[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2023 Edition]
[From the U.S. Government Publishing Office]
[[Page i]]
Title 21
Food and Drugs
________________________
Parts 1 to 99
Revised as of April 1, 2023
Containing a codification of documents of general
applicability and future effect
As of April 1, 2023
Published by the Office of the Federal Register
National Archives and Records Administration as a
Special Edition of the Federal Register
[[Page ii]]
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[[Page iii]]
Table of Contents
Page
Explanation................................................. v
Title 21:
Chapter I--Food and Drug Administration, Department
of Health and Human Services 3
Finding Aids:
Table of CFR Titles and Chapters........................ 599
Alphabetical List of Agencies Appearing in the CFR...... 619
List of CFR Sections Affected........................... 629
[[Page iv]]
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Cite this Code: CFR
To cite the regulations in
this volume use title,
part and section number.
Thus, 21 CFR 1.1 refers to
title 21, part 1, section
1.
----------------------------
[[Page v]]
EXPLANATION
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
departments and agencies of the Federal Government. The Code is divided
into 50 titles which represent broad areas subject to Federal
regulation. Each title is divided into chapters which usually bear the
name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1
The appropriate revision date is printed on the cover of each
volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially
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HOW TO USE THE CODE OF FEDERAL REGULATIONS
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To determine whether a Code volume has been amended since its
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EFFECTIVE AND EXPIRATION DATES
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OMB CONTROL NUMBERS
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Federal agencies to display an OMB control number with their information
collection request.
[[Page vi]]
Many agencies have begun publishing numerous OMB control numbers as
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PAST PROVISIONS OF THE CODE
Provisions of the Code that are no longer in force and effect as of
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for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.
``[RESERVED]'' TERMINOLOGY
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INCORPORATION BY REFERENCE
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This material, like any other properly issued regulation, has the force
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What is a proper incorporation by reference? The Director of the
Federal Register will approve an incorporation by reference only when
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approval is based are:
(a) The incorporation will substantially reduce the volume of
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(b) The matter incorporated is in fact available to the extent
necessary to afford fairness and uniformity in the administrative
process.
(c) The incorporating document is drafted and submitted for
publication in accordance with 1 CFR part 51.
What if the material incorporated by reference cannot be found? If
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CFR INDEXES AND TABULAR GUIDES
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that volume.
[[Page vii]]
The Federal Register Index is issued monthly in cumulative form.
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the revision dates of the 50 CFR titles.
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Oliver A. Potts,
Director,
Office of the Federal Register
April 1, 2023
[[Page ix]]
THIS TITLE
Title 21--Food and Drugs is composed of nine volumes. The parts in
these volumes are arranged in the following order: Parts 1-99, 100-169,
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300 to end.
The first eight volumes, containing parts 1-1299, comprise Chapter I--
Food and Drug Administration, Department of Health and Human Services.
The ninth volume, containing part 1300 to end, includes Chapter II--Drug
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes
represent all current regulations codified under this title of the CFR
as of April 1, 2023.
For this volume, Kenneth R. Payne was Chief Editor. The Code of
Federal Regulations publication program is under the direction of John
Hyrum Martinez, assisted by Stephen J. Frattini.
[[Page 1]]
TITLE 21--FOOD AND DRUGS
(This book contains parts 1 to 99)
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Part
chapter i--Food and Drug Administration, Department of
Health and Human Services................................. 1
[[Page 3]]
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
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Editorial Note: Nomenclature changes to chapter I appear at 66 FR
56035, Nov. 6, 2001, 69 FR 13717, Mar. 24, 2004, and 69 FR 18803, Apr.
9, 2004.
SUBCHAPTER A--GENERAL
Part Page
1 General enforcement regulations............. 5
2 General administrative rulings and decisions 167
3 Product jurisdiction........................ 172
4 Regulation of combination products.......... 177
5 Organization................................ 183
7 Enforcement policy.......................... 195
10 Administrative practices and procedures..... 205
11 Electronic records; electronic signatures... 241
12 Formal evidentiary public hearing........... 246
13 Public hearing before a public board of
inquiry................................. 263
14 Public hearing before a public advisory
committee............................... 268
15 Public hearing before the Commissioner...... 295
16 Regulatory hearing before the Food and Drug
Administration.......................... 298
17 Civil money penalties hearings.............. 304
19 Standards of conduct and conflicts of
interest................................ 317
20 Public information.......................... 319
21 Protection of privacy....................... 352
25 Environmental impact considerations......... 368
26 Mutual recognition of pharmaceutical good
manufacturing practice reports, medical
device quality system audit reports, and
certain medical device product
evaluation reports: United States and
the European Community.................. 380
50 Protection of human subjects................ 411
54 Financial disclosure by clinical
investigators........................... 423
56 Institutional Review Boards................. 427
58 Good laboratory practice for nonclinical
laboratory studies...................... 437
[[Page 4]]
60 Patent term restoration..................... 450
70 Color additives............................. 457
71 Color additive petitions.................... 465
73 Listing of color additives exempt from
certification........................... 472
74 Listing of color additives subject to
certification........................... 528
80 Color additive certification................ 566
81 General specifications and general
restrictions for provisional color
additives for use in foods, drugs, and
cosmetics............................... 573
82 Listing of certified provisionally listed
colors and specifications............... 579
83-98
[Reserved]
99 Dissemination of information on unapproved/
new uses for marketed drugs, biologics,
and devices............................. 585
[[Page 5]]
SUBCHAPTER A_GENERAL
PART 1_GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart A_General Provisions
Sec.
1.1 General.
1.3 Definitions.
1.4 Authority citations.
Subpart B_General Labeling Requirements
1.20 Presence of mandatory label information.
1.21 Failure to reveal material facts.
1.23 Procedures for requesting variations and exemptions from required
label statements.
1.24 Exemptions from required label statements.
Subpart C [Reserved]
Subpart D_Electronic Import Entries
1.70 Scope.
1.71 Definitions.
1.72 Data elements that must be submitted in ACE for articles regulated
by FDA.
1.73 Food.
1.74 Human drugs.
1.75 Animal drugs and veterinary devices.
1.76 Medical devices.
1.77 Radiation-emitting electronic products.
1.78 Biological products, HCT/Ps, and related drugs and medical devices.
1.79 Tobacco products.
1.80 Cosmetics.
1.81 Rejection of entry.
Subpart E_Imports and Exports
1.83 Definitions.
1.90 Notice of sampling.
1.91 Payment for samples.
1.94 Hearing on refusal of admission or destruction.
1.95 Application for authorization to relabel and recondition.
1.96 Granting of authorization to relabel and recondition.
1.97 Bonds.
1.99 Costs chargeable in connection with relabeling and reconditioning
inadmissible imports.
1.101 Notification and recordkeeping.
Subparts F-G [Reserved]
Subpart H_Registration of Food Facilities
General Provisions
1.225 Who must register under this subpart?
1.226 Who does not have to register under this subpart?
1.227 What definitions apply to this subpart?
Procedures for Registration of Food Facilities
1.230 When must you register or renew your registration?
1.231 How and where do you register or renew your registration?
1.232 What information is required in the registration?
1.233 Are there optional items included in the registration form?
1.234 How and when do you update your facility's registration
information?
1.235 How and when do you cancel your facility's registration
information?
Additional Provisions
1.240 What other registration requirements apply?
1.241 What are the consequences of failing to register, update, renew,
or cancel your registration?
1.242 What does assignment of a registration number mean?
1.243 Is food registration information available to the public?
1.245 Waiver request.
Subpart I_Prior Notice of Imported Food
General Provisions
1.276 What definitions apply to this subpart?
1.277 What is the scope of this subpart?
Requirements to Submit Prior Notice of Imported Food
1.278 Who is authorized to submit prior notice?
1.279 When must prior notice be submitted to FDA?
1.280 How must you submit prior notice?
1.281 What information must be in a prior notice?
1.282 What must you do if information changes after you have received
confirmation of a prior notice from FDA?
Consequences
1.283 What happens to food that is imported or offered for import
without adequate prior notice?
1.284 What are the other consequences of failing to submit adequate
prior notice
[[Page 6]]
or otherwise failing to comply with this subpart?
1.285 What happens to food that is imported or offered for import from
unregistered facilities that are required to register under
subpart H of this part?
Subpart J_Establishment, Maintenance, and Availability of Records
General Provisions
1.326 Who is subject to this subpart?
1.327 Who is excluded from all or part of the regulations in this
subpart?
1.328 What definitions apply to this subpart?
1.329 Do other statutory provisions and regulations apply?
1.330 Can existing records satisfy the requirements of this subpart?
Requirements for Nontransporters To Establish and Maintain Records To
Identify the Nontransporter and Transporter Immediate Previous Sources
of Food
1.337 What information must nontransporters establish and maintain to
identify the nontransporter and transporter immediate previous
sources of food?
Requirements for Nontransporters To Establish and Maintain Records To
Identify the Nontransporter and Transporter Immediate Subsequent
Recipients of Food
1.345 What information must nontransporters establish and maintain to
identify the nontransporter and transporter immediate
subsequent recipients of food?
Requirements for Transporters To Establish and Maintain Records
1.352 What information must transporters establish and maintain?
General Requirements
1.360 What are the record retention requirements?
1.361 What are the record availability requirements?
1.362 What records are excluded from this subpart?
1.363 What are the consequences of failing to establish or maintain
records or make them available to FDA as required by this
subpart?
Compliance Dates
1.368 What are the compliance dates for this subpart?
Subpart K_Administrative Detention of Food for Human or Animal
Consumption
General Provisions
1.377 What definitions apply to this subpart?
1.378 What criteria does FDA use to order a detention?
1.379 How long may FDA detain an article of food?
1.380 Where and under what conditions must the detained article of food
be held?
1.381 May a detained article of food be delivered to another entity or
transferred to another location?
1.382 What labeling or marking requirements apply to a detained article
of food?
1.383 What expedited procedures apply when FDA initiates a seizure
action against a detained perishable food?
1.384 When does a detention order terminate?
How does FDA order a detention?
1.391 Who approves a detention order?
1.392 Who receives a copy of the detention order?
1.393 What information must FDA include in the detention order?
What is the appeal process for a detention order?
1.401 Who is entitled to appeal?
1.402 What are the requirements for submitting an appeal?
1.403 What requirements apply to an informal hearing?
1.404 Who serves as the presiding officer for an appeal and for an
informal hearing?
1.405 When does FDA have to issue a decision on an appeal?
1.406 How will FDA handle classified information in an informal hearing?
Subpart L_Foreign Supplier Verification Programs for Food Importers
1.500 What definitions apply to this subpart?
1.501 To what foods do the requirements in this subpart apply?
1.502 What foreign supplier verification program (FSVP) must I have?
1.503 Who must develop my FSVP and perform FSVP activities?
1.504 What hazard analysis must I conduct?
1.505 What evaluation for foreign supplier approval and verification
must I conduct?
1.506 What foreign supplier verification and related activities must I
conduct?
1.507 What requirements apply when I import a food that cannot be
consumed without the hazards being controlled or for which the
hazards are controlled after importation?
[[Page 7]]
1.508 What corrective actions must I take under my FSVP?
1.509 How must the importer be identified at entry?
1.510 How must I maintain records of my FSVP?
1.511 What FSVP must I have if I am importing a food subject to certain
requirements in the dietary supplement current good
manufacturing practice regulation?
1.512 What FSVP may I have if I am a very small importer or if I am
importing certain food from certain small foreign suppliers?
1.513 What FSVP may I have if I am importing certain food from a country
with an officially recognized or equivalent food safety
system?
1.514 What are some consequences of failing to comply with the
requirements of this subpart?
Subpart M_Accreditation of Third-Party Certification Bodies To Conduct
Food Safety Audits and To Issue Certifications
1.600 What definitions apply to this subpart?
1.601 Who is subject to this subpart?
Recognition of Accreditation Bodies Under This Subpart
1.610 Who is eligible to seek recognition?
1.611 What legal authority must an accreditation body have to qualify
for recognition?
1.612 What competency and capacity must an accreditation body have to
qualify for recognition?
1.613 What protections against conflicts of interest must an
accreditation body have to qualify for recognition?
1.614 What quality assurance procedures must an accreditation body have
to qualify for recognition?
1.615 What records procedures must an accreditation body have to qualify
for recognition?
Requirements for Accreditation Bodies That Have Been Recognized Under
This Subpart
1.620 How must a recognized accreditation body evaluate third-party
certification bodies seeking accreditation?
1.621 How must a recognized accreditation body monitor the performance
of third-party certification bodies it accredited?
1.622 How must a recognized accreditation body monitor its own
performance?
1.623 What reports and notifications must a recognized accreditation
body submit to FDA?
1.624 How must a recognized accreditation body protect against conflicts
of interest?
1.625 What records requirements must an accreditation body that has been
recognized meet?
Procedures for Recognition of Accreditation Bodies Under This Subpart
1.630 How do I apply to FDA for recognition or renewal of recognition?
1.631 How will FDA review my application for recognition or renewal of
recognition and what happens once FDA decides on my
application?
1.632 What is the duration of recognition?
1.633 How will FDA monitor recognized accreditation bodies?
1.634 When will FDA revoke recognition?
1.635 What if I want to voluntarily relinquish recognition or do not
want to renew recognition?
1.636 How do I request reinstatement of recognition?
Accreditation of Third-Party Certification Bodies Under This Subpart
1.640 Who is eligible to seek accreditation?
1.641 What legal authority must a third-party certification body have to
qualify for accreditation?
1.642 What competency and capacity must a third-party certification body
have to qualify for accreditation?
1.643 What protections against conflicts of interest must a third-party
certification body have to qualify for accreditation?
1.644 What quality assurance procedures must a third-party certification
body have to qualify for accreditation?
1.645 What records procedures must a third-party certification body have
to qualify for accreditation?
Requirements for Third-Party Certification Bodies That Have Been
Accredited Under This Subpart
1.650 How must an accredited third-party certification body ensure its
audit agents are competent and objective?
1.651 How must an accredited third-party certification body conduct a
food safety audit of an eligible entity?
1.652 What must an accredited third-party certification body include in
food safety audit reports?
1.653 What must an accredited third-party certification body do when
issuing food or facility certifications?
1.654 When must an accredited third-party certification body monitor an
eligible entity that it has issued a food or facility
certification?
1.655 How must an accredited third-party certification body monitor its
own performance?
1.656 What reports and notifications must an accredited third-party
certification body submit?
[[Page 8]]
1.657 How must an accredited third-party certification body protect
against conflicts of interest?
1.658 What records requirements must a third-party certification body
that has been accredited meet?
Procedures for Accreditation of Third-Party Certification Bodies Under
This Subpart
1.660 Where do I apply for accreditation or renewal of accreditation by
a recognized accreditation body and what happens once the
recognized accreditation body decides on my application?
1.661 What is the duration of accreditation by a recognized
accreditation body?
1.662 How will FDA monitor accredited third-party certification bodies?
1.663 How do I request an FDA waiver or waiver extension for the 13-
month limit for audit agents conducting regulatory audits?
1.664 When would FDA withdraw accreditation?
1.665 What if I want to voluntarily relinquish accreditation or do not
want to renew accreditation?
1.666 How do I request reaccreditation?
Additional Procedures for Direct Accreditation of Third-Party
Certification Bodies Under This Subpart
1.670 How do I apply to FDA for direct accreditation or renewal of
direct accreditation?
1.671 How will FDA review my application for direct accreditation or
renewal of direct accreditation and what happens once FDA
decides on my application?
1.672 What is the duration of direct accreditation?
Requirements for Eligible Entities Under This Subpart
1.680 How and when will FDA monitor eligible entities?
1.681 How frequently must eligible entities be recertified?
General Requirements of This Subpart
1.690 How will FDA make information about recognized accreditation
bodies and accredited third-party certification bodies
available to the public?
1.691 How do I request reconsideration of a denial by FDA of an
application or a waiver request?
1.692 How do I request internal agency review of a denial of an
application or waiver request upon reconsideration?
1.693 How do I request a regulatory hearing on a revocation of
recognition or withdrawal of accreditation?
1.694 Are electronic records created under this subpart subject to the
electronic records requirements of part 11 of this chapter?
1.695 Are the records obtained by FDA under this subpart subject to
public disclosure?
Requirements for User Fees Under This Subpart
1.700 Who is subject to a user fee under this subpart?
1.705 What user fees are established under this subpart?
1.710 How will FDA notify the public about the fee schedule?
1.715 When must a user fee required by this subpart be submitted?
1.720 Are user fees under this subpart refundable?
1.725 What are the consequences of not paying a user fee under this
subpart on time?
Subpart N [Reserved]
Subpart O_Sanitary Transportation of Human and Animal Food
General Provisions
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
[[Page 9]]
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 P [Reserved]
Subpart Q_Administrative Detention of Drugs Intended for Human or Animal
Use
1.980 Administrative detention of drugs.
Subpart R_Laboratory Accreditation for Analyses of Foods
General Provisions
1.1101 What documents are incorporated by reference in this subpart?
1.1102 What definitions apply to this subpart?
1.1103 Who is subject to this subpart?
General Requirements
1.1107 When must food testing be conducted under this subpart?
1.1108 When and how will FDA issue a directed food laboratory order?
1.1109 How will FDA make information about recognized accreditation
bodies and LAAF-accredited laboratories available to the
public?
1.1110 What are the general requirements for submitting information to
FDA under this subpart?
FDA Recognition of Accreditation Bodies
1.1113 What are the eligibility requirements for a recognized
accreditation body?
1.1114 How does an accreditation body apply to FDA for recognition or
renewal of recognition?
1.1115 How will FDA evaluate applications for recognition and renewal of
recognition?
1.1116 What must a recognized accreditation body do to voluntarily
relinquish or not renew its recognition?
1.1117 How may an accreditation body request reinstatement of
recognition?
Requirements for Recognized Accreditation Bodies
1.1119 What are the conflict of interest requirements for a recognized
accreditation body?
1.1120 How must a recognized accreditation body assess laboratories
seeking LAAF-accreditation and oversee LAAF-accredited
laboratories?
1.1121 When must a recognized accreditation body require corrective
action, suspend a LAAF-accredited laboratory, or reduce the
scope of or withdraw the LAAF-accreditation of a laboratory?
1.1122 What procedures must a recognized accreditation body provide for
appeals of decisions to suspend, reduce the scope of,
withdraw, or deny LAAF-accreditation?
1.1123 What reports, notifications, and documentation must a recognized
accreditation body submit to FDA?
1.1124 What are the records requirements for a recognized accreditation
body?
1.1125 What are the internal audit requirements for a recognized
accreditation body?
FDA Oversight of Recognized Accreditation Bodies
1.1130 How will FDA oversee recognized accreditation bodies?
1.1131 When will FDA require corrective action, put a recognized
accreditation body on probation, or revoke the recognition of
an accreditation body?
LAAF-Accreditation of Laboratories
1.1138 What are the eligibility requirements for a LAAF-accredited
laboratory?
1.1139 How does a laboratory apply for LAAF-accreditation or extend its
scope of LAAF-accreditation?
1.1140 What must a LAAF-accredited laboratory do to voluntarily
relinquish its LAAF-accreditation?
1.1141 What is the effect on a LAAF-accredited laboratory if its
recognized accreditation body is no longer recognized by FDA?
1.1142 How does a laboratory request reinstatement of LAAF-
accreditation?
Requirements for LAAF-Accredited Laboratories
1.1147 What are the impartiality and conflict of interest requirements
for a LAAF-accredited laboratory?
1.1149 What oversight standards apply to sampling?
1.1150 What are the requirements for analysis of samples by a LAAF-
accredited laboratory?
1.1151 What requirements apply to the methods of analysis a LAAF-
accredited laboratory uses to conduct food testing under this
subpart?
[[Page 10]]
1.1152 What notifications, results, reports, and studies must a LAAF-
accredited laboratory submit to FDA?
1.1153 What are the requirements for submitting abridged analytical
reports?
1.1154 What other records requirements must a LAAF-accredited laboratory
meet?
FDA Oversight of LAAF-Accredited Laboratories
1.1159 How will FDA oversee LAAF-accredited laboratories?
1.1160 How will FDA review test results and analytical reports?
1.1161 When will FDA require corrective action, put a LAAF-accredited
laboratory on probation, or disqualify a LAAF-accredited
laboratory from submitting analytical reports?
1.1162 What are the consequences if FDA puts a LAAF-accredited
laboratory on probation or disqualifies a LAAF-accredited
laboratory?
Requesting FDA Reconsideration or Regulatory Hearings of FDA Decisions
Under This Subpart
1.1171 How does an accreditation body request reconsideration by FDA of
a decision to deny its application for recognition, renewal,
or reinstatement?
1.1173 How does an accreditation body or laboratory request a regulatory
hearing on FDA'sdecision to revoke the accreditation body's
recognition or disqualify a LAAF-accredited laboratory?
1.1174 How does an owner or consignee request a regulatory hearing on a
directed food laboratory order?
Electronic Records and Public Disclosure Requirements
1.1199 Are electronic records created under this subpart subject to the
electronic records requirements of part 11 of this chapter?
1.1200 Are the records obtained by FDA under this subpart subject to
public disclosure?
Subpart S_Additional Traceability Records for Certain Foods
General Provisions
1.1300 Who is subject to this subpart?
1.1305 What foods and persons are exempt from this subpart?
1.1310 What definitions apply to this subpart?
Traceability Plan
1.1315 What traceability plan must I have for foods on the Food
Traceability List that I manufacture, process, pack, or hold?
1.1320 When must I assign traceability lot codes to foods on the Food
Traceability List?
1.1325 What records must I keep and provide when I harvest or cool a raw
agricultural commodity on the Food Traceability List?
1.1330 What records must I keep when I am performing the initial packing
of a raw agricultural commodity (other than a food obtained
from a fishing vessel) on the Food Traceability List?
1.1335 What records must I keep when I am the first land-based receiver
of a food on the Food Traceability List that was obtained from
a fishing vessel?
1.1340 What records must I keep and provide when I ship a food on the
Food Traceability List?
1.1345 What records must I keep when I receive a food on the Food
Traceability List?
1.1350 What records must I keep when I transform a food on the Food
Traceability List?
Procedures for Modified Requirements and Exemptions
1.1360 Under what circumstances will FDA modify the requirements in this
subpart that apply to a food or type of entity or exempt a
food or type of entity from the requirements of this subpart?
1.1365 When will FDA consider whether to adopt modified requirements or
grant an exemption from the requirements of this subpart?
1.1370 What must be included in a petition requesting modified
requirements or an exemption from the requirements?
1.1375 What information submitted in a petition requesting modified
requirements or an exemption, or information in comments on
such a petition, is publicly available?
1.1380 What process applies to a petition requesting modified
requirements or an exemption?
1.1385 What process will FDA follow when adopting modified requirements
or granting an exemption on our own initiative?
1.1390 When will modified requirements that we adopt or an exemption
that we grant become effective?
1.1395 Under what circumstances may FDA revise or revoke modified
requirements or an exemption?
1.1400 What procedures apply if FDA tentatively determines that modified
requirements or an exemption should be revised or revoked?
[[Page 11]]
Waivers
1.1405 Under what circumstances will FDA waive one or more of the
requirements of this subpart for an individual entity or a
type of entity?
1.1410 When will FDA consider whether to waive a requirement of this
subpart?
1.1415 How may I request a waiver for an individual entity?
1.1420 What process applies to a request for a waiver for an individual
entity?
1.1425 What must be included in a petition requesting a waiver for a
type of entity?
1.1430 What information submitted in a petition requesting a waiver for
a type of entity, or information in comments on such a
petition, is publicly available?
1.1435 What process applies to a petition requesting a waiver for a type
of entity?
1.1440 What process will FDA follow when waiving a requirement of this
subpart on our own initiative?
1.1445 Under what circumstances may FDA modify or revoke a waiver?
1.1450 What procedures apply if FDA tentatively determines that a waiver
should be modified or revoked?
Records Maintenance and Availability
1.1455 How must records required by this subpart be maintained and made
available?
Consequences of Failure To Comply
1.1460 What consequences could result from failing to comply with the
requirements of this subpart?
Updating the Food Traceability List
1.1465 How will FDA update the Food Traceability List?
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, 342, 343, 350c, 350d,
350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381,
382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262,
264, 271.
Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec. 1.1 General.
(a) The provisions of regulations promulgated under the Federal
Food, Drug, and Cosmetic Act with respect to the doing of any act shall
be applicable also to the causing of such act to be done.
(b) The definitions and interpretations of terms contained in
sections 201 and 900 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 and 387) shall be applicable also to such terms when used in
regulations promulgated under that act.
(c) The definition of package in Sec. 1.20 and of principal display
panel in Sec. Sec. 101.1, 201.60, 501.1, 701.10 and 801.60 of this
chapter; and the requirements pertaining to uniform location, lack of
qualification, and separation of the net quantity declaration in
Sec. Sec. 101.7(f), 201.62(e), 501.105(f), 701.13(f) and 801.62(e) of
this chapter to type size requirements for net quantity declaration in
Sec. Sec. 101.7(i), 201.62(h), 501.105(i), 701.13(i) and 801.62(h) of
this chapter, to initial statement of ounces in the dual declaration of
net quantity in Sec. Sec. 101.7(j) and (m), 201.62(i) and (k),
501.105(j) and (m), 701.13(j) and (m) and 801.62(i) and (k) of this
chapter, to initial statement of inches in declaration of net quantity
in Sec. Sec. 201.62(m), 701.13(o) and 801.62(m) of this chapter, to
initial statement of square inches in declaration of net quantity in
Sec. Sec. 201.62(n), 701.13(p) and 801.62(n) of this chapter, to
prohibition of certain supplemental net quantity statements in
Sec. Sec. 101.7(o), 201.62(o), 501.105(o), 701.13(q) and 801.62(o) of
this chapter, and to servings representations in Sec. 501.8 of this
chapter are provided for solely by the Fair Packaging and Labeling Act.
The other requirements part of this part are issued under both the Fair
Packaging and Labeling Act and the Federal Food, Drug, and Cosmetic Act,
or by the latter act solely, and are not limited in their application by
section 10 of the Fair Packaging and Labeling Act.
[42 FR 15553, Mar. 22, 1977, as amended at 58 FR 17085, Apr. 1, 1993; 75
FR 73953, Nov. 30, 2010; 78 FR 69543, Nov. 20, 2013; 81 FR 59131, Aug.
29, 2016]
Sec. 1.3 Definitions.
(a) Labeling includes all written, printed, or graphic matter
accompanying an article at any time while such article is in interstate
commerce or held for sale after shipment or delivery in interstate
commerce.
(b) Label means any display of written, printed, or graphic matter
on the immediate container of any article, or
[[Page 12]]
any such matter affixed to any consumer commodity or affixed to or
appearing upon a package containing any consumer commodity.
Sec. 1.4 Authority citations.
(a) For each part of its regulations, the Food and Drug
Administration includes a centralized citation of all of the statutory
provisions that provide authority for any regulation that is included in
that part.
(b) The agency may rely on any one or more of the authorities that
are listed for a particular part in implementing or enforcing any
section in that part.
(c) All citations of authority in this chapter will list the
applicable sections in the organic statute if the statute is the Federal
Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Fair
Packaging and Labeling Act. References to an act or a section thereof
include references to amendments to that act or section. These citations
will also list the corresponding United States Code (U.S.C.) sections.
For example, a citation to section 701 of the Federal Food, Drug, and
Cosmetic Act would be listed: Sec. 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371).
(d) If the organic statute is one other than those specified in
paragraph (c) of this section, the citations of authority in this
chapter generally will list only the applicable U.S.C. sections. For
example, a citation to section 552 of the Administrative Procedure Act
would be listed: 5 U.S.C. 552. The agency may, where it determines that
such measures are in the interest of clarity and public understanding,
list the applicable sections in the organic statute and the
corresponding U.S.C. section in the same manner set out in paragraph (c)
of this section. References to an act or a section thereof include
references to amendments to that act or section.
(e) Where there is no U.S.C. provision, the agency will include a
citation to the U.S. Statutes at Large. Citations to the U.S. Statutes
at Large will refer to volume and page.
(f) The authority citations will include a citation to executive
delegations (i.e., Executive Orders), if any, necessary to link the
statutory authority to the agency.
[54 FR 39630, Sept. 27, 1989]
Subpart B_General Labeling Requirements
Sec. 1.20 Presence of mandatory label information.
In the regulations specified in Sec. 1.1(c) of this chapter, the
term package means any container or wrapping in which any food, drug,
device, or cosmetic is enclosed for use in the delivery or display of
such commodities to retail purchasers, but does not include:
(a) Shipping containers or wrappings used solely for the
transportation of any such commodity in bulk or in quantity to
manufacturers, packers, processors, or wholesale or retail distributors;
(b) Shipping containers or outer wrappings used by retailers to ship
or deliver any such commodity to retail customers if such containers and
wrappings bear no printed matter pertaining to any particular commodity;
or
(c) Containers subject to the provisions of the Act of August 3,
1912 (37 Stat. 250, as amended; 15 U.S.C. 231-233), the Act of March 4,
1915 (38 Stat. 1186, as amended; 15 U.S.C. 234-236), the Act of August
31, 1916 (39 Stat. 673, as amended; 15 U.S.C. 251-256), or the Act of
May 21, 1928 (45 Stat. 635, as amended; 15 U.S.C. 257-257i).
(d) Containers used for tray pack displays in retail establishments.
(e) Transparent wrappers or containers which do not bear written,
printed, or graphic matter obscuring the label information required by
this part.
A requirement contained in this part that any word, statement, or other
information appear on the label shall not be considered to be complied
with unless such word, statement, or information also appears on the
outer container or wrapper of the retail package of the article, or, as
stated in paragraph (e) of this section, such information is easily
legible by virtue of the transparency of the outer wrapper or
[[Page 13]]
container. Where a consumer commodity is marketed in a multiunit retail
package bearing the mandatory label information as required by this part
and the unit containers are not intended to be sold separately, the net
weight placement requirement of Sec. 101.7(f) applicable to such unit
containers is waived if the units are in compliance with all the other
requirements of this part.
[42 FR 15553, Mar. 22, 1977, as amended at 75 FR 73953, Nov. 30, 2010;
78 FR 69543, Nov. 20, 2013; 81 FR 59131, Aug. 29, 2016]
Sec. 1.21 Failure to reveal material facts.
(a) Labeling of a food, drug, device, cosmetic, or tobacco product
shall be deemed to be misleading if it fails to reveal facts that are:
(1) Material in light of other representations made or suggested by
statement, word, design, device or any combination thereof; or
(2) Material with respect to consequences which may result from use
of the article under: (i) The conditions prescribed in such labeling or
(ii) such conditions of use as are customary or usual.
(b) Affirmative disclosure of material facts pursuant to paragraph
(a) of this section may be required, among other appropriate regulatory
procedures, by
(1) Regulations in this chapter promulgated pursuant to section
701(a) of the act; or
(2) Direct court enforcement action.
(c) Paragraph (a) of this section does not:
(1) Permit a statement of differences of opinion with respect to
warnings (including contraindications, precautions, adverse reactions,
and other information relating to possible product hazards) required in
labeling for food, drugs, devices, cosmetics, or tobacco products under
the Federal Food, Drug, and Cosmetic Act.
(2) Permit a statement of differences of opinion with respect to the
effectiveness of a drug unless each of the opinions expressed is
supported by substantial evidence of effectiveness as defined in
sections 505(d) and 512(d) of the act.
[42 FR 15553, Mar. 22, 1977, as amended at 77 FR 5176, Feb. 2, 2012]
Sec. 1.23 Procedures for requesting variations and exemptions from
required label statements.
Section 403(e) of the act (in this part 1, the term act means the
Federal Food, Drug, and Cosmetic Act) provides for the establishment by
regulation of reasonable variations and exemptions for small packages
from the required declaration of net quantity of contents. Section
403(i) of the act provides for the establishment by regulation of
exemptions from the required declaration of ingredients where such
declaration is impracticable, or results in deception or unfair
competition. Section 502(b) of the act provides for the establishment by
regulation of reasonable variations and exemptions for small packages
from the required declaration of net quantity of contents. Section
602(b) of the act provides for the establishment by regulation of
reasonable variations and exemptions for small packages from the
required declaration of net quantity of contents. Section 5(b) of the
Fair Packaging and Labeling Act provides for the establishment by
regulation of exemptions from certain required declarations of net
quantity of contents, identity of commodity, identity and location of
manufacturer, packer, or distributor, and from declaration of net
quantity of servings represented, based on a finding that full
compliance with such required declarations is impracticable or not
necessary for the adequate protection of consumers, and a further
finding that the nature, form, or quantity of the packaged consumer
commodity or other good and sufficient reasons justify such exemptions.
The Commissioner, on his own initiative or on petition of an interested
person, may propose a variation or exemption based upon any of the
foregoing statutory provisions, including proposed findings if section
5(b) of the Fair Packaging and Labeling Act applies, pursuant to parts
10, 12, 13, 14, 15, 16, and 19 of this chapter.
Sec. 1.24 Exemptions from required label statements.
The following exemptions are granted from label statements required
by this part:
[[Page 14]]
(a) Foods. (1) While held for sale, a food shall be exempt from the
required declaration of net quantity of contents specified in this part
if said food is received in bulk containers at a retail establishment
and is accurately weighed, measured, or counted either within the view
of the purchaser or in compliance with the purchaser's order.
(2) Random food packages, as defined in Sec. 101.7(j) of this
chapter, bearing labels declaring net weight, price per pound or per
specified number of pounds, and total price shall be exempt from the
type size, dual declaration, and placement requirements of Sec. 101.7
of this chapter if the accurate statement of net weight is presented
conspicuously on the principal display panel of the package. In the case
of food packed in random packages at one place for subsequent shipment
and sale at another, the price sections of the label may be left blank
provided they are filled in by the seller prior to retail sale. This
exemption shall also apply to uniform weight packages of cheese and
cheese products labeled in the same manner and by the same type of
equipment as random food packages exempted by this paragraph (a)(2)
except that the labels shall bear a declaration of price per pound and
not price per specified number of pounds.
(3) Individual serving-size packages of foods containing less than
\1/2\ ounce or less than \1/2\ fluid ounce for use in restaurants,
institutions, and passenger carriers, and not intended for sale at
retail, shall be exempt from the required declaration of net quantity of
contents specified in this part.
(4) Individually wrapped pieces of penny candy and other
confectionery of less than one-half ounce net weight per individual
piece shall be exempt from the labeling requirements of this part when
the container in which such confectionery is shipped is in conformance
with the labeling requirements of this part. Similarly, when such
confectionery items are sold in bags or boxes, such items shall be
exempt from the labeling requirements of this part, including the
required declaration of net quantity of contents specified in this part
when the declaration on the bag or box meets the requirements of this
part.
(5)(i) Soft drinks packaged in bottles shall be exempt from the
placement requirements for the statement of identity prescribed by Sec.
101.3 (a) and (d) of this chapter if such statement appears
conspicuously on the bottle closure. When such soft drinks are marketed
in a multiunit retail package, the multiunit retail package shall be
exempt from the statement of identity declaration requirements
prescribed by Sec. 101.3 of this chapter if the statement of identity
on the unit container is not obscured by the multiunit retail package.
(ii) A multiunit retail package for soft drinks shall be exempt from
the declaration regarding name and place of business required by Sec.
101.5 of this chapter if the package does not obscure the declaration on
unit containers or if it bears a statement that the declaration can be
found on the unit containers and the declaration on the unit containers
complies with Sec. 101.5 of this chapter. The declaration required by
Sec. 101.5 of this chapter may appear on the top or side of the closure
of bottled soft drinks if the statement is conspicuous and easily
legible.
(iii) Soft drinks packaged in bottles which display other required
label information only on the closure shall be exempt from the placement
requirements for the declaration of contents prescribed by Sec.
101.7(f) of this chapter if the required content declaration is blown,
formed, or molded into the surface of the bottle in close proximity to
the closure.
(iv) Where a trademark on a soft drink package also serves as, or
is, a statement of identity, the use of such trademark on the package in
lines not parallel to the base on which the package rests shall be
exempted from the requirement of Sec. 101.3(d) of this chapter that the
statement be in lines parallel to the base so long as there is also at
least one statement of identity in lines generally parallel to the base.
(v) A multiunit retail package for soft drinks in cans shall be
exempt from the declaration regarding name and place of business
required by Sec. 101.5 of this chapter if the package does not obscure
the declaration on unit containers or if it bears a statement that the
declaration can be found on the unit containers and the declaration on
[[Page 15]]
the unit containers complies with Sec. 101.5 of this chapter. The
declaration required by Sec. 101.5 of this chapter may appear on the
top of soft drinks in cans if the statement is conspicuous and easily
legible, provided that when the declaration is embossed, it shall appear
in type size at least one-eighth inch in height, or if it is printed,
the type size shall not be less than one-sixteenth inch in height. The
declaration may follow the curvature of the lid of the can and shall not
be removed or obscured by the tab which opens the can.
(6)(i) Ice cream, french ice cream, ice milk, fruit sherbets, water
ices, quiescently frozen confections (with or without dairy
ingredients), special dietary frozen desserts, and products made in
semblance of the foregoing, when measured by and packaged in \1/2\-
liquid pint and \1/2\-gallon measure-containers, as defined in the
``Measure Container Code of National Bureau of Standards Handbook 44,''
Specifications, Tolerances, and Other Technical Requirements for
Weighing and Measuring Devices, Sec. 4.45 ``Measure-Containers,'' which
is incorporated by reference, are exempt from the requirements of Sec.
101.7(b)(2) of this chapter to the extent that net contents of 8-fluid
ounces and 64-fluid ounces (or 2 quarts) may be expressed as \1/2\ pint
and \1/2\ gallon, respectively. Copies are available from the Center for
Food Safety and Applied Nutrition (HFS-150), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/ federal_register/ code_of_federal_regulations/
ibr_locations.html.
(ii) The foods named in paragraph (a)(6)(i) of this section, when
measured by and packaged in 1-liquid pint, 1-liquid quart, and \1/2\-
gallon measure-containers, as defined in the ``Measure Container Code of
National Bureau of Standards Handbook 44,'' Specifications, Tolerances,
and Other Technical Requirements for Weighing and Measuring Devices,
Sec. 4.45 ``Measure-Containers,'' which is incorporated by reference,
are exempt from the dual net-contents declaration requirement of Sec.
101.7 of this chapter. Copies are available from the Center for Food
Safety and Applied Nutrition (HFS-150), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740, or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/ federal_register/ code_of_federal_regulations/
ibr_locations.html.
(iii) The foods named in paragraph (a)(6)(i) of this section, when
measured by and packaged in \1/2\-liquid pint, 1-liquid pint, 1-liquid
quart, \1/2\-gallon, and 1-gallon measured-containers, as defined in the
``Measure Container Code of National Bureau of Standards Handbook 44,''
Specifications, Tolerances, and Other Technical Requirements for
Weighing and Measuring Devices, Sec. 4.45 ``Measure-Containers,'' which
is incorporated by reference, are exempt from the requirement of Sec.
101.7(f) of this chapter that the declaration of net contents be located
within the bottom 30 percent of the principal display panel. Copies are
available from the Center for Food Safety and Applied Nutrition (HFS-
150), Food and Drug Administration, 5001 Campus Dr., College Park, MD
20740, or at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/ federal_register/
code_of_federal_regulations/ ibr_locations.html.
(7)(i) Milk, cream, light cream, coffee or table cream, whipping
cream, light whipping cream, heavy or heavy whipping cream, sour or
cultured sour cream, half-and-half, sour or cultured half-and-half,
reconstituted or recombined milk and milk products, concentrated milk
and milk products, skim or skimmed milk, vitamin D milk and milk
products, fortified milk and milk products, homogenized milk, flavored
milk and milk products, buttermilk, cultured buttermilk, cultured milk
or cultured whole buttermilk, low-fat milk (0.5 to 2.0 percent
butterfat), and acidified milk and milk products, when packaged in
containers of 8- and 64-fluid-ounce capacity, are exempt from the
requirements of
[[Page 16]]
Sec. 101.7(b)(2) of this chapter to the extent that net contents of 8
fluid ounces and 64 fluid ounces (or 2 quarts) may be expressed as \1/2\
pint and \1/2\ gallon, respectively.
(ii) The products listed in paragraph (a)(7)(i) of this section,
when packaged in glass or plastic containers of \1/2\-pint, 1-pint, 1-
quart, \1/2\-gallon, and 1-gallon capacities are exempt from the
placement requirement of Sec. 101.7(f) of this chapter that the
declaration of net contents be located within the bottom 30 percent of
the principal display panel, provided that other required label
information is conspicuously displayed on the cap or outside closure and
the required net quantity of contents declaration is conspicuously
blown, formed, or molded into or permanently applied to that part of the
glass or plastic container that is at or above the shoulder of the
container.
(iii) The products listed in paragraph (a)(7)(i) of this section,
when packaged in containers of 1-pint, 1-quart, and \1/2\-gallon
capacities are exempt from the dual net-contents declaration requirement
of Sec. 101.7(j) of this chapter.
(8) Wheat flour products, as defined by Sec. Sec. 137.105, 137.155,
137.160, 137.165, 137.170, 137.175, 137.180, 137.185, 137.200, and
137.205 of this chapter, packaged:
(i) In conventional 2-, 5-, 10-, 25-, 50-, and 100-pound packages
are exempt from the placement requirement of Sec. 101.7(f) of this
chapter that the declaration of net contents be located within the
bottom 30 percent of the area of the principal display panel of the
label; and
(ii) In conventional 2-pound packages are exempt from the dual net-
contents declaration requirement of Sec. 101.107 of this chapter
provided the quantity of contents is expressed in pounds.
(9)(i) Twelve shell eggs packaged in a carton designed to hold 1
dozen eggs and designed to permit the division of such carton by the
retail customer at the place of purchase into two portions of one-half
dozen eggs each are exempt from the labeling requirements of this part
with respect to each portion of such divided carton if the carton, when
undivided, is in conformance with the labeling requirements of this
part.
(ii) Twelve shell eggs packaged in a carton designed to hold 1 dozen
eggs are exempt from the placement requirements for the declaration of
contents prescribed by Sec. 101.7(f) of this chapter if the required
content declaration is otherwise placed on the principal display panel
of such carton and if, in the case of such cartons designed to permit
division by retail customers into two portions of one-half dozen eggs
each, the required content declaration is placed on the principal
display panel in such a manner that the context of the content
declaration is destroyed upon division of the carton.
(10) Butter as defined in 42 Stat. 1500 (excluding whipped butter):
(i) In 8-ounce and in 1-pound packages is exempt from the
requirements of Sec. 101.7(f) of this chapter that the net contents
declaration be placed within the bottom 30 percent of the area of the
principal display panel;
(ii) In 1-pound packages is exempt from the requirements of Sec.
101.7(j)(1) of this chapter that such declaration be in terms of ounces
and pounds, to permit declaration of ``1-pound'' or ``one pound''; and
(iii) In 4-ounce, 8-ounce, and 1-pound packages with continuous
label copy wrapping is exempt from the requirements of Sec. Sec. 101.3
and 101.7(f) of this chapter that the statement of identity and net
contents declaration appear in lines generally parallel to the base on
which the package rests as it is designed to be displayed, provided that
such statement and declaration are not so positioned on the label as to
be misleading or difficult to read as the package is customarily
displayed at retail.
(11) Margarine as defined in Sec. 166.110 of this chapter and
imitations thereof in 1-pound rectangular packages, except for packages
containing whipped or soft margarine or packages that contain more than
four sticks, are exempt from the requirement of Sec. 101.7(f) of this
chapter that the declaration of the net quantity of contents appear
within the bottom 30 percent of the principal display panel and from the
requirement of Sec. 101.7(j)(1) of this chapter that such declaration
be expressed both in ounces and in pounds to permit declaration of ``1-
pound'' or ``one
[[Page 17]]
pound,'' provided an accurate statement of net weight appears
conspicuously on the principal display panel of the package.
(12) Corn flour and related products, as they are defined by
Sec. Sec. 137.211, 137.215, and Sec. Sec. 137.230 through 137.290 of
this chapter, packaged in conventional 5-, 10-, 25-, 50-, and 100-pound
bags are exempt from the placement requirement of Sec. 101.7(f) of this
chapter that the declaration of net contents be located within the
bottom 30 percent of the area of the principal display panel of the
label.
(13)(i) Single strength and less than single strength fruit juice
beverages, imitations thereof, and drinking water when packaged in glass
or plastic containers of \1/2\-pint, 1-pint, 1-quart, \1/2\-gallon, and
1-gallon capacities are exempt from the placement requirement of Sec.
101.7(f) of this chapter that the declaration of net contents be located
within the bottom 30 percent of the principal display panel: Provided,
That other required label information is conspicuously displayed on the
cap or outside closure and the required net quantity of contents
declaration is conspicuously blown, formed, or molded into or
permanently applied to that part of the glass or plastic container that
is at or above the shoulder of the container.
(ii) Single strength and less than single strength fruit juice
beverages, imitations thereof, and drinking water when packaged in
glass, plastic, or paper (fluid milk type) containers of 1-pint, 1-
quart, and \1/2\-gallon capacities are exempt from the dual net-contents
declaration requirement of Sec. 101.7(j) of this chapter.
(iii) Single strength and less than single strength fruit juice
beverages, imitations thereof, and drinking water when packaged in
glass, plastic, or paper (fluid milk type) containers of 8- and 64-
fluid-ounce capacity, are exempt from the requirements of Sec.
101.7(b)(2) of this chapter to the extent that net contents of 8 fluid
ounces and 64 fluid ounces (or 2 quarts) may be expressed as \1/2\ pint
(or half pint) and \1/2\ gallon (or half gallon), respectively.
(14) The unit containers in a multiunit or multicomponent retail
food package shall be exempt from regulations of section 403 (e)(1),
(g)(2), (i)(2), (k), and (q) of the act with respect to the requirements
for label declaration of the name and place of business of the
manufacturer, packer, or distributor; label declaration of ingredients;
and nutrition information when:
(i) The multiunit or multicomponent retail food package labeling
meets all the requirements of this part;
(ii) The unit containers are securely enclosed within and not
intended to be separated from the retail package under conditions of
retail sale; and
(iii) Each unit container is labeled with the statement ``This Unit
Not Labeled For Retail Sale'' in type size not less than one-sixteenth
of an inch in height. The word ``Individual'' may be used in lieu of or
immediately preceding the word ``Retail'' in the statement.
(b) Drugs. Liquid over-the-counter veterinary preparations intended
for injection shall be exempt from the declaration of net quantity of
contents in terms of the U.S. gallon of 231 cubic inches and quart,
pint, and fluid-ounce subdivisions thereof as required by Sec. 201.62
(b), (i), and (j) of this chapter, and from the dual declaration
requirements of Sec. 201.62(i) of this chapter, if such declaration of
net quantity of contents is expressed in terms of the liter and
milliliter, or cubic centimeter, with the volume expressed at 68 [deg]F
(20 [deg]C).
(c) Cosmetics. Cosmetics in packages containing less than one-fourth
ounce avoirdupois or one-eighth fluid ounce shall be exempt from
compliance with the requirements of section 602(b)(2) of the Federal
Food, Drug, and Cosmetic Act and section 4(a)(2) of the Fair Packaging
and Labeling Act:
(1) When such cosmetics are affixed to a display card labeled in
conformance with all labeling requirements of this part; or
(2) When such cosmetics are sold at retail as part of a cosmetic
package consisting of an inner and outer container and the inner
container is not for separate retail sale and the outer container is
labeled in conformance
[[Page 18]]
with all labeling requirements of this part.
[42 FR 15553, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 47
FR 32421, July 27, 1982; 49 FR 13339, Apr. 4, 1984; 54 FR 9033, Mar. 3,
1989; 58 FR 2174, Jan. 6, 1993; 61 FR 14478, Apr. 2, 1996; 66 FR 56035,
Nov. 6, 2001; 81 FR 49895, July 29, 2016; 81 FR 59131, Aug. 29, 2016; 85
FR 72906, Nov. 16, 2020]
Subpart C [Reserved]
Subpart D_Electronic Import Entries
Source: 81 FR 85870, Nov. 29, 2016, unless otherwise noted.
Sec. 1.70 Scope.
This subpart specifies the data elements that are required by the
Food and Drug Administration (FDA) to be included in an electronic
import entry submitted in the Automated Commercial Environment (ACE)
system or any other U.S. Customs and Border Protection (CBP)-authorized
electronic data interchange (EDI) system, which contains an article that
is being imported or offered for import into the United States and that
is regulated by FDA.
Sec. 1.71 Definitions.
For purposes of subpart D:
ACE filer means the person who is authorized to submit an electronic
import entry for an FDA-regulated product in the Automated Commercial
Environment or any other CBP-authorized EDI system.
Acidified food means acidified food, as defined in Sec. 114.3(b) of
this chapter, and subject to the requirements in parts 108 and 114 of
this chapter.
Automated Commercial Environment or ACE means the automated and
electronic system for processing commercial importations that is
operated by U.S. Customs and Border Protection in accordance with the
National Customs Automation Program established in Subtitle B of Title
VI--Customs Modernization, in the North American Free Trade Agreement
Implementation Act (Pub. L. 103-182, 107 Stat. 2057, 2170, December 8,
1993) (Customs Modernization Act), or any other CBP-authorized EDI
system.
Biological product means a biological product as defined in section
351(i)(1) of the Public Health Service Act.
Cosmetic means a cosmetic as defined in section 201(i) of the
Federal Food, Drug, and Cosmetic Act.
CBP or U.S. Customs and Border Protection means the Federal Agency
that is primarily responsible for maintaining the integrity of the
borders and ports of entry of the United States.
Drug means those articles meeting the definition of a drug in
section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act.
FDA or Agency means the U.S. Food and Drug Administration.
Food means food as defined in section 201(f) of the Federal Food,
Drug, and Cosmetic Act.
Food contact substance means any substance, as defined in section
409(h)(6) of the Federal Food, Drug, and Cosmetic Act, that is intended
for use as a component of materials used in manufacturing, packing,
packaging, transporting, or holding food if such use is not intended to
have any technical effect in such food.
HCT/Ps means human cells, tissues, or cellular or tissue-based
products, as defined in Sec. 1271.3(d) of this chapter.
Low-acid canned food means a thermally processed low-acid food (as
defined in Sec. 113.3(n) of this chapter) in a hermetically sealed
container (as defined in Sec. 113.3(j) of this chapter), and subject to
the requirements in parts 108 and 113 of this chapter.
Medical device means a device as defined in section 201(h) of the
Federal Food, Drug, and Cosmetic Act, that is intended for use in
humans.
Radiation-emitting electronic product means an electronic product as
defined in section 531 of the Federal Food, Drug, and Cosmetic Act.
Tobacco product means a tobacco product as defined in section
201(rr) of the Federal Food, Drug, and Cosmetic Act.
Veterinary device means a device as defined in section 201(h) of the
Federal Food, Drug, and Cosmetic Act, that is intended for use in
animals.
[81 FR 85870, Nov. 29, 2016, as amended at 87 FR 62984, Oct. 18, 2022]
[[Page 19]]
Sec. 1.72 Data elements that must be submitted in ACE for articles
regulated by FDA.
General. When filing an entry in ACE, the ACE filer shall submit the
following information for food contact substances, drugs, biological
products, HCT/Ps, medical devices, veterinary devices, radiation-
emitting electronic products, cosmetics, and tobacco products.
(a) Product identifying information for the article that is being
imported or offered for import. This consists of:
(1) FDA Country of Production, which is the country where the
article was last manufactured, processed, or grown (including harvested,
or collected and readied for shipment to the United States). The FDA
Country of Production for an article that has undergone any
manufacturing or processing is the country where that activity occurred
provided that the manufacturing or processing had more than a minor,
negligible, or insignificant effect on the article.
(2) The Complete FDA Product Code, which must be consistent with the
invoice description of the product.
(3) The Full Intended Use Code.
(b) Importer of record contact information, which is the telephone
and email address of the importer of record.
[81 FR 85870, Nov. 29, 2016, as amended at 87 FR 62984, Oct. 18, 2022]
Sec. 1.73 Food.
(a) Food contact substances. An ACE filer must submit the
information specified in Sec. 1.72 at the time of filing entry in ACE
for food that is a food contact substance.
(b) Low-acid canned food. For an article of food that is a low-acid
canned food, the ACE filer must submit at the time of filing entry the
Food Canning Establishment Number and the Submission Identifier, and can
dimensions or volume, except that the ACE filer does not need to submit
this information in ACE at the time of entry if the article is being
imported or offered for import for laboratory analysis only and will not
be taste tested or otherwise ingested.
(c) Acidified food. For an article of food that is an acidified
food, the ACE filer must submit at the time of filing entry the Food
Canning Establishment Number and the Submission Identifier, and can
dimensions or volume, except that the ACE filer does not need to submit
this information in ACE at the time of entry if the article is being
imported or offered for import for laboratory analysis only and will not
be taste tested or otherwise ingested.
Sec. 1.74 Human drugs.
In addition to the data required to be submitted in Sec. 1.72, an
ACE filer must submit the following information at the time of filing
entry in ACE for drugs, including biological products and eligible
prescription drugs as defined in Sec. 251.2 of this chapter that are
imported or offered for import under section 804 of the Federal Food,
Drug, and Cosmetic Act, intended for human use that are regulated by the
FDA Center for Drug Evaluation and Research.
(a) For a drug intended for human use that is not an eligible
prescription drug covered under paragraph (b) of this section:
(1) Registration and listing. The Drug Registration Number and the
Drug Listing Number of the foreign establishment where the human drug
was manufactured, prepared, propagated, compounded, or processed before
being imported or offered for import into the United States is required
to register and list the drug under part 207 of this chapter. For the
purposes of this section, the Drug Registration Number that must be
submitted at the time of entry filing in ACE is the unique facility
identifier of the foreign establishment where the human drug was
manufactured, prepared, propagated, compounded, or processed before
being imported or offered for import into the United States. The unique
facility identifier is the identifier submitted by a registrant in
accordance with the system specified under section 510 of the Federal
Food, Drug, and Cosmetic Act. For the purposes of this section, the Drug
Listing Number is the National Drug Code number of the human drug
article being imported or offered for import.
(2) Drug application number. For a drug intended for human use that
is the subject of an approved application
[[Page 20]]
under section 505(b) or 505(j) of the Federal Food, Drug, and Cosmetic
Act, the number of the new drug application or abbreviated new drug
application. For a biological product regulated by the FDA Center for
Drug Evaluation and Research that is required to have an approved
biologics license application, the number of the applicable application.
(3) Investigational new drug application number. For a drug intended
for human use that is the subject of an investigational new drug
application under section 505(i) of the Federal Food, Drug, and Cosmetic
Act, the number of the investigational new drug application.
(b) For an eligible prescription drug as defined in Sec. 251.2 of
this chapter that is imported or offered for import under section 804 of
the Federal Food, Drug, and Cosmetic Act:
(1) Registration and listing. The Drug Registration Number and the
Drug Listing Number. For the purposes of this section, the Drug
Registration Number that must be submitted in ACE is the unique facility
identifier submitted by the Foreign Seller registrant under Sec. 251.9
of this chapter in accordance with the system specified under section
510 of the Federal Food, Drug, and Cosmetic Act. For the purposes of
this section, the Drug Listing Number is the National Drug Code number
that the Importer will use when relabeling the eligible prescription
drug as required in Sec. 251.13 of this chapter.
(2) Drug application number. The number of the new drug application
or abbreviated new drug application for the counterpart FDA-approved
drug.
(3) Lot or control number. The lot or control number assigned by the
manufacturer of the eligible prescription drug.
(4) FDA Quantity. FDA Quantity, which is the quantity of each
eligible prescription drug in an import line delineated by packaging
level, including the type of package from the largest packaging unit to
the smallest packaging unit; the quantity of each packaging unit; and
the volume and/or weight of each of the smallest of the packaging units.
(5) Pre-Import Request number. The Pre-Import Request number
assigned by FDA.
[85 FR 62125, Oct. 1, 2020, as mended at 86 FR 17060, Apr. 1, 2021]
Sec. 1.75 Animal drugs and veterinary devices.
(a) Animal drugs. In addition to the data required to be submitted
in Sec. 1.72, an ACE filer must submit the following information at the
time of filing entry in ACE for animal drugs:
(1) Registration and listing. For a drug intended for animal use,
the Drug Registration Number and the Drug Listing Number if the foreign
establishment where the drug was manufactured, prepared, propagated,
compounded, or processed before being imported or offered for import
into the United States is required to register and list the drug under
part 207 of this chapter. For the purposes of this section, the Drug
Registration Number that must be submitted in ACE at the time of entry
is the Unique Facility Identifier of the foreign establishment where the
animal drug was manufactured, prepared, propagated, compounded, or
processed before being imported or offered for import into the United
States. The Unique Facility Identifier is the identifier submitted by a
registrant in accordance with the system specified under section 510(b)
of the Federal Food, Drug, and Cosmetic Act. For the purposes of this
section, the Drug Listing Number is the National Drug Code number of the
animal drug article being imported or offered for import.
(2) New animal drug application number. For a drug intended for
animal use that is the subject of an approved application under section
512 of the Federal Food, Drug, and Cosmetic Act, the number of the new
animal drug application or abbreviated new animal drug application. For
a drug intended for animal use that is the subject of a conditionally
approved application under section 571 of the Federal Food, Drug, and
Cosmetic Act, the application number for the conditionally approved new
animal drug.
(3) Veterinary minor species index file number. For a drug intended
for use in animals that is the subject of an Index listing under section
572 of the Federal
[[Page 21]]
Food, Drug, and Cosmetic Act, the Minor Species Index File number of the
new animal drug on the Index of Legally Marketed Unapproved New Animal
Drugs for Minor Species.
(4) Investigational new animal drug file number. For a drug intended
for animal use that is the subject of an investigational new animal drug
or generic investigational new animal drug file under part 511 of this
chapter, the number of the investigational new animal drug or generic
investigational new animal drug file.
(b) Veterinary devices. An ACE filer must submit the data specified
in Sec. 1.72 at the time of filing entry in ACE for veterinary devices.
[87 FR 62984, Oct. 18, 2022]
Sec. 1.76 Medical devices.
In addition to the data required to be submitted in Sec. 1.72, an
ACE filer must submit the following information at the time of filing
entry in ACE for medical devices regulated by the FDA Center for Devices
and Radiological Health.
(a) Registration and listing. For a medical device, the Registration
Number for Foreign Manufacturers, Foreign Exporters, and/or Domestic
Manufacturers, and the Device Listing Number, required under section 510
of the Federal Food, Drug, and Cosmetic Act and part 807 of this
chapter.
(b) Investigational devices. For an investigational medical device
that has an investigational device exemption granted under section
520(g) of the Federal Food, Drug, and Cosmetic Act, the Investigational
Device Exemption Number. For an investigational medical device being
imported or offered for import for use in a nonsignificant risk or
exempt study, ``NSR'' to be entered in the Affirmation of Compliance for
the ``investigational device exemption'' that identifies the device as
being used in a nonsignificant risk or exempt study.
(c) Premarket number. For a medical device that has one, the
Premarket Number. This is the Premarket Approval Number for those
medical devices that have received premarket approval under section 515
of the Federal Food, Drug, and Cosmetic Act; the Product Development
Protocol Number for those medical devices for which FDA has declared the
product development protocol complete under section 515(f) of the
Federal Food, Drug, and Cosmetic Act; the De Novo number for those
medical devices granted marketing authorization under section 513(f)(2)
of the Federal Food, Drug, and Cosmetic Act; the Premarket Notification
Number for those medical devices that received premarket clearance under
section 510(k) of the Federal Food, Drug, and Cosmetic Act; or the
Humanitarian Device Exemption Number for those medical devices for which
an exemption has been granted under section 520(m) of the Federal Food,
Drug, and Cosmetic Act.
(d) Component. If applicable for a medical device, an affirmation
identifying that the article being imported or offered for import is a
component that requires further processing or inclusion into a finished
medical device.
(e) Lead wire/patient cable. For electrode lead wires and patient
cables intended for use with a medical device, an Affirmation of
Compliance with the applicable performance standard under Sec. 898.12
of this chapter.
(f) Impact resistant lens. For impact resistant lenses in eyeglasses
and sunglasses, an Affirmation of Compliance with the applicable
requirements of Sec. 801.410 of this chapter.
(g) Convenience kit. If applicable for a medical device, an
Affirmation of Compliance that the article imported or offered for
import is a convenience kit or part of a convenience kit.
Sec. 1.77 Radiation-emitting electronic products.
In addition to the data required to be submitted in Sec. 1.72, an
ACE filer must submit all of the declarations required in Form FDA 2877
electronically in ACE at the time of filing entry for products subject
to the standards under parts 1020-1050 of this chapter.
Sec. 1.78 Biological products, HCT/Ps, and related drugs and medical
devices.
In addition to the data required to be submitted in Sec. 1.72, an
ACE filer must submit the following information at the time of filing
entry in ACE for biological products, HCT/Ps, and related drugs and
medical devices regulated by
[[Page 22]]
the FDA Center for Biologics Evaluation and Research.
(a) Product name which identifies the article being imported or
offered for import by the name commonly associated with that article
including the established name, trade name, brand name, proper name, or
product description if the article does not have an established name,
trade name, brand name, or proper name.
(b) HCT/P registration and affirmation. (1) For an HCT/P regulated
solely under section 361 of the Public Health Service Act and the
regulations in part 1271 of this chapter that is manufactured by an
establishment that is required to be registered under part 1271 of this
chapter, the HCT/P Registration Number; and
(2) For an HCT/P regulated solely under section 361 of the Public
Health Service Act and the regulations in part 1271 of this chapter, an
Affirmation of Compliance with the applicable requirements of part 1271
of this chapter.
(c) Licensed biological products. For a biological product that is
the subject of an approved biologics license application under section
351 of the Public Health Service Act, the Submission Tracking Number of
the biologics license application and/or the Biologics License Number.
(d) Drug registration. For a drug intended for human use, the Drug
Registration Number if the foreign establishment where the human drug
was manufactured, prepared, propagated, compounded, or processed before
being imported or offered for import into the United States is required
to register the drug under part 207 or part 607 of this chapter as
applicable. For the purposes of this section, the Drug Registration
Number that must be submitted at the time of entry in ACE is the unique
facility identifier of the foreign establishment where the human drug
was manufactured, prepared, propagated, compounded, or processed before
being imported or offered for import into the United States. The unique
facility identifier is the identifier submitted by a registrant in
accordance with the system specified under section 510 of the Federal
Food, Drug, and Cosmetic Act.
(e) Drug application number. For a drug intended for human use that
is the subject of an approved application under section 505(b) or 505(j)
of the Federal Food, Drug, and Cosmetic Act, the number of the new drug
application or the abbreviated new drug application.
(f) Investigational new drug application number. For a drug intended
for human use that is the subject of an investigational new drug
application under section 505(i) of the Federal Food, Drug, and Cosmetic
Act, the number of the investigational new drug application.
(g) Medical device registration and listing. For a medical device
subject to the registration and listing procedures contained in part 807
of this chapter, the Registration Number for Foreign Manufacturers,
Foreign Exporters, and/or Domestic Manufacturers, and the Device Listing
Number, required under section 510 of the Federal Food, Drug, and
Cosmetic Act and part 807 of this chapter.
(h) Investigational devices. For an investigational medical device
that has an investigational device exemption granted under section
520(g) of the Federal Food, Drug, and Cosmetic Act, the Investigational
Device Exemption Number. For an investigational medical device being
imported or offered for import for use in a nonsignificant risk or
exempt study, ``NSR'' to be entered in the Affirmation of Compliance for
the ``investigational device exemption'' that identifies the device as
being used in a nonsignificant risk or exempt study.
(i) Medical device premarket number. For a medical device that has
one, the Premarket Number. This is the Premarket Approval Number for
those medical devices that have received premarket approval under
section 515 of the Federal Food, Drug, and Cosmetic Act; the Product
Development Protocol Number for those medical devices for which FDA has
declared the product development protocol complete under section 515(f)
of the Federal Food, Drug, and Cosmetic Act; the De Novo number for
those medical devices granted marketing authorization under section
513(f)(2) of the Federal Food, Drug, and Cosmetic Act; the Premarket
Notification Number for those
[[Page 23]]
medical devices that received premarket clearance under section 510(k)
of the Federal Food, Drug, and Cosmetic Act; or the Humanitarian Device
Exemption Number for those medical devices for which an exemption has
been granted under section 520(m) of the Federal Food, Drug, and
Cosmetic Act.
(j) Medical device component. If applicable for a medical device, an
affirmation identifying that the article being imported or offered for
import is a component that requires further processing or inclusion into
a finished medical device.
[81 FR 85870, Nov. 29, 2016, as mended at 86 FR 17060, Apr. 1, 2021]
Sec. 1.79 Tobacco products.
In addition to the data required to be submitted in Sec. 1.72, an
ACE filer must submit the following information at the time of filing
entry in ACE.
(a) Brand name of an article that is a tobacco product that is being
imported or offered for import. If the article does not have a specific
brand name, the ACE filer must submit a commercial name for the brand
name. This data element is not applicable to those products solely
intended either for further manufacturing or as investigational tobacco
products.
(b) [Reserved]
Sec. 1.80 Cosmetics.
An ACE filer must submit the data specified in Sec. 1.72 at the
time of filing entry in ACE.
Sec. 1.81 Rejection of entry filing.
FDA may reject an entry filing for failure to provide complete and
accurate information that is required pursuant to this subpart.
Subpart E_Imports and Exports
Sec. 1.83 Definitions.
For the purposes of regulations prescribed under section 801(a),
(b), and (c) of the Federal Food, Drug, and Cosmetic Act:
(a) The term owner or consignee means the person who makes entry
under the provisions of section 484 of the Tariff Act of 1930, as
amended (19 U.S.C. 1484), namely, the ``importer of record.''
(b) The term division director means the director of the division of
the Food and Drug Administration having jurisdiction over the port of
entry through which an article is imported or offered for import, or
such officer of the division as he or she may designate to act on his or
her behalf in administering and enforcing the provisions of section
801(a), (b), and (c).
[42 FR 15553, Mar. 22, 1977, as amended at 81 FR 85872, Nov. 29, 2016;
85 FR 50781, Aug. 18, 2020]
Sec. 1.90 Notice of sampling.
When a sample of an article offered for import has been requested by
the division director, FDA shall provide to the owner or consignee
prompt notice of delivery of, or intention to deliver, such sample. Upon
receipt of the notice, the owner or consignee shall hold such article
and not distribute it until further notice from the division director or
U.S. Customs and Border Protection of the results of examination of the
sample.
[85 FR 50781, Aug. 18, 2020]
Sec. 1.91 Payment for samples.
The Food and Drug Administration will pay for all import samples
which are found to be in compliance with the requirements of the Federal
Food, Drug, and Cosmetic Act. Billing for reimbursement should be made
by the owner or consignee to the Food and Drug Administration division
where the shipment was offered for import. Payment for samples will not
be made if the article is found to be in violation of the act, even
though subsequently brought into compliance under the terms of an
authorization to bring the article into compliance or rendered not a
food, drug, device, or cosmetic as set forth in Sec. 1.95.
[42 FR 15553, Mar. 22, 1977, as amended at 85 FR 50781, Aug. 18, 2020]
Sec. 1.94 Hearing on refusal of admission or destruction.
(a) If it appears that the article may be subject to refusal of
admission or that the article is a drug that may be subject to
destruction under section
[[Page 24]]
801(a) of the Federal Food, Drug, and Cosmetic Act, the division
director shall give the owner or consignee a written or electronic
notice to that effect, stating the reasons therefor. The notice shall
specify a place and a period of time during which the owner or consignee
shall have an opportunity to introduce testimony. Upon timely request
giving reasonable grounds therefor, such time and place may be changed.
Such testimony shall be confined to matters relevant to the
admissibility or destruction of the article, and may be introduced
orally or in writing.
(b) If such owner or consignee submits or indicates his or her
intention to submit an application for authorization to relabel or
perform other action to bring the article into compliance with the
Federal Food, Drug, and Cosmetic Act or to render it other than a food,
drug, device, or cosmetic, such testimony shall include evidence in
support of such application. If such application is not submitted at or
prior to the hearing on refusal of admission, the division director
shall specify a time limit, reasonable in the light of the
circumstances, for filing such application.
(c) If the article is a drug that may be subject to destruction
under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the
division director may give the owner or consignee a single written or
electronic notice that provides the notice of refusal of admission and
the notice of destruction of an article described in paragraph (a) of
this section. The division director may also combine the hearing on
refusal of admission with the hearing on destruction of the article
described in paragraph (a) of this section into a single proceeding.
[80 FR 55242, Sept. 15, 2015, as amended at 81 FR 85873, Nov. 29, 2016;
85 FR 50781, Aug. 18, 2020]
Sec. 1.95 Application for authorization to relabel and recondition.
Application for authorization to relabel or perform other action to
bring the article into compliance with the Federal Food, Drug, and
Cosmetic Act or to render it other than a food, drug, device, or
cosmetic may be filed only by the owner or consignee, and shall:
(a) Contain detailed proposals for bringing the article into
compliance with the act or rendering it other than a food, drug, device,
or cosmetic.
(b) Specify the time and place where such operations will be carried
out and the approximate time for their completion.
[42 FR 15553, Mar. 22, 1977, as amended at 85 FR 50781, Aug. 18, 2020]
Sec. 1.96 Granting of authorization to relabel and recondition.
(a) When authorization of a proposal under Sec. 1.95 is granted by
the division director, the applicant shall be notified of authorization,
in writing, which may include:
(1) The procedure to be followed;
(2) The disposition of the rejected articles or portions thereof;
(3) That the operations are to be carried out under the supervision
of an officer of the Food and Drug Administration or U.S. Customs and
Border Protection, as appropriate;
(4) A time limit, reasonable in the light of the circumstances, for
completion of the operations; and
(5) Such other conditions as are necessary to maintain adequate
supervision and control over the article.
(b) Upon receipt of a written request for extension of time to
complete such operations, containing reasonable grounds therefor, the
division director may grant such additional time as he or she deems
necessary.
(c) An authorization may be amended upon a showing of reasonable
grounds therefor and the filing of an amended application for
authorization with the division director.
(d) If ownership of an article covered by an authorization changes
before the operations specified in the authorization have been
completed, the original owner will be held responsible, unless the new
owner has executed a bond with U.S. Customs and Border Protection and
obtained a new authorization from the Food and Drug Administration
division director. Any authorization granted under this section shall
supersede and nullify any previously
[[Page 25]]
granted authorization with respect to the article.
[42 FR 15553, Mar. 22, 1977, as amended at 54 FR 9033, Mar. 3, 1989; 85
FR 50781, Aug. 18, 2020]
Sec. 1.97 Bonds.
(a) The bond requirements under section 801(b) of the Federal Food,
Drug, and Cosmetic Act may be satisfied by the owner or consignee
executing, on the appropriate U.S. Customs and Border Protection form, a
single-transaction or continuous bond, containing a condition for the
redelivery of the merchandise or any part thereof upon demand of U.S.
Customs and Border Protection and containing a provision for the
performance of conditions as may legally be imposed for the relabeling
or other action necessary to bring the article into compliance with the
act or rendering it other than a food, drug, device, or cosmetic, in
such manner as is prescribed for such bond in the customs regulations in
force on the date of request for authorization. The bond shall be filed
with U.S. Customs and Border Protection.
(b) U.S. Customs and Border Protection may cancel the liability for
liquidated damages incurred under the above-mentioned provisions of such
a bond, if U.S. Customs and Border Protection receives an application
for relief therefrom, upon the payment of a lesser amount or upon such
other terms and conditions as shall be deemed appropriate under the law
and in view of the circumstances, but U.S. Customs and Border Protection
shall not act under this regulation unless the Food and Drug
Administration division director is in full agreement with the action.
[85 FR 50782, Aug. 18, 2020]
Sec. 1.99 Costs chargeable in connection with relabeling and reconditioning inadmissible imports.
The cost of supervising the relabeling or other action in connection
with an import of food, drugs, devices, or cosmetics which fails to
comply with the Federal Food, Drug, and Cosmetic Act shall be paid by
the owner or consignee who files an application requesting such action
and executes a bond, pursuant to section 801(b) of the act, as amended.
The cost of such supervision shall include, but not be restricted to,
the following:
(a) Travel expenses of the supervising officer.
(b) Per diem in lieu of subsistence of the supervising officer when
away from his or her home station, as provided by law.
(c) The charge for the services of the supervising officer, which
shall include administrative support, shall be computed at a rate per
hour equal to 267 percent of the hourly rate of regular pay of a grade
GS-11/4 employee, except that such services performed by a customs
officer and subject to the provisions of the act of February 13, 1911,
as amended (sec. 5, 36 Stat. 901, as amended (19 U.S.C. 267)), shall be
calculated as provided in that act.
(d) The charge for the service of the analyst, which shall include
administrative and laboratory support, shall be computed at a rate per
hour equal to 267 percent of the hourly rate of regular pay of a grade
GS-12/4 employee. The rate per hour equal to 267 percent of the
equivalent hourly rate of regular pay of the supervising officer (GS-11/
4) and the analyst (GS-12/4) is computed as follows:
Table 1 to Paragraph (d)
------------------------------------------------------------------------
Hours
------------------------------------------------------------------------
Gross number of working hours in 52 40-hr weeks................ 2,080
Less:
10 legal public holidays--New Year's Day, Birthday of 80
Martin Luther King, Jr., Washington's Birthday, Memorial
Day, Independence Day, Labor Day, Columbus Day, Veterans
Day, Thanksgiving Day, and Christmas Day..................
Annual leave--26 d......................................... 208
Sick leave--13 d........................................... 104
--------
Total.................................................. 392
--------
[[Page 26]]
Net number of working hours............................ 1,688
------------------------------------------------------------------------
Gross number of working hours in 52 40-hr weeks................ 2,080
Working hour equivalent of Government contributions for 176
employee retirement, life insurance, and health benefits
computed at 8\1/2\ pct. of annual rate of pay of employee.....
Equivalent annual working hours............................ 2,256
Support required to equal to 1 person-year..................... 2,256
Equivalent gross annual working hours charged to Food and 4,512
Drug appropriation........................................
------------------------------------------------------------------------
Note: Ratio of equivalent gross annual number of working hours charged
to Food and Drug appropriation to net number of annual working hours
4,512/1,688 = 267 pct.
(e) The minimum charge for services of supervising officers and of
analysts shall be not less than the charge for 1 hour, and time after
the first hour shall be computed in multiples of 1 hour, disregarding
fractional parts less than \1/2\ hour.
[42 FR 15553, Mar. 22, 1977, as amended at 85 FR 50782, Aug. 18, 2020]
Sec. 1.101 Notification and recordkeeping.
(a) Scope. This section pertains to notifications and records
required for human drug, biological product, device, animal drug, food,
cosmetic, and tobacco product exports under sections 801 or 802 of the
Federal Food, Drug, and Cosmetic Act or (21 U.S.C. 381 and 382) or
section 351 of the Public Health Service Act (42 U.S.C. 262).
(b) Recordkeeping requirements for human drugs, biological products,
devices, animal drugs, foods, cosmetics, and tobacco products exported
under or subject to section 801(e)(1) of the Federal Food, Drug, and
Cosmetic Act. Persons exporting an article under section 801(e)(1) of
the act or an article otherwise subject to section 801(e)(1) of the act
shall maintain records as enumerated in paragraphs (b)(1) through (b)(4)
of this section demonstrating that the product meets the requirements of
section 801(e)(1) of the act. Such records shall be maintained for the
same period of time as required for records subject to good
manufacturing practice or quality systems regulations applicable to the
product, except that records pertaining to the export of foods and
cosmetics under section 801(e)(1) of the act shall be kept for 3 years
after the date of exportation. The records shall be made available to
the Food and Drug Administration (FDA), upon request, during an
inspection for review and copying by FDA.
(1) Records demonstrating that the product meets the foreign
purchaser's specifications: The records must contain sufficient
information to match the foreign purchaser's specifications to a
particular export;
(2) Records demonstrating that the product does not conflict with
the laws of the importing country: This may consist of either a letter
from an appropriate foreign government agency, department, or other
authorized body stating that the product has marketing approval from the
foreign government or does not conflict with that country's laws, or a
notarized certification by a responsible company official in the United
States that the product does not conflict with the laws of the importing
country and that includes a statement acknowledging that he or she is
subject to the provisions of 18 U.S.C. 1001;
(3) Records demonstrating that the product is labeled on the outside
of the shipping package that it is intended for export: This may consist
of copies of any labels or labeling statements, such as ``For export
only,'' that are placed on the shipping packages or, if the exported
product does not have a shipping package or container, on shipping
invoices or other documents accompanying the exported product; and
(4) Records demonstrating that the product is not sold or offered
for sale in the United States: This may consist of production and
shipping records for the exported product and promotional materials.
(c) Additional recordkeeping requirements for partially processed
biological products exported under section 351(h) of
[[Page 27]]
the Public Health Service Act. In addition to the requirements in
paragraph (b) of this section, persons exporting a partially processed
biological product under section 351(h) of the Public Health Service Act
shall maintain, for the same period of time as required for records
subject to good manufacturing practice or quality systems regulations
applicable to the product, and make available to FDA, upon request,
during an inspection for review and copying by FDA, the following
records:
(1) Records demonstrating that the product for export is a partially
processed biological product and not in a form applicable to the
prevention, treatment, or cure of diseases or injuries of man;
(2) Records demonstrating that the partially processed biological
product was manufactured in conformity with current good manufacturing
practice requirements;
(3) Records demonstrating the distribution of the exported partially
processed biological products; and
(4) Copies of all labeling that accompanies the exported partially
processed biological product and other records demonstrating that the
exported partially processed biological product is intended for further
manufacture into a final dosage form outside the United States; this may
include a container label with the statement, ``Caution: For Further
Manufacturing Use Only'' and any package insert.
(d) Notification requirements for drugs, biological products, and
devices exported under section 802 of the act. (1) Persons exporting a
human drug, biological product, or device under section 802 of the act,
other than a drug, biological product, or device for investigational use
exported under section 802(c) of the act, or a drug, biological product,
or device exported in anticipation of marketing authorization under
section 802(d) of the act, shall provide written notification to FDA.
The notification shall identify:
(i) The product's trade name;
(ii) If the product is a drug or biological product, the product's
abbreviated or proper name or, if the product is a device, the type of
device;
(iii) If the product is a drug or biological product, a description
of the product's strength and dosage form or, if the product is a
device, the product's model number; and
(iv) If the export is to a country not listed in section 802(b)(1)
of the act, the country that is to receive the exported article. The
notification may, but is not required to, identify countries listed in
section 802(b)(1) of the act or state that the export is intended for a
listed country without identifying the listed country.
(2) The notification shall be sent to the following addresses:
(i) For biological products and devices regulated by the Center for
Biologics Evaluation and Research--Food and Drug Administration, Center
for Biologics Evaluation and Research, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002.
(ii) For human drug products, biological products, and devices
regulated by the Center for Drug Evaluation and Research--Office of Drug
Security, Integrity and Response, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002.
(iii) For devices--DRP2: Division of Establishment Support, Office
of Regulatory Programs, Office of Product Evaluation and Quality, Center
for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66,
Rm. 1423, Silver Spring, MD 20993.
(e) Recordkeeping requirements for products subject to section
802(g) of the act. (1) Any person exporting a product under any
provision of section 802 of the act shall maintain records of all drugs,
biological products, and devices exported and the countries to which the
products were exported. In addition to the requirements in paragraph (b)
of this section, such records include, but are not limited to, the
following:
(i) The product's trade name;
(ii) If the product is a drug or biological product, the product's
abbreviated or proper name or, if the product is a device, the type of
device;
(iii) If the product is a drug or biological product, a description
of its strength and dosage form and the product's lot or control number
or, if the
[[Page 28]]
product is a device, the product's model number;
(iv) The consignee's name and address; and
(v) The date on which the product was exported and the quantity of
product exported.
(2) These records shall be kept at the site from which the products
were exported or manufactured, and be maintained for the same period of
time as required for records subject to good manufacturing practice or
quality systems regulations applicable to the product. The records shall
be made available to FDA, upon request, during an inspection for review
and copying by FDA.
[66 FR 65447, Dec. 19, 2001, as amended at 69 FR 48774, Aug. 11, 2004;
70 FR 14980, Mar. 24, 2005; 74 FR 13112, Mar. 26, 2009; 75 FR 20914,
Apr. 22, 2010; 77 FR 5176, Feb. 2, 2012; 80 FR 18090, Apr. 3, 2015; 85
FR 50782, Aug. 18, 2020]
Subparts F-G [Reserved]
Subpart H_Registration of Food Facilities
Source: 68 FR 58960, Oct. 10, 2003, unless otherwise noted.
General Provisions
Sec. 1.225 Who must register under this subpart?
(a) You must register your facility under this subpart if you are
the owner, operator, or agent in charge of either a domestic or foreign
facility, as defined in this subpart, and your facility is engaged in
the manufacturing/processing, packing, or holding of food for
consumption in the United States, unless your facility qualifies for one
of the exemptions in Sec. 1.226.
(b) If you are an owner, operator, or agent in charge of a domestic
facility, you must register your facility whether or not the food from
the facility enters interstate commerce.
(c) If you are the owner, operator, or agent in charge of a
facility, you may authorize an individual to register your facility on
your behalf.
Sec. 1.226 Who does not have to register under this subpart?
This subpart does not apply to the following facilities:
(a) A foreign facility, if food from such facility undergoes further
manufacturing/processing (including packaging) by another facility
outside the United States. A facility is not exempt under this provision
if the further manufacturing/processing (including packaging) conducted
by the subsequent facility consists of adding labeling or any similar
activity of a de minimis nature;
(b) Farms;
(c) Retail food establishments;
(d) Restaurants;
(e) Nonprofit food establishments in which food is prepared for, or
served directly to, the consumer;
(f) Fishing vessels, including those that not only harvest and
transport fish but also engage in practices such as heading,
eviscerating, or freezing intended solely to prepare fish for holding on
board a harvest vessel. However, those fishing vessels otherwise engaged
in processing fish are subject to this subpart. For the purposes of this
section, ``processing'' means handling, storing, preparing, shucking,
changing into different market forms, manufacturing, preserving,
packing, labeling, dockside unloading, holding, or heading,
eviscerating, or freezing other than solely to prepare fish for holding
on board a harvest vessel;
(g) Facilities 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. 1.227 What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug,
and Cosmetic Act apply to such terms when used in this subpart. In
addition, for the purposes of this subpart:
Calendar day means every day shown on the calendar.
Facility means any establishment, structure, or structures under one
ownership at one general physical location, or, in the case of a mobile
facility,
[[Page 29]]
traveling to multiple locations, that manufactures/processes, packs, or
holds food for consumption in the United States. Transport vehicles are
not facilities if they hold food only in the usual course of business as
carriers. A facility may consist of one or more contiguous structures,
and a single building may house more than one distinct facility if the
facilities are under separate ownership. The private residence of an
individual is not a facility. Nonbottled water drinking water collection
and distribution establishments and their structures are not facilities.
(1) Domestic facility means any facility located in any State or
Territory of the United States, the District of Columbia, or the
Commonwealth of Puerto Rico that manufactures/processes, packs, or holds
food for consumption in the United States.
(2) Foreign facility means a facility other than a domestic facility
that manufactures/processes, packs, or holds food for consumption in the
United States.
Farm means:
(1) Primary production farm. A primary production farm is an
operation under one management in one general (but not necessarily
contiguous) physical location devoted to the growing of crops, the
harvesting of crops, the raising of animals (including seafood), or any
combination of these activities. The term ``farm'' includes operations
that, in addition to these activities:
(i) Pack or hold raw agricultural commodities;
(ii) Pack or hold processed food, provided that all processed food
used in such activities is either consumed on that farm or another farm
under the same management, or is processed food identified in paragraph
(1)(iii)(B)(1) of this definition; and
(iii) Manufacture/process food, provided that:
(A) All food used in such activities is consumed on that farm or
another farm under the same management; or
(B) Any manufacturing/processing of food that is not consumed on
that farm or another farm under the same management consists only of:
(1) Drying/dehydrating raw agricultural commodities to create a
distinct commodity (such as drying/dehydrating grapes to produce
raisins), and packaging and labeling such commodities, without
additional manufacturing/processing (an example of additional
manufacturing/processing is slicing);
(2) Treatment to manipulate the ripening of raw agricultural
commodities (such as by treating produce with ethylene gas), and
packaging and labeling treated raw agricultural commodities, without
additional manufacturing/processing; and
(3) Packaging and labeling raw agricultural commodities, when these
activities do not involve additional manufacturing/processing (an
example of additional manufacturing/processing is irradiation); or
(2) Secondary activities farm. A secondary activities farm is an
operation, not located on a primary production farm, devoted to
harvesting (such as hulling or shelling), packing, and/or holding of raw
agricultural commodities, provided that the primary production farm(s)
that grows, harvests, and/or raises the majority of the raw agricultural
commodities harvested, packed, and/or held by the secondary activities
farm owns, or jointly owns, a majority interest in the secondary
activities farm. A secondary activities farm may also conduct those
additional activities allowed on a primary production farm as described
in paragraphs (1)(ii) and (iii) of this definition.
Food has the meaning given in section 201(f) of the Federal Food,
Drug, and Cosmetic Act:
(1) Except for purposes of this subpart, it does not include:
(i) Food contact substances as defined in section 409(h)(6) of the
Federal Food, Drug, and Cosmetic Act; or
(ii) Pesticides as defined in 7 U.S.C. 136(u).
(2) Examples of food include: Fruits, vegetables, fish, dairy
products, eggs, raw agricultural commodities for use as food or as
components of food, animal feed (including pet food), food and feed
ingredients, food and feed additives, dietary supplements and dietary
ingredients, infant formula, beverages (including alcoholic beverages
and bottled water), live food animals, bakery goods, snack foods, candy,
and canned foods.
[[Page 30]]
Harvesting applies to farms and farm mixed-type facilities and means
activities that are traditionally performed on farms for the purpose of
removing raw agricultural commodities from the place they were grown or
raised and preparing them for use as food. Harvesting is limited to
activities performed on raw agricultural commodities, or on processed
foods created by drying/dehydrating a raw agricultural commodity without
additional manufacturing/processing, on a farm. Harvesting does not
include activities that transform a raw agricultural commodity into a
processed food as defined in section 201(gg) of the Federal Food, Drug,
and Cosmetic Act. Examples of harvesting include cutting (or otherwise
separating) the edible portion of the raw agricultural commodity from
the crop plant and removing or trimming part of the raw agricultural
commodity (e.g., foliage, husks, roots or stems). Examples of harvesting
also include cooling, field coring, filtering, gathering, hulling,
shelling, sifting, threshing, trimming of outer leaves of, and washing
raw agricultural commodities grown on a farm.
Holding means storage of food and also includes activities performed
incidental to storage of a food (e.g., activities performed for the safe
or effective storage of that food, such as fumigating food during
storage, and drying/dehydrating raw agricultural commodities when the
drying/dehydrating does not create a distinct commodity (such as drying/
dehydrating hay or alfalfa)). Holding also includes activities performed
as a practical necessity for the distribution of that food (such as
blending of the same raw agricultural commodity and breaking down
pallets), but does not include activities that transform a raw
agricultural commodity into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities
could include warehouses, cold storage facilities, storage silos, grain
elevators, and liquid storage tanks.
Manufacturing/processing means making food from one or more
ingredients, or synthesizing, preparing, treating, modifying or
manipulating food, including food crops or ingredients. Examples of
manufacturing/processing activities include: Baking, boiling, bottling,
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw
agricultural commodities to create a distinct commodity (such as drying/
dehydrating grapes to produce raisins), evaporating, eviscerating,
extracting juice, formulating, freezing, grinding, homogenizing,
irradiating, labeling, milling, mixing, packaging (including modified
atmosphere packaging), pasteurizing, peeling, rendering, treating to
manipulate ripening, trimming, washing, or waxing. For farms and farm
mixed-type facilities, manufacturing/processing does not include
activities that are part of harvesting, packing, or holding.
Mixed-type facility means an establishment that engages in both
activities that are exempt from registration under section 415 of the
Federal Food, Drug, and Cosmetic Act and activities that require the
establishment to be registered. An example of such a facility is a
``farm mixed-type facility,'' which is an establishment that is a farm,
but also conducts activities outside the farm definition that require
the establishment to be registered.
Nonprofit food establishment means a charitable entity that prepares
or serves food directly to the consumer or otherwise provides food or
meals for consumption by humans or animals in the United States. The
term includes central food banks, soup kitchens, and nonprofit food
delivery services. To be considered a nonprofit food establishment, the
establishment must meet the terms of section 501(c)(3) of the U.S.
Internal Revenue Code (26 U.S.C. 501(c)(3)).
Packaging (when used as a verb) means placing food into a container
that directly contacts the food and that the consumer receives.
Packing means placing food into a container other than packaging the
food and also includes re-packing and activities performed incidental to
packing or re-packing a food (e.g., activities performed for the safe or
effective packing or re-packing of that food (such as sorting, culling,
grading, and weighing or conveying incidental to packing or re-
packing)), but does not include activities that transform a raw
agricultural commodity, as defined in
[[Page 31]]
section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a
processed food as defined in section 201(gg) of the Federal Food, Drug,
and Cosmetic Act.
Restaurant means a facility that prepares and sells food directly to
consumers for immediate consumption. ``Restaurant'' does not include
facilities that provide food to interstate conveyances, central
kitchens, and other similar facilities that do not prepare and serve
food directly to consumers.
(1) Entities in which food is provided to humans, such as
cafeterias, lunchrooms, cafes, bistros, fast food establishments, food
stands, saloons, taverns, bars, lounges, catering facilities, hospital
kitchens, day care kitchens, and nursing home kitchens are restaurants;
and
(2) Pet shelters, kennels, and veterinary facilities in which food
is provided to animals are restaurants.
Retail food establishment means an establishment that sells food
products directly to consumers as its primary function. The term
``retail food establishment'' includes facilities that manufacture,
process, pack, or hold food if the establishment's primary function is
to sell from that establishment food, including food that it
manufactures, processes, packs, or holds, directly to consumers. A
retail food establishment's primary function is to sell food directly to
consumers if the annual monetary value of sales of food products
directly to consumers exceeds the annual monetary value of sales of food
products to all other buyers. The term ``consumers'' does not include
businesses. A ``retail food establishment'' includes grocery stores,
convenience stores, and vending machine locations. A ``retail food
establishment'' also includes certain farm-operated businesses selling
food directly to consumers as their primary function.
(1) Sale of food directly to consumers from an establishment located
on a farm includes sales by that establishment directly to consumers:
(i) At a roadside stand (a stand situated on the side of or near a
road or thoroughfare at which a farmer sells food from his or her farm
directly to consumers) or farmers' market (a location where one or more
local farmers assemble to sell food from their farms directly to
consumers);
(ii) Through a community supported agriculture program. Community
supported agriculture (CSA) program means a program under which a farmer
or group of farmers grows food for a group of shareholders (or
subscribers) who pledge to buy a portion of the farmer's crop(s) for
that season. This includes CSA programs in which a group of farmers
consolidate their crops at a central location for distribution to
shareholders or subscribers; and
(iii) At other such direct-to-consumer sales platforms, including
door-to-door sales; mail, catalog and Internet order, including online
farmers markets and online grocery delivery; religious or other
organization bazaars; and State and local fairs.
(2) Sale of food directly to consumers by a farm-operated business
includes the sale of food by that farm-operated business directly to
consumers:
(i) At a roadside stand (a stand situated on the side of or near a
road or thoroughfare at which a farmer sells food from his or her farm
directly to consumers) or farmers' market (a location where one or more
local farmers assemble to sell food from their farms directly to
consumers);
(ii) Through a community supported agriculture program. Community
supported agriculture (CSA) program means a program under which a farmer
or group of farmers grows food for a group of shareholders (or
subscribers) who pledge to buy a portion of the farmer's crop(s) for
that season. This includes CSA programs in which a group of farmers
consolidate their crops at a central location for distribution to
shareholders or subscribers; and
(iii) At other such direct-to-consumer sales platforms, including
door-to-door sales; mail, catalog and Internet order, including online
farmers markets and online grocery delivery; religious or other
organization bazaars; and State and local fairs.
(3) For the purposes of this definition, ``farm-operated business''
means a business that is managed by one or more farms and conducts
manufacturing/processing not on the farm(s).
[[Page 32]]
Trade name means the name or names under which the facility conducts
business, or additional names by which the facility is known. A trade
name is associated with a facility, and a brand name is associated with
a product.
U.S. agent means a person (as defined in section 201(e) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(e))) residing or
maintaining a place of business in the United States whom a foreign
facility designates as its agent for purposes of this subpart. A U.S.
agent may not be in the form of a mailbox, answering machine or service,
or other place where an individual acting as the foreign facility's
agent is not physically present.
(1) The U.S. agent acts as a communications link between FDA and the
foreign facility for both emergency and routine communications. The U.S.
agent will be the person FDA contacts when an emergency occurs, unless
the registration specifies another emergency contact.
(2) FDA will treat representations by the U.S. agent as those of the
foreign facility, and will consider information or documents provided to
the U.S. agent the equivalent of providing the information or documents
to the foreign facility. FDA will consider the U.S. agent the equivalent
of the registrant for purposes of sharing information and
communications. The U.S. agent of a foreign facility may view the
information submitted in the foreign facility's registration.
(3) Having a single U.S. agent for the purposes of this subpart does
not preclude facilities from having multiple agents (such as foreign
suppliers) for other business purposes. A firm's commercial business in
the United States need not be conducted through the U.S. agent
designated for purposes of this subpart.
You or registrant means the owner, operator, or agent in charge of a
facility that manufactures/processes, packs, or holds food for
consumption in the United States.
[80 FR 56141, Sept. 17, 2015, as amended at 81 FR 3715, Jan. 22, 2016;
81 FR 45950, July 14, 2016]
Procedures for Registration of Food Facilities
Sec. 1.230 When must you register or renew your registration?
(a) Registration. You must register before your facility begins to
manufacture, process, pack, or hold food for consumption in the United
States. You may authorize an individual to register the facility on your
behalf.
(b) Registration renewal. You must submit a registration renewal
containing the information required under Sec. 1.232 every other year,
during the period beginning on October 1 and ending on December 31 of
each even-numbered year. You may authorize an individual to renew a
facility's registration on your behalf. If the individual submitting the
registration renewal is not the owner, operator, or agent in charge of
the facility, the registration renewal must also include a statement in
which the individual certifies that the information submitted is true
and accurate, certifies that he/she is authorized to submit the
registration renewal, and identifies by name, address, and telephone
number, the individual who authorized submission of the registration
renewal. In addition, the registration renewal must also identify the
individual who authorized submission of the registration renewal by
email address, unless FDA has granted a waiver under Sec. 1.245. Each
registration renewal must include the name of the individual submitting
the registration renewal, and the individual's signature (for the paper
option). Each electronic registration renewal must include the name of
the individual submitting the renewal.
(c) Abbreviated registration renewal process. If you do not have any
changes to the information required under Sec. 1.232 since you
submitted the preceding registration, registration renewal, or update
for your facility, you may use the abbreviated registration renewal
process. If you use the abbreviated registration renewal process, you
must confirm that no changes have been made to the information required
under Sec. 1.232 since you submitted the preceding registration,
registration renewal or update, and you must certify that the
information submitted is
[[Page 33]]
truthful and accurate. Each abbreviated registration renewal must
include the name of the individual submitting the abbreviated renewal,
and the individual's signature (for the paper option). Each electronic
abbreviated registration renewal must include the name of the individual
submitting the abbreviated renewal. For abbreviated registration
renewals not submitted by the owner, operator, or agent in charge of the
facility, the abbreviated renewal must provide the email address of the
individual who authorized submission of the abbreviated renewal, unless
FDA has granted a waiver under Sec. 1.245. You must use Form FDA 3537
to submit abbreviated registration renewals to FDA.
[81 FR 45950, July 14, 2016]
Sec. 1.231 How and where do you register or renew your registration?
(a) Electronic registration and registration renewal. (1) To
register or renew a registration electronically, you must go to http://
www.fda.gov/furls, which is available for registration 24 hours a day, 7
days a week. This Web site is available from wherever the Internet is
accessible, including libraries, copy centers, schools, and Internet
cafes. An individual authorized by the owner, operator, or agent in
charge of a facility may also register a facility electronically.
(2) Beginning on January 4, 2020, you must submit your registration
or registration renewal to FDA electronically, unless FDA has granted
you a waiver under Sec. 1.245.
(3) After you submit your electronic registration, FDA will verify
the accuracy of your unique facility identifier (UFI) recognized as
acceptable by FDA and will also verify that the facility-specific
address associated with the UFI is the same address associated with your
registration. FDA will not confirm your registration or provide you with
a registration number until FDA verifies the accuracy of your facility's
UFI and verifies that the facility-specific address associated with the
UFI is the same address associated with your registration. With respect
to electronic registration renewals, after you submit your electronic
registration renewal, FDA will provide you with an electronic
confirmation of your registration renewal. When you update your
facility's UFI as part of your electronic registration renewal, FDA will
verify the accuracy of your facility's UFI and will also verify that the
facility-specific address associated with the UFI is the same address
associated with your registration. FDA will not provide you with a
confirmation of your registration renewal until FDA verifies the
accuracy of your UFI and verifies that the facility-specific address
associated with the UFI is the same address associated with your
registration.
(4) For electronic registrations not submitted by the owner,
operator, or agent in charge of the facility, after submission of the
registration, FDA will verify that the individual identified as having
authorized submission of the registration in fact authorized the
submission on behalf of the facility. FDA will not confirm the
registration or provide a registration number until that individual
confirms that he or she authorized the submission. With respect to
electronic registration renewals, after completion of the electronic
registration renewal, FDA will provide an electronic confirmation of the
registration renewal. For electronic registration renewals not submitted
by the owner, operator, or agent in charge of the facility, FDA will
verify that the individual identified as having authorized submission of
the registration renewal in fact authorized the submission on behalf of
the facility. FDA will not provide an electronic confirmation of the
registration renewal until that individual confirms that he or she
authorized the submission.
(5) For a foreign facility, after you submit your electronic
registration, FDA will verify that the person identified as the U.S.
agent for your foreign facility has agreed to serve as your U.S. agent.
FDA will not confirm your registration or provide you with a
registration number until that person confirms that the person agreed to
serve as your U.S. agent. With respect to electronic registration
renewals, after you complete your electronic registration renewal, FDA
will provide you with an electronic confirmation of your registration
renewal. When you
[[Page 34]]
update information about your U.S. agent as part of your electronic
registration renewal, FDA will verify that the person identified as the
U.S. agent for your foreign facility has agreed to serve as your U.S.
agent. FDA will not provide you with an electronic confirmation of your
registration renewal until that person confirms that the person agreed
to serve as your U.S. agent.
(6) If any information you previously submitted was incorrect at the
time of submission, you must immediately update your facility's
registration as specified in Sec. 1.234.
(7) You will be considered registered once FDA electronically sends
you your confirmation and registration number.
(b) Registration or registration renewal by mail or fax. Beginning
January 4, 2020, you must submit your registration or registration
renewal to FDA electronically, unless FDA has granted you a waiver under
Sec. 1.245. If FDA has granted you a waiver under Sec. 1.245, you may
register or renew a registration by mail or by fax.
(1) You must register or renew a registration (including abbreviated
registration renewals) using Form FDA 3537. You may obtain a copy of
this form by writing to the U.S. Food and Drug Administration, Center
for Food Safety and Applied Nutrition, 5001 Campus Dr. (HFS-681),
College Park, MD 20740 or by requesting the form by phone at 1-800-216-
7331 or 301-575-0156.
(2) When you receive the form, you must fill it out completely and
legibly and either mail it to the address in paragraph (b)(1) of this
section or fax it to 301-436-2804.
(3) If any required information on the form is incomplete or
illegible when FDA receives it, FDA will return the form to you for
revision, provided that your mailing address or fax number is legible
and valid. When returning a registration form for revision, FDA will use
the means by which the form was received by the Agency (i.e., by mail or
fax).
(4) FDA will enter complete and legible mailed and faxed
registration submissions into its registration system, as soon as
practicable, in the order FDA receives them.
(5) After you submit your registration, FDA will verify the accuracy
of your facility's UFI and will also verify that the facility-specific
address associated with the UFI is the same address associated with your
registration. FDA will not confirm your registration or provide you with
a registration number until FDA verifies the accuracy of your facility's
UFI and verifies that the facility-specific address associated with the
UFI is the same address associated with your registration. With respect
to registration renewals, after you submit your registration renewal by
mail or fax, FDA will provide you with a confirmation of your
registration renewal. When you update your facility's UFI as part of
your registration renewal, FDA will verify the accuracy of your
facility's UFI and will also verify that the facility-specific address
associated with the UFI is the same address associated with your
registration. FDA will not provide you with a confirmation of your
registration renewal until FDA verifies the accuracy of your UFI and
verifies that the facility-specific address associated with the UFI is
the same address associated with your registration.
(6) For registrations not submitted by the owner, operator, or agent
in charge of the facility, after submission of the registration by mail
or fax, FDA will verify that the individual identified as having
authorized submission of the registration in fact authorized the
submission on behalf of the facility. FDA will not confirm the
registration or provide a registration number until that individual
confirms that he or she authorized the submission. With respect to
registration renewals, after completion of the registration renewal by
mail or fax, FDA will provide a confirmation of the registration
renewal. For registration renewals not submitted by the owner, operator,
or agent in charge of the facility, FDA will verify that the individual
identified as having authorized submission of the registration renewal
in fact authorized the submission on behalf of the facility. FDA will
not provide a confirmation of the registration renewal until that
individual confirms that he or she authorized the submission.
[[Page 35]]
(7) For a foreign facility, after you submit your registration by
mail or fax, FDA will verify that the person identified as the U.S.
agent for your foreign facility has agreed to serve as your U.S. agent.
FDA will not confirm your registration or provide you with a
registration number until that person confirms that the person agreed to
serve as your U.S. agent. With respect to registration renewals, after
you complete your registration renewal by mail or fax, FDA will provide
you with a confirmation of your registration renewal. When you update
information about your U.S. agent as part of your registration renewal,
FDA will verify that the person identified as the U.S. agent for your
foreign facility has agreed to serve as your U.S. agent. FDA will not
provide you with a confirmation of your registration renewal until that
person confirms that the person agreed to serve as your U.S. agent.
(8) FDA will mail or fax you a copy of the registration as entered,
confirmation of registration, and your registration number. When
responding to a registration submission, FDA will use the means by which
the registration was received by the Agency (i.e., by mail or fax).
(9) If any information you previously submitted was incorrect at the
time of submission, you must immediately update your facility's
registration as specified in Sec. 1.234.
(10) Your facility is considered registered once FDA enters your
facility's registration data into the registration system and the system
generates a registration number.
(c) Fees. No registration fee is required.
(d) Language. You must submit all registration information in the
English language except an individual's name, the name of a company, the
name of a street, and a trade name may be submitted in a foreign
language. All information, including these items, must be submitted
using the Latin (Roman) alphabet.
[81 FR 45950, July 14, 2016]
Sec. 1.232 What information is required in the registration?
(a) For a domestic and foreign facility, the following information
is required:
(1) The name, full address, and phone number of the facility;
(2) Beginning October 1, 2020, the facility's UFI recognized as
acceptable by FDA;
(3) The preferred mailing address, if different from that of the
facility;
(4) The name, full address, and phone number of the parent company,
if the facility is a subsidiary of the parent company;
(5) All trade names the facility uses;
(6) The name, full address, and phone number of the owner, operator,
or agent in charge of the facility. In addition, the email address of
the owner, operator, or agent in charge is required, unless FDA has
granted you a waiver under Sec. 1.245;
(7) The applicable food product categories of any food manufactured/
processed, packed, or held at the facility as identified on Form FDA
3537;
(8) The type of activity conducted at the facility for each food
product category identified. You may select more than one activity type
for each food product category identified. The activity type options are
as follows:
(i) Ambient human food storage warehouse/holding facility;
(ii) Refrigerated human food warehouse/holding facility;
(iii) Frozen human food warehouse/holding facility;
(iv) Interstate conveyance caterer/catering point;
(v) Contract sterilizer;
(vi) Labeler/relabeler;
(vii) Manufacturer/processor;
(viii) Acidified food processor;
(ix) Low-acid food processor;
(x) Farm mixed-type facility;
(xi) Packer/repacker;
(xii) Salvage operator (reconditioner);
(xiii) Animal food warehouse/holding facility;
(xiv) Other activity.
(9) A statement in which the owner, operator, or agent in charge
provides an assurance that FDA will be permitted to inspect the facility
at the times and in the manner permitted by
[[Page 36]]
the Federal Food, Drug, and Cosmetic Act;
(10) A statement in which the owner, operator, or agent in charge
certifies that the information submitted is true and accurate. If the
individual submitting the form is not the owner, operator, or agent in
charge of the facility, the registration must also include a statement
in which the individual certifies that the information submitted is true
and accurate, certifies that he/she is authorized to submit the
registration, and identifies by name, address, and telephone number, the
individual who authorized submission of the registration. In addition,
the registration must identify the individual who authorized submission
of the registration by email address, unless FDA has granted a waiver
under Sec. 1.245. Each registration must include the name of the
individual submitting the registration, and the individual's signature
(for the paper option).
(b) For a domestic facility, the following additional information is
required:
(1) The email address for the contact person of the facility;
(2) An emergency contact phone number and email address if different
from the email address for the contact person in paragraph (b)(1) of
this section.
(c) For a foreign facility, the following additional information is
required:
(1) The name, full address, phone number, and email address of the
foreign facility's U.S. agent;
(2) An emergency contact phone number and email address.
[81 FR 45951, July 14, 2016]
Sec. 1.233 Are there optional items included in the registration form?
Yes. FDA encourages, but does not require, you to submit items that
are indicated as optional on the Form FDA 3537 that you submit.
[81 FR 45952, July 14, 2016]
Sec. 1.234 How and when do you update your facility's registration
information?
(a) Update requirements. You must update a facility's registration
within 60 calendar days of any change to any of the information
previously submitted under Sec. 1.232 (e.g., change of operator, agent
in charge, or U.S. agent), except a change of the owner. You may
authorize an individual to update a facility's registration on your
behalf. For updates not submitted by the owner, operator, or agent in
charge of the facility, the update must provide the email address of the
individual who authorized submission of the update, unless FDA has
granted a waiver under Sec. 1.245.
(b) Cancellation due to ownership changes. If the reason for the
update is that the facility has a new owner, the former owner must
cancel the facility's registration as specified in Sec. 1.235 within 60
calendar days of the change and the new owner must submit a new
registration for the facility as specified in Sec. 1.231. The former
owner may authorize an individual to cancel a facility's registration.
(c) Electronic update. (1) To update your registration
electronically, you must update at http://www.fda.gov/furls.
(2) After you submit your electronic update, FDA will provide you
with an electronic confirmation of your update. When updating UFI
information, FDA will verify the accuracy of your facility's UFI and
will also verify that the facility-specific address associated with the
UFI is the same address associated with your registration. FDA will not
provide you with an electronic confirmation of your registration update
until FDA verifies the accuracy of your facility's UFI and verifies that
the facility-specific address associated with the UFI is the same
address associated with your registration. For foreign facilities, when
updating information about your U.S. agent, FDA will verify that the
person identified as the U.S. agent for your foreign facility has agreed
to serve as your U.S. agent. FDA will not provide you with an electronic
confirmation of your registration update until that person confirms that
the person agreed to serve as your U.S. agent.
(3) For electronic updates not submitted by the owner, operator, or
agent in charge of the facility, after submission of the electronic
update, FDA will verify that the individual
[[Page 37]]
identified as having authorized submission of the update in fact
authorized the submission on behalf of the facility. FDA will not
confirm the update to the registration until that individual confirms
that he or she authorized the submission.
(4) Your registration will be considered updated once FDA sends you
your update confirmation, unless notified otherwise.
(d) Update by mail or fax. Beginning January 4, 2020, you must
submit your update electronically, unless FDA has granted you a waiver
under Sec. 1.245. If FDA has granted you a waiver under Sec. 1.245,
you may update your facility's registration by mail or by fax.
(1) You must update your registration using Form FDA 3537. You may
obtain a copy of this form by writing to the U.S. Food and Drug
Administration, Center for Food Safety and Applied Nutrition, 5001
Campus Dr. (HFS-681), College Park, MD 20740 or by requesting the form
by phone at 1-800-216-7331 or 301-575-0156.
(2) When you receive the form, you must legibly fill out the
sections of the form reflecting your updated information and either mail
it to the address in paragraph (d)(1) of this section or fax it to 301-
436-2804.
(3) If the information on the form is incomplete or illegible when
FDA receives it, FDA will return the form to you for revision, provided
that your mailing address or fax number is legible and valid. When
returning a registration form for revision, FDA will use the means by
which the registration was received by the Agency (i.e., by mail or
fax).
(4) FDA will enter complete and legible updates into its
registration system as soon as practicable, in the order FDA receives
them.
(5) FDA will then mail to the address or fax to the fax number on
the registration form a copy of the update as entered and confirmation
of the update. When responding to an update submission, FDA will use the
means by which the form was received by the Agency (i.e., by mail or
fax). After you submit your update by mail or fax, FDA will verify the
accuracy of your facility's UFI and will also verify that the facility-
specific address associated with the UFI is the same address associated
with your registration. FDA will not provide a confirmation of your
registration update until FDA verifies the accuracy of your facility's
UFI and verifies that the facility-specific address associated with the
UFI is the same address associated with your registration. For foreign
facilities, when updating information about your U.S. agent, FDA will
verify that the person identified as the U.S. agent for your foreign
facility has agreed to serve as your U.S. agent. FDA will not provide
you with a confirmation of your registration update until that person
confirms that the person agreed to serve as your U.S. agent.
(6) For registration updates not submitted by the owner, operator,
or agent in charge of the facility, after submission of the registration
update by mail or fax, FDA will verify that the individual identified as
having authorized submission of the update in fact authorized the
submission on behalf of the facility. FDA will not confirm the
registration update until that individual confirms that he or she
authorized the update.
(7) If any update information you previously submitted was incorrect
at the time of submission, you must immediately resubmit your update.
(8) Your registration will be considered updated once FDA enters
your facility's update data into the registration system and the system
generates an update confirmation.
[81 FR 45952, July 14, 2016]
Sec. 1.235 How and when do you cancel your facility's registration
information?
(a) Notification of registration cancellation. You must cancel a
registration within 60 calendar days of the reason for cancellation
(e.g., your facility ceases operations, ceases providing food for
consumption in the United States, or is sold to a new owner).
(b) Cancellation requirements. The cancellation of a facility's
registration must include the following information:
(1) The facility's registration number;
(2) Whether the facility is domestic or foreign;
[[Page 38]]
(3) The facility name and address;
(4) The name, address, and email address (if available) of the
individual submitting the cancellation;
(5) For registration cancellations not submitted by the owner,
operator, or agent in charge of the facility, the email address of the
individual who authorized submission of the registration cancellation,
unless FDA has granted a waiver under Sec. 1.245; and
(6) A statement certifying that the information submitted is true
and accurate, and that the person submitting the cancellation is
authorized by the facility to cancel its registration.
(c) Electronic cancellation. (1) To cancel your registration
electronically, you must cancel at http://www.fda.gov/furls.
(2) Once you complete your electronic cancellation, FDA will provide
you with an electronic confirmation of your cancellation.
(3) For registration cancellations not submitted by the owner,
operator, or agent in charge of the facility, after submission of the
registration cancellation, FDA will verify that the individual
identified as having authorized submission of the cancellation in fact
authorized the submission on behalf of the facility. FDA will not
confirm the registration cancellation until that individual confirms
that he or she authorized the registration cancellation.
(4) Your registration will be considered cancelled once FDA sends
you your cancellation confirmation.
(d) Cancellation by mail or fax. Beginning January 4, 2020, you must
cancel your registration electronically, unless FDA has granted you a
waiver under Sec. 1.245. If FDA has granted a waiver under Sec. 1.245,
you may cancel your facility's registration by mail or fax.
(1) You must cancel your registration using Form FDA 3537a. You may
obtain a copy of this form by writing to the U.S. Food and Drug
Administration, Center for Food Safety and Applied Nutrition, 5001
Campus Dr. (HFS-681), College Park, MD 20740 or by requesting the form
by phone at 1-800-216-7331 or 301-575-0156.
(2) When you receive the form, you must completely and legibly fill
out the form and either mail it to the address in paragraph (d)(1) of
this section or fax it to 301-436-2804.
(3) If the information on the form is incomplete or illegible when
FDA receives it, FDA will return the form to you for revision, provided
that your mailing address or fax number is legible and valid. When
returning a cancellation form for revision, FDA will use the means by
which the cancellation was received by the Agency (i.e., by mail or
fax).
(4) FDA will enter complete and legible mailed and faxed
cancellations into its registration system as soon as practicable, in
the order FDA receives them.
(5) FDA will mail to the address or fax to the fax number on the
cancellation form a copy of the cancellation as entered and confirmation
of the cancellation. When responding to a cancellation, FDA will use the
means by which the form was received by the Agency (i.e., by mail or
fax).
(6) For registration cancellations not submitted by the owner,
operator, or agent in charge of the facility, after submission of the
registration cancellation by mail or fax, FDA will verify that the
individual identified as having authorized submission of the
cancellation in fact authorized the submission on behalf of the
facility. FDA will not confirm the registration cancellation until that
individual confirms that he or she authorized the registration
cancellation.
(7) Your registration will be considered cancelled once FDA enters
your facility's cancellation data into the registration system. FDA will
send you your cancellation confirmation.
[81 FR 45952, July 14, 2016]
Additional Provisions
Sec. 1.240 What other registration requirements apply?
In addition to the requirements of this subpart, you must comply
with the registration regulations found in part 108 of this chapter,
related to emergency permit control, and any other Federal, State, or
local registration requirements that apply to your facility.
[[Page 39]]
Sec. 1.241 What are the consequences of failing to register, update,
renew, or cancel your registration?
(a) Section 301 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331) prohibits the doing of certain acts or causing such acts to
be done. Under section 302 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 332), the United States can bring a civil action in Federal
court to enjoin a person who commits a prohibited act. Under section 303
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), the United
States can bring a criminal action in Federal court to prosecute a
person who is responsible for the commission of a prohibited act. Under
section 306 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
335a), FDA can seek debarment of any person who has been convicted of a
felony relating to importation of food into the United States. Failure
of an owner, operator, or agent in charge of a domestic or foreign
facility to register its facility, renew the registration of its
facility, update required elements of its facility's registration, or
cancel its registration in accordance with the requirements of this
subpart is a prohibited act under section 301(dd) of the Federal Food,
Drug, and Cosmetic Act.
(b) FDA will consider a registration for a food facility to be
expired if the registration is not renewed, as required by Sec.
1.230(b). Thus, if you previously submitted a registration to FDA, but
do not submit a registration renewal to FDA during the period beginning
on October 1 and ending on December 31 of each even-numbered year, FDA
will consider the registration for the facility to be expired. FDA will
consider a food facility with an expired registration to have failed to
register in accordance with section 415 of the Federal Food, Drug, and
Cosmetic Act.
(c) FDA will cancel a registration if FDA independently verifies
that the facility is no longer in business or has changed owners, and
the owner, operator, or agent in charge of the facility fails to cancel
the registration, or if FDA determines that the registration is for a
facility that does not exist, is not required to register, or where the
information about the facility's address was not updated in a timely
manner in accordance with Sec. 1.234(a) or the registration was
submitted by a person not authorized to submit the registration under
Sec. 1.225. Also, FDA will cancel a registration if the facility's
registration has expired because the facility has failed to renew its
registration in accordance with Sec. 1.230(b). If FDA cancels a
facility's registration, FDA will send a confirmation of the
cancellation using contact information submitted by the facility in the
registration database.
(d) If an article of food is imported or offered for import into the
United States and a foreign facility that manufactured/processed,
packed, or held that article of food has not registered in accordance
with this subpart, the disposition of the article of food shall be
governed by the procedures set out in subpart I of this part.
[81 FR 45953, July 14, 2016]
Sec. 1.242 What does assignment of a registration number mean?
Assignment of a registration number to a facility means that the
facility is registered with FDA. Assignment of a registration number
does not in any way convey FDA's approval or endorsement of a facility
or its products.
Sec. 1.243 Is food registration information available to the public?
(a) The list of registered facilities and registration documents
submitted under this subpart are not subject to disclosure under 5
U.S.C. 552 (the Freedom of Information Act). In addition, any
information derived from such list or registration documents that would
disclose the identity or location of a specific registered person, is
not subject to disclosure under 5 U.S.C. 552 (the Freedom of Information
Act).
(b) Paragraph (a) of this section does not apply to any information
obtained by other means or that has previously been disclosed to the
public as defined in Sec. 20.81 of this chapter.
Sec. 1.245 Waiver request.
Under Sec. Sec. 1.231(a)(2) and (b), 1.234(d), and 1.235(d),
beginning January 4, 2020, you must submit your registration,
registration renewal, updates, and cancellations to FDA electronically
unless FDA has granted a waiver from such
[[Page 40]]
requirement. Under Sec. 1.232(a)(6), you must provide the email address
of the owner, operator, or agent in charge of the facility unless FDA
has granted a waiver from such requirement. In addition, under
Sec. Sec. 1.230(b) and (c), 1.232(a)(10), 1.234(a), and 1.235(b)(5),
registration renewals, abbreviated registration renewals, registrations,
updates, and cancellations not submitted by the owner, operator, or
agent in charge must include the email address for the individual who
authorized the submission, unless FDA has granted a waiver. To request a
waiver from these requirements, you must submit a written request to FDA
that explains why it is not reasonable for you to submit your
registration, registration renewal, update, or cancellation to FDA
electronically or to provide the email address of the owner, operator,
or agent in charge of the facility. You must submit your request to:
U.S. Food and Drug Administration, Center for Food Safety and Applied
Nutrition, 5001 Campus Dr. (HFS-681), College Park, MD 20740.
[81 FR 45953, July 14, 2016]
Subpart I_Prior Notice of Imported Food
Source: 73 FR 66402, Nov. 7, 2008, unless otherwise noted.
General Provisions
Sec. 1.276 What definitions apply to this subpart?
(a) The act means the Federal Food, Drug, and Cosmetic Act.
(b) The definitions of terms in section 201 of the act (21 U.S.C.
321) apply when the terms are used in this subpart, unless defined in
this section.
(1) Calendar day means every day shown on the calendar.
(2) Country from which the article originates means FDA Country of
Production.
(3) Country from which the article is shipped means the country in
which the article of food is loaded onto the conveyance that brings it
to the United States or, in the case of food sent by international mail,
the country from which the article is mailed.
(4) FDA Country of Production means: (i) For an article of food that
is in its natural state, the country where the article of food was
grown, including harvested or collected and readied for shipment to the
United States. If an article of food is wild fish, including seafood
that was caught or harvested outside the waters of the United States by
a vessel that is not registered in the United States, the FDA Country of
Production is the country in which the vessel is registered. If an
article of food that is in its natural state was grown, including
harvested or collected and readied for shipment, in a Territory, the FDA
Country of Production is the United States.
(ii) For an article of food that is no longer in its natural state,
the country where the article was made; except that, if an article of
food is made from wild fish, including seafood, aboard a vessel, the FDA
Country of Production is the country in which the vessel is registered.
If an article of food that is no longer in its natural state was made in
a Territory, the FDA Country of Production is the United States.
(5) Food has the meaning given in section 201(f) of the act, except
as provided in paragraph (b)(5)(i) of this section.
(i) For purposes of this subpart, food does not include:
(A) Food contact substances as defined in section 409(h)(6) of the
act (21 U.S.C. 348(h)(6)); or
(B) Pesticides as defined in 7 U.S.C. 136(u).
(ii) Examples of food include fruits, vegetables, fish, including
seafood, dairy products, eggs, raw agricultural commodities for use as
food or as components of food, animal feed (including pet food), food
and feed ingredients, food and feed additives, dietary supplements and
dietary ingredients, infant formula, beverages (including alcoholic
beverages and bottled water), live food animals, bakery goods, snack
foods, candy, and canned foods.
(6) Full address means the facility's street name and number; suite/
unit number, as appropriate; city; Province or State as appropriate;
mail code as appropriate; and country.
[[Page 41]]
(7) Grower means a person who engages in growing and harvesting or
collecting crops (including botanicals), raising animals (including
fish, which includes seafood), or both.
(8) International mail means foreign national mail services.
International mail does not include express consignment operators or
carriers or other private delivery services unless such service is
operating under contract as an agent or extension of a foreign mail
service.
(9) Manufacturer means the last facility, as that word is defined in
Sec. 1.227, that manufactured/processed the food. A facility is
considered the last facility even if the food undergoes further
manufacturing/processing that consists of adding labeling or any similar
activity of a de minimis nature. If the food undergoes further
manufacturing/processing that exceeds an activity of a de minimis
nature, then the subsequent facility that performed the additional
manufacturing/processing is considered the manufacturer.
(10) No longer in its natural state means that an article of food
has been made from one or more ingredients or synthesized, prepared,
treated, modified, or manipulated. Examples of activities that render
food no longer in its natural state are cutting, peeling, trimming,
washing, waxing, eviscerating, rendering, cooking, baking, freezing,
cooling, pasteurizing, homogenizing, mixing, formulating, bottling,
milling, grinding, extracting juice, distilling, labeling, or packaging.
Crops that have been cleaned (e.g., dusted, washed), trimmed, or cooled
attendant to harvest or collection or treated against pests, or polished
are still in their natural state for purposes of this subpart. Whole
fish headed, eviscerated, or frozen attendant to harvest are still in
their natural state for purposes of this subpart.
(11) Port of arrival means the water, air, or land port at which the
article of food is imported or offered for import into the United
States. For an article of food arriving by water or air, this is the
port of unloading. For an article of food arriving by land, this is the
port where the article of food first crosses the border into the United
States. The port of arrival may be different than the port where
consumption or warehouse entry or foreign trade zone admission
documentation is presented to the U.S. Customs and Border Protection
(CBP).
(12) Port of entry, in section 801(m) and (l) of the act (21 U.S.C.
381(m) and (l)), means the port of entry as defined in 19 CFR 101.1.
(13) Registration number means the registration number assigned to a
facility by FDA under section 415 of the act (21 U.S.C. 350d) and
subpart H of this part.
(14) Shipper means the owner or exporter of the article of food who
consigns and ships the article from a foreign country or the person who
sends an article of food by international mail or express consignment
operators or carriers or other private delivery service to the United
States.
(15) United States means the Customs territory of the United States
(i.e., the 50 States, the District of Columbia, and the Commonwealth of
Puerto Rico), but not the Territories.
(16) You means the person submitting the prior notice, i.e., the
submitter or the transmitter, if any.
[73 FR 66402, Nov. 7, 2008, as amended at 80 FR 56143, Sept. 17, 2015]
Sec. 1.277 What is the scope of this subpart?
(a) This subpart applies to all food for humans and other animals
that is imported or offered for import into the United States for use,
storage, or distribution in the United States, including food for gifts
and trade and quality assurance/quality control samples, food for
transshipment through the United States to another country, food for
future export, and food for use in a U.S. Foreign Trade Zone.
(b) Notwithstanding paragraph (a) of this section, this subpart does
not apply to:
(1) Food for an individual's personal use when it is carried by or
otherwise accompanies the individual when arriving in the United States;
(2) Food that was made by an individual in his/her personal
residence and sent by that individual as a personal gift (i.e., for
nonbusiness reasons) to an individual in the United States;
[[Page 42]]
(3) Food that is imported then exported without leaving the port of
arrival until export;
(4) Meat food products that at the time of importation are subject
to the exclusive jurisdiction of the U.S. Department of Agriculture
(USDA) under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);
(5) Poultry products that at the time of importation are subject to
the exclusive jurisdiction of USDA under the Poultry Products Inspection
Act (21 U.S.C. 451 et seq.);
(6) Egg products that at the time of importation are subject to the
exclusive jurisdiction of USDA under the Egg Products Inspection Act (21
U.S.C. 1031 et seq.); and
(7) Articles of food subject to Article 27(3) of The Vienna
Convention on Diplomatic Relations (1961), i.e., shipped as baggage or
cargo constituting the diplomatic bag.
Requirements To Submit Prior Notice of Imported Food
Sec. 1.278 Who is authorized to submit prior notice?
A prior notice for an article of food may be submitted by any person
with knowledge of the required information. This person is the
submitter. The submitter also may use another person to transmit the
required information on his/her behalf. The person who transmits the
information is the transmitter. The submitter and transmitter may be the
same person.
Sec. 1.279 When must prior notice be submitted to FDA?
(a) Except as provided in paragraph (c) of this section, you must
submit the prior notice to FDA and the prior notice submission must be
confirmed by FDA for review as follows:
(1) If the article of food is arriving by land by road, no less than
2 hours before arriving at the port of arrival;
(2) If the article of food is arriving by land by rail, no less than
4 hours before arriving at the port of arrival;
(3) If the article of food is arriving by air, no less than 4 hours
before arriving at the port of arrival; or
(4) If the article of food is arriving by water, no less than 8
hours before arriving at the port of arrival.
(b) Except in the case of an article of food imported or offered for
import by international mail:
(1) If prior notice is submitted via the Automated Broker Interface/
Automated Commercial Environment/International Trade Data System (ABI/
ACE/ITDS), you may not submit prior notice more than 30-calendar days
before the anticipated date of arrival.
(2) If prior notice is submitted via the FDA Prior Notice System
Interface (FDA PNSI), you may not submit prior notice more than 15-
calendar days before the anticipated date of arrival.
(c) Notwithstanding paragraphs (a) and (b) of this section, if the
article of food is arriving by international mail, you must submit the
prior notice before the article of food is sent to the United States.
(d) FDA will notify you that your prior notice has been confirmed
for review with a reply message that contains a Prior Notice (PN)
Confirmation Number. Your prior notice will be considered submitted and
the prior notice time will start when FDA has confirmed your prior
notice for review.
(e) The PN Confirmation Number must accompany any article of food
arriving by international mail. The PN Confirmation Number must appear
on the Customs Declaration (e.g., CN22 or CN23 or U.S. equivalent) that
accompanies the package.
(f) A copy of the confirmation, including the PN Confirmation
Number, must accompany any article of food that is subject to this
subpart when it is carried by or otherwise accompanies an individual
when arriving in the United States. The copy of the confirmation must be
provided to U.S. Customs and Border Protection (CBP) or FDA upon
arrival.
(g) The PN Confirmation Number must accompany any article of food
for which the prior notice was submitted through the FDA PNSI when the
article arrives in the United States and must be provided to CBP or FDA
upon arrival.
[73 FR 66402, Nov. 7, 2008, as amended at 82 FR 15629, Mar. 30, 2017]
[[Page 43]]
Sec. 1.280 How must you submit prior notice?
(a) You must submit the prior notice electronically to FDA. You must
submit all prior notice information in the English language, except that
an individual's name, the name of a company, and the name of a street
may be submitted in a foreign language. All information, including the
items listed in the previous sentence, must be submitted using the Latin
(Roman) alphabet. Unless paragraph (c) of this section applies, you must
submit prior notice through:
(1) The U.S. Customs and Border Protection (CBP) Automated Broker
Interface/Automated Commercial Environment/International Trade Data
System (ABI/ACE/ITDS); or
(2) The FDA PNSI at https://www.access.fda.gov/. You must submit
prior notice through the FDA Prior Notice System Interface (FDA PNSI)
for articles of food imported or offered for import by international
mail, and other transaction types that cannot be made through ABI/ACE/
ITDS.
(b) If a customhouse broker's or self-filer's system is not working
or if the ABI/ACE/ITDS interface is not working, prior notice must be
submitted through the FDA PNSI.
(c) If FDA determines that FDA PNSI or the Operational and
Administration System for Import Support (OASIS) is not working, FDA
will post prominent notification and instructions at https://
www.access.fda.gov--see log-in page. FDA will accept prior notice
submissions in the format it deems appropriate during the system(s)
outage.
[73 FR 66402, Nov. 7, 2008, as amended at 82 FR 15629, Mar. 30, 2017; 85
FR 50782, Aug. 18, 2020]
Sec. 1.281 What information must be in a prior notice?
(a) General. For each article of food that is imported or offered
for import into the United States, except by international mail, you
must submit the information for the article that is required in
paragraphs (a)(1) through (18) of this section:
(1) The name of the individual submitting the prior notice and his/
her business address, phone number, and e-mail address, and the name and
address of the submitting firm, if applicable. If the business address
of the individual submitting the prior notice is a registered facility,
then the facility's registration number, city, and country may be
provided instead of the facility's full address;
(2) If different from the submitter, the name of the individual and
firm, if applicable, transmitting the prior notice on behalf of the
submitter and his/her business address, phone number, and e-mail
address. If the business address of the individual transmitting the
prior notice is a registered facility, then the facility's registration
number, city, and country may be provided instead of the facility's full
address;
(3) The entry type;
(4) The U.S. Customs and Border Protection (CBP) entry identifier
(e.g., CBP entry number or in-bond number), if available;
(5) The identity of the article of food being imported or offered
for import, as follows:
(i) The complete FDA product code;
(ii) The common or usual name or market name;
(iii) The estimated quantity of food that will be shipped, described
from largest container to smallest package size; and
(iv) The lot or code numbers or other identifier of the food if
required by the act or FDA regulations, e.g., low-acid canned foods, by
Sec. 113.60(c) of this chapter; acidified foods, by Sec. 114.80(b) of
this chapter; and infant formula, by Sec. 106.90 of this chapter;
(6) For an article of food that is no longer in its natural state,
the identity of the manufacturer, as follows:
(i) The name of the manufacturer; and
(ii) Either the registration number, city, and country of the
manufacturer or both the full address of the manufacturer and the reason
the registration number is not provided;
(7) For an article of food that is in its natural state, the name
and growing location address of the grower, if known. If the submitter
does not know the identity of the grower or, if the article has been
consolidated and the submitter does not know the identity of any of the
growers, you may provide
[[Page 44]]
the name and address of the firm that has consolidated the articles of
food from different growers or different growing locations;
(8) The FDA Country of Production;
(9) If the shipper is different from the manufacturer, the identity
of the shipper, as follows:
(i) The name of the shipper; and
(ii) The full address of the shipper. If the address of the shipper
is a registered facility, you also may submit the registration number of
the shipper's registered facility;
(10) The country from which the article is shipped;
(11) Anticipated arrival information about the article of food being
imported or offered for import, as follows:
(i) The anticipated port of arrival;
(ii) The anticipated date on which the article of food will arrive
at the anticipated port of arrival;
(iii) The anticipated time of that arrival; and
(iv) Notwithstanding paragraphs (a)(11) introductory text and
(a)(11)(i) through (iii) of this section, if the article of food is
arriving by express consignment operator or carrier, the express
consignment operator or carrier tracking number may be submitted in lieu
of the information required in paragraphs (a)(11) introductory text and
(a)(11)(i) through (iii) of this section.
(12) The name and full address of the importer. If the business
address of the importer is a registered facility, you also may submit
the registration number of the importer's registered facility. The
identity of the importer is not required for an article of food that is
imported or offered for import for transshipment through the United
States under a Transportation and Exportation entry;
(13) The name and full address of the owner if different from the
importer or ultimate consignee. If the business address of the owner is
a registered facility, you also may submit the registration number of
the owner's registered facility. The identity of the owner is not
required for an article of food that is imported or offered for import
for transshipment through the United States under a Transportation and
Exportation entry;
(14) The name and full address of the ultimate consignee. If the
business address of the ultimate consignee is a registered facility, you
also may submit the registration number of the ultimate consignee's
registered facility. The identity of the ultimate consignee is not
required for an article of food that is imported or offered for import
for transshipment through the United States under a Transportation and
Exportation entry;
(15) The mode of transportation;
(16) The Standard Carrier Abbreviation Code (SCAC) or International
Air Transportation Association (IATA) code of the carrier which is, or
will be, carrying the article of food from the country from which the
article is shipped to the United States to the port of arrival, or if
this code is not applicable, then the name of the carrier. If the
carrier is a privately owned vehicle, the license plate number of the
vehicle and the State or Province that issued the license plate number;
(17) Planned shipment information, as applicable to the mode of
transportation and when it exists:
(i) The Airway Bill number(s) or Bill of Lading number(s), as
applicable. This information is not required for an article of food when
carried by or otherwise accompanying an individual when entering the
United States. If the article of food is arriving by express consignment
operator or carrier, the express consignment operator or carrier
tracking number may by submitted in lieu of the Airway Bill number(s) or
Bill of Lading number(s), as applicable;
(ii) For food arriving by ocean vessel, the vessel name and voyage
number;
(iii) For food arriving by air carrier, the flight number. If the
article of food is arriving by express consignment operator or carrier,
the express consignment operator or carrier tracking number may be
submitted in lieu of the flight number;
(iv) For food arriving by truck, bus, or rail, the trip number;
(v) For food arriving as containerized cargo by water, air, or land,
the container number(s). This information is not required for an article
of food when carried by or otherwise accompanying
[[Page 45]]
an individual when entering the United States; and
(vi) For food arriving by rail, the car number. This information is
not required for an article of food when carried by or otherwise
accompanying an individual.
(18) Any country to which the article has been refused entry.
(b) Articles arriving by international mail. For each article of
food that is imported or offered for import into the United States by
international mail, you must submit the information for the article that
is required in paragraphs (b)(1) through (12) of this section:
(1) The name of the individual submitting the prior notice and his/
her business address, phone number, and e-mail address, and the name and
address of the submitting firm, if applicable. If the business address
of the individual submitting the prior notice is a registered facility,
then the facility's registration number, city, and country may be
provided instead of the facility's full address;
(2) If different from the submitter, the name of the individual and
firm, if applicable, transmitting the prior notice on behalf of the
submitter and his/her business address, phone number, and e-mail
address. If the business address of the individual transmitting the
prior notice is a registered facility, then the facility's registration
number, city, and country may be provided instead of the facility's full
address;
(3) The entry type (which will be a mail entry);
(4) The identity of the article of food being imported or offered
for import, as follows:
(i) The complete FDA product code;
(ii) The common or usual name or market name;
(iii) The estimated quantity of food that will be shipped, described
from largest container to smallest package size; and
(iv) The lot or code numbers or other identifier of the food if
required by the act or FDA regulations, e.g., low-acid canned foods, by
Sec. 113.60(c) of this chapter; acidified foods, by Sec. 114.80(b) of
this chapter; and infant formula, Sec. 106.90 of this chapter;
(5) For an article of food that is no longer in its natural state,
the identity of the manufacturer, as follows:
(i) The name of the manufacturer; and
(ii) Either the registration number, city, and country of the
manufacturer or both the full address of the manufacturer and the reason
the registration number is not provided;
(6) For an article of food that is in its natural state, the name
and growing location address of the grower, if known. If the submitter
does not know the identity of the grower or, if the article has been
consolidated and the submitter does not know the identity of any of the
growers, you may provide the name and address of the firm that has
consolidated the articles of food from different growers or different
growing locations;
(7) The FDA Country of Production;
(8) If the shipper is different from the manufacturer, the identity
of the shipper, as follows:
(i) The name of the shipper; and
(ii) The full address of the shipper. If the address of the shipper
is a registered facility, you also may submit the registration number of
the shipper's registered facility;
(9) The country from which the article is shipped (i.e., mailed);
(10) The anticipated date of mailing; and
(11) The name and address of the U.S. recipient.
(12) Any country to which the article has been refused entry.
(c) Refused articles. If the article of food has been refused under
section 801(m)(1) of the act and under this subpart, you must submit the
information for the article that is required in paragraphs (c)(1)
through (19) of this section. However, if the refusal is based on Sec.
1.283(a)(1)(iii) (Untimely Prior Notice), you do not have to resubmit
any information previously submitted unless it has changed or the
article has been exported and the original prior notice was submitted
through ABI/ACE/ITDS. If the refusal is based on Sec. 1.283(a)(1)(ii),
you should cancel the previous submission per Sec. 1.282(b) and (c).
(1) The name of the individual submitting the prior notice and his/
her
[[Page 46]]
business address, phone number, and e-mail address, and the name and
address of the submitting firm, if applicable. If the business address
of the individual submitting the prior notice is a registered facility,
then the facility's registration number, city, and country may be
provided instead of the facility's full address;
(2) If different from the submitter, the name of the individual and
firm, if applicable, transmitting the prior notice on behalf of the
submitter and his/her business address, phone number, and e-mail
address. If the business address of the individual transmitting the
prior notice is a registered facility, then the facility's registration
number, city, and country may be provided instead of the facility's full
address;
(3) The entry type;
(4) The CBP entry identifier (e.g., CBP entry number or in-bond
number), if available;
(5) The identity of the article of food being imported or offered
for import, as follows:
(i) The complete FDA product code;
(ii) The common or usual name or market name;
(iii) The quantity of food that was shipped, described from largest
container to smallest package size; and
(iv) The lot or code numbers or other identifier of the food if
required by the act or FDA regulations, e.g., low-acid canned foods, by
Sec. 113.60(c) of this chapter; acidified foods, by Sec. 114.80(b) of
this chapter; and infant formula, by Sec. 106.90 of this chapter;
(6) For an article of food that is no longer in its natural state,
the identity of the manufacturer, as follows:
(i) The name of the manufacturer; and
(ii) Either the registration number, city, and country of the
manufacturer or both the full address of the manufacturer and the reason
the registration number is not provided;
(7) For an article of food that is in its natural state, the name
and growing location address of the grower, if known. If the submitter
does not know the identity of the grower or, if the article has been
consolidated and the submitter does not know any of the growers, you may
provide the name and address of the firm that has consolidated the
articles of food from different growers or different growing locations;
(8) The FDA Country of Production;
(9) If the shipper is different from the manufacturer, the identity
of the shipper, as follows:
(i) The name of the shipper; and
(ii) The full address of the shipper. If the address of the shipper
is a registered facility, you also may submit the registration number of
the shipper's registered facility;
(10) The country from which the article is shipped;
(11) Arrival information about the article of food being imported or
offered for import, as follows:
(i) The port of arrival; and
(ii) The date on which the article of food arrived at the port of
arrival.
(iii) Notwithstanding paragraphs (c)(11) introductory text and
(c)(11)(i) and (ii) of this section, if the article of food arrived by
express consignment operator or carrier, the express consignment
operator or carrier tracking number may be submitted in lieu of the
information required in paragraphs (c)(11) introductory text and
(c)(11)(i) and (ii) of this section.
(12) The name and full address of the importer. If the business
address of the importer is a registered facility, you also may submit
the registration number of the importer's registered facility. The
identity of the importer is not required for an article of food that is
imported or offered for import for transshipment through the United
States under a Transportation and Exportation entry;
(13) The name and full address of the owner, if different from the
importer or ultimate consignee. If the business address of the owner is
a registered facility, you also may submit the registration number of
the importer's registered facility. The identity of the owner is not
required for an article of food that is imported or offered for import
for transshipment through the United States under a Transportation and
Exportation entry;
(14) The name and full address of the ultimate consignee. If the
business address of the ultimate consignee is a
[[Page 47]]
registered facility, you also may submit the registration number of the
ultimate consignee's registered facility. The identity of the ultimate
consignee is not required for an article of food that is imported or
offered for import for transshipment through the United States under a
Transportation and Exportation entry;
(15) The mode of transportation;
(16) The SCAC or IATA code of the carrier which carried the article
of food from the country from which the article is shipped to the United
States to the port of arrival, or if this code is not applicable, then
the name of the carrier. If the carrier is a privately owned vehicle,
the license plate number of the vehicle and the State or Province that
issued the license plate number;
(17) Shipment information, as applicable to the mode of
transportation and when it exists:
(i) The Airway Bill number(s) or Bill of Lading number(s), as
applicable; however, this information is not required for an article of
food when carried by or otherwise accompanying an individual when
entering the United States. If the article of food arrived by express
consignment operator or carrier, the express consignment operator or
carrier tracking number may be submitted in lieu of the Airway Bill
number(s) or Bill of Lading number(s), as applicable;
(ii) For food that arrived by ocean vessel, the vessel name and
voyage number;
(iii) For food that arrived by air carrier, the flight number. If
the article of food arrived by express consignment operator or carrier,
the express consignment operator or carrier tracking number may be
submitted in lieu of the flight number;
(iv) For food that arrived by truck, bus, or rail, the trip number;
(v) For food that arrived as containerized cargo by water, air, or
land, the container number(s); however, this information is not required
for an article of food when carried by or otherwise accompanying an
individual when entering the United States; and
(vi) For food that arrived by rail, the car number; however, this
information is not required for an article of food when carried by or
otherwise accompanying an individual;
(18) The location and address where the article of refused food will
be or is being held, the date the article has arrived or will arrive at
that location, and identification of a contact at that location.
(19) Any country to which the article has been refused entry.
[73 FR 66402, Nov. 7, 2008, as amended at 76 FR 25545, May 5, 2011; 82
FR 15629, Mar. 30, 2017]
Sec. 1.282 What must you do if information changes after you have
received confirmation of a prior notice from FDA?
(a)(1) If any of the information required in Sec. 1.281(a), except
the information required in:
(i) Section 1.281(a)(5)(iii) (quantity),
(ii) Section 1.281(a)(11) (anticipated arrival information), or
(iii) Section 1.281(a)(17) (planned shipment information), changes
after you receive notice that FDA has confirmed your prior notice
submission for review, you must resubmit prior notice in accordance with
this subpart unless the article of food will not be offered for import
or imported into the United States.
(2) If any of the information required in Sec. 1.281(b), except the
information required in Sec. 1.281(b)(10) (the anticipated date of
mailing), changes after you receive notice that FDA has confirmed your
prior notice submission for review, you must resubmit prior notice in
accordance with this subpart, unless the article of food will not be
offered for import or imported into the United States.
(b) If you submitted the prior notice via the FDA PNSI, you should
cancel the prior notice via the FDA PNSI.
(c) If you submitted the prior notice via ABI/ACE/ITDS, you should
cancel the prior notice via ACE by requesting that CBP cancel the entry.
[73 FR 66402, Nov. 7, 2008, as amended at 82 FR 15629, Mar. 30, 2017]
[[Page 48]]
Consequences
Sec. 1.283 What happens to food that is imported or offered for import
without adequate prior notice?
(a) For each article of food that is imported or offered for import
into the United States, except for food arriving by international mail
or food carried by or otherwise accompanying an individual, the
consequences are:
(1) Inadequate prior notice--(i) No prior notice. If an article of
food arrives at the port of arrival and no prior notice has been
submitted and confirmed by FDA for review, the food is subject to
refusal of admission under section 801(m)(1) of the act (21 U.S.C.
381(m)(1)). If an article of food is refused for lack of prior notice,
unless U.S. Customs and Border Protection (CBP) concurrence is obtained
for export and the article is immediately exported from the port of
arrival under CBP supervision, it must be held within the port of entry
for the article unless directed by CBP or FDA.
(ii) Inaccurate prior notice. If prior notice has been submitted and
confirmed by FDA for review, but upon review of the notice or
examination of the article of food, the notice is determined to be
inaccurate, the food is subject to refusal of admission under section
801(m)(1) of the act. If the article of food is refused due to
inaccurate prior notice, unless CBP concurrence is obtained for export
and the article is immediately exported from the port of arrival under
CBP supervision, it must be held within the port of entry for the
article unless directed by CBP or FDA.
(iii) Untimely prior notice. If prior notice has been submitted and
confirmed by FDA for review, but the full time that applies under Sec.
1.279 for prior notice has not elapsed when the article of food arrives,
the food is subject to refusal of admission under section 801(m)(1) of
the act, unless FDA has already reviewed the prior notice, determined
its response to the prior notice, and advised CBP of that response. If
the article of food is refused due to untimely prior notice, unless CBP
concurrence is obtained for export and the article is immediately
exported from the port of arrival under CBP supervision, it must be held
within the port of entry for the article unless directed by CBP or FDA.
(2) Status and movement of refused food. (i) An article of food that
has been refused under section 801(m)(1) of the act and paragraph (a) of
this section shall be considered general order merchandise as described
in section 490 of the Tariff Act of 1930, as amended (19 U.S.C. 1490).
(ii) Refused food must be moved under appropriate custodial bond
unless immediately exported under CBP supervision. If the food is to be
held at the port, FDA must be notified of the location where the food is
held at that port before the food is moved there. If the food is to be
held at a secure facility outside the port, FDA must be notified of the
location of the secure facility before the food is moved there. The
refused food shall not be entered and shall not be delivered to any
importer, owner, or ultimate consignee. If the food is to be held at a
secure facility outside a port, the food must be taken directly to that
secure facility.
(3) Segregation of refused foods. If an article of food that is
refused is part of a shipment that contains articles of food that have
not been placed under hold or other merchandise not subject to this
subpart, the refused article of food may be segregated from the rest of
the shipment. This segregation must take place where the article is
held. FDA or CBP may supervise segregation. If FDA or CBP determines
that supervision is necessary, segregation must not take place without
supervision.
(4) Costs. Neither FDA nor CBP are liable for transportation,
storage, or other expenses resulting from refusal.
(5) Export after refusal. An article of food that has been refused
under paragraph (a) of this section may be exported with CBP concurrence
and under CBP supervision unless it is seized or administratively
detained by FDA or CBP under other authority. If an article of food that
has been refused admission under paragraph (a) of this section is
exported, the prior notice should be cancelled within 5-business days of
exportation.
(6) No post-refusal submission or request for review. If an article
of food is refused under section 801(m)(1) of the act
[[Page 49]]
and no prior notice is submitted or resubmitted, no request for FDA
review is submitted in accordance with paragraph (d) of this section, or
export has not occurred in accordance with paragraph (a)(5) of this
section, the article of food shall be dealt with as set forth in CBP
regulations relating to general order merchandise (19 CFR part 127),
except that, unless otherwise agreed to by CBP and FDA, the article may
only be sold for export or destroyed.
(b) Food carried by or otherwise accompanying an individual. If food
carried by or otherwise accompanying an individual arriving in the
United States is not for personal use and does not have adequate prior
notice or the individual cannot provide FDA or CBP with a copy of the
prior notice (PN) confirmation, the food is subject to refusal of
admission under section 801(m)(1) of the act. If before leaving the
port, the individual does not arrange to have the food held at the port
or exported, FDA or CBP may destroy the article of food.
(c) Post-Refusal prior notice submissions. (1) If an article of food
is refused under paragraph (a)(1)(i) of this section (no prior notice)
and the food is not exported, prior notice must be submitted in
accordance with Sec. Sec. 1.280 and 1.281(c).
(2) If an article of food is refused under paragraph (a)(1)(ii) of
this section (inaccurate prior notice) and the food is not exported, the
prior notice should be canceled in accordance with Sec. 1.282 and you
must resubmit prior notice in accordance with Sec. Sec. 1.280 and
1.281(c).
(3) Once the prior notice has been submitted or resubmitted and
confirmed by FDA for review, FDA will endeavor to review and respond to
the prior notice submission within the timeframes set out in Sec.
1.279.
(d) FDA review after refusal. (1) If an article of food has been
refused admission under section 801(m)(1) of the act, a request may be
submitted asking FDA to review whether the article is subject to the
requirements of this subpart under Sec. 1.277, or whether the
information submitted in a prior notice is complete and accurate. A
request for review may not be used to submit prior notice or to resubmit
an inaccurate prior notice.
(2) A request may be submitted only by the carrier, submitter,
importer, owner, or ultimate consignee. A request must identify which
one the requester is.
(3) A request must be submitted in writing to FDA and delivered by
fax or e-mail. The location for receipt of a request is listed at http:/
/www.fda.gov--see Prior Notice. A request must include all factual and
legal information necessary for FDA to conduct its review. Only one
request for review may be submitted for each refused article.
(4) The request must be submitted within 5-calendar days of the
refusal. FDA will review and respond within 5-calendar days of receiving
the request.
(5) If FDA determines that the article is not subject to the
requirements of this subpart under Sec. 1.277 or that the prior notice
submission is complete and accurate, it will notify the requester, the
transmitter, and CBP that the food is no longer subject to refusal under
section 801(m)(1) of the act.
(e) International mail. If an article of food arrives by
international mail with inadequate prior notice or the PN confirmation
number is not affixed as required, the parcel will be held by CBP for 72
hours for FDA inspection and disposition. If FDA refuses the article
under section 801(m)(1) of the act and there is a return address, the
parcel may be returned to sender marked ``No Prior Notice--FDA
Refused.'' If the article is refused and there is no return address or
FDA determines that the article of food in the parcel appears to present
a hazard, FDA may dispose of or destroy the parcel at its expense. If
FDA does not respond within 72 hours of the CBP hold, CBP may return the
parcel to the sender or, if there is no return address, destroy the
parcel, at FDA expense.
(f) Prohibitions on delivery and transfer. (1) Notwithstanding
section 801(b) of the act, an article of food refused under section
801(m)(1) of the act may not be delivered to the importer, owner, or
ultimate consignee until prior notice is submitted to FDA in accordance
with this subpart, FDA has examined the prior notice, FDA has determined
that the prior notice is adequate, and FDA has notified CBP and the
transmitter that the article of food
[[Page 50]]
is no longer refused admission under section 801(m)(1) of the act.
(2) During the time an article of food that has been refused under
section 801(m)(1) of the act is held, the article may not be transferred
by any person from the port or other designated secure facility until
prior notice is submitted to FDA in accordance with this subpart, FDA
has examined the prior notice, FDA has determined that the prior notice
is adequate, and FDA has notified CBP and the transmitter that the
article of food no longer is refused admission under section 801(m)(1)
of the act. After this notification by FDA to CBP and transmitter, entry
may be made in accordance with law and regulation.
(g) Relationship to other admissibility decisions. A determination
that an article of food is no longer refused under section 801(m)(1) of
the act is different than, and may come before, determinations of
admissibility under other provisions of the act or other U.S. laws. A
determination that an article of food is no longer refused under section
801(m)(1) of the act does not mean that it will be granted admission
under other provisions of the act or other U.S. laws.
Sec. 1.284 What are the other consequences of failing to submit adequate
prior notice or otherwise failing to comply with this subpart?
(a) The importing or offering for import into the United States of
an article of food in violation of the requirements of section 801(m) of
the act, including the requirements of this subpart, is a prohibited act
under section 301(ee) of the act (21 U.S.C. 331(ee)).
(b) Section 301 of the act prohibits the doing of certain acts or
causing such acts to be done.
(1) Under section 302 of the act (21 U.S.C. 332), the United States
can bring a civil action in Federal court to enjoin persons who commit a
prohibited act.
(2) Under sections 301 and 303 of the act (21 U.S.C. 331 and 333),
the United States can bring a criminal action in Federal court to
prosecute persons who are responsible for the commission of a prohibited
act.
(c) Under section 306 of the act (21 U.S.C. 335a), FDA can seek
debarment of any person who has been convicted of a felony relating to
importation of food into the United States or any person who has engaged
in a pattern of importing or offering for import adulterated food that
presents a threat of serious adverse health consequences or death to
humans or animals.
Sec. 1.285 What happens to food that is imported or offered for import
from unregistered facilities that are required to register under
subpart H of this part?
(a) Consequences. If an article of food from a foreign facility that
is not registered as required under section 415 of the act (21 U.S.C.
350d) and subpart H of this part is imported or offered for import into
the United States, the food is subject to being held under section
801(l) of the act (21 U.S.C. 381(l)).
(b) Hold. Unless CBP concurrence is obtained for export and the
article is immediately exported from the port of arrival, if an article
of food has been placed under hold under section 801(l) of the act, it
must be held within the port of entry for the article unless directed by
CBP or FDA.
(c) Status and movement of held food. (1) An article of food that
has been placed under hold under section 801(l) of the act shall be
considered general order merchandise as described in section 490 of the
Tariff Act of 1930, as amended (19 U.S.C. 1490).
(2) Food under hold under section 801(l) of the act must be moved
under appropriate custodial bond unless immediately exported under CBP
supervision. If the food is to be held at the port, FDA must be notified
of the location where the food is held at the port before the food is
moved there. If the food is to be held at a secure facility outside the
port, FDA must be notified of the location of the secure facility before
the food is moved there. The food subject to hold shall not be entered
and shall not be delivered to any importer, owner, or ultimate
consignee. If the food is to be held at a secure facility outside a
port, the food must be taken directly to that secure facility.
(d) Segregation of held foods. If an article of food that has been
placed under
[[Page 51]]
hold under section 801(l) of the act is part of a shipment that contains
articles that have not been placed under hold, the food under hold may
be segregated from the rest of the shipment. This segregation must take
place where the article is held. FDA or CBP may supervise segregation.
If FDA or CBP determine that supervision is necessary, segregation must
not take place without supervision.
(e) Costs. Neither FDA nor CBP will be liable for transportation,
storage, or other expenses resulting from any hold.
(f) Export after hold. An article of food that has been placed under
hold under section 801(l) of the act may be exported with CBP
concurrence and under CBP supervision unless it is seized or
administratively detained by FDA or CBP under other authority.
(g) No registration or request for review. If an article of food is
placed under hold under section 801(l) of the act and no registration
number or request for FDA review is submitted in accordance with
paragraph (j) of this section or export has not occurred in accordance
with paragraph (f) of this section, the food shall be dealt with as set
forth in CBP regulations relating to general order merchandise, except
that, unless otherwise agreed to by CBP and FDA, the article may only be
sold for export or destroyed.
(h) Food carried by or otherwise accompanying an individual. If an
article of food carried by or otherwise accompanying an individual
arriving in the United States is not for personal use and is placed
under hold under section 801(l) of the act because it is from a foreign
facility that is not registered as required under section 415 of the act
and subpart H of this part, the individual may arrange to have the food
held at the port or exported. If such arrangements cannot be made, the
article of food may be destroyed.
(i) Post-hold submissions. (1) To resolve a hold, if an article of
food is held under paragraph (b) of this section because it is from a
foreign facility that is not registered, the facility must be registered
and a registration number must be obtained.
(2) The FDA Division of Food Defense Targeting must be notified of
the applicable registration number in writing. The notification must
provide the name and contact information for the person submitting the
information. The notification may be delivered to FDA by fax or e-mail.
The contact information for these delivery methods is listed at http://
www.fda.gov--see Prior Notice. The notification should include the
applicable CBP entry identifier.
(3) If FDA determines that the article is no longer subject to hold,
it will notify the person who provided the registration information and
CBP that the food is no longer subject to hold under section 801(l) of
the act.
(j) FDA review after hold. (1) If an article of food has been placed
under hold under section 801(l) of the act, a request may be submitted
asking FDA to review whether the facility associated with the article is
subject to the requirements of section 415 of the act. A request for
review may not be submitted to obtain a registration number.
(2) A request may be submitted only by the carrier, submitter,
importer, owner, or ultimate consignee of the article. A request must
identify which one the requestor is.
(3) A request must be submitted in writing to FDA and delivered by
fax or e-mail. The location for receipt of a request is listed at http:/
/www.fda.gov--see Prior Notice. A request must include all factual and
legal information necessary for FDA to conduct its review. Only one
request for review may be submitted for each article under hold.
(4) The request must be submitted within 5-calendar days of the
hold. FDA will review and respond within 5-calendar days of receiving
the request.
(5) If FDA determines that the article is not from a facility
subject to the requirements of section 415 of the act, it will notify
the requestor and CBP that the food is no longer subject to hold under
section 801(l) of the act.
(k) International mail. If an article of food that arrives by
international mail is from a foreign facility that is not registered as
required under section 415 of the act and subpart H of this part, the
parcel will be held by CBP for 72 hours for FDA inspection and
disposition. If the article is placed under hold under section 801(l) of
the act and there
[[Page 52]]
is a return address, the parcel may be returned to sender marked ``No
Registration--No Admission Permitted.'' If the article is under hold and
there is no return address or FDA determines that the article of food in
the parcel appears to present a hazard, FDA may dispose of or destroy
the parcel at its expense. If FDA does not respond within 72 hours of
the CBP hold, CBP may return the parcel to the sender marked ``No
Registration--No Admission Permitted'' or, if there is no return
address, destroy the parcel, at FDA expense.
(l) Prohibitions on delivery and transfer. Notwithstanding section
801(b) of the act, while an article of food is under hold under section
801(l) of the act, it may not be delivered to the importer, owner, or
ultimate consignee. If an article of food is no longer subject to hold
under section 801(l) of the act, entry may be made in accordance with
law and regulation.
(m) Relationship to other admissibility provisions. A determination
that an article of food is no longer subject to hold under section
801(l) of the act is different than, and may come before, determinations
of admissibility under other provisions of the act or other U.S. laws. A
determination that an article of food is no longer under hold under
section 801(l) of the act does not mean that it will be granted
admission under other provisions of the act or other U.S. laws.
[73 FR 66402, Nov. 7, 2008, as amended at 82 FR 15629, Mar. 30, 2017]
Subpart J_Establishment, Maintenance, and Availability of Records
Source: 69 FR 71651, Dec. 9, 2004, unless otherwise noted.
General Provisions
Sec. 1.326 Who is subject to this subpart?
(a) Persons who manufacture, process, pack, transport, distribute,
receive, hold, or import food in the United States are subject to the
regulations in this subpart, unless you qualify for one of the
exclusions in Sec. 1.327. If you conduct more than one type of activity
at a location, you are required to keep records with respect to those
activities covered by this subpart, but are not required by this subpart
to keep records with respect to activities that fall within one of the
exclusions in Sec. 1.327.
(b) Persons subject to the regulations in this subpart must keep
records whether or not the food is being offered for or enters
interstate commerce.
Sec. 1.327 Who is excluded from all or part of the regulations in
this subpart?
(a) Farms are excluded from all of the requirements in this subpart.
(b) Restaurants are excluded from all of the requirements in this
subpart. A restaurant/retail facility is excluded from all of the
requirements in this subpart if its sales of food it prepares and sells
to consumers for immediate consumption are more than 90 percent of its
total food sales.
(c) Fishing vessels, including those that not only harvest and
transport fish but also engage in practices such as heading,
eviscerating, or freezing intended solely to prepare fish for holding on
board a harvest vessel, are excluded from all of the requirements in
this subpart, except Sec. Sec. 1.361 and 1.363. However, those fishing
vessels otherwise engaged in processing fish are subject to all of the
requirements in this subpart. For the purposes of this section,
``processing'' means handling, storing, preparing, shucking, changing
into different market forms, manufacturing, preserving, packing,
labeling, dockside unloading, holding or heading, eviscerating, or
freezing other than solely to prepare fish for holding on board a
harvest vessel.
(d) Persons who distribute food directly to consumers are excluded
from the requirements in Sec. 1.345 to establish and maintain records
to identify the nontransporter and transporter immediate subsequent
recipients as to those transactions. The term ``consumers'' does not
include businesses.
(e) Persons who operate retail food establishments that distribute
food to persons who are not consumers are subject to all of the
requirements in this subpart. However, the requirements in Sec. 1.345
to establish and maintain
[[Page 53]]
records to identify the nontransporter and transporter immediate
subsequent recipients that are not consumers applies as to those
transactions only to the extent the information is reasonably available.
(1) For purposes of this section, retail food establishment is
defined to mean an establishment that sells food products directly to
consumers as its primary function. The term ``consumers'' does not
include businesses.
(2) A retail food establishment may manufacture/process, pack, or
hold food if the establishment's primary function is to sell from that
establishment food, including food that it manufactures/processes,
packs, or holds, directly to consumers.
(3) A retail food establishment's primary function is to sell food
directly to consumers if the annual monetary value of sales of food
products directly to consumers exceeds the annual monetary value of
sales of food products to all other buyers.
(4) A ``retail food establishment'' includes grocery stores,
convenience stores, and vending machine locations.
(f) Retail food establishments that employ 10 or fewer full-time
equivalent employees are excluded from all of the requirements in this
subpart, except Sec. Sec. 1.361 and 1.363. The exclusion is based on
the number of full-time equivalent employees at each retail food
establishment and not the entire business, which may own numerous retail
stores.
(g) Persons who manufacture, process, pack, transport, distribute,
receive, hold, or import food in the United States that is within the
exclusive jurisdiction of the U.S. Department of Agriculture (USDA)
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.) are excluded from all
of the requirements in this subpart with respect to that food while it
is under the exclusive jurisdiction of USDA.
(h) Foreign persons, except for foreign persons who transport food
in the United States, are excluded from all of the requirements of this
subpart.
(i) Persons who manufacture, process, pack, transport, distribute,
receive, hold, or import food are subject to Sec. Sec. 1.361 and 1.363
with respect to its packaging (the outer packaging of food that bears
the label and does not contact the food). All other persons who
manufacture, process, pack, transport, distribute, receive, hold, or
import packaging are excluded from all of the requirements of this
subpart.
(j) Persons who manufacture, process, pack, transport, distribute,
receive, hold, or import food contact substances other than the finished
container that directly contacts food are excluded from all of the
requirements of this subpart, except Sec. Sec. 1.361 and 1.363.
(k) Persons who place food directly in contact with its finished
container are subject to all of the requirements of this subpart as to
the finished container that directly contacts that food. All other
persons who manufacture, process, pack, transport, distribute, receive,
hold, or import the finished container that directly contacts the food
are excluded from the requirements of this subpart as to the finished
container, except Sec. Sec. 1.361 and 1.363.
(l) Nonprofit food establishments are excluded from all of the
requirements in this subpart, except Sec. Sec. 1.361 and 1.363.
(m) Persons who manufacture, process, pack, transport, distribute,
receive, hold, or import food for personal consumption are excluded from
all of the requirements of this subpart.
(n) Persons who receive or hold food on behalf of specific
individual consumers and who are not also parties to the transaction and
who are not in the business of distributing food are excluded from all
of the requirements of this subpart.
Sec. 1.328 What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C. 321) apply to such terms when used
in this subpart. In addition, for the purposes of this subpart:
Farm means:
(1) Primary production farm. A primary production farm is an
operation under one management in one general (but not necessarily
contiguous) physical location devoted to the growing of
[[Page 54]]
crops, the harvesting of crops, the raising of animals (including
seafood), or any combination of these activities. The term ``farm''
includes operations that, in addition to these activities:
(i) Pack or hold raw agricultural commodities;
(ii) Pack or hold processed food, provided that all processed food
used in such activities is either consumed on that farm or another farm
under the same management, or is processed food identified in paragraph
(1)(iii)(B)(1) of this definition; and
(iii) Manufacture/process food, provided that:
(A) All food used in such activities is consumed on that farm or
another farm under the same management; or
(B) Any manufacturing/processing of food that is not consumed on
that farm or another farm under the same management consists only of:
(1) Drying/dehydrating raw agricultural commodities to create a
distinct commodity (such as drying/dehydrating grapes to produce
raisins), and packaging and labeling such commodities, without
additional manufacturing/processing (an example of additional
manufacturing/processing is slicing);
(2) Treatment to manipulate the ripening of raw agricultural
commodities (such as by treating produce with ethylene gas), and
packaging and labeling treated raw agricultural commodities, without
additional manufacturing/processing; and
(3) Packaging and labeling raw agricultural commodities, when these
activities do not involve additional manufacturing/processing (an
example of additional manufacturing/processing is irradiation); or
(2) Secondary activities farm. A secondary activities farm is an
operation, not located on a primary production farm, devoted to
harvesting (such as hulling or shelling), packing, and/or holding of raw
agricultural commodities, provided that the primary production farm(s)
that grows, harvests, and/or raises the majority of the raw agricultural
commodities harvested, packed, and/or held by the secondary activities
farm owns, or jointly owns, a majority interest in the secondary
activities farm. A secondary activities farm may also conduct those
additional activities allowed on a primary production farm as described
in paragraphs (1)(ii) and (iii) of this definition.
Food has the meaning given in section 201(f) of the Federal Food,
Drug, and Cosmetic Act. Examples of food include, but are not limited to
fruits; vegetables; fish; dairy products; eggs; raw agricultural
commodities for use as food or as components of food; animal feed,
including pet food; food and feed ingredients and additives, including
substances that migrate into food from the finished container and other
articles that contact food; dietary supplements and dietary ingredients;
infant formula; beverages, including alcoholic beverages and bottled
water; live food animals; bakery goods; snack foods; candy; and canned
foods.
Full-time equivalent employee means all individuals employed by the
person claiming the exemption. 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 person and of all of its
affiliates by the number of hours of work in 1 year, 2,080 hours (i.e.,
40 hours x 52 weeks).
Harvesting applies to farms and farm mixed-type facilities and means
activities that are traditionally performed on farms for the purpose of
removing raw agricultural commodities from the place they were grown or
raised and preparing them for use as food. Harvesting is limited to
activities performed on raw agricultural commodities, or on processed
foods created by drying/dehydrating a raw agricultural commodity without
additional manufacturing/processing, on a farm. Harvesting does not
include activities that transform a raw agricultural commodity into a
processed food as defined in section 201(gg) of the Federal Food, Drug,
and Cosmetic Act. Examples of harvesting include cutting (or otherwise
separating) the edible portion of the raw agricultural commodity from
the crop plant and removing or trimming part of the raw agricultural
commodity (e.g., foliage, husks, roots, or stems). Examples of
harvesting also include cooling, field coring, filtering, gathering,
hulling, shelling, sifting, threshing, trimming of outer leaves of,
[[Page 55]]
and washing raw agricultural commodities grown on a farm.
Holding means storage of food and also includes activities performed
incidental to storage of a food (e.g., activities performed for the safe
or effective storage of that food, such as fumigating food during
storage, and drying/dehydrating raw agricultural commodities when the
drying/dehydrating does not create a distinct commodity (such as drying/
dehydrating hay or alfalfa)). Holding also includes activities performed
as a practical necessity for the distribution of that food (such as
blending of the same raw agricultural commodity and breaking down
pallets), but does not include activities that transform a raw
agricultural commodity into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities
could include warehouses, cold storage facilities, storage silos, grain
elevators, and liquid storage tanks.
Manufacturing/processing means making food from one or more
ingredients, or synthesizing, preparing, treating, modifying or
manipulating food, including food crops or ingredients. Examples of
manufacturing/processing activities include: Baking, boiling, bottling,
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw
agricultural commodities to create a distinct commodity (such as drying/
dehydrating grapes to produce raisins), evaporating, eviscerating,
extracting juice, formulating, freezing, grinding, homogenizing,
irradiating, labeling, milling, mixing, packaging (including modified
atmosphere packaging), pasteurizing, peeling, rendering, treating to
manipulate ripening, trimming, washing, or waxing. For farms and farm
mixed-type facilities, manufacturing/processing does not include
activities that are part of harvesting, packing, or holding.
Mixed-type facility means an establishment that engages in both
activities that are exempt from registration under section 415 of the
Federal Food, Drug, and Cosmetic Act and activities that require the
establishment to be registered. An example of such a facility is a
``farm mixed-type facility,'' which is an establishment that is a farm,
but also conducts activities outside the farm definition that require
the establishment to be registered.
Nonprofit food establishment means a charitable entity that prepares
or serves food directly to the consumer or otherwise provides food or
meals for consumption by humans or animals in the United States. The
term includes central food banks, soup kitchens, and nonprofit food
delivery services. To be considered a nonprofit food establishment, the
establishment must meet the terms of section 501(c)(3) of the U.S.
Internal Revenue Code (26 U.S.C. 501(c)(3)).
Nontransporter means a person who owns food or who holds,
manufactures, processes, packs, imports, receives, or distributes food
for purposes other than transportation.
Nontransporter immediate previous source means a person that last
had food before transferring it to another nontransporter.
Nontransporter immediate subsequent recipient means a nontransporter
that acquires food from another nontransporter.
Packaging (when used as a noun) means the outer packaging of food
that bears the label and does not contact the food. Packaging does not
include food contact substances as they are defined in section 409(h)(6)
of the Federal Food, Drug, and Cosmetic Act.
Packaging (when used as a verb) means placing food into a container
that directly contacts the food and that the consumer receives.
Packing means placing food into a container other than packaging the
food and also includes re-packing and activities performed incidental to
packing or re-packing a food (e.g., activities performed for the safe or
effective packing or re-packing of that food (such as sorting, culling,
grading, and weighing or conveying incidental to packing or re-
packing)), but does not include activities that transform a raw
agricultural commodity, as defined in section 201(r) of the Federal
Food, Drug, and Cosmetic Act, into a processed food as defined in
section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
Person includes individual, partnership, corporation, and
association.
[[Page 56]]
Recipe means the formula, including ingredients, quantities, and
instructions, necessary to manufacture a food product. Because a recipe
must have all three elements, a list of the ingredients used to
manufacture a product without quantity information and manufacturing
instructions is not a recipe.
Restaurant means a facility that prepares and sells food directly to
consumers for immediate consumption. ``Restaurant'' does not include
facilities that provide food to interstate conveyances, central
kitchens, and other similar facilities that do not prepare and serve
food directly to consumers.
(1) Facilities in which food is directly provided to humans, such as
cafeterias, lunchrooms, cafes, bistros, fast food establishments, food
stands, saloons, taverns, bars, lounges, catering facilities, hospital
kitchens, day care kitchens, and nursing home kitchens, are restaurants.
(2) Pet shelters, kennels, and veterinary facilities in which food
is directly provided to animals are restaurants.
Transporter means a person who has possession, custody, or control
of an article of food in the United States for the sole purpose of
transporting the food, whether by road, rail, water, or air. Transporter
also includes a foreign person that transports food in the United
States, regardless of whether that foreign person has possession,
custody, or control of that food for the sole purpose of transporting
that food.
Transporter's immediate previous source means a person from whom a
transporter received food. This source can be either another transporter
or a nontransporter.
Transporter's immediate subsequent recipient means a person to whom
a transporter delivered food. This recipient can be either another
transporter or a nontransporter.
You means a person subject to this subpart under Sec. 1.326.
[69 FR 71651, Dec. 9, 2004, as amended at 80 FR 56143, Sept. 17, 2015;
81 FR 3715, Jan. 22, 2016]
Sec. 1.329 Do other statutory provisions and regulations apply?
(a) In addition to the regulations in this subpart, you must comply
with all other applicable statutory provisions and regulations related
to the establishment and maintenance of records for foods except as
described in paragraph (b) of this section. For example, the regulations
in this subpart are in addition to existing recordkeeping regulations
for low acid canned foods, juice, seafood, infant formula, color
additives, bottled water, animal feed, and medicated animal feed.
(b) Records established or maintained to satisfy the requirements of
this subpart that meet the definition of electronic records in Sec.
11.3(b)(6) (21 CFR 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 are also required under other
applicable statutory provisions or regulations remain subject to part 11
of this chapter.
Sec. 1.330 Can existing records satisfy the requirements of this
subpart?
The regulations in this subpart do not require duplication of
existing records if those records contain all of the information
required by this subpart. If a covered person keeps records of all of
the information as required by this subpart to comply with other
Federal, State, or local regulations, or for any other reason, then
those records may be used to meet these requirements. Moreover, persons
do not have to keep all of the information required by this rule in one
set of records. If they have records containing some of the required
information, they may keep those existing records and keep, either
separately or in a combined form, any new information required by this
rule. There is no obligation to create an entirely new record or
compilation of records containing both existing and new information,
even if the records containing some of the required information were not
created at the time the food was received or released.
[[Page 57]]
Requirements for Nontransporters To Establish and Maintain Records To
Identify the Nontransporter and Transporter Immediate Previous Sources
of Food
Sec. 1.337 What information must nontransporters establish and maintain
to identify the nontransporter and transporter immediate previous sources
of food?
(a) If you are a nontransporter, you must establish and maintain the
following records for all food you receive:
(1) The name of the firm, address, telephone number and, if
available, the fax number and e-mail address of the nontransporter
immediate previous source, whether domestic or foreign;
(2) An adequate description of the type of food received, to include
brand name and specific variety (e.g., brand x cheddar cheese, not just
cheese; or romaine lettuce, not just lettuce);
(3) The date you received the food;
(4) For persons who manufacture, process, or pack food, the lot or
code number or other identifier of the food (to the extent this
information exists);
(5) The quantity and how the food is packaged (e.g., 6 count
bunches, 25 pound (lb) carton, 12 ounce (oz) bottle, 100 gallon (gal)
tank); and
(6) The name of the firm, address, telephone number, and, if
available, the fax number and e-mail address of the transporter
immediate previous source (the transporter who transported the food to
you).
Requirements for Nontransporters To Establish and Maintain Records To
Identify the Nontransporter and Transporter Immediate Subsequent
Recipients of Food
Sec. 1.345 What information must nontransporters establish and maintain
to identify the nontransporter and transporter immediate subsequent
recipients of food?
(a) If you are a nontransporter, you must establish and maintain the
following records for food you release:
(1) The name of the firm, address, telephone number, and, if
available, the fax number and e-mail address of the nontransporter
immediate subsequent recipient, whether domestic or foreign;
(2) An adequate description of the type of food released, to include
brand name and specific variety (e.g., brand x cheddar cheese, not just
cheese; or romaine lettuce, not just lettuce);
(3) The date you released the food;
(4) For persons who manufacture, process, or pack food, the lot or
code number or other identifier of the food (to the extent this
information exists);
(5) The quantity and how the food is packaged (e.g., 6 count
bunches, 25 lb carton, 12 oz bottle, 100 gal tank);
(6) The name of the firm, address, telephone number, and, if
available, the fax number and e-mail address of the transporter
immediate subsequent recipient (the transporter who transported the food
from you); and
(b) Your records must include information reasonably available to
you to identify the specific source of each ingredient used to make
every lot of finished product.
Requirements for Transporters To Establish and Maintain Records
Sec. 1.352 What information must transporters establish and maintain?
If you are a transporter, you must establish and maintain the
following records for each food you transport in the United States. You
may fulfill this requirement by either:
(a) Establishing and maintaining the following records:
(1) Names of the transporter's immediate previous source and
transporter's immediate subsequent recipient;
(2) Origin and destination points;
(3) Date shipment received and date released;
(4) Number of packages;
(5) Description of freight;
(6) Route of movement during the time you transported the food; and
(7) Transfer point(s) through which shipment moved; or
(b) Establishing and maintaining records containing the following
information currently required by the Department of Transportation's
Federal Motor Carrier Safety Administration (of roadway interstate
transporters (49 CFR 373.101 and 373.103) as of December 9, 2004:
(1) Names of consignor and consignee;
(2) Origin and destination points;
(3) Date of shipment;
[[Page 58]]
(4) Number of packages;
(5) Description of freight;
(6) Route of movement and name of each carrier participating in the
transportation; and
(7) Transfer points through which shipment moved; or
(c) Establishing and maintaining records containing the following
information currently required by the Department of Transportation's
Surface Transportation Board of rail and water interstate transporters
(49 CFR 1035.1 and 1035.2) as of December 9, 2004:
(1) Date received;
(2) Received from;
(3) Consigned to;
(4) Destination;
(5) State of;
(6) County of;
(7) Route;
(8) Delivering carrier;
(9) Car initial;
(10) Car no;
(11) Trailer initials/number;
(12) Container initials/number;
(13) No. packages; and
(14) Description of articles; or
(d) Establishing and maintaining records containing the following
information currently required by the Warsaw Convention of international
air transporters on air waybills:
(1) Shipper's name and address;
(2) Consignee's name and address;
(3) Customs reference/status;
(4) Airport of departure and destination;
(5) First carrier; and
(6) Description of goods; or
(e) Entering into an agreement with the nontransporter immediate
previous source located in the United States and/or the nontransporter
immediate subsequent recipient located in the United States to
establish, maintain, or establish and maintain, the information in Sec.
1.352(a), (b), (c), or (d). The agreement must contain the following
elements:
(1) Effective date;
(2) Printed names and signatures of authorized officials;
(3) Description of the records to be established and/or maintained;
(4) Provision for the records to be maintained in compliance with
Sec. 1.360, if the agreement provides for maintenance of records;
(5) Provision for the records to be available to FDA as required by
Sec. 1.361, if the agreement provides for maintenance of records;
(6) Acknowledgement that the nontransporter assumes legal
responsibility under Sec. 1.363 for establishing and/or maintaining the
records as required by this subpart; and
(7) Provision that if the agreement is terminated in writing by
either party, responsibility for compliance with the applicable
establishment, maintenance, and access provisions of this subpart
reverts to the transporter as of the date of termination.
General Requirements
Sec. 1.360 What are the record retention requirements?
(a) You must create the required records when you receive and
release food, except to the extent that the information is contained in
existing records.
(b) If you are a nontransporter, you must retain for 6 months after
the dates you receive and release the food all required records for any
food having a significant risk of spoilage, loss of value, or loss of
palatability within 60 days after the date you receive or release the
food.
(c) If you are a nontransporter, you must retain for 1 year after
the dates you receive and release the food all required records for any
food for which a significant risk of spoilage, loss of value, or loss of
palatability occurs only after a minimum of 60 days, but within 6
months, after the date you receive or release the food.
(d) If you are a nontransporter, you must retain for 2 years after
the dates you receive and release the food all required records for any
food for which a significant risk of spoilage, loss of value, or loss of
palatability does not occur sooner than 6 months after the date you
receive or release the food, including foods preserved by freezing,
dehydrating, or being placed in a hermetically sealed container.
(e) If you are a nontransporter, you must retain for 1 year after
the dates you receive and release the food all required records for
animal food, including pet food.
[[Page 59]]
(f) If you are a transporter or nontransporter retaining records on
behalf of a transporter, you must retain for 6 months after the dates
you receive and release the food all required records for any food
having a significant risk of spoilage, loss of value, or loss of
palatability within 60 days after the date the transporter receives or
releases the food. If you are a transporter, or nontransporter retaining
records on behalf of a transporter, you must retain for 1 year after the
dates you receive and release the food, all required records for any
food for which a significant risk of spoilage, loss of value, or loss of
palatability occurs only after a minimum of 60 days after the date the
transporter receives or releases the food.
(g) You must retain all records at the establishment where the
covered activities described in the records occurred (onsite) or at a
reasonably accessible location.
(h) The maintenance of electronic records is acceptable. Electronic
records are considered to be onsite if they are accessible from an
onsite location.
Sec. 1.361 What are the record availability requirements?
When FDA has a reasonable belief that an article of food, and any
other article of food that FDA reasonably believes is likely to be
affected in a similar manner, is adulterated and presents a threat of
serious adverse health consequences or death to humans or animals, or
when FDA believes that there is a reasonable probability that the use of
or exposure to an article of food, and any other article of food that
FDA reasonably believes is likely to be affected in a similar manner,
will cause serious adverse health consequences or death to humans or
animals, any records and other information accessible to FDA under
section 414 or 704(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 350c and 374(a)) must be made readily available for inspection
and photocopying or other means of reproduction. Such records and other
information must be made available as soon as possible, not to exceed 24
hours from the time of receipt of the official request, from an officer
or employee duly designated by the Secretary of Health and Human
Services who presents appropriate credentials and a written notice.
[77 FR 10662, Feb. 23, 2012]
Sec. 1.362 What records are excluded from this subpart?
The establishment and maintenance of records as required by this
subpart does not extend to recipes for food as defined in Sec. 1.328;
financial data, pricing data, personnel data, research data, or sales
data (other than shipment data regarding sales).
Sec. 1.363 What are the consequences of failing to establish or maintain
records or make them available to FDA as required by this subpart?
(a) The failure to establish or maintain records as required by
section 414(b) of the Federal Food, Drug, and Cosmetic Act and this
regulation or the refusal to permit access to or verification or copying
of any such required record is a prohibited act under section 301 of the
Federal Food, Drug, and Cosmetic Act.
(b) The failure of a nontransporter immediate previous source or a
nontransporter immediate subsequent recipient who enters an agreement
under Sec. 1.352(e) to establish, maintain, or establish and maintain,
records required under Sec. 1.352(a), (b), (c), or (d), or the refusal
to permit access to or verification or copying of any such required
record, is a prohibited act under section 301 of the Federal Food, Drug,
and Cosmetic Act.
(c) The failure of any person to make records or other information
available to FDA as required by section 414 or 704(a) of the Federal
Food, Drug, and Cosmetic Act and this regulation is a prohibited act
under section 301 of the Federal Food, Drug, and Cosmetic Act.
[80 FR 56144, Sept. 17, 2015
Compliance Dates
Sec. 1.368 What are the compliance dates for this subpart?
The compliance date for the requirements in this subpart is December
9, 2005. However, the compliance dates for small and very small
businesses are contained in paragraphs (a) and (b) of this section. The
size of the business is
[[Page 60]]
determined using the total number of full-time equivalent employees in
the entire business, not each individual location or establishment. A
full-time employee counts as one full-time equivalent employee. Two
part-time employees, each working half time, count as one full-time
equivalent employee.
(a) The compliance date for the requirements in this subpart is June
9, 2006, for small businesses employing fewer that 500, but more than 10
full-time equivalent employees.
(b) The compliance date for the requirements in this subpart is
December 11, 2006, for very small businesses that employ 10 or fewer
full-time equivalent employees.
[69 FR 71651, Dec. 9, 2004, as amended at 70 FR 8727, Feb. 23, 2005]
Subpart K_Administrative Detention of Food for Human or Animal
Consumption
Source: 69 FR 31701, June 4, 2004, unless otherwise noted.
General Provisions
Sec. 1.377 What definitions apply to this subpart?
The definitions of terms that appear in section 201 of the act (21
U.S.C. 321) apply when the terms are used in this subpart. In addition,
for the purposes of this subpart:
Act means the Federal Food, Drug, and Cosmetic Act.
Authorized FDA representative means an FDA Division Director in
whose division the article of food involved is located or an FDA
official senior to such director.
Calendar day means every day shown on the calendar.
Food has the meaning given in section 201(f) of the act (21 U.S.C.
321(f)). Examples of food include, but are not limited to, fruits,
vegetables, fish, dairy products, eggs, raw agricultural commodities for
use as food or components of food, animal feed, including pet food, food
and feed ingredients and additives, including substances that migrate
into food from food packaging and other articles that contact food,
dietary supplements and dietary ingredients, infant formula, beverages,
including alcoholic beverages and bottled water, live food animals,
bakery goods, snack foods, candy, and canned foods.
Perishable food means food that is not heat-treated; not frozen; and
not otherwise preserved in a manner so as to prevent the quality of the
food from being adversely affected if held longer than 7 calendar days
under normal shipping and storage conditions.
We means the U.S. Food and Drug Administration (FDA).
Working day means any day from Monday through Friday, excluding
Federal holidays.
You means any person who received the detention order or that
person's representative.
[69 FR 31701, June 4, 2004, as amended at 85 FR 16550, Mar. 24, 2020]
Sec. 1.378 What criteria does FDA use to order a detention?
An officer or qualified employee of FDA may order the detention of
any article of food that is found during an inspection, examination, or
investigation under the act if the officer or qualified employee has
reason to believe that the article of food is adulterated or misbranded.
[76 FR 25541, May 5, 2011]
Sec. 1.379 How long may FDA detain an article of food?
(a) FDA may detain an article of food for a reasonable period that
may not exceed 20 calendar days after the detention order is issued.
However, an article may be detained for 10 additional calendar days if a
greater period of time is required to institute a seizure or injunction
action. The authorized FDA representative may approve the additional 10-
calendar day detention period at the time the detention order is issued,
or at any time within the 20-calendar day period by amending the
detention order.
(b) The entire detention period may not exceed 30 calendar days.
(c) An authorized FDA representative may, in accordance with Sec.
1.384, terminate a detention order before the expiration of the
detention period.
[[Page 61]]
Sec. 1.380 Where and under what conditions must the detained article
of food be held?
(a) You must hold the detained article of food in the location and
under the conditions specified by FDA in the detention order.
(b) If FDA determines that removal to a secure facility is
appropriate, the article of food must be removed to a secure facility. A
detained article of food remains under detention before, during, and
after movement to a secure facility. FDA will also state in the
detention order any conditions of transportation applicable to the
detained article.
(c) If FDA directs you to move the detained article of food to a
secure facility, you must receive a modification of the detention order
under Sec. 1.381(c) before you move the detained article of food to a
secure facility.
(d) You must ensure that any required tags or labels under Sec.
1.382 accompany the detained article during and after movement. The tags
or labels must remain with the article of food until FDA terminates the
detention order or the detention period expires, whichever occurs first,
unless otherwise permitted by the authorized FDA representative.
(e) The movement of an article of food in violation of a detention
order issued under Sec. 1.393 is a prohibited act under section 301 of
the act (21 U.S.C. 331).
Sec. 1.381 May a detained article of food be delivered to another entity
or transferred to another location?
(a) An article of food subject to a detention order under this
subpart may not be delivered under the execution of a bond.
Notwithstanding section 801(b) of the act (21 U.S.C. 381(b)), while any
article of food is subject to a detention order under section 304(h) of
the act (21 U.S.C. 334(h)), it may not be delivered to any of its
importers, owners, or consignees. This section does not preclude
movement at FDA's direction of imported food to a secure facility under
an appropriate Customs' bond when that bond is required by Customs' law
and regulation.
(b) Except as provided in paragraph (c) of this section, no person
may transfer a detained article of food within or from the place where
it has been ordered detained, or from the place to which it was removed,
until an authorized FDA representative releases the article of food
under Sec. 1.384 or the detention period expires under Sec. 1.379,
whichever occurs first.
(c) The authorized FDA representative may approve, in writing, a
request to modify a detention order to permit movement of a detained
article of food for any of the following purposes:
(1) To destroy the article of food,
(2) To move the detained article of food to a secure facility under
the terms of a detention order,
(3) To maintain or preserve the integrity or quality of the article
of food, or
(4) For any other purpose that the authorized FDA representative
believes is appropriate in the case.
(d) You must submit your request for modification of the detention
order in writing to the authorized FDA representative who approved the
detention order. You must state in your request the reasons for
movement; the exact address of and location in the new facility (or the
new location within the same facility) where the detained article of
food will be transferred; an explanation of how the new address and
location will be secure, if FDA has directed that the article be
detained in a secure facility; and how the article will be held under
any applicable conditions described in the detention order. If you are
requesting modification of a detention order for the purpose of
destroying the detained article of food, you also must submit a verified
statement identifying the ownership or proprietary interest you have in
the detained article of food, in accordance with Supplemental Rule C to
the ``Federal Rules of Civil Procedure.''
(e) If FDA approves a request for modification of a detention order,
the article may be transferred but remains under detention before,
during, and after the transfer. FDA will state any conditions of
transportation applicable to the detained article. You may not transfer
a detained article of food without FDA supervision unless FDA has
declined in writing to supervise the transfer. If FDA has declined in
writing to supervise the transfer of a detained
[[Page 62]]
article, you must immediately notify in writing the authorized FDA
representative who approved the modification of the detention order that
the article of food has reached its new location, and the specific
location of the detained article within the new location. Such written
notification may be in the form of a fax, e-mail, or other form as
agreed to by the authorized FDA representative.
(f) You must ensure that any required tags or labels under Sec.
1.382 accompany the detained article during and after movement. The tags
or labels must remain with the article of food until FDA terminates the
detention order or the detention period expires, whichever occurs first,
unless otherwise permitted by the authorized FDA representative who
approves the modification of a detention order under this section.
(g) The transfer of an article of food in violation of a detention
order issued under Sec. 1.393 is a prohibited act under section 301 of
the act.
Sec. 1.382 What labeling or marking requirements apply to a detained
article of food?
The officer or qualified employee of FDA issuing a detention order
under Sec. 1.393 may label or mark the detained article of food with
official FDA tags or labels that include the following information:
(a) A statement that the article of food is detained by FDA in
accordance with section 304(h) of the act;
(b) A statement that the article of food must not be consumed,
moved, altered, or tampered with in any manner for the period shown,
without the written permission of an authorized FDA representative;
(c) A statement that the violation of a detention order or the
removal or alteration of the tag or label is a prohibited act,
punishable by fine or imprisonment or both; and
(d) The detention order number, the date and hour of the detention
order, the detention period, and the name of the officer or qualified
employee of FDA who issued the detention order.
Sec. 1.383 What expedited procedures apply when FDA initiates a seizure
action against a detained perishable food?
If FDA initiates a seizure action under section 304(a) of the act
against a perishable food subject to a detention order under this
subpart, FDA will send the seizure recommendation to the Department of
Justice (DOJ) within 4 calendar days after the detention order is
issued, unless extenuating circumstances exist. If the fourth calendar
day is not a working day, FDA will advise the DOJ of its plans to
recommend a seizure action on the last working day before the fourth
calendar day and send the recommendation as soon as practicable on the
first working day that follows. For purposes of this section, an
extenuating circumstance includes, but is not limited to, instances when
the results of confirmatory testing or other evidentiary development
requires more than 4 calendar days to complete.
Sec. 1.384 When does a detention order terminate?
If FDA terminates a detention order or the detention period expires,
an authorized FDA representative will issue a detention termination
notice releasing the article of food to any person who received the
detention order or that person's representative and will remove, or
authorize in writing the removal of, the required labels or tags. If FDA
fails to issue a detention termination notice and the detention period
expires, the detention is deemed to be terminated.
How Does FDA Order a Detention?
Sec. 1.391 Who approves a detention order?
An authorized FDA representative must approve a detention order. If
prior written approval is not feasible, prior oral approval must be
obtained and confirmed in writing as soon as possible.
[69 FR 31701, June 4, 2004, as amended at 85 FR 16550, Mar. 24, 2020]
[[Page 63]]
Sec. 1.392 Who receives a copy of the detention order?
(a) FDA must issue the detention order to the owner, operator, or
agent in charge of the place where the article of food is located. If
the owner of the article of food is different from the owner, operator,
or agent in charge of the place where the article is detained, FDA must
provide a copy of the detention order to the owner of the article of
food if the owner's identity can be determined readily.
(b) If FDA issues a detention order for an article of food located
in a vehicle or other carrier used to transport the detained article of
food, FDA also must provide a copy of the detention order to the shipper
of record and the owner and operator of the vehicle or other carrier, if
their identities can be determined readily.
Sec. 1.393 What information must FDA include in the detention order?
(a) FDA must issue the detention order in writing, in the form of a
detention notice, signed and dated by the officer or qualified employee
of FDA who has reason to believe that such article of food is
adulterated or misbranded.
(b) The detention order must include the following information:
(1) The detention order number;
(2) The date and hour of the detention order;
(3) Identification of the detained article of food;
(4) The period of the detention;
(5) A statement that the article of food identified in the order is
detained for the period shown;
(6) A brief, general statement of the reasons for the detention;
(7) The address and location where the article of food is to be
detained and the appropriate storage conditions;
(8) Any applicable conditions of transportation of the detained
article of food;
(9) A statement that the article of food is not to be consumed,
moved, altered, or tampered with in any manner during the detention
period, unless the detention order is first modified under Sec.
1.381(c);
(10) The text of section 304(h) of the act and Sec. Sec. 1.401 and
1.402;
(11) A statement that any informal hearing on an appeal of a
detention order must be conducted as a regulatory hearing under part 16
of this chapter, with certain exceptions described in Sec. 1.403;
(12) The mailing address, telephone number, email address, fax
number, and the name of the FDA Division Director in whose division the
detained article of food is located;
(13) A statement indicating the manner in which approval of the
detention order was obtained, i.e., verbally or in writing; and
(14) The name and the title of the authorized FDA representative who
approved the detention order.
[69 FR 31701, June 4, 2004, as amended at 76 FR 25541, May 5, 2011; 85
FR 16550, Mar. 24, 2020]
What Is the Appeal Process for a Detention Order?
Sec. 1.401 Who is entitled to appeal?
Any person who would be entitled to be a claimant for the article of
food, if seized under section 304(a) of the act, may appeal a detention
order as specified in Sec. 1.402. Procedures for establishing
entitlement to be a claimant for purposes of section 304(a) of the act
are governed by Supplemental Rule C to the ``Federal Rules of Civil
Procedure.''
Sec. 1.402 What are the requirements for submitting an appeal?
(a) If you want to appeal a detention order, you must submit your
appeal in writing to the FDA Division Director in whose division the
detained article of food is located, at the mailing address, email
address, or fax number identified in the detention order according to
the following applicable timeframes:
(1) Perishable food: If the detained article is a perishable food,
as defined in Sec. 1.377, you must file an appeal within 2 calendar
days of receipt of the detention order.
(2) Nonperishable food: If the detained article is not a perishable
food, as defined in Sec. 1.377, you must file a notice of an intent to
request a hearing within 4 calendar days of receipt of the detention
order. If the notice of intent is not
[[Page 64]]
filed within 4 calendar days, you will not be granted a hearing. If you
have not filed a timely notice of intent to request a hearing, you may
file an appeal without a hearing request. Whether or not it includes a
request for hearing, your appeal must be filed within 10 calendar days
of receipt of the detention order.
(b) Your request for appeal must include a verified statement
identifying your ownership or proprietary interest in the detained
article of food, in accordance with Supplemental Rule C to the ``Federal
Rules of Civil Procedure.''
(c) The process for the appeal of a detention order under this
section terminates if FDA institutes either a seizure action under
section 304(a) of the act or an injunction under section 302 of the act
(21 U.S.C. 276) regarding the article of food involved in the detention
order.
(d) As part of the appeals process, you may request an informal
hearing. Your request for a hearing must be in writing and must be
included in your request for an appeal specified in paragraph (a) of
this section. If you request an informal hearing, and FDA grants your
request, the hearing will be held within 2 calendar days after the date
the appeal is filed.
[69 FR 31701, June 4, 2004, as amended at 85 FR 16550, Mar. 24, 2020]
Sec. 1.403 What requirements apply to an informal hearing?
If FDA grants a request for an informal hearing on an appeal of a
detention order, FDA must conduct the hearing in accordance with part 16
of this chapter, except that:
(a) The detention order under Sec. 1.393, rather than the notice
under Sec. 16.22(a) of this chapter, provides notice of opportunity for
a hearing under this section and is part of the administrative record of
the regulatory hearing under Sec. 16.80(a) of this chapter;
(b) A request for a hearing under this section must be addressed to
the FDA Division Director in whose division the article of food involved
is located;
(c) The provision in Sec. 16.22(b) of this chapter, providing that
a person not be given less than 3 working days after receipt of notice
to request a hearing, does not apply to a hearing under this subpart;
(d) The provision in Sec. 16.24(e) of this chapter, stating that a
hearing may not be required to be held at a time less than 2 working
days after receipt of the request for a hearing, does not apply to a
hearing under this subpart;
(e) Section 1.406, rather than Sec. 16.24(f) of this chapter,
describes the statement that will be provided to an appellant where a
detention order is based on classified information;
(f) Section 1.404, rather than Sec. 16.42(a) of this chapter,
describes the FDA employees who preside at hearings under this subpart;
(g) The presiding officer may require that a hearing conducted under
this section be completed within 1 calendar day, as appropriate;
(h) Section 16.60(e) and (f) of this chapter does not apply to a
hearing under this subpart. The presiding officer must prepare a written
report of the hearing. All written material presented at the hearing
will be attached to the report. The presiding officer must include as
part of the report of the hearing a finding on the credibility of
witnesses (other than expert witnesses) whenever credibility is a
material issue, and must include a proposed decision, with a statement
of reasons. The hearing participant may review and comment on the
presiding officer's report within 4 hours of issuance of the report. The
presiding officer will then issue the final agency decision.
(i) Section 16.80(a)(4) of this chapter does not apply to a
regulatory hearing under this subpart. The presiding officer's report of
the hearing and any comments on the report by the hearing participant
under Sec. 1.403(h) are part of the administrative record.
(j) No party shall have the right, under Sec. 16.119 of this
chapter to petition the Commissioner of Food and Drugs for
reconsideration or a stay of the presiding officer's final agency
decision.
(k) If FDA grants a request for an informal hearing on an appeal of
a detention order, the hearing must be conducted as a regulatory hearing
pursuant to regulation in accordance with part 16 of this chapter,
except that Sec. 16.95(b) does not apply to a hearing under this
subpart. With respect to a regulatory hearing under this subpart,
[[Page 65]]
the administrative record of the hearing specified in Sec. Sec.
16.80(a)(1), (a)(2), (a)(3), and (a)(5), and 1.403(i) constitutes the
exclusive record for the presiding officer's final decision on an
administrative detention. For purposes of judicial review under Sec.
10.45 of this chapter, the record of the administrative proceeding
consists of the record of the hearing and the presiding officer's final
decision.
[69 FR 31701, June 4, 2004, as amended at 82 FR 14144, Mar. 17, 2017; 85
FR 16550, Mar. 24, 2020]
Sec. 1.404 Who serves as the presiding officer for an appeal and for
an informal hearing?
The presiding officer for an appeal, and for an informal hearing,
must be an Office of Regulatory Affairs Program Director or another FDA
official senior to an FDA Division Director.
[85 FR 16550, Mar. 24, 2020]
Sec. 1.405 When does FDA have to issue a decision on an appeal?
(a) The presiding officer must issue a written report that includes
a proposed decision confirming or revoking the detention by noon on the
fifth calendar day after the appeal is filed; after your 4 hour
opportunity for submitting comments under Sec. 1.403(h), the presiding
officer must issue a final decision within the 5-calendar day period
after the appeal is filed. If FDA either fails to provide you with an
opportunity to request an informal hearing, or fails to confirm or
terminate the detention order within the 5-calendar day period, the
detention order is deemed terminated.
(b) If you appeal the detention order, but do not request an
informal hearing, the presiding officer must issue a decision on the
appeal confirming or revoking the detention within 5 calendar days after
the date the appeal is filed. If the presiding officer fails to confirm
or terminate the detention order during such 5-calendar day period, the
detention order is deemed terminated.
(c) If you appeal the detention order and request an informal
hearing and your hearing request is denied, the presiding officer must
issue a decision on the appeal confirming or revoking the detention
within 5 calendar days after the date the appeal is filed. If the
presiding officer fails to confirm or terminate the detention order
during such 5-calendar day period, the detention order is deemed
terminated.
(d) If the presiding officer confirms a detention order, the article
of food continues to be detained until we terminate the detention under
Sec. 1.384 or the detention period expires under Sec. 1.379, whichever
occurs first.
(e) If the presiding officer terminates a detention order, or the
detention period expires, FDA must terminate the detention order as
specified under Sec. 1.384.
(f) Confirmation of a detention order by the presiding officer is
considered a final agency action for purposes of 5 U.S.C. 702.
Sec. 1.406 How will FDA handle classified information in an informal
hearing?
Where the credible evidence or information supporting the detention
order is classified under the applicable Executive order as requiring
protection from unauthorized disclosure in the interest of national
security (``classified information''), FDA will not provide you with
this information. The presiding officer will give you notice of the
general nature of the information and an opportunity to offer opposing
evidence or information, if he or she may do so consistently with
safeguarding the information and its source. If classified information
was used to support the detention, then any confirmation of such
detention will state whether it is based in whole or in part on that
classified information.
Subpart L_Foreign Supplier Verification Programs for Food Importers
Source: 80 FR 74340, Nov. 27, 2015, unless otherwise noted.
Sec. 1.500 What definitions apply to this subpart?
The following definitions apply to words and phrases as they are
used in this subpart. Other definitions of these terms may apply when
they are used in other subparts of this part.
Adequate means that which is needed to accomplish the intended
purpose in
[[Page 66]]
keeping with good public health practice.
Audit means the systematic, independent, and documented examination
(through observation, investigation, discussions with employees of the
audited entity, records review, and, as appropriate, sampling and
laboratory analysis) to assess an audited entity's food safety processes
and procedures.
Dietary supplement has the meaning given in section 201(ff) of the
Federal Food, Drug, and Cosmetic Act.
Dietary supplement component means any substance intended for use in
the manufacture of a dietary supplement, including those that may not
appear in the finished batch of the dietary supplement. Dietary
supplement components include dietary ingredients (as described in
section 201(ff) of the Federal Food, Drug, and Cosmetic Act) and other
ingredients.
Environmental pathogen means a pathogen capable of surviving and
persisting within the manufacturing, processing, packing, or holding
environment such that food may be contaminated and may result in
foodborne illness if that food is consumed without treatment to
significantly minimize the environmental pathogen. Examples of
environmental pathogens for the purposes of this part include Listeria
monocytogenes and Salmonella spp. but do not include the spores of
pathogenic sporeforming bacteria.
Facility means a domestic facility or a foreign facility that is
required to register under section 415 of the Federal Food, Drug, and
Cosmetic Act, in accordance with the requirements of subpart H of this
part.
Farm means farm as defined in Sec. 1.227.
Farm mixed-type facility means an establishment that is a farm but
that also conducts activities outside the farm definition that require
the establishment to be registered under section 415 of the Federal
Food, Drug, and Cosmetic Act.
Food has the meaning given in section 201(f) of the Federal Food,
Drug, and Cosmetic Act, except that food does not include pesticides (as
defined in 7 U.S.C. 136(u)).
Food allergen means a major food allergen as defined in section
201(qq) of the Federal Food, Drug, and Cosmetic Act.
Foreign supplier means, for an article of food, the establishment
that manufactures/processes the food, raises the animal, or grows the
food that is exported to the United States without further
manufacturing/processing by another establishment, except for further
manufacturing/processing that consists solely of the addition of
labeling or any similar activity of a de minimis nature.
Good compliance standing with a foreign food safety authority means
that the foreign supplier--
(1) Appears on the current version of a list, issued by the food
safety authority of the country in which the foreign supplier is located
and which has regulatory oversight of the supplier, of food producers
that are in good compliance standing with the food safety authority; or
(2) Has otherwise been designated by such food safety authority as
being in good compliance standing.
Harvesting applies to applies to farms and farm mixed-type
facilities and means activities that are traditionally performed on
farms for the purpose of removing raw agricultural commodities from the
place they were grown or raised and preparing them for use as food.
Harvesting is limited to activities performed on raw agricultural
commodities, or on processed foods created by drying/dehydrating a raw
agricultural commodity without additional manufacturing/processing, on a
farm. Harvesting does not include activities that transform a raw
agricultural commodity into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of
harvesting include cutting (or otherwise separating) the edible portion
of the raw agricultural commodity from the crop plant and removing or
trimming part of the raw agricultural commodity (e.g., foliage, husks,
roots, or stems). Examples of harvesting also include cooling, field
coring, filtering, gathering, hulling, shelling, sifting, threshing,
trimming of outer leaves of, and washing raw agricultural commodities
grown on a farm.
[[Page 67]]
Hazard means any biological, chemical (including radiological), or
physical agent that is reasonably likely to cause illness or injury.
Hazard requiring a control means a known or reasonably foreseeable
hazard for which a person knowledgeable about the safe manufacturing,
processing, packing, or holding of food would, based on the outcome of a
hazard analysis (which includes an assessment of the probability that
the hazard will occur in the absence of controls or measures and the
severity of the illness or injury if the hazard were to occur),
establish one or more controls or measures to significantly minimize or
prevent the hazard in a food and components to manage those controls or
measures (such as monitoring, corrections or corrective actions,
verification, and records) as appropriate to the food, the facility, and
the nature of the control or measure and its role in the facility's food
safety system.
Holding means storage of food and also includes activities performed
incidental to storage of a food (e.g., activities performed for the safe
or effective storage of that food, such as fumigating food during
storage, and drying/dehydrating raw agricultural commodities when the
drying/dehydrating does not create a distinct commodity (such as drying/
dehydrating hay or alfalfa)). Holding also includes activities performed
as a practical necessity for the distribution of that food (such as
blending of the same raw agricultural commodity and breaking down
pallets), but does not include activities that transform a raw
agricultural commodity into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities
could include warehouses, cold storage facilities, storage silos, grain
elevators, and liquid storage tanks.
Importer means the U.S. owner or consignee of an article of food
that is being offered for import into the United States. If there is no
U.S. owner or consignee of an article of food at the time of U.S. entry,
the importer is the U.S. agent or representative of the foreign owner or
consignee at the time of entry, as confirmed in a signed statement of
consent to serve as the importer under this subpart.
Known or reasonably foreseeable hazard means a biological, chemical
(including radiological), or physical hazard that is known to be, or has
the potential to be, associated with a food or the facility in which it
is manufactured/processed.
Lot means the food produced during a period of time and identified
by an establishment's specific code.
Manufacturing/processing means making food from one or more
ingredients, or synthesizing, preparing, treating, modifying, or
manipulating food, including food crops or ingredients. Examples of
manufacturing/processing activities include: Baking, boiling, bottling,
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw
agricultural commodities to create a distinct commodity (such as drying/
dehydrating grapes to produce raisins), evaporating, eviscerating,
extracting juice, extruding (of animal food), formulating, freezing,
grinding, homogenizing, irradiating, labeling, milling, mixing,
packaging (including modified atmosphere packaging), pasteurizing,
peeling, pelleting (of animal food), rendering, treating to manipulate
ripening, trimming, washing, or waxing. For farms and farm mixed-type
facilities, manufacturing/processing does not include activities that
are part of harvesting, packing, or holding.
Microorganisms means yeasts, molds, bacteria, viruses, protozoa, and
microscopic parasites and includes species that are pathogens.
Packing means placing food into a container other than packaging the
food and also includes re-packing and activities performed incidental to
packing or re-packing a food (e.g., activities performed for the safe or
effective packing or re-packing of that food (such as sorting, culling,
grading, and weighing or conveying incidental to packing or re-
packing)), but does not include activities that transform a raw
agricultural commodity into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act.
Pathogen means a microorganism of public health significance.
[[Page 68]]
Qualified auditor means a person who is a qualified individual as
defined in this section and has technical expertise obtained through
education, training, or experience (or a combination thereof) necessary
to perform the auditing function as required by Sec. 1.506(e)(1)(i) or
Sec. 1.511(c)(5)(i)(A). Examples of potential qualified auditors
include:
(1) A government employee, including a foreign government employee;
and
(2) An audit agent of a certification body that is accredited in
accordance with subpart M of this part.
Qualified individual means a person who has the education, training,
or experience (or a combination thereof) necessary to perform an
activity required under this subpart, and can read and understand the
language of any records that the person must review in performing this
activity. A qualified individual may be, but is not required to be, an
employee of the importer. A government employee, including a foreign
government employee, may be a qualified individual.
Raw agricultural commodity has the meaning given in section 201(r)
of the Federal Food, Drug, and Cosmetic Act.
Ready-to-eat food (RTE food) means any food that is normally eaten
in its raw state or any food, including a processed food, for which it
is reasonably foreseeable that the food will be eaten without further
processing that would significantly minimize biological hazards.
Receiving facility means a facility that is subject to subparts C
and G of part 117 of this chapter, or subparts C and E of part 507 of
this chapter, and that manufactures/processes a raw material or other
ingredient that it receives from a supplier.
U.S. owner or consignee means the person in the United States who,
at the time of U.S. entry, either owns the food, has purchased the food,
or has agreed in writing to purchase the food.
Very small importer means:
(1) With respect to the importation of human food, an importer
(including any subsidiaries and affiliates) averaging less than $1
million per year, adjusted for inflation, during the 3-year period
preceding the applicable calendar year, in sales of human food combined
with the U.S. market value of human food imported, manufactured,
processed, packed, or held without sale (e.g., imported for a fee); and
(2) With respect to the importation of animal food, an importer
(including any subsidiaries and affiliates) averaging less than $2.5
million per year, adjusted for inflation, during the 3-year period
preceding the applicable calendar year, in sales of animal food combined
with the U.S. market value of animal food imported, manufactured,
processed, packed, or held without sale (e.g., imported for a fee).
You means a person who is subject to some or all of the requirements
in this subpart.
[80 FR 74340, Nov. 27, 2015, as amended at 81 FR 25327, Apr. 28, 2016]
Sec. 1.501 To what foods do the requirements in this subpart apply?
(a) General. Except as specified otherwise in this section, the
requirements in this subpart apply to all food imported or offered for
import into the United States and to the importers of such food.
(b) Exemptions for juice and seafood--(1) Importers of certain juice
and seafood products. This subpart does not apply with respect to juice,
fish, and fishery products that are imported from a foreign supplier
that is required to comply with, and is in compliance with, the
requirements in part 120 or part 123 of this chapter. If you import
juice or fish and fishery products that are subject to part 120 or part
123, respectively, you must comply with the requirements applicable to
importers of those products under Sec. 120.14 or Sec. 123.12 of this
chapter, respectively.
(2) Certain importers of juice or seafood raw materials or other
ingredients subject to part 120 or part 123 of this chapter. This
subpart does not apply with respect to any raw materials or other
ingredients that you import and use in manufacturing or processing juice
subject to part 120 or fish and fishery products subject to part 123,
provided that you are in compliance with the requirements in part 120 or
part 123 with respect to the juice or fish or fishery product that you
manufacture or process from the imported raw materials or other
ingredients.
[[Page 69]]
(c) Exemption for food imported for research or evaluation. This
subpart does not apply to food that is imported for research or
evaluation use, provided that such food:
(1) Is not intended for retail sale and is not sold or distributed
to the public;
(2) Is labeled with the statement ``Food for research or evaluation
use'';
(3) Is imported in a small quantity that is consistent with a
research, analysis, or quality assurance purpose, the food is used only
for this purpose, and any unused quantity is properly disposed of; and
(4) Is accompanied, when filing entry with U.S. Customs and Border
Protection, by an electronic declaration that the food will be used for
research or evaluation purposes and will not be sold or distributed to
the public.
(d) Exemption for food imported for personal consumption. This
subpart does not apply to food that is imported for personal
consumption, provided that such food is not intended for retail sale and
is not sold or distributed to the public. Food is imported for personal
consumption only if it is purchased or otherwise acquired by a person in
a small quantity that is consistent with a non-commercial purpose and is
not sold or distributed to the public.
(e) Exemption for alcoholic beverages. (1) This subpart does not
apply with respect to alcoholic beverages that are imported from a
foreign supplier that is a facility that meets the following two
conditions:
(i) Under the Federal Alcohol Administration Act (27 U.S.C. 201 et
seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986
(26 U.S.C. 5001 et seq.), the facility is a foreign facility of a type
that, if it were a domestic facility, would require obtaining a permit
from, registering with, or obtaining approval of a notice or application
from the Secretary of the Treasury as a condition of doing business in
the United States; and
(ii) Under section 415 of the Federal Food, Drug, and Cosmetic Act,
the facility is required to register as a facility because it is engaged
in manufacturing/processing one or more alcoholic beverages.
(2) This subpart does not apply with respect to food that is not an
alcoholic beverage that is imported from a foreign supplier described in
paragraph (e)(1) of this section, provided such food:
(i) Is in prepackaged form that prevents any direct human contact
with such food; and
(ii) Constitutes not more than 5 percent of the overall sales of the
facility, as determined by the Secretary of the Treasury.
(3) This subpart does not apply with respect to raw materials and
other ingredients that are imported for use in alcoholic beverages
provided that:
(i) The imported raw materials and other ingredients are used in the
manufacturing/processing, packing, or holding of alcoholic beverages;
(ii) Such manufacturing/processing, packing, or holding is performed
by the importer;
(iii) The importer is required to register under section 415 of the
Federal Food, Drug, and Cosmetic Act; and
(iv) The importer is exempt from the regulations in part 117 of this
chapter in accordance with Sec. 117.5(i) of this chapter.
(f) Inapplicability to food that is transshipped or imported for
processing and export. This subpart does not apply to food:
(1) That is transshipped through the United States to another
country and is not sold or distributed to the public in the United
States; or
(2) That is imported for processing and future export and that is
not sold or distributed to the public in the United States.
(g) Inapplicability to U.S. food returned. This subpart does not
apply to food that is manufactured/processed, raised, or grown in the
United States, exported, and returned to the United States without
further manufacturing/processing in a foreign country.
(h) Inapplicability to certain meat, poultry, and egg products. This
subpart does not apply with respect to:
(1) Meat food products that at the time of importation are subject
to the requirements of the U.S. Department of Agriculture (USDA) under
the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);
[[Page 70]]
(2) Poultry products that at the time of importation are subject to
the requirements of the USDA under the Poultry Products Inspection Act
(21 U.S.C. 451 et seq.); and
(3) Egg products that at the time of importation are subject to the
requirements of the USDA under the Egg Products Inspection Act (21
U.S.C. 1031 et seq.).
[80 FR 74340, Nov. 27, 2015, as amended at 81 FR 25327, Apr. 28, 2016]
Sec. 1.502 What foreign supplier verification program (FSVP) must
I have?
(a) General. Except as specified in paragraph (b) of this section,
for each food you import, you must develop, maintain, and follow an FSVP
that provides adequate assurances that your foreign supplier is
producing the food in compliance with processes and procedures that
provide at least the same level of public health protection as those
required under section 418 (regarding hazard analysis and risk-based
preventive controls for certain foods) or 419 (regarding standards for
produce safety), if either is applicable, and the implementing
regulations, and is producing the food in compliance with sections 402
(regarding adulteration) and 403(w) (if applicable) (regarding
misbranding with respect to labeling for the presence of major food
allergens) of the Federal Food, Drug, and Cosmetic Act.
(b) Low-acid canned foods--(1) Importers of low-acid canned foods
not subject to further manufacturing or processing. With respect to
those microbiological hazards that are controlled by part 113 of this
chapter, if you import a thermally processed low-acid food packaged in a
hermetically sealed container (low-acid canned food), you must verify
and document that the food was produced in accordance with part 113.
With respect to all matters that are not controlled by part 113, you
must have an FSVP as specified in paragraph (a) of this section.
(2) Certain importers of raw materials or other ingredients subject
to part 113 of this chapter. With respect to microbiological hazards
that are controlled by part 113, you are not required to comply with the
requirements of this subpart for raw materials or other ingredients that
you import and use in the manufacturing or processing of low-acid canned
food provided that you are in compliance with part 113 with respect to
the low-acid canned food that you manufacture or process from the
imported raw materials or other ingredients. With respect to all hazards
other than microbiological hazards that are controlled by part 113, you
must have an FSVP as specified in paragraph (a) of this section for the
imported raw materials and other ingredients that you use in the
manufacture or processing of low-acid canned foods.
(c) Importers subject to section 418 of the Federal Food, Drug, and
Cosmetic Act. You are deemed to be in compliance with the requirements
of this subpart for a food you import, except for the requirements in
Sec. 1.509, if you are a receiving facility as defined in Sec. 117.3
or Sec. 507.3 of this chapter and you are in compliance with the
following requirements of part 117 or part 507 of this chapter, as
applicable:
(1) You implement preventive controls for the hazards in the food in
accordance with Sec. 117.135 or Sec. 507.34 of this chapter;
(2) You are not required to implement a preventive control under
Sec. 117.136 or Sec. 507.36 of this chapter with respect to the food;
or
(3) You have established and implemented a risk-based supply-chain
program in compliance with subpart G of part 117 or subpart E of part
507 of this chapter with respect to the food.
Sec. 1.503 Who must develop my FSVP and perform FSVP activities?
(a) Qualified individual. A qualified individual must develop your
FSVP and perform each of the activities required under this subpart. A
qualified individual must have the education, training, or experience
(or a combination thereof) necessary to perform their assigned
activities and must be able to read and understand the language of any
records that must be reviewed in performing an activity.
(b) Qualified auditor. A qualified auditor must conduct any audit
conducted in accordance with Sec. 1.506(e)(1)(i) or Sec.
1.511(c)(5)(i)(A). A qualified auditor must have technical expertise
obtained
[[Page 71]]
through education, training, or experience (or a combination thereof)
necessary to perform the auditing function.
Sec. 1.504 What hazard analysis must I conduct?
(a) Requirement for a hazard analysis. Except as specified in
paragraph (d) of this section, you must conduct a hazard analysis to
identify and evaluate, based on experience, illness data, scientific
reports, and other information, known or reasonably foreseeable hazards
for each type of food you import to determine whether there are any
hazards requiring a control. Your hazard analysis must be written
regardless of its outcome.
(b) Hazard identification. (1) Your analysis of the known or
reasonably foreseeable hazards in each food must include the following
types of hazards:
(i) Biological hazards, including microbiological hazards such as
parasites, environmental pathogens, and other pathogens;
(ii) Chemical hazards, including radiological hazards, pesticide and
drug residues, natural toxins, decomposition, unapproved food or color
additives, food allergens, and (in animal food) nutrient deficiencies or
toxicities; and
(iii) Physical hazards (such as stones, glass, and metal fragments).
(2) Your analysis must include known or reasonably foreseeable
hazards that may be present in a food for any of the following reasons:
(i) The hazard occurs naturally;
(ii) The hazard may be unintentionally introduced; or
(iii) The hazard may be intentionally introduced for purposes of
economic gain.
(c) Hazard evaluation. (1) Your hazard analysis must include an
evaluation of the hazards identified in paragraph (b) of this section to
assess the probability that the hazard will occur in the absence of
controls and the severity of the illness or injury if the hazard were to
occur.
(2) The hazard evaluation required by paragraph (c)(1) of this
section must include an evaluation of environmental pathogens whenever a
ready-to-eat food is exposed to the environment before packaging and the
packaged food does not receive a treatment or otherwise include a
control or measure (such as a formulation lethal to the pathogen) that
would significantly minimize the pathogen.
(3) Your hazard evaluation must consider the effect of the following
on the safety of the finished food for the intended consumer:
(i) The formulation of the food;
(ii) The condition, function, and design of the establishment and
equipment of a typical entity that manufactures/processes, grows,
harvests, or raises this type of food;
(iii) Raw materials and other ingredients;
(iv) Transportation practices;
(v) Harvesting, raising, manufacturing, processing, and packing
procedures;
(vi) Packaging and labeling activities;
(vii) Storage and distribution;
(viii) Intended or reasonably foreseeable use;
(ix) Sanitation, including employee hygiene; and
(x) Any other relevant factors, such as the temporal (e.g., weather-
related) nature of some hazards (e.g., levels of natural toxins).
(d) Review of another entity's hazard analysis. If another entity
(including your foreign supplier) has, using a qualified individual,
analyzed the known or reasonably foreseeable hazards for the food to
determine whether there are any hazards requiring a control, you may
meet your requirement to determine whether there are any hazards
requiring a control in a food by reviewing and assessing the hazard
analysis conducted by that entity. You must document your review and
assessment of that hazard analysis, including documenting that the
hazard analysis was conducted by a qualified individual.
(e) Hazards in raw agricultural commodities that are fruits or
vegetables. If you are importing a raw agricultural commodity that is a
fruit or vegetable that is ``covered produce'' as defined in Sec. 112.3
of this chapter, you are not required to determine whether there are any
biological hazards requiring a control in such food because the
biological
[[Page 72]]
hazards in such fruits or vegetables require a control and compliance
with the requirements in part 112 of this chapter significantly
minimizes or prevents the biological hazards. However, you must
determine whether there are any other types of hazards requiring a
control in such food.
(f) No hazards requiring a control. If you evaluate the known and
reasonably foreseeable hazards in a food and determine that there are no
hazards requiring a control, you are not required to conduct an
evaluation for foreign supplier approval and verification under Sec.
1.505 and you are not required to conduct foreign supplier verification
activities under Sec. 1.506. This paragraph (f) does not apply if the
food is a raw agricultural commodity that is a fruit or vegetable that
is ``covered produce'' as defined in Sec. 112.3 of this chapter.
Sec. 1.505 What evaluation for foreign supplier approval and
verification must I conduct?
(a) Evaluation of a foreign supplier's performance and the risk
posed by a food. (1) Except as specified in paragraphs (d) and (e) of
this section, in approving your foreign suppliers and determining the
appropriate supplier verification activities that must be conducted for
a foreign supplier of a type of food you import, you must consider the
following:
(i) The hazard analysis of the food conducted in accordance with
Sec. 1.504, including the nature of the hazard requiring a control.
(ii) The entity or entities that will be significantly minimizing or
preventing the hazards requiring a control or verifying that such
hazards have been significantly minimized or prevented, such as the
foreign supplier, the foreign supplier's raw material or other
ingredient supplier, or another entity in your supply chain.
(iii) Foreign supplier performance, including:
(A) The foreign supplier's procedures, processes, and practices
related to the safety of the food;
(B) Applicable FDA food safety regulations and information relevant
to the foreign supplier's compliance with those regulations, including
whether the foreign supplier is the subject of an FDA warning letter,
import alert, or other FDA compliance action related to food safety (or,
when applicable, the relevant laws and regulations of a country whose
food safety system FDA has officially recognized as comparable or
determined to be equivalent to that of the United States, and
information relevant to the supplier's compliance with those laws and
regulations); and
(C) The foreign supplier's food safety history, including available
information about results from testing foods for hazards, audit results
relating to the safety of the food, and responsiveness of the foreign
supplier in correcting problems.
(iv) Any other factors as appropriate and necessary, such as storage
and transportation practices.
(2) You must document the evaluation you conduct under paragraph
(a)(1) of this section.
(b) Approval of foreign suppliers. You must approve your foreign
suppliers on the basis of the evaluation that you conducted under
paragraph (a) of this section or that you review and assess under
paragraph (d) of this section, and document your approval.
(c) Reevaluation of a foreign supplier's performance and the risk
posed by a food. (1) Except as specified in paragraph (d) of this
section, you must promptly reevaluate the concerns associated with the
factors in paragraph (a)(1) of this section when you become aware of new
information about these factors, and the reevaluation must be
documented. If you determine that the concerns associated with importing
a food from a foreign supplier have changed, you must promptly determine
(and document) whether it is appropriate to continue to import the food
from the foreign supplier and whether the supplier verification
activities conducted under Sec. 1.506 or Sec. 1.511(c) need to be
changed.
(2) If at the end of any 3-year period you have not reevaluated the
concerns associated with the factors in paragraph (a)(1) of this section
in accordance with paragraph (c)(1) of this section, you must reevaluate
those concerns and take other appropriate actions, if necessary, in
accordance with paragraph (c)(1). You must document your reevaluation
and any subsequent
[[Page 73]]
actions you take in accordance with paragraph (c)(1).
(d) Review of another entity's evaluation or reevaluation of a
foreign supplier's performance and the risk posed by a food. If an
entity other than the foreign supplier has, using a qualified
individual, performed the evaluation described in paragraph (a) of this
section or the reevaluation described in paragraph (c) of this section,
you may meet the requirements of the applicable paragraph by reviewing
and assessing the evaluation or reevaluation conducted by that entity.
You must document your review and assessment, including documenting that
the evaluation or reevaluation was conducted by a qualified individual.
(e) Inapplicability to certain circumstances. You are not required
to conduct an evaluation under this section or to conduct foreign
supplier verification activities under Sec. 1.506 if one of the
circumstances described in Sec. 1.507 applies to your importation of a
food and you are in compliance with that section.
Sec. 1.506 What foreign supplier verification and related activities
must I conduct?
(a) Use of approved foreign suppliers. (1) You must establish and
follow written procedures to ensure that you import foods only from
foreign suppliers you have approved based on the evaluation conducted
under Sec. 1.505 (or, when necessary and appropriate, on a temporary
basis from unapproved foreign suppliers whose foods you subject to
adequate verification activities before importing the food). You must
document your use of these procedures.
(2) You may rely on an entity other than your foreign supplier to
establish the procedures and perform and document the activities
required under paragraph (a)(1) of this section provided that you review
and assess that entity's documentation of the procedures and activities,
and you document your review and assessment.
(b) Foreign supplier verification procedures. You must establish and
follow adequate written procedures for ensuring that appropriate foreign
supplier verification activities are conducted with respect to the foods
you import.
(c) Requirement of supplier verification. The foreign supplier
verification activities must provide assurance that the hazards
requiring a control in the food you import have been significantly
minimized or prevented.
(d) Determination of appropriate foreign supplier verification
activities--(1)(i) General. Except as provided in paragraphs (d)(2) and
(3) of this section, before importing a food from a foreign supplier,
you must determine and document which verification activity or
activities listed in paragraphs (d)(1)(ii)(A) through (D) of this
section, as well as the frequency with which the activity or activities
must be conducted, are needed to provide adequate assurances that the
food you obtain from the foreign supplier is produced in accordance with
paragraph (c) of this section. Verification activities must address the
entity or entities that are significantly minimizing or preventing the
hazards or verifying that the hazards have been significantly minimized
or prevented (e.g., when an entity other than the grower of produce
subject to part 112 of this chapter harvests or packs the produce and
significantly minimizes or prevents the hazard or verifies that the
hazard has been significantly minimized or prevented, or when the
foreign supplier's raw material supplier significantly minimizes or
prevents a hazard). The determination of appropriate supplier
verification activities must be based on the evaluation of the food and
foreign supplier conducted under Sec. 1.505.
(ii) Appropriate verification activities. The following are
appropriate supplier verification activities:
(A) Onsite audits as specified in paragraph (e)(1)(i) of this
section;
(B) Sampling and testing of a food as specified in paragraph
(e)(1)(ii) of this section;
(C) Review of the foreign supplier's relevant food safety records as
specified in paragraph (e)(1)(iii) of this section; and
(D) Other appropriate supplier verification activities as specified
in paragraph (e)(1)(iv) of this section.
(2) Verification activities for certain serious hazards. When a
hazard in a food will be controlled by the foreign supplier and is one
for which there is a
[[Page 74]]
reasonable probability that exposure to the hazard will result in
serious adverse health consequences or death to humans or animals, you
must conduct or obtain documentation of an onsite audit of the foreign
supplier before initially importing the food and at least annually
thereafter, unless you make an adequate written determination that,
instead of such initial and annual onsite auditing, other supplier
verification activities listed in paragraph (d)(1)(ii) of this section
and/or less frequent onsite auditing are appropriate to provide adequate
assurances that the foreign supplier is producing the food in accordance
with paragraph (c) of this section, based on the determination made
under Sec. 1.505.
(3) Reliance on a determination by another entity. You may rely on a
determination of appropriate foreign supplier verification activities in
accordance with paragraph (d)(1) or (2) of this section made by an
entity other than the foreign supplier if you review and assess whether
the entity's determination regarding appropriate activities (including
the frequency with which such activities must be conducted) is
appropriate. You must document your review and assessment, including
documenting that the determination of appropriate verification
activities was made by a qualified individual.
(e) Performance of foreign supplier verification activities--(1)
Verification activities. Except as provided in paragraph (e)(2) of this
section, based on the determination made in accordance with paragraph
(d) of this section, you must conduct (and document) or obtain
documentation of one or more of the supplier verification activities
listed in paragraphs (e)(1)(i) through (iv) of this section for each
foreign supplier before importing the food and periodically thereafter.
(i) Onsite audit of the foreign supplier. (A) An onsite audit of a
foreign supplier must be performed by a qualified auditor.
(B) If the food is subject to one or more FDA food safety
regulations, an onsite audit of the foreign supplier must consider such
regulations and include a review of the supplier's written food safety
plan, if any, and its implementation, for the hazard being controlled
(or, when applicable, an onsite audit may consider relevant laws and
regulations of a country whose food safety system FDA has officially
recognized as comparable or determined to be equivalent to that of the
United States).
(C) If the onsite audit is conducted solely to meet the requirements
of paragraph (e) of this section by an audit agent of a certification
body that is accredited in accordance with subpart M of this part, the
audit is not subject to the requirements in that subpart.
(D) You must retain documentation of each onsite audit, including
the audit procedures, the dates the audit was conducted, the conclusions
of the audit, any corrective actions taken in response to significant
deficiencies identified during the audit, and documentation that the
audit was conducted by a qualified auditor.
(E) The following inspection results may be substituted for an
onsite audit, provided that the inspection was conducted within 1 year
of the date by which the onsite audit would have been required to be
conducted:
(1) The written results of an appropriate inspection of the foreign
supplier for compliance with applicable FDA food safety regulations
conducted by FDA, representatives of other Federal Agencies (such as the
USDA), or representatives of State, local, tribal, or territorial
agencies; or
(2) The written results of an inspection of the foreign supplier by
the food safety authority of a country whose food safety system FDA has
officially recognized as comparable or determined to be equivalent to
that of the United States, provided that the food that is the subject of
the onsite audit is within the scope of the official recognition or
equivalence determination, and the foreign supplier is in, and under the
regulatory oversight of, such country.
(ii) Sampling and testing of the food. You must retain documentation
of each sampling and testing of a food, including identification of the
food tested (including lot number, as appropriate), the number of
samples tested, the test(s) conducted (including the analytical
method(s) used), the date(s) on
[[Page 75]]
which the test(s) were conducted and the date of the report of the
testing, the results of the testing, any corrective actions taken in
response to detection of hazards, information identifying the laboratory
conducting the testing, and documentation that the testing was conducted
by a qualified individual.
(iii) Review of the foreign supplier's relevant food safety records.
You must retain documentation of each record review, including the
date(s) of review, the general nature of the records reviewed, the
conclusions of the review, any corrective actions taken in response to
significant deficiencies identified during the review, and documentation
that the review was conducted by a qualified individual.
(iv) Other appropriate activity. (A) You may conduct (and document)
or obtain documentation of other supplier verification activities that
are appropriate based on foreign supplier performance and the risk
associated with the food.
(B) You must retain documentation of each activity conducted in
accordance with paragraph (e)(1)(iv) of this section, including a
description of the activity, the date on which it was conducted, the
findings or results of the activity, any corrective actions taken in
response to significant deficiencies identified, and documentation that
the activity was conducted by a qualified individual.
(2) Reliance upon performance of activities by other entities. (i)
Except as specified in paragraph (e)(2)(ii) of this section, you may
rely on supplier verification activities conducted in accordance with
paragraph (e)(1) of this section by another entity provided that you
review and assess the results of these activities in accordance with
paragraph (e)(3) of this section.
(ii) You may not rely on the foreign supplier itself or employees of
the foreign supplier to perform supplier verification activities, except
with respect to sampling and testing of food in accordance with
paragraph (e)(1)(ii) of this section.
(3) Review of results of verification activities. You must promptly
review and assess the results of the verification activities that you
conduct or obtain documentation of under paragraph (e)(1) of this
section, or that are conducted by other entities in accordance with
paragraph (e)(2) of this section. You must document your review and
assessment of the results of verification activities. If the results do
not provide adequate assurances that the hazards requiring a control in
the food you obtain from the foreign supplier have been significantly
minimized or prevented, you must take appropriate action in accordance
with Sec. 1.508(a). You are not required to retain documentation of
supplier verification activities conducted by other entities, provided
that you can obtain the documentation and make it available to FDA in
accordance with Sec. 1.510(b).
(4) Independence of qualified individuals conducting verification
activities. There must not be any financial conflicts of interests that
influence the results of the verification activities set forth in
paragraph (e)(1) of this section, and payment must not be related to the
results of the activity.
Sec. 1.507 What requirements apply when I import a food that cannot be
consumed without the hazards being controlled or for which the hazards are
controlled after importation?
(a) Circumstances. You are not required to conduct an evaluation of
a food and foreign supplier under Sec. 1.505 or supplier verification
activities under Sec. 1.506 when you identify a hazard requiring a
control (identified hazard) in a food and any of the following
circumstances apply:
(1) You determine and document that the type of food (e.g., raw
agricultural commodities such as cocoa beans and coffee beans) could not
be consumed without application of an appropriate control;
(2) You rely on your customer who is subject to the requirements for
hazard analysis and risk-based preventive controls in subpart C of part
117 or subpart C of part 507 of this chapter to ensure that the
identified hazard will be significantly minimized or prevented and you:
(i) Disclose in documents accompanying the food, in accordance with
the practice of the trade, that the food
[[Page 76]]
is ``not processed to control [identified hazard]''; and
(ii) Annually obtain from your customer written assurance, subject
to the requirements of paragraph (c) of this section, that the customer
has established and is following procedures (identified in the written
assurance) that will significantly minimize or prevent the identified
hazard;
(3) You rely on your customer who is not subject to the requirements
for hazard analysis and risk-based preventive controls in subpart C of
part 117 or subpart C of part 507 of this chapter to provide assurance
it is manufacturing, processing, or preparing the food in accordance
with the applicable food safety requirements and you:
(i) Disclose in documents accompanying the food, in accordance with
the practice of the trade, that the food is ``not processed to control
[identified hazard]''; and
(ii) Annually obtain from your customer written assurance that it is
manufacturing, processing, or preparing the food in accordance with
applicable food safety requirements;
(4) You rely on your customer to provide assurance that the food
will be processed to control the identified hazard by an entity in the
distribution chain subsequent to the customer and you:
(i) Disclose in documents accompanying the food, in accordance with
the practice of the trade, that the food is ``not processed to control
[identified hazard]''; and
(ii) Annually obtain from your customer written assurance, subject
to the requirements of paragraph (c) of this section, that your
customer:
(A) Will disclose in documents accompanying the food, in accordance
with the practice of the trade, that the food is ``not processed to
control [identified hazard]''; and
(B) Will only sell the food to another entity that agrees, in
writing, it will:
(1) Follow procedures (identified in a written assurance) that will
significantly minimize or prevent the identified hazard (if the entity
is subject to the requirements for hazard analysis and risk-based
preventive controls in subpart C of part 117 or subpart C of part 507 of
this chapter) or manufacture, process, or prepare the food in accordance
with applicable food safety requirements (if the entity is not subject
to the requirements for hazard analysis and risk-based preventive
controls in subpart C of part 117 or subpart C of part 507); or
(2) Obtain a similar written assurance from the entity's customer,
subject to the requirements of paragraph (c) of this section, as in
paragraphs (a)(4)(ii)(A) and (B) of this section, as appropriate; or
(5) You have established, documented, and implemented a system that
ensures control, at a subsequent distribution step, of the hazards in
the food you distribute and you document your implementation of that
system.
(b) Written assurances. Any written assurances required under this
section must contain the following:
(1) Effective date;
(2) Printed names and signatures of authorized officials; and
(3) The assurance specified in the applicable paragraph.
(c) Provision of assurances. The customer or other subsequent entity
in the distribution chain for a food that provides a written assurance
under paragraph (a)(2), (3), or (4) of this section must act
consistently with the assurance and document its actions taken to
satisfy the written assurance.
Sec. 1.508 What corrective actions must I take under my FSVP?
(a) You must promptly take appropriate corrective actions if you
determine that a foreign supplier of food you import does not produce
the food in compliance with processes and procedures that provide at
least the same level of public health protection as those required under
section 418 or 419 of the Federal Food, Drug, and Cosmetic Act, if
either is applicable, and the implementing regulations, or produces food
that is adulterated under section 402 or misbranded under section 403(w)
(if applicable) of the Federal Food, Drug, and Cosmetic Act. This
determination could be based on a review of consumer, customer, or other
complaints related to food safety, the verification activities conducted
under Sec. 1.506 or Sec. 1.511(c), a reevaluation of the risks posed
by the food and the foreign
[[Page 77]]
supplier's performance conducted under Sec. 1.505(c) or (d), or any
other relevant information you obtain. The appropriate corrective
actions will depend on the circumstances but could include discontinuing
use of the foreign supplier until the cause or causes of noncompliance,
adulteration, or misbranding have been adequately addressed. You must
document any corrective actions you take in accordance with this
paragraph.
(b) If you determine, by means other than the verification
activities conducted under Sec. 1.506 or Sec. 1.511(c) or a
reevaluation conducted under Sec. 1.505(c) or (d), that a foreign
supplier of food that you import does not produce food in compliance
with processes and procedures that provide at least the same level of
public health protection as those required under section 418 or 419 of
the Federal Food, Drug, and Cosmetic Act, if either is applicable, and
the implementing regulations, or produces food that is adulterated under
section 402 or misbranded under section 403(w) (if applicable) of the
Federal Food, Drug, and Cosmetic Act, you must promptly investigate to
determine whether your FSVP is adequate and, when appropriate, modify
your FSVP. You must document any investigations, corrective actions, and
changes to your FSVP that you undertake in accordance with this
paragraph.
(c) This section does not limit your obligations with respect to
other laws enforced by FDA, such as those relating to product recalls.
Sec. 1.509 How must the importer be identified at entry?
(a) You must ensure that, for each line entry of food product
offered for importation into the United States, your name, electronic
mail address, and unique facility identifier recognized as acceptable by
FDA, identifying you as the importer of the food, are provided
electronically when filing entry with U.S. Customs and Border
Protection.
(b) Before an article of food is imported or offered for import into
the United States, the foreign owner or consignee of the food (if there
is no U.S. owner or consignee) must designate a U.S. agent or
representative as the importer of the food for the purposes of the
definition of ``importer'' in Sec. 1.500.
Sec. 1.510 How must I maintain records of my FSVP?
(a) General requirements for records. (1) You must keep records as
original records, true copies (such as photocopies, pictures, scanned
copies, microfilm, microfiche, or other accurate reproductions of the
original records), or electronic records.
(2) You must sign and date records concerning your FSVP upon initial
completion and upon any modification of the FSVP.
(3) All records must be legible and stored to prevent deterioration
or loss.
(b) Record availability. (1) You must make all records required
under this subpart available promptly to an authorized FDA
representative, upon request, for inspection and copying. Upon FDA
request, you must provide within a reasonable time an English
translation of records maintained in a language other than English.
(2) Offsite storage of records, including records maintained by
other entities in accordance with Sec. 1.504, Sec. 1.505, or Sec.
1.506, is permitted if such records can be retrieved and provided onsite
within 24 hours of request for official review. Electronic records are
considered to be onsite if they are accessible from an onsite location.
(3) If requested in writing by FDA, you must send records to the
Agency electronically, or through another means that delivers the
records promptly, rather than making the records available for review at
your place of business.
(c) Record retention. (1) Except as specified in paragraph (c)(2) of
this section, you must retain records referenced in this subpart until
at least 2 years after you created or obtained the records.
(2) You must retain records that relate to your processes and
procedures, including the results of evaluations and determinations you
conduct, for at least 2 years after their use is discontinued (e.g.,
because you no longer import a particular food, you no longer use a
particular foreign supplier, you
[[Page 78]]
have reevaluated the risks associated with a food and the foreign
supplier, or you have changed your supplier verification activities for
a particular food and foreign supplier).
(d) Electronic records. 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.
(e) Use of existing records. (1) You do not need to duplicate
existing records you have (e.g., records that you maintain to comply
with other Federal, State, or local regulations) if they contain all of
the information required by this subpart. You may supplement any such
existing records as necessary to include all of the information required
by this subpart.
(2) You do not need to maintain the information required by this
subpart in one set of records. If existing records you have contain some
of the required information, you may maintain any new information
required by this subpart either separately or combined with the existing
records.
(f) Public disclosure. Records obtained by FDA in accordance with
this subpart are subject to the disclosure requirements under part 20 of
this chapter.
Sec. 1.511 What FSVP must I have if I am importing a food subject to
certain requirements in the dietary supplement current good manufacturing
practice regulation?
(a) Importers subject to certain requirements in the dietary
supplement current good manufacturing practice regulation. If you are
required to establish specifications under Sec. 111.70(b) or (d) of
this chapter with respect to a food that is a dietary supplement or
dietary supplement component you import for further manufacturing,
processing, or packaging as a dietary supplement, and you are in
compliance with the requirements in Sec. Sec. 111.73 and 111.75 of this
chapter applicable to determining whether the specifications you
established are met for such food, then for that food you must comply
with the requirements in Sec. Sec. 1.503 and 1.509, but you are not
required to comply with the requirements in Sec. 1.502, Sec. Sec.
1.504 through 1.508, or Sec. 1.510. This requirement does not limit
your obligations with respect to part 111 of this chapter or any other
laws enforced by FDA.
(b) Importers whose customer is subject to certain requirements in
the dietary supplement current good manufacturing practice regulation.
If your customer is required to establish specifications under Sec.
111.70(b) or (d) of this chapter with respect to a food that is a
dietary supplement or dietary supplement component you import for
further manufacturing, processing, or packaging as a dietary supplement,
your customer is in compliance with the requirements of Sec. Sec.
111.73 and 111.75 of this chapter applicable to determining whether the
specifications it established are met for such food, and you annually
obtain from your customer written assurance that it is in compliance
with those requirements, then for that food you must comply with the
requirements in Sec. Sec. 1.503, 1.509, and 1.510, but you are not
required to comply with the requirements in Sec. 1.502 or Sec. Sec.
1.504 through 1.508.
(c) Other importers of dietary supplements--(1) General. If the food
you import is a dietary supplement and neither paragraph (a) or (b) of
this section is applicable, you must comply with paragraph (c) of this
section and the requirements in Sec. Sec. 1.503, 1.505(a)(1)(ii)
through (iv), (a)(2), and (b) through (d), and 1.508 through 1.510, but
you are not required to comply with the requirements in Sec. Sec.
1.504, 1.505(a)(1)(i), 1.506, and 1.507. This requirement does not limit
your obligations with respect to part 111 of this chapter or any other
laws enforced by FDA.
(2) Use of approved foreign suppliers. (i) You must establish and
follow written procedures to ensure that you import foods only from
foreign suppliers that you have approved based on the evaluation
conducted under Sec. 1.505 (or, when necessary and appropriate, on a
temporary basis from unapproved foreign suppliers whose foods you
subject to adequate verification activities before
[[Page 79]]
importing the food). You must document your use of these procedures.
(ii) You may rely on an entity other than the foreign supplier to
establish the procedures and perform and document the activities
required under paragraph (c)(2)(i) of this section provided that you
review and assess that entity's documentation of the procedures and
activities, and you document your review and assessment.
(3) Foreign supplier verification procedures. You must establish and
follow adequate written procedures for ensuring that appropriate foreign
supplier verification activities are conducted with respect to the foods
you import.
(4) Determination of appropriate foreign supplier verification
activities--(i) General. Except as provided in paragraph (c)(4)(iii) of
this section, before importing a dietary supplement from a foreign
supplier, you must determine and document which verification activity or
activities listed in paragraphs (c)(4)(ii)(A) through (D) of this
section, as well as the frequency with which the activity or activities
must be conducted, are needed to provide adequate assurances that the
foreign supplier is producing the dietary supplement in accordance with
processes and procedures that provide the same level of public health
protection as those required under part 111 of this chapter. This
determination must be based on the evaluation conducted under Sec.
1.505.
(ii) Appropriate verification activities. The following are
appropriate supplier verification activities:
(A) Onsite audits as specified in paragraph (c)(5)(i)(A) of this
section;
(B) Sampling and testing of a food as specified in paragraph
(c)(5)(i)(B) of this section;
(C) Review of the foreign supplier's relevant food safety records as
specified in paragraph (c)(5)(i)(C) of this section; and
(D) Other appropriate supplier verification activities as specified
in paragraph (c)(5)(i)(D) of this section.
(iii) Reliance upon determination by other entity. You may rely on a
determination of appropriate foreign supplier verification activities in
accordance with paragraph (c)(4)(i) of this section made by an entity
other than the foreign supplier if you review and assess whether the
entity's determination regarding appropriate activities (including the
frequency with which such activities must be conducted) is appropriate
based on the evaluation conducted in accordance with Sec. 1.505. You
must document your review and assessment, including documenting that the
determination of appropriate verification activities was made by a
qualified individual.
(5) Performance of foreign supplier verification activities. (i)
Except as provided in paragraph (c)(5)(ii) of this section, for each
dietary supplement you import under paragraph (c) of this section, you
must conduct (and document) or obtain documentation of one or more of
the verification activities listed in paragraphs (c)(5)(i)(A) through
(D) of this section before importing the dietary supplement and
periodically thereafter.
(A) Onsite auditing. You conduct (and document) or obtain
documentation of a periodic onsite audit of your foreign supplier.
(1) An onsite audit of a foreign supplier must be performed by a
qualified auditor.
(2) The onsite audit must consider the applicable requirements of
part 111 of this chapter and include a review of the foreign supplier's
written food safety plan, if any, and its implementation (or, when
applicable, an onsite audit may consider relevant laws and regulations
of a country whose food safety system FDA has officially recognized as
comparable or determined to be equivalent to that of the United States).
(3) If the onsite audit is conducted solely to meet the requirements
of paragraph (c)(5) of this section by an audit agent of a certification
body that is accredited in accordance with subpart M of this part, the
audit is not subject to the requirements in that subpart.
(4) You must retain documentation of each onsite audit, including
the audit procedures, the dates the audit was conducted, the conclusions
of the audit, any corrective actions taken in response to significant
deficiencies identified during the audit, and documentation that the
audit was conducted by a qualified auditor.
[[Page 80]]
(5) The following inspection results may be substituted for an
onsite audit, provided that the inspection was conducted within 1 year
of the date by which the onsite audit would have been required to be
conducted:
(i) The written results of appropriate inspection of the foreign
supplier for compliance with the applicable requirements in part 111 of
this chapter conducted by FDA, representatives of other Federal Agencies
(such as the USDA), or representatives of State, local, tribal, or
territorial agencies; or
(ii) The written results of an inspection by the food safety
authority of a country whose food safety system FDA has officially
recognized as comparable or determined to be equivalent to that of the
United States, provided that the food that is the subject of the onsite
audit is within the scope of the official recognition or equivalence
determination, and the foreign supplier is in, and under the regulatory
oversight of, such country.
(B) Sampling and testing of the food. You must retain documentation
of each sampling and testing of a dietary supplement, including
identification of the food tested (including lot number, as
appropriate), the number of samples tested, the test(s) conducted
(including the analytical method(s) used), the date(s) on which the
test(s) were conducted and the date of the report of the testing, the
results of the testing, any corrective actions taken in response to
detection of hazards, information identifying the laboratory conducting
the testing, and documentation that the testing was conducted by a
qualified individual.
(C) Review of the foreign supplier's food safety records. You must
retain documentation of each record review, including the date(s) of
review, the general nature of the records reviewed, the conclusions of
the review, any corrective actions taken in response to significant
deficiencies identified during the review, and documentation that the
review was conducted by a qualified individual.
(D) Other appropriate activity. (1) You may conduct (and document)
or obtain documentation of other supplier verification activities that
are appropriate based on foreign supplier performance and the risk
associated with the food.
(2) You must retain documentation of each activity conducted in
accordance with paragraph (c)(5)(i)(D)(1) of this section, including a
description of the activity, the date on which it was conducted, the
findings or results of the activity, any corrective actions taken in
response to significant deficiencies identified, and documentation that
the activity was conducted by a qualified individual.
(ii) Reliance upon performance of activities by other entities. (A)
Except as specified in paragraph (c)(5)(ii)(B) of this section, you may
rely on supplier verification activities conducted in accordance with
paragraph (c)(5)(i) by another entity provided that you review and
assess the results of these activities in accordance with paragraph
(c)(5)(iii) of this section.
(B) You may not rely on the foreign supplier or employees of the
foreign supplier to perform supplier verification activities, except
with respect to sampling and testing of food in accordance with
paragraph (c)(5)(i)(B) of this section.
(iii) Review of results of verification activities. You must
promptly review and assess the results of the verification activities
that you conduct or obtain documentation of under paragraph (c)(5)(i) of
this section, or that are conducted by other entities in accordance with
paragraph (c)(5)(ii) of this section. You must document your review and
assessment of the results of verification activities. If the results
show that the foreign supplier is not producing the dietary supplement
in accordance with processes and procedures that provide the same level
of public health protection as those required under part 111 of this
chapter, you must take appropriate action in accordance with Sec.
1.508(a). You are not required to retain documentation of supplier
verification activities conducted by other entities, provided that you
can obtain the documentation and make it available to FDA in accordance
with Sec. 1.510(b).
(iv) Independence of qualified individuals conducting verification
activities.
[[Page 81]]
There must not be any financial conflicts of interest that influence the
results of the verification activities set forth in paragraph (c)(5)(i)
of this section, and payment must not be related to the results of the
activity.
[80 FR 74340, Nov. 27, 2015, as amended at 81 FR 25327, Apr. 28, 2016]
Sec. 1.512 What FSVP may I have if I am a very small importer or I am
importing certain food from certain small foreign suppliers?
(a) Eligibility. This section applies only if:
(1) You are a very small importer; or
(2) You are importing certain food from certain small foreign
suppliers as follows:
(i) The foreign supplier is a qualified facility as defined by Sec.
117.3 or Sec. 507.3 of this chapter;
(ii) You are importing produce from a foreign supplier that is a
farm that grows produce and is not a covered farm under part 112 of this
chapter in accordance with Sec. 112.4(a) of this chapter, or in
accordance with Sec. Sec. 112.4(b) and 112.5 of this chapter; or
(iii) You are importing shell eggs from a foreign supplier that is
not subject to the requirements of part 118 of this chapter because it
has fewer than 3,000 laying hens.
(b) Applicable requirements--(1) Documentation of eligibility--(i)
Very small importer status. (A) If you are a very small importer and you
choose to comply with the requirements in this section, you must
document that you meet the definition of very small importer in Sec.
1.500 with respect to human food and/or animal food before initially
importing food as a very small importer and thereafter on an annual
basis by December 31 of each calendar year.
(B) For the purpose of determining whether you satisfy the
definition of very small importer with respect to human food and/or
animal food for a given calendar year, the relevant 3-year period of
sales (and U.S. market value of human or animal food, as appropriate) is
the period ending 1 year before the calendar year for which you intend
to import food as a very small importer. The baseline year for
calculating the adjustment for inflation is 2011. If you conduct any
food sales in currency other than U.S. dollars, you must use the
relevant currency exchange rate in effect on December 31 of the year in
which sales occurred to calculate the value of these sales.
(ii) Small foreign supplier status. If you are a importing food from
a small foreign supplier as specified in paragraph (a)(2) of this
section and you choose to comply with the requirements in this section,
you must obtain written assurance that your foreign supplier meets the
criteria in paragraph (a)(2)(i), (ii), or (iii) of this section before
first approving the supplier for an applicable calendar year and
thereafter on an annual basis by December 31 of each calendar year, for
the following calendar year.
(2) Additional requirements. If this section applies and you choose
to comply with the requirements in paragraph (b) of this section, you
also are required to comply with the requirements in Sec. Sec. 1.502,
1.503, and 1.509, but you are not required to comply with the
requirements in Sec. Sec. 1.504 through 1.508 or Sec. 1.510.
(3) Foreign supplier verification activities. (i) If you are a very
small importer, for each food you import, you must obtain written
assurance, before importing the food and at least every 2 years
thereafter, that your foreign supplier is producing the food in
compliance with processes and procedures that provide at least the same
level of public health protection as those required under section 418 or
419 of the Federal Food, Drug, and Cosmetic Act, if either is
applicable, and the implementing regulations, and is producing the food
in compliance with sections 402 and 403(w) (if applicable) of the
Federal Food, Drug, and Cosmetic Act.
(ii) If your foreign supplier is a qualified facility as defined by
Sec. 117.3 or Sec. 507.3 of this chapter and you choose to comply with
the requirements in this section, you must obtain written assurance,
before importing the food and at least every 2 years thereafter, that
the foreign supplier is producing the food in compliance with applicable
FDA food safety regulations (or, when applicable, relevant laws and
regulations of a country whose food safety system FDA has officially
recognized as comparable or determined to be equivalent
[[Page 82]]
to that of the United States). The written assurance must include
either:
(A) A brief description of the preventive controls that the supplier
is implementing to control the applicable hazard in the food; or
(B) A statement that the supplier is in compliance with State,
local, county, tribal, or other applicable non-Federal food safety law,
including relevant laws and regulations of foreign countries.
(iii) If your foreign supplier is a farm that grows produce and is
not a covered farm under part 112 of this chapter in accordance with
Sec. 112.4(a) of this chapter, or in accordance with Sec. Sec.
112.4(b) and 112.5 of this chapter, and you choose to comply with the
requirements in this section, you must obtain written assurance, before
importing the produce and at least every 2 years thereafter, that the
farm acknowledges that its food is subject to section 402 of the Federal
Food, Drug, and Cosmetic Act (or, when applicable, that its food is
subject to relevant laws and regulations of a country whose food safety
system FDA has officially recognized as comparable or determined to be
equivalent to that of the United States).
(iv) If your foreign supplier is a shell egg producer that is not
subject to the requirements of part 118 of this chapter because it has
fewer than 3,000 laying hens and you choose to comply with the
requirements in this section, you must obtain written assurance, before
importing the shell eggs and at least every 2 years thereafter, that the
shell egg producer acknowledges that its food is subject to section 402
of the Federal Food, Drug, and Cosmetic Act (or, when applicable, that
its food is subject to relevant laws and regulations of a country whose
food safety system FDA has officially recognized as comparable or
determined to be equivalent to that of the United States).
(4) Corrective actions. You must promptly take appropriate
corrective actions if you determine that a foreign supplier of food you
import does not produce the food consistent with the assurance provided
in accordance with Sec. 1.512(b)(3)(i) through (iv). The appropriate
corrective actions will depend on the circumstances but could include
discontinuing use of the foreign supplier until the cause or causes of
noncompliance, adulteration, or misbranding have been adequately
addressed. You must document any corrective actions you take in
accordance with this paragraph (b)(4). This paragraph (b)(4) does not
limit your obligations with respect to other laws enforced by FDA, such
as those relating to product recalls.
(5) Records--(i) General requirements for records. (A) You must keep
records as original records, true copies (such as photocopies, pictures,
scanned copies, microfilm, microfiche, or other accurate reproductions
of the original records), or electronic records.
(B) You must sign and date records concerning your FSVP upon initial
completion and upon any modification of the FSVP.
(C) All records must be legible and stored to prevent deterioration
or loss.
(ii) Availability. (A) You must make all records required under this
subpart available promptly to an authorized FDA representative, upon
request, for inspection and copying. Upon FDA request, you must provide
within a reasonable time an English translation of records maintained in
a language other than English.
(B) Offsite storage of records, including records retained by other
entities in accordance with paragraph (c) of this section, is permitted
if such records can be retrieved and provided onsite within 24 hours of
request for official review. Electronic records are considered to be
onsite if they are accessible from an onsite location.
(C) If requested in writing by FDA, you must send records to the
Agency electronically or through another means that delivers the records
promptly, rather than making the records available for review at your
place of business.
(iii) Record retention. (A) Except as specified in paragraph
(b)(5)(iii)(B) or (C) of this section, you must retain records required
under this subpart for a period of at least 2 years after you created or
obtained the records.
(B) If you are subject to paragraph (c) of this section, you must
retain records
[[Page 83]]
that relate to your processes and procedures, including the results of
evaluations of foreign suppliers and procedures to ensure the use of
approved suppliers, for at least 2 years after their use is discontinued
(e.g., because you have reevaluated a foreign supplier's compliance
history or changed your procedures to ensure the use of approved
suppliers).
(C) You must retain for at least 3 years records that you rely on
during the 3-year period preceding the applicable calendar year to
support your status as a very small importer.
(iv) Electronic records. 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 part, but that also are required under other
applicable statutory provisions or regulations, remain subject to part
11.
(v) Use of existing records. (A) You do not need to duplicate
existing records you have (e.g., records that you maintain to comply
with other Federal, State, or local regulations) if they contain all of
the information required by this subpart. You may supplement any such
existing records as necessary to include all of the information required
by this subpart.
(B) You do not need to maintain the information required by this
subpart in one set of records. If existing records you have contain some
of the required information, you may maintain any new information
required by this subpart either separately or combined with the existing
records.
(vi) Public disclosure. Records obtained by FDA in accordance with
this subpart are subject to the disclosure requirements under part 20 of
this chapter.
(c) Requirements for importers of food from certain small foreign
suppliers. The following additional requirements apply if you are
importing food from certain small foreign suppliers as specified in
paragraph (a)(2) of this section and you are not a very small importer:
(1) Evaluation of foreign supplier compliance history--(i) Initial
evaluation. Except as specified in paragraph (c)(1)(iii) of this
section, in approving your foreign suppliers, you must evaluate the
applicable FDA food safety regulations and information relevant to the
foreign supplier's compliance with those regulations, including whether
the foreign supplier is the subject of an FDA warning letter, import
alert, or other FDA compliance action related to food safety, and
document the evaluation. You may also consider other factors relevant to
a foreign supplier's performance, including those specified in Sec.
1.505(a)(1)(iii)(A) and (C).
(ii) Reevaluation of foreign supplier compliance history. (A) Except
as specified in paragraph (c)(1)(iii) of this section, you must promptly
reevaluate the concerns associated with the foreign supplier's
compliance history when you become aware of new information about the
matters in paragraph (c)(1)(i) of this section, and the reevaluation
must be documented. If you determine that the concerns associated with
importing a food from a foreign supplier have changed, you must promptly
determine (and document) whether it is appropriate to continue to import
the food from the foreign supplier.
(B) If at the end of any 3-year period you have not reevaluated the
concerns associated with the foreign supplier's compliance history in
accordance with paragraph (c)(1)(ii)(A) of this section, you must
reevaluate those concerns and take other appropriate actions, if
necessary, in accordance with paragraph (c)(1)(ii)(A). You must document
your reevaluation and any subsequent actions you take in accordance with
paragraph (c)(1)(ii)(A).
(iii) Review of another entity's evaluation or reevaluation of
foreign supplier compliance history. If an entity other than the foreign
supplier has, using a qualified individual, performed the evaluation
described in paragraph (c)(1)(i) of this section or the reevaluation
described in paragraph (c)(1)(ii), you may meet the requirements of the
applicable paragraph by reviewing and assessing the evaluation or
reevaluation conducted by that entity. You must document your review and
assessment, including documenting that the
[[Page 84]]
evaluation or reevaluation was conducted by a qualified individual.
(2) Approval of foreign supplier. You must approve your foreign
suppliers on the basis of the evaluation you conducted under paragraph
(c)(1)(i) of this section or that you review and assess under paragraph
(c)(1)(iii) of this section, and document your approval.
(3) Use of approved foreign suppliers. (i) You must establish and
follow written procedures to ensure that you import foods only from
foreign suppliers you have approved based on the evaluation conducted
under paragraph (c)(1)(i) of this section (or, when necessary and
appropriate, on a temporary basis from unapproved foreign suppliers
whose foods you subject to adequate verification activities before
importing the food). You must document your use of these procedures.
(ii) You may rely on an entity other than the foreign supplier to
establish the procedures and perform and document the activities
required under paragraph (c)(3)(i) of this section provided that you
review and assess that entity's documentation of the procedures and
activities, and you document your review and assessment.
[80 FR 74340, Nov. 27, 2015, as amended at 81 FR 25327, Apr. 28, 2016]
Sec. 1.513 What FSVP may I have if I am importing certain food from
a country with an officially recognized or equivalent food safety system?
(a) General. (1) If you meet the conditions and requirements of
paragraph (b) of this section for a food of the type specified in
paragraph (a)(2) of this section that you are importing, then you are
not required to comply with the requirements in Sec. Sec. 1.504 through
1.508. You would still be required to comply with the requirements in
Sec. Sec. 1.503, 1.509, and 1.510.
(2) This section applies to food that is not intended for further
manufacturing/processing, including packaged food products and raw
agricultural commodities that will not be commercially processed further
before consumption.
(b) Conditions and requirements. (1) Before importing a food from
the foreign supplier and annually thereafter, you must document that the
foreign supplier is in, and under the regulatory oversight of, a country
whose food safety system FDA has officially recognized as comparable or
determined to be equivalent to that of the United States, and that the
food is within the scope of that official recognition or equivalency
determination.
(2) Before importing a food from the foreign supplier, you must
determine and document whether the foreign supplier of the food is in
good compliance standing with the food safety authority of the country
in which the foreign supplier is located. You must continue to monitor
whether the foreign supplier is in good compliance standing and promptly
review any information obtained. If the information indicates that food
safety hazards associated with the food are not being significantly
minimized or prevented, you must take prompt corrective action. The
appropriate corrective action will depend on the circumstances but could
include discontinuing use of the foreign supplier. You must document any
corrective actions that you undertake in accordance with this paragraph
(b)(2).
Sec. 1.514 What are some consequences of failing to comply with the
requirements of this subpart?
(a) Refusal of admission. An article of food is subject to refusal
of admission under section 801(a)(3) of the Federal Food, Drug, and
Cosmetic Act if it appears that the importer of that food fails to
comply with this subpart with respect to that food. If there is no U.S.
owner or consignee of an article of food at the time the food is offered
for entry into the United States, the article of food may not be
imported into the United States unless the foreign owner or consignee
has appropriately designated a U.S. agent or representative as the
importer in accordance with Sec. 1.500.
(b) Prohibited act. The importation or offering for importation into
the United States of an article of food without the importer having an
FSVP that meets the requirements of section 805 of the Federal Food,
Drug, and Cosmetic Act, including the requirements of this subpart, is
prohibited under section 301(zz) of the Federal Food, Drug, and Cosmetic
Act.
[[Page 85]]
Subpart M_Accreditation of Third-Party Certification Bodies To Conduct
Food Safety Audits and To Issue Certifications
Source: 80 FR 74650, Nov. 27, 2015, unless otherwise noted.
Sec. 1.600 What definitions apply to this subpart?
(a) The FD&C Act means the Federal Food, Drug, and Cosmetic Act.
(b) Except as otherwise defined in paragraph (c) of this section,
the definitions of terms in section 201 of the FD&C Act apply when the
terms are used in this subpart.
(c) In addition, for the purposes of this subpart:
Accreditation means a determination by a recognized accreditation
body (or, in the case of direct accreditation, by FDA) that a third-
party certification body meets the applicable requirements of this
subpart.
Accreditation body means an authority that performs accreditation of
third-party certification bodies.
Accredited third-party certification body means a third-party
certification body that a recognized accreditation body (or, in the case
of direct accreditation, FDA) has determined meets the applicable
requirements of this subpart and is accredited to conduct food safety
audits and to issue food or facility certifications to eligible
entities. An accredited third-party certification body has the same
meaning as accredited third-party auditor as defined in section
808(a)(4) of the FD&C Act.
Assessment means:
(i) With respect to an accreditation body, an evaluation by FDA of
the competency and capacity of the accreditation body under the
applicable requirements of this subpart for the defined scope of
recognition. An assessment of the competency and capacity of the
accreditation body involves evaluating the competency and capacity of
the operations of the accreditation body that are relevant to decisions
on recognition and, if recognized, an evaluation of its performance and
the validity of its accreditation decisions under the applicable
requirements of this subpart.
(ii) With respect to a third-party certification body, an evaluation
by a recognized accreditation body (or, in the case of direct
accreditation, FDA) of the competency and capacity of a third-party
certification body under the applicable requirements of this subpart for
the defined scope of accreditation. An assessment of the competency and
capacity of the third-party certification body involves evaluating the
competency and capacity of the operations of the third-party
certification body that are relevant to decisions on accreditation and,
if accredited, an evaluation of its performance and the validity of its
audit results and certification decisions under the applicable
requirements of this subpart.
Audit means the systematic and functionally independent examination
of an eligible entity under this subpart by an accredited third-party
certification body or by FDA. An audit conducted under this subpart is
not considered an inspection under section 704 of the FD&C Act.
Audit agent means an individual who is an employee or other agent of
an accredited third-party certification body who, although not
individually accredited, is qualified to conduct food safety audits on
behalf of an accredited third-party certification body. An audit agent
includes a contractor of the accredited third-party certification body
but excludes subcontractors or other agents under outsourcing
arrangements for conducting food safety audits without direct control by
the accredited third-party certification body.
Consultative audit means an audit of an eligible entity:
(i) To determine whether such entity is in compliance with the
applicable food safety requirements of the FD&C Act, FDA regulations,
and industry standards and practices;
(ii) The results of which are for internal purposes only; and
(iii) That is conducted in preparation for a regulatory audit; only
the results of a regulatory audit may form the basis for issuance of a
food or facility certification under this subpart.
[[Page 86]]
Direct accreditation means accreditation of a third-party
certification body by FDA.
Eligible entity means a foreign entity in the import supply chain of
food for consumption in the United States that chooses to be subject to
a food safety audit under this subpart conducted by an accredited third-
party certification body. Eligible entities include foreign facilities
required to be registered under subpart H of this part.
Facility means any structure, or structures of an eligible entity
under one ownership at one general physical location, or, in the case of
a mobile facility, traveling to multiple locations, that manufactures/
processes, packs, holds, grows, harvests, or raises animals for food for
consumption in the United States. Transport vehicles are not facilities
if they hold food only in the usual course of business as carriers. A
facility may consist of one or more contiguous structures, and a single
building may house more than one distinct facility if the facilities are
under separate ownership. The private residence of an individual is not
a facility. Non-bottled water drinking water collection and distribution
establishments and their structures are not facilities. Facilities for
the purposes of this subpart are not limited to facilities required to
be registered under subpart H of this part.
Facility certification means an attestation, issued for purposes of
section 801(q) or 806 of the FD&C Act by an accredited third-party
certification body, after conducting a regulatory audit and any other
activities necessary to establish whether a facility complies with the
applicable food safety requirements of the FD&C Act and FDA regulations.
Food has the meaning given in section 201(f) of the FD&C Act, except
that food does not include pesticides (as defined in 7 U.S.C. 136(u)).
Food certification means an attestation, issued for purposes of
section 801(q) of the FD&C Act by an accredited third-party
certification body, after conducting a regulatory audit and any other
activities necessary to establish whether a food of an eligible entity
complies with the applicable food safety requirements of the FD&C Act
and FDA regulations.
Food safety audit means a regulatory audit or a consultative audit
that is conducted to determine compliance with the applicable food
safety requirements of the FD&C Act, FDA regulations, and for
consultative audits, also includes conformance with industry standards
and practices. An eligible entity must declare that an audit is to be
conducted as a regulatory audit or consultative audit at the time of
audit planning and the audit will be conducted on an unannounced basis
under this subpart.
Foreign cooperative means an autonomous association of persons,
identified as members, who are united through a jointly owned enterprise
to aggregate food from member growers or processors that is intended for
export to the United States.
Recognized accreditation body means an accreditation body that FDA
has determined meets the applicable requirements of this subpart and is
authorized to accredit third-party certification bodies under this
subpart.
Regulatory audit means an audit of an eligible entity:
(i) To determine whether such entity is in compliance with the
applicable food safety requirements of the FD&C Act and FDA regulations;
and
(ii) The results of which are used in determining eligibility for
certification under section 801(q) or under section 806 of the FD&C Act.
Relinquishment means:
(i) With respect to an accreditation body, a decision to cede
voluntarily its authority to accredit third-party certification bodies
as a recognized accreditation body prior to expiration of its
recognition under this subpart; and
(ii) With respect to a third-party certification body, a decision to
cede voluntarily its authority to conduct food safety audits and to
issue food and facility certifications to eligible entities as an
accredited third-party certification body prior to expiration of its
accreditation under this subpart.
Self-assessment means an evaluation conducted by a recognized
accreditation body or by an accredited third-
[[Page 87]]
party certification body of its competency and capacity under the
applicable requirements of this subpart for the defined scope of
recognition or accreditation. For recognized accreditation bodies this
involves evaluating the competency and capacity of the entire operations
of the accreditation body and the validity of its accreditation
decisions under the applicable requirements of this subpart. For
accredited third-party certification bodies this involves evaluating the
competency and capacity of the entire operations of the third-party
certification body and the validity of its audit results under the
applicable requirements of this subpart.
Third-party certification body has the same meaning as third-party
auditor as that term is defined in section 808(a)(3) of the FD&C Act and
means a foreign government, agency of a foreign government, foreign
cooperative, or any other third party that is eligible to be considered
for accreditation to conduct food safety audits and to certify that
eligible entities meet the applicable food safety requirements of the
FD&C Act and FDA regulations. A third-party certification body may be a
single individual or an organization. Once accredited, a third-party
certification body may use audit agents to conduct food safety audits.
Sec. 1.601 Who is subject to this subpart?
(a) Accreditation bodies. Any accreditation body seeking recognition
from FDA to accredit third-party certification bodies to conduct food
safety audits and to issue food and facility certifications under this
subpart.
(b) Third-party certification bodies. Any third-party certification
body seeking accreditation from a recognized accreditation body or
direct accreditation by FDA for:
(1) Conducting food safety audits; and
(2) Issuing certifications that may be used in satisfying a
condition of admissibility of an article of food under section 801(q) of
the FD&C Act; or issuing a facility certification for meeting the
eligibility requirements for the Voluntary Qualified Importer Program
under section 806 of the FD&C Act.
(c) Eligible entities. Any eligible entity seeking a food safety
audit or a food or facility certification from an accredited third-party
certification body under this subpart.
(d) Limited exemptions from section 801(q) of the FD&C Act--(1)
Alcoholic beverages. (i) Any certification required under section 801(q)
of the FD&C Act does not apply with respect to alcoholic beverages from
an eligible entity that is a facility that meets the following two
conditions:
(A) Under the Federal Alcohol Administration Act (27 U.S.C. 201 et
seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986
(26 U.S.C. 5001 et seq.), the facility is a foreign facility of a type
that, if it were a domestic facility, would require obtaining a permit
from, registering with, or obtaining approval of a notice or application
from the Secretary of the Treasury as a condition of doing business in
the United States; and
(B) Under section 415 of the FD&C Act, the facility is required to
register as a facility because it is engaged in manufacturing/processing
one or more alcoholic beverages.
(ii) Any certification required under section 801(q) of the FD&C Act
does not apply with respect to food that is not an alcoholic beverage
that is received and distributed by a facility described in paragraph
(d)(1)(i) of this section, provided such food:
(A) Is received and distributed in prepackaged form that prevents
any direct human contact with such food; and
(B) Constitutes not more than 5 percent of the overall sales of the
facility, as determined by the Secretary of the Treasury.
(iii) Any certification required under section 801(q) of the FD&C
Act does not apply with respect to raw materials or other ingredients
that are imported for use in alcoholic beverages provided that:
(A) The imported raw materials or other ingredients are used in the
manufacturing/processing, packing, or holding of alcoholic beverages;
(B) Such manufacturing/processing, packing, or holding is performed
by the importer;
(C) The importer is required to register under section 415 of the
Federal Food, Drug, and Cosmetic Act; and
[[Page 88]]
(D) The importer is exempt from the regulations in part 117 of this
chapter in accordance with Sec. 117.5(i).
(2) Certain meat, poultry, and egg products. Any certification
required under section 801(q) of the FD&C Act does not apply with
respect to:
(i) Meat food products that at the time of importation are subject
to the requirements of the United States Department of Agriculture
(USDA) under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);
(ii) Poultry products that at the time of importation are subject to
the requirements of the USDA under the Poultry Products Inspection Act
(21 U.S.C. 451 et seq.); and
(iii) Egg products that at the time of importation are subject to
the requirements of the USDA under the Egg Products Inspection Act (21
U.S.C. 1031 et seq.).
Recognition of Accreditation Bodies Under This Subpart
Sec. 1.610 Who is eligible to seek recognition?
An accreditation body is eligible to seek recognition by FDA if it
can demonstrate that it meets the requirements of Sec. Sec. 1.611
through 1.615. The accreditation body may use documentation of
conformance with International Organization for Standardization/
International Electrotechnical Commission (ISO/IEC) 17011:2004,
supplemented as necessary, in meeting the applicable requirements of
this subpart.
Sec. 1.611 What legal authority must an accreditation body have to
qualify for recognition?
(a) An accreditation body seeking recognition must demonstrate that
it has the authority (as a governmental entity or as a legal entity with
contractual rights) to perform assessments of a third-party
certification body as are necessary to determine its capability to
conduct audits and certify food facilities and food, including authority
to:
(1) Review any relevant records;
(2) Conduct onsite assessments of the performance of third-party
certification bodies, such as by witnessing the performance of a
representative sample of its agents (or, in the case of a third-party
certification body that is an individual, such individual) conducting a
representative sample of audits;
(3) Perform any reassessments or surveillance necessary to monitor
compliance of accredited third-party certification bodies; and
(4) Suspend, withdraw, or reduce the scope of accreditation for
failure to comply with the requirements of accreditation.
(b) An accreditation body seeking recognition must demonstrate that
it is capable of exerting the authority (as a governmental entity or as
a legal entity with contractual rights) necessary to meet the applicable
requirements of this subpart, if recognized.
Sec. 1.612 What competency and capacity must an accreditation body have
to qualify for recognition?
An accreditation body seeking recognition must demonstrate that it
has:
(a) The resources required to adequately implement its accreditation
program, including:
(1) Adequate numbers of employees and other agents with relevant
knowledge, skills, and experience to effectively evaluate the
qualifications of third-party certification bodies seeking accreditation
and to effectively monitor the performance of accredited third-party
certification bodies; and
(2) Adequate financial resources for its operations; and
(b) The capability to meet the applicable assessment and monitoring
requirements, the reporting and notification requirements, and the
procedures of this subpart, if recognized.
Sec. 1.613 What protections against conflicts of interest must an
accreditation body have to qualify for recognition?
An accreditation body must demonstrate that it has:
(a) Implemented written measures to protect against conflicts of
interest between the accreditation body (and its officers, employees,
and other agents involved in accreditation activities) and any third-
party certification body (and its officers, employees, and other agents
involved in auditing and certification activities) seeking accreditation
[[Page 89]]
from, or accredited by, such accreditation body; and
(b) The capability to meet the applicable conflict of interest
requirements of this subpart, if recognized.
Sec. 1.614 What quality assurance procedures must an accreditation
body have to qualify for recognition?
An accreditation body seeking recognition must demonstrate that it
has:
(a) Implemented a written program for monitoring and evaluating the
performance of its officers, employees, and other agents and its
accreditation program, including procedures to:
(1) Identify areas in its accreditation program or performance where
deficiencies exist; and
(2) Quickly execute corrective actions that effectively address
deficiencies when identified; and
(b) The capability to meet the applicable quality assurance
requirements of this subpart, if recognized.
Sec. 1.615 What records procedures must an accreditation body have to
qualify for recognition?
An accreditation body seeking recognition must demonstrate that it
has:
(a) Implemented written procedures to establish, control, and retain
records (including documents and data) for the period of time necessary
to meet its contractual and legal obligations pertaining to this subpart
and to provide an adequate basis for evaluating its program and
performance; and
(b) The capability to meet the applicable reporting and notification
requirements of this subpart, if recognized.
Requirements for Accreditation Bodies That Have Been Recognized Under
This Subpart
Sec. 1.620 How must a recognized accreditation body evaluate third-party
certification bodies seeking accreditation?
(a) Prior to accrediting a third-party certification body under this
subpart, a recognized accreditation body must perform, at a minimum, the
following:
(1) In the case of a foreign government or an agency of a foreign
government, such reviews and audits of the government's or agency's food
safety programs, systems, and standards as are necessary to determine
that it meets the eligibility requirements of Sec. 1.640(b).
(2) In the case of a foreign cooperative or any other third-party
seeking accreditation as a third-party certification body, such reviews
and audits of the training and qualifications of agents conducting
audits for such cooperative or other third party (or in the case of a
third-party certification body that is an individual, such individual)
and such reviews of internal systems and any other investigation of the
cooperative or other third party necessary to determine that it meets
the eligibility requirements of Sec. 1.640(c).
(3) In conducting a review and audit under paragraph (a)(1) or (2)
of this section, an observation of a representative sample of onsite
audits examining compliance with the applicable food safety requirements
of the FD&C Act and FDA regulations as conducted by the third-party
certification body or its agents (or, in the case of a third-party
certification body that is an individual, such individual).
(b) A recognized accreditation body must require a third-party
certification body, as a condition of accreditation under this subpart,
to comply with the reports and notification requirements of Sec. Sec.
1.652 and 1.656 and to agree to submit to FDA, electronically and in
English, any food or facility certifications it issues for purposes of
sections 801(q) or 806 of the FD&C Act.
(c) A recognized accreditation body must maintain records on any
denial of accreditation (in whole or in part) and on any withdrawal,
suspension, or reduction in scope of accreditation of a third-party
certification body under this subpart. The records must include the name
and contact information for the third-party certification body; the date
of the action; the scope of accreditation denied, withdrawn, suspended,
or reduced; and the basis for such action.
(d) A recognized accreditation body must notify any third-party
certification body of an adverse decision associated with its
accreditation under
[[Page 90]]
this subpart, including denial of accreditation or the withdrawal,
suspension, or reduction in the scope of its accreditation. The
recognized accreditation body must establish and implement written
procedures for receiving and addressing appeals from any third-party
certification body challenging such an adverse decision and for
investigating and deciding on appeals in a fair and meaningful manner.
The appeals procedures must provide similar protections to those offered
by FDA under Sec. Sec. 1.692 and 1.693, and include requirements to:
(1) Make the appeals procedures publicly available;
(2) Use competent persons, who may or may not be external to the
recognized accreditation body, who are free from bias or prejudice and
have not participated in the accreditation decision or be subordinate to
a person who has participated in the accreditation decision to
investigate and decide appeals;
(3) Advise third-party certification bodies of the final decisions
on their appeals; and
(4) Maintain records under Sec. 1.625 of appeals, final decisions
on appeals, and the bases for such decisions.
Sec. 1.621 How must a recognized accreditation body monitor the
performance of third-party certification bodies it accredited?
(a) A recognized accreditation body must annually conduct a
comprehensive assessment of the performance of each third-party
certification body it accredited under this subpart by reviewing the
accredited third-party certification body's self-assessments (including
information on compliance with the conflict of interest requirements of
Sec. Sec. 1.643 and 1.657); its regulatory audit reports and
notifications submitted to FDA under Sec. 1.656; and any other
information reasonably available to the recognized accreditation body
regarding the compliance history of eligible entities the accredited
third-party certification body certified under this subpart; or that is
otherwise relevant to a determination whether the accredited third-party
certification body is in compliance with this subpart.
(b) No later than 1 year after the initial date of accreditation of
the third-party certification body and every 2 years thereafter for
duration of its accreditation under this subpart, a recognized
accreditation body must conduct onsite observations of a representative
sample of regulatory audits performed by the third-party certification
body (or its audit agents) (or, in the case of a third-party
certification body that is an individual, such individual) accredited
under this subpart and must visit the accredited third-party
certification body's headquarters (or other location that manages audit
agents conducting food safety audits under this subpart, if different
than its headquarters). The recognized accreditation body will consider
the results of such observations and visits in the annual assessment of
the accredited third-party certification body required by paragraph (a)
of this section.
Sec. 1.622 How must a recognized accreditation body monitor its own
performance?
(a) A recognized accreditation body must annually, and as required
under Sec. 1.664(g), conduct a self-assessment that includes evaluation
of compliance with this subpart, including:
(1) The performance of its officers, employees, or other agents
involved in accreditation activities and the degree of consistency in
conducting accreditation activities;
(2) The compliance of the recognized accreditation body and its
officers, employees, and other agents involved in accreditation
activities, with the conflict of interest requirements of Sec. 1.624;
and
(3) If requested by FDA, any other aspects of its performance
relevant to a determination whether the recognized accreditation body is
in compliance with this subpart.
(b) As a means to evaluate the recognized accreditation body's
performance, the self-assessment must include onsite observation of
regulatory audits of a representative sample of third-party
certification bodies it accredited under this subpart. In meeting this
requirement, the recognized accreditation body may use the results of
onsite observations performed under Sec. 1.621(b).
[[Page 91]]
(c) Based on the evaluations conducted under paragraphs (a) and (b)
of this section, the recognized accreditation body must:
(1) Identify any area(s) where deficiencies exist;
(2) Quickly implement corrective action(s) that effectively address
those deficiencies; and
(3) Establish and maintain records of any such corrective action(s)
under Sec. 1.625.
(d) The recognized accreditation body must prepare, and as required
by Sec. 1.623(b) submit, a written report of the results of its self-
assessment that includes the following elements. Documentation of
conformance to ISO/IEC 17011:2004 may be used, supplemented as
necessary, in meeting the requirements of this paragraph.
(1) A description of any corrective actions taken under paragraph
(c) of this section;
(2) A statement disclosing the extent to which the recognized
accreditation body, and its officers, employees, and other agents
involved in accreditation activities, complied with the conflict of
interest requirements in Sec. 1.624; and
(3) A statement attesting to the extent to which the recognized
accreditation body complied with applicable requirements of this
subpart.
Sec. 1.623 What reports and notifications must a recognized
accreditation body submit to FDA?
(a) Reporting results of assessments of accredited third-party
certification body performance. A recognized accreditation body must
submit to FDA electronically, in English, a report of the results of any
assessment conducted under Sec. 1.621, no later than 45 days after
completing such assessment. The report must include an up-to-date list
of any audit agents used by the accredited third-party certification
body to conduct food safety audits under this subpart.
(b) Reporting results of recognized accreditation body self-
assessments. A recognized accreditation body must submit to FDA
electronically, in English:
(1) A report of the results of an annual self-assessment required
under Sec. 1.622, no later than 45 days after completing such self-
assessment; and
(2) For a recognized accreditation body subject to Sec.
1.664(g)(1), a report of such self-assessment to FDA within 60 days of
the third-party certification body's withdrawal. A recognized
accreditation body may use a report prepared for conformance to ISO/IEC
17011:2004, supplemented as necessary, in meeting the requirements this
section.
(c) Immediate notification to FDA. A recognized accreditation body
must notify FDA electronically, in English, immediately upon:
(1) Granting (including expanding the scope of) accreditation to a
third-party certification body under this subpart, and include:
(i) The name, address, telephone number, and email address of the
accredited third-party certification body;
(ii) The name of one or more officers of the accredited third-party
certification body;
(iii) A list of the accredited third-party certification body's
audit agents; and
(iv) The scope of accreditation, the date on which it was granted,
and its expiration date.
(2) Withdrawing, suspending, or reducing the scope of an
accreditation under this subpart, and include:
(i) The basis for such action; and
(ii) Any additional changes to accreditation information previously
submitted to FDA under paragraph (c)(1) of this section.
(3) Determining that a third-party certification body it accredited
failed to comply with Sec. 1.653 in issuing a food or facility
certification under this subpart, and include:
(i) The basis for such determination; and
(ii) Any changes to accreditation information previously submitted
to FDA under paragraph (c)(1) of this section.
(d) Other notification to FDA. A recognized accreditation body must
notify FDA electronically, in English, within 30 days after:
(1) Denying accreditation (in whole or in part) under this subpart
and include:
(i) The name, address, telephone number, and email address of the
third-party certification body;
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(ii) The name of one or more officers of the third-party
certification body;
(iii) The scope of accreditation requested; and
(iv) The scope and basis for such denial.
(2) Making any significant change that would affect the manner in
which it complies with the applicable requirements of this subpart and
include:
(i) A description of the change; and
(ii) An explanation for the purpose of the change.
Sec. 1.624 How must a recognized accreditation body protect against
conflicts of interest?
(a) A recognized accreditation body must implement a written program
to protect against conflicts of interest between the recognized
accreditation body (and its officers, employees, and other agents
involved in accreditation activities) and any third-party certification
body (and its officers, employees, and other agents involved in auditing
and certification activities) seeking accreditation from, or accredited
by, such recognized accreditation body, including the following:
(1) Ensuring that the recognized accreditation body (and its
officers, employees, or other agents involved in accreditation
activities) does not own or have a financial interest in, manage, or
otherwise control the third-party certification body (or any affiliate,
parent, or subsidiary); and
(2) Prohibiting officers, employees, or other agents involved in
accreditation activities of the recognized accreditation body from
accepting any money, gift, gratuity, or item of value from the third-
party certification body.
(3) The items specified in paragraph (a)(2) of this section do not
include:
(i) Money representing payment of fees for accreditation services
and reimbursement of direct costs associated with an onsite assessment
of the third-party certification body; or
(ii) Lunch of de minimis value provided during the course of an
assessment and on the premises where the assessment is conducted, if
necessary to facilitate the efficient conduct of the assessment.
(b) A recognized accreditation body may accept the payment of fees
for accreditation services and the reimbursement of direct costs
associated with assessment of a certification body only after the date
on which the report of such assessment was completed or the date of
which the accreditation was issued, whichever comes later. Such payment
is not considered a conflict of interest for purposes of paragraph (a)
of this section.
(c) The financial interests of the spouses and children younger than
18 years of age of a recognized accreditation body's officers,
employees, and other agents involved in accreditation activities will be
considered the financial interests of such officers, employees, and
other agents involved in accreditation activities.
(d) A recognized accreditation body must maintain on its Web site an
up-to-date list of the third-party certification bodies it accredited
under this subpart and must identify the duration and scope of each
accreditation and the date(s) on which the accredited third-party
certification body paid any fee or reimbursement associated with such
accreditation. If the accreditation of a certification body is
suspended, withdrawn, or reduced in scope, this list must also include
the date of suspension, withdrawal, or reduction in scope and maintain
that information for the duration of accreditation or until the
suspension is lifted, the certification body is reaccredited, or the
scope of accreditation is reinstated, whichever comes first.
Sec. 1.625 What records requirements must an accreditation body that
has been recognized meet?
(a) An accreditation body that has been recognized must maintain
electronically for 5 years records created while it is recognized
(including documents and data) demonstrating its compliance with this
subpart, including records relating to:
(1) Applications for accreditation and renewal of accreditation
under Sec. 1.660;
(2) Decisions to grant, deny, suspend, withdraw, or expand or reduce
the scope of an accreditation;
(3) Challenges to adverse accreditation decisions under Sec.
1.620(c);
(4) Its monitoring of accredited third-party certification bodies
under Sec. 1.621;
[[Page 93]]
(5) Self-assessments and corrective actions under Sec. 1.622;
(6) Regulatory audit reports, including any supporting information,
that an accredited third-party certification body may have submitted;
(7) Any reports or notifications to FDA under Sec. 1.623, including
any supporting information; and
(8) Records of fee payments and reimbursement of direct costs.
(b) An accreditation body that has been recognized must make records
required by paragraph (a) of this section available for inspection and
copying promptly upon written request of an authorized FDA officer or
employee at the place of business of the accreditation body or at a
reasonably accessible location. If the records required by paragraph (a)
of this section are requested by FDA electronically, the records must be
submitted to FDA electronically not later than 10 business days after
the date of the request. Additionally, if the requested records are
maintained in a language other than English, the accreditation body must
electronically submit an English translation within a reasonable time.
(c) An accreditation body that has been recognized must not prevent
or interfere with FDA's access to its accredited third-party
certification bodies and the accredited third-party certification body
records required by Sec. 1.658.
Procedures for Recognition of Accreditation Bodies Under This Subpart
Sec. 1.630 How do I apply to FDA for recognition or renewal of
recognition?
(a) Applicant for recognition. An accreditation body seeking
recognition must submit an application demonstrating that it meets the
eligibility requirements in Sec. 1.610.
(b) Applicant for renewal of recognition. An accreditation body
seeking renewal of its accreditation must submit a renewal application
demonstrating that it continues to meet the requirements of this
subpart.
(c) Submission. Recognition and renewal applications and any
documents provided as part of the application process must be submitted
electronically, in English. An applicant must provide any translation
and interpretation services needed by FDA during the processing of the
application, including during onsite assessments of the applicant by
FDA.
(d) Signature. Recognition and renewal applications must be signed
in the manner designated by FDA, by an individual authorized to act on
behalf of the applicant for purposes of seeking recognition or renewal
of recognition.
Sec. 1.631 How will FDA review my application for recognition or
renewal of recognition and what happens once FDA decides on my application?
(a) Review of recognition or renewal application. FDA will examine
an accreditation body's recognition or renewal application for
completeness and notify the applicant of any deficiencies. FDA will
review an accreditation body's recognition or renewal application on a
first in, first out basis according to the date on which the completed
application was submitted; however, FDA may prioritize the review of
specific applications to meet the needs of the program.
(b) Evaluation of recognition or renewal. FDA will evaluate any
completed recognition or renewal application to determine whether the
applicant meets the applicable requirements of this subpart. Such
evaluation may include an onsite assessment of the accreditation body.
FDA will notify the applicant, in writing, regarding whether the
application has been approved or denied. FDA may make such notification
electronically. If FDA does not reach a final decision on a renewal
application before an accreditation body's recognition terminates by
expiration, FDA may extend such recognition for a specified period of
time or until the Agency reaches a final decision on the renewal
application.
(c) Issuance of recognition. FDA will notify an applicant that its
recognition or renewal application has been approved through issuance of
recognition that will list any limitations associated with the
recognition.
(d) Issuance of denial of recognition or renewal application. FDA
will notify an applicant that its recognition or renewal application has
been denied
[[Page 94]]
through issuance of a denial of recognition or denial of a renewal
application that will state the basis for such denial and provide the
procedures for requesting reconsideration of the application under Sec.
1.691.
(e) Notice of records custodian after denial of an application for
renewal of recognition. An applicant whose renewal application was
denied must notify FDA electronically, in English, within 10 business
days of the date of issuance of a denial of a renewal application, of
the name and contact information of the custodian who will maintain the
records required by Sec. 1.625(a) and make them available to FDA as
required by Sec. 1.625(b). The contact information for the custodian
must include, at a minimum, an email address and the physical address
where the records required by Sec. 1.625(a) will be located.
(f) Effect of denial of an application for renewal of recognition of
an accreditation body on accredited third-party certification bodies.
(1) FDA will issue a notice of the denial of a recognition renewal to
any third-party certification bodies accredited by the accreditation
body whose renewal application was denied. The third-party certification
body's accreditation will remain in effect so long as the third-party
certification body:
(i) No later than 60 days after FDA's issuance of the notice of the
denial of recognition renewal, conducts a self-assessment under Sec.
1.655 and reports the results of the self-assessment to FDA under Sec.
1.656(b); and
(ii) No later than 1 year after issuance of the notice of denial of
recognition renewal or the original date of the expiration of the
accreditation, whichever comes first, becomes accredited by another
recognized accreditation body or by FDA through direct accreditation.
(2) FDA may withdraw the accreditation of a third-party
certification body whenever FDA determines there is good cause for
withdrawal of accreditation under Sec. 1.664(c).
(g) Effect of denial of an application for renewal of recognition of
an accreditation body on food or facility certifications issued to
eligible entities. A food or facility certification issued by a third-
party certification body accredited by a recognized accreditation body
prior to issuance of a denial of the renewal application will remain in
effect until the certification expires. If FDA has reason to believe
that a certification issued for purposes of section 801(q) or 806 of the
FD&C Act is not valid or reliable, FDA may refuse to consider the
certification in determining the admissibility of the article of food
for which the certification was offered or in determining the importer's
eligibility for participation in the voluntary qualified importer
program (VQIP).
(h) Public notice of denial of an application for renewal of
recognition of an accreditation body. FDA will provide notice on the Web
site described in Sec. 1.690 of the date of issuance of a denial of a
renewal application and will describe the basis for the denial.
Sec. 1.632 What is the duration of recognition?
FDA may grant recognition of an accreditation body for a period not
to exceed 5 years from the date of recognition.
Sec. 1.633 How will FDA monitor recognized accreditation bodies?
(a) FDA will evaluate the performance of each recognized
accreditation body to determine its compliance with the applicable
requirements of this subpart. Such assessment must occur by at least 4
years after the date of recognition for a 5-year recognition period, or
by no later than the mid-term point for a recognition period of less
than 5 years. FDA may conduct additional assessments of a recognized
accreditation body at any time.
(b) An FDA assessment of a recognized accreditation body may include
onsite assessments of a representative sample of third-party
certification bodies the recognized accreditation body accredited and
onsite audits of a representative sample of eligible entities certified
by such third-party certification bodies under this subpart. These may
be conducted at any time and, as FDA determines necessary or
appropriate, may occur without the recognized accreditation body or, in
the case of an audit of an eligible entity, the accredited third-party
certification body present.
[[Page 95]]
Sec. 1.634 When will FDA revoke recognition?
(a) Grounds for revocation of recognition. FDA will revoke the
recognition of an accreditation body found not to be in compliance with
the requirements of this subpart, including for any one or more of the
following:
(1) Refusal by the accreditation body to allow FDA to access records
required by Sec. 1.625, or to conduct an assessment or investigation of
the accreditation body or of a third-party certification body it
accredited to ensure the accreditation body's continued compliance with
the requirements of this subpart.
(2) Failure to take timely and necessary corrective action when:
(i) The accreditation of a third-party certification body it
accredited is withdrawn by FDA under Sec. 1.664(a);
(ii) A significant deficiency is identified through self-assessment
under Sec. 1.622, monitoring under Sec. 1.621, or self-assessment by
one or more of its accredited third-party certification bodies under
Sec. 1.655; or
(iii) Directed to do so by FDA to ensure compliance with this
subpart.
(3) A determination by FDA that the accreditation body has committed
fraud or has submitted material false statements to the Agency.
(4) A determination by FDA that there is otherwise good cause for
revocation, including:
(i) Demonstrated bias or lack of objectivity when conducting
activities under this subpart; or
(ii) Failure to adequately support one or more decisions to grant
accreditation under this subpart.
(iii) Failure to pay the annual user fee within 90 days of the
payment due date, as specified in Sec. 1.725(b)(3).
(b) Records request associated with revocation. To assist in
determining whether revocation is warranted under paragraph (a) of this
section, FDA may request records of the accreditation body required by
Sec. 1.625 or the records, required by Sec. 1.658, of one or more of
the third-party certification bodies it accredited under this subpart.
(c) Issuance of revocation of recognition. (1) FDA will notify an
accreditation body that its recognition has been revoked through
issuance of a revocation that will state the grounds for revocation, the
procedures for requesting a regulatory hearing under Sec. 1.693 on the
revocation, and the procedures for requesting reinstatement of
recognition under Sec. 1.636.
(2) Within 10 business days of the date of issuance of the
revocation, the accreditation body must notify FDA electronically, in
English, of the name of the custodian who will maintain the records and
make them available to FDA as required by Sec. 1.625. The contact
information for the custodian must provide, at a minimum, an email
address and the physical address where the records will be located.
(d) Effect of revocation of recognition of an accreditation body on
accredited third-party certification bodies. (1) FDA will issue a notice
of the revocation of recognition to any accredited third-party
certification body accredited by the accreditation body whose
recognition was revoked. The third-party certification body's
accreditation will remain in effect if the third-party certification
body:
(i) No later than 60 days after FDA's issuance of the notice of
revocation, conducts a self-assessment under Sec. 1.655 and reports the
results of the self-assessment to FDA under Sec. 1.656(b); and
(ii) No later than 1 year after issuance of the notice of the
revocation, or the original date of expiration of the accreditation,
whichever comes first, becomes accredited by another recognized
accreditation body or by FDA through direct accreditation.
(2) FDA may withdraw the accreditation of a third-party
certification body whenever FDA determines there is good cause for
withdrawal of accreditation under Sec. 1.664(c).
(e) Effect of revocation of recognition of an accreditation body on
food or facility certifications issued to eligible entities. A food or
facility certification issued by a third-party certification body
accredited by a recognized accreditation body prior to issuance of the
revocation of recognition will remain in effect until the certificate
terminates by expiration. If FDA has reason to believe that a
certification issued for purposes of section 801(q) or 806 of the FD&C
Act is not valid or reliable, FDA may refuse
[[Page 96]]
to consider the certification in determining the admissibility of the
article of food for which the certification was offered or in
determining the importer's eligibility for participation in VQIP.
(f) Public notice of revocation of recognition. FDA will provide
notice on the Web site described in Sec. 1.690 of the issuance of the
revocation of recognition of an accreditation body and will describe the
basis for revocation.
[80 FR 74650, Nov. 27, 2015, as amended at 81 FR 90193, Dec. 14, 2016]
Sec. 1.635 What if I want to voluntarily relinquish recognition or
do not want to renew recognition?
(a) Notice to FDA of intent to relinquish or not to renew
recognition. A recognized accreditation body must notify FDA
electronically, in English, at least 60 days before voluntarily
relinquishing recognition or before allowing recognition to expire
without seeking renewal. The recognized accreditation body must provide
the name and contact information of the custodian who will maintain the
records required under Sec. 1.625(a) after the date of relinquishment
or the date recognition expires, as applicable, and make them available
to FDA as required by Sec. 1.625(b). The contact information for the
custodian must include, at a minimum, an email address and the physical
address where the records required by Sec. 1.625(a) will be located.
(b) Notice to accredited third-party certification bodies of intent
to relinquish or not to renew recognition. No later than 15 business
days after notifying FDA under paragraph (a) of this section, the
recognized accreditation body must notify any currently accredited
third-party certification body that it intends to relinquish recognition
or to allow its recognition to expire, specifying the date on which
relinquishment or expiration will occur. The recognized accreditation
body must establish and maintain records of such notification under
Sec. 1.625.
(c)(1) Effect of voluntary relinquishment or expiration of
recognition on third-party certification bodies. The accreditation of a
third-party certification body issued prior to the relinquishment or
expiration of its accreditation body's recognition will remain in
effect, so long as the third-party certification body:
(i) No later than 60 days after the date of relinquishment or the
date of expiration of the recognition, conducts a self-assessment under
Sec. 1.655 and reports the results of the self-assessment to FDA under
Sec. 1.656(b); and
(ii) No later than 1 year after the date of relinquishment or the
date of expiration of recognition, or the original date of the
expiration of the accreditation, whichever comes first, becomes
accredited by another recognized accreditation body or by FDA through
direct accreditation.
(2) FDA may withdraw the accreditation of a third-party
certification body whenever FDA determines there is good cause for
withdrawal of accreditation under Sec. 1.664(c).
(d) Effect of voluntary relinquishment or expiration of recognition
of an accreditation body on food or facility certifications issued to
eligible entities. A food or facility certification issued by a third-
party certification body accredited by a recognized accreditation body
prior to relinquishment or expiration of its recognition will remain in
effect until the certification expires. If FDA has reason to believe
that a certification issued for purposes of section 801(q) or 806 of the
FD&C Act is not valid or reliable, FDA may refuse to consider the
certification in determining the admissibility of the article of food
for which the certification was offered or in determining the importer's
eligibility for participation in VQIP.
(e) Public notice of voluntary relinquishment or expiration of
recognition. FDA will provide notice on the Web site described in Sec.
1.690 of the voluntary relinquishment or expiration of recognition of an
accreditation body under this subpart.
Sec. 1.636 How do I request reinstatement of recognition?
(a) Application following revocation. An accreditation body that has
had its recognition revoked may seek reinstatement by submitting a new
application for recognition under Sec. 1.630. The accreditation body
must submit evidence that the grounds for revocation
[[Page 97]]
have been resolved, including evidence addressing the cause or
conditions that were the basis for revocation and identifying measures
that have been implemented to help ensure that such cause(s) or
condition(s) are unlikely to recur.
(b) Application following relinquishment. An accreditation body that
previously relinquished its recognition under Sec. 1.635 may seek
recognition by submitting a new application for recognition under Sec.
1.630.
Accreditation of Third-Party Certification Bodies Under This Subpart
Sec. 1.640 Who is eligible to seek accreditation?
(a) A foreign government, agency of a foreign government, foreign
cooperative, or any other third party may seek accreditation from a
recognized accreditation body (or, where direct accreditation is
appropriate, FDA) to conduct food safety audits and to issue food and
facility certifications to eligible entities under this subpart. An
accredited third-party certification body may use documentation of
conformance with ISO/IEC 17021: 2011 or ISO/IEC 17065: 2012,
supplemented as necessary, in meeting the applicable requirements of
this subpart.
(b) A foreign government or an agency of a foreign government is
eligible for accreditation if it can demonstrate that its food safety
programs, systems, and standards meet the requirements of Sec. Sec.
1.641 through 1.645.
(c) A foreign cooperative or other third party is eligible for
accreditation if it can demonstrate that the training and qualifications
of its agents used to conduct audits (or, in the case of a third-party
certification body that is an individual, such individual) and its
internal systems and standards meet the requirements of Sec. Sec. 1.641
through 1.645.
Sec. 1.641 What legal authority must a third-party certification body
have to qualify for accreditation?
(a) A third-party certification body seeking accreditation from a
recognized accreditation body or from FDA must demonstrate that it has
the authority (as a governmental entity or as a legal entity with
contractual rights) to perform such examinations of facilities, their
process(es), and food(s) as are necessary to determine compliance with
the applicable food safety requirements of the FD&C Act and FDA
regulations, and conformance with applicable industry standards and
practices and to issue certifications where appropriate based on a
review of the findings of such examinations. This includes authority to:
(1) Review any relevant records;
(2) Conduct onsite audits of an eligible entity; and
(3) Suspend or withdraw certification for failure to comply with
applicable requirements.
(b) A third-party certification body seeking accreditation must
demonstrate that it is capable of exerting the authority (as a
governmental entity or as legal entity with contractual rights)
necessary to meet the applicable requirements of accreditation under
this subpart if accredited.
Sec. 1.642 What competency and capacity must a third-party certification
body have to qualify for accreditation?
A third-party certification body seeking accreditation must
demonstrate that it has:
(a) The resources necessary to fully implement its certification
program, including:
(1) Adequate numbers of employees and other agents with relevant
knowledge, skills, and experience to effectively examine for compliance
with applicable FDA food safety requirements of the FD&C Act and FDA
regulations, conformance with applicable industry standards and
practices, and issuance of valid and reliable certifications; and
(2) Adequate financial resources for its operations; and
(b) The competency and capacity to meet the applicable requirements
of this subpart, if accredited.
Sec. 1.643 What protections against conflicts of interest must a
third-party certification body have to qualify for accreditation?
A third-party certification body must demonstrate that it has:
[[Page 98]]
(a) Implemented written measures to protect against conflicts of
interest between the third-party certification body (and its officers,
employees, and other agents involved in auditing and certification
activities) and clients seeking examinations or certification from, or
audited or certified by, such third-party certification body; and
(b) The capability to meet the conflict of interest requirements in
Sec. 1.657, if accredited.
Sec. 1.644 What quality assurance procedures must a third-party
certification body have to qualify for accreditation?
A third-party certification body seeking accreditation must
demonstrate that it has:
(a) Implemented a written program for monitoring and evaluating the
performance of its officers, employees, and other agents involved in
auditing and certification activities, including procedures to:
(1) Identify deficiencies in its auditing and certification program
or performance; and
(2) Quickly execute corrective actions that effectively address any
identified deficiencies; and
(b) The capability to meet the quality assurance requirements of
Sec. 1.655, if accredited.
Sec. 1.645 What records procedures must a third-party certification
body have to qualify for accreditation?
A third-party certification body seeking accreditation must
demonstrate that it:
(a) Implemented written procedures to establish, control, and retain
records (including documents and data) for a period of time necessary to
meet its contractual and legal obligations and to provide an adequate
basis for evaluating its program and performance; and
(b) Is capable of meeting the reporting, notification, and records
requirements of this subpart, if accredited.
Requirements for Third-Party Certification Bodies That Have Been
Accredited Under This Subpart
Sec. 1.650 How must an accredited third-party certification body ensure
its audit agents are competent and objective?
(a) An accredited third-party certification body that uses audit
agents to conduct food safety audits must ensure that each such audit
agent meets the following requirements with respect to the scope of its
accreditation under this subpart. If the accredited third-party
certification body is an individual, that individual is also subject to
the following requirements, as applicable:
(1) Has relevant knowledge and experience that provides an adequate
basis for the audit agent to evaluate compliance with applicable food
safety requirements of the FD&C Act and FDA regulations and, for
consultative audits, also includes conformance with applicable industry
standards and practices;
(2) Has been determined by the accredited third-party certification
body, through observations of a representative sample of audits, to be
competent to conduct food safety audits under this subpart relevant to
the audits they will be assigned to perform;
(3) Has completed annual food safety training that is relevant to
activities conducted under this subpart;
(4) Is in compliance with the conflict of interest requirements of
Sec. 1.657 and has no other conflicts of interest with the eligible
entity to be audited that might impair the audit agent's objectivity;
and
(5) Agrees to notify its accredited third-party certification body
immediately upon discovering, during a food safety audit, any condition
that could cause or contribute to a serious risk to the public health.
(b) In assigning an audit agent to conduct a food safety audit at a
particular eligible entity, an accredited third-party certification body
must determine that the audit agent is qualified to conduct such audit
under the criteria established in paragraph (a) of this section and
based on the scope and
[[Page 99]]
purpose of the audit and the type of facility, its process(es), and
food.
(c) An accredited third-party certification body cannot use an audit
agent to conduct a regulatory audit at an eligible entity if such audit
agent conducted a consultative audit or regulatory audit for the same
eligible entity in the preceding 13 months, except that such limitation
may be waived if the accredited third-party certification body
demonstrates to FDA, under Sec. 1.663, there is insufficient access to
audit agents in the country or region where the eligible entity is
located. If the accredited third-party certification body is an
individual, that individual is also subject to such limitations.
Sec. 1.651 How must an accredited third-party certification body
conduct a food safety audit of an eligible entity?
(a) Audit planning. Before beginning to conduct a food safety audit
under this subpart, an accredited third-party certification body must:
(1) Require the eligible entity seeking a food safety audit to:
(i) Identify the scope and purpose of the food safety audit,
including the facility, process(es), or food to be audited; whether the
food safety audit is to be conducted as a consultative or regulatory
audit subject to the requirements of this subpart, and if a regulatory
audit, the type(s) of certification(s) sought; and
(ii) Provide a 30-day operating schedule for such facility that
includes information relevant to the scope and purpose of the audit; and
(2) Determine whether the requested audit is within its scope of
accreditation.
(b) Authority to audit. In arranging a food safety audit with an
eligible entity under this subpart, an accredited third-party
certification body must ensure it has authority, whether contractual or
otherwise, to:
(1) Conduct an unannounced audit to determine whether the facility,
process(es), and food of the eligible entity (within the scope of the
audit) comply with the applicable food safety requirements of the FD&C
Act and FDA regulations and, for consultative audits, also includes
conformance with applicable industry standards and practices;
(2) Access any records and any area of the facility, process(es),
and food of the eligible entity relevant to the scope and purpose of
such audit;
(3) When, for a regulatory audit, sampling and analysis is
conducted, the accredited third-party certification body must use a
laboratory that is accredited in accordance with ISO/IEC 17025:2017 to
perform the analysis.
(4) Notify FDA immediately if, at any time during a food safety
audit, the accredited third-party certification body (or its audit
agent, where applicable) discovers a condition that could cause or
contribute to a serious risk to the public health and provide
information required by Sec. 1.656(c);
(5) Prepare reports of audits conducted under this subpart as
follows:
(i) For consultative audits, prepare reports that contain the
elements specified in Sec. 1.652(a) and maintain such records, subject
to FDA access in accordance with section 414 of the FD&C Act; and
(ii) For regulatory audits, prepare reports that contain the
elements specified in Sec. 1.652(b) and submit them to FDA and to its
recognized accreditation body (where applicable) under Sec. 1.656(a);
and
(6) Allow FDA and the recognized accreditation body that accredited
such third-party certification body, if any, to observe any food safety
audit conducted under this subpart for purposes of evaluating the
accredited third-party certification body's performance under Sec. Sec.
1.621 and 1.662 or, where appropriate, the recognized accreditation
body's performance under Sec. Sec. 1.622 and 1.633.
(c) Audit protocols. An accredited third-party certification body
(or its audit agent, where applicable) must conduct a food safety audit
in a manner consistent with the identified scope and purpose of the
audit and within the scope of its accreditation.
(1) With the exception of records review, which may be scheduled,
the audit must be conducted without announcement during the 30-day
timeframe identified under paragraph
[[Page 100]]
(a)(1)(ii) of this section and must be focused on determining whether
the facility, its process(es), and food are in compliance with
applicable food safety requirements of the FD&C Act and FDA regulations,
and, for consultative audits, also includes conformance with applicable
industry standards and practices that are within the scope of the audit.
(2) The audit must include records review prior to the onsite
examination; an onsite examination of the facility, its process(es), and
the food that results from such process(es); and where appropriate or
when required by FDA, environmental or product sampling and analysis.
When, for a regulatory audit, sampling and analysis is conducted, the
accredited third-party certification body must use a laboratory that is
accredited in accordance with paragraph (b)(3) of this section to
conduct the analysis. The audit may include any other activities
necessary to determine compliance with applicable food safety
requirements of the FD&C Act and FDA regulations, and, for consultative
audits, also includes conformance with applicable industry standards and
practices.
(3) The audit must be sufficiently rigorous to allow the accredited
third-party certification body to determine whether the eligible entity
is in compliance with the applicable food safety requirements of the
FD&C Act and FDA regulations, and for consultative audits, also includes
conformance with applicable industry standards and practices, at the
time of the audit; and for a regulatory audit, whether the eligible
entity, given its food safety system and practices would be likely to
remain in compliance with the applicable food safety requirements of the
FD&C Act and FDA regulations for the duration of any certification
issued under this subpart. An accredited third-party certification body
(or its audit agent, where applicable) that identifies a deficiency
requiring corrective action may verify the effectiveness of a corrective
action once implemented by the eligible entity but must not recommend or
provide input to the eligible entity in identifying, selecting, or
implementing the corrective action.
(4) Audit observations and other data and information from the
examination, including information on corrective actions, must be
documented and must be used to support the findings contained in the
audit report required by Sec. 1.652 and maintained as a record under
Sec. 1.658.
[80 FR 74650, Nov. 27, 2015, as amended at 86 FR 68817, Dec. 3, 2021]
Sec. 1.652 What must an accredited third-party certification body
include in food safety audit reports?
(a) Consultative audits. An accredited third-party certification
body must prepare a report of a consultative audit not later than 45
days after completing such audit and must provide a copy of such report
to the eligible entity and must maintain such report under Sec. 1.658,
subject to FDA access in accordance with the requirements of section 414
of the FD&C Act. A consultative audit report must include:
(1) The identity of the site or location where the consultative
audit was conducted, including:
(i) The name, address and the FDA Establishment Identifier of the
facility subject to the consultative audit and a unique facility
identifier, if designated by FDA; and
(ii) Where applicable, the FDA registration number assigned to the
facility under subpart H of this part;
(2) The identity of the eligible entity, if different from the
facility, including the name, address, the FDA Establishment Identifier
and unique facility identifier, if designated by FDA, and, where
applicable, registration number under subpart H of this part;
(3) The name(s) and telephone number(s) of the person(s) responsible
for compliance with the applicable food safety requirements of the FD&C
Act and FDA regulations
(4) The dates and scope of the consultative audit;
(5) The process(es) and food(s) observed during such consultative
audit; and
(6) Any deficiencies observed that relate to or may influence a
determination of compliance with the applicable food safety requirements
of the FD&C Act and FDA regulations that require corrective action, the
corrective action
[[Page 101]]
plan, and the date on which such corrective actions were completed. Such
consultative audit report must be maintained as a record under Sec.
1.658 and must be made available to FDA in accordance with section 414
of the FD&C Act.
(b) Regulatory audits. An accredited third-party certification body
must, no later than 45 days after completing a regulatory audit, prepare
and submit electronically, in English, to FDA and to its recognized
accreditation body (or, in the case of direct accreditation, only to
FDA) and must provide to the eligible entity a report of such regulatory
audit that includes the following information:
(1) The identity of the site or location where the regulatory audit
was conducted, including:
(i) The name, address, and FDA Establishment Identifier of the
facility subject to the regulatory audit and a unique facility
identifier, if designated by FDA; and
(ii) Where applicable, the FDA registration number assigned to the
facility under subpart H of this part;
(2) The identity of the eligible entity, if different from the
facility, including the name, address, FDA Establishment Identifier, and
unique facility identifier, if designated by FDA, and, where applicable,
registration number under subpart H of this part;
(3) The dates and scope of the regulatory audit;
(4) The process(es) and food(s) observed during such regulatory
audit;
(5) The name(s) and telephone number(s) of the person(s) responsible
for the facility's compliance with the applicable food safety
requirements of the FD&C Act and FDA regulations;
(6) Any deficiencies observed during the regulatory audit that
present a reasonable probability that the use of or exposure to a
violative product:
(i) Will cause serious adverse health consequences or death to
humans and animals; or
(ii) May cause temporary or medically reversible adverse health
consequences or where the probability of serious adverse health
consequences or death to humans or animals is remote;
(7) The corrective action plan for addressing each deficiency
identified under paragraph (b)(6) of this section, unless corrective
action was implemented immediately and verified onsite by the accredited
third-party certification body (or its audit agent, where applicable);
(8) Whether any sampling and laboratory analysis (e.g., under a
microbiological sampling plan) is performed in or used by the facility;
and
(9) Whether the eligible entity has made significant changes to the
facility, its process(es), or food products during the 2 years preceding
the regulatory audit.
(c) Submission of regulatory audit report. An accredited third-party
certification body must submit a completed regulatory audit report as
required by paragraph (b) of this section, regardless of whether the
certification body issued a food or facility certification to the
eligible entity.
(d) Notice and appeals of adverse regulatory audit results. An
accredited third-party certification body must notify an eligible entity
of a denial of certification and must establish and implement written
procedures for receiving and addressing appeals from eligible entities
challenging such adverse regulatory audit results and for investigating
and deciding on appeals in a fair and meaningful manner. The appeals
procedures must provide similar protections to those offered by FDA
under Sec. Sec. 1.692 and 1.693, including requirements to:
(1) Make the appeals procedures publicly available;
(2) Use competent persons, who may or may not be external to the
accredited third-party certification body, who are free from bias or
prejudice and have not participated in the certification decision or be
subordinate to a person who has participated in the certification
decision, to investigate and decide appeals;
(3) Advise the eligible entity of the final decision on its appeal;
and
(4) Maintain records under Sec. 1.658 of the appeal, the final
decision, and the basis for such decision.
[[Page 102]]
Sec. 1.653 What must an accredited third-party certification body do
when issuing food or facility certifications?
(a) Basis for issuance of a food or facility certification. (1)
Prior to issuing a food or facility certification to an eligible entity,
an accredited third-party certification body (or, where applicable, an
audit agent on its behalf) must complete a regulatory audit that meets
the requirements of Sec. 1.651 and any other activities that may be
necessary to determine compliance with the applicable food safety
requirements of the FD&C Act and FDA regulations.
(2) If, as a result of an observation during a regulatory audit, an
eligible entity must implement a corrective action plan to address a
deficiency, an accredited third-party certification body may not issue a
food or facility certification to such entity until after the accredited
third-party certification body verifies that eligible entity has
implemented the corrective action plan through methods that reliably
verify the corrective action was taken and as a result the identified
deficiency is unlikely to recur, except onsite verification is required
for corrective actions required to address deficiencies that are the
subject of a notification under Sec. 1.656(c).
(3) An accredited third-party certification body must consider each
observation and the data and other information from a regulatory audit
and other activities conducted under Sec. 1.651 to determine whether
the entity was in compliance with the applicable food safety
requirements of the FD&C Act and FDA regulations at the time of the
audit and whether the eligible entity, given its food safety system and
practices, would be likely to remain in compliance for the duration of
any certification issued under this subpart.
(4) A single regulatory audit may result in issuance of one or more
food or facility certifications under this subpart, provided that the
requirements of issuance are met as to each such certification.
(5) Where an accredited third-party certification body uses an audit
agent to conduct a regulatory audit of an eligible entity under this
subpart, the accredited third-party certification body (and not the
audit agent) must make the determination whether to issue a food or
facility certification based on the results of such regulatory audit.
(b) Issuance of a food or facility certification and submission to
FDA. (1) Any food or facility certification issued under this subpart
must be submitted to FDA electronically and in English. The accredited
third-party certification body may issue a food or facility
certification under this subpart for a term of up to 12 months.
(2) A food or facility certification must contain, at a minimum, the
following elements:
(i) The name and address of the accredited third-party certification
body and the scope and date of its accreditation under this subpart;
(ii) The name, address, FDA Establishment Identifier, and unique
facility identifier, if designated by FDA, of the eligible entity to
which the food or facility certification was issued;
(iii) The name, address, FDA Establishment Identifier, and unique
facility identifier, if designated by FDA, of the facility where the
regulatory audit was conducted, if different than the eligible entity;
(iv) The scope and date(s) of the regulatory audit and the
certification number;
(v) The name of the audit agent(s) (where applicable) conducting the
regulatory audit; and
(vi) The scope of the food or facility certification, date of
issuance, and date of expiration.
(3) FDA may refuse to accept any certification for purposes of
section 801(q) or 806 of the FD&C Act, if FDA determines, that such food
or facility certification is not valid or reliable because, for example:
(i) The certification is offered in support of the admissibility of
a food that was not within the scope of the certification;
(ii) The certification was issued by an accredited third-party
certification body acting outside the scope of its accreditation under
this subpart; or
(iii) The certification was issued without reliable demonstration
that the requirements of paragraph (a) of this section were met.
[[Page 103]]
Sec. 1.654 When must an accredited third-party certification body
monitor an eligible entity that it has issued a food or facility
certification?
If an accredited third-party certification body has reason to
believe that an eligible entity to which it issued a food or facility
certification may no longer be in compliance with the applicable food
safety requirements of the FD&C Act and FDA regulations, the accredited
third-party certification body must conduct any monitoring (including an
onsite audit) of such eligible entity necessary to determine whether the
entity is in compliance with such requirements. The accredited third-
party certification body must immediately notify FDA, under Sec.
1.656(d), if it withdraws or suspends a food or facility certification
because it determines that the entity is no longer in compliance with
the applicable food safety requirements of the FD&C Act and FDA
regulations. The accredited third-party certification body must maintain
records of such monitoring under Sec. 1.658.
Sec. 1.655 How must an accredited third-party certification body
monitor its own performance?
(a) An accredited third-party certification body must annually, upon
FDA request made for cause, or as required under Sec. 1.631(f)(1)(i),
Sec. 1.634(d)(1)(i), or Sec. 1.635(c)(1)(i), conduct a self-assessment
that includes evaluation of compliance with this subpart, including:
(1) The performance of its officers, employees, or other agents
involved in auditing and certification activities, including the
performance of audit agents in examining facilities, process(es), and
food using the applicable food safety requirements of the FD&C Act and
FDA regulations;
(2) The degree of consistency among its officers, employees, or
other agents involved in auditing and certification activities,
including evaluating whether its audit agents interpreted audit
protocols in a consistent manner;
(3) The compliance of the accredited third-party certification body
and its officers, employees, and other agents involved in auditing and
certification activities, with the conflict of interest requirements of
Sec. 1.657;
(4) Actions taken in response to the results of any assessments
conducted by FDA or, where applicable, the recognized accreditation body
under Sec. 1.621; and
(5) As requested by FDA, any other aspects of its performance
relevant to a determination of whether the accredited third-party
certification body is in compliance with this subpart.
(b) As a means to assess its performance, the accredited third-party
certification body may evaluate the compliance of one or more of
eligible entities to which a food or facility certification was issued
under this subpart.
(c) Based on the assessments and evaluations conducted under
paragraphs (a) and (b) of this section, the accredited third-party
certification body must:
(1) Identify any deficiencies in complying with the requirements of
this subpart;
(2) Quickly implement corrective action(s) that effectively address
the identified deficiencies; and
(3) Under Sec. 1.658, establish and maintain records of such
corrective action(s).
(d) The accredited third-party certification body must prepare a
written report of the results of its self-assessment that includes:
(1) A description of any corrective action(s) taken under paragraph
(c) of this section;
(2) A statement disclosing the extent to which the accredited third-
party certification body, and its officers, employees, and other agents
involved in auditing and certification activities, complied with the
conflict of interest requirements in Sec. 1.657; and
(3) A statement attesting to the extent to which the accredited
third-party certification body complied with the applicable requirements
of this subpart.
(e) An accredited third-party certification body may use a report,
supplemented as necessary, on its conformance to ISO/IEC 17021: 2011 or
ISO/IEC 17065: 2012 in meeting the requirements of this section.
[[Page 104]]
Sec. 1.656 What reports and notifications must an accredited
third-party certification body submit?
(a) Reporting results of regulatory audits. An accredited third-
party certification body must submit a regulatory audit report, as
described in Sec. 1.652(b), electronically, in English, to FDA and to
the recognized accreditation body that granted its accreditation (where
applicable), no later than 45 days after completing such audit.
(b) Reporting results of accredited third-party certification body
self-assessments. An accredited third-party certification body must
submit the report of its annual self-assessment required by Sec. 1.655
electronically to its recognized accreditation body (or, in the case of
direct accreditation, electronically and in English, to FDA), within 45
days of the anniversary date of its accreditation under this subpart.
For an accredited third-party certification body subject to an FDA
request for cause, or Sec. 1.631(f)(1)(i), Sec. 1.634(d)(1)(i), or
Sec. 1.635(c)(1)(i), the report of its self-assessment must be
submitted to FDA electronically, in English, within 60 days of the FDA
request, denial of renewal, revocation, or relinquishment of recognition
of the accreditation body that granted its accreditation. Such report
must include an up-to-date list of any audit agents it uses to conduct
audits under this subpart.
(c) Notification to FDA of a serious risk to public health. An
accredited third-party certification body must immediately notify FDA
electronically, in English, if during a regulatory or consultative
audit, any of its audit agents or the accredited third-party
certification body itself discovers a condition that could cause or
contribute to a serious risk to the public health, providing the
following information:
(1) The name, physical address, and unique facility identifier, if
designated by FDA, of the eligible entity subject to the audit, and,
where applicable, the registration number under subpart H of this part;
(2) The name, physical address, and unique facility identifier, if
designated by FDA, of the facility where the condition was discovered
(if different from that of the eligible entity) and, where applicable,
the registration number assigned to the facility under subpart H of this
part; and
(3) The condition for which notification is submitted.
(d) Immediate notification to FDA of withdrawal or suspension of a
food or facility certification. An accredited third-party certification
body must notify FDA electronically, in English, immediately upon
withdrawing or suspending any food or facility certification of an
eligible entity and the basis for such action.
(e) Notification to its recognized accreditation body or an eligible
entity. (1) After notifying FDA under paragraph (c) of this section, an
accredited third-party certification body must immediately notify the
eligible entity of such condition and must immediately thereafter notify
the recognized accreditation body that granted its accreditation, except
for third-party certification bodies directly accredited by FDA. Where
feasible and reliable, the accredited third-party certification body may
contemporaneously notify its recognized accreditation body and/or the
eligible entity when notifying FDA.
(2) An accredited third-party certification body must notify its
recognized accreditation body (or, in the case of direct accreditation,
FDA) electronically, in English, within 30 days after making any
significant change that would affect the manner in which it complies
with the requirements of this subpart and must include with such
notification the following information:
(i) A description of the change; and
(ii) An explanation for the purpose of the change.
Sec. 1.657 How must an accredited third-party certification body
protect against conflicts of interest?
(a) An accredited third-party certification body must implement a
written program to protect against conflicts of interest between the
accredited third-party certification body (and its officers, employees,
and other agents involved in auditing and certification activities) and
an eligible entity seeking a food safety audit or food or facility
certification from, or audited or certified by, such accredited third-
party
[[Page 105]]
certification body, including the following:
(1) Ensuring that the accredited third-party certification body and
its officers, employees, or other agents involved in auditing and
certification activities do not own, operate, have a financial interest
in, manage, or otherwise control an eligible entity to be certified, or
any affiliate, parent, or subsidiary of the entity;
(2) Ensuring that the accredited third-party certification body and,
its officers, employees, or other agents involved in auditing and
certification activities are not owned, managed, or controlled by any
person that owns or operates an eligible entity to be certified;
(3) Ensuring that an audit agent of the accredited third-party
certification body does not own, operate, have a financial interest in,
manage, or otherwise control an eligible entity or any affiliate,
parent, or subsidiary of the entity that is subject to a consultative or
regulatory audit by the audit agent; and
(4) Prohibiting an accredited third-party certification body's
officer, employee, or other agent involved in auditing and certification
activities from accepting any money, gift, gratuity, or other item of
value from the eligible entity to be audited or certified under this
subpart.
(5) The items specified in paragraph (a)(4) of this section do not
include:
(i) Money representing payment of fees for auditing and
certification services and reimbursement of direct costs associated with
an onsite audit by the third-party certification body; or
(ii) Lunch of de minimis value provided during the course of an
audit and on the premises where the audit is conducted, if necessary to
facilitate the efficient conduct of the audit.
(b) An accredited third-party certification body may accept the
payment of fees for auditing and certification services and the
reimbursement of direct costs associated with an audit of an eligible
entity only after the date on which the report of such audit was
completed or the date a food or facility certification was issued,
whichever is later. Such payment is not considered a conflict of
interest for purposes of paragraph (a) of this section.
(c) The financial interests of the spouses and children younger than
18 years of age of accredited third-party certification body's officers,
employees, and other agents involved in auditing and certification
activities will be considered the financial interests of such officers,
employees, and other agents involved in auditing and certification
activities.
(d) An accredited third-party certification body must maintain on
its Web site an up-to-date list of the eligible entities to which it has
issued food or facility certifications under this subpart. For each such
eligible entity, the Web site also must identify the duration and scope
of the food or facility certification and date(s) on which the eligible
entity paid the accredited third-party certification body any fee or
reimbursement associated with such audit or certification.
Sec. 1.658 What records requirements must a third-party certification
body that has been accredited meet?
(a) A third-party certification body that has been accredited must
maintain electronically for 4 years records created during its period of
accreditation (including documents and data) that document compliance
with this subpart, including:
(1) Any audit report and other documents resulting from a
consultative audit conducted under this subpart, including the audit
agent's observations, correspondence with the eligible entity,
verification of any corrective action(s) taken to address deficiencies
identified during the audit;
(2) Any request for a regulatory audit from an eligible entity;
(3) Any audit report and other documents resulting from a regulatory
audit conducted under this subpart, including the audit agent's
observations, correspondence with the eligible entity, verification of
any corrective action(s) taken to address deficiencies identified during
the audit, and, when sampling and analysis is conducted, laboratory
testing records and results from a laboratory that is accredited in
[[Page 106]]
accordance with Sec. 1.651(b)(3), and documentation demonstrating such
laboratory is accredited in accordance with Sec. 1.651(b)(3);
(4) Any notification submitted by an audit agent to the accredited
third-party certification body in accordance with Sec. 1.650(a)(5);
(5) Any challenge to an adverse regulatory audit decision and the
disposition of the challenge;
(6) Any monitoring it conducted of an eligible entity to which food
or facility certification was issued;
(7) Its self-assessments and corrective actions taken to address any
deficiencies identified during a self-assessment; and
(8) Significant changes to its auditing or certification program
that might affect compliance with this subpart.
(b) An accredited third-party certification body must make the
records of a consultative audit required by paragraph (a)(1) of this
section available to FDA in accordance with section 414 of the FD&C Act.
(c) An accredited third-party certification body must make the
records required by paragraphs (a)(2) through (8) of this section
available for inspection and copying promptly upon written request of an
authorized FDA officer or employee at the place of business of the
accredited third-party certification body or at a reasonably accessible
location. If such records are requested by FDA electronically, the
records must be submitted electronically not later than 10 business days
after the date of the request. Additionally, if the records are
maintained in a language other than English, an accredited third-party
certification body must electronically submit an English translation
within a reasonable time.
Procedures for Accreditation of Third-Party Certification Bodies Under
This Subpart
Sec. 1.660 Where do I apply for accreditation or renewal of accreditation
by a recognized accreditation body and what happens once the recognized
accreditation body decides on my application?
(a) Submission of accreditation or renewal application to a
recognized accreditation body. A third-party certification body seeking
accreditation must submit its request for accreditation or renewal of
accreditation by a recognized accreditation body identified on the Web
site described in Sec. 1.690.
(b) Notice of records custodian after denial of application for
renewal of accreditation. An applicant whose renewal application was
denied by a recognized accreditation body must notify FDA
electronically, in English, within 10 business days of the date of
issuance of a denial of accreditation or denial of the renewal
application, of the name and contact information of the custodian who
will maintain the records required by Sec. 1.658(a) and make them
available to FDA as required by Sec. 1.658(b) and (c). The contact
information for the custodian must include, at a minimum, an email
address and the physical address where the records required by Sec.
1.658(a) will be located.
(c) Effect of denial of an application for renewal of accreditation
on food or facility certifications issued to eligible entities. A food
or facility certification issued by an accredited third-party
certification body prior to issuance of the denial of its renewal
application l will remain in effect until the certification expires. If
FDA has reason to believe that a certification issued for purposes of
section 801(q) or 806 of the FD&C Act is not valid or reliable, FDA may
refuse to consider the certification in determining the admissibility of
the article of food for which the certification was offered or in
determining the importer's eligibility for participation in VQIP.
(d) Public notice of denial of an application for renewal of
accreditation. FDA will provide notice on the Web site described in
Sec. 1.690 of the date of issuance of a denial of renewal of
accreditation of a third-party certification body that had previous been
accredited.
Sec. 1.661 What is the duration of accreditation by a recognized
accreditation body?
A recognized accreditation body may grant accreditation to a third-
party certification body under this subpart for a period not to exceed 4
years.
[[Page 107]]
Sec. 1.662 How will FDA monitor accredited third-party certification
bodies?
(a) FDA will periodically evaluate the performance of each
accredited third-party certification body to determine whether the
accredited third-party certification body continues to comply with the
applicable requirements of this subpart and whether there are
deficiencies in the performance of the accredited third-party
certification body that, if not corrected, would warrant withdrawal of
its accreditation under Sec. 1.664. FDA will evaluate each directly
accredited third-party certification body annually. For a third-party
certification body accredited by a recognized accreditation body, FDA
will evaluate an accredited third-party certification body not later
than 3 years after the date of accreditation for a 4-year term of
accreditation, or by no later than the mid-term point for accreditation
granted for less than 4 years. FDA may conduct additional performance
assessments of an accredited third-party certification body at any time.
(b) In evaluating the performance of an accredited third-party
certification body under paragraph (a) of this section, FDA may review
any one or more of the following:
(1) Regulatory audit reports and food and facility certifications;
(2) The accredited third-party certification body's self-assessments
under Sec. 1.655;
(3) Reports of assessments by a recognized accreditation body under
Sec. 1.621;
(4) Documents and other information relevant to a determination of
the accredited third-party certification body's compliance with the
applicable requirements of this subpart; and
(5) Information obtained by FDA, including during inspections,
audits, onsite observations, or investigations, of one or more eligible
entities to which a food or facility certification was issued by such
accredited third-party certification body.
(c) FDA may conduct its evaluation of an accredited third-party
certification body through a site visit to an accredited third-party
certification body's headquarters (or other location that manages audit
agents conducting food safety audits under this subpart, if different
than its headquarters), through onsite observation of an accredited
third party certification body's performance during a food safety audit
of an eligible entity, or through document review.
Sec. 1.663 How do I request an FDA waiver or waiver extension for the
13-month limit for audit agents conducting regulatory audits?
(a) An accredited third-party certification body may submit a
request to FDA to waive the requirements of Sec. 1.650(c) preventing an
audit agent from conducting a regulatory audit of an eligible entity if
the audit agent (or, in the case that the third-party certification body
is an individual, the third-party certification body) has conducted a
food safety audit of such entity during the previous 13 months. The
accredited third-party certification body seeking a waiver or waiver
extension must demonstrate there is insufficient access to audit agents
and any third-party certification bodies that are comprised of an
individual in the country or region where the eligible entity is
located.
(b) Requests for a waiver or waiver extension and all documents
provided in support of the request must be submitted to FDA
electronically, in English. The requestor must provide such translation
and interpretation services as are needed by FDA to process the request.
(c) The request must be signed by the requestor or by any individual
authorized to act on behalf of the requestor for purposes of seeking
such waiver or waiver extension.
(d) FDA will review requests for waivers and waiver extensions on a
first in, first out basis according to the date on which the completed
submission is received; however, FDA may prioritize the review of
specific requests to meet the needs of the program. FDA will evaluate
any completed waiver request to determine whether the criteria for
waiver have been met.
(e) FDA will notify the requestor whether the request for a waiver
or waiver extension is approved or denied.
[[Page 108]]
(f) If FDA approves the request, issuance of the waiver will state
the duration of the waiver and list any limitations associated with it.
If FDA denies the request, the issuance of a denial of a waiver request
will state the basis for denial and will provide the address and
procedures for requesting reconsideration of the request under Sec.
1.691.
(g) Unless FDA notifies a requestor that its waiver request has been
approved, an accredited third-party certification body must not use the
audit agent to conduct a regulatory audit of such eligible entity until
the 13-month limit in Sec. 1.650(c) has elapsed.
Sec. 1.664 When would FDA withdraw accreditation?
(a) Mandatory withdrawal. FDA will withdraw accreditation from a
third-party certification body:
(1) Except as provided in paragraph (b) of this section, if the food
or facility certified under this subpart is linked to an outbreak of
foodborne illness or chemical or physical hazard that has a reasonable
probability of causing serious adverse health consequences or death in
humans or animals;
(2) Following an evaluation and finding by FDA that the third-party
certification body no longer complies with the applicable requirements
of this subpart; or
(3) Following its refusal to allow FDA to access records under Sec.
1.658 or to conduct an audit, assessment, or investigation necessary to
ensure continued compliance with this subpart.
(4) If payment of the third-party certification body's annual fee is
not received within 90 days of the payment due date, as specified in
Sec. 1.725(c)(3).
(b) Exception. FDA may waive mandatory withdrawal under paragraph
(a)(1) of this section, if FDA:
(1) Conducts an investigation of the material facts related to the
outbreak of human or animal illness;
(2) Reviews the relevant audit records and the actions taken by the
accredited third-party certification body in support of its decision to
certify; and
(3) Determines that the accredited third-party certification body
satisfied the requirements for issuance of certification under this
subpart.
(c) Discretionary withdrawal. FDA may withdraw accreditation, in
whole or in part, from a third-party certification body when such third-
party certification body is accredited by an accreditation body for
which recognition is revoked under Sec. 1.634, if FDA determines there
is good cause for withdrawal, including:
(1) Demonstrated bias or lack of objectivity when conducting
activities under this subpart; or
(2) Performance that calls into question the validity or reliability
of its food safety audits or certifications.
(d) Records access. FDA may request records of the accredited third-
party certification body under Sec. 1.658 and, where applicable, may
request records under Sec. 1.625 of an accreditation body that has been
recognized under Sec. 1.625, when considering withdrawal under
paragraph (a)(1), (a)(2), or (c) of this section.
(e) Notice to the third-party certification body of withdrawal of
accreditation. (1) FDA will notify a third-party certification body of
the withdrawal of its accreditation through issuance of a withdrawal
that will state the grounds for withdrawal, the procedures for
requesting a regulatory hearing under Sec. 1.693 on the withdrawal, and
the procedures for requesting reaccreditation under Sec. 1.666.
(2) Within 10 business days of the date of issuance of the
withdrawal, the third-party certification body must notify FDA
electronically, in English, of the name of the custodian who will
maintain the records required by Sec. 1.658, and provide contact
information for the custodian, which will at least include an email
address, and the street address where the records will be located.
(f) Effect of withdrawal of accreditation on eligible entities. A
food or facility certification issued by a third-party certification
body prior to withdrawal will remain in effect until the certification
terminates by expiration. If FDA has reason to believe that a
certification issued for purposes of section 801(q) or 806 of the FD&C
Act is not valid or reliable, FDA may refuse to
[[Page 109]]
consider the certification in determining the admissibility of the
article of food for which the certification was offered or in
determining the importer's eligibility for participation in VQIP.
(g) Effect of withdrawal of accreditation on recognized
accreditation bodies. (1) FDA will notify a recognized accreditation
body if the accreditation of a third-party certification body it
accredited is withdrawn by FDA. Such accreditation body's recognition
will remain in effect if, no later than 60 days after withdrawal, the
accreditation body conducts a self-assessment under Sec. 1.622 and
reports the results of the self-assessment to FDA as required by Sec.
1.623(b).
(2) FDA may revoke the recognition of an accreditation body whenever
FDA determines there is good cause for revocation of recognition under
Sec. 1.634.
(h) Public notice of withdrawal accreditation. FDA will provide
notice on the Web site described in Sec. 1.690 of its withdrawal of
accreditation of a third-party certification body and provide a
description of the basis for withdrawal.
[80 FR 74650, Nov. 27, 2015, as amended at 81 FR 90193, Dec. 14, 2016]
Sec. 1.665 What if I want to voluntarily relinquish accreditation or
do not want to renew accreditation?
(a) Notice to FDA of intent to relinquish or not to renew
accreditation. A third-party certification body must notify FDA
electronically, in English, at least 60 days before voluntarily
relinquishing accreditation or before allowing accreditation to expire
without seeking renewal. The certification body must provide the name
and contact information of the custodian who will maintain the records
required under Sec. 1.658(a) after the date of relinquishment or the
date accreditation expires, as applicable, and make them available to
FDA as required by Sec. 1.658(b) and (c). The contact information for
the custodian must include, at a minimum, an email address and the
physical address where the records required by Sec. 1.658(a) will be
located.
(b) Notice to recognized accreditation body and eligible entities of
intent to relinquish or not to renew accreditation. No later than 15
business days after notifying FDA under paragraph (a) of this section,
the certification body must notify its recognized accreditation body and
any eligible entity with current certifications that it intends to
relinquish accreditation or to allow its accreditation to expire,
specifying the date on which relinquishment or expiration will occur.
The recognized accreditation body must establish and maintain records of
such notification under Sec. 1.625(a).
(c) Effect of voluntary relinquishment or expiration of
accreditation on food or facility certifications issued to eligible
entities. A food or facility certification issued by a third-party
certification body prior to relinquishment or expiration of its
accreditation will remain in effect until the certification expires. If
FDA has reason to believe that a certification issued for purposes of
section 801(q) or 806 of the FD&C Act is not valid or reliable, FDA may
refuse to consider the certification in determining the admissibility of
the article of food for which the certification was offered or in
determining the importer's eligibility for participation in VQIP.
(d) Public notice of voluntary relinquishment or expiration of
accreditation. FDA will provide notice on the Web site described in
Sec. 1.690 of the voluntary relinquishment or expiration of
accreditation of a certification body under this subpart.
Sec. 1.666 How do I request reaccreditation?
(a) Application following withdrawal. FDA will reinstate the
accreditation of a third-party certification body for which it has
withdrawn accreditation:
(1) If, in the case of direct accreditation, FDA determines, based
on evidence presented by the third-party certification body, that the
third-party certification body satisfies the applicable requirements of
this subpart and adequate grounds for withdrawal no longer exist; or
(2) In the case of a third-party certification body accredited by an
accreditation body for which recognition has been revoked under Sec.
1.634:
(i) If the third-party certification body becomes accredited by
another recognized accreditation body or by
[[Page 110]]
FDA through direct accreditation no later than 1 year after withdrawal
of accreditation, or the original date of the expiration of
accreditation, whichever comes first; or
(ii) Under such conditions as FDA may impose in withdrawing
accreditation.
(b) Application following voluntary relinquishment. A third-party
certification body that previously relinquished its accreditation under
Sec. 1.665 may seek accreditation by submitting a new application for
accreditation under Sec. 1.660 or, where applicable, Sec. 1.670.
Additional Procedures for Direct Accreditation of Third-Party
Certification Bodies Under This Subpart
Sec. 1.670 How do I apply to FDA for direct accreditation or renewal
of direct accreditation?
(a) Eligibility. (1) FDA will accept applications from third-party
certification bodies for direct accreditation or renewal of direct
accreditation only if FDA determines that it has not identified and
recognized an accreditation body to meet the requirements of section 808
of the FD&C Act within 2 years after establishing the accredited third-
party audits and certification program. Such FDA determination may
apply, as appropriate, to specific types of third-party certification
bodies, types of expertise, or geographic location; or through
identification by FDA of any requirements of section 808 of the FD&C Act
not otherwise met by previously recognized accreditation bodies. FDA
will only accept applications for direct accreditation and renewal
applications that are within the scope of the determination.
(2) FDA may revoke or modify a determination under paragraph (a)(1)
of this section if FDA subsequently identifies and recognizes an
accreditation body that affects such determination.
(3) FDA will provide notice on the Web site described in Sec. 1.690
of a determination under paragraph (a)(1) of this section and of a
revocation or modification of the determination under paragraph (a)(1)
of this section, as described in paragraph (a)(2) of this section.
(b) Application for direct accreditation or renewal of direct
accreditation. (1) A third-party certification body seeking direct
accreditation or renewal of direct accreditation must submit an
application to FDA, demonstrating that it is within the scope of the
determination issued under paragraph (a)(1) of this section, and it
meets the eligibility requirements of Sec. 1.640.
(2) Applications and all documents provided as part of the
application process must be submitted electronically, in English. An
applicant must provide such translation and interpretation services as
are needed by FDA to process the application, including during an onsite
audit of the applicant.
(3) The application must be signed in the manner designated by FDA
by an individual authorized to act on behalf of the applicant for
purposes of seeking or renewing direct accreditation.
Sec. 1.671 How will FDA review my application for direct accreditation
or renewal of direct accreditation and what happens once FDA decides on
my application?
(a) Review of a direct accreditation or renewal application. FDA
will examine a third-party certification body's direct accreditation or
renewal application for completeness and notify the applicant of any
deficiencies. FDA will review applications for direct accreditation and
for renewal of direct accreditation on a first in, first out basis
according to the date the completed submission is received; however, FDA
may prioritize the review of specific applications to meet the needs of
the program.
(b) Evaluation of a direct accreditation or renewal application. FDA
will evaluate any completed application to determine whether the
applicant meets the requirements for direct accreditation under this
subpart. If FDA does not reach a final decision on a renewal application
before the expiration of the direct accreditation, FDA may extend the
duration of such direct accreditation for a specified period of time or
until the Agency reaches a final decision on the renewal application.
(c) Notice of approval or denial. FDA will notify the applicant that
its direct accreditation or renewal application
[[Page 111]]
has been approved through issuance of or denied.
(d) Issuance of direct accreditation. If an application has been
approved, the issuance of the direct accreditation that will list any
limitations associated with the accreditation.
(e) Issuance of denial of direct accreditation. If FDA issues a
denial of direct accreditation or denial of a renewal application, the
issuance of the denial of direct accreditation will state the basis for
such denial and provide the procedures for requesting reconsideration of
the application under Sec. 1.691.
(f) Notice of records custodian after denial of application for
renewal of direct accreditation. An applicant whose renewal application
was denied must notify FDA electronically, in English, within 10
business days of the date of issuance of a denial of a renewal
application, of the name and contact information of the custodian who
will maintain the records required by Sec. 1.658(a) and make them
available to FDA as required by Sec. 1.658(b) and (c). The contact
information for the custodian must include, at a minimum, an email
address and the physical address where the records required by Sec.
1.658(b) will be located.
(g) Effect of denial of renewal of direct accreditation on food or
facility certifications issued to eligible entities. A food or facility
certification issued by an accredited third-party certification body
prior to issuance of the denial of its renewal application will remain
in effect until the certification expires. If FDA has reason to believe
that a certification issued for purposes of section 801(q) or 806 of the
FD&C Act is not valid or reliable, FDA may refuse to consider the
certification in determining the admissibility of the article of food
for which the certification was offered or in determining the importer's
eligibility for participation in VQIP.
(h) Public notice of denial of renewal of direct accreditation. FDA
will provide notice on the Web site described in Sec. 1.690 of the
issuance of a denial of renewal application for direct accreditation
under this subpart.
Sec. 1.672 What is the duration of direct accreditation?
FDA will grant direct accreditation of a third-party certification
body for a period not to exceed 4 years.
Requirements for Eligible Entities Under This Subpart
Sec. 1.680 How and when will FDA monitor eligible entities?
FDA may, at any time, conduct an onsite audit of an eligible entity
that has received food or facility certification from an accredited
third-party certification body under this subpart. Where FDA determines
necessary or appropriate, the unannounced audit may be conducted with or
without the accredited third-party certification body or the recognized
accreditation body (where applicable) present. An FDA audit conducted
under this section will be conducted on an unannounced basis and may be
preceded by a request for a 30-day operating schedule.
Sec. 1.681 How frequently must eligible entities be recertified?
An eligible entity seeking recertification of a food or facility
certification under this subpart must apply for recertification prior to
the expiration of its certification. For certifications used in meeting
the requirements of section 801(q) or 806 of the FD&C Act, FDA may
require an eligible entity to apply for recertification at any time FDA
determines appropriate under such section.
General Requirements of This Subpart
Sec. 1.690 How will FDA make information about recognized accreditation
bodies and accredited third-party certification bodies available to the
public?
FDA will place on its Web site a registry of recognized
accreditation bodies and accredited third-party certification bodies,
including the name, contact information, and scope and duration of
recognition or accreditation. The registry may provide information on
third-party certification bodies accredited by recognized accreditation
bodies through links to the Web sites
[[Page 112]]
of such recognized accreditation bodies. FDA will also place on its Web
site a list of accreditation bodies for which it has denied renewal of
recognition, for which FDA has revoked recognition, and that have
relinquished their recognition or have allowed their recognition to
expire. FDA will also place in its Web site a list of certification
bodies whose renewal of accreditation has been denied, for which FDA has
withdrawn accreditation, and that have relinquished their accreditations
or have allowed their accreditations to expire. FDA will place on its
Web site determinations under Sec. 1.670(a)(1) and modifications of
such determinations under Sec. 1.670(a)(2).
Sec. 1.691 How do I request reconsideration of a denial by FDA of an
application or a waiver request?
(a) An accreditation body may seek reconsideration of the denial of
an application for recognition, renewal of recognition, or reinstatement
of recognition no later than 10 business days after the date of the
issuance of such denial.
(b) A third-party certification body may seek reconsideration of the
denial of an application for direct accreditation, renewal of direct
accreditation, reaccreditation of directly accredited third-party
certification body, a request for a waiver of the conflict of interest
requirement in Sec. 1.650(b), or a waiver extension no later than 10
business days after the date of the issuance of such denial.
(c) A request to reconsider an application or waiver request under
paragraph (a) or (b) of this section must be signed by the requestor or
by an individual authorized to act on its behalf in submitting the
request for reconsideration. The request must be submitted
electronically in English and must comply with the procedures described
in the notice.
(d) After completing its review and evaluation of the request for
reconsideration, FDA will notify the requestor through the issuance of
the recognition, direct accreditation, or waiver upon reconsideration or
through the issuance of a denial of the application or waiver request
under paragraph (a) or (b) of this section upon reconsideration.
Sec. 1.692 How do I request internal agency review of a denial of an
application or waiver request upon reconsideration?
(a) No later than 10 business days after the date of issuance of a
denial of an application or waiver request upon reconsideration under
Sec. 1.691, the requestor may seek internal agency review of such
denial under Sec. 10.75(c)(1) of this chapter.
(b) The request for internal agency review under paragraph (a) of
this section must be signed by the requestor or by an individual
authorized to act on its behalf in submitting the request for internal
review. The request must be submitted electronically in English to the
address specified in the denial upon reconsideration and must comply
with procedures it describes.
(c) Under Sec. 10.75(d) of this chapter, internal agency review of
such denial must be based on the information in the administrative file,
which will include any supporting information submitted under Sec.
1.691(c).
(d) After completing the review and evaluation of the administrative
file, FDA will notify the requestor of its decision to overturn the
denial and grant the application or waiver request through issuance of
an application or waiver request upon reconsideration or to affirm the
denial of the application or waiver request upon reconsideration through
issuance of a denial of an application or waiver request upon
reconsideration.
(e) Issuance by FDA of a denial of an application or waiver request
upon reconsideration constitutes final agency action under 5 U.S.C. 702.
Sec. 1.693 How do I request a regulatory hearing on a revocation of
recognition or withdrawal of accreditation?
(a) Request for hearing on revocation. No later than 10 business
days after the date of issuance of a revocation of recognition of an
accreditation body under Sec. 1.634, an individual authorized to act on
the accreditation body's behalf may submit a request for a regulatory
hearing on the revocation under part 16 of this chapter. The issuance of
[[Page 113]]
revocation issued under Sec. 1.634 will contain all of the elements
required by Sec. 16.22 of this chapter and will thereby constitute the
notice of an opportunity for hearing under part 16 of this chapter.
(b) Request for hearing on withdrawal. No later than 10 business
days after the date of issuance of a withdrawal of accreditation of a
third-party certification body under Sec. 1.664, an individual
authorized to act on the third-party certification body's behalf may
submit a request for a regulatory hearing on the withdrawal under part
16 of this chapter. The issuance of withdrawal under Sec. 1.664 will
contain all of the elements required by Sec. 16.22 of this chapter and
will thereby constitute the notice of opportunity of hearing under part
16 of this chapter.
(c) Submission of request for regulatory hearing. The request for a
regulatory hearing under paragraph (a) or (b) of this section must be
submitted with a written appeal that responds to the basis for the FDA
decision, as described in the issuance of revocation or withdrawal, as
appropriate, and includes any supporting information upon which the
requestor is relying. The request, appeal, and supporting information
must be submitted in English to the address specified in the notice and
must comply with the procedures it describes.
(d) Effect of submission of request on FDA decision. The submission
of a request for a regulatory hearing under paragraph (a) or (b) of this
section will not operate to delay or stay the effect of a decision by
FDA to revoke recognition of an accreditation body or to withdraw
accreditation of a third-party certification body unless FDA determines
that a delay or a stay is in the public interest.
(e) Presiding officer. The presiding officer for a regulatory
hearing for a revocation or withdrawal under this subpart will be
designated after a request for a regulatory hearing is submitted to FDA.
(f) Denial of a request for regulatory hearing. The presiding
officer may deny a request for regulatory hearing for a revocation or
withdrawal under Sec. 16.26(a) of this chapter when no genuine or
substantial issue of fact has been raised.
(g) Conduct of regulatory hearing. (1) If the presiding officer
grants a request for a regulatory hearing for a revocation or
withdrawal, the hearing will be held within 10 business days after the
date the request was filed or, if applicable, within a timeframe agreed
upon in writing by requestor, the presiding officer, and FDA.
(2) The presiding officer must conduct the regulatory hearing for
revocation or withdrawal under part 16 of this chapter, except that,
under Sec. 16.5(b) of this chapter, such procedures apply only to the
extent that the procedures are supplementary and do not conflict with
the procedures specified for regulatory hearings under this subpart.
Accordingly, the following requirements of part 16 are inapplicable to
regulatory hearings under this subpart: Sec. 16.22 (Initiation of a
regulatory hearing); Sec. 16.24(e) (timing) and (f) (contents of
notice); Sec. 16.40 (Commissioner); Sec. 16.60(a) (public process);
Sec. 16.95(b) (administrative decision and record for decision); and
Sec. 16.119 (Reconsideration and stay of action).
(3) A decision by the presiding officer to affirm the revocation of
recognition or the withdrawal of accreditation is considered a final
agency action under 5 U.S.C. 702.
Sec. 1.694 Are electronic records created under this subpart subject
to the electronic records requirements of part 11 of this chapter?
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.
Sec. 1.695 Are the records obtained by FDA under this subpart subject
to public disclosure?
Records obtained by FDA under this subpart are subject to the
disclosure requirements under part 20 of this chapter.
[[Page 114]]
Requirements for User Fees Under This Subpart
Source: Sections 1.700 through 1.725 appear at 81 FR 90193, Dec. 14,
2016, unless otherwise noted.
Sec. 1.700 Who is subject to a user fee under this subpart?
(a) Accreditation bodies submitting applications or renewal
applications for recognition in the third-party certification program;
(b) Recognized accreditation bodies participating in the third-party
certification program;
(c) Third-party certification bodies submitting applications or
renewal applications for direct accreditation; and
(d) Accredited third-party certification bodies (whether accredited
by recognized accreditation bodies or by FDA through direct
accreditation) participating in the third-party certification program.
Sec. 1.705 What user fees are established under this subpart?
(a) The following application fees:
(1) Accreditation bodies applying for recognition are subject to an
application fee for the estimated average cost of the work FDA performs
in reviewing and evaluating applications for recognition of
accreditation bodies.
(2) Recognized accreditation bodies submitting renewal applications
are subject to a renewal application fee for the estimated average cost
of the work FDA performs in reviewing and evaluating renewal
applications for recognition of accreditation bodies.
(3) Third-party certification bodies applying for direct
accreditation are subject to an application fee for the estimated
average cost of the work FDA performs in reviewing and evaluating
applications for direct accreditation.
(4) Accredited third-party certification bodies applying for renewal
of direct accreditation are subject to an application fee for the
estimated average cost of the work FDA performs in reviewing and
evaluating renewal applications for direct accreditation.
(b) The following annual fees:
(1) Recognized accreditation bodies are subject to an annual fee for
the estimated average cost of the work FDA performs to monitor
performance of recognized accreditation bodies under Sec. 1.633.
(2) Third-party certification bodies directly accredited by FDA are
subject to an annual fee for the estimated average cost of the work FDA
performs to monitor directly accredited third-party certification bodies
under Sec. 1.662.
(3) Third-party certification bodies accredited by recognized
accreditation bodies are subject to an annual fee for the estimated
average cost of the work FDA performs to monitor third-party
certification bodies that are accredited by a recognized accreditation
body under Sec. 1.662.
Sec. 1.710 How will FDA notify the public about the fee schedule?
FDA will notify the public of the fee schedule annually. The fee
notice will be made publicly available prior to the beginning of the
fiscal year for which the fees apply, except for the first fiscal year
in which this regulation is effective. Each new fee schedule will be
adjusted for inflation and improvements in the estimates of the cost to
FDA of performing relevant work for the upcoming year.
Sec. 1.715 When must a user fee required by this subpart be submitted?
(a) Accreditation bodies applying for recognition and third-party
certification bodies applying for direct accreditation must submit a fee
concurrently with submitting an application or a renewal application.
(b) Accreditation bodies and third-party certification bodies
subject to an annual fee must submit payment within 30 days of receiving
billing for the fee.
Sec. 1.720 Are user fees under this subpart refundable?
User fees accompanying completed applications and annual fees under
this subpart are not refundable.
Sec. 1.725 What are the consequences of not paying a user fee under
this subpart on time?
(a) An application for recognition or renewal of recognition will
not be considered complete for the purposes of
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Sec. 1.631(a) until the date that FDA receives the application fee. An
application for direct accreditation or for renewal of direct
accreditation will not be considered complete for the purposes of Sec.
1.671(a) until FDA receives the application fee.
(b) A recognized accreditation body that fails to submit its annual
user fee within 30 days of the due date will have its recognition
suspended.
(1) FDA will notify the accreditation body electronically that its
recognition is suspended. FDA will notify the public of the suspension
on the Web site described in Sec. 1.690.
(2) While an accreditation body's recognition is suspended, the
accreditation body will not be able to accredit additional third-party
certification bodies. The accreditation of third-party certification
bodies that occurred prior to an accreditation body's suspension, as
well as food or facility certifications issued by such third-party
certification bodies, would remain in effect.
(3) If payment is not received within 90 days of the payment due
date, FDA will revoke the accreditation body's recognition under Sec.
1.634(a)(4)(iii), and provide notice of such revocation in accordance
with Sec. 1.634.
(c) An accredited third-party certification body that fails to
submit its annual fee within 30 days of the due date will have its
accreditation suspended.
(1) FDA will notify the third-party certification body that its
accreditation is suspended, electronically and in English. FDA will
notify a recognized accreditation body, electronically and in English,
if the accreditation of one if its third-party certification bodies is
suspended. FDA will notify the public of the suspension on the Web site
described in Sec. 1.690.
(2) While a third-party certification body's accreditation is
suspended, the third-party certification body will not be able to issue
food or facility certifications. A food or facility certification issued
by a third-party certification body prior to the suspension of the
auditor/certification body accreditation will remain in effect.
(3) If payment is not received within 90 days of the payment due
date, FDA will withdraw the third-party certification body's
accreditation under Sec. 1.664(a)(4), and provide notice of such
withdrawal in accordance with Sec. 1.664.
Subpart N [Reserved]
Subpart O_Sanitary Transportation of Human and Animal Food
Source: 81 FR 20166, Apr. 6, 2016, unless otherwise noted.
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.).
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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
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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
[[Page 118]]
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).
[[Page 119]]
(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
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(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.
[[Page 121]]
(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
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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.
Subpart P [Reserved]
Subpart Q_Administrative Detention of Drugs Intended for Human or Animal
Use
Sec. 1.980 Administrative detention of drugs.
(a) General. This section sets forth the procedures for detention of
drugs believed to be adulterated or misbranded. Administrative detention
is intended to protect the public by preventing distribution or use of
drugs encountered during inspections that may
[[Page 123]]
be adulterated or misbranded, until the Food and Drug Administration
(FDA) has had time to consider what action it should take concerning the
drugs, and to initiate legal action, if appropriate. Drugs that FDA
orders detained may not be used, moved, altered, or tampered with in any
manner by any person during the detention period, except as authorized
under paragraph (h) of this section, until FDA terminates the detention
order under paragraph (j) of this section, or the detention period
expires, whichever occurs first.
(b) Criteria for ordering detention. Administrative detention of
drugs may be ordered in accordance with this section when an authorized
FDA representative, during an inspection under section 704 of the
Federal Food, Drug, and Cosmetic Act, has reason to believe that a drug,
as defined in section 201(g) of the Federal Food, Drug, and Cosmetic
Act, is adulterated or misbranded.
(c) Detention period. The detention is to be for a reasonable period
that may not exceed 20 calendar days after the detention order is
issued, unless the FDA Division Director in whose division the drugs are
located determines that a greater period is required to seize the drugs,
to institute injunction proceedings, or to evaluate the need for legal
action, in which case the Division Director may authorize detention for
10 additional calendar days. The additional 10-calendar-day detention
period may be ordered at the time the detention order is issued or at
any time thereafter. The entire detention period may not exceed 30
calendar days, except when the detention period is extended under
paragraph (g)(6) of this section. An authorized FDA representative may,
in accordance with paragraph (j) of this section, terminate a detention
before the expiration of the detention period.
(d) Issuance of detention order. (1) The detention order must be
issued in writing, in the form of a detention notice, signed by the
authorized FDA representative who has reason to believe that the drugs
are adulterated or misbranded, and issued to the owner, operator, or
agent in charge of the place where the drugs are located. If the owner
or the user of the drugs is different from the owner, operator, or agent
in charge of the place where the drugs are detained, a copy of the
detention order must be provided to the owner or user of the drugs if
the owner's or user's identity can be readily determined.
(2) If detention of drugs in a vehicle or other carrier is ordered,
a copy of the detention order must be provided to the shipper of record
and the owner of the vehicle or other carrier, if their identities can
be readily determined.
(3) The detention order must include the following information:
(i) A statement that the drugs identified in the order are detained
for the period shown;
(ii) A brief, general statement of the reasons for the detention;
(iii) The location of the drugs;
(iv) A statement that these drugs are not to be used, moved,
altered, or tampered with in any manner during that period, except as
permitted under paragraph (h) of this section, without the written
permission of an authorized FDA representative;
(v) Identification of the detained drugs;
(vi) The detention order number;
(vii) The date and hour of the detention order;
(viii) The period of the detention;
(ix) The text of section 304(g) of the Federal Food, Drug, and
Cosmetic Act and paragraphs (g)(1) and (g)(2) of this section;
(x) A statement that any informal hearing on an appeal of a
detention order must be conducted as a regulatory hearing under part 16
of this chapter, with certain exceptions described in paragraph (g)(3)
of this section; and
(xi) The mailing address, telephone number, and name of the FDA
Division Director.
(e) Approval of detention order. A detention order, before issuance,
must be approved by the FDA Division Director in whose division the
drugs are located. If prior written approval is not feasible, prior oral
approval must be obtained and confirmed by written memorandum within FDA
as soon as possible.
[[Page 124]]
(f) Labeling or marking a detained drug. An FDA representative
issuing a detention order under paragraph (d) of this section must label
or mark the drugs with official FDA tags that include the following
information:
(1) A statement that the drugs are detained by the U.S. Government
in accordance with section 304(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 334(g)).
(2) A statement that the drugs must not be used, moved, altered, or
tampered with in any manner for the period shown, without the written
permission of an authorized FDA representative, except as authorized in
paragraph (h) of this section.
(3) A statement that the violation of a detention order or the
removal or alteration of the tag is punishable by fine or imprisonment
or both (section 303 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 333)).
(4) The detention order number, the date and hour of the detention
order, the detention period, and the name of the FDA representative who
issued the detention order.
(g) Appeal of a detention order. (1) A person who would be entitled
to claim the drugs, if seized, may appeal a detention order. Any appeal
must be submitted in writing to the FDA Division Director in whose
division the drugs are located within 5 working days of receipt of a
detention order. If the appeal includes a request for an informal
hearing, as defined in section 201(x) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(x)), the appellant must request either that
a hearing be held within 5 working days after the appeal is filed or
that the hearing be held at a later date, which must not be later than
20 calendar days after receipt of a detention order.
(2) The appellant of a detention order must state the ownership or
proprietary interest the appellant has in the detained drugs. If the
detained drugs are located at a place other than an establishment owned
or operated by the appellant, the appellant must include documents
showing that the appellant would have legitimate authority to claim the
drugs if seized.
(3) Any informal hearing on an appeal of a detention order must be
conducted as a regulatory hearing under regulation in accordance with
part 16 of this chapter, except that:
(i) The detention order under paragraph (d) of this section, rather
than the notice under Sec. 16.22(a) of this chapter, provides notice of
opportunity for a hearing under this section and is part of the
administrative record of the regulatory hearing under Sec. 16.80(a) of
this chapter;
(ii) A request for a hearing under this section should be addressed
to the FDA Division Director;
(iii) The last sentence of Sec. 16.24(e) of this chapter, stating
that a hearing may not be required to be held at a time less than 2
working days after receipt of the request for a hearing, does not apply
to a hearing under this section;
(iv) Paragraph (g)(4) of this section, rather than Sec. 16.42(a) of
this chapter, describes the FDA employees who preside at hearings under
this section.
(4) The presiding officer of a regulatory hearing on an appeal of a
detention order, who also must decide the appeal, must be an Office of
Regulatory Affairs Program Director or another FDA official senior to an
FDA Division Director who is permitted by Sec. 16.42(a) of this chapter
to preside over the hearing.
(5) If the appellant requests a regulatory hearing and requests that
the hearing be held within 5 working days after the appeal is filed, the
presiding officer must, within 5 working days, hold the hearing and
render a decision affirming or revoking the detention.
(6) If the appellant requests a regulatory hearing and requests that
the hearing be held at a date later than within 5 working days after the
appeal is filed, but not later than 20 calendar days after receipt of a
detention order, the presiding officer must hold the hearing at a date
agreed upon by FDA and the appellant. The presiding officer must decide
whether to affirm or revoke the detention within 5 working days after
the conclusion of the hearing. The detention period extends to the date
of the decision even if the 5-working-day period for making the decision
extends beyond the otherwise applicable 20-calendar-day or 30-calendar-
day detention period.
[[Page 125]]
(7) If the appellant appeals the detention order but does not
request a regulatory hearing, the presiding officer must render a
decision on the appeal, affirming or revoking the detention within 5
working days after the filing of the appeal.
(8) If the presiding officer affirms a detention order, the drugs
continue to be detained until FDA terminates the detention under
paragraph (j) of this section or the detention period expires, whichever
occurs first.
(9) If the presiding officer revokes a detention order, FDA must
terminate the detention under paragraph (j) of this section.
(h) Movement of detained drugs. (1) Except as provided in this
paragraph, no person may move detained drugs within or from the place
where they have been ordered detained until FDA terminates the detention
under paragraph (j) of this section or the detention period expires,
whichever occurs first.
(2) If detained drugs are not in final form for shipment, the
manufacturer may move them within the establishment where they are
detained to complete the work needed to put them in final form. As soon
as the drugs are moved for the purpose in the preceding sentence, the
individual responsible for their movement must orally notify the FDA
representative who issued the detention order, or another responsible
division office official, of the movement of the drugs. As soon as the
drugs are put in final form, they must be segregated from other drugs,
and the individual responsible for their movement must orally notify the
FDA representative who issued the detention order, or another
responsible division office official, of their new location. The drugs
put in final form must not be moved further without FDA approval.
(3) The FDA representative who issued the detention order, or
another responsible division office official, may approve, in writing,
the movement of detained drugs for any of the following purposes:
(i) To prevent interference with an establishment's operations or
harm to the drugs;
(ii) To destroy the drugs;
(iii) To bring the drugs into compliance;
(iv) For any other purpose that the FDA representative who issued
the detention order, or other responsible division office official,
believes is appropriate in the case.
(4) If an FDA representative approves the movement of detained drugs
under paragraph (h)(3) of this section, the detained drugs must remain
segregated from other drugs and the person responsible for their
movement must immediately orally notify the official who approved the
movement of the drugs, or another responsible FDA division office
official, of the new location of the detained drugs.
(5) Unless otherwise permitted by the FDA representative who is
notified of, or who approves, the movement of drugs under this
paragraph, the required tags must accompany the drugs during and after
movement and must remain with the drugs until FDA terminates the
detention or the detention period expires, whichever occurs first.
(i) Actions involving adulterated or misbranded drugs. If FDA
determines that the detained drugs, including any that have been put in
final form, are adulterated or misbranded, or both, it may initiate
legal action against the drugs or the responsible individuals, or both,
or request that the drugs be destroyed or otherwise brought into
compliance with the Federal Food, Drug, and Cosmetic Act under FDA's
supervision.
(j) Detention termination. If FDA decides to terminate a detention
or when the detention period expires, whichever occurs first, an FDA
representative authorized to terminate a detention will issue a
detention termination notice releasing the drugs to any person who
received the original detention order or that person's representative
and will remove, or authorize in writing the removal of, the required
labels or tags.
(k) Recordkeeping requirements. (1) After issuance of a detention
order under paragraph (d) of this section, the owner, operator, or agent
in charge of any factory, warehouse, other establishment, or consulting
laboratory where detained drugs are manufactured, processed, packed, or
held, must
[[Page 126]]
have, or establish, and maintain adequate records relating to how the
detained drugs may have become adulterated or misbranded, records on any
distribution of the drugs before and after the detention period, records
on the correlation of any in-process detained drugs that are put in
final form under paragraph (h) of this section to the completed drugs,
records of any changes in, or processing of, the drugs permitted under
the detention order, and records of any other movement under paragraph
(h) of this section. Records required under this paragraph must be
provided to FDA on request for review and copying. Any FDA request for
access to records required under this paragraph must be made at a
reasonable time, must state the reason or purpose for the request, and
must identify to the fullest extent practicable the information or type
of information sought in the records to which access is requested.
(2) Records required under this paragraph must be maintained for a
maximum period of 2 years after the issuance of the detention order or
for such other shorter period as FDA directs. When FDA terminates the
detention or when the detention period expires, whichever occurs first,
FDA will advise all persons required under this paragraph to keep
records concerning that detention whether further recordkeeping is
required for the remainder of the 2-year, or shorter, period. FDA
ordinarily will not require further recordkeeping if the Agency
determines that the drugs are not adulterated or misbranded or that
recordkeeping is not necessary to protect the public health, unless the
records are required under other regulations in this chapter (e.g., the
good manufacturing practice regulation in part 211 of this chapter).
[79 FR 30719, May 29, 2014, as amended at 82 FR 14144, Mar. 17, 2017; 85
FR 16551, Mar. 24, 2020]
Subpart R_Laboratory Accreditation for Analyses of Foods
Source: 86 FR 68817, Dec. 3, 2021; 87 FR 5660, Feb. 2, 2022, unless
otherwise noted.
General Provisions
Sec. 1.1101 What documents are incorporated by reference in this subpart
(a) Certain material is incorporated by reference into this subpart
with the approval of the Director of the Federal Register under 5 U.S.C.
552(a) and 1 CFR part 51. All approved material is available for
inspection at the Food and Drug Administration's Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500,
and is available from the source listed elsewhere in this section. It is
also available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, email [email protected] or go to https://
www.archives.gov/ federal-register/cfr/ibr-locations.html.
(b) International Organization for Standardization (ISO), Chemin de
Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland; Telephone 41 22
749 01 11, https://www.iso.org/home.html.
(1) ISO/IEC 17011:2017(E), Conformity assessment--Requirements for
accreditation bodies accrediting conformity assessment bodies, Second
edition, November 2017, IBR approved for Sec. Sec. 1.1113(a) and (c),
1.1114(b), 1.1120(c), 1.1131(a).
(2) ISO/IEC 17025:2017(E), General requirements for the competence
of testing and calibration laboratories, Third edition, November 2017,
IBR approved for Sec. Sec. 1.1120(c), 1.1121(a), 1.1138(a), 1.1139(b)
and (c), 1.1141(a), 1.1152(a) and (d), 1.1153(c), and 1.1161(a).
Sec. 1.1102 What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug,
and Cosmetic Act apply to such terms when used in this subpart, unless
otherwise specified. For the purposes of this subpart, the following
definitions also apply:
Analyst means an individual who analyzes samples.
Corrective action means an action taken by an accreditation body or
laboratory to investigate and eliminate the cause of a deficiency so
that it does not recur.
[[Page 127]]
Directed food laboratory order means an order issued by FDA under
Sec. 1.1108 requiring food testing to be conducted under this subpart
by or on behalf of an owner or consignee.
Food has the meaning given in section 201(f) of the Federal Food,
Drug, and Cosmetic Act, except that food does not include pesticides (as
defined in 7 U.S.C. 136(u)).
Food testing and testing of food means the analysis of food product
samples or environmental samples.
Laboratory accreditation for analyses of foods (LAAF)-accreditation
means a determination by a recognized accreditation body that a
laboratory meets the applicable requirements of this subpart to conduct
food testing under this subpart using one or more methods of analysis.
LAAF-accredited laboratory means a laboratory that a recognized
accreditation body has determined meets the applicable requirements of
this subpart and has been LAAF-accredited to conduct food testing under
this subpart using one or more methods of analysis.
Owner or consignee means any person with an ownership or consignment
interest in the food product or environment that is the subject of food
testing conducted under Sec. 1.1107(a).
Recognition means a determination by FDA that an accreditation body
meets the applicable requirements of this subpart and is authorized to
LAAF-accredit laboratories under this subpart.
Recognized accreditation body means an accreditation body that FDA
has determined meets the applicable requirements of this subpart and is
authorized to LAAF-accredit laboratories under this subpart.
Representative sample means a sample that accurately, to a
statistically acceptable degree, represents the characteristics and
qualities of the food product or environment from which the sample was
collected.
Sampler means an individual who collects samples.
Sampling firm means an entity that provides sampling services.
Scope of LAAF-accreditation refers to the methods of analysis for
which the laboratory is LAAF-accredited.
Street address means the full physical address, including the
country. For purposes of this rule, a post office box number alone is
insufficient; however, a post office box number may be provided in
addition to the street address.
Sec. 1.1103 Who is subject to this subpart?
(a) Accreditation bodies. An accreditation body is subject to this
subpart if it has been or is seeking to be recognized by FDA to LAAF-
accredit laboratories to conduct food testing under this subpart.
(b) Laboratories. A laboratory is subject to this subpart if it has
been or is seeking to be LAAF-accredited by a recognized accreditation
body to conduct food testing under this subpart.
(c) Owners and consignees. An owner or consignee is subject to this
subpart if it is required to use a LAAF-accredited laboratory to conduct
food testing under this subpart.
General Requirements
Sec. 1.1107 When must food testing be conducted under this subpart?
(a) Food testing must be conducted under this subpart whenever such
testing is conducted by or on behalf of an owner or consignee:
(1) In response to explicit testing requirements that address an
identified or suspected food safety problem, which are contained in the
following provisions:
(i) Sprouts. Section 112.146(a), (c), and (d) of this chapter;
(ii) Shell eggs. Sections 118.4(a)(2)(iii), 118.5(a)(2)(ii) and
(b)(2)(ii), and 118.6(a)(2) and (e) of this chapter; and
(iii) Bottled drinking water. Section 129.35(a)(3)(i) of this
chapter (for the requirement to test five samples from the same sampling
site that originally tested positive for Escherichia coli);
(2) As required by FDA in a directed food laboratory order issued
under Sec. 1.1108;
(3) To address an identified or suspected food safety problem and
presented to FDA as part of evidence for a hearing under section 423(c)
of the Federal Food, Drug, and Cosmetic Act prior to the issuance of a
mandatory food recall order, as part of a corrective action plan under
section
[[Page 128]]
415(b)(3)(A) of the Federal Food, Drug, and Cosmetic Act submitted after
an order suspending the registration of a food facility, or as part of
evidence submitted for an appeal of an administrative detention order
under section 304(h)(4)(A) of the Federal Food, Drug, and Cosmetic Act.
(4) In support of admission of an article of food under section
801(a) of the Federal Food, Drug, and Cosmetic Act; and
(5) To support removal from an import alert through successful
consecutive testing.
(b) When food testing is conducted under paragraph (a) of this
section, analysis of samples must be conducted by a laboratory that is
LAAF-accredited for the appropriate analytical method by a recognized
accreditation body under this subpart.
(c) Food testing conducted on articles of food offered for import
into the United States under section 801(a) of the Federal Food, Drug,
and Cosmetic Act pursuant to paragraph (a)(4) or (a)(5) of this section
may only be conducted after the articles offered for import have arrived
in the United States unless the owner or consignee has written approval
from FDA that a sample taken prior to arrival is or would be a
representative sample of the article offered for import into the United
States.
Sec. 1.1108 When and how will FDA issue a directed food laboratory order?
(a) FDA may require the owner or consignee to conduct food testing,
or to have food testing conducted on their behalf, under this subpart to
address an identified or suspected food safety problem, as FDA deems
appropriate.
(b) The directed food laboratory order will specify the food product
or environment to be tested; whether the food testing may be conducted
using a LAAF-accredited laboratory that is owned, operated, or
controlled by the owner or consignee; the timeframe in which the food
testing must be conducted; and the manner of the food testing, such as
the methods that must be used.
(c) The directed food laboratory order will contain all the elements
required by Sec. 16.22(a) of this chapter and will thereby constitute
the notice of an opportunity for hearing under part 16 of this chapter.
An affected owner or consignee may request a regulatory hearing on a
directed food laboratory order pursuant to Sec. 1.1174.
Sec. 1.1109 How will FDA make information about recognized accreditation
bodies and LAAF-accredited laboratories available to the public?
FDA will place on its website a publicly available registry listing
of:
(a) Recognized accreditation bodies, including for each: the name,
contact information, and duration of recognition of the recognized
accreditation body;
(b) Accreditation bodies that have a change in recognition,
including for each: the name of the accreditation body, the specific
change in recognition (i.e., probation, revocation of recognition,
denial of renewal of recognition, relinquishment of recognition, or
expiration of recognition) and the effective date of the change;
(c) LAAF-accredited laboratories, including for each: the name,
contact information, and scope of LAAF-accreditation, and the name and
contact information of the recognized accreditation body that has LAAF-
accredited the laboratory; and
(d) Laboratories that have a change in LAAF-accreditation, including
for each: the name of the laboratory, the specific change in LAAF-
accreditation (i.e., suspension, reduction of scope, or withdrawal of
LAAF-accreditation by the recognized accreditation body, probation or
disqualification by FDA, or relinquishment of LAAF-accreditation), and
the effective date of the change.
Sec. 1.1110 What are the general requirements for submitting information
to FDA under this subpart?
(a) All applications, reports, notifications, and records submitted
to FDA under this subpart must be submitted electronically and in
English unless otherwise specified. If FDA requests inspection or
submission of records that are maintained in any language other than
English, the recognized accreditation body or LAAF-accredited laboratory
must provide an English translation within a reasonable time.
[[Page 129]]
(b) A program applicant must provide any translation and
interpretation services needed by FDA during the processing of the
application, including during any onsite assessments of the applicant by
FDA.
FDA Recognition of Accreditation Bodies
Sec. 1.1113 What are the eligibility requirements for a recognized
accreditation body?
A recognized accreditation body or an accreditation body seeking
recognition must meet all of the following requirements:
(a) Demonstrates compliance with ISO/IEC 17011:2017(E) (incorporated
by reference, see Sec. 1.1101).
(b) Demonstrates that it is a full member of the International
Laboratory Accreditation Cooperative (ILAC).
(c) Demonstrates that it is a signatory to the ILAC Mutual
Recognition Arrangement (MRA) that has demonstrated competence to ISO/
IEC 17011:2017(E) with a scope of ``Testing: ISO/IEC 17025.''
(d) Will comply with all additional requirements for recognized
accreditation bodies under this subpart while recognized.
Sec. 1.1114 How does an accreditation body apply to FDA for recognition
or renewal of recognition?
(a) Application for recognition or renewal of recognition. An
accreditation body seeking initial recognition or renewal of recognition
must submit an application to FDA demonstrating that it meets the
eligibility requirements in Sec. 1.1113.
(b) Documentation of conformance with requirements. The
accreditation body must submit documentation of conformance with ISO/IEC
17011:2017(E) (incorporated by reference, see Sec. 1.1101) and separate
documentation of ILAC membership and ILAC MRA signatory status
demonstrating competence to ISO/IEC 17011:2017(E) with a scope of
``Testing: ISO/IEC 17025,'' in meeting the requirements of Sec.
1.1113(a) through (c). The accreditation body also must submit
documentation of its compliance with Sec. 1.1113(d).
(c) Signature. An application for recognition or renewal of
recognition must be signed in the manner designated by FDA by an
individual authorized to act on behalf of the applicant for purposes of
seeking recognition or renewal of recognition.
Sec. 1.1115 How will FDA evaluate applications for recognition and
renewal of recognition?
(a) Review of application for recognition or renewal of recognition.
FDA will review an accreditation body's application for recognition or
renewal of recognition for completeness and notify the applicant of any
insufficiencies. FDA generally will review accreditation body
applications for recognition or renewal of recognition in the order in
which completed applications are received; however, FDA may prioritize
the review of specific applications to meet program needs.
(b) Evaluation of application for recognition or renewal of
recognition. FDA will evaluate a complete application for recognition or
renewal of recognition to determine whether the applicant meets the
requirements for recognition. Such evaluation may include an onsite
evaluation of the accreditation body. If FDA does not reach a final
decision on an application for renewal of recognition before an
accreditation body's recognition expires, FDA may extend the existing
term of recognition for a specified period of time or until FDA reaches
a final decision on the application for renewal of recognition.
(c) Grant of recognition. FDA will notify the applicant that its
application for recognition or renewal of recognition has been approved
and will include any conditions associated with the recognition.
(d) Duration of recognition. FDA may grant recognition of an
accreditation body for a period not to exceed 5 years from the date of
recognition, except under the circumstances described in paragraph (b)
of this section.
(e) Denial of application for recognition or renewal of recognition.
FDA will notify the applicant that its application for recognition or
renewal of recognition has been denied and will state the basis for such
denial and describe the procedures for requesting reconsideration of the
application under Sec. 1.1171.
[[Page 130]]
(f) Notice of records custodian after denial of an application for
renewal of recognition. Within 10 business days of the date of FDA's
issuance of a denial of an application for renewal of recognition, the
applicant must provide the name and contact information of the custodian
who will maintain required records and make them available to FDA under
Sec. 1.1124. The contact information must include an email address for
the records custodian and the street address where the records required
under Sec. 1.1124 will be located.
(g) FDA notice to LAAF-accredited laboratories. FDA will promptly
notify all laboratories LAAF-accredited by the accreditation body whose
application for renewal of recognition was denied, informing them of
such denial.
(h) Public notice of denial of an application for renewal of
recognition of an accreditation body. FDA will provide public notice on
the website described in Sec. 1.1109 of the issuance of a denial of an
application for renewal of recognition and will include the date of the
issuance of such denial.
Sec. 1.1116 What must a recognized accreditation body do to voluntarily
relinquish or not renew its recognition?
(a) Notice to FDA of intent to relinquish or not to renew
recognition. At least 60 calendar days before voluntarily relinquishing
its recognition or before allowing its recognition to expire without
seeking renewal, a recognized accreditation body must notify FDA of its
intention to leave the program, specifying the date on which the
relinquishment or expiration will occur. The recognized accreditation
body must provide the name and contact information of the custodian who
will maintain and make available to FDA the records required by Sec.
1.1124 after the date of relinquishment or the date recognition expires,
as applicable. The contact information must include an email address for
the records custodian and the street address where the records required
under Sec. 1.1124 will be located.
(b) Notice to LAAF-accredited laboratories of intent to relinquish
or not to renew recognition. At least 60 calendar days before
voluntarily relinquishing its recognition or before allowing its
recognition to expire without seeking renewal, a recognized
accreditation body must notify the laboratories it LAAF accredits of its
intention to leave the program, specifying the date on which
relinquishment or expiration will occur.
(c) Public notice of voluntary relinquishment or expiration of
recognition. FDA will provide notice on the website described in Sec.
1.1109 of the voluntary relinquishment or expiration of recognition of
an accreditation body.
Sec. 1.1117 How may an accreditation body request reinstatement of
recognition?
(a) Application following revocation of recognition. An
accreditation body that has had its recognition revoked by FDA (as
described in Sec. 1.1131) may seek reinstatement by submitting a new
application for recognition under Sec. 1.1114. The accreditation body
must also submit evidence to FDA with its application to demonstrate
that the issues resulting in revocation of recognition have been
resolved, including evidence addressing the cause or condition of the
grounds for revocation of recognition. The evidence also must identify
measures that have been implemented to help ensure that such cause or
condition is unlikely to recur.
(b) Application following relinquishment or expiration of
recognition. An accreditation body that previously relinquished its
recognition or allowed its recognition to expire (as described in Sec.
1.1116) may seek reinstatement by submitting a new application for
recognition under Sec. 1.1114.
Requirements for Recognized Accreditation Bodies
Sec. 1.1119 What are the conflict of interest requirements for a
recognized accreditation body?
(a) In addition to meeting the impartiality and conflict of interest
requirements of Sec. 1.1113(a), a recognized accreditation body must:
(1) Ensure that the recognized accreditation body (and its officers,
employees, or other agents involved in LAAF-accreditation activities)
does not own or have a financial interest in,
[[Page 131]]
manage, or otherwise control any laboratory (or any affiliate, parent,
or subsidiary) it LAAF-accredits, subject to the exceptions in
paragraphs (c) and (d) of this section; and
(2) Prohibit, subject to the exceptions in paragraph (e) of this
section, officers, employees, or other agents involved in LAAF-
accreditation activities of the recognized accreditation body from
accepting any money, gift, gratuity, or other item of value from any
laboratory the recognized accreditation body LAAF-accredits or assesses
for LAAF-accreditation.
(b) The financial interests of any children younger than 18 years of
age or a spouse of a recognized accreditation body's officers,
employees, and other agents involved in LAAF-accreditation activities
are considered the financial interests of such officers, employees, and
other agents involved in LAAF-accreditation activities.
(c) An accreditation body (and its officers, employees, or other
agents involved in LAAF-accreditation activities) may have an interest
in a publicly traded or publicly available investment fund (e.g., a
mutual fund), or a widely held pension or similar fund if the
accreditation body (and its officers, employees, or other agents
involved in LAAF-accreditation activities) neither exercises control nor
has the ability to exercise control over the financial interests held in
the fund.
(d) A recognized accreditation body's agent that is a contract
assessor will be permitted to own or have a financial interest in,
manage, or otherwise control a LAAF-accredited laboratory if all of the
following circumstances apply:
(1) The contract assessor's primary occupation is owning or having a
financial interest in, managing, or otherwise controlling a LAAF-
accredited laboratory;
(2) The assessor contracts with the recognized accreditation body to
provide assessment services on an intermittent or part-time basis;
(3) The contract assessor does not assess the LAAF-accredited
laboratory that the assessor owns or has a financial interest in,
manages, or otherwise controls; and
(4) The contract assessor and the recognized accreditation body
inform any laboratory that the contract assessor may assess or reassess
for LAAF-accreditation that the contract assessor owns or has a
financial interest in, manages, or otherwise controls a LAAF-accredited
laboratory. The laboratory seeking LAAF-accreditation assessment or
reassessment must acknowledge that the contract assessor owns or has a
financial interest in, manages, or otherwise controls a LAAF-accredited
laboratory and be provided the option to be assessed by a different
representative of the recognized accreditation body.
(e) The prohibited items of value specified in paragraph (a)(2) of
this section do not include:
(1) Money representing payment of fees for LAAF-accreditation
services or reimbursement of direct costs associated with an onsite
assessment or reassessment of the laboratory; or
(2) Meal of de minimis value provided during the course of an
assessment or reassessment and on the premises where the assessment or
reassessment is conducted, if necessary for the efficient conduct of the
assessment or reassessment.
Sec. 1.1120 How must a recognized accreditation body assess laboratories
seeking LAAF-accreditation and oversee LAAF-accredited laboratories?
(a) A recognized accreditation body must conduct an initial
assessment of a laboratory seeking LAAF-accreditation in accordance with
the requirements of this subpart, to determine whether the laboratory
meets the requirements of Sec. 1.1138.
(b) Subject to the exception in paragraph (c) of this section, the
initial assessment must be conducted onsite, although certain assessment
activities may be conducted remotely if it will not aid the assessment
to conduct them onsite.
(c) If, within the previous 2 years, the recognized accreditation
body conducted an onsite assessment of the laboratory in accordance with
ISO/IEC 17011:2017(E) (incorporated by reference, see Sec. 1.1101) to
assess whether the laboratory meets the requirements of ISO/IEC
17025:2017(E) (incorporated
[[Page 132]]
by reference, see Sec. 1.1101), then the initial assessment under this
section:
(1) May be conducted remotely, and
(2) Need only address whether the laboratory meets the requirements
of Sec. 1.1138(a)(2) and (3) and (b).
(d) A recognized accreditation body must oversee the performance of
a laboratory it LAAF-accredits in accordance with the requirements of
Sec. 1.1113(a), except as otherwise provided by this subpart, to
determine whether the LAAF-accredited laboratory continues to meet the
applicable requirements of this subpart.
(e) A recognized accreditation body must conduct a reassessment of a
LAAF-accredited laboratory in accordance with this subpart at least
every 2 years. Such reassessment must be conducted onsite, although
certain reassessment activities may be conducted remotely if it will not
aid in the reassessment to conduct the activities onsite.
(f) If the recognized accreditation body conducted the initial
assessment of the LAAF-accredited laboratory remotely in accordance with
paragraph (c) of this section, the recognized accreditation body must
conduct its first reassessment of the LAAF-accredited laboratory no
later than 2 years after the recognized accreditation body last
conducted an onsite assessment of the laboratory.
(g) The reassessment at the end of the LAAF-accredited laboratory's
ISO/IEC 17025:2017-accreditation cycle, which the recognized
accreditation body must conduct in accordance with this subpart, must be
conducted onsite, although certain reassessment activities may be
conducted remotely if it will not aid the reassessment to conduct them
onsite.
(h) Any assessments or reassessments conducted by a recognized
accreditation body in addition to the assessments or reassessments
referred to in paragraphs (a), (e), and (g) of this section may be
conducted remotely if it will not aid the assessment or reassessment to
conduct it onsite.
Sec. 1.1121 When must a recognized accreditation body require corrective
action, suspend a LAAF-accredited laboratory, or reduce the scope of or
withdraw the LAAF-accreditation of a laboratory?
(a) Corrective action. A recognized accreditation body may require
corrective action using the procedures described by ISO/IEC
17025:2017(E) (incorporated by reference, see Sec. 1.1101) section 8.7
to address any deficiencies identified while assessing and overseeing a
LAAF-accredited laboratory.
(1) The recognized accreditation body must notify the LAAF-
accredited laboratory of all deficiencies requiring corrective action
and will either specify a deadline to implement corrective action or
will require the LAAF-accredited laboratory to submit a corrective
action plan and timeframe for implementation to the recognized
accreditation body for approval.
(2) The LAAF-accredited laboratory must implement appropriate
corrective action under ISO/IEC 17025:2017(E) section 8.7, and submit
the results of the corrective action to the recognized accreditation
body.
(3) The recognized accreditation body will review the corrective
action and will notify the LAAF-accredited laboratory whether the
corrective action is acceptable.
(b) Suspension. If a recognized accreditation body determines that a
laboratory it LAAF-accredits has not effectively implemented corrective
action or otherwise fails to address deficiencies identified, the
recognized accreditation body may temporarily suspend the LAAF-
accredited laboratory for one or more LAAF-accredited methods, and
require corrective action under paragraph (a) of this section.
(1) The recognized accreditation body must notify the LAAF-
accredited laboratory of the grounds for the suspension, the LAAF-
accredited methods subject to the suspension, and all deficiencies that
must be addressed via the process described in paragraph (a) of this
section.
(2) The recognized accreditation body must notify FDA of the
suspension under this section in accordance with the requirements of
Sec. 1.1123(d)(5). FDA
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will provide notice of the LAAF-accredited laboratory's suspension on
the website described in Sec. 1.1109.
(3) The recognized accreditation body will review the corrective
action required under paragraph (b) of this section and will notify the
LAAF-accredited laboratory whether the corrective action is acceptable.
(4) A LAAF-accredited laboratory shall remain suspended until it
demonstrates to the recognized accreditation body's satisfaction that
the LAAF-accredited laboratory has successfully implemented appropriate
corrective action.
(5) If the recognized accreditation body determines that a LAAF-
accredited laboratory on suspension has failed to implement appropriate
corrective action or otherwise fails to address deficiencies identified,
the recognized accreditation body may reduce the scope of or withdraw
the LAAF-accreditation of the laboratory under paragraph (c) of this
section.
(c) Reduction of scope or withdrawal of LAAF-accreditation. A
recognized accreditation body must reduce the scope of or withdraw the
LAAF-accreditation of a laboratory it LAAF-accredits when the laboratory
substantially fails to comply with this subpart. When only certain
methods within the laboratory's scope of LAAF-accreditation are affected
by the noncompliance, the recognized accreditation body may reduce the
scope of the laboratory's LAAF-accreditation for only those affected
methods. If all methods are affected, the recognized accreditation body
must withdraw the laboratory's LAAF-accreditation.
(d) Procedures for reduction of scope or withdrawal of LAAF-
accreditation. (1) The recognized accreditation body must notify the
laboratory of any reduction of scope or withdrawal of LAAF-
accreditation, including:
(i) The grounds for the reduction of scope or withdrawal of LAAF-
accreditation;
(ii) The method(s) to which the reduction of scope applies;
(iii) The procedures for appealing the reduction of scope or
withdrawal of LAAF-accreditation as described in Sec. 1.1122; and
(iv) The date the reduction of scope or withdrawal of LAAF-
accreditation is effective.
(2) The recognized accreditation body must notify FDA of the
reduction of scope or withdrawal of LAAF-accreditation under this
section in accordance with the requirements in Sec. 1.1123(d)(4). FDA
will provide notice of the reduction of scope or withdrawal of the
laboratory's LAAF-accreditation on the website described in Sec.
1.1109.
(e) Records request associated with suspension, reduction of scope,
or withdrawal of LAAF-accreditation. To assist the recognized
accreditation body in determining whether a suspension, reduction of
scope, or withdrawal of LAAF-accreditation is warranted under this
section, the recognized accreditation body may require the submission of
records that the LAAF-accredited laboratory is required to maintain
under Sec. 1.1154.
(f) Consequences of suspension, reduction of scope, or withdrawal of
LAAF-accreditation. (1) A LAAF-accredited laboratory may not conduct
food testing under this subpart using suspended methods.
(2) If the recognized accreditation body withdraws the laboratory's
LAAF-accreditation, the laboratory is immediately ineligible to conduct
any food testing under this subpart. If the recognized accreditation
body reduces the laboratory's scope of LAAF-accreditation, the
laboratory is immediately ineligible to use the methods to which the
reduction of scope applies to conduct food testing under this subpart.
Sec. 1.1122 What procedures must a recognized accreditation body provide
for appeals of decisions to suspend, reduce the scope of, withdraw, or
deny LAAF-accreditation?
A recognized accreditation body must consider a laboratory's appeal
regarding a decision to suspend, reduce the scope of, withdraw, or deny
LAAF-accreditation in accordance with the requirements of Sec.
1.1113(a). Appeals must be reviewed and decided by a competent person(s)
free from bias or prejudice who has not participated in the LAAF-
accreditation decision and is not the subordinate of a person who
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participated in the LAAF-accreditation decision. For the purposes of
appeals, the competent person(s) may be external to the recognized
accreditation body.
Sec. 1.1123 What reports, notifications, and documentation must a
recognized accreditation body submit to FDA?
(a) General requirements. All reports and notifications required by
this section must include:
(1) The name, street address, telephone number, and email address of
the recognized accreditation body associated with the report or
notification, and the name of an appropriate point of contact for the
recognized accreditation body, and
(2) If the report or notification concerns a LAAF-accredited
laboratory, the name, street address, telephone number, and email
address of the LAAF-accredited laboratory, and the name of an
appropriate point of contact for the LAAF-accredited laboratory.
(b) Internal audit reports. A recognized accreditation body must
submit to FDA a report of the results of the internal audit conducted
pursuant to Sec. 1.1125 within 45 calendar days of completing the
audit. The audit report must include:
(1) A description of the internal audit conducted;
(2) A description of any identified deficiencies;
(3) A description of any corrective action taken or planned,
including the timeline for such corrective action; and
(4) A statement disclosing the extent to which the internal audit
was conducted by personnel different from those who perform the activity
or activities that were audited.
(c) Changes affecting recognition. A recognized accreditation body
must notify FDA within 48 hours when the recognized accreditation body
is aware of a change that would affect the recognition of such
accreditation body, and the notification must include:
(1) A description of the change, and
(2) If the change is one made by the recognized accreditation body,
an explanation of the purpose of the change.
(d) Changes in LAAF-accreditation. A recognized accreditation body
must notify FDA and submit a certificate reflecting the scope of
accreditation within 48 hours when any of the following occur:
(1) The recognized accreditation body grants or extends LAAF-
accreditation of a laboratory, and the notification must include:
(i) The scope of LAAF-accreditation requested by the laboratory,
(ii) The scope of LAAF-accreditation granted, and
(iii) The effective date of the grant or extension;
(2) The recognized accreditation body denies LAAF-accreditation of a
laboratory, and the notification must include:
(i) The scope of LAAF-accreditation requested by the laboratory,
(ii) The scope of LAAF-accreditation denied, and
(iii) The grounds for the denial;
(3) The recognized accreditation body receives notice that a
laboratory it LAAF-accredits intends to relinquish its LAAF-
accreditation and the laboratory has not provided notice to FDA 60
calendar days prior to relinquishment as required under Sec. 1.1140.
The recognized accreditation body's notification must include:
(i) The scope of LAAF-accreditation to which the relinquishment
applies, as applicable, and
(ii) The effective date of the relinquishment;
(4) The recognized accreditation body reduces the scope of or
withdraws the LAAF-accreditation of a laboratory, and the notification
must include:
(i) The scope of LAAF-accreditation to which the reduction applies,
(ii) The grounds for the reduction of scope or withdrawal, and
(iii) The effective date of the reduction of scope or withdrawal;
(5) The recognized accreditation body suspends or lifts the
suspension of a LAAF-accredited laboratory, and the notification must
include:
(i) The scope of LAAF-accreditation to which the suspension applies,
(ii) The grounds for the suspension or for lifting the suspension,
and
(iii) The effective date of the suspension or date the suspension is
lifted.
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(e) Laboratory fraud. A recognized accreditation body must notify
FDA within 48 hours if the recognized accreditation body knows that a
laboratory it LAAF-accredits has committed fraud or submitted material
false statements to FDA, and the notification must include:
(1) A description of the basis for the recognized accreditation
body's knowledge of the fraud or material false statements,
(2) A description of the fraud or material false statements, and
(3) The action(s) taken by the recognized accreditation body with
respect to such LAAF-accredited laboratory.
Sec. 1.1124 What are the records requirements for a recognized
accreditation body?
(a) In addition to meeting the requirements of Sec. 1.1113(a)
related to records, a recognized accreditation body must maintain, for 5
years after the date of creation of the records, records created while
it is recognized demonstrating its compliance with this subpart,
including records relating to:
(1) Applications for LAAF-accreditation;
(2) Assessments, reassessments, and decisions to grant, extend the
scope of, renew, deny, reduce the scope of, or withdraw LAAF-
accreditation or to suspend or lift the suspension of a LAAF-accredited
laboratory;
(3) Appeals of suspensions, denials, reductions of scope of, and
withdrawals of LAAF-accreditation, final decisions on such appeals, and
the bases for such final decisions;
(4) Its oversight of laboratories it has LAAF-accredited;
(5) Its oversight of its own performance, including all records
related to internal audits, complaints, and corrective actions;
(6) Any reports or notifications required to be submitted to FDA
under Sec. 1.1123, including any supporting information;
(7) Records of fee payments and reimbursement of direct costs; and
(8) Any documents demonstrating compliance with the requirements for
assessment activities by contract assessors with certain financial
interests described in Sec. 1.1119(d).
(b) A recognized accreditation body must make the records it is
required to maintain by paragraph (a) of this section available for
inspection and copying or for electronic submission upon written request
of an authorized officer or employee of FDA. If FDA requests records for
inspection and copying, the recognized accreditation body must make such
records promptly available at the physical location of the recognized
accreditation body or at another reasonably accessible location. If FDA
requests electronic submission, the records must be submitted within 10
business days of the request.
(c) A recognized accreditation body must not prevent or interfere
with FDA's access to the records the LAAF-accredited laboratories it
LAAF-accredits are required to maintain under Sec. 1.1154.
Sec. 1.1125 What are the internal audit requirements for a recognized
accreditation body?
As part of the internal audit a recognized accreditation body is
required to conduct pursuant to Sec. 1.1113(a), the recognized
accreditation body must audit its compliance with the requirements of
Sec. 1.1113(d).
FDA Oversight of Recognized Accreditation Bodies
Sec. 1.1130 How will FDA oversee recognized accreditation bodies?
(a) FDA will evaluate each recognized accreditation body to
determine its compliance with the applicable requirements of this
subpart no later than:
(1) Year 4 of a 5-year recognition period; or
(2) The midpoint of a recognition period less than 5 years.
(b) An FDA evaluation of a recognized accreditation body may include
review of records, an onsite evaluation of the accreditation body, and
onsite reviews of one or more LAAF-accredited laboratories the
recognized accreditation body LAAF-accredits, with or without the
recognized accreditation body present. Certain evaluation activities may
be conducted remotely if it will not aid in the evaluation to conduct
them onsite.
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(c) FDA may conduct additional evaluations of a recognized
accreditation body at any time to determine whether the recognized
accreditation body complies with the applicable requirements of this
subpart.
Sec. 1.1131 When will FDA require corrective action, put a recognized
accreditation body on probation, or revoke the recognition of an
accreditation body?
(a) Corrective action. FDA may require corrective action to address
any deficiencies identified while evaluating a recognized accreditation
body under this subpart.
(1) FDA will notify the recognized accreditation body of all
deficiencies requiring corrective action and will either specify a
deadline to implement corrective action or will require the recognized
accreditation body to submit a corrective action plan and timeframe for
implementation to FDA for approval.
(2) The recognized accreditation body must handle FDA's notification
as a complaint under ISO/IEC 17011:2017(E) (incorporated by reference,
see Sec. 1.1101) section 7.12, implement appropriate corrective action
under ISO/IEC 17011:2017(E) section 9.5, and submit both the results of
the complaint investigation and subsequent corrective action to FDA.
(3) FDA will review the corrective action and will notify the
recognized accreditation body whether the corrective action is
acceptable.
(b) Probation. If FDA determines that a recognized accreditation
body has not effectively implemented corrective action or otherwise
fails to address deficiencies identified, FDA may put the recognized
accreditation body on probation and require corrective action under
paragraph (a) of this section.
(1) FDA will notify the recognized accreditation body of the grounds
for the probation and all deficiencies requiring corrective action via
the process described in paragraph (a) of this section.
(2) FDA will notify all laboratories LAAF-accredited by the
recognized accreditation body that the recognized accreditation body is
on probation and will provide notice of the probation on the website
described in Sec. 1.1109.
(3) FDA will review the corrective action and will notify the
recognized accreditation body whether the corrective action is
acceptable.
(4) A recognized accreditation body shall remain on probation until
the recognized accreditation body demonstrates to FDA's satisfaction
that it has successfully implemented appropriate corrective action.
(5) If FDA determines that a recognized accreditation body on
probation has failed to implement appropriate corrective action or
otherwise fails to address deficiencies identified, FDA may revoke
recognition of the recognized accreditation body under paragraph (c) of
this section.
(c) Revocation of recognition. FDA will revoke the recognition of an
accreditation body if it fails to meet the requirements of this subpart,
if FDA determines the accreditation body has committed fraud or
submitted material false statements to FDA, or if FDA determines that a
recognized accreditation body on probation has failed to implement
appropriate corrective action or otherwise fails to address deficiencies
identified.
(d) Revocation of recognition procedures. (1) FDA will issue a
notice of revocation of recognition to the recognized accreditation body
that will include the grounds for revocation, the date on which
revocation is effective, the procedures for requesting a regulatory
hearing on the revocation under Sec. 1.1173, and the procedures for
requesting reinstatement of recognition under Sec. 1.1117.
(2) FDA will notify all laboratories LAAF-accredited by the
recognized accreditation body that recognition has been revoked and will
provide notice of the revocation of recognition of an accreditation body
on the website described in Sec. 1.1109.
(3) Within 10 business days of the date of issuance of revocation,
the accreditation body must provide the name and contact information of
the custodian who will maintain records and make them available to FDA
as required by Sec. 1.1124. The contact information must include an
email address for the records custodian and the street address where the
records required by Sec. 1.1124 will be located.
[[Page 137]]
(e) Effect of probation or revocation of recognition on the
accreditation body. (1) A recognized accreditation body that is put on
probation by FDA must continue to oversee laboratories that it has LAAF-
accredited under this subpart and may continue to LAAF-accredit
laboratories under Sec. 1.1120.
(2) An accreditation body that has had its recognition revoked by
FDA may not LAAF-accredit laboratories under this subpart or continue to
oversee the laboratories it has previously LAAF-accredited while the
accreditation body is not recognized.
[86 FR 68817, Dec. 3, 2021; 87 FR 5660, Feb. 2, 2022]
LAAF-Accreditation of Laboratories
Sec. 1.1138 What are the eligibility requirements for a LAAF-accredited
laboratory?
(a) A laboratory that is LAAF-accredited or seeking LAAF-
accreditation must demonstrate it is capable of conducting each method
of food testing for which it is or will be LAAF-accredited by meeting
all of the following requirements:
(1) For each method, the laboratory is accredited by a recognized
accreditation body to ISO/IEC 17025:2017(E) (incorporated by reference,
see Sec. 1.1101).
(2)(i) Except as provided in paragraph (a)(2)(ii) of this section,
the laboratory has successfully passed a proficiency test provided by a
competent proficiency testing organization within the last 12 months for
each method within the scope of LAAF-accreditation.
(ii) If the laboratory determines there is no proficiency testing
program available or practicable for a method, it may use a comparison
program. A laboratory must request approval from the recognized
accreditation body regarding the determination prior to using a
comparison program in lieu of an annual proficiency test. The laboratory
is required to demonstrate competency through participation in the
comparison program.
(iii) A laboratory must submit all proficiency test and comparison
program results, regardless of outcome, to the recognized accreditation
body within 30 calendar days of receipt.
(3) The laboratory ensures that its procedures for monitoring the
validity of the results of testing it conducts under this subpart
include the use of reference materials or quality control samples with
each batch of samples it tests under this subpart.
(b) Will comply with all additional requirements for LAAF-accredited
laboratories under this subpart while LAAF-accredited.
Sec. 1.1139 How does a laboratory apply for LAAF-accreditation or extend
its scope of LAAF-accreditation?
(a) Application for LAAF-accreditation. A laboratory seeking LAAF-
accreditation or extension of its scope of LAAF-accreditation must
submit its application for LAAF-accreditation to a recognized
accreditation body identified on the website described in Sec. 1.1109.
The recognized accreditation body will review and assess the application
in accordance with the requirements of this subpart. If the laboratory
seeking LAAF-accreditation had its LAAF-accreditation withdrawn or one
or more methods within its scope of LAAF-accreditation reduced by a
recognized accreditation body or has been previously disqualified by
FDA, the laboratory must meet the additional requirements specified by
Sec. 1.1142(a).
(b) Documentation of conformance with ISO/IEC 17025:2017(E). The
laboratory may use documentation of conformance with ISO/IEC
17025:2017(E) (incorporated by reference, see Sec. 1.1101), as
applicable and supplemented as necessary, in meeting the applicable
requirements of this subpart.
(c) Duration of accreditation. If a LAAF-accredited laboratory
maintains compliance with all requirements of this subpart, including
accreditation to ISO/IEC 17025:2017(E), the laboratory's LAAF-
accreditation will not end until reduced in scope, withdrawn,
relinquished, or the laboratory is disqualified, under this subpart.
Sec. 1.1140 What must a LAAF-accredited laboratory do to voluntarily
relinquish its LAAF-accreditation?
(a) Notice to FDA and the recognized accreditation body of intent to
relinquish. A LAAF-accredited laboratory must
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notify FDA and its recognized accreditation body at least 60 calendar
days before voluntarily relinquishing LAAF-accreditation or any method
within the scope of LAAF-accreditation. The notice must include the date
on which relinquishment will occur. If the laboratory will relinquish
all methods within its scope of LAAF-accreditation, the notification
must also include the name and contact information of the custodian who
will maintain the records required by Sec. 1.1154 after the date of
relinquishment. The contact information for the records custodian must
include an email address and the street address where the records
required by Sec. 1.1154 will be located.
(b) Public notice of voluntary relinquishment of accreditation. FDA
will provide notice on the website described in Sec. 1.1109 of the
voluntary relinquishment of LAAF-accreditation of a laboratory.
Sec. 1.1141 What is the effect on a LAAF-accredited laboratory if its
recognized accreditation body is no longer recognized by FDA?
If a recognized accreditation body has its application for renewal
of recognition denied, relinquishes its recognition or allows its
recognition to expire, or has its recognition revoked, any laboratory
LAAF-accredited by the accreditation body must take either the actions
in paragraph (a) of this section or the action in paragraph (b) of this
section no later than 30 calendar days after receiving the notice to the
LAAF-accredited laboratory required under Sec. 1.1115(g), Sec.
1.1116(b), or Sec. 1.1131(d)(2):
(a)(1) The LAAF-accredited laboratory must submit to FDA
documentation of the LAAF-accredited laboratory's most recent internal
audit, required under Sec. 1.1154(a)(5), documentation showing
compliance with the conflict of interest requirements in Sec. 1.1147,
and documentation of the most recent proficiency test or comparison
program result for each test method within the laboratory's scope of
LAAF-accreditation, to show compliance with Sec. 1.1138(a)(2); and
(2) The laboratory must become LAAF-accredited by another recognized
accreditation body before the laboratory's ISO/IEC 17025:2017(E)
(incorporated by reference, see Sec. 1.1101) accreditation lapses or
not later than 1 year after the LAAF-accredited laboratory receives the
applicable notice under Sec. 1.1115(g), Sec. 1.1116(b), or Sec.
1.1131(d)(2), whichever is sooner.
(b) The LAAF-accredited laboratory initiates relinquishment of its
LAAF-accreditation under Sec. 1.1140, with the relinquishment to occur
within 90 calendar days.
Sec. 1.1142 How does a laboratory request reinstatement of
LAAF-accreditation?
(a) Application following reduction of scope or withdrawal of LAAF-
accreditation by a recognized accreditation body or disqualification by
FDA. A laboratory that has had any methods within its scope of LAAF-
accreditation reduced or has had its LAAF-accreditation withdrawn by a
recognized accreditation body or that has been disqualified by FDA may
seek reinstatement of LAAF-accreditation by submitting a new application
for LAAF-accreditation to a recognized accreditation body under Sec.
1.1139. The laboratory must also:
(1) Notify FDA prior to submitting a new application for LAAF-
accreditation to the recognized accreditation body, including in the
notification the name of the laboratory, contact information for the
laboratory, the name of the recognized accreditation body to which the
laboratory will be submitting the application, and the date that the
laboratory expects to submit the new application for LAAF-accreditation;
and
(2) Demonstrate, to the satisfaction of the recognized accreditation
body to which it is submitting the new application, that the grounds for
the reduction of scope or withdrawal of LAAF-accreditation or
disqualification have been resolved and that the laboratory has
implemented measures to prevent such grounds from recurring.
(b) Application following voluntary relinquishment of LAAF-
accreditation. A laboratory that voluntarily relinquished any methods
within the scope of its LAAF-accreditation pursuant to Sec. 1.1140, may
seek reaccreditation by submitting a new application for
[[Page 139]]
LAAF-accreditation to a recognized accreditation body under Sec.
1.1139.
Requirements for LAAF-Accredited Laboratories
Sec. 1.1147 What are the impartiality and conflict of interest requirements
for a LAAF-accredited laboratory?
(a) In addition to the impartiality and conflict of interest
requirements in Sec. 1.1138(a)(1), a LAAF-accredited laboratory must,
subject to the exceptions in paragraph (b) of this section, prohibit the
LAAF-accredited laboratory's employees, contractors, and agents involved
in food testing under this subpart and related activities from accepting
any money, gift, gratuity, or other item of value from the owner or
consignee of the food that is being tested or will be tested by the
LAAF-accredited laboratory.
(b) The prohibited items of value in paragraph (a) of this section
do not include:
(1) Payment of fees for food testing under this subpart and related
services;
(2) Reimbursement of direct costs associated with the food testing
by the LAAF-accredited laboratory; and
(3) With respect to a LAAF-accredited laboratory that is owned by
the owner or consignee of the food that is or will be tested, payment of
the officer's, employee's, contractor's, or agent's compensation in the
normal course of business.
(c) The LAAF-accredited laboratory must require the owner's or
consignee's payment to the LAAF-accredited laboratory of fees for food
testing services and reimbursement of direct costs associated with food
testing to be independent of the outcome of the test results.
Sec. 1.1149 What oversight standards apply to sampling?
(a) Documents. Before analyzing a sample, the LAAF-accredited
laboratory must develop (if it collected the sample) or obtain (if
another firm collected the sample) the following information to be
submitted with test results (see Sec. 1.1152(c)):
(1) Written documentation of the sampler's applicable qualifications
by training and experience. A LAAF-accredited laboratory only needs to
develop or obtain documentation of a sampler's qualifications the first
time that sampler collects a sample for the LAAF-accredited laboratory
under this subpart. If a LAAF-accredited laboratory has previously
submitted the sampler's qualifications to FDA under Sec. 1.1152(c), the
LAAF-accredited laboratory may refer to its previously submitted
qualifications.
(2) The written sampling plan used to conduct the sampling. The
written sampling plan must identify the sampler and sampling firm and
must list factors that will be controlled to ensure the sampling does
not impact the validity of the subsequent analytical testing, including
controlling for the representational nature of the sample; and
(3) A written sample collection report for each sample collected.
The written sample collection report must include:
(i) The product code of the food product (if product is being
sampled) or the location and a description of the environment (if
environment is being sampled);
(ii) The date of the sampling;
(iii) The lot number, size, identity, and quantity of the sample;
(iv) Documentation of sample collection procedures and any sample
preparation techniques; and
(v) Documentation of the chain of custody of the sample and of
measures taken to ensure the validity of the subsequent analytical
testing, including controlling for the representational nature of the
sample.
(b) Potential consequences. If any of the requirements in paragraph
(a) of this section is not met, FDA may consider the analysis of the
sample to be invalid.
(c) Advance notice of sampling. (1) If FDA determines that sampling
conducted may materially differ from the sampling documented in the
associated sampling plan or sample collection report, or if FDA
determines that the sampling otherwise may have been improper, FDA may
require the LAAF-accredited laboratory that analyzed the associated
sample, and other LAAF-accredited laboratories that have analyzed
samples previously collected by the sampling firm, to obtain from the
sampling firm, and submit, or require
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the sampling firm to submit, an advance notice of sampling. The advance
notice of sampling must be submitted to FDA at least 48 hours before
each of the next 10 occasions that the sampling firm will collect a
sample that the LAAF-accredited laboratory will analyze under this
subpart.
(2) FDA may, as appropriate:
(i) Specify that the requirement applies to samples collected by a
particular sampler;
(ii) Specify the type of food product or environment that requires
advance notice of sampling under this subpart;
(iii) Determine that an amount of time other than 48 hours in
advance is required, from a minimum of 24 hours up to 7 business days in
advance;
(iv) Determine that a number of occasions other than 10 is required,
from a minimum of 1 occasion to a maximum of 20 occasions;
(v) Notify affected LAAF-accredited laboratories that submission of
additional notices of sampling are not required; and
(vi) Notify the owner or consignee that the advance notice applies
to sampling for food testing being conducted on their behalf.
(3) The advance notice of sampling must contain:
(i) A unique identification for the advance notice of sampling;
(ii) The name of the LAAF-accredited laboratory that will conduct
analysis of the sample;
(iii) The name and street address of the sampling firm that will
conduct the sampling;
(iv) A primary contact (name and phone number) for the sampling
firm;
(v) The reason why the food product or environment will be sampled;
(vi) The location of the food product or environment that will be
sampled, including sufficient information to identify the food product
or environment to be sampled;
(vii) As applicable, the U.S. Customs and Border Protection entry
and line number;
(viii) The product code of the food product (if product is being
sampled) or the location and a description of the environment (if
environment is being sampled); and
(ix) The date and approximate time the sampling will begin.
Sec. 1.1150 What are the requirements for analysis of samples by a
LAAF-accredited laboratory?
In addition to the sample analysis requirements of Sec. 1.1138(a):
(a) The analysis must be conducted on either the sample received
from the sampling firm or, if appropriate, on a representative sample of
the sample received from the sampling firm.
(b) The analyst must:
(1) Be qualified by appropriate education, training, and/or
experience to conduct the analysis;
(2) Have appropriately demonstrated their ability to perform the
method properly in the specific context of the food testing to be
conducted; and
(3) Be in compliance with the conflict of interest requirements of
Sec. Sec. 1.1138(a) and 1.1147.
(c) The method used to conduct the food testing must meet the
requirements of Sec. 1.1151.
(d) The LAAF-accredited laboratory must document the testing
information and test results to the extent necessary to account for all
information that is required to be included in a full analytical report
(see Sec. 1.1152(d)).
Sec. 1.1151 What requirements apply to the methods of analysis a
LAAF-accredited laboratory uses to conduct food testing under this
subpart?
In addition to the requirements of Sec. 1.1138(a), a LAAF-
accredited laboratory must meet the following requirements:
(a) The method of analysis used to conduct food testing under this
subpart must be:
(1) Fit for purpose;
(2) Within the laboratory's scope of LAAF-accreditation;
(3) Appropriately validated for use in such food testing, in
accordance with paragraph (c) of this section; and
(4) Appropriately verified by the LAAF-accredited laboratory for use
in such food testing, in accordance with paragraph (d) of this section.
(b) Food testing must be conducted using the specified method:
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(1) Under Sec. 1.1107(a)(1), if the Federal Food, Drug, and
Cosmetic Act or implementing regulations prescribe a test method.
(2) Under Sec. 1.1107(a)(2), if the directed food laboratory order
prescribes a test method.
(c)(1) A LAAF-accredited laboratory must validate methods in
accordance with the requirements of Sec. 1.1138(a).
(2) A LAAF-accredited laboratory performing validation of a method
under this subpart must record the information required by Sec.
1.1138(a) and the supporting analytical data.
(d)(1) Before a LAAF-accredited laboratory conducts food testing
under this subpart using a method for a specific intended use for which
the method has been validated, but for which the LAAF-accredited
laboratory has not previously applied the method under this subpart, the
LAAF-accredited laboratory must have verified it can properly perform
the method for the specific intended use.
(2) A LAAF-accredited laboratory performing verification of a method
under this subpart must record the method that is the subject of the
verification, the intended purpose of the analysis, the results of the
verification, the procedure used for the verification, supporting
analytical data, and whether the LAAF-accredited laboratory is able to
properly perform the method.
(e) A LAAF-accredited laboratory may submit a written request to FDA
requesting permission to use a method outside of its scope of LAAF-
accreditation for food testing. FDA may approve the request if both
following conditions are satisfied:
(1) A new method or methodology has been developed and validated but
no reasonably available laboratory has been LAAF-accredited to perform
such method or methodology, and
(2) The use of such method is necessary to prevent, control, or
mitigate a food emergency or foodborne illness outbreak.
Sec. 1.1152 What notifications, results, reports, and studies must a
LAAF-accredited laboratory submit to FDA?
(a) General requirements. (1) All notifications, results, reports,
and studies required to be submitted to FDA by a LAAF-accredited
laboratory under this subpart must:
(i) Include the name and street address of the LAAF-accredited
laboratory;
(ii) Identify a point of contact for the LAAF-accredited laboratory,
including email and telephone number, whom FDA may contact with
questions or comments;
(iii) Display an identification unique to the test results, report,
notification, or study; and
(iv) Be true, accurate, unambiguous, and objective.
(2) The LAAF-accredited laboratory that conducts the analysis of the
sample under this subpart is responsible for the submission of all
notifications, results, reports, and studies to FDA as required by this
section.
(3) If the LAAF-accredited laboratory becomes aware that any aspect
of the submitted material is inaccurate, the LAAF-accredited laboratory
must immediately inform FDA and submit a corrected version. Such
corrections must meet the requirements for amendments to reports
specified by ISO/IEC 17025:2017(E) (incorporated by reference, see Sec.
1.1101) section 7.8.8.
(4) Any opinions and interpretations in any notification, result,
report, or study submitted to FDA under this subpart must meet the
requirements in ISO/IEC 17025:2017(E) section 7.8.7 and any statements
of conformity to a specification or standard in any notification,
result, report, or study submitted to FDA under this subpart must meet
the requirements of ISO/IEC 17025:2017(E) section 7.8.6.
(b) Test results. (1) The LAAF-accredited laboratory must submit the
results of all testing required to be conducted under this subpart
directly to FDA via the location specified by the website described in
Sec. 1.1109, unless another location is specified by FDA regarding
testing conducted under Sec. 1.1107(a)(2) or (3).
(2) The test results must be clear and identify:
(i) The name and street address of the owner or consignee for which
the testing was conducted,
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(ii) As appropriate, the U.S. Customs and Border Protection entry
and line number(s), and
(iii) The associated notifications, reports, and studies required to
be submitted with the test results under this subpart.
(c) Documentation required to be submitted with test results. The
following documentation must be included with each full analytical
report (see paragraph (d) of this section) and each abridged analytical
report (see Sec. 1.1153) submitted to FDA under this subpart:
(1) All sampling plans and sample collection reports related to the
food testing conducted as developed or obtained by the LAAF-accredited
laboratory in accordance with Sec. 1.1149;
(2) Written documentation of the sampler's qualifications or an
indication that the sampler's qualifications have been submitted
previously, in accordance with Sec. 1.1149(a)(1);
(3) For any validation studies required by Sec. 1.1151(c)(1), the
documentation required by Sec. 1.1151(c)(2);
(4) For any verification studies required by Sec. 1.1151(d)(1), the
documentation required by Sec. 1.1151(d)(2);
(5) The justification for any modification to or deviation from the
method(s) of analysis used and documentation of the LAAF-accredited
laboratory's authorization for the modification or deviation; and
(6) A certification from one or more members of the LAAF-accredited
laboratory's management certifying that the test results, notifications,
reports, and studies are true and accurate; and that the documentation
includes the results of all tests conducted under this subpart. The
certification must include the name, title, and signature of any
certifiers.
(d) Full analytical report contents. In addition to the
documentation required to be submitted with all test results (see
paragraph (c) of this section), a full analytical report must include:
(1) All information described by ISO/IEC 17025:2017(E) sections
7.8.2.1(a) through (p) and 7.8.3.1(a) through (d);
(2) Documentation of references for the method of analysis used;
(3) Name and signature of the analyst who conducted each analytical
step, including any applicable validation and verification steps, and
the date each step was performed;
(4) Calculations, presented in a legible and logical manner;
(5) As applicable, references to chromatograms, charts, graphs,
observations, photographs of thin layer chromatographic plates, and
spectra. References must be in color when appropriate and presented in a
clear order;
(6) Identification of the source and purity of reference standards
used, and, as applicable: Certified reference materials, certified
reference cultures traceable to a nationally or internationally
recognized type culture collection (including concentration, units,
preparation, and storage conditions), and reference standard preparation
information (including who prepared the reference standard, date of
preparation, expiration date, chemical balance, and solvent used);
(7) A copy of the label from any immediate container sampled, if
available, and any additional labeling needed to evaluate the product;
(8) All original compilations of raw data secured in the course of
the analysis, including discarded, unused, or re-worked data, with the
justification for discarding or re-working such data, corresponding
supporting data, and quality control results (including the expected
result and whether it is acceptable), all identified with unique sample
identification, date, and time, associated with the test;
(9) Any other relevant additional supporting information such as the
storage location of analyzed samples, appropriate attachments such as
instrument printouts, computer generated charts and data sheets, and
photocopies or original labels for the product analyzed;
(10) Identification of any software used;
(11) Any certificate of analysis for standards and software; and
(12) The following information about the qualifications of each
analyst involved in the analysis conducted under this subpart, if the
LAAF-accredited laboratory has not previously submitted documentation of
the analyst's qualifications to FDA or the analyst's qualifications have
significantly
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changed since the LAAF-accredited laboratory last submitted
documentation of the analyst's qualifications to FDA:
(i) The analyst's curriculum vitae;
(ii) Training records for the applicable methods that the analyst is
qualified to perform, including the dates of such training and the name
of the trainer or training provider; and
(iii) Any other documentation of the analyst's ability to perform
the method properly in the context of the food testing to be conducted,
pursuant to Sec. 1.1150(b).
(e) Additional information about non-standard methods. If the LAAF-
accredited laboratory conducts the analysis using a method that is not
published in a reputable international or national standard or that is
otherwise not publicly and readily available, upon request by FDA the
LAAF-accredited laboratory must submit documentation of the method to
FDA.
(f) Immediate notification of significant changes. The LAAF-
accredited laboratory must notify FDA and the recognized accreditation
body that LAAF-accredited the laboratory of changes that affect the
LAAF-accreditation of the laboratory within 48 hours, including a
detailed description of such changes, and an explanation of how such
changes affect the LAAF-accreditation of the laboratory. LAAF-accredited
laboratories are not required to notify FDA of changes that a recognized
accreditation body must provide to FDA under Sec. 1.1123(d).
(g) Consequence of omission. If FDA does not receive all information
required to be submitted to FDA under this section, FDA may consider the
related food testing to be invalid.
Sec. 1.1153 What are the requirements for submitting abridged analytical
reports?
(a) Requesting permission. A LAAF-accredited laboratory may request
permission to submit abridged analytical reports for each major food
testing discipline: Biological, chemical, and physical.
(1) FDA will grant permission to submit abridged analytical reports
for a single major food testing discipline if all of the following
conditions are met:
(i) The LAAF-accredited laboratory is not on suspension or probation
for any method within the major food testing discipline that is the
subject of its request (see Sec. 1.1121(b) or Sec. 1.1161(b));
(ii) The LAAF-accredited laboratory has successfully implemented any
required corrective action under Sec. 1.1121(a) or Sec. 1.1161(a); and
(iii) The last five full analytical reports for the major food
testing discipline contain no shortcomings that call into question the
validity of the test results or repeated administrative errors.
(2) FDA will notify the LAAF-accredited laboratory if permission is
granted or denied.
(b) FDA review of abridged analytical reports. (1) FDA will review
all abridged analytical reports submitted.
(2) FDA will notify the LAAF-accredited laboratory if FDA identifies
a shortcoming that calls into question the validity of the test results
or repeated administrative errors, will require corrective action under
Sec. 1.1161(a), and may revoke permission to submit abridged analytical
reports for the specific major food testing discipline.
(3) If FDA identifies a shortcoming that calls into question the
validity of the test results or repeated administrative errors in
abridged analytical reports from a LAAF-accredited laboratory that has
previously had its permission to submit abridged analytical reports
revoked for any major food testing discipline, FDA may put the LAAF-
accredited laboratory on probation for one or more methods under Sec.
1.1161(b). Under Sec. 1.1162(a), a laboratory on probation for one or
more methods may not submit abridged analytical reports for the major
food testing disciplines of which the probationary methods are a part.
(4) A LAAF-accredited laboratory that has had permission to submit
abridged analytical reports revoked for one or more major food testing
disciplines may request permission to submit abridged analytical reports
as described in paragraph (a) of this section for each major food
testing discipline.
(c) Contents of abridged analytical reports. In addition to the
documentation required to be submitted with all test
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results (see Sec. 1.1152(c)), an abridged analytical report must
include:
(1) All information described by ISO/IEC 17025:2017(E) (incorporated
by reference, see Sec. 1.1101) sections 7.8.2.1(a) through (p) and
7.8.3.1(a) through (d); and
(2) Quality control results (including the expected result and
whether it is acceptable).
(d) Exceptions. FDA may require additional documentation or a full
analytical report from a LAAF-accredited laboratory permitted to submit
abridged analytical reports in the following circumstances:
(1) FDA may require a full analytical report related to an FDA
investigation or FDA enforcement proceeding.
(2) Occasionally, for the purposes of auditing abridged analytical
reports and otherwise protecting the public health and the integrity of
this food testing program, FDA will require additional documentation or
a full analytical report within 72 hours of FDA's request.
(e) Consequence of omission. If FDA does not receive all information
required to be submitted to FDA under paragraph (c) of this section, FDA
may consider the related food testing to be invalid.
Sec. 1.1154 What other records requirements must a LAAF-accredited
laboratory meet?
(a) In addition to the records requirements of Sec. 1.1138(a), a
LAAF-accredited laboratory must maintain, for 5 years after the date of
creation, records created and received while it is LAAF-accredited that
relate to compliance with this subpart, including:
(1) Documents related to the LAAF-accredited laboratory's grant of
LAAF-accreditation (and, if applicable, extensions and reductions of
scope of LAAF-accreditation) from its recognized accreditation body,
including all required proficiency test and comparison program records
for each method within the scope of LAAF-accreditation under Sec.
1.1138(a)(2);
(2) Documentation of food testing the LAAF-accredited laboratory
conducted under this subpart sufficient to account for all information
required by Sec. 1.1152(d), in accordance with Sec. 1.1150(d);
(3) All documents that the LAAF-accredited laboratory was required
to submit to FDA under Sec. Sec. 1.1152 and 1.1153, and associated
correspondence between the LAAF-accredited laboratory (and its officers,
employees, and other agents) and the owner or consignee (and its
officers, employees, and other agents) regarding food testing under this
subpart;
(4) All requests for food testing from an owner or consignee that
would be conducted under this subpart;
(5) Documentation of any internal investigations, internal audits,
and corrective action taken to address any problems or deficiencies
related to activities under this subpart;
(6) All documentation related to suspension, probation, reduction of
scope, or withdrawal of LAAF-accreditation, or laboratory
disqualification under this subpart; and
(7) Documentation of changes to its management system or food
testing activities that may affect its compliance with this subpart.
(b) Make the records required by paragraph (a) of this section
available for inspection and copying or for electronic submission upon
written request of an authorized officer or employee of FDA. If FDA
requests records for inspection and copying, the laboratory must make
such records promptly available at the physical location of the
laboratory or at another reasonably accessible location. If the
authorized officer or employee of FDA requests electronic submission,
the records must be submitted within 10 business days of the request.
(c) Ensure that significant amendments to records described by this
section can be tracked to previous and original versions. If such a
significant amendment is made, both the original document and amended
document must be maintained by the LAAF-accredited laboratory during the
time period for which the amended document must be maintained under this
subpart. The laboratory must also document the date of amendment, the
personnel responsible for the amendment, and a conspicuous indication on
the original document stating that the document
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has been altered and that a more recent version of the document exists.
FDA Oversight of LAAF-Accredited Laboratories
Sec. 1.1159 How will FDA oversee LAAF-accredited laboratories?
(a) FDA may review the performance of LAAF-accredited laboratories
at any time to determine whether the LAAF-accredited laboratory
continues to comply with the applicable requirements of this subpart and
whether there are deficiencies in the performance of the LAAF-accredited
laboratory that, if not corrected, would warrant corrective action,
probation, or disqualification under Sec. 1.1161.
(b) In evaluating the performance of a LAAF-accredited laboratory,
FDA may review any of the following:
(1) Records the LAAF-accredited laboratory is required to maintain
under this subpart;
(2) Records the recognized accreditation body that LAAF-accredited
the laboratory is required to maintain under this subpart;
(3) Information obtained by FDA during a review of the LAAF-
accredited laboratory conducted pursuant to paragraph (c) of this
section;
(4) Information obtained by FDA during an evaluation of the
recognized accreditation body that LAAF-accredits the laboratory;
(5) Analytical reports and test results submitted to FDA; and
(6) Any other information obtained by FDA, including during FDA's
inspections or investigations of one or more owners or consignees.
(c) FDA may conduct an onsite review of a LAAF-accredited laboratory
at any reasonable time, with or without a recognized accreditation body
(or its officers, employees, and other agents) present, to review the
performance of a LAAF-accredited laboratory under this subpart. Certain
review activities may be conducted remotely if it will not aid in the
review to conduct them onsite.
(d) FDA may report any observations and deficiencies identified
during its review of LAAF-accredited laboratory performance under this
subpart to the recognized accreditation body.
Sec. 1.1160 How will FDA review test results and analytical reports?
(a) If FDA finds that any test result, analytical report, related
documents, or the associated analysis contains deficiencies or otherwise
indicates that any aspect of the food testing is not being conducted in
compliance with this subpart, FDA will notify the LAAF-accredited
laboratory that submitted the analytical report of any deficiency and
may:
(1) Require the laboratory to correct the test result, analytical
report, related documents, or the associated analysis;
(2) Revoke permission to submit abridged reports for that major food
testing discipline under Sec. 1.1153(b);
(3) Require a corrective action under Sec. 1.1161(a);
(4) Consider the analysis to be invalid; and/or
(5) Notify the owner or consignee of the deficiency.
(b) FDA may report any deficiencies identified during its review of
any test results, reports, and related documents under this subpart to
the recognized accreditation body that LAAF-accredits the laboratory.
(c) Nothing in this subpart shall be construed to limit the ability
of FDA to review and act on information received about food testing,
including determining the sufficiency of such information and testing.
Sec. 1.1161 When will FDA require corrective action, put a LAAF-accredited
laboratory on probation, or disqualify a LAAF-accredited laboratory from
submitting analytical reports?
(a) Corrective action. FDA may require corrective action to address
any deficiencies identified while reviewing a LAAF-accredited
laboratory's performance under this subpart.
(1) FDA will notify the LAAF-accredited laboratory of all
deficiencies requiring corrective action and will either specify a
deadline to implement corrective action or will require the LAAF-
accredited laboratory to submit a corrective action plan and timeframe
for implementation to FDA for approval.
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(2) The LAAF-accredited laboratory must handle FDA's notification as
a complaint under ISO/IEC 17025:2017(E) (incorporated by reference, see
Sec. 1.1101) section 7.9, implement appropriate corrective action under
ISO/IEC 17025:2017(E) section 8.7, and submit both the results of the
complaint investigation and subsequent corrective action to FDA.
(3) FDA will review the corrective action and will notify the LAAF-
accredited laboratory whether the corrective action is acceptable.
(b) Probation. If FDA determines that a LAAF-accredited laboratory
has not effectively implemented corrective action or otherwise fails to
address deficiencies identified, FDA may put the LAAF-accredited
laboratory on probation for one or more methods and require corrective
action under paragraph (a) of this section.
(1) FDA will notify the LAAF-accredited laboratory and its
recognized accreditation body of the grounds for the probation, the
method(s) covered by the probation, and all deficiencies requiring
corrective action via the process described in paragraph (a) of this
section.
(2) FDA will provide notice of a LAAF-accredited laboratory's
probation on the website described in Sec. 1.1109.
(3) FDA will review the corrective action and will notify the LAAF-
accredited laboratory and its recognized accreditation body whether the
corrective action is acceptable.
(4) A LAAF-accredited laboratory will remain on probation until the
LAAF-accredited laboratory demonstrates to FDA's satisfaction that it
has successfully implemented appropriate corrective action.
(5) If FDA determines that a LAAF-accredited laboratory on probation
has failed to implement appropriate corrective action or otherwise fails
to address deficiencies identified, FDA may disqualify the LAAF-
accredited laboratory under paragraph (c) of this section.
(c) Disqualification. FDA may disqualify a LAAF-accredited
laboratory from submitting analytical reports under this subpart for one
or more methods for good cause, which may include any of the following
reasons:
(1) Deliberate falsification of analytical reports, testing results,
or other records submitted to FDA.
(2) Failure of a LAAF-accredited laboratory on probation to
effectively implement corrective action or otherwise address identified
deficiencies.
(3) Other failure to substantially comply with this subpart where
the laboratory's recognized accreditation body has not reduced the scope
of or withdrawn LAAF-accreditation of the laboratory.
(d) Disqualification procedures. (1) FDA will issue a notice of
disqualification to a LAAF-accredited laboratory and its recognized
accreditation body, which will include:
(i) The grounds for disqualification;
(ii) The method or methods to which the disqualification applies;
(iii) The date the disqualification will be effective;
(iv) The procedures for requesting a regulatory hearing on the
disqualification under Sec. 1.1173; and
(v) The procedures for requesting reinstatement after
disqualification under Sec. 1.1142.
(2) FDA will provide notice of a LAAF-accredited laboratory's
disqualification on the website described in Sec. 1.1109.
Sec. 1.1162 What are the consequences if FDA puts a LAAF-accredited
laboratory on probation or disqualifies a LAAF-accredited laboratory?
(a) A LAAF-accredited laboratory that FDA has put on probation for
one or more methods is permitted to continue to conduct food testing
under this subpart; however, a LAAF-accredited laboratory that is on
probation for one or more methods is not permitted to submit abridged
analytical reports for the major food testing discipline of which the
probationary methods are part.
(b) If FDA disqualifies a LAAF-accredited laboratory for all methods
within its scope of LAAF-accreditation, the laboratory is immediately
ineligible to conduct food testing under this subpart. If FDA
disqualifies a LAAF-accredited laboratory for specific methods within
the scope of LAAF-accreditation, the laboratory is immediately
ineligible to use the methods for which the laboratory has
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been disqualified to conduct food testing under this subpart.
(c) With respect to food testing conducted by the laboratory prior
to its disqualification, FDA may refuse to consider results and
associated reports of food testing conducted under this subpart if the
basis for the disqualification of the laboratory indicates that the
specific food testing conducted by the laboratory may not be reliable.
(d) Within 10 business days of the date of issuance of
disqualification, the laboratory must provide the name and email address
of the custodian who will maintain and make available to FDA the records
required by Sec. 1.1154, and the street address where the records will
be located.
(e) Within 10 business days of the date of issuance of a notice of
probation or disqualification, the laboratory must notify any owners or
consignees for which it is conducting food testing using methods for
which it is being placed on probation or disqualified under this
subpart, that it is on probation or has been disqualified.
Requesting FDA Reconsideration or Regulatory Hearings of FDA Decisions
Under This Subpart
Sec. 1.1171 How does an accreditation body request reconsideration by
FDA of a decision to deny its application for recognition, renewal,
or reinstatement?
(a) Timing of request. An accreditation body may seek
reconsideration of FDA's decision to deny its application for
recognition or renewal of recognition under Sec. 1.1114, or
reinstatement of recognition under Sec. 1.1117, no later than 10
business days after the date of the issuance of such denial.
(b) Submission of request. The request to reconsider an application
under paragraph (a) of this section must be signed by the accreditation
body, as appropriate, or by an individual authorized to act on its
behalf. The accreditation body must submit the request, together with
any supporting information, to FDA in accordance with the procedures
described in the notice of denial.
(c) Notification of FDA's decision. After completing its review and
evaluation of the request for reconsideration and any supporting
information submitted pursuant to paragraph (b) of this section, FDA
will notify the accreditation body of its decision to grant or deny
recognition upon reconsideration.
Sec. 1.1173 How does an accreditation body or laboratory request a
regulatory hearing on FDA's decision to revoke the accreditation body's
recognition or disqualify a LAAF-accredited laboratory?
(a) Request for hearing. No later than 10 business days after the
date FDA issued a revocation of recognition of an accreditation body
pursuant to Sec. 1.1131 or disqualification of a LAAF-accredited
laboratory under Sec. 1.1161, the accreditation body, laboratory, or an
individual authorized to act on the accreditation body's or laboratory's
behalf, may submit a request for a regulatory hearing, conducted
pursuant to part 16 of this chapter, on the revocation or
disqualification. The notice of revocation issued under Sec. 1.1131 or
notice of disqualification issued under Sec. 1.1161, as applicable,
will contain all the elements required by Sec. 16.22(a) of this chapter
and will thereby constitute the notice of an opportunity for hearing
under part 16 of this chapter.
(b) Submission of request for regulatory hearing. The request for a
regulatory hearing under this subpart must be submitted with a written
appeal that responds to the bases for the FDA decision described in the
written notice of revocation or disqualification, together with any
supporting information. The request, appeal, and supporting information
must be submitted to FDA in accordance with the procedures described in
the notice of revocation or disqualification.
(c) Effect of submitting a request for a regulatory hearing on an
FDA decision. The submission of a request for a regulatory hearing under
this subpart will not operate to delay or stay the effect of a decision
by FDA to revoke the recognition of an accreditation body or disqualify
the LAAF-accredited laboratory unless FDA determines that delay or a
stay is in the public interest.
(d) Presiding officer. The presiding officer for a regulatory
hearing under this subpart will be designated after a
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request for a regulatory hearing is submitted to FDA.
(e) Denial of a request for regulatory hearing. The presiding
officer may deny a request for regulatory hearing under this subpart
pursuant to Sec. 16.26(a) of this chapter when no genuine or
substantial issue of fact has been raised.
(f) Conduct of regulatory hearing. (1) If the presiding officer
grants a request for a regulatory hearing, the hearing will be held
within 10 business days after the date the request was filed or, if
applicable, within a timeframe agreed upon in writing by the
accreditation body or laboratory, and the presiding officer and FDA.
(2) The presiding officer must conduct the hearing in accordance
with part 16 of this chapter, except that, pursuant to Sec. 16.5(b) of
this chapter, the procedures for a regulatory hearing apply only to the
extent that such procedures are supplementary and do not conflict with
the procedures specified for regulatory hearings under this subpart.
Accordingly, the following requirements of part 16 of this chapter are
inapplicable to regulatory hearings conducted under this subpart: The
requirements of Sec. 16.22 (Initiation of regulatory hearing); Sec.
16.24(e) (timing) and (f) (contents of notice); Sec. 16.40
(Commissioner); Sec. 16.60(a) (public process); Sec. 16.95(b)
(administrative decision and record for decision); and Sec. 16.119
(Reconsideration and stay of action).
(3) A decision by the presiding officer to affirm the revocation of
recognition or laboratory disqualification is considered a final agency
action under 5 U.S.C. 702.
Sec. 1.1174 How does an owner or consignee request a regulatory hearing
on a directed food laboratory order?
(a) Request for hearing. No later than 3 business days after FDA has
issued the directed food laboratory order, an owner or consignee may
submit a request for a regulatory hearing, conducted pursuant to part 16
of this chapter, on the directed food laboratory order. The directed
food laboratory order will contain all of the elements required by Sec.
16.22 of this chapter and will thereby constitute the notice of an
opportunity for hearing under part 16 of this chapter.
(b) Submission of request for regulatory hearing. The request for a
regulatory hearing must be submitted with a written appeal that responds
to the bases, as appropriate, for FDA's determinations described in the
directed food laboratory order, together with any supporting
information. The request, appeal, and supporting information must be
submitted in accordance with the procedures described in the directed
food laboratory order.
(c) Presiding officer. The presiding officer for a regulatory
hearing under this subpart will be designated after a request for a
regulatory hearing is submitted to FDA.
(d) Denial of a request for regulatory hearing. The presiding
officer may deny a request for regulatory hearing under this subpart
pursuant to Sec. 16.26(a) of this chapter.
(e) Conduct of regulatory hearing. (1) If the presiding officer
grants a request for a regulatory hearing, such hearing will be held
within 2 business days after the date the request was filed or, if
applicable, within a timeframe agreed upon in writing by the requestor
and the presiding officer and FDA.
(2) The presiding officer may require that a hearing conducted under
this subpart be completed within 1 business day, as appropriate.
(3) The presiding officer must conduct the hearing in accordance
with part 16 of this chapter, except that, pursuant to Sec. 16.5(b) of
this chapter, the procedures for a regulatory hearing described in part
16 of this chapter apply only to the extent that such procedures are
supplementary and not in conflict with the procedures specified for the
conduct of regulatory hearings under this subpart. Accordingly, the
following requirements of part 16 of this chapter are inapplicable to
regulatory hearings conducted under this subpart: Sec. 16.22
(Initiation of regulatory hearing); Sec. 16.24(e) (timing) and (f)
(contents of notice); Sec. 16.40 (Commissioner); Sec. 16.60(a) (public
process); Sec. 16.95(b) (administrative decision and record for
decision); and Sec. 16.119 (Reconsideration and stay of action).
[[Page 149]]
(4) A decision by the presiding officer to affirm the directed food
laboratory order is considered a final agency action under 5 U.S.C. 702.
Electronic Records and Public Disclosure Requirements
Sec. 1.1199 Are electronic records created under this subpart subject
to the electronic records requirements of part 11 of this chapter?
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.
Sec. 1.1200 Are the records obtained by FDA under this subpart subject
to public disclosure?
Records obtained by FDA under this subpart are subject to the
disclosure requirements under part 20 of this chapter.
Subpart S_Additional Traceability Records for Certain Foods
Source: 87 FR 71077, Nov. 21, 2022, unless otherwise noted.
General Provisions
Sec. 1.1300 Who is subject to this subpart?
Except as otherwise specified in this subpart, the requirements in
this subpart apply to persons who manufacture, process, pack, or hold
foods that appear on the list of foods for which additional traceability
records are required in accordance with section 204(d)(2) of the FDA
Food Safety Modernization Act (Food Traceability List). FDA will publish
the Food Traceability List on its website, www.fda.gov., in accordance
with section 204(d)(2)(B) of the FDA Food Safety Modernization Act.
Sec. 1.1305 What foods and persons are exempt from this subpart?
(a) Exemptions for certain small producers. (1) Certain produce
farms. (i) This subpart does not apply to farms or the farm activities
of farm mixed-type facilities with respect to the produce they grow,
when the farm is not a covered farm under part 112 of this chapter in
accordance with Sec. 112.4(a) of this chapter,
(ii) This subpart does not apply to produce farms when the average
annual sum of the monetary value of their sales of produce and the
market value of produce they manufacture, process, pack, or hold without
sale (e.g., held for a fee) during the previous 3-year period is no more
than $25,000 (on a rolling basis), adjusted for inflation using 2020 as
the baseline year for calculating the adjustment.
(2) Certain shell egg producers. This subpart does not apply to
shell egg producers with fewer than 3,000 laying hens at a particular
farm, with respect to the shell eggs they produce at that farm.
(3) Certain other producers of raw agricultural commodities. This
subpart does not apply to producers of raw agricultural commodities
other than produce or shell eggs (e.g., aquaculture operations) when the
average annual sum of the monetary value of their sales of raw
agricultural commodities and the market value of the raw agricultural
commodities they manufacture, process, pack, or hold without sale (e.g.,
held for a fee) during the previous 3-year period is no more than
$25,000 (on a rolling basis), adjusted for inflation using 2020 as the
baseline year for calculating the adjustment.
(b) Exemption for farms when food is sold or donated directly to
consumers. This subpart does not apply to a farm with respect to food
produced on the farm (including food that is also packaged on the farm)
that is sold or donated directly to a consumer by the owner, operator,
or agent in charge of the farm.
(c) Inapplicability to certain food produced and packaged on a farm.
This subpart does not apply to food produced and packaged on a farm,
provided that:
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(1) The packaging of the food remains in place until the food
reaches the consumer, and such packaging maintains the integrity of the
product and prevents subsequent contamination or alteration of the
product; and
(2) The labeling of the food that reaches the consumer includes the
name, complete address (street address, town, State, country, and zip or
other postal code for a domestic farm and comparable information for a
foreign farm), and business phone number of the farm on which the food
was produced and packaged. FDA will waive the requirement to include a
business phone number, as appropriate, to accommodate a religious belief
of the individual in charge of the farm.
(d) Exemptions and partial exemptions for foods that receive certain
types of processing. This subpart does not apply to the following foods
that receive certain types of processing:
(1) Produce that receives commercial processing that adequately
reduces the presence of microorganisms of public health significance,
provided the conditions set forth in Sec. 112.2(b) of this chapter are
met for the produce;
(2) Shell eggs when all eggs produced at the particular farm receive
a treatment (as defined in Sec. 118.3 of this chapter) in accordance
with Sec. 118.1(a)(2) of this chapter;
(3) Food that you subject to a kill step, provided that you maintain
records containing:
(i) The information specified in Sec. 1.1345 for your receipt of
the food to which you apply the kill step (unless you have entered into
a written agreement concerning your application of a kill step to the
food in accordance with paragraph (d)(6) of this section); and
(ii) A record of your application of the kill step;
(4) Food that you change such that the food is no longer on the Food
Traceability List, provided that you maintain records containing the
information specified in Sec. 1.1345 for your receipt of the food you
change;
(5) Food that you receive that has previously been subjected to a
kill step or that has previously been changed such that the food is no
longer on the Food Traceability List;
(6) Food that will be subjected to a kill step by an entity other
than a retail food establishment, restaurant, or consumer; or that will
be changed by an entity other than a retail food establishment,
restaurant, or consumer, such that the food will no longer be on the
Food Traceability List, provided that:
(i) There is a written agreement between the shipper of the food and
the receiver stating that the receiver will apply a kill step to the
food or change the food such that it is no longer on the Food
Traceability List; or
(ii) There is a written agreement between the shipper of the food
and the receiver stating that an entity in the supply chain subsequent
to the receiver will apply a kill step to the food or change the food
such that it is no longer on the Food Traceability List and that the
receiver will only ship the food to another entity that agrees, in
writing, it will:
(A) Apply a kill step to the food or change the food such that it is
no longer on the Food Traceability List; or
(B) Enter into a similar written agreement with a subsequent
receiver stating that a kill step will be applied to the food or that
the food will be changed such that it is no longer on the Food
Traceability List.
(iii) A written agreement entered into in accordance with paragraph
(d)(6)(i) or (ii) of this section must include the effective date,
printed names and signatures of the persons entering into the agreement,
and the substance of the agreement; and
(iv) A written agreement entered into in accordance with paragraph
(d)(6)(i) or (ii) must be maintained by both parties for as long as it
is in effect and must be renewed at least once every 3 years.
(e) Exemption for produce that is rarely consumed raw. This subpart
does not apply to produce that is listed as rarely consumed raw in Sec.
112.2(a)(1) of this chapter.
(f) Exemption for raw bivalve molluscan shellfish. This subpart does
not apply to raw bivalve molluscan shellfish that are covered by the
requirements of the National Shellfish Sanitation Program, subject to
the requirements of
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part 123, subpart C, and Sec. 1240.60 of this chapter, or covered by a
final equivalence determination by FDA for raw bivalve molluscan
shellfish.
(g) Exemption for persons who manufacture, process, pack, or hold
certain foods subject to regulation by the U.S. Department of
Agriculture (USDA). This subpart does not apply to persons who
manufacture, process, pack, or hold food on the Food Traceability List
during or after the time when the food is within the exclusive
jurisdiction of the USDA 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.).
(h) Partial exemption for commingled raw agricultural commodities.
(1) Except as specified in paragraph (h)(3) of this section, this
subpart does not apply to commingled raw agricultural commodities
(which, as defined in Sec. 1.1310, do not include types of fruits and
vegetables to which the standards for the growing, harvesting, packing,
and holding of produce for human consumption in part 112 of this chapter
apply).
(2) Except as specified in paragraph (h)(3) of this section, this
subpart does not apply to a raw agricultural commodity that will become
a commingled raw agricultural commodity, provided that:
(i) There is a written agreement between the shipper of the raw
agricultural commodity and the receiver stating that the receiver will
include the commodity as part of a commingled raw agricultural
commodity; or
(ii) There is a written agreement between the shipper of the raw
agricultural commodity and the receiver stating that an entity in the
supply chain subsequent to the receiver will include the commodity as
part of a commingled raw agricultural commodity and that the receiver
will only ship the raw agricultural commodity to another entity that
agrees, in writing, it will either:
(A) Include the raw agricultural commodity as part of a commingled
raw agricultural commodity; or
(B) Enter into a similar written agreement with a subsequent
receiver stating that the raw agricultural commodity will become part of
a commingled raw agricultural commodity;
(iii) A written agreement entered into in accordance with paragraph
(h)(2)(i) or (ii) of this section must include the effective date,
printed names and signatures of the persons entering into the agreement,
and the substance of the agreement; and
(iv) A written agreement entered into in accordance with paragraph
(h)(2)(i) or (ii) must be maintained by both parties for as long as it
is in effect and must be renewed at least once every 3 years;
(3) With respect to a commingled raw agricultural commodity that
qualifies for either of the exemptions set forth in paragraphs (h)(1)
and (2) of this section, if a person who manufactures, processes, packs,
or holds such commodity is required to register with FDA under section
415 of the Federal Food, Drug, and Cosmetic Act with respect to the
manufacturing, processing, packing, or holding of the applicable raw
agricultural commodity, such person must maintain records identifying
the immediate previous source of such raw agricultural commodity and the
immediate subsequent recipient of such food in accordance with
Sec. Sec. 1.337 and 1.345. Such records must be maintained for 2 years.
(i) Exemption for small retail food establishments and small
restaurants. This subpart does not apply to retail food establishments
and restaurants with an average annual monetary value of food sold or
provided during the previous 3-year period of no more than $250,000 (on
a rolling basis), adjusted for inflation using 2020 as the baseline year
for calculating the adjustment.
(j) Partial exemption for retail food establishments and restaurants
purchasing directly from a farm. (1) Except as specified in paragraph
(j)(2) of this section, this subpart does not apply to a retail food
establishment or restaurant with respect to a food that is produced on a
farm (including food produced and packaged on the farm) and both sold
and shipped directly to the retail food establishment or restaurant by
the owner, operator, or agent in charge of that farm.
(2) When a retail food establishment or restaurant purchases a food
directly
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from a farm in accordance with paragraph (j)(1) of this section, the
retail food establishment or restaurant must maintain a record
documenting the name and address of the farm that was the source of the
food. The retail food establishment or restaurant must maintain such a
record for 180 days.
(k) Partial exemption for retail food establishments and restaurants
making certain purchases from another retail food establishment or
restaurant. (1) Except as specified in paragraph (k)(2) of this section,
this subpart does not apply to either entity when a purchase is made by
a retail food establishment or restaurant from another retail food
establishment or restaurant, and the purchase occurs on an ad hoc basis
outside of the buyer's usual purchasing practice (e.g., not pursuant to
a contractual agreement to purchase food from the seller).
(2) When a retail food establishment or restaurant purchases a food
on the Food Traceability List from another retail food establishment or
restaurant in accordance with paragraph (k)(1) of this section, the
retail food establishment or restaurant that makes the purchase must
maintain a record (e.g., a sales receipt) documenting the name of the
product purchased, the date of purchase, and the name and address of the
place of purchase.
(l) Partial exemption for farm to school and farm to institution
programs. (1) Except as specified in paragraph (l)(2) of this section,
this subpart does not apply to an institution operating a child
nutrition program authorized under the Richard B. Russell National
School Lunch Act or Section 4 of the Child Nutrition Act of 1966, or any
other entity conducting a farm to school or farm to institution program,
with respect to a food that is produced on a farm (including food
produced and packaged on the farm) and sold or donated to the school or
institution.
(2) When a school or institution conducting a farm to school or farm
to institution program obtains a food from a farm in accordance with
paragraph (l)(1) of this section, the school food authority or relevant
food procurement entity must maintain a record documenting the name and
address of the farm that was the source of the food. The school food
authority or relevant food procurement entity must maintain such record
for 180 days.
(m) Partial exemption for owners, operators, or agents in charge of
fishing vessels. (1) Except as specified in paragraph (m)(2) of this
section, with respect to a food that is obtained from a fishing vessel,
this subpart does not apply to the owner, operator, or agent in charge
of the fishing vessel, and this subpart also does not apply to persons
who manufacture, process, pack, or hold the food until such time as the
food is sold by the owner, operator, or agent in charge of the fishing
vessel.
(2) With respect to any person who receives the partial exemption
set forth in paragraph (m)(1) of this section, if such person is
required to register with FDA under section 415 of the Federal Food,
Drug, and Cosmetic Act with respect to the manufacturing, processing,
packing, or holding of the applicable food, such person must maintain
records identifying the immediate previous source of such food and the
immediate subsequent recipient of such food in accordance with
Sec. Sec. 1.337 and 1.345. Such records must be maintained for 2 years.
(n) Exemption for transporters. This subpart does not apply to
transporters of food.
(o) Exemption for nonprofit food establishments. This subpart does
not apply to nonprofit food establishments.
(p) Exemption for persons who manufacture, process, pack, or hold
food for personal consumption. This subpart does not apply to persons
who manufacture, process, pack, or hold food for personal consumption.
(q) Exemption for certain persons who hold food on behalf of
individual consumers. This subpart does not apply to persons who hold
food on behalf of specific individual consumers, provided that these
persons:
(1) Are not parties to the transaction involving the food they hold;
and
(2) Are not in the business of distributing food.
(r) Exemption for food for research or evaluation. This subpart does
not apply to food for research or evaluation use, provided that such
food:
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(1) Is not intended for retail sale and is not sold or distributed
to the public; and
(2) Is accompanied by the statement ``Food for research or
evaluation use.''
Sec. 1.1310 What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug,
and Cosmetic Act apply to such terms when used in this subpart. In
addition, the following definitions apply to words and phrases as they
are used in this subpart:
Commingled raw agricultural commodity means any commodity that is
combined or mixed after harvesting but before processing, except that
the term ``commingled raw agricultural commodity'' does not include
types of fruits and vegetables that are raw agricultural commodities to
which the standards for the growing, harvesting, packing, and holding of
produce for human consumption in part 112 of this chapter apply. For the
purpose of this definition, a commodity is ``combined or mixed'' only
when the combination or mixing involves food from different farms under
different company management; except that for food obtained from a
fishing vessel, a commodity is ``combined or mixed'' only when the
combination or mixing involves food from different landing vessels and
occurs after the vessels have landed. Also, for the purpose of this
definition, the term ``processing'' means operations that alter the
general state of the commodity, such as canning, cooking, freezing,
dehydration, milling, grinding, pasteurization, or homogenization.
Cooling means active temperature reduction of a raw agricultural
commodity using hydrocooling, icing (except icing of seafood), forced
air cooling, vacuum cooling, or a similar process.
Critical tracking event means an event in the supply chain of a food
involving the harvesting, cooling (before initial packing), initial
packing of a raw agricultural commodity other than a food obtained from
a fishing vessel, first land-based receiving of a food obtained from a
fishing vessel, shipping, receiving, or transformation of the food.
Farm means farm as defined in Sec. 1.328. For producers of shell
eggs, ``farm'' means all poultry houses and grounds immediately
surrounding the poultry houses covered under a single biosecurity
program, as set forth in Sec. 118.3 of this chapter.
First land-based receiver means the person taking possession of a
food for the first time on land directly from a fishing vessel.
Fishing vessel means any vessel, boat, ship, or other craft which is
used for, equipped to be used for, or of a type which is normally used
for fishing or aiding or assisting one or more vessels at sea in the
performance of any activity relating to fishing, including, but not
limited to, preparation, supply, storage, refrigeration, transportation,
or processing, as set forth in the Magnuson-Stevens Fishery Conservation
and Management Act (16 U.S.C. 1802(18)).
Food Traceability List means the list of foods for which additional
traceability records are required to be maintained, as designated in
accordance with section 204(d)(2) of the FDA Food Safety Modernization
Act. The term ``Food Traceability List'' includes both the foods
specifically listed and foods that contain listed foods as ingredients,
provided that the listed food that is used as an ingredient remains in
the same form (e.g., fresh) in which it appears on the list.
Harvesting applies to farms and farm mixed-type facilities and means
activities that are traditionally performed on farms for the purpose of
removing raw agricultural commodities from the place they were grown or
raised and preparing them for use as food. Harvesting is limited to
activities performed on raw agricultural commodities, or on processed
foods created by drying/dehydrating a raw agricultural commodity without
additional manufacturing/processing, on a farm. Harvesting does not
include activities that transform a raw agricultural commodity into a
processed food as defined in section 201(gg) of the Federal Food, Drug,
and Cosmetic Act. Examples of harvesting include cutting (or otherwise
separating) the edible portion of the raw agricultural commodity from
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the crop plant and removing or trimming part of the raw agricultural
commodity (e.g., foliage, husks, roots, or stems). Examples of
harvesting also include cooling, field coring, filtering, gathering,
hulling, shelling, sifting, threshing, trimming of outer leaves of, and
washing raw agricultural commodities grown on a farm.
Holding means storage of food and also includes activities performed
incidental to storage of a food (e.g., activities performed for the safe
or effective storage of that food, such as fumigating food during
storage, and drying/dehydrating raw agricultural commodities when the
drying/dehydrating does not create a distinct commodity (such as drying/
dehydrating hay or alfalfa)). Holding also includes activities performed
as a practical necessity for the distribution of that food (such as
blending of the same raw agricultural commodity and breaking down
pallets), but does not include activities that transform a raw
agricultural commodity into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities
could include warehouses, cold storage facilities, storage silos, grain
elevators, and liquid storage tanks.
Initial packing means packing a raw agricultural commodity (other
than a food obtained from a fishing vessel) for the first time.
Key data element means information associated with a critical
tracking event for which a record must be maintained and/or provided in
accordance with this subpart.
Kill step means lethality processing that significantly minimizes
pathogens in a food.
Location description means key contact information for the location
where a food is handled, specifically the business name, phone number,
physical location address (or geographic coordinates), and city, State,
and zip code for domestic locations and comparable information for
foreign locations, including country.
Manufacturing/processing means making food from one or more
ingredients, or synthesizing, preparing, treating, modifying, or
manipulating food, including food crops or ingredients. Examples of
manufacturing/processing activities include: Baking, boiling, bottling,
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw
agricultural commodities to create a distinct commodity (such as drying/
dehydrating grapes to produce raisins), evaporating, eviscerating,
extracting juice, formulating, freezing, grinding, homogenizing,
irradiating, labeling, milling, mixing, packaging (including modified
atmosphere packaging), pasteurizing, peeling, rendering, treating to
manipulate ripening, trimming, washing, or waxing. For farms and farm
mixed-type facilities, manufacturing/processing does not include
activities that are part of harvesting, packing, or holding.
Mixed-type facility means an establishment that engages in both
activities that are exempt from registration under section 415 of the
Federal Food, Drug, and Cosmetic Act and activities that require the
establishment to be registered. An example of such a facility is a
``farm mixed-type facility,'' which is an establishment that is a farm,
but also conducts activities outside the farm definition that require
the establishment to be registered.
Nonprofit food establishment means a charitable entity that prepares
or serves food directly to the consumer or otherwise provides food or
meals for consumption by humans or animals in the United States. The
term includes central food banks, soup kitchens, and nonprofit food
delivery services. To be considered a nonprofit food establishment, the
establishment must meet the terms of section 501(c)(3) of the U.S.
Internal Revenue Code (26 U.S.C. 501(c)(3)).
Packing means placing food into a container other than packaging the
food and also includes re-packing and activities performed incidental to
packing or re-packing a food (e.g., activities performed for the safe or
effective packing or re-packing of that food (such as sorting, culling,
grading, and weighing or conveying incidental to packing or re-
packing)), but does not include activities that transform a raw
agricultural commodity into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act.
[[Page 155]]
Person includes an individual, partnership, corporation, and
association.
Point of contact means an individual having familiarity with an
entity's procedures for traceability, including their name and/or job
title, and their phone number.
Produce means produce as defined in Sec. 112.3 of this chapter.
Product description means a description of a food product and
includes the product name (including, if applicable, the brand name,
commodity, and variety), packaging size, and packaging style. For
seafood, the product name may include the species and/or acceptable
market name.
Raw agricultural commodity means ``raw agricultural commodity'' as
defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act.
Receiving means an event in a food's supply chain in which a food is
received by someone other than a consumer after being transported (e.g.,
by truck or ship) from another location. Receiving includes receipt of
an intracompany shipment of food from one location at a particular
street address of a firm to another location at a different street
address of the firm.
Reference document means a business transaction document, record, or
message, in electronic or paper form, that may contain some or all of
the key data elements for a critical tracking event in the supply chain
of a food. A reference document may be established by you or obtained
from another person. Reference document types may include, but are not
limited to, bills of lading, purchase orders, advance shipping notices,
work orders, invoices, database records, batch logs, production logs,
field tags, catch certificates, and receipts.
Reference document number means the identification number assigned
to a specific reference document.
Restaurant means a facility that prepares and sells food directly to
consumers for immediate consumption. ``Restaurant'' does not include
facilities that provide food to interstate conveyances, central
kitchens, and other similar facilities that do not prepare and serve
food directly to consumers.
(1) Entities in which food is provided to humans, such as
cafeterias, lunchrooms, cafes, bistros, fast food establishments, food
stands, saloons, taverns, bars, lounges, catering facilities, hospital
kitchens, day care kitchens, and nursing home kitchens are restaurants;
and
(2) Pet shelters, kennels, and veterinary facilities in which food
is provided to animals are restaurants.
Retail food establishment means an establishment that sells food
products directly to consumers as its primary function. The term
``retail food establishment'' includes facilities that manufacture,
process, pack, or hold food if the establishment's primary function is
to sell from that establishment food, including food that it
manufactures, processes, packs, or holds, directly to consumers. A
retail food establishment's primary function is to sell food directly to
consumers if the annual monetary value of sales of food products
directly to consumers exceeds the annual monetary value of sales of food
products to all other buyers. The term ``consumers'' does not include
businesses. A ``retail food establishment'' includes grocery stores,
convenience stores, and vending machine locations. A ``retail food
establishment'' also includes certain farm-operated businesses selling
food directly to consumers as their primary function.
(1) Sale of food directly to consumers from an establishment located
on a farm includes sales by that establishment directly to consumers:
(i) At a roadside stand (a stand situated on the side of or near a
road or thoroughfare at which a farmer sells food from his or her farm
directly to consumers) or farmers' market (a location where one or more
local farmers assemble to sell food from their farms directly to
consumers);
(ii) Through a community supported agriculture program. Community
supported agriculture (CSA) program means a program under which a farmer
or group of farmers grows food for a group of shareholders (or
subscribers) who pledge to buy a portion of the farmer's crop(s) for
that season. This includes CSA programs in which a group of farmers
consolidate their
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crops at a central location for distribution to shareholders or
subscribers; and
(iii) At other such direct-to-consumer sales platforms, including
door-to-door sales; mail, catalog and internet order, including online
farmers' markets and online grocery delivery; religious or other
organization bazaars; and State and local fairs.
(2) Sale of food directly to consumers by a farm-operated business
includes the sale of food by that farm-operated business directly to
consumers:
(i) At a roadside stand (a stand situated on the side of or near a
road or thoroughfare at which a farmer sells food from his or her farm
directly to consumers) or farmers' market (a location where one or more
local farmers assemble to sell food from their farms directly to
consumers);
(ii) Through a community supported agriculture program. Community
supported agriculture (CSA) program means a program under which a farmer
or group of farmers grows food for a group of shareholders (or
subscribers) who pledge to buy a portion of the farmer's crop(s) for
that season. This includes CSA programs in which a group of farmers
consolidate their crops at a central location for distribution to
shareholders or subscribers; and
(iii) At other such direct-to-consumer sales platforms, including
door-to-door sales; mail, catalog and internet order, including online
farmers' markets and online grocery delivery; religious or other
organization bazaars; and State and local fairs.
(3) For the purposes of this definition, ``farm-operated business''
means a business that is managed by one or more farms and conducts
manufacturing/processing not on the farm(s).
Shipping means an event in a food's supply chain in which a food is
arranged for transport (e.g., by truck or ship) from one location to
another location. Shipping does not include the sale or shipment of a
food directly to a consumer or the donation of surplus food. Shipping
includes sending an intracompany shipment of food from one location at a
particular street address of a firm to another location at a different
street address of the firm.
Traceability lot means a batch or lot of food that has been
initially packed (for raw agricultural commodities other than food
obtained from a fishing vessel), received by the first land-based
receiver (for food obtained from a fishing vessel), or transformed.
Traceability lot code means a descriptor, often alphanumeric, used
to uniquely identify a traceability lot within the records of the
traceability lot code source.
Traceability lot code source means the place where a food was
assigned a traceability lot code.
Traceability lot code source reference means an alternative method
for providing FDA with access to the location description for the
traceability lot code source as required under this subpart. Examples of
a traceability lot code source reference include, but are not limited
to, the FDA Food Facility Registration Number for the traceability lot
code source or a web address that provides FDA with the location
description for the traceability lot code source.
Transformation means an event in a food's supply chain that involves
manufacturing/processing a food or changing a food (e.g., by
commingling, repacking, or relabeling) or its packaging or packing, when
the output is a food on the Food Traceability List. Transformation does
not include the initial packing of a food or activities preceding that
event (e.g., harvesting, cooling).
Transporter means a person who has possession, custody, or control
of an article of food for the sole purpose of transporting the food,
whether by road, rail, water, or air.
You means a person subject to this subpart under Sec. 1.1300.
Traceability Plan
Sec. 1.1315 What traceability plan must I have for foods on the Food
Traceability List that I manufacture, process, pack, or hold?
(a) If you are subject to the requirements in this subpart, you must
establish and maintain a traceability plan containing the following
information:
(1) A description of the procedures you use to maintain the records
you are required to keep under this subpart, including the format and
location of these records.
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(2) A description of the procedures you use to identify foods on the
Food Traceability List that you manufacture, process, pack, or hold;
(3) A description of how you assign traceability lot codes to foods
on the Food Traceability List in accordance with Sec. 1.1320, if
applicable;
(4) A statement identifying a point of contact for questions
regarding your traceability plan and records; and
(5) If you grow or raise a food on the Food Traceability List (other
than eggs), a farm map showing the areas in which you grow or raise such
foods.
(i) Except as specified in paragraph (a)(5)(ii) of this section, the
farm map must show the location and name of each field (or other growing
area) in which you grow a food on the Food Traceability List, including
geographic coordinates and any other information needed to identify the
location of each field or growing area.
(ii) For aquaculture farms, the farm map must show the location and
name of each container (e.g., pond, pool, tank, cage) in which you raise
seafood on the Food Traceability List, including geographic coordinates
and any other information needed to identify the location of each
container.
(b) You must update your traceability plan as needed to ensure that
the information provided reflects your current practices and to ensure
that you are in compliance with the requirements of this subpart. You
must retain your previous traceability plan for 2 years after you update
the plan.
Sec. 1.1320 When must I assign traceability lot codes to foods on the
Food Traceability List?
(a) You must assign a traceability lot code when you do any of the
following: Initially pack a raw agricultural commodity other than a food
obtained from a fishing vessel; perform the first land-based receiving
of a food obtained from a fishing vessel; or transform a food.
(b) Except as otherwise specified in this subpart, you must not
establish a new traceability lot code when you conduct other activities
(e.g., shipping) for a food on the Food Traceability List.
Records of Critical Tracking Events
Sec. 1.1325 What records must I keep and provide when I harvest or cool
a raw agricultural commodity on the Food Traceability List?
(a) Harvesting. (1) For each raw agricultural commodity (not
obtained from a fishing vessel) on the Food Traceability List that you
harvest, you must maintain records containing the following information:
(i) The location description for the immediate subsequent recipient
(other than a transporter) of the food;
(ii) The commodity and, if applicable, variety of the food;
(iii) The quantity and unit of measure of the food (e.g., 75 bins,
200 pounds);
(iv) The location description for the farm where the food was
harvested;
(v) For produce, the name of the field or other growing area from
which the food was harvested (which must correspond to the name used by
the grower), or other information identifying the harvest location at
least as precisely as the field or other growing area name;
(vi) For aquacultured food, the name of the container (e.g., pond,
pool, tank, cage) from which the food was harvested (which must
correspond to the container name used by the aquaculture farmer) or
other information identifying the harvest location at least as precisely
as the container name;
(vii) The date of harvesting; and
(viii) The reference document type and reference document number.
(2) For each raw agricultural commodity (not obtained from a fishing
vessel) on the Food Traceability List that you harvest, you must provide
(in electronic, paper, or other written form) your business name, phone
number, and the information in paragraphs (a)(1)(i) through (vii) of
this section to the initial packer of the raw agricultural commodity you
harvest, either directly or through the supply chain.
(b) Cooling before initial packing. (1) For each raw agricultural
commodity (not obtained from a fishing vessel) on the Food Traceability
List that you cool before it is initially packed, you must maintain
records containing the following information:
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(i) The location description for the immediate subsequent recipient
(other than a transporter) of the food;
(ii) The commodity and, if applicable, variety of the food;
(iii) The quantity and unit of measure of the food (e.g., 75 bins,
200 pounds);
(iv) The location description for where you cooled the food;
(v) The date of cooling;
(vi) The location description for the farm where the food was
harvested; and
(vii) The reference document type and reference document number.
(2) For each raw agricultural commodity (not obtained from a fishing
vessel) on the Food Traceability List that you cool before it is
initially packed, you must provide (in electronic, paper, or other
written form) the information in paragraphs (b)(1)(i) through (vi) of
this section to the initial packer of the raw agricultural commodity you
cool, either directly or through the supply chain.
Sec. 1.1330 What records must I keep when I am performing the initial
packing of a raw agricultural commodity (other than a food obtained from
a fishing vessel) on the Food Traceability List?
(a) Except as specified in paragraph (c) of this section, for each
traceability lot of a raw agricultural commodity (other than a food
obtained from a fishing vessel) on the Food Traceability List you
initially pack, you must maintain records containing the following
information and linking this information to the traceability lot:
(1) The commodity and, if applicable, variety of the food received;
(2) The date you received the food;
(3) The quantity and unit of measure of the food received (e.g., 75
bins, 200 pounds);
(4) The location description for the farm where the food was
harvested;
(5) For produce, the name of the field or other growing area from
which the food was harvested (which must correspond to the name used by
the grower), or other information identifying the harvest location at
least as precisely as the field or other growing area name;
(6) For aquacultured food, the name of the container (e.g., pond,
pool, tank, cage) from which the food was harvested (which must
correspond to the container name used by the aquaculture farmer) or
other information identifying the harvest location at least as precisely
as the container name;
(7) The business name and phone number for the harvester of the
food;
(8) The date of harvesting;
(9) The location description for where the food was cooled (if
applicable);
(10) The date of cooling (if applicable);
(11) The traceability lot code you assigned;
(12) The product description of the packed food;
(13) The quantity and unit of measure of the packed food (e.g., 6
cases, 25 reusable plastic containers, 100 tanks, 200 pounds);
(14) The location description for where you initially packed the
food (i.e., the traceability lot code source), and (if applicable) the
traceability lot code source reference;
(15) The date of initial packing; and
(16) The reference document type and reference document number.
(b) For each traceability lot of sprouts (except soil- or substrate-
grown sprouts harvested without their roots) you initially pack, you
must also maintain records containing the following information and
linking this information to the traceability lot:
(1) The location description for the grower of seeds for sprouting
and the date of seed harvesting, if either is available;
(2) The location description for the seed conditioner or processor,
the associated seed lot code, and the date of conditioning or
processing;
(3) The location description for the seed packinghouse (including
any repackers), the date of packing (and of repacking, if applicable),
and any associated seed lot code assigned by the seed packinghouse;
(4) The location description for the seed supplier, any seed lot
code assigned by the seed supplier (including the master lot and sub-lot
codes), and any new seed lot code assigned by the sprouter;
(5) A description of the seeds, including the seed type or taxonomic
name,
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growing specifications, type of packaging, and (if applicable)
antimicrobial treatment;
(6) The date of receipt of the seeds by the sprouter; and
(7) The reference document type and reference document number.
(c) For each traceability lot of a raw agricultural commodity (other
than a food obtained from a fishing vessel) on the Food Traceability
List you initially pack that you receive from a person to whom this
subpart does not apply, you must maintain records containing the
following information and linking this information to the traceability
lot:
(1) The commodity and, if applicable, variety of the food received;
(2) The date you received the food;
(3) The quantity and unit of measure of the food received (e.g., 75
bins, 200 pounds);
(4) The location description for the person from whom you received
the food;
(5) The traceability lot code you assigned;
(6) The product description of the packed food;
(7) The quantity and unit of measure of the packed food (e.g., 6
cases, 25 reusable plastic containers, 100 tanks, 200 pounds);
(8) The location description for where you initially packed the food
(i.e., the traceability lot code source), and (if applicable) the
traceability lot code source reference;
(9) The date of initial packing; and
(10) The reference document type and reference document number.
Sec. 1.1335 What records must I keep when I am the first land-based
receiver of a food on the Food Traceability List that was obtained from
a fishing vessel?
For each traceability lot of a food obtained from a fishing vessel
for which you are the first land-based receiver, you must maintain
records containing the following information and linking this
information to the traceability lot:
(a) The traceability lot code you assigned;
(b) The species and/or acceptable market name for unpackaged food,
or the product description for packaged food;
(c) The quantity and unit of measure of the food (e.g., 300 kg);
(d) The harvest date range and locations (as identified under the
National Marine Fisheries Service Ocean Geographic Code, the United
Nations Food and Agriculture Organization Major Fishing Area list, or
any other widely recognized geographical location standard) for the trip
during which the food was caught;
(e) The location description for the first land-based receiver
(i.e., the traceability lot code source), and (if applicable) the
traceability lot code source reference;
(f) The date the food was landed; and
(g) The reference document type and reference document number.