will
establish a public docket so that interested parties may submit written
submissions on our determination.
    (b) We will consider timely written submissions submitted to the
public docket from interested parties.
    (c) We will publish a notice of our decision in the Federal
Register. The effective date of the decision will be the date of
publication of the notice.

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

0
3. The authority citation for 21 CFR part 11 continues to read as
follows:

    Authority:  21 U.S.C. 321-393; 42 U.S.C. 262.

0
4. Section 11.1 is amended by adding paragraph (n) to read as follows:

Sec.  11.1  Scope.

* * * * *
    (n) This part does not apply to records required to be established
or maintained by subpart O of part 1 of this chapter. Records that
satisfy the requirements of subpart O of part 1 of this chapter, but
that also are required under other applicable statutory provisions or
regulations, remain subject to this part.

    Dated: March 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07330 Filed 4-5-16; 8:45 am]
 BILLING CODE 4164-01-P