[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2017 Edition]
[From the U.S. Government Publishing Office]
[[Page i]]
Title 21
Food and Drugs
________________________
Parts 1 to 99
Revised as of April 1, 2017
Containing a codification of documents of general
applicability and future effect
As of April 1, 2017
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........................ 551
Alphabetical List of Agencies Appearing in the CFR...... 571
List of CFR Sections Affected........................... 581
[[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
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie
evidence of the text of the original documents (44 U.S.C. 1510).
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
Each volume of the Code contains amendments published in the Federal
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OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires
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
amendments to existing regulations in the CFR. These OMB numbers are
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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
The term ``[Reserved]'' is used as a place holder within the Code of
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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
the requirements of 1 CFR part 51 are met. Some of the elements on which
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
you have any problem locating or obtaining a copy of material listed as
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CFR INDEXES AND TABULAR GUIDES
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alphabetical list of agencies publishing in the CFR are also included in
this volume.
[[Page vii]]
An index to the text of ``Title 3--The President'' is carried within
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INQUIRIES
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Oliver A. Potts,
Director,
Office of the Federal Register.
April 1, 2017.
[[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, 2017.
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 123
3 Product jurisdiction........................ 128
4 Regulation of combination products.......... 133
5 Organization................................ 139
7 Enforcement policy.......................... 150
10 Administrative practices and procedures..... 160
11 Electronic records; electronic signatures... 197
12 Formal evidentiary public hearing........... 201
13 Public hearing before a public board of
inquiry................................. 218
14 Public hearing before a public advisory
committee............................... 223
15 Public hearing before the Commissioner...... 251
16 Regulatory hearing before the Food and Drug
Administration.......................... 253
17 Civil money penalties hearings.............. 260
19 Standards of conduct and conflicts of
interest................................ 272
20 Public information.......................... 275
21 Protection of privacy....................... 306
25 Environmental impact considerations......... 322
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.................. 334
50 Protection of human subjects................ 365
54 Financial disclosure by clinical
investigators........................... 377
56 Institutional Review Boards................. 381
58 Good laboratory practice for nonclinical
laboratory studies...................... 391
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60 Patent term restoration..................... 404
70 Color additives............................. 411
71 Color additive petitions.................... 419
73 Listing of color additives exempt from
certification........................... 426
74 Listing of color additives subject to
certification........................... 479
80 Color additive certification................ 516
81 General specifications and general
restrictions for provisional color
additives for use in foods, drugs, and
cosmetics............................... 523
82 Listing of certified provisionally listed
colors and specifications............... 530
83-98
[Reserved]
99 Dissemination of information on unapproved/
new uses for marketed drugs, biologics,
and devices............................. 535
[[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.
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.
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,
350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371,
373, 374, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a, 387c, 393; 42
U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188, 116 Stat. 594,
668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.
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 Secs. 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
Secs. 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
Secs. 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 Secs. 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 Secs. 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 Secs. 201.62(n), 701.13(p) and
801.62(n) of this chapter, to prohibition of certain supplemental net
quantity statements in Secs. 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 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 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.
[[Page 10]]
(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 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]
[[Page 11]]
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:
(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
[[Page 12]]
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
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.
[[Page 13]]
(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. 101.105(j) 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 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
[[Page 14]]
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 Secs. 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. 101.105(j) 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 Secs. 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 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
Secs. 137.211, 137.215, and Secs. 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.
[[Page 15]]
(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 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]
Subpart C [Reserved]
Subpart D_Electronic Import Entries
Source: 81 FR 85870, Nov. 29, 2016, unless otherwise noted.
[[Page 16]]
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.
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, 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
[[Page 17]]
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.
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, intended for
human use that are regulated by the FDA Center for Drug Evaluation and
Research.
(a) Registration and listing. For a drug intended for human use, the
Drug Registration Number and the Drug Listing 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 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
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(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
human drug article being imported or offered for import.
(b) 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 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 new drug application or an approved
biologics license application, the number of the applicable application.
(c) 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.
Sec. 1.75 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:
(a) 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
[[Page 18]]
under part 207 of this chapter. For the purposes of this section, the
Drug Registration Number that must be submitted in ACE 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.
(b) 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.
(c) 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 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.
(d) Investigational new animal drug number. For a drug intended for
animal use that is the subject of an investigational new animal drug or
generic investigational new animal drug application under part 511 of
this chapter, the number of the investigational new animal drug or
generic investigational new animal drug file.
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.
[[Page 19]]
(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 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(b) 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.
[[Page 20]]
(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 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.
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 district director means the director of the district 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 district as he may designate to act in his 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]
Sec. 1.90 Notice of sampling.
When a sample of an article offered for import has been requested by
the district 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
[[Page 21]]
further notice from the district director or U.S. Customs and Border
Protection of the results of examination of the sample.
[81 FR 85872, Nov. 29, 2016]
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 district
headquarters in whose territory 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.
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 801(a) of the Federal Food, Drug, and Cosmetic
Act, the district 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 district 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
district 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 district 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]
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 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.
Sec. 1.96 Granting of authorization to relabel and recondition.
(a) When authorization contemplated by Sec. 1.95 is granted, the
district director shall notify the applicant in writing, specifying:
(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 the U.S. Customs
Service, as the case may be;
(4) A time limit, reasonable in the light of the circumstances, for
completion of the operations; and
[[Page 22]]
(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
district director may grant such additional time as he 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 district 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 and obtained a new authorization. Any
authorization granted under this section shall supersede and nullify any
previously granted authorization with respect to the article.
[42 FR 15553, Mar. 22, 1977, as amended at 54 FR 9033, Mar. 3, 1989]
Sec. 1.97 Bonds.
(a) The bonds required under section 801(b) of the act may be
executed by the owner or consignee on the appropriate form of a customs
single-entry or term bond, containing a condition for the redelivery of
the merchandise or any part thereof upon demand of the collector of
customs 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 the collector of
customs.
(b) The collector of customs may cancel the liability for liquidated
damages incurred under the above-mentioned provisions of such a bond, if
he 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 the
collector shall not act under this regulation in any case unless the
district director is in full agreement with the action.
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 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 266 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 266 percent of the hourly rate of regular pay of a grade
GS-12/4 employee. The rate per hour equal to 266 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:
Hours
Gross number of working hours in 52 40-hr weeks................ 2,080
Less:
9 legal public holidays--New Years Day, Washington's 72
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.................................................... 384
Net number of working hours.............................. 1,696
Gross number of working hours in 52 40-hr weeks................ 2,080
[[Page 23]]
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 man-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 4,512/1,696 = 266 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.
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 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:
[[Page 24]]
(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--Division of
New Drugs and Labeling Compliance, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002.
(iii) For devices--Food and Drug Administration, Center for Devices
and Radiological Health, Division of Program Operations, 10903 New
Hampshire Ave., Bldg. 66, rm. 5429, Silver Spring, MD 20993-0002.
(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 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
[[Page 25]]
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]
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, 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
[[Page 26]]
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.
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,
[[Page 27]]
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 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,
[[Page 28]]
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).
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,
[[Page 29]]
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 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
[[Page 30]]
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 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.
[[Page 31]]
(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.
(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
[[Page 32]]
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 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
[[Page 33]]
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 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
[[Page 34]]
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;
(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.
[[Page 35]]
(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.
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
[[Page 36]]
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 Secs. 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 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 Secs. 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,
[[Page 37]]
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.
(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
[[Page 38]]
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;
(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
[[Page 39]]
(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]
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
[[Page 40]]
(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 http://www.fda.gov.
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]
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 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;
[[Page 41]]
(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 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
[[Page 42]]
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 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;
[[Page 43]]
(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 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;
[[Page 44]]
(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]
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
[[Page 45]]
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 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
[[Page 46]]
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 Secs. 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 Secs. 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 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
[[Page 47]]
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 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
[[Page 48]]
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 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,
[[Page 49]]
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 Secs. 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 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
[[Page 50]]
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 Secs. 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 Secs. 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 Secs. 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 Secs. 1.361 and 1.363.
(l) Nonprofit food establishments are excluded from all of the
requirements in this subpart, except Secs. 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 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:
[[Page 51]]
(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, 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
[[Page 52]]
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.
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,
[[Page 53]]
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.
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);
[[Page 54]]
(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;
(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;
[[Page 55]]
(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.
(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.
[[Page 56]]
(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 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]
[[Page 57]]
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 District Director in
whose district 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.
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.
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.
[[Page 58]]
(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 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
[[Page 59]]
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, i.e., the FDA District Director in
whose district the article of food involved is located or an FDA
official senior to such director, 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.
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.
[[Page 60]]
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 Secs. 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, e-mail address, and fax
number of the FDA district office and the name of the FDA District
Director in whose district 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]
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 District Director, in whose district the
detained article of food is located, at the mailing address, e-mail
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 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.
[[Page 61]]
(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.
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 District Director in whose district 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, i.e., Office of Regulatory Affairs Program
Directors or other officials senior to a District Director, 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, the
administrative record of the hearing specified in Secs. 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]
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 District Director.
[82 FR 14144, Mar. 17, 2017]
[[Page 62]]
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 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.
[[Page 63]]
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.
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.
[[Page 64]]
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.
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.
[[Page 65]]
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.
(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
[[Page 66]]
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.);
(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
[[Page 67]]
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 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
[[Page 68]]
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 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)
[[Page 69]]
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 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.
[[Page 70]]
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 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
[[Page 71]]
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 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.
[[Page 72]]
(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 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
[[Page 73]]
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 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
[[Page 74]]
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 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
[[Page 75]]
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 Secs. 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
Secs. 1.503 and 1.509, but you are not required to comply with the
requirements in Sec. 1.502, Secs. 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 Secs. 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 Secs. 1.503, 1.509, and 1.510, but you are not required
to comply with the requirements in Sec. 1.502 or Secs. 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 Secs. 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 Secs. 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 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
[[Page 76]]
(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.
(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
[[Page 77]]
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. 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
[[Page 78]]
farm under part 112 of this chapter in accordance with Sec. 112.4(a) of
this chapter, or in accordance with Secs. 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 Secs. 1.502, 1.503,
and 1.509, but you are not required to comply with the requirements in
Secs. 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 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 Secs. 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
[[Page 79]]
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 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
[[Page 80]]
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 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
[[Page 81]]
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 Secs. 1.504 through
1.508. You would still be required to comply with the requirements in
Secs. 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.
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
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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.
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
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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-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
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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
(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.).
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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 Secs. 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
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
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(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 Secs. 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 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 Secs. 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
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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
Secs. 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).
(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.
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(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;
(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
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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;
(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
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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 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
[[Page 91]]
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.
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.
[[Page 92]]
(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 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]
[[Page 93]]
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 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.
[[Page 94]]
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 Secs. 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 Secs. 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:
(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.
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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 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.
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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:
(i) ISO/IEC 17025:2005; or
(ii) Another laboratory accreditation standard that provides at
least a similar level of assurance in the validity and reliability of
sampling methodologies, analytical methodologies, and analytical
results.
(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
Secs. 1.621 and 1.662 or, where appropriate, the recognized
accreditation body's performance under Secs. 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 (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,
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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. 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.
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 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:
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(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 Secs. 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.
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
[[Page 99]]
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.
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
[[Page 100]]
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.
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
[[Page 101]]
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 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
[[Page 102]]
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
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.
[[Page 103]]
(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.
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
[[Page 104]]
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.
(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:
[[Page 105]]
(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 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.
[[Page 106]]
(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 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.
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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 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
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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 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).
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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
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
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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.
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
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(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 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
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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.).
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.
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Sec. 1.904 What definitions apply to this subpart?
The definitions and interpretations of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act are applicable to such terms when
used in this part. The following definitions also apply:
Adequate means that which is needed to accomplish the intended
purpose in keeping with good public health practice.
Animal food means food for animals other than man, and includes pet
food, animal feed, and raw materials and ingredients.
Bulk vehicle means a tank truck, hopper truck, rail tank car, hopper
car, cargo tank, portable tank, freight container, or hopper bin, or any
other vehicle in which food is shipped in bulk, with the food coming
into direct contact with the vehicle.
Carrier means a person who physically moves food by rail or motor
vehicle in commerce within the United States. The term carrier does not
include any person who transports food while operating as a parcel
delivery service.
Cross-contact means the unintentional incorporation of a food
allergen as defined in section 201(qq) of the Federal Food, Drug, and
Cosmetic Act into food, except animal food.
Farm has the meaning given in Sec. 1.227 of this chapter.
Food not completely enclosed by a container means any food that is
placed into a container in such a manner that it is partially open to
the surrounding environment. Examples of such containers include an open
wooden basket or crate, an open cardboard box, a vented cardboard box
with a top, or a vented plastic bag. This term does not include food
transported in a bulk vehicle as defined in this subpart.
Full-time equivalent employee is a term used to represent the number
of employees of a business entity for the purpose of determining whether
the business is a small business. The number of full-time equivalent
employees is determined by dividing the total number of hours of salary
or wages paid directly to employees of the business entity and of all of
its affiliates and subsidiaries by the number of hours of work in 1
year, 2,080 hours (i.e., 40 hours x 52 weeks). If the result is not a
whole number, round down to the next lowest whole number.
Loader means a person that loads food onto a motor or rail vehicle
during transportation operations.
Non-covered business means a shipper, loader, receiver, or carrier
engaged in transportation operations that has less than $500,000, as
adjusted for inflation, in average annual revenues, calculated on a
rolling basis, during the 3-year period preceding the applicable
calendar year. For the purpose of determining an entity's 3-year average
revenue threshold as adjusted for inflation, the baseline year for
calculating the adjustment for inflation is 2011.
Operating temperature means a temperature sufficient to ensure that
under foreseeable circumstances of temperature variation during
transport, e.g., seasonal conditions, refrigeration unit defrosting,
multiple vehicle loading and unloading stops, the operation will meet
the requirements of Sec. 1.908(a)(3).
Pest means any objectionable animals or insects including birds,
rodents, flies, and larvae.
Receiver means any person who receives food at a point in the United
States after transportation, whether or not that person represents the
final point of receipt for the food.
Shipper means a person, e.g., the manufacturer or a freight broker,
who arranges for the transportation of food in the United States by a
carrier or multiple carriers sequentially.
Small business means a business employing fewer than 500 full-time
equivalent employees except that for carriers by motor vehicle that are
not also shippers and/or receivers, this term would mean a business
subject to Sec. 1.900(a) having less than $27,500,000 in annual
receipts.
Transportation means any movement of food in by motor vehicle or
rail vehicle in commerce within the United States.
Transportation equipment means equipment used in food transportation
operations, e.g., bulk and non-bulk containers, bins, totes, pallets,
pumps, fittings, hoses, gaskets, loading systems, and unloading systems.
Transportation
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equipment also includes a railcar not attached to a locomotive or a
trailer not attached to a tractor.
Transportation operations means all activities associated with food
transportation that may affect the sanitary condition of food including
cleaning, inspection, maintenance, loading and unloading, and operation
of vehicles and transportation equipment. Transportation operations do
not include any activities associated with the transportation of food
that is completely enclosed by a container except a food that requires
temperature control for safety, compressed food gases, food contact
substances as defined in section 409(h)(6) of the Federal Food, Drug,
and Cosmetic Act, human food byproducts transported for use as animal
food without further processing, or live food animals except molluscan
shellfish. In addition, transportation operations do not include any
transportation activities that are performed by a farm.
Vehicle means a land conveyance that is motorized, e.g., a motor
vehicle, or that moves on rails, e.g., a railcar, which is used in
transportation operations.
Vehicles and Transportation Equipment
Sec. 1.906 What requirements apply to vehicles and transportation equipment?
(a) Vehicles and transportation equipment used in transportation
operations must be so designed and of such material and workmanship as
to be suitable and adequately cleanable for their intended use to
prevent the food they transport from becoming unsafe, i.e., adulterated
within the meaning of section 402(a)(1), (2), and (4) of the Federal
Food, Drug, and Cosmetic Act during transportation operations.
(b) Vehicles and transportation equipment must be maintained in such
a sanitary condition for their intended use as to prevent the food they
transport from becoming unsafe during transportation operations.
(c) Vehicles and transportation equipment used in transportation
operations for food requiring temperature control for safety must be
designed, maintained, and equipped as necessary to provide adequate
temperature control to prevent the food from becoming unsafe during
transportation operations.
(d) Vehicles and transportation equipment must be stored in a manner
that prevents it from harboring pests or becoming contaminated in any
other manner that could result in food for which it will be used
becoming unsafe during transportation operations.
Transportation Operations
Sec. 1.908 What requirements apply to transportation operations?
(a) General requirements. (1) Unless stated otherwise in this
section, the requirements of this section apply to all shippers,
carriers, loaders, and receivers engaged in transportation operations. A
person may be subject to these requirements in multiple capacities,
e.g., the shipper may also be the loader and the carrier, if the person
also performs the functions of those respective persons as defined in
this subpart. An entity subject to this subpart (shipper, loader,
carrier, or receiver) may reassign, in a written agreement, its
responsibilities under this subpart to another party subject to this
subpart. The written agreement is subject to the records requirements of
Sec. 1.912(d).
(2) Responsibility for ensuring that transportation operations are
carried out in compliance with all requirements in this subpart must be
assigned to competent supervisory personnel.
(3) All transportation operations must be conducted under such
conditions and controls necessary to prevent the food from becoming
unsafe during transportation operations including:
(i) Taking effective measures such as segregation, isolation, or the
use of packaging to protect food from contamination by raw foods and
nonfood items in the same load.
(ii) Taking effective measures such as segregation, isolation, or
other protective measures, such as hand washing, to protect food
transported in bulk vehicles or food not completely enclosed by a
container from contamination and cross-contact during transportation
operations.
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(iii) Taking effective measures to ensure that food that requires
temperature control for safety is transported under adequate temperature
control.
(4) The type of food, e.g., animal feed, pet food, human food, and
its production stage, e.g., raw material, ingredient or finished food,
must be considered in determining the necessary conditions and controls
for the transportation operation.
(5) Shippers, receivers, loaders, and carriers, which are under the
ownership or operational control of a single legal entity, as an
alternative to meeting the requirements of paragraphs (b), (d), and (e)
of this section may conduct transportation operations in conformance
with common, integrated written procedures that ensure the sanitary
transportation of food consistent with the requirements of this section.
The written procedures are subject to the records requirements of
Sec. 1.912(e).
(6) If a shipper, loader, receiver, or carrier becomes aware of an
indication of a possible material failure of temperature control or
other conditions that may render the food unsafe during transportation,
the food shall not be sold or otherwise distributed, and these persons
must take appropriate action including, as necessary, communication with
other parties to ensure that the food is not sold or otherwise
distributed unless a determination is made by a qualified individual
that the temperature deviation or other condition did not render the
food unsafe.
(b) Requirements applicable to shippers engaged in transportation
operations. (1) Unless the shipper takes other measures in accordance
with paragraph (b)(3) of this section to ensure that vehicles and
equipment used in its transportation operations are in appropriate
sanitary condition for the transportation of the food, i.e., that will
prevent the food from becoming unsafe, the shipper must specify to the
carrier and, when necessary, the loader, in writing, all necessary
sanitary specifications for the carrier's vehicle and transportation
equipment to achieve this purpose, including any specific design
specifications and cleaning procedures. One-time notification shall be
sufficient unless the design requirements and cleaning procedures
required for sanitary transport change based upon the type of food being
transported, in which case the shipper shall so notify the carrier in
writing before the shipment. The information submitted by the shipper to
the carrier is subject to the records requirements in Sec. 1.912(a).
(2) Unless the shipper takes other measures in accordance with
paragraph (b)(5) of this section to ensure that adequate temperature
control is provided during the transportation of food that requires
temperature control for safety under the conditions of shipment, a
shipper of such food must specify in writing to the carrier, except a
carrier who transports the food in a thermally insulated tank, and, when
necessary, the loader, an operating temperature for the transportation
operation including, if necessary, the pre-cooling phase. One-time
notification shall be sufficient unless a factor, e.g., the conditions
of shipment, changes, necessitating a change in the operating
temperature, in which case the shipper shall so notify the carrier in
writing before the shipment. The information submitted by the shipper to
the carrier is subject to the records requirements in Sec. 1.912(a).
(3) A shipper must develop and implement written procedures, subject
to the records requirements of Sec. 1.912(a), adequate to ensure that
vehicles and equipment used in its transportation operations are in
appropriate sanitary condition for the transportation of the food, i.e.,
will prevent the food from becoming unsafe during the transportation
operation. Measures to implement these procedures may be accomplished by
the shipper or by the carrier or another party covered by this subpart
under a written agreement subject to the records requirements of
Sec. 1.912(a).
(4) A shipper of food transported in bulk must develop and implement
written procedures, subject to the records requirements of
Sec. 1.912(a), adequate to ensure that a previous cargo does not make
the food unsafe. Measures to ensure the safety of the food may be
accomplished by the shipper or by the carrier or another party covered
by this subpart under a written agreement
[[Page 116]]
subject to the records requirements of Sec. 1.912(a).
(5) The shipper of food that requires temperature control for safety
under the conditions of shipment must develop and implement written
procedures, subject to the records requirements of Sec. 1.912(a), to
ensure that the food is transported under adequate temperature control.
Measures to ensure the safety of the food may be accomplished by the
shipper or by the carrier or another party covered by this subpart under
a written agreement subject to the records requirements of Sec. 1.912(a)
and must include measures equivalent to those specified for carriers
under paragraphs (e)(1) through (3) of this section.
(c) Requirements applicable to loaders engaged in transportation
operations. (1) Before loading food not completely enclosed by a
container onto a vehicle or into transportation equipment the loader
must determine, considering, as appropriate, specifications provided by
the shipper in accordance with paragraph (b)(1) of this section, that
the vehicle or transportation equipment is in appropriate sanitary
condition for the transport of the food, e.g., it is in adequate
physical condition, and free of visible evidence of pest infestation and
previous cargo that could cause the food to become unsafe during
transportation. This may be accomplished by any appropriate means.
(2) Before loading food that requires temperature control for
safety, the loader must verify, considering, as appropriate,
specifications provided by the shipper in accordance with paragraph
(b)(2) of this section, that each mechanically refrigerated cold storage
compartment or container is adequately prepared for the transportation
of such food, including that it has been properly pre-cooled, if
necessary, and meets other sanitary conditions for food transportation.
(d) Requirements applicable to receivers engaged in transportation
operations. Upon receipt of food that requires temperature control for
safety under the conditions of shipment, the receiver must take steps to
adequately assess that the food was not subjected to significant
temperature abuse, such as determining the food's temperature, the
ambient temperature of the vehicle and its temperature setting, and
conducting a sensory inspection, e.g., for off-odors.
(e) Requirements applicable to carriers engaged in transportation
operations. When the carrier and shipper have a written agreement that
the carrier is responsible, in whole or in part, for sanitary conditions
during the transportation operation, the carrier is responsible for the
following functions as applicable per the agreement:
(1) A carrier must ensure that vehicles and transportation equipment
meet the shipper's specifications and are otherwise appropriate to
prevent the food from becoming unsafe during the transportation
operation.
(2) A carrier must, once the transportation operation is complete
and if requested by the receiver, provide the operating temperature
specified by the shipper in accordance with paragraph (b)(2) of this
section and, if requested by the shipper or receiver, demonstrate that
it has maintained temperature conditions during the transportation
operation consistent with the operating temperature specified by the
shipper in accordance with paragraph (b)(2) of this section. Such
demonstration may be accomplished by any appropriate means agreeable to
the carrier and shipper, such as the carrier presenting measurements of
the ambient temperature upon loading and unloading or time/temperature
data taken during the shipment.
(3) Before offering a vehicle or transportation equipment with an
auxiliary refrigeration unit for use for the transportation of food that
requires temperature control for safety under the conditions of the
shipment during transportation, a carrier must pre-cool each
mechanically refrigerated cold storage compartment as specified by the
shipper in accordance with paragraph (b)(2) of this section.
(4) If requested by the shipper, a carrier that offers a bulk
vehicle for food transportation must provide information to the shipper
that identifies the previous cargo transported in the vehicle.
(5) If requested by the shipper, a carrier that offers a bulk
vehicle for food
[[Page 117]]
transportation must provide information to the shipper that describes
the most recent cleaning of the bulk vehicle.
(6) A carrier must develop and implement written procedures subject
to the records requirements of Sec. 1.912(b) that:
(i) Specify practices for cleaning, sanitizing if necessary, and
inspecting vehicles and transportation equipment that the carrier
provides for use in the transportation of food to maintain the vehicles
and the transportation equipment in appropriate sanitary condition as
required by Sec. 1.906(b);
(ii) Describe how it will comply with the provisions for temperature
control in paragraph (e)(2) of this section, and;
(iii) Describe how it will comply with the provisions for the use of
bulk vehicles in paragraphs (e)(4) and (5) of this section.
Training
Sec. 1.910 What training requirements apply to carriers engaged in
transportation operations?
(a) When the carrier and shipper have agreed in a written contract
that the carrier is responsible, in whole or in part, for the sanitary
conditions during transportation operations, the carrier must provide
adequate training to personnel engaged in transportation operations that
provides an awareness of potential food safety problems that may occur
during food transportation, basic sanitary transportation practices to
address those potential problems, and the responsibilities of the
carrier under this part. The training must be provided upon hiring and
as needed thereafter.
(b) Carriers must establish and maintain records documenting the
training described in paragraph (a) of this section. Such records must
include the date of the training, the type of training, and the
person(s) trained. These records are subject to the records requirements
of Sec. 1.912(c).
Records
Sec. 1.912 What record retention and other records requirements apply to
shippers, receivers, loaders, and carriers engaged in transportation operations?
(a) Shippers must retain records:
(1) That demonstrate that they provide specifications and operating
temperatures to carriers as required by Sec. 1.908(b)(1) and (2) as a
regular part of their transportation operations for a period of 12
months beyond the termination of the agreements with the carriers.
(2) Of written agreements and the written procedures required by
Sec. 1.908(b)(3), (4), and (5), for a period of 12 months beyond when
the agreements and procedures are in use in their transportation
operations.
(b) Carriers must retain records of the written procedures required
by Sec. 1.908(e)(6) for a period of 12 months beyond when the agreements
and procedures are in use in their transportation operations.
(c) Carriers must retain training records required by Sec. 1.910(b)
for a period of 12 months beyond when the person identified in any such
records stops performing the duties for which the training was provided.
(d) Any person subject to this subpart must retain any other written
agreements assigning tasks in compliance with this subpart for a period
of 12 months beyond the termination of the agreements.
(e) Shippers, receivers, loaders, and carriers, which operate under
the ownership or control of a single legal entity in accordance with the
provisions of Sec. 1.908(a)(5), must retain records of the written
procedures for a period of 12 months beyond when the procedures are in
use in their transportation operations.
(f) Shippers, receivers, loaders, and carriers must make all records
required by this subpart available to a duly authorized individual
promptly upon oral or written request.
(g) All records required by this subpart must be kept as original
records, true copies (such as photocopies, pictures, scanned copies,
microfilm,
[[Page 118]]
microfiche, or other accurate reproductions of the original records), or
electronic records.
(h) Records that are established or maintained to satisfy the
requirements of this subpart and that meet the definition of electronic
records in Sec. 11.3(b)(6) of this chapter are exempt from the
requirements of part 11 of this chapter. Records that satisfy the
requirements of this subpart, but that also are required under other
applicable statutory provisions or regulations, remain subject to part
11 of this chapter.
(i) Except for the written procedures required by
Sec. 1.908(e)(6)(i), offsite storage of records is permitted if such
records can be retrieved and provided onsite within 24 hours of request
for official review. The written procedures required by
Sec. 1.908(e)(6)(i) must remain onsite as long as the procedures are in
use in transportation operations. Electronic records are considered to
be onsite if they are accessible from an onsite location.
(j) All records required by this subpart are subject to the
disclosure requirements under part 20 of this chapter.
Waivers
Sec. 1.914 Under what circumstances will we waive a requirement of this subpart?
We will waive any requirement of this subpart with respect to any
class of persons, vehicles, food, or nonfood products, when we determine
that:
(a) The waiver will not result in the transportation of food under
conditions that would be unsafe for human or animal health; and
(b) The waiver will not be contrary to the public interest.
Sec. 1.916 When will we consider whether to waive a requirement of this subpart?
We will consider whether to waive a requirement of this subpart on
our own initiative or on the petition submitted under Sec. 10.30 of this
chapter by any person who is subject to the requirements of this subpart
with respect to any class of persons, vehicles, food, or nonfood
products.
Sec. 1.918 What must be included in the Statement of Grounds in a
petition requesting a waiver?
In addition to the requirements set forth in Sec. 10.30 of this
chapter, the Statement of Grounds in a petition requesting a waiver
must:
(a) Describe with particularity the waiver requested, including the
persons, vehicles, food, or nonfood product(s) to which the waiver would
apply and the requirement(s) of this subpart to which the waiver would
apply; and
(b) Present information demonstrating that the waiver will not
result in the transportation of food under conditions that would be
unsafe for human or animal health and will not be contrary to the public
interest.
Sec. 1.920 What information submitted in a petition requesting a waiver or
submitted in comments on such a petition is publicly available?
We will presume that information submitted in a petition requesting
a waiver and comments submitted on such a petition does not contain
information exempt from public disclosure under part 20 of this chapter
and would be made public as part of the docket associated with this
request.
Sec. 1.922 Who will respond to a petition requesting a waiver?
The Director or Deputy Directors of the Center for Food Safety and
Applied Nutrition (CFSAN) or the Center for Veterinary Medicine (CVM),
or the Director, Office of Compliance, CFSAN, or the Director, Office of
Surveillance and Compliance, CVM, will respond to a petition requesting
a waiver.
Sec. 1.924 What process applies to a petition requesting a waiver?
(a) In general, the procedures set forth in Sec. 10.30 of this
chapter govern our response to a petition requesting a waiver.
(b) Under Sec. 10.30(h)(3) of this chapter, we will publish a notice
in the Federal Register, requesting information and views on a filed
petition, including information and views from persons who could be
affected by the waiver if the petition were to be granted.
[[Page 119]]
(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 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
[[Page 120]]
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 District Director in whose district 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 District 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 location and telephone number of the FDA district office
and the name of the FDA District Director.
(e) Approval of detention order. A detention order, before issuance,
must be approved by the FDA District Director in whose district 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.
(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)).
[[Page 121]]
(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 District Director in whose
district 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 District 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, i.e., Office of Regulatory
Affairs Program Directors or other FDA officials senior to an FDA
District Director, 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 District 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.
(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.
[[Page 122]]
(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 this purpose, the individual responsible for
their movement must orally notify the FDA representative who issued the
detention order, or another responsible district 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 district 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 district 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 district 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 district 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 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
[[Page 123]]
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]
PART 2_GENERAL ADMINISTRATIVE RULINGS AND DECISIONS--Table of Contents
Subpart A_General Provisions
Sec.
2.5 Imminent hazard to the public health.
2.10 Examination and investigation samples.
2.19 Methods of analysis.
Subpart B_Human and Animal Foods
2.25 Grain seed treated with poisonous substances; color identification
to prevent adulteration of human and animal food.
2.35 Use of secondhand containers for the shipment or storage of food
and animal feed.
Subparts C-E [Reserved]
Subpart F_Caustic Poisons
2.110 Definition of ammonia under Federal Caustic Poison Act.
Subpart G_Provisions Applicable to Specific Products Subject to the
Federal Food, Drug, and Cosmetic Act
2.125 Use of ozone-depleting substances in foods, drugs, devices, or
cosmetics.
Authority: 15 U.S.C. 402, 409; 21 U.S.C. 321, 331, 335, 342, 343,
346a, 348, 351, 352, 355, 360b, 361, 362, 371, 372, 374; 42 U.S.C. 7671
et seq.
Source: 42 FR 15559, Mar. 22, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec. 2.5 Imminent hazard to the public health.
(a) Within the meaning of the Federal Food, Drug, and Cosmetic Act
an imminent hazard to the public health is considered to exist when the
evidence is sufficient to show that a product or practice, posing a
significant threat of danger to health, creates a public health
situation (1) that should be corrected immediately to prevent injury and
(2) that should not be permitted to continue while a hearing or other
formal proceeding is being held. The imminent hazard may be declared at
any point in the chain of events which may ultimately result in harm to
the public health. The occurrence of the final anticipated injury is not
essential to establish that an imminent hazard of such occurrence
exists.
(b) In exercising his judgment on whether an imminent hazard exists,
the Commissioner will consider the number of injuries anticipated and
the nature, severity, and duration of the anticipated injury.
Sec. 2.10 Examination and investigation samples.
(a)(1) When any officer or employee of the Department collects a
sample of a food, drug, or cosmetic for analysis under the act, the
sample shall be designated as an official sample if records or other
evidence is obtained by him or any other officer or employee of the
Department indicating that the shipment or other lot of the article from
which such sample was collected was
[[Page 124]]
introduced or delivered for introduction into interstate commerce, or
was in or was received in interstate commerce, or was manufactured
within a Territory. Only samples so designated by an officer or employee
of the Department shall be considered to be official samples.
(2) For the purpose of determining whether or not a sample is
collected for analysis, the term analysis includes examinations and
tests.
(3) The owner of a food, drug, or cosmetic of which an official
sample is collected is the person who owns the shipment or other lot of
the article from which the sample is collected.
(b) When an officer or employee of the Department collects an
official sample of a food, drug, or cosmetic for analysis under the act,
he shall collect at least twice the quantity estimated by him to be
sufficient for analysis, unless:
(1) The amount of the article available and reasonably accessible
for sampling is less than twice the quantity so estimated, in which case
he shall collect as much as is available and reasonably accessible.
(2) The cost of twice the quantity so estimated exceeds $150.
(3) The sample cannot by diligent use of practicable preservation
techniques available to the Food and Drug Administration be kept in a
state in which it could be readily and meaningfully analyzed in the same
manner and for the same purposes as the Food and Drug Administration's
analysis.
(4) The sample is collected from a shipment or other lot which is
being imported or offered for import into the United States.
(5) The sample is collected from a person named on the label of the
article or his agent, and such person is also the owner of the article.
(6) The sample is collected from the owner of the article, or his
agent, and such article bears no label or, if it bears a label, no
person is named thereon.
In addition to the quantity of sample set forth in this paragraph, the
officer or employee shall, if practicable, collect such further amount
as he estimates will be sufficient for use as trial exhibits.
(c) After the Food and Drug Administration has completed such
analysis of an official sample of a food, drug, or cosmetic as it
determines, in the course of analysis and interpretation of analytical
results, to be adequate to establish the respects, if any, in which the
article is adulterated or misbranded within the meaning of the act, or
otherwise subject to the prohibitions of the act, and has reserved an
amount of the article it estimates to be adequate for use as exhibits in
the trial of any case that may arise under the act based on the sample,
a part of the sample, if any remains available, shall be provided for
analysis, upon written request, by any person named on the label of the
article, or the owner thereof, or the attorney or agent of such person
or owner, except when:
(1) After collection, the sample or remaining part thereof has
become decomposed or otherwise unfit for analysis, or
(2) The request is not made within a reasonable time before the
trial of any case under the act, based on the sample to which such
person or owner is a party. The person, owner, attorney, or agent who
requests the part of sample shall specify the amount desired. A request
from an owner shall be accompanied by a showing of ownership, and a
request from an attorney or agent by a showing of authority from such
person or owner to receive the part of sample. When two or more requests
for parts of the same sample are received the requests shall be complied
with in the order in which they were received so long as any part of the
sample remains available therefor.
(d) When an official sample of food, drug, or cosmetic is the basis
of a notice given under section 305 of the act, or of a case under the
act, and the person to whom the notice was given, or any person who is a
party to the case, has no right under paragraph (c) of this section to a
part of the sample, such person or his attorney or agent may obtain a
part of the sample upon request accompanied by a written waiver of right
under such paragraph (c) from each person named on the label of the
article and owner thereof, who has not
[[Page 125]]
exercised his right under such paragraph (c). The operation of this
paragraph shall be subject to the exceptions, terms, and conditions
prescribed in paragraph (c) of this section.
(e) The Food and Drug Administration is authorized to destroy:
(1) Any official sample when it determines that no analysis of such
sample will be made;
(2) Any official sample or part thereof when it determines that no
notice under section 305 of the act, and no case under the act, is or
will be based on such sample;
(3) Any official sample or part thereof when the sample was the
basis of a notice under section 305 of the act, and when, after
opportunity for presentation of views following such notice, it
determines that no other such notice, and no case under the act, is or
will be based on such sample;
(4) Any official sample or part thereof when the sample was the
basis of a case under the act which has gone to final judgment, and when
it determines that no other such case is or will be based on such
sample;
(5) Any official sample or part thereof if the article is
perishable;
(6) Any official sample or part thereof when, after collection, such
sample or part has become decomposed or otherwise unfit for analysis;
(7) That part of any official sample which is in excess of three
times the quantity it estimates to be sufficient for analysis.
[42 FR 15559, Mar. 22, 1977, as amended at 63 FR 51299, Sept. 25, 1998]
Sec. 2.19 Methods of analysis.
Where the method of analysis is not prescribed in a regulation, it
is the policy of the Food and Drug Administration in its enforcement
programs to utilize the methods of analysis of the AOAC INTERNATIONAL
(AOAC) as published in the latest edition (13th Ed., 1980) of their
publication ``Official Methods of Analysis of the Association of
Official Analytical Chemists,'' and the supplements thereto (``Changes
in Methods'' as published in the March issues of the ``Journal of the
Association of Official Analytical Chemists''), which are incorporated
by reference, when available and applicable. Copies are available from
the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877, 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. In the
absence of an AOAC method, the Commissioner will furnish a copy of the
particular method, or a reference to the published method, that the Food
and Drug Administration will use in its enforcement program. Other
methods may be used for quality control, specifications, contracts,
surveys, and similar nonregulatory functions, but it is expected that
they will be calibrated in terms of the method which the Food and Drug
Administration uses in its enforcement program. Use of an AOAC method
does not relieve the practioner of the responsibility to demonstrate
that he can perform the method properly through the use of positive and
negative controls and recovery and reproducibility studies.
[42 FR 15559, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 54
FR 9034, Mar. 3, 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8,
2005]
Subpart B_Human and Animal Foods
Sec. 2.25 Grain seed treated with poisonous substances; color identification
to prevent adulteration of human and animal food.
(a) In recent years there has developed increasing use of poisonous
treatments on seed for fungicidal and other purposes. Such treated seed,
if consumed, presents a hazard to humans and livestock. It is not
unusual for stocks of such treated food seeds to remain on hand after
the planting season has passed. Despite the cautions required by the
Federal Seed Act (53 Stat. 1275, as amended 72 Stat. 476, 7 U.S.C. 1551
et seq.) in the labeling of the treated seed, the Food and Drug
Administration has encountered many cases where such surplus stocks of
treated wheat, corn, oats, rye, barley, and sorghum seed had been mixed
with untreated seed and sent to market for
[[Page 126]]
food or feed use. This has resulted in livestock injury and in legal
actions under the Federal Food, Drug, and Cosmetic Act against large
quantities of food adulterated through such admixture of poisonous
treated seeds with good food. Criminal cases were brought against some
firms and individuals. Where the treated seeds are prominently colored,
buyers and users or processors of agricultural food seed for food
purposes are able to detect the admixture of the poisonous seed and thus
reject the lots; but most such buyers, users, and processors do not have
the facilities or scientific equipment to determine the presence of the
poisonous chemical at the time crops are delivered, in cases where the
treated seeds have not been so colored. A suitable color for this use is
one that is in sufficient contrast to the natural color of the food seed
as to make admixture of treated, denatured seeds with good food easily
apparent, and is so applied that it is not readily removed.
(b) On and after December 31, 1964, the Food and Drug Administration
will regard as adulterated any interstate shipment of the food seeds
wheat, corn, oats, rye, barley, and sorghum bearing a poisonous
treatment in excess of a recognized tolerance or treatment for which no
tolerance or exemption from tolerance is recognized in regulations
promulgated pursuant to section 408 of the Federal Food, Drug, and
Cosmetic Act, unless such seeds have been adequately denatured by a
suitable color to prevent their subsequent inadvertent use as food for
man or feed for animals.
(c) Attention is called to the labeling requirements of the Federal
Hazardous Substances Act, where applicable to denatured seeds in
packages suitable for household use.
Sec. 2.35 Use of secondhand containers for the shipment or storage
of food and animal feed.
(a) Investigations by the Food and Drug Administration, the National
Communicable Disease Center of the U.S. Public Health Service, the
Consumer and Marketing Service of the U.S. Department of Agriculture,
and by various State public health agencies have revealed practices
whereby food and animal feed stored or shipped in secondhand containers
have been rendered dangerous to health. Such contamination has been the
result of the original use of these containers for the storage and
shipment of articles containing or bearing disease organisms or
poisonous or deleterious substances.
(b) The Commissioner concludes that such dangerous or potentially
dangerous practices include, but are not limited to, the following:
(1) Some vegetable growers and packers employ used poultry crates
for shipment of fresh vegetables, including cabbage and celery.
Salmonella organisms are commonly present on dressed poultry and in
excreta and fluid exudates from dressed birds. Thus wooden crates in
which dressed poultry has been iced and packed are potential sources of
Salmonella or other enteropathogenic microorganisms that may contaminate
fresh vegetables which are frequently consumed without heat treatment.
(2) Some potato growers and producers of animal feeds use secondhand
bags for shipment of these articles. Such bags may have originally been
used for shipping or storing pesticide-treated seed or other articles
bearing or containing poisonous substances. Thus these secondhand bags
are potential sources of contamination of the food or animal feed stored
or shipped therein.
(c) In a policy statement issued April 11, 1968, the Food and Drug
Administration declared adulterated within the meaning of section 402(a)
of the Federal Food, Drug, and Cosmetic Act shipments of vegetables or
other edible food in used crates or containers that may render the
contents injurious to health. This policy statement is extended so that
the Food and Drug Administration will regard as adulterated within the
meaning of section 402(a) of the act shipments of vegetables, other
edible food, or animal feed in used crates, bags, or other containers
that may render the contents injurious to health.
Subparts C-E [Reserved]
[[Page 127]]
Subpart F_Caustic Poisons
Sec. 2.110 Definition of ammonia under Federal Caustic Poison Act.
For the purpose of determining whether an article containing ammonia
is subject to the Federal Caustic Poison Act, the ammonia content is to
be calculated as NH3.
Subpart G_Provisions Applicable to Specific Products Subject to the
Federal Food, Drug, and Cosmetic Act
Sec. 2.125 Use of ozone-depleting substances in foods, drugs, devices,
or cosmetics.
(a) As used in this section, ozone-depleting substance (ODS) means
any class I substance as defined in 40 CFR part 82, appendix A to
subpart A, or class II substance as defined in 40 CFR part 82, appendix
B to subpart A.
(b) Except as provided in paragraph (c) of this section, any food,
drug, device, or cosmetic that is, consists in part of, or is contained
in an aerosol product or other pressurized dispenser that releases an
ODS is not an essential use of the ODS under the Clean Air Act.
(c) A food, drug, device, or cosmetic that is, consists in part of,
or is contained in an aerosol product or other pressurized dispenser
that releases an ODS is an essential use of the ODS under the Clean Air
Act if paragraph (e) of this section specifies the use of that product
as essential. For drugs, including biologics and animal drugs, and for
devices, an investigational application or an approved marketing
application must be in effect, as applicable.
(d) [Reserved]
(e) The use of ODSs in the following products is essential:
(1) Metered-dose corticosteroid human drugs for oral inhalation.
Oral pressurized metered-dose inhalers containing the following active
moieties:
(i)-(v) [Reserved]
(2) Metered-dose short-acting adrenergic bronchodilator human drugs
for oral inhalation. Oral pressurized metered-dose inhalers containing
the following active moieties:
(i)-(v) [Reserved]
(3) [Reserved]
(4) Other essential uses. (i)-(ii) [Reserved]
(iii) Anesthetic drugs for topical use on accessible mucous
membranes of humans where a cannula is used for application.
(iv)- (ix) [Reserved]
(f) Any person may file a petition under part 10 of this chapter to
request that FDA initiate rulemaking to amend paragraph (e) of this
section to add an essential use. FDA may initiate notice-and-comment
rulemaking to add an essential use on its own initiative or in response
to a petition, if granted.
(1) If the petition is to add use of a noninvestigational product,
the petitioner must submit compelling evidence that:
(i) Substantial technical barriers exist to formulating the product
without ODSs;
(ii) The product will provide an unavailable important public health
benefit; and
(iii) Use of the product does not release cumulatively significant
amounts of ODSs into the atmosphere or the release is warranted in view
of the unavailable important public health benefit.
(2) If the petition is to add use of an investigational product, the
petitioner must submit compelling evidence that:
(i) Substantial technical barriers exist to formulating the
investigational product without ODSs;
(ii) A high probability exists that the investigational product will
provide an unavailable important public health benefit; and
(iii) Use of the investigational product does not release
cumulatively significant amounts of ODSs into the atmosphere or the
release is warranted in view of the high probability of an unavailable
important public health benefit.
(g) Any person may file a petition under part 10 of this chapter to
request that FDA initiate rulemaking to amend paragraph (e) of this
section to remove an essential use. FDA may initiate notice-and-comment
rulemaking to remove an essential use on its own initiative or in
response to a petition, if granted. If the petition is to remove
[[Page 128]]
an essential use from paragraph (e) of this section, the petitioner must
submit compelling evidence of any one of the following criteria:
(1) The product using an ODS is no longer being marketed; or
(2) After January 1, 2005, FDA determines that the product using an
ODS no longer meets the criteria in paragraph (f) of this section after
consultation with a relevant advisory committee(s) and after an open
public meeting; or
(3) For individual active moieties marketed as ODS products and
represented by one new drug application (NDA):
(i) At least one non-ODS product with the same active moiety is
marketed with the same route of administration, for the same indication,
and with approximately the same level of convenience of use as the ODS
product containing that active moiety;
(ii) Supplies and production capacity for the non-ODS product(s)
exist or will exist at levels sufficient to meet patient need;
(iii) Adequate U.S. postmarketing use data is available for the non-
ODS product(s); and
(iv) Patients who medically required the ODS product are adequately
served by the non-ODS product(s) containing that active moiety and other
available products; or
(4) For individual active moieties marketed as ODS products and
represented by two or more NDAs:
(i) At least two non-ODS products that contain the same active
moiety are being marketed with the same route of delivery, for the same
indication, and with approximately the same level of convenience of use
as the ODS products; and
(ii) The requirements of paragraphs (g)(3)(ii), (g)(3)(iii), and
(g)(3)(iv) of this section are met.
[67 FR 48384, July 24, 2002, as amended at 71 FR 70873, Dec. 7, 2006; 70
FR 17192, Apr. 4, 2005; 75 FR 19241, Apr. 14, 2010; 73 FR 69552, Nov.
19, 2008; 75 FR 19241, Apr. 14, 2010; 81 FR 74302, Oct. 26, 2016]
PART 3_PRODUCT JURISDICTION--Table of Contents
Subpart A_Assignment of Agency Component for Review of Premarket
Applications
Sec.
3.1 Purpose.
3.2 Definitions.
3.3 Scope.
3.4 Designated agency component.
3.5 Procedures for identifying the designated agency component.
3.6 Product jurisdiction officer.
3.7 Request for designation.
3.8 Letter of designation.
3.9 Effect of letter of designation.
3.10 Stay of review time.
Subpart B [Reserved]
Authority: 21 U.S.C. 321, 351, 353, 355, 360, 360c-360f, 360h-360j,
360gg-360ss, 360bbb-2, 371(a), 379e, 381, 394; 42 U.S.C. 216, 262, 264.
Source: 56 FR 58756, Nov. 21, 1991, unless otherwise noted.
Subpart A_Assignment of Agency Component for Review of Premarket
Applications
Sec. 3.1 Purpose.
This regulation relates to agency management and organization and
has two purposes. The first is to implement section 503(g) of the act,
as added by section 16 of the Safe Medical Devices Act of 1990 (Public
Law 101-629) and amended by section 204 of the Medical Device User Fee
and Modernization Act of 2002 (Public Law 107-250), by specifying how
FDA will determine the organizational component within FDA designated to
have primary jurisdiction for the premarket review and regulation of
products that are comprised of any combination of a drug and a device; a
device and a biological; a biological and a drug; or a drug, a device
and a biological. This determination will eliminate, in most cases, the
need to receive approvals from more than one FDA component for such
combination products. The second purpose of this regulation is to
enhance the efficiency of agency management and operations by providing
procedures for determining which agency component will have primary
jurisdiction for any drug, device, or biological product
[[Page 129]]
where such jurisdiction is unclear or in dispute. Nothing in this
section prevents FDA from using any agency resources it deems necessary
to ensure adequate review of the safety and effectiveness of any
product, or the substantial equivalence of any device to a predicate
device.
[56 FR 58756, Nov. 21, 1991, as amended at 68 FR 37077, June 23, 2003]
Sec. 3.2 Definitions.
For the purpose of this part:
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) Agency component means the Center for Biologics Evaluation and
Research, the Center for Devices and Radiological Health, the Center for
Drug Evaluation and Research, or alternative organizational component of
the agency.
(c) Applicant means any person who submits or plans to submit an
application to the Food and Drug Administration for premarket review.
For purposes of this section, the terms ``sponsor'' and ``applicant''
have the same meaning.
(d) Biological product has the meaning given the term in section
351(a) of the Public Health Service Act (42 U.S.C. 262(a)).
(e) Combination product includes:
(1) A product comprised of two or more regulated components, i.e.,
drug/device, biologic/device, drug/biologic, or drug/device/biologic,
that are physically, chemically, or otherwise combined or mixed and
produced as a single entity;
(2) Two or more separate products packaged together in a single
package or as a unit and comprised of drug and device products, device
and biological products, or biological and drug products;
(3) A drug, device, or biological product packaged separately that
according to its investigational plan or proposed labeling is intended
for use only with an approved individually specified drug, device, or
biological product where both are required to achieve the intended use,
indication, or effect and where upon approval of the proposed product
the labeling of the approved product would need to be changed, e.g., to
reflect a change in intended use, dosage form, strength, route of
administration, or significant change in dose; or
(4) Any investigational drug, device, or biological product packaged
separately that according to its proposed labeling is for use only with
another individually specified investigational drug, device, or
biological product where both are required to achieve the intended use,
indication, or effect.
(f) Device has the meaning given the term in section 201(h) of the
act.
(g) Drug has the meaning given the term in section 201(g)(1) of the
act.
(h) FDA means Food and Drug Administration.
(i) Letter of designation means the written notice issued by the
product jurisdiction officer specifying the agency component with
primary jurisdiction for a combination product.
(j) Letter of request means an applicant's written submission to the
product jurisdiction officer seeking the designation of the agency
component with primary jurisdiction.
(k) Mode of action is the means by which a product achieves an
intended therapeutic effect or action. For purposes of this definition,
``therapeutic'' action or effect includes any effect or action of the
combination product intended to diagnose, cure, mitigate, treat, or
prevent disease, or affect the structure or any function of the body.
When making assignments of combination products under this part, the
agency will consider three types of mode of action: The actions provided
by a biological product, a device, and a drug. Because combination
products are comprised of more than one type of regulated article
(biological product, device, or drug), and each constituent part
contributes a biological product, device, or drug mode of action,
combination products will typically have more than one identifiable mode
of action.
(1) A constituent part has a biological product mode of action if it
acts by means of a virus, therapeutic serum, toxin, antitoxin, vaccine,
blood, blood component or derivative, allergenic product, or analogous
product applicable to the prevention, treatment, or cure of a disease or
condition of human
[[Page 130]]
beings, as described in section 351(i) of the Public Health Service Act.
(2) A constituent part has a device mode of action if it meets the
definition of device contained in section 201(h)(1) to (h)(3) of the
act, it does not have a biological product mode of action, and it does
not achieve its primary intended purposes through chemical action within
or on the body of man or other animals and is not dependent upon being
metabolized for the achievement of its primary intended purposes.
(3) A constituent part has a drug mode of action if it meets the
definition of drug contained in section 201(g)(1) of the act and it does
not have a biological product or device mode of action.
(l) Premarket review includes the examination of data and
information in an application for premarket review described in sections
505, 510(k), 513(f), 515, or 520(g) or 520(l) of the act or section 351
of the Public Health Service Act of data and information contained in
any investigational new drug (IND) application, investigational device
exemption (IDE), new drug application (NDA), biologics license
application, device premarket notification, device reclassification
petition, and premarket approval application (PMA).
(m) Primary mode of action is the single mode of action of a
combination product that provides the most important therapeutic action
of the combination product. The most important therapeutic action is the
mode of action expected to make the greatest contribution to the overall
intended therapeutic effects of the combination product.
(n) Product means any article that contains any drug as defined in
section 201(g)(1) of the act; any device as defined in section 201(h) of
the act; or any biologic as defined in section 351(a) of the Public
Health Service Act (42 U.S.C. 262(a)).
(o) Product jurisdiction officer is the person or persons
responsible for designating the component of FDA with primary
jurisdiction for the premarket review and regulation of a combination
product or any product requiring a jurisdictional designation under this
part.
(p) Sponsor means ``applicant'' (see Sec. 3.2(c)).
[56 FR 58756, Nov. 21, 1991, as amended at 64 FR 398, Jan. 5, 1999; 64
FR 56447, Oct. 20, 1999; 68 FR 37077, June 23, 2003; 70 FR 49861, Aug.
25, 2005]
Sec. 3.3 Scope.
This section applies to:
(a) Any combination product, or
(b) Any product where the agency component with primary jurisdiction
is unclear or in dispute.
Sec. 3.4 Designated agency component.
(a) To designate the agency component with primary jurisdiction for
the premarket review and regulation of a combination product, the agency
shall determine the primary mode of action of the product. Where the
primary mode of action is that of:
(1) A drug (other than a biological product), the agency component
charged with premarket review of drugs shall have primary jurisdiction;
(2) A device, the agency component charged with premarket review of
devices shall have primary jurisdiction;
(3) A biological product, the agency component charged with
premarket review of biological products shall have primary jurisdiction.
(b) In some situations, it is not possible to determine, with
reasonable certainty, which one mode of action will provide a greater
contribution than any other mode of action to the overall therapeutic
effects of the combination product. In such a case, the agency will
assign the combination product to the agency component that regulates
other combination products that present similar questions of safety and
effectiveness with regard to the combination product as a whole. When
there are no other combination products that present similar questions
of safety and effectiveness with regard to the combination product as a
whole, the agency will assign the combination product to the agency
component with the most expertise related to the most significant safety
and effectiveness questions presented by the combination product.
[[Page 131]]
(c) The designation of one agency component as having primary
jurisdiction for the premarket review and regulation of a combination
product does not preclude consultations by that component with other
agency components or, in appropriate cases, the requirement by FDA of
separate applications.
[56 FR 58756, Nov. 21, 1991, as amended at 70 FR 49861, Aug. 25, 2005]
Sec. 3.5 Procedures for identifying the designated agency component.
(a)(1) The Center for Biologics Evaluation and Research, the Center
for Devices and Radiological Health, and the Center for Drug Evaluation
and Research have entered into agreements clarifying product
jurisdictional issues. These guidance documents are on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and are entitled
``Intercenter Agreement Between the Center for Drug Evaluation and
Research and the Center for Devices and Radiological Health;''
``Intercenter Agreement Between the Center for Devices and Radiological
Health and the Center for Biologics Evaluation and Research;''
``Intercenter Agreement Between the Center for Drug Evaluation and
Research and the Center for Biologics Evaluation and Research.'' The
availability of any amendments to these intercenter agreements will be
announced by Federal Register notice.
(2) These guidance documents describe the allocation of
responsibility for categories of products or specific products. These
intercenter agreements, and any amendments thereto, are nonbinding
determinations designed to provide useful guidance to the public.
(3) The sponsor of a premarket application or required
investigational filing for a combination or other product covered by
these guidance documents may contact the designated agency component
identified in the intercenter agreement before submitting an application
of premarket review or to confirm coverage and to discuss the
application process.
(b) For a combination product not covered by a guidance document or
for a product where the agency component with primary jurisdiction is
unclear or in dispute, the sponsor of an application for premarket
review should follow the procedures set forth in Sec. 3.7 to request a
designation of the agency component with primary jurisdiction before
submitting the application.
[56 FR 58756, Nov. 21, 1991, as amended at 68 FR 24879, May 9, 2003]
Sec. 3.6 Product jurisdiction officer.
The Office of Combination Products (Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD 20993-
0002, 301-796-8930,, e-mail: [email protected], is the designated
product jurisdiction officer.
[68 FR 37077, June 23, 2003, as amended at 71 FR 16033, Mar. 30, 2006;
75 FR 13678, Mar. 23, 2010]
Sec. 3.7 Request for designation.
(a) Who should file: the sponsor of:
(1) Any combination product the sponsor believes is not covered by
an intercenter agreement; or
(2) Any product where the agency component with primary jurisdiction
is unclear or in dispute.
(b) When to file: a sponsor should file a request for designation
before filing any application for premarket review, whether an
application for marketing approval or a required investigational notice.
Sponsors are encouraged to file a request for designation as soon as
there is sufficient information for the agency to make a determination.
(c) What to file: an original and two copies of the request for
designation must be filed. The request for designation must not exceed
15 pages, including attachments, and must set forth:
(1) The identity of the sponsor, including company name and address,
establishment registration number, company contact person and telephone
number.
(2) A description of the product, including:
(i) Classification, name of the product and all component products,
if applicable;
[[Page 132]]
(ii) Common, generic, or usual name of the product and all component
products;
(iii) Proprietary name of the product;
(iv) Identification of any component of the product that already has
received premarket approval, is marketed as not being subject to
premarket approval, or has received an investigational exemption, the
identity of the sponsors, and the status of any discussions or
agreements between the sponsors regarding the use of this product as a
component of a new combination product.
(v) Chemical, physical, or biological composition;
(vi) Status and brief reports of the results of developmental work,
including animal testing;
(vii) Description of the manufacturing processes, including the
sources of all components;
(viii) Proposed use or indications;
(ix) Description of all known modes of action, the sponsor's
identification of the single mode of action that provides the most
important therapeutic action of the product, and the basis for that
determination.
(x) Schedule and duration of use;
(xi) Dose and route of administration of drug or biologic;
(xii) Description of related products, including the regulatory
status of those related products; and
(xiii) Any other relevant information.
(3) The sponsor's recommendation as to which agency component should
have primary jurisdiction based on the mode of action that provides the
most important therapeutic action of the combination product. If the
sponsor cannot determine with reasonable certainty which mode of action
provides the most important therapeutic action of the combination
product, the sponsor's recommendation must be based on the assignment
algorithm set forth in Sec. 3.4(b) and an assessment of the assignment
of other combination products the sponsor wishes FDA to consider during
the assignment of its combination product.
(d) Where to file: all communications pursuant to this subpart shall
be addressed to the attention of the product jurisdiction officer. Such
a request, in its mailing cover should be plainly marked ``Request for
Designation.'' Concurrent submissions of electronic copies of Requests
for Designation may be addressed to [email protected].
[56 FR 58756, Nov. 21, 1991, as amended at 68 FR 37077, June 23, 2003;
70 FR 49861, Aug. 25, 2005]
Sec. 3.8 Letter of designation.
(a) Each request for designation will be reviewed for completeness
within 5 working days of receipt. Any request for designation determined
to be incomplete will be returned to the applicant with a request for
the missing information. The sponsor of an accepted request for
designation will be notified of the filing date.
(b) Within 60 days of the filing date of a request for designation,
the product jurisdiction officer will issue a letter of designation to
the sponsor, with copies to the centers, specifying the agency component
designated to have primary jurisdiction for the premarket review and
regulation of the product at issue, and any consulting agency
components. The product jurisdiction officer may request a meeting with
the sponsor during the review period to discuss the request for
designation. If the product jurisdiction officer has not issued a letter
of designation within 60 days of the filing date of a request for
designation, the sponsor's recommendation of the center with primary
jurisdiction, in accordance with Sec. 3.7(c)(3), shall become the
designated agency component.
(c) Request for reconsideration by sponsor: If the sponsor disagrees
with the designation, it may request the product jurisdiction officer to
reconsider the decision by filing, within 15 days of receipt of the
letter of designation, a written request for reconsideration not
exceeding 5 pages. No new information may be included in a request for
reconsideration. The product jurisdiction officer shall review and act
on the request in writing within 15 days of its receipt.
Sec. 3.9 Effect of letter of designation.
(a) The letter of designation constitutes an agency determination
that is subject to change only as provided in paragraph (b) of this
section.
[[Page 133]]
(b) The product jurisdiction officer may change the designated
agency component with the written consent of the sponsor, or without its
consent to protect the public health or for other compelling reasons. A
sponsor shall be given 30 days written notice of any proposed
nonconsensual change in designated agency component. The sponsor may
request an additional 30 days to submit written objections, not to
exceed 15 pages, to the proposed change, and shall be granted, upon
request, a timely meeting with the product jurisdiction officer and
appropriate center officials. Within 30 days of receipt of the sponsor's
written objections, the product jurisdiction officer shall issue to the
sponsor, with copies to appropriate center officials, a written
determination setting forth a statement of reasons for the proposed
change in designated agency component. A nonconsensual change in the
designated agency component requires the concurrence of the Principal
Associate Commissioner.
[56 FR 58756, Nov. 21, 1991, as amended at 68 FR 37077, June 23, 2003]
Sec. 3.10 Stay of review time.
Any filing with or review by the product jurisdiction officer stays
the review clock or other established time periods for agency action for
an application for marketing approval or required investigational notice
during the pendency of the review by the product jurisdiction officer.
Subpart B [Reserved]
PART 4_REGULATION OF COMBINATION PRODUCTS--Table of Contents
Subpart A_Current Good Manufacturing Practice Requirements for
Combination Products
Sec.
4.1 What is the scope of this subpart?
4.2 How does FDA define key terms and phrases in this subpart?
4.3 What current good manufacturing practice requirements apply to my
combination product?
4.4 How can I comply with these current good manufacturing practice
requirements for a co-packaged or single-entity combination
product?
Subpart B_Postmarketing Safety Reporting for Combination Products
4.100 What is the scope of this subpart?
4.101 How does FDA define key terms and phrases in this subpart?
4.102 What reports must you submit to FDA for your combination product
or constituent part?
4.103 What information must you share with other constituent part
applicants for the combination product?
4.104 How and where must you submit postmarketing safety reports for
your combination product or constituent part?
4.105 What are the postmarketing safety reporting recordkeeping
requirements for your combination product or constituent part?
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360b-360f,
360h-360j, 360l, 360hh-360ss, 360aaa-360bbb, 371(a), 372-374, 379e, 381,
383, 394; 42 U.S.C. 216, 262, 263a, 264, 271.
Source: 78 FR 4321, Jan. 22, 2013, unless otherwise noted.
Subpart A_Current Good Manufacturing Practice Requirements for
Combination Products
Sec. 4.1 What is the scope of this subpart?
This subpart applies to combination products. It establishes which
current good manufacturing practice requirements apply to these
products. This subpart clarifies the application of current good
manufacturing practice regulations to combination products, and provides
a regulatory framework for designing and implementing the current good
manufacturing practice operating system at facilities that manufacture
co-packaged or single-entity combination products.
Sec. 4.2 How does FDA define key terms and phrases in this subpart?
The terms listed in this section have the following meanings for
purposes of this subpart:
Biological product has the meaning set forth in Sec. 3.2(d) of this
chapter. A biological product also meets the definitions of either a
drug or device as these terms are defined under this section.
Combination product has the meaning set forth in Sec. 3.2(e) of this
chapter.
Constituent part is a drug, device, or biological product that is
part of a combination product.
[[Page 134]]
Co-packaged combination product has the meaning set forth in
Sec. 3.2(e)(2) of this chapter.
Current good manufacturing practice operating system means the
operating system within an establishment that is designed and
implemented to address and meet the current good manufacturing practice
requirements for a combination product.
Current good manufacturing practice requirements means the
requirements set forth under Sec. 4.3(a) through (d).
Device has the meaning set forth in Sec. 3.2(f) of this chapter. A
device that is a constituent part of a combination product is considered
a finished device within the meaning of the QS regulation.
Drug has the meaning set forth in Sec. 3.2(g) of this chapter. A
drug that is a constituent part of a combination product is considered a
drug product within the meaning of the drug CGMPs.
Drug CGMPs refers to the current good manufacturing practice
regulations set forth in parts 210 and 211 of this chapter.
HCT/Ps refers to human cell, tissue, and cellular and tissue-based
products, as defined in Sec. 1271.3(d) of this chapter. An HCT/P that is
not solely regulated under section 361 of the Public Health Service Act
may be a constituent part of a combination product. Such an HCT/P is
subject to part 1271 of this chapter and is also regulated as a drug,
device, and/or biological product.
Manufacture includes, but is not limited to, designing, fabricating,
assembling, filling, processing, testing, labeling, packaging,
repackaging, holding, and storage.
QS regulation refers to the quality system regulation in part 820 of
this chapter.
Single-entity combination product has the meaning set forth in
Sec. 3.2(e)(1) of this chapter.
Type of constituent part refers to the category of the constituent
part, which can be either a biological product, a device, or a drug, as
these terms are defined under this section.
Sec. 4.3 What current good manufacturing practice requirements
apply to my combination product?
If you manufacture a combination product, the requirements listed in
this section apply as follows:
(a) The current good manufacturing practice requirements in parts
210 and 211 of this chapter apply to a combination product that includes
a drug constituent part;
(b) The current good manufacturing practice requirements in part 820
of this chapter apply to a combination product that includes a device
constituent part;
(c) The current good manufacturing practice requirements among the
requirements (including standards) for biological products in parts 600
through 680 of this chapter apply to a combination product that includes
a biological product constituent part to which those requirements would
apply if that constituent part were not part of a combination product;
and
(d) The current good tissue practice requirements including donor
eligibility requirements for HCT/Ps in part 1271 of this chapter apply
to a combination product that includes an HCT/P.
Sec. 4.4 How can I comply with these current good manufacturing practice
requirements for a co-packaged or single-entity combination product?
(a) Under this subpart, for single entity or co-packaged combination
products, compliance with all applicable current good manufacturing
practice requirements for the combination product shall be achieved
through the design and implementation of a current good manufacturing
practice operating system that is demonstrated to comply with:
(1) The specifics of each set of current good manufacturing practice
regulations listed under Sec. 4.3 as they apply to each constituent part
included in the combination product; or
(2) Paragraph (b) of this section.
(b) If you elect to establish a current good manufacturing practice
operating system in accordance with paragraph (b) of this section, the
following requirements apply:
(1) If the combination product includes a device constituent part
and a
[[Page 135]]
drug constituent part, and the current good manufacturing practice
operating system has been shown to comply with the drug CGMPs, the
following provisions of the QS regulation must also be shown to have
been satisfied; upon demonstration that these requirements have been
satisfied, no additional showing of compliance with respect to the QS
regulation need be made:
(i) Section 820.20 of this chapter. Management responsibility.
(ii) Section 820.30 of this chapter. Design controls.
(iii) Section 820.50 of this chapter. Purchasing controls.
(iv) Section 820.100 of this chapter. Corrective and preventive
action.
(v) Section 820.170 of this chapter. Installation.
(vi) Section 820.200 of this chapter. Servicing.
(2) If the combination product includes a device constituent part
and a drug constituent part, and the current good manufacturing practice
operating system has been shown to comply with the QS regulation, the
following provisions of the drug CGMPs must also be shown to have been
satisfied; upon demonstration that these requirements have been
satisfied, no additional showing of compliance with respect to the drug
CGMPs need be made:
(i) Section 211.84 of this chapter. Testing and approval or
rejection of components, drug product containers, and closures.
(ii) Section 211.103 of this chapter. Calculation of yield.
(iii) Section 211.132 of this chapter. Tamper-evident packaging
requirements for over-the-counter (OTC) human drug products.
(iv) Section 211.137 of this chapter. Expiration dating.
(v) Section 211.165 of this chapter. Testing and release for
distribution.
(vi) Section 211.166 of this chapter. Stability testing.
(vii) Section 211.167 of this chapter. Special testing requirements.
(viii) Section 211.170 of this chapter. Reserve samples.
(3) In addition to being shown to comply with the other applicable
manufacturing requirements listed under Sec. 4.3, if the combination
product includes a biological product constituent part, the current good
manufacturing practice operating system must also be shown to implement
and comply with all manufacturing requirements identified under
Sec. 4.3(c) that would apply to that biological product if that
constituent part were not part of a combination product.
(4) In addition to being shown to comply with the other applicable
current good manufacturing practice requirements listed under Sec. 4.3,
if the combination product includes an HCT/P, the current good
manufacturing practice operating system must also be shown to implement
and comply with all current good tissue practice requirements identified
under Sec. 4.3(d) that would apply to that HCT/P if it were not part of
a combination product.
(c) During any period in which the manufacture of a constituent part
to be included in a co-packaged or single entity combination product
occurs at a separate facility from the other constituent part(s) to be
included in that single-entity or co-packaged combination product, the
current good manufacturing practice operating system for that
constituent part at that facility must be demonstrated to comply with
all current good manufacturing practice requirements applicable to that
type of constituent part.
(d) When two or more types of constituent parts to be included in a
single-entity or co-packaged combination product have arrived at the
same facility, or the manufacture of these constituent parts is
proceeding at the same facility, application of a current good
manufacturing process operating system that complies with paragraph (b)
of this section may begin.
(e) The requirements set forth in this subpart and in parts 210,
211, 820, 600 through 680, and 1271 of this chapter listed in Sec. 4.3,
supplement, and do not supersede, each other unless the regulations
explicitly provide otherwise. In the event of a conflict between
regulations applicable under this subpart to combination products,
including their constituent parts, the regulations most specifically
applicable to the constituent part in question shall supersede the more
general.
[[Page 136]]
Subpart B_Postmarketing Safety Reporting for Combination Products
Source: 81 FR 92624, Dec. 20, 2016, unless otherwise noted.
Sec. 4.100 What is the scope of this subpart?
(a) This subpart identifies postmarketing safety reporting
requirements for combination product applicants and constituent part
applicants.
(b) This subpart does not apply to investigational combination
products, combination products that have not received marketing
authorization, or to persons other than combination product applicants
and constituent part applicants.
(c) This subpart supplements and does not supersede other provisions
of this chapter, including the provisions in parts 314, 600, 606, 803,
and 806 of this chapter, unless a regulation explicitly provides
otherwise.
Sec. 4.101 How does the FDA define key terms and phrases in this subpart?
Abbreviated new drug application (ANDA) has the same meaning given
the term ``abbreviated application'' in Sec. 314.3(b) of this chapter.
Agency or we means Food and Drug Administration.
Applicant means, for the purposes of this subpart, a person holding
an application under which a combination product or constituent part of
a combination product has received marketing authorization (such as
approval, licensure, or clearance). For the purposes of this subpart,
applicant is used interchangeably with the term ``you.''
Application means, for purposes of this subpart, a BLA, an NDA, an
ANDA, or a device application, including all amendments and supplements
to them.
Biological product has the meaning given the term in section 351 of
the Public Health Service Act (42 U.S.C. 262).
Biological product deviation report (BPDR) is a report as described
in Secs. 600.14 and 606.171 of this chapter.
Biologics license application (BLA) has the meaning given the term
in section 351 of the Public Health Service Act (42 U.S.C. 262) and
Sec. 601.2 of this chapter.
Combination product has the meaning given the term in Sec. 3.2(e) of
this chapter.
Combination product applicant means an applicant that holds the
application(s) for a combination product.
Constituent part has the meaning given the term in Sec. 4.2.
Constituent part applicant means the applicant for a constituent
part of a combination product the constituent parts of which are
marketed under applications held by different applicants.
Correction or removal report is a report as described in Sec. 806.10
of this chapter.
De novo classification request is a submission requesting de novo
classification under section 513(f)(2) of the Federal Food, Drug, and
Cosmetic Act.
Device has the meaning given the term in section 201(h) of the
Federal Food, Drug, and Cosmetic Act.
Device application means a PMA, PDP, premarket notification
submission, de novo classification request, or HDE.
Drug has the meaning given the term in section 201(g)(1) of the
Federal Food, Drug, and Cosmetic Act.
Field alert report is a report as described in Sec. 314.81 of this
chapter.
Fifteen-day report is a report required to be submitted within 15
days as described in Sec. 314.80 of this chapter or Sec. 600.80 of this
chapter, as well as followup reports to such a report.
Five-day report is a report as described in Secs. 803.3 and 803.53
of this chapter, as well as supplemental or followup reports to such a
report as described in Sec. 803.56 of this chapter.
Humanitarian device exemption (HDE) has the meaning given the term
in Sec. 814.3 of this chapter.
Malfunction report is a report as described in Sec. 803.50 of this
chapter as well as supplemental or followup reports to such a report as
described in Sec. 803.56 of this chapter.
New drug application (NDA) has the meaning given the term
``application'' in Sec. 314.3(b) of this chapter.
Premarket approval application (PMA) has the meaning given the term
in Sec. 814.3 of this chapter.
[[Page 137]]
Premarket notification submission is a submission as described in
Sec. 807.87 of this chapter.
Product Development Protocol (PDP) is a submission as set forth in
section 515(f) of the Federal Food, Drug, and Cosmetic Act.
Sec. 4.102 What reports must you submit to FDA for your combination
product or constituent part?
(a) In general. If you are a constituent part applicant, the
reporting requirements applicable to you that are identified in this
section apply to your constituent part, and if you are a combination
product applicant, the reporting requirements applicable to you that are
identified in this section apply to your combination product as a whole.
(b) Reporting requirements applicable to both combination product
applicants and constituent part applicants. If you are a combination
product applicant or constituent part applicant, you must comply with
the reporting requirements identified in paragraphs (b)(1), (b)(2), or
(b)(3) of this section for your product based on its application type.
If you are a combination product applicant, you are required to submit a
report as specified in this paragraph unless you have already submitted
a report in accordance with paragraph (c) of this section for the same
event that: Includes the information required under the applicable
regulations identified in this paragraph, is required to be submitted in
the same manner under Sec. 4.104, and meets the deadlines under the
applicable regulations identified in this paragraph.
(1) If your combination product or device constituent part received
marketing authorization under a device application, you must comply with
the requirements for postmarketing safety reporting described in parts
803 and 806 of this chapter with respect to your product.
(2) If your combination product or drug constituent part received
marketing authorization under an NDA or ANDA, you must comply with the
requirements for postmarketing safety reporting described in part 314 of
this chapter with respect to your product.
(3) If your combination product or biological product constituent
part received marketing authorization under a BLA, you must comply with
the requirements for postmarketing safety reporting described in parts
600 and 606 of this chapter with respect to your product.
(c) Reporting requirements applicable only to combination product
applicants. If you are a combination product applicant, in addition to
compliance with paragraph (a) of this section, you must also comply with
the reporting requirements identified under this paragraph as applicable
to your product based on its constituent parts. If you are a combination
product applicant, you are required to submit a report as specified in
this paragraph unless you have already submitted a report in accordance
with paragraph (b) of this section for the same event that: Includes the
information required under the applicable regulations for the report
identified in this paragraph; is required to be submitted in the same
manner under Sec. 4.104 of this chapter; and, unless otherwise specified
in this paragraph, meets the deadlines under the applicable regulations
for the report identified in this paragraph.
(1) If your combination product contains a device constituent part,
you must submit:
(i) Five-day reports;
(ii) Malfunction reports; and
(iii) Correction or removal reports, and maintain records as
described in Sec. 806.20 of this chapter for corrections and removals
not required to be reported.
(2) If your combination product contains a drug constituent part,
you must submit:
(i) Field alert reports; and
(ii) Fifteen-day reports as described in Sec. 314.80 of this
chapter, which must be submitted within 30 calendar days instead of 15
calendar days if your combination product received marketing
authorization under a device application.
(3) If your combination product contains a biological product
constituent part, you must submit:
(i) Biological product deviation reports; and
[[Page 138]]
(ii) Fifteen-day reports as described in Sec. 600.80 of this
chapter, which must be submitted within 30 calendar days instead of 15
calendar days if your combination product received marketing
authorization under a device application.
(d) Other reporting requirements for combination product applicants.
(1) If you are the combination product applicant for a combination
product that contains a device constituent part and that received
marketing authorization under an NDA, ANDA, or BLA, in addition to the
information otherwise required in the periodic safety reports you submit
under Sec. 314.80 or Sec. 600.80 of this chapter, your periodic safety
reports must also include a summary and analysis of the reports
identified in paragraphs (c)(1)(i) and (ii) of this section that were
submitted during the report interval.
(2) If you are the combination product applicant for a combination
product that received marketing authorization under a device
application, in addition to the reports required under paragraphs (b)
and (c) of this section, you must submit reports regarding postmarketing
safety events if notified by the Agency in writing that the Agency
requires additional information. We will specify what safety information
is needed and will require such information if we determine that
protection of the public health requires additional or clarifying safety
information for the combination product. In any request under this
section, we will state the reason or purpose for the safety information
request, specify the due date for submitting the information, and
clearly identify the reported event(s) related to our request.
Sec. 4.103 What information must you share with other constituent
part applicants for the combination product?
(a) When you receive information regarding an event that involves a
death or serious injury as described in Sec. 803.3 of this chapter, or
an adverse experience as described in Sec. 314.80(a) of this chapter or
Sec. 600.80(a) of this chapter, associated with the use of the
combination product, you must provide the information to the other
constituent part applicant(s) for the combination product no later than
5 calendar days of your receipt of the information.
(b) With regard to information you must provide to the other
constituent part applicant(s) for the combination product, you must
maintain records that include:
(1) A copy of the information you provided,
(2) The date the information was received by you,
(3) The date the information was provided to the other constituent
part applicant(s), and
(4) The name and address of the other constituent part applicant(s)
to whom you provided the information.
Sec. 4.104 How and where must you submit postmarketing safety reports
for your combination product or constituent part?
(a) If you are a constituent part applicant, you must submit
postmarketing safety reports in accordance with the regulations
identified in Sec. 4.102(b) that are applicable to your product based on
its application type.
(b) If you are a combination product applicant, you must submit
postmarketing safety reports required under Sec. 4.102 in the manner
specified in the regulation applicable to the type of report, with the
following exceptions:
(1) You must submit the postmarketing safety reports identified in
Sec. 4.102(c)(1)(i) and (ii) in accordance with Sec. 314.80(g) of this
chapter if your combination product received marketing authorization
under an NDA or ANDA or in accordance with Sec. 600.80(h) of this
chapter if your combination product received marketing authorization
under a BLA.
(2) You must submit the postmarketing safety reports identified in
Sec. 4.102(c)(2)(ii) and (c)(3)(ii) in accordance with Sec. 803.12(a) of
this chapter if your combination product received marketing
authorization under a device application.
Sec. 4.105 What are the postmarketing safety reporting recordkeeping
requirements for your combination product or constituent part?
(a) If you are a constituent part applicant:
[[Page 139]]
(1) You must maintain records in accordance with the recordkeeping
requirements in the applicable regulation(s) described in Sec. 4.102(b).
(2) You must maintain records required under Sec. 4.103(b) for the
longest time period required for records under the postmarketing safety
reporting regulations applicable to your product under Sec. 4.102(b).
(b) If you are a combination product applicant, you must maintain
records in accordance with the longest time period required for records
under the regulations applicable to your product under Sec. 4.102.
PART 5_ORGANIZATION--Table of Contents
Subparts A-L [Reserved]
Subpart M_Organization
Sec.
5.1100 Headquarters.
5.1105 Chief Counsel, Food and Drug Administration.
5.1110 FDA Public Information Offices.
Authority: 5 U.S.C. 552; 21 U.S.C. 301-397.
Source: 77 FR 15962, Mar. 19, 2012, unless otherwise noted.
Subparts A-L [Reserved]
Subpart M_Organization
Sec. 5.1100 Headquarters.
Office of the Commissioner.\1\
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\1\ Mailing address: 10903 New Hampshire Ave., Silver Spring, MD
20993.
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Office of the Chief Counsel.
Office of the Executive Secretariat.
Freedom of Information Staff.
Dockets Management Staff.
Office of the Chief Scientist.\1\
Office of Counter-Terrorism and Emerging Threats.
Office of Scientific Integrity.
Office of Regulatory Science and Innovation.
Division of Science Innovation and Critical Path.
Division of Scientific Computing and Medical Information.
Office of Scientific Professional Development.
Office of Health Informatics.
Office of Women's Health.
Office of External Affairs.
Office of Media Affairs.
Office of Communications.
Office of Health and Constituent Affairs.
Office of Minority Health.
National Center for Toxicological Research.\2\
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\2\ Mailing address: Food and Drug Administration, 3900 NCTR Rd.,
Jefferson, AR 72079.
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Office of the Center Director.
Office of Management.
Office of Research.
Division of Biochemical Toxicology.
Division of Genetic and Molecular Toxicology.
Division of Microbiology.
Division of Systems Biology.
Division of Neurotoxicology.
Division of Bioinformatics and Biostatistics.
Office of Scientific Coordination.
Office of Foods and Veterinary Medicine.\3\
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\3\ Mailing address: Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993.
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Communications and Public Engagement Staff.
Executive Secretariat Staff.
Office of Resource Planning and Strategic Management.
Strategic Planning and Budget Formulation Staff.
Risk Analytics Staff.
Office of Coordinated Outbreak Response and Evaluation Network.\4\
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\4\ Mailing address: 4300 River Rd., University Station (HFS-015),
College Park, MD 20740.
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Prevention Staff.
Response Staff.
Center for Food Safety and Applied Nutrition.\5\
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\5\ Mailing address: Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740.
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Office of the Center Director.
International Affairs Staff.
Executive Operations Staff.
Office of Management.
Safety Staff.
Division of Budget & Planning.
Division of Program Services.
Office of Analytics and Outreach.
Food Defense and Emergency Coordination Staff.
Biostatistics and Bioinformatics Staff.
Division of Education, Outreach and Information.
Education and Outreach Branch.
Information Center Branch.
Web Branch.
Division of Public Health Informatics and Analytics.
Epidemiology and Surveillance Branch.
Signals Management Branch.
Consumers Studies Branch.
Division of Risk and Decision Analysis.
Risk Analysis Branch.
Contaminant Assessment Branch.
Exposure Assessment Branch.
Office of Food Safety.
[[Page 140]]
Retail Food Production Staff.
Multi-Commodity Foods Staff.
Division of Seafood Science and Technology.
Chemical Hazard Science Branch.
Microbiological Hazards Science Branch.
Division of Food Processing Science & Technology.
Process Engineering Branch.
Food Technology Branch.
Division of Plant and Dairy Food Safety.
Plant Products Branch.
Dairy and Egg Branch.
Division of Seafood Safety.
Shellfish and Aquaculture Policy Branch.
Seafood Processing and Technology Policy Branch.
Division of Produce Safety.
Fresh Produce Branch.
Processed Produce Branch.
Division of Dairy, Egg, and Meat Products.
Milk and Milk Products Branch.
Egg and Meat Products Branch.
Division of Plant Products and Beverages.
Plant Products Branch.
Beverages Branch.
Office of Cosmetics and Colors.
Division of Color Certification and Technology.
Division of Cosmetics.
Office of Regulatory Science.
Division of Analytical Chemistry.
Methods Development Branch.
Spectroscopy and Mass Spectrometry Branch.
Division of Microbiology.
Microbial Methods and Development Branch.
Molecular Methods and Subtyping Branch.
Division of Bioanalytical Chemistry.
Chemical Contaminants Branch.
Bioanalytical Methods Branch.
Office of Food Additive Safety.
Division of Food Contract Notifications.
Division of Biotechnology and GRAS Notice Review.
Division of Petition Review.
Office of Compliance.
Division of Enforcement.
Division of Field Programs and Guidance.
Office of Applied Research and Safety Assessment.
Division of Molecular Biology.
Division of Virulence Assessment.
Virulence Mechanisms Branch.
Immunobiology Branch.
Division of Toxicology.
Office of Regulations, Policy and Social Sciences.
Regulations and Special Government Employee Management Staff.
Division of Social Sciences.
Office of Nutrition and Food Labeling.
Food Labeling and Standards Staff.
Nutrition Programs Staff.
Office of Dietary Supplement Program.
Evaluation and Research Staff.
Regulatory Implementation Staff.
Center for Veterinary Medicine.\6\
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\6\ Mailing address: Food and Drug Administration, 7519 Standish
Pl., Rockville MD 20855.
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Office of the Center Director.
Office of Management.
Program and Resources Management Staff.
Human Capital Management Staff.
Talent Development Staff.
Management Logistics Staff.
Budget Planning and Evaluation Staff.
Office of New Animal Drug Evaluation.
Division of Therapeutic Drugs for Food Animals.
Division of Production Drugs.
Division of Therapeutic Drugs for Non-Food Animals.
Division of Human Food Safety.
Division of Manufacturing Technologies.
Division of Scientific Support.
Division of Generic Animal Drugs.
Division of Business Information Science and Management.
Office of Surveillance and Compliance.
Division of Surveillance.
Division of Animal Feeds.
Division of Compliance.
Division of Veterinary Product Safety.
Office of Research.
Division of Residue Chemistry.
Division of Applied Veterinary Research.
Division of Animal and Food Microbiology.
Office of Minor Use and Minor Species Animal Drug Development.
OFFICE OF MEDICAL PRODUCTS AND TOBACCO
Office of Medical Products and Tobacco--Immediate Office.\7\
---------------------------------------------------------------------------
\7\ Mailing address: 10903 New Hampshire Ave., Bldg. 1, Silver
Spring, MD 20993.
---------------------------------------------------------------------------
Office of Special Medical Programs--Immediate Office.\8\
---------------------------------------------------------------------------
\8\ Mailing address: 10903 New Hampshire Ave., Bldg. 32, Silver
Spring, MD 20993.
---------------------------------------------------------------------------
Advisory Committee Oversight and Management Staff.
Good Clinical Practice Staff.
Office of Pediatric Therapeutics.
Office of Orphan Products Development.
Office of Combination Products.
Center for Biologics Evaluation and Research.\9\
---------------------------------------------------------------------------
\9\ Mailing address: 10903 New Hampshire Ave., Bldg. 71, Silver
Spring, MD 20993.
---------------------------------------------------------------------------
Office of the Center Director.
Executive Operations Staff.
Regulatory Information Management Staff.
Regulations and Policy Staff.
Records Management Staff.
Bioinformatics Support Staff.
Business Operations Staff.
Office of Management.
Planning and Performance Management Staff.
[[Page 141]]
Division of Program Services.
Program Operations Branch.
Program Services Branch.
Division of Budget and Resource Management.
Budget Analysis and Formulation Branch.
Resource Management Branch.
Division of Program Services.
Building Operations Staff.
Program Management Services Branch.
Program Operations Branch.
Division of Scientific Advisors and Consultants.
Division of Veterinary Services.
Office of Compliance and Biologics Quality.
Division of Case Management.
Blood and Tissue Compliance Branch.
Advertising and Promotional Labeling Branch.
Biological Drug and Device Compliance Branch.
Division of Manufacturing and Product Quality.
Product Release Branch.
Manufacturing Review Branch I.
Manufacturing Review Branch II.
Applications Review Branch.
Division of Inspections and Surveillance.
Program Surveillance Branch.
Bioresearch Monitoring Branch.
Division of Biological Standards and Quality Control.
Laboratory of Analytical Chemistry and Blood Related Products.
Quality Assurance Branch.
Laboratory of Microbiology, In-vivo Testing and Standards.
Office of Blood Research and Review.
Administrative Staff.
Policy and Publication Staff.
Regulatory Project Management Staff.
Division of Emerging and Transfusion Transmitted Diseases.
Laboratory of Molecular Virology.
Laboratory of Emerging Pathogens.
Laboratory of Bacterial and Transmissible Spongiform Encephalopathy
Agents.
Product Review Branch.
Division of Hematology Clinical Review.
Hematology Product Review Branch.
Clinical Review Branch.
Division of Blood Components and Devices.
Blood and Plasma Branch.
Devices and Review Branch.
Division of Hematology Research and Review.
Laboratory of Cellular Hematology.
Laboratory of Hemostasis.
Laboratory of Plasma Derivatives.
Laboratory of Biochemistry and Vascular Biology.
Office of Vaccine Research and Review.
Program Operations Staff.
Division of Bacterial, Parasitic, and Allergenic Products.
Laboratory of Immunobiochemistry.
Laboratory of Respiratory and Special Pathogens.
Laboratory of Bacterial Polysaccharides.
Laboratory of Mucosal Pathogens and Cellular Immunology.
Division of Viral Products.
Laboratory of Pediatric and Respiratory Viral Diseases.
Laboratory of Hepatitis Viruses.
Laboratory of Retroviruses.
Laboratory of DNA Viruses.
Laboratory of Vector-Borne Diseases.
Laboratory of Method Development.
Laboratory of Immunoregulation.
Division of Vaccines and Related Products Applications.
Clinical Review Branch 1.
Clinical Review Branch 2.
CMC Review Branch 1.
CMC Review Branch 2.
CMC Review Branch 3.
Review Management Support Branch.
Office of Communication, Outreach, and Development.
Division of Disclosure and Oversight Management.
Congressional and Oversight Branch.
Access Litigation and Freedom of Information Branch.
Division of Manufacturers Assistance and Training.
Career Development and Directed Training Branch.
Manufacturers Assistance and Technical Training Branch.
Division of Communication and Consumer Affairs.
Communication Technology Branch.
Consumer Affairs Branch.
Office of Biostatistics and Epidemiology.
Division of Biostatistics.
Vaccine Evaluation Branch.
Therapeutics Evaluation Branch.
Division of Epidemiology.
Pharmacovigilance Branch.
Analytic Epidemiology Branch.
Office of Cellular, Tissue and Gene Therapies.
Regulatory Management Staff.
Division of Cellular and Gene Therapies.
Cell Therapies Branch.
Gene Therapies Branch.
Gene Transfer and Immunogencity Branch.
Tumor Vaccine and Biotechnology Branch.
Cellular and Tissue Therapy Branch.
Division of Clinical Evaluation and Pharmacological Toxicology
Review.
General Medicine Branch.
Pharmacology/Toxicology Branch.
Oncology Branch.
Division of Human Tissues.
Human Tissue and Reproduction Branch.
Center for Tobacco Products.\10\
---------------------------------------------------------------------------
\10\ Mailing address: 10903 New Hampshire Ave., Bldg. 75, Silver
Spring, MD 20993.
---------------------------------------------------------------------------
Office of the Center Director.
[[Page 142]]
Office of Management.
Acquisitions and Assistance Staff.
Information and Technology Staff.
Management and Logistics Staff.
Division of Financial Management.
Division of Human Capital.
Office of Regulations.
Office of Science.
Regulatory Science and Management Staff.
Research Staff.
Division of Regulatory Project Management.
Regulatory Project Management Branch I.
Regulatory Project Management Branch II.
Regulatory Project Management Branch III.
Regulatory Project Management Branch IV.
Division of Regulatory Science Informatics.
Division of Product Science.
Division of Individual Health Science.
Division of Population Health Science.
Division of Non-Clinical Science.
Office of Health Communication and Education.
Division of Public Health Education.
Division of Health, Scientific, and Regulatory Communication.
Office of Compliance and Enforcement.
Division of Enforcement and Manufacturing.
Division of Promotion, Advertising and Labeling.
Division of State Programs.
Division of Business Operations.
Center for Drug Evaluation and Research.\11\
---------------------------------------------------------------------------
\11\ Mailing address: 10903 New Hampshire Ave., Bldg. 51, Silver
Spring, MD 20993.
---------------------------------------------------------------------------
Office of the Center Director.
Controlled Substance Staff.
Professional Affairs and Stakeholder Engagement Staff.
Counter-Terrorism and Emergency Coordination Staff.
Drug Shortages Staff.
Office of Regulatory Policy.
Division of Regulatory Policy I.
Division of Regulatory Policy II.
Division of Regulatory Policy III.
Division of Information Disclosure Policy.
Proactive Disclosure Branch.
Freedom of Information Branch.
Office of Management.
Strategic Programs and Initiatives Staff.
Ethics Liaison Staff.
Division of Budget Execution and Resource Management.
Budget Execution Branch.
Acquisitions Support Branch.
Financial Accountability Branch.
Division of Management Services.
Human Capital Management Branch.
Human Capital Programs Branch.
Facilities Operations Branch.
Property and Travel Services Branch.
Leave and Performance Management Branch.
Division of User Fee Management and Budget Formulation.
Generics Branch.
Policy and Operations Branch.
Brands Branch.
Office of Communications.
Division of Online Communications.
Division of Health Communications.
Division of Drug Information.
Office of Compliance.
Program Management and Analysis Staff.
Office of Manufacturing Quality.
Manufacturing Guidance and Policy Staff.
Division of Drug Quality I.
Global Compliance Branch I.
Global Compliance Branch II.
Division of Drug Quality II.
Global Compliance Branch III.
Global Compliance Branch IV.
Office of Unapproved Drugs and Labeling Compliance.
Division of Prescription Drugs.
Prescription Drugs Branch.
Compounding and Pharmacy Practices Branch.
Division of Non-Prescription Drugs and Health Fraud.
Over-the-Counter Drugs Branch.
Health Fraud Branch.
Office of Scientific Investigations.
Policy Staff.
Division of Enforcement and Postmarket Safety.
Compliance Enforcement Branch.
Postmarketing Safety Branch.
Division of Clinical Compliance Evaluation.
Good Clinical Practice Compliance Oversight Branch.
Good Clinical Practice Assessment Branch.
Office of Drug Security, Integrity and Response.
Division of Import Exports and Recalls.
Recalls and Shortages Branch.
Import Export Compliance Branch.
Division of Supply Chain Integrity.
Supply Chain Strategy and Policy Branch.
Supply Chain Response and Enforcement Branch.
Office of Program and Regulatory Operations.
Project Management and Coordination Staff I.
Project Management and Coordination Staff II.
Drug Registration and Listing Staff.
Office of Medical Policy.
Office of Prescription Drug Promotion.
Division of Consumer Drug Promotion.
Division of Professional Drug Promotion.
Office of Medical Policy Initiatives.
Division of Medical Policy Development.
Division of Medical Policy Programs.
Division of Clinical Trial Quality.
[[Page 143]]
Office of Translational Science.
Program Management and Analysis Staff.
Office of Biostatistics.
Division of Biometrics I.
Division of Biometrics II.
Division of Biometrics III.
Division of Biometrics IV.
Division of Biometrics V.
Division of Biometrics VI.
Division of Biometrics VII.
Division of Biometrics VIII.
Office of Clinical Pharmacology.
Division of Clinical Pharmacology I.
Division of Clinical Pharmacology II.
Division of Clinical Pharmacology III.
Division of Clinical Pharmacology IV.
Division of Clinical Pharmacology V.
Division of Pharmacometrics.
Division of Applied Regulatory Science.
Office of Computational Science.
Office of Study Integrity and Surveillance.
Division of New Drug Bioequivalence Evaluation.
Division of Generic Drug Bioequivalence Evaluation.
Office of Executive Programs.
Division of Learning and Organizational Development.
Scientific and Regulatory Education Branch.
Training Design and Delivery Branch.
Leadership and Organizational Development Branch.
Division of Executive Operations.
Division of Advisory Committee and Consultant Management.
Office of Surveillance and Epidemiology.
Regulatory Science Staff.
Regulatory Affairs Staff.
Program Management and Analysis Staff.
Project Management Staff.
Office of Medication Error Prevention and Risk Management.
Division of Medication Error Prevention and Analysis.
Division of Risk Management.
Office of Pharmacovigilance and Epidemiology.
Division of Epidemiology I.
Division of Epidemiology II.
Division of Pharmacovigilance I.
Division of Pharmacovigilance II.
Office of New Drugs.
Program Management and Analysis Staff.
Pharmacology/Toxicology Staff.
Regulatory Affairs Staff.
Office of Drug Evaluation I.
Division of Cardiovascular and Renal Products.
Division of Neurology Products.
Division of Psychiatry Products.
Office of Drug Evaluation II.
Division of Metabolism and Endocrinology Products.
Division of Pulmonary, Allergy, and Rheumatology Products.
Division of Anesthesia, Analgesia, and Addiction Products.
Office of Drug Evaluation III.
Division of Gastroenterology and Inborn Effects Products.
Division of Bone, Reproductive and Urologic Products.
Division of Dermatology and Dental Products.
Office of Antimicrobial Products.
Division of Anti-Infective Products.
Division of Anti-Viral Products.
Division of Transplant and Ophthalmology Products.
Office of Drug Evaluation IV.
Division of Nonprescription Drug Products.
Division of Medical Imaging Products.
Division of Pediatrics and Maternal Health.
Office of Hematology and Oncology Drug Products.
Division of Oncology Products I.
Division of Oncology Products II.
Division of Hematology Products.
Division of Hematology Oncology Toxicology.
Office of Strategic Programs.
Office of Program and Strategic Analysis.
Program Evaluation and Implementation Staff.
Economics Staff.
Performance Analysis and Data Services Staff.
Lean Management Staff.
Office of Business Informatics.
Division of Regulatory Review and Drug Safety Services and
Solutions.
Division of Business Management Services and Solutions.
Division of Data Management Services and Solutions.
Division of Drug Quality and Compliance Services and Solutions.
Office of Generic Drugs.
Clinical Safety Surveillance Staff.
Program Management and Analysis Staff.
Communications Staff.
Office of Research and Standards.
Division of Therapeutic Performance.
Division of Quantitative Methods and Modeling.
Office of Bioequivalence.
Division of Bioequivalence I.
Division of Bioequivalence II.
Division of Bioequivalence III.
Division of Clinical Review.
Office of Generic Drug Policy.
Division of Legal and Regulatory Support.
Division of Policy Development.
Office of Regulatory Operations.
Division of Labeling Review.
Division of Filing Review.
Division of Project Management.
Division of Quality Management Systems.
Office of Pharmaceutical Quality.
Scientific Staff.
Program Management and Analysis Staff.
Office of Biotechnology Products.
[[Page 144]]
Division of Biotechnology Review and Research I.
Division of Biotechnology Review and Research II.
Division of Biotechnology Review and Research III.
Division of Biotechnology Review and Research IV.
Office of New Drug Products.
Division of Life Cycle API.
Life Cycle Branch I.
Life Cycle Branch II.
Life Cycle Branch III.
Division of New Drug API.
New Drug Branch I.
New Drug Branch II.
Division of New Drug Products I.
New Drug Products Branch I.
New Drug Products Branch II.
New Drug Products Branch III.
Division of New Drug Products II.
New Drug Products Branch IV.
New Drug Products Branch V.
New Drug Products Branch VI.
Division of Biopharmaceutics.
Biopharmaceutics Branch I.
Biopharmaceutics Branch II.
Biopharmaceutics Branch III.
Office of Policy for Pharmaceutical Quality.
Division of Regulations, Guidance and Standards.
Policy Development and Evaluation Branch I.
Policy Development and Evaluation Branch II.
Compendial Operations and Standards Branch.
Division of Internal Policies and Programs.
Policy Development and Evaluation Branch I.
Policy Development and Evaluation Branch II.
Office of Process and Facilities.
Division of Process Assessment I.
Process Assessment Branch I.
Process Assessment Branch II.
Process Assessment Branch III.
Division of Process Assessment II.
Process Assessment Branch IV.
Process Assessment Branch V.
Process Assessment Branch VI.
Division of Process Assessment III.
Process Assessment Branch VII.
Process Assessment Branch VIII.
Process Assessment Branch IX.
Division of Microbiology Assessment.
Microbiology Assessment Branch I.
Microbiology Assessment Branch II.
Microbiology Assessment Branch III.
Microbiology Assessment Branch IV.
Division of Inspectional Assessment.
Inspectional Assessment Branch I.
Inspectional Assessment Branch II.
Inspectional Assessment Branch III.
Office of Surveillance.
Division of Quality Intelligence, Risk Analysis, and Modeling.
Data Integrity Branch.
Quality Intelligence Branch.
Analysis and Modeling Branch.
Division of Quality Surveillance Assessment.
Quality Deviation and Assessment Branch.
Inspection Assessment Branch.
Office of Testing and Research.
Division of Product Quality Research.
Product Quality Branch I.
Product Quality Branch II.
Division of Pharmaceutical Analysis.
Pharmaceutical Analysis Branch I.
Pharmaceutical Analysis Branch II.
Office of Program and Regulatory Operations.
Division of Regulatory and Business Process Management I.
Regulatory and Business Process Management Branch I.
Regulatory and Business Process Management Branch II.
Division of Regulatory and Business Process Management II.
Regulatory and Business Process Management Branch III.
Regulatory and Business Process Management Branch IV.
Division of Operational Excellence, Learning, and Professional
Development.
Learning and Professional Development Branch.
Organizational Excellence Branch.
Office of Lifecycle Drug Products.
Division of Immediate Release Products I.
Immediate Release Branch I.
Immediate Release Branch II.
Immediate Release Branch III.
Division of Immediate Release Products II.
Immediate Release Branch IV.
Immediate Release Branch V.
Immediate Release Branch VI.
Division of Modified Release Products.
Modified Release Branch I.
Modified Release Branch II.
Modified Release Branch III.
Division of Liquid-Based Products.
Liquid-Based Branch I.
Liquid-Based Branch II.
Liquid-Based Branch III.
Division of Post-Marketing Activities I.
Post-Marketing Branch I.
Post-Marketing Branch II.
Division of Post-Marketing Activities II.
Post-Marketing Branch III.
Post-Marketing Branch IV.
Post-Marketing Branch V.
Center for Devices and Radiological Health. \12\
---------------------------------------------------------------------------
\12\ Mailing address: 10903 New Hampshire Ave., Bldg. 66, Silver
Spring, MD 20993.
---------------------------------------------------------------------------
Office of the Center Director.
Regulations Staff.
Office of Management Operations.
Division of Ethics and Management Operations.
Human Resources and Administrative Management Branch.
[[Page 145]]
Integrity, Conference and Committee Management Branch.
Division of Planning, Analysis and Finance and Property.
Planning Branch.
Financial Management Branch.
Office of Compliance.
Program Management Staff.
Division of Bioresearch Monitoring.
Bioresearch Compliance Branch I.
Bioresearch Compliance Branch II.
Division of Analysis and Program Operations.
Quality Management System and Executive Secretary Staff.
Field Inspections Support Branch.
Recall Branch.
Registration and Risk Branch.
Allegations of Regulatory Misconduct Branch.
Division of Manufacturing and Quality.
Physical Medicine, Orthopedic, Neurology, and Dental Devices Branch.
Cardiovascular Devices Branch.
Abdominal and Surgical Devices Branch.
Respiratory, Ear/Nose/Throat, General Hospital, and Ophthalmic
Devices Branch.
Division of Premarket and Labeling Compliance.
Surveillance and Enforcement Branch I.
Surveillance and Enforcement Branch II
Division of International Compliance Operations.
Foreign Enforcement Branch.
Imports Branch.
Exports Branch.
Office of Device Evaluation.
Program Management Staff.
Program Operations Staff.
Pre-Market Approval Staff.
Investigational Device Exemption Staff.
Pre-Market Notification Section.
Division of Cardiovascular Devices.
Circulatory Support Devices Branch.
Cardiac Diagnostics Devices Branch.
Implantable Electrophysiology Devices Branch.
Vascular Surgery Devices Branch.
Structural Heart Devices Branch.
Interventional Cardiology Devices Branch.
Cardiac Electrophysiology Devices Branch.
Peripheral Interventional Devices Branch.
Division of Reproductive, Gastro-Renal, and Urological Devices.
Obstetrics/Gynecology Devices Branch.
Urology and Lithotripsy Devices Branch.
Renal Devices Branch.
Gastroenterology Devices Branch.
Division of Orthopedic Devices.
Restorative and Repair Devices Branch.
Joint and Fixation Branch I.
Joint and Fixation Branch II.
Anterior Spine Devices Branch.
Posterior Spine Devices Branch.
Division of Ophthalmic and Ear, Nose, and Throat Devices.
Intraocular and Corneal Implant Devices Branch.
Diagnostic and Surgical Devices Branch.
Contact Lenses and Retinal Devices Branch.
Ear, Nose and Throat Devices Branch.
Division of Anesthesiology, General Hospital, Respiratory Infection
Control, and Dental Devices.
General Hospital Devices Branch.
Infection Control Devices Branch.
Dental Devices Branch.
Anesthesiology Devices Branch.
Respiratory Devices Branch.
Division of Neurological and Physical Medicine Devices.
Neurostimulation Devices Branch.
Neurodiagnostic and Neurosurgical Devices Branch.
Physical Medicine Devices Branch.
Division of Surgical Devices.
General Surgery Devices Branch I.
General Surgery Devices Branch II.
Plastic and Reconstructive Surgery Devices Branch I.
Plastic and Reconstructive Surgery Devices Branch II.
Office of Science and Engineering Laboratories.
Division of Biology, Chemistry, and Materials Science.
Division of Biomedical Physics.
Division of Imaging, Diagnostics, and Software Reliability.
Division of Applied Mechanics.
Division of Administrative and Laboratory Support.
Office of Communication and Education.
Program Management Operations Staff.
Digital Communication Media Staff.
Division of Health Communication.
Web Communication Branch.
Strategic Communication Branch.
Division of Industry and Consumer Education.
Postmarket and Consumer Branch.
Premarket Programs Branch.
Division of Information Disclosure.
Freedom of Information Branch A.
Freedom of Information Branch B.
Division of Employee Training and Development.
Employee Development Branch.
Technology and Learning Management Branch.
Office of Surveillance and Biometrics.
Program Management Staff.
Informatics Staff.
Signal Management Staff.
Division of Biostatistics.
Therapeutic Statistics Branch I.
Therapeutic Statistics Branch II.
Therapeutic Statistics Branch III.
Diagnostic Statistics Branch I.
Diagnostic Statistics Branch II.
Division of Postmarket Surveillance.
Product Evaluation Branch I.
Product Evaluation Branch II.
[[Page 146]]
Product Evaluation Branch III.
Information Analysis Branch.
MDR Policy Branch.
Division of Patient Safety Partnership.
Clinical Outreach Branch I.
Clinical Outreach Branch II.
Division of Epidemiology.
Epidemiologic Evaluation and Research Branch I.
Epidemiologic Evaluation and Research Branch II.
Epidemiologic Evaluation and Research Branch III.
Office of In Vitro Diagnostics and Radiological Health.
Division of Chemistry and Toxicology Devices.
Chemistry Branch.
Diabetes Branch.
Toxicology Branch.
Cardio-Renal Diagnostics Branch.
Division of Immunology and Hematology Devices.
Hematology Branch.
Immunology and Flow Cytometry Branch.
Division of Microbiology Devices.
Viral Respiratory and HPV Branch.
General Viral and Hepatitis Branch.
General Bacterial and Antimicrobial Susceptibility Branch.
Bacterial Respiratory and Medical Countermeasures Branch.
Division of Radiological Health.
Magnetic Resonance and Electronic Products Branch.
Diagnostic X-Ray Systems Branch.
Nuclear Medicine and Radiation Therapy Branch.
Mammography, Ultrasound and Imaging Software Branch.
Division of Mammography Quality Standards.
Program Management Branch.
Information Management Branch.
Division of Program Operations and Management.
Division of Molecular Genetics and Pathology.
Molecular Pathology and Cytology Branch.
Molecular Genetics Branch.
Office of Global Regulatory Operations and Policy. \13\
---------------------------------------------------------------------------
\13\ Mailing address: 10903 New Hampshire Ave., Bldg. 1, Silver
Spring, MD 20993.
---------------------------------------------------------------------------
Office of International Programs.\14\
---------------------------------------------------------------------------
\14\ Mailing address: 12420 Parklawn Dr., Element Building,
Rockville, MD 20857.
---------------------------------------------------------------------------
Office of Regulatory Affairs.\15\
---------------------------------------------------------------------------
\15\ Mailing address: 10903 New Hampshire Ave., Bldg. 31, Silver
Spring, MD 20993.
---------------------------------------------------------------------------
Office of the Associate Commissioner for Regulatory Affairs.
Executive Secretariat Staff.
Information Technology Staff.
Office of Resource Management.\16\
---------------------------------------------------------------------------
\16\ Mailing address: 12420 Parklawn Dr., Element Building,
Rockville, MD 20857.
---------------------------------------------------------------------------
Division of Planning Evaluation and Management.
Program Planning and Workforce Management Branch.
Program Evaluation Branch.
Division of Budget Formulation and Execution.
Division of Human Resources Development.
Division of Management Operations.
Office of Criminal Investigations.\17\
---------------------------------------------------------------------------
\17\ Mailing address: 7500 Standish Pl., MPN2 Building, Rockville,
MD 20855.
---------------------------------------------------------------------------
Mid-Atlantic Area Office.
Philadelphia Resident Unit.
Midwest Area Office.
Northeast Area Office.
Boston, MA Resident Unit.
Pacific Area Office.
San Francisco, CA Resident Unit.
Southeast Area Office.
San Juan, PR Resident Unit.
Atlanta, GA Resident Unit.
New Orleans, LA Resident Unit.
Southwest Area Office.
Dallas, TX Resident Unit.
Office of Communications and Quality Program Management.
Quality Management Systems Staff.
Project Coordination Staff.
Division of Communications.
Public Affairs and Editorial Services Branch.
Web and Digital Media Strategies Branch.
Office of Partnerships.\18\
---------------------------------------------------------------------------
\18\ Mailing address: 12420 Parklawn Dr., Element Building,
Rockville, MD 20857.
---------------------------------------------------------------------------
Standards Implementation Staff.
Contracts and Grants Staff.
Office of Policy and Risk Management.\19\
---------------------------------------------------------------------------
\19\ Mailing address: 12420 Parklawn Dr., Element Building,
Rockville, MD 20857.
---------------------------------------------------------------------------
Food and Feed Policy Staff.
Medical Products and Tobacco Policy Staff.
Risk Management Staff.
Division of Planning Evaluation and Management.
Program Evaluation Branch.
Work Planning Branch.
Office of Operations.\20\
---------------------------------------------------------------------------
\20\ Mailing address: 10903 New Hampshire Ave., Bldg. 31, Silver
Spring, MD 20993.
---------------------------------------------------------------------------
Audit Staff.
Office of Enforcement and Import Operations.\21\
---------------------------------------------------------------------------
\21\ Mailing address: 12420 Parklawn Dr., Element Building,
Rockville, MD 20857.
---------------------------------------------------------------------------
Division of Enforcement.
Division of Compliance Systems.
Enforcement Systems Branch.
Import Compliance Systems Branch.
Division of Import Operations.
[[Page 147]]
Import Operations and Maintenance Branch.
Import Program Development and Implementation Branch.
Office of Regulatory Science.\22\
---------------------------------------------------------------------------
\22\ Mailing address: 12420 Parklawn Dr., Element Building,
Rockville, MD 20857.
---------------------------------------------------------------------------
Food and Feed Scientific Staff.
Medical Products and Tobacco Scientific Staff.
Laboratory Operations and Support Staff.
Office of Food and Feed Operations.\23\
---------------------------------------------------------------------------
\23\ Mailing address: 12420 Parklawn Dr., Element Building,
Rockville, MD 20857.
---------------------------------------------------------------------------
Division of Food Defense Targeting.
Division of Food and Feed Program Operations and Inspections.
Food and Feed Program Operations Branch.
Food and Feed Inspection Branch.
Food and Feed Trip Planning Branch.
Office of Medical Products and Tobacco Operations.\24\
---------------------------------------------------------------------------
\24\ Mailing address: 12420 Parklawn Dr., Element Building,
Rockville, MD 20857.
---------------------------------------------------------------------------
Division of Products and Tobacco Program Operations.
Medical Device and Tobacco Program Operations Branch.
Team Biological Branch.
Division of Medical Products and Tobacco Inspections.
Medical Products and Tobacco Inspection Branch.
Drug Inspection Branch.
Medical Products and Tobacco Trip Planning Branch.
Regional Field Office, Northeast Region, Jamaica, NY.\25\
---------------------------------------------------------------------------
\25\ Mailing address: 158-15 Liberty Ave., Jamaica, NY 11433.
---------------------------------------------------------------------------
Operations Staff.
Intergovernmental Affairs Staff.
District Office New York.\26\
---------------------------------------------------------------------------
\26\ Mailing address: 158-15 Liberty Ave., Jamaica, NY 11433.
---------------------------------------------------------------------------
Domestic Compliance Branch.
Domestic Investigations Branch.
Resident Post Long Island, NY.
Resident Post White Plains, NY.
Resident Post Albany, NY.
Resident Post Binghamton, NY.
Resident Post Rochester, NY.
Resident Post Newburgh, NY.
Resident Post Syracuse, NY.
Import Operations Branch (Downstate).
Resident Post Port Elizabeth, NJ.
Import Operations Branch (Upstate).
Resident Post Champlain, NY.
Resident Post Alexandra Bay, NY.
Resident Post Massena, NY.
Resident Post Ogdensburg, NY.
Northeast Regional Laboratory.\27\
---------------------------------------------------------------------------
\27\ Mailing address: 158-15 Liberty Ave., Jamaica, NY 11433.
---------------------------------------------------------------------------
Microbiological Science Branch.
Chemistry Branch 1.
Chemistry Branch 2.
New England District Office.\28\
---------------------------------------------------------------------------
\28\ Mailing address: 1 Montvale Ave., 4th Floor, Stoneham, MA
02180-3500.
---------------------------------------------------------------------------
Compliance Branch.
Investigations Branch.
Resident Post Augusta, ME.
Resident Post Bridgeport, CT.
Resident Post Concord, NH.
Resident Post Hartford, CT.
Resident Post Providence, RI.
Resident Post Worcester, MA.
Resident Post Calais, ME.
Resident Post Houlton, ME.
Resident Post Highgate, VT.
Winchester Engineering and Analytical Center.\29\
---------------------------------------------------------------------------
\29\ Mailing address: 109 Holton St., Winchester, MA 01890.
---------------------------------------------------------------------------
Analytical Branch.
Engineering Branch.
Regional Field Office, Southwest Region, Dallas, TX.\30\
---------------------------------------------------------------------------
\30\ Mailing address: 4040 North Central Expressway, Dallas, TX
75204-3128.
---------------------------------------------------------------------------
State Cooperative Programs Staff.
Resident Post Pharr.
Dallas District Office.\31\
---------------------------------------------------------------------------
\31\ Mailing address: 4040 North Central Expressway, Suite 300,
Dallas, TX 75204-3128.
---------------------------------------------------------------------------
Compliance Branch.
Investigations Branch.
Resident Post Austin, TX.
Resident Post Fort Worth, TX.
Resident Post Houston, TX.
Resident Post San Antonio, TX.
Resident Post Oklahoma City, OK.
Resident Post Little Rock, AR.
Kansas City District Office.\32\
---------------------------------------------------------------------------
\32\ Mailing address: 8050 Marshal Dr., Suite 250, Lenexa, KS 66214.
---------------------------------------------------------------------------
Investigations Branch.
Resident Post Wichita, KS.
Resident Post Omaha, NE.
Resident Post Des Moines, IA.
Resident Post Springfield, MO.
Resident Post St Louis, MO.
Resident Post Davenport, IA.
Compliance Branch.
Denver District Office.\33\
---------------------------------------------------------------------------
\33\ Mailing address: Sixth Avenue and Kipling Street, Building 20,
P.O. Box 25087, Denver, CO 80255-0087--Denver Federal Center.
---------------------------------------------------------------------------
Compliance Branch.
Investigations Branch.
Resident Post Salt Lake City, UT.
Resident Post Albuquerque, NM.
Arkansas Regional Laboratory.\34\
---------------------------------------------------------------------------
\34\ Mailing address: 3900 NCTR Rd., Bldg. 26, Jefferson, AR 72079.
---------------------------------------------------------------------------
General Chemistry Branch.
Pesticide Chemistry Branch.
Microbiology Branch.
[[Page 148]]
Southwest Import District Office Dallas, TX.\35\
---------------------------------------------------------------------------
\35\ Mailing address: 4040 North Central Expressway, Suite 300,
Dallas, TX 75204-3128.
---------------------------------------------------------------------------
Compliance Branch.
Investigations Branch.
Resident Post Calexico.
Resident Post Eagle Pass.
Resident Post El Paso Bota.
Resident Post El Paso Bota Westmoreland.
Resident Post El Paso Ysleta Bridge.
Resident Post Houston (SWID).
Resident Post Laredo 2 Bridge.
Resident Post Laredo Columbia Bridge.
Resident Post Laredo World Trade Bridge.
Resident Post Los Tomates.
Resident Post Nogales 1.
Resident Post Nogales 2.
Resident Post Otay Mesa 1.
Resident Post Otay Mesa 2.
Resident Post Pharr.
Resident Post Rio Grande City.
Resident Post San Luis.
Kansas City Laboratory.\36\
---------------------------------------------------------------------------
\36\ Mailing address: 11510 West 80th St., Lenexa, KS 66214.
---------------------------------------------------------------------------
Denver Laboratory.\37\
---------------------------------------------------------------------------
\37\ Mailing address: Sixth Avenue and Kipling Street, Building 20,
Denver, CO 80255-0087--Denver Federal Center.
---------------------------------------------------------------------------
Central Regional Field Office Chicago IL.\38\
---------------------------------------------------------------------------
\38\ Mailing address: 20 N. Michigan Ave., Suite 510, Chicago, IL
60602.
---------------------------------------------------------------------------
State Cooperative Programs Staff I.
State Cooperative Programs Staff II.
Regional Operations Staff.
Baltimore District Office Baltimore, MD.\39\
---------------------------------------------------------------------------
\39\ Mailing address: 6000 Metro Dr., Suite 101, Baltimore, MD
21215.
---------------------------------------------------------------------------
Compliance Branch.
Investigations Branch.
Resident Post Charleston, WV.
Resident Post Falls Church, VA.
Resident Post Seva.
Resident Post Richmond, VA.
Resident Post Roanoke, VA.
Resident Post Dundalk Marine Terminal, MD.
Resident Post Morgantown, WV.
District Office Cincinnati, OH.\40\
---------------------------------------------------------------------------
\40\ Mailing address: 6751 Steger Dr., Cincinnati, OH 45237.
---------------------------------------------------------------------------
Compliance Branch.
Investigations Branch.
Resident Post Brunswick, OH.
Resident Post Columbus, OH.
Resident Post Toledo, OH.
Resident Post Louisville, KY.
Forensic Chemistry Center.\41\
---------------------------------------------------------------------------
\41\ Mailing address: 6751 Steger Dr., Cincinnati, OH 45237.
---------------------------------------------------------------------------
Inorganic Chemistry Branch.
Organic Chemistry Branch.
District Office Parsippany, NJ.\42\
---------------------------------------------------------------------------
\42\ Mailing address: 10 Waterview Blvd., 3rd Floor, Parsippany, NJ
07054--Waterview Corporate Center.
---------------------------------------------------------------------------
Compliance Branch.
Investigations Branch.
Resident Post Voorhees, NJ.
Resident Post North Brunswick, NJ.
District Office Philadelphia, PA.\43\
---------------------------------------------------------------------------
\43\ Mailing address: 200 Chestnut St., Room 900, Philadelphia, PA
19106--U.S. Customs House.
---------------------------------------------------------------------------
Compliance Branch.
Investigations Branch.
Resident Post Harrisburg, PA.
Resident Post Pittsburgh, PA.
Resident Post Wilkes-Barre, PA.
Resident Post Wilmington, PA.
District Office Chicago, IL.\44\
---------------------------------------------------------------------------
\44\ Mailing address: 550 West Jackson Blvd., Suite 1500, Chicago,
IL 60661.
---------------------------------------------------------------------------
Compliance Branch.
Investigations Branch.
Resident Post Peoria, IL.
Resident Post Hinsdale, IL.
Resident Post Gurnee, IL.
Resident Post Springfield, IL.
Resident Post O'Hare Airport.
District Office Minneapolis, MN.\45\
---------------------------------------------------------------------------
\45\ Mailing address: 250 Marquette Ave., Suite 600, Minneapolis, MN
55401.
---------------------------------------------------------------------------
Compliance Branch.
Investigations Branch.
Resident Post La Crosse, WI.
Resident Post Green Bay, WI.
Resident Post Milwaukee, WI.
Resident Post Madison, WI.
Resident Post Fargo, ND.
Resident Post Stevens Point, WI.
Resident Post Sioux, SD.
District Office Detroit, MI.\46\
---------------------------------------------------------------------------
\46\ Mailing address: 300 River Pl., Suite 5900, Detroit, MI 48207.
---------------------------------------------------------------------------
Compliance Branch.
Investigations Branch.
Resident Post Kalamazoo, MI.
Resident Post South Bend, IN.
Resident Post Indianapolis, IN.
Resident Post Evansville, IN.
Resident Post
Philadelphia Laboratory.\47\
---------------------------------------------------------------------------
\47\ Mailing address: 200 Chestnut St., Room 900, Philadelphia, PA
19106--U.S. Customs House.
---------------------------------------------------------------------------
Detroit Laboratory.\48\
---------------------------------------------------------------------------
\48\ Mailing address: 300 River Pl., Suite 5900, Detroit, MI 48207.
---------------------------------------------------------------------------
Southeast Regional Field Office Atlanta, GA.\49\
---------------------------------------------------------------------------
\49\ Mailing address: 60 Eighth St. NE., Atlanta, GA 30309.
---------------------------------------------------------------------------
State Cooperative Programs Staff
Atlanta District Office.\50\
---------------------------------------------------------------------------
\50\ Mailing address: 60 Eighth St. NE., Atlanta, GA 30309.
---------------------------------------------------------------------------
Compliance Branch.
[[Page 149]]
Investigations Branch.
Resident Post Savannah, GA.
Resident Post Tifton, GA.
Resident Post Charlotte, NC.
Resident Post Greensboro, NC.
Resident Post Greenville, NC.
Resident Post Raleigh, NC.
Resident Post Charleston, SC.
Resident Post Columbia, SC.
Resident Post Greenville, SC.
Resident Post Asheville, NC.
Florida District Office.\51\
---------------------------------------------------------------------------
\51\ Mailing address: 555 Winderley Pl., Suite 200, Maitland, FL
32751.
---------------------------------------------------------------------------
Compliance Branch.
Investigations Branch.
Resident Post Jacksonville, FL.
Resident Post Miami, FL.
Resident Post Tallahassee, FL.
Resident Post Tampa, FL.
Resident Post Boca Raton, FL.
Resident Post Ft. Meyers, FL.
Resident Post Port Everglades, FL.
New Orleans, LA, District Office.\52\
---------------------------------------------------------------------------
\52\ Mailing address: 404 BNA Dr., Building 200, Suite 500,
Nashville, TN 37217.
---------------------------------------------------------------------------
Compliance Branch.
Investigations Branch.
Resident Post Baton Rouge, LA.
Resident Post Lafayette, LA.
Resident Post Covington, LA.
Resident Post Jackson, MS.
Resident Post Mobile, AL.
Nashville Branch.
Resident Post Knoxville, TN.
Resident Post Memphis, TN.
Resident Post Birmingham, AL.
Resident Post Montgomery, AL.
San Juan District Office.\53\
---------------------------------------------------------------------------
\53\ Mailing address: 466 Fernandez Juncos Ave., San Juan, PR 00901.
---------------------------------------------------------------------------
Compliance Branch.
Investigations Branch.
Resident Post Aquada, PR.
Resident Post Ponce, PR.
Southeast Regional Laboratory Atlanta, GA.\54\
---------------------------------------------------------------------------
\54\ Mailing address: 60 Eighth St., Atlanta, GA 30309.
---------------------------------------------------------------------------
Chemistry Branch I.
Microbiology Branch.
Atlanta Center for Nutrient Analysis.
Chemistry Branch II.
San Juan Laboratory.\55\
---------------------------------------------------------------------------
\55\ Mailing address: 466 Fernandez Juncos Ave., San Juan, PR 00901.
---------------------------------------------------------------------------
Regional Field Office, Pacific Region, Oakland, CA.\56\
---------------------------------------------------------------------------
\56\ Mailing address: 1301 Clay St., Room 1180N, Oakland, CA 94612.
---------------------------------------------------------------------------
State Cooperative Programs Staff.
District Office San Francisco, CA.\57\
---------------------------------------------------------------------------
\57\ Mailing address: 1431 Harbor Bay Pkwy., Alameda, CA 94502.
---------------------------------------------------------------------------
Compliance Branch.
Investigations Branch.
Resident Post Las Vegas, NV.
Resident Post Fresno, CA.
Resident Post Sacramento, CA.
Resident Post Honolulu, HI.
Resident Post San Jose, CA.
Resident Post Stockton, CA.
Resident Post South San Francisco.
District Office Los Angeles, CA.\58\
---------------------------------------------------------------------------
\58\ Mailing address: 19701 Fairchild Rd., Irvine, CA 92612.
---------------------------------------------------------------------------
Compliance Branch.
Import Operations Branch.
Resident Post Los Angeles Airport.
Resident Post Ontario, CA--Import.
Domestic Investigations Branch.
Resident Post Woodland Hills, CA.
Resident Post San Diego, CA.
Resident Post Tempe, AZ.
Resident Post Ontario, CA--Domestic.
District Office Seattle, WA.\59\
---------------------------------------------------------------------------
\59\ Mailing address: 22215 26th Ave. SE., Suite 210, Bothell, WA
98021.
---------------------------------------------------------------------------
Compliance Branch.
Investigations Branch.
Resident Post Anchorage, AK.
Resident Post Boise, ID.
Resident Post Portland, ID.
Resident Post Spokane, WA.
Resident Post Oroville, WA.
Resident Post Portland, OR--Airport.
Resident Post Blaine, WA.
Resident Post Helena, MT.
Resident Post Sweetgrass, MT.
Resident Post Tacoma, WA.
Resident Post Puget Sound, WA.
Pacific Regional Laboratory Southwest.\60\
---------------------------------------------------------------------------
\60\ Mailing address: 19701 Fairchild Rd., Irvine, CA 92612.
---------------------------------------------------------------------------
Food Chemistry Branch.
Drug Chemistry Branch.
Microbiology Branch.
Pacific Regional Laboratory Northwest.\61\
---------------------------------------------------------------------------
\61\ Mailing address: 22201 23rd Dr. SE., Bothell, WA 98021-4421.
---------------------------------------------------------------------------
Chemistry Branch.
Microbiology Branch.
Seafood Products Research Center.
Office of Operations.
Office of Business Services.
Business Operations Staff.
Employee Resource and Information Center.
Division of Ethics and Integrity.
Office of Equal Employment Opportunity.
Compliance Staff.
Office of Finance, Budget, and Acquisitions.
Office of Budget.
Division of Budget Formulation.
Division of Budget Execution and Control.
Office of Acquisition and Grant Services.
Division of Acquisition Operations.
Division of Acquisition Programs.
Division of Acquisition Support and Grants.
[[Page 150]]
Division of Information Technology.
Office of Financial Operations.
Office of Financial Management.
Office of Financial Services.
Office of Human Resources.
Commission Corps Affairs Staff.
Management Analysis Services Staff.
Business Operations Staff.
Division of Workforce Relations.
Division of Policy, Programs, and Executive Resources.
Division of Human Resource Services for Office of the Commissioner/
Office of Operations.
Division of Human Resource Services for Office of Foods and
Veterinary Medicine/Office of Global Operations and Policy.
Division of Human Resource Services for Office of Medical Products
and Tobacco.
FDA University.
Office of Facilities, Engineering and Mission Support Services.
Jefferson Laboratories Complex Staff.
Division of Operations Management and Community Relations.
Division of Planning, Engineering and Safety Management.
Office of Information Management and Technology.
Office of Information Management.
Office of Technology and Delivery.
Division of Infrastructure Operations.
Division of Application Services.
Division of Delivery Management and Support.
Office of Business and Customer Assurance.
Division of Business Partnership and Support.
Division of Management Services.
Office of Enterprise and Portfolio Management.
Office of Safety, Security, and Crisis Management.
Office of Security Operations.
Office of Crisis Management.
Office of Emergency Operations.
Office of Policy, Planning, Legislation, and Analysis.\62\
---------------------------------------------------------------------------
\62\ Mailing address: 10903 New Hampshire Ave., Silver Spring, MD
20993.
---------------------------------------------------------------------------
Management and Operations Staff.
Intergovernment Affairs Staff.
Office of Policy.
Regulations Policy and Management Staff.
Policy Development and Coordination Staff.
Office of Planning.
Planning Staff.
Program Evaluation and Process Improvement Staff.
Economics Staff.
Risk Communication Staff.
Office of Legislation.
Office of Public Health Strategy and Analysis.
[81 FR 78033, Nov. 7, 2016]
Sec. 5.1105 Chief Counsel, Food and Drug Administration.
The Office of the Chief Counsel's mailing address is White Oak Bldg.
1, 10903 New Hampshire Ave., Silver Spring, MD 20993.
Sec. 5.1110 FDA public information offices.
(a) Division of Dockets Management. The Division of Dockets
Management public room is located in rm. 1061, 5630 Fishers Lane,
Rockville, MD 20852, Telephone: 301-827-6860.
(b) Freedom of Information Staff. The Freedom of Information Staff's
Public Reading Room is located at the address available on the agency's
web site at http://www.fda.gov.
(c) Press Relations Staff. Press offices are located in White Oak
Bldg. 1, 10903 New Hampshire Ave., Silver Spring, MD 20993, Telephone:
301-827-6242; and at5001 Campus Dr., College Park, MD 20740, Telephone:
301-436-2335.
[77 FR 15962, Mar. 19, 2012, as amended at 79 FR 68114, Nov. 14, 2014;
81 FR 49895, July 29, 2016]
PART 7_ENFORCEMENT POLICY--Table of Contents
Subpart A_General Provisions
Sec.
7.1 Scope.
7.3 Definitions.
7.12 Guaranty.
7.13 Suggested forms of guaranty.
Subpart B [Reserved]
Subpart C_Recalls (Including Product Corrections)_Guidance on Policy,
Procedures, and Industry Responsibilities
7.40 Recall policy.
7.41 Health hazard evaluation and recall classification.
7.42 Recall strategy.
7.45 Food and Drug Administration-requested recall.
7.46 Firm-initiated recall.
7.49 Recall communications.
7.50 Public notification of recall.
7.53 Recall status reports.
7.55 Termination of a recall.
7.59 General industry guidance.
Subpart D [Reserved]
[[Page 151]]
Subpart E_Criminal Violations
7.84 Opportunity for presentation of views before report of criminal
violation.
7.85 Conduct of a presentation of views before report of criminal
violation.
7.87 Records related to opportunities for presentation of views
conducted before report of criminal violation.
Authority: 21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n, 264.
Source: 42 FR 15567, Mar. 22, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec. 7.1 Scope.
This part governs the practices and procedures applicable to
regulatory enforcement actions initiated by the Food and Drug
Administration pursuant to the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) and other laws that it administers. This part also
provides guidance for manufacturers and distributors to follow with
respect to their voluntary removal or correction of marketed violative
products. This part is promulgated to clarify and explain the regulatory
practices and procedures of the Food and Drug Administration, enhance
public understanding, improve consumer protection, and assure uniform
and consistent application of practices and procedures throughout the
agency.
[43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000]
Sec. 7.3 Definitions.
(a) Agency means the Food and Drug Administration.
(b) Citation or cite means a document and any attachments thereto
that provide notice to a person against whom criminal prosecution is
contemplated of the opportunity to present views to the agency regarding
an alleged violation.
(c) Respondent means a person named in a notice who presents views
concerning an alleged violation either in person, by designated
representative, or in writing.
(d) Responsible individual includes those in positions of power or
authority to detect, prevent, or correct violations of the Federal Food,
Drug, and Cosmetic Act.
(e) [Reserved]
(f) Product means an article subject to the jurisdiction of the Food
and Drug Administration, including any food, drug, and device intended
for human or animal use, any cosmetic and biologic intended for human
use, any tobacco product intended for human use, and any item subject to
a quarantine regulation under part 1240 of this chapter. Product does
not include an electronic product that emits radiation and is subject to
parts 1003 and 1004 of this chapter.
(g) Recall means a firm's removal or correction of a marketed
product that the Food and Drug Administration considers to be in
violation of the laws it administers and against which the agency would
initiate legal action, e.g., seizure. Recall does not include a market
withdrawal or a stock recovery.
(h) Correction means repair, modification, adjustment, relabeling,
destruction, or inspection (including patient monitoring) of a product
without its physical removal to some other location.
(i) Recalling firm means the firm that initiates a recall or, in the
case of a Food and Drug Administration-requested recall, the firm that
has primary responsibility for the manufacture and marketing of the
product to be recalled.
(j) Market withdrawal means a firm's removal or correction of a
distributed product which involves a minor violation that would not be
subject to legal action by the Food and Drug Administration or which
involves no violation, e.g., normal stock rotation practices, routine
equipment adjustments and repairs, etc.
(k) Stock recovery means a firm's removal or correction of a product
that has not been marketed or that has not left the direct control of
the firm, i.e., the product is located on premises owned by, or under
the control of, the firm and no portion of the lot has been released for
sale or use.
(l) Recall strategy means a planned specific course of action to be
taken in conducting a specific recall, which addresses the depth of
recall, need for public warnings, and extent of effectiveness checks for
the recall.
[[Page 152]]
(m) Recall classification means the numerical designation, i.e., I,
II, or III, assigned by the Food and Drug Administration to a particular
product recall to indicate the relative degree of health hazard
presented by the product being recalled.
(1) Class I is a situation in which there is a reasonable
probability that the use of, or exposure to, a violative product will
cause serious adverse health consequences or death.
(2) Class II is a situation in which use of, or exposure to, a
violative product may cause temporary or medically reversible adverse
health consequences or where the probability of serious adverse health
consequences is remote.
(3) Class III is a situation in which use of, or exposure to, a
violative product is not likely to cause adverse health consequences.
(n) Consignee means anyone who received, purchased, or used the
product being recalled.
[42 FR 15567, Mar. 22, 1977, as amended at 43 FR 26218, June 16, 1978;
44 FR 12167, Mar. 6, 1979; 77 FR 5176, Feb. 2, 2012]
Sec. 7.12 Guaranty.
In case of the giving of a guaranty or undertaking referred to in
section 303(c)(2) or (3) of the act, each person signing such guaranty
or undertaking shall be considered to have given it.
Sec. 7.13 Suggested forms of guaranty.
(a) A guaranty or undertaking referred to in section 303(c)(2) of
the act may be:
(1) Limited to a specific shipment or other delivery of an article,
in which case it may be a part of or attached to the invoice or bill of
sale covering such shipment or delivery, or
(2) General and continuing, in which case, in its application to any
shipment or other delivery of an article, it shall be considered to have
been given at the date such article was shipped or delivered by the
person who gives the guaranty or undertaking.
(b) The following are suggested forms of guaranty or undertaking
under section 303(c)(2) of the act:
(1) Limited form for use on invoice or bill of sale.
(Name of person giving the guaranty or undertaking) hereby
guarantees that no article listed herein is adulterated or misbranded
within the meaning of the Federal Food, Drug, and Cosmetic Act, or is an
article which may not, under the provisions of section 404, 505, or 512
of the act, be introduced into interstate commerce.
(Signature and post-office address of person giving the guaranty or
undertaking.)
(2) General and continuing form.
The article comprising each shipment or other delivery hereafter
made by (name of person giving the guaranty or undertaking) to, or in
the order of (name and post-office address of person to whom the
guaranty or undertaking is given) is hereby guaranteed, as of the date
of such shipment or delivery, to be, on such date, not adulterated or
misbranded within the meaning of the Federal Food, Drug, and Cosmetic
Act, and not an article which may not, under the provisions of section
404, 505, or 512 of the act, be introduced into interstate commerce.
(Signature and post-office address of person giving the guaranty of
undertaking.)
(c) The application of a guaranty or undertaking referred to in
section 303(c)(2) of the act to any shipment or other delivery of an
article shall expire when such article, after shipment or delivery by
the person who gave such guaranty or undertaking, becomes adulterated or
misbranded within the meaning of the act, or becomes an article which
may not, under the provisions of section 404, 505, or 512 of the act, be
introduced into interstate commerce.
(d) A guaranty or undertaking referred to in section 303(c)(3) of
the act shall state that the shipment or other delivery of the color
additive covered thereby was manufactured by a signer thereof. It may be
a part of or attached to the invoice or bill of sale covering such
color. If such shipment or delivery is from a foreign manufacturer, such
guaranty or undertaking shall be signed by such manufacturer and by an
agent of such manufacturer who resides in the United States.
(e) The following are suggested forms of guaranty or undertaking
under section 303(c)(3) of the act:
(1) For domestic manufacturers:
(Name of manufacturer) hereby guarantees that all color additives
listed herein were manufactured by him, and (where color additive
regulations require certification) are from batches certified in
accordance with the applicable regulations promulgated
[[Page 153]]
under the Federal Food, Drug, and Cosmetic Act.
(Signature and post-office address of manufacturer.)
(2) For foreign manufacturers:
(Name of manufacturer and agent) hereby severally guarantee that all
color additives listed herein were manufactured by (name of
manufacturer), and (where color additive regulations require
certification) are from batches certified in accordance with the
applicable regulations promulgated under the Federal Food, Drug, and
Cosmetic Act.
(Signature and post-office address of manufacturer.)
(Signature and post-office address of agent.)
(f) For the purpose of a guaranty or undertaking under section
303(c)(3) of the act the manufacturer of a shipment or other delivery of
a color additive is the person who packaged such color.
(g) A guaranty or undertaking, if signed by two or more persons,
shall state that such persons severally guarantee the article to which
it applies.
(h) No representation or suggestion that an article is guaranteed
under the act shall be made in labeling.
Subpart B [Reserved]
Subpart C_Recalls (Including Product Corrections)_Guidance on Policy,
Procedures, and Industry Responsibilities
Source: 43 FR 26218, June 16, 1978, unless otherwise noted.
Sec. 7.40 Recall policy.
(a) Recall is an effective method of removing or correcting consumer
products that are in violation of laws administered by the Food and Drug
Administration. Recall is a voluntary action that takes place because
manufacturers and distributors carry out their responsibility to protect
the public health and well-being from products that present a risk of
injury or gross deception or are otherwise defective. This section and
Secs. 7.41 through 7.59 recognize the voluntary nature of recall by
providing guidance so that responsible firms may effectively discharge
their recall responsibilities. These sections also recognize that recall
is an alternative to a Food and Drug Administration-initiated court
action for removing or correcting violative, distributed products by
setting forth specific recall procedures for the Food and Drug
Administration to monitor recalls and assess the adequacy of a firm's
efforts in recall.
(b) Recall may be undertaken voluntarily and at any time by
manufacturers and distributors, or at the request of the Food and Drug
Administration. A request by the Food and Drug Administration that a
firm recall a product is reserved for urgent situations and is to be
directed to the firm that has primary responsibility for the manufacture
and marketing of the product that is to be recalled.
(c) Recall is generally more appropriate and affords better
protection for consumers than seizure, when many lots of product have
been widely distributed. Seizure, multiple seizure, or other court
action is indicated when a firm refuses to undertake a recall requested
by the Food and Drug Administration, or where the agency has reason to
believe that a recall would not be effective, determines that a recall
is ineffective, or discovers that a violation is continuing.
[43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000]
Sec. 7.41 Health hazard evaluation and recall classification.
(a) An evaluation of the health hazard presented by a product being
recalled or considered for recall will be conducted by an ad hoc
committee of Food and Drug Administration scientists and will take into
account, but need not be limited to, the following factors:
(1) Whether any disease or injuries have already occurred from the
use of the product.
(2) Whether any existing conditions could contribute to a clinical
situation that could expose humans or animals to a health hazard. Any
conclusion shall be supported as completely as possible by scientific
documentation and/or statements that the conclusion is the opinion of
the individual(s) making the health hazard determination.
(3) Assessment of hazard to various segments of the population,
e.g., children, surgical patients, pets, livestock,
[[Page 154]]
etc., who are expected to be exposed to the product being considered,
with particular attention paid to the hazard to those individuals who
may be at greatest risk.
(4) Assessment of the degree of seriousness of the health hazard to
which the populations at risk would be exposed.
(5) Assessment of the likelihood of occurrence of the hazard.
(6) Assessment of the consequences (immediate or long-range) of
occurrence of the hazard.
(b) On the basis of this determination, the Food and Drug
Administration will assign the recall a classification, i.e., Class I,
Class II, or Class III, to indicate the relative degree of health hazard
of the product being recalled or considered for recall.
Sec. 7.42 Recall strategy.
(a) General. (1) A recall strategy that takes into account the
following factors will be developed by the agency for a Food and Drug
Administration-requested recall and by the recalling firm for a firm-
initiated recall to suit the individual circumstances of the particular
recall:
(i) Results of health hazard evaluation.
(ii) Ease in identifying the product.
(iii) Degree to which the product's deficiency is obvious to the
consumer or user.
(iv) Degree to which the product remains unused in the market-place.
(v) Continued availability of essential products.
(2) The Food and Drug Administration will review the adequacy of a
proposed recall strategy developed by a recalling firm and recommend
changes as appropriate. A recalling firm should conduct the recall in
accordance with an approved recall strategy but need not delay
initiation of a recall pending review of its recall strategy.
(b) Elements of a recall strategy. A recall strategy will address
the following elements regarding the conduct of the recall:
(1) Depth of recall. Depending on the product's degree of hazard and
extent of distribution, the recall strategy will specify the level in
the distribution chain to which the recall is to extend, as follows:
(i) Consumer or user level, which may vary with product, including
any intermediate wholesale or retail level; or
(ii) Retail level, including any intermediate wholesale level; or
(iii) Wholesale level.
(2) Public warning. The purpose of a public warning is to alert the
public that a product being recalled presents a serious hazard to
health. It is reserved for urgent situations where other means for
preventing use of the recalled product appear inadequate. The Food and
Drug Administration in consultation with the recalling firm will
ordinarily issue such publicity. The recalling firm that decides to
issue its own public warning is requested to submit its proposed public
warning and plan for distribution of the warning for review and comment
by the Food and Drug Administration. The recall strategy will specify
whether a public warning is needed and whether it will issue as:
(i) General public warning through the general news media, either
national or local as appropriate, or
(ii) Public warning through specialized news media, e.g.,
professional or trade press, or to specific segments of the population
such as physicians, hospitals, etc.
(3) Effectiveness checks. The purpose of effectiveness checks is to
verify that all consignees at the recall depth specified by the strategy
have received notification about the recall and have taken appropriate
action. The method for contacting consignees may be accomplished by
personal visits, telephone calls, letters, or a combination thereof. A
guide entitled ``Methods for Conducting Recall Effectiveness Checks''
that describes the use of these different methods is available upon
request from the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The
recalling firm will ordinarily be responsible for conducting
effectiveness checks, but the Food and Drug Administration will assist
in this task where necessary and appropriate. The recall strategy will
specify the method(s) to be used for
[[Page 155]]
and the level of effectiveness checks that will be conducted, as
follows:
(i) Level A--100 percent of the total number of consignees to be
contacted;
(ii) Level B--Some percentage of the total number of consignees to
be contacted, which percentage is to be determined on a case-by-case
basis, but is greater that 10 percent and less than 100 percent of the
total number of consignees;
(iii) Level C--10 percent of the total number of consignees to be
contacted;
(iv) Level D--2 percent of the total number of consignees to be
contacted; or
(v) Level E--No effectiveness checks.
[43 FR 26218, June 16, 1978, as amended at 46 FR 8455, Jan. 27, 1981; 59
FR 14363, Mar. 28, 1994; 68 FR 24879, May 9, 2003]
Sec. 7.45 Food and Drug Administration-requested recall.
(a) The Commissioner of Food and Drugs or designee may request a
firm to initiate a recall when the following determinations have been
made:
(1) That a product that has been distributed presents a risk of
illness or injury or gross consumer deception.
(2) That the firm has not initiated a recall of the product.
(3) That an agency action is necessary to protect the public health
and welfare.
(b) The Commissioner or his designee will notify the firm of this
determination and of the need to begin immediately a recall of the
product. Such notification will be by letter or telegram to a
responsible official of the firm, but may be preceded by oral
communication or by a visit from an authorized representative of the
local Food and Drug Administration district office, with formal, written
confirmation from the Commissioner or his designee afterward. The
notification will specify the violation, the health hazard
classification of the violative product, the recall strategy, and other
appropriate instructions for conducting the recall.
(c) Upon receipt of a request to recall, the firm may be asked to
provide the Food and Drug Administration any or all of the information
listed in Sec. 7.46(a). The firm, upon agreeing to the recall request,
may also provide other information relevant to the agency's
determination of the need for the recall or how the recall should be
conducted.
[43 FR 26218, June 16, 1978, as amended at 69 FR 17290, Apr. 2, 2004]