81 FR 25326 - Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 82 (April 28, 2016)

Page Range		25326-25328
FR Document		2016-09784

The Food and Drug Administration (FDA) is amending a final rule published in the Federal Register of November 27, 2015. That final rule established requirements for importers to verify that food they import into the United States is produced consistent with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling. The final rule published with some editorial and inadvertent errors. This document corrects those errors.

Federal Register, Volume 81 Issue 82 (Thursday, April 28, 2016)

[Federal Register Volume 81, Number 82 (Thursday, April 28, 2016)]
[Rules and Regulations]
[Pages 25326-25328]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-09784]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2011-N-0143]
RIN 0910-AG64


Foreign Supplier Verification Programs for Importers of Food for 
Humans and Animals; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending a final 
rule published in the Federal Register of November 27, 2015. That final 
rule established requirements for importers to verify that food they 
import into the United States is produced consistent with the hazard 
analysis and risk-based preventive controls and standards for produce 
safety provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act), is not adulterated, and is not misbranded with respect to food 
allergen labeling. The final rule published with some editorial and 
inadvertent errors. This document corrects those errors.

DATES: Effective April 28, 2016.

FOR FURTHER INFORMATION CONTACT: Brian Pendleton, Office of Policy, 
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, 
MD 20993-0002, 301-796-4614, email: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of November 27, 2015 
(80 FR 74226), FDA published the final rule ``Foreign Supplier 
Verification Programs for Importers of Food for Humans and Animals'' 
with some editorial and inadvertent errors. We are taking this action 
to correct inadvertent errors in the preamble to the final rule

[[Page 25327]]

and to improve the accuracy of the provisions added to the Code of 
Federal Regulations.
    1. On page 74271, in the second paragraph of section III.E.5, in 
the discussion of allowing importers to obtain certain information 
needed to meet their FSVP requirements from other entities as described 
in certain sections of the document, the reference to ``sections 
III.E.5, III.F.4, and III.G.4'' is corrected to read ``sections 
III.A.7, III.F.4, and III.G.4''.
    2. On page 74332, in the third column, in the second ``bullet'' 
point in Response 334, ``For the importation of food from a supplier 
that is subject to the preventive controls regulations for human food 
or animal food or the produce safety regulation, 6 months after the 
foreign supplier of the food is required to comply with the relevant 
regulations;'' is corrected to read ``For the importation of food from 
a supplier that is subject to the preventive controls regulation for 
human food, the preventive controls or CGMP requirements in the 
preventive controls regulation for animal food, or the produce safety 
regulation, 6 months after the foreign supplier of the food is required 
to comply with the relevant regulations;''.

List of Subjects in 21 CFR Part 1

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

PART 1--GENERAL ENFORCEMENT REGULATIONS

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

    Authority:  15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 
350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 
374, 381, 382, 384a, 384b, 384d, 387, 387a, 387c, 393; 42 U.S.C. 
216, 241, 243, 262, 264, 271.


0
2. Amend Sec.  1.500 by revising the definitions of ``Environmental 
pathogen'', ``Harvesting'', and ``Manufacturing/processing'' to read as 
follows:


Sec.  1.500  What definitions apply to this subpart?

* * * * *
    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.
* * * * *
    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.
* * * * *
    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.
* * * * *

0
3. Revise the section heading of Sec.  1.501 to read as follows:


Sec.  1.501  To what foods do the requirements in this subpart apply?

* * * * *

0
4. Revise the section heading and the paragraph headings in paragraphs 
(a) and (b) of Sec.  1.511 to read as follows:


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. * * *
    (b) Importers whose customer is subject to certain requirements in 
the dietary supplement current good manufacturing practice regulation. 
* * *
* * * * *

0
5. In Sec.  1.512, revise the first sentence of paragraphs (b)(3)(ii) 
introductory text and (c)(1)(i) and revise paragraphs (b)(3)(iii) and 
(iv) to read as follows:


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?

* * * * *
    (b) * * *
    (3) * * *
    (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). * * *
* * * * *
    (iii) If your foreign supplier is a farm that grows produce and is 
not a covered farm under part 112 of this chapter in accordance with 
Sec.  112.4(a) of this chapter, or in accordance with Sec. Sec.  
112.4(b) and 112.5 of this chapter, and you choose to comply with the 
requirements in this section, you must obtain written assurance, before 
importing the produce and at least every 2 years thereafter, that the 
farm acknowledges that its food is subject to section 402 of the 
Federal Food, Drug, and Cosmetic Act (or, when applicable, that its 
food is subject to relevant laws

[[Page 25328]]

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).
* * * * *
    (c) * * *
    (1) * * *
    (i) 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. * * *
* * * * *

    Dated: April 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09784 Filed 4-27-16; 8:45 am]
 BILLING CODE 4164-01-P

25326 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Rules and Regulations

2012), 77 FR 69738 (Nov. 21, 2012), 77 Register approves this incorporation by ‘‘That airspace extending upward from
FR 70105 (Nov. 23, 2012), 78 FR 4726 reference action under Title 1, Code of 1,200 feet above the surface bounded by a
(Jan. 22, 2013), 78 FR 6408 (Jan. 30, Federal Regulations, part 51, subject to line beginning at lat. 46°41′00″ N., long.
2013), 78 FR 6856 (Jan. 31, 2013), 78 FR the annual revision of FAA Order 114°08′00″ W.; to lat. 47°03′00″ N., long.
113°33′00″ W.; to lat. 46°28′00″ N., long.
10368 (Feb. 13, 2013), 78 FR 10902 (Feb. 7400.9 and publication of conforming 112°15′00″ W.; to lat. 45°41′00″ N., long.
14, 2013), 78 FR 11280 (Feb. 15, 2013), amendments. 112°13′00″ W.; to lat. 45°44′00″ N., long.
78 FR 18795 (Mar. 28, 2013), 78 FR FOR FURTHER INFORMATION CONTACT: 113°03′00″ W.; thence to the point of origin.’’
25818 (May 3, 2013), 78 FR 30739 (May Richard Roberts, Operations Support Issued in Seattle, Washington, on_April 18,
23, 2013), 78 FR 32547 (May 31, 2013), Group, Western Service Center, Federal 2016.
78 FR 35430 (June 12, 2013), 78 FR Aviation Administration, P.O. Box Tracey Johnson,
44686 (July 24, 2013), 78 FR 45842 (July 20636, Atlanta, Georgia 30320;
30, 2013), 78 FR 60382 (Oct. 1, 2013), Manager, Operations Support Group, Western
telephone (425) 203–4517. Service Center.
78 FR 62993 (Oct. 23, 2013), 78 FR SUPPLEMENTARY INFORMATION: [FR Doc. 2016–09699 Filed 4–27–16; 8:45 am]
70194 (Nov. 25, 2013), 78 FR 76033
(Dec. 16, 2013), 78 FR 78520 (Dec. 26, History BILLING CODE 4910–13–P

2013), 78 FR 79286 (Dec. 30, 2013), 78 The FAA published a final rule in the
FR 79730 (Dec. 31, 2013), 79 FR 41631 Federal Register amending Class E
(July 17, 2014), 79 FR 48015 (Aug. 15, DEPARTMENT OF HEALTH AND
Airspace extending upward from 700
2014), 79 FR 56483 (Sept. 22, 2014), 79 HUMAN SERVICES
feet above the surface at Deer Lodge-
FR 65300 (Nov. 3, 2014), 79 FR 77855 City-County Airport, Deer Lodge, MT.
(Dec. 29, 2014), 79 FR 78296 (Dec. 30, Food and Drug Administration
(81 FR 17377, March 29, 2016) Docket
2014), 80 FR 8767 (Feb. 19, 2015), 80 FR No. FAA–2015–3773. Subsequent to
21153 (Apr. 17, 2015), 80 FR 22091 21 CFR Part 1
publication, the Aeronautical
(Apr. 21, 2015), 80 FR 32658 (June 9, Information Services branch identified [Docket No. FDA–2011–N–0143]
2015), 80 FR 43911 (July 24, 2015), 80 that the Class E airspace extending RIN 0910–AG64
FR 56895 (Sept. 21, 2015), 80 FR 59944 upward from 1,200 feet above the
(Oct. 2, 2015), 80 FR 73943 (Nov. 27, surface was inadvertently left out of the Foreign Supplier Verification Programs
2015), 80 FR 73947 (Nov. 27, 2015), 80 regulatory text describing the boundary for Importers of Food for Humans and
FR 79674 (Dec. 23, 2015), 80 FR 80228 for the airport. This action reestablishes Animals; Technical Amendment
(Dec. 24, 2015), 81 FR 7032 (Feb. 10, the airspace extending upward from
2016), and 81 FR 16074 (Mar. 25, 2016); 1,200 feet above the surface as part of AGENCY: Food and Drug Administration,
and N. 76 FR 79276 (Dec. 21, 2011). that description. HHS.
Dated: April 12, 2016. Class E airspace designations are Final rule; technical
ACTION:
Richard Cordray, published in paragraph 6005, of FAA amendment.
Director, Bureau of Consumer Financial Order 7400.9Z, dated August 6, 2015,
SUMMARY: The Food and Drug
Protection. and effective September 15, 2015, which
Administration (FDA) is amending a
[FR Doc. 2016–09431 Filed 4–27–16; 8:45 am] is incorporated by reference in 14 CFR
final rule published in the Federal
71.1. The Class E airspace designations
BILLING CODE 4810–AM–P Register of November 27, 2015. That
listed in this document will be
final rule established requirements for
published subsequently in the Order.
importers to verify that food they import
DEPARTMENT OF TRANSPORTATION Availability and Summary of into the United States is produced
Documents for Incorporation by consistent with the hazard analysis and
Federal Aviation Administration Reference risk-based preventive controls and
This document amends FAA Order standards for produce safety provisions
14 CFR Part 71 of the Federal Food, Drug, and Cosmetic
7400.9Z, Airspace Designations and
[Docket No. FAA–2015–3773; Airspace Reporting Points, dated August 6, 2015, Act (the FD&C Act), is not adulterated,
Docket No. 15–ANM–22] and effective September 15, 2015. and is not misbranded with respect to
Availability information for FAA Order food allergen labeling. The final rule
Amendment of Class E Airspace; Deer 7400.9Z can be found in the original published with some editorial and
Lodge MT final rule (81 FR 17377, March 29, inadvertent errors. This document
2016). FAA Order 7400.9Z lists Class A, corrects those errors.
AGENCY: Federal Aviation
Administration (FAA), DOT. B, C, D, and E airspace areas, air traffic DATES: Effective April 28, 2016.

ACTION: Final rule, correction.
service routes, and reporting points. FOR FURTHER INFORMATION CONTACT:
Correction to Final Rule Brian Pendleton, Office of Policy, Food
SUMMARY: This action corrects a final and Drug Administration, 10903 New
rule published in the Federal Register Accordingly, pursuant to the Hampshire Ave., Silver Spring, MD
of March 29, 2016, amending Class E authority delegated to me, in the 20993–0002, 301–796–4614, email:
airspace extending upward from 700 Federal Register of March 29, 2016 (81 brian.pendleton@fda.hhs.gov.
feet above the surface at Deer Lodge- FR 17377) FR Doc. 2016–06934, SUPPLEMENTARY INFORMATION: In the
Amendment of Class E Airspace; Deer
asabaliauskas on DSK3SPTVN1PROD with RULES

City-County Airport, Deer Lodge, MT. Federal Register of November 27, 2015
The FAA identified that the Class E Lodge, MT, is corrected as follows: (80 FR 74226), FDA published the final
airspace area extending upward from § 71.1 [Amended] rule ‘‘Foreign Supplier Verification
1,200 feet above the surface was omitted Programs for Importers of Food for
from the Class E airspace description for ANM MT E5 Deer Lodge, MT Humans and Animals’’ with some
the airport. [Corrected] editorial and inadvertent errors. We are
DATES: Effective 0901 UTC, May 26, On page 17378, column 3, after line taking this action to correct inadvertent
2016. The Director of the Federal 48, add the following text: errors in the preamble to the final rule

VerDate Sep<11>2014 16:16 Apr 27, 2016 Jkt 238001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\28APR1.SGM 28APR1

25328 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Rules and Regulations

and regulations of a country whose food application-related actions for new ACTION: Final regulations.
safety system FDA has officially animal drug applications (NADAs) and
recognized as comparable or determined abbreviated new animal drug SUMMARY: This document contains final
to be equivalent to that of the United applications (ANADAs) during January regulations relating to the penalty under
States). and February 2016. That rule included section 6708 of the Internal Revenue
(iv) If your foreign supplier is a shell two amendatory instructions that cited Code for failing to make available lists
egg producer that is not subject to the incorrect sections of 21 CFR part 524. of advisees with respect to reportable
requirements of part 118 of this chapter DATES: Effective: April 28, 2016.
transactions. Section 6708 imposes a
because it has fewer than 3,000 laying penalty upon material advisors for
FOR FURTHER INFORMATION CONTACT:
hens and you choose to comply with the failing to make available to the
George K. Haibel, Center for Veterinary
requirements in this section, you must Secretary, upon written request, the list
Medicine (HFV–6), Food and Drug
obtain written assurance, before required to be maintained by section
Administration, 7519 Standish Pl.,
importing the shell eggs and at least 6112 of the Internal Revenue Code
Rockville, MD 20855, 240–402–5689,
every 2 years thereafter, that the shell within 20 business days after the date of
george.haibel@fda.hhs.gov.
egg producer acknowledges that its food such request. The final regulations
SUPPLEMENTARY INFORMATION: In FR Doc. primarily affect individuals and entities
is subject to section 402 of the Federal 2016–08827, appearing on page 22520
Food, Drug, and Cosmetic Act (or, when who are material advisors, as defined in
in the Federal Register of Monday, section 6111 of the Internal Revenue
applicable, that its food is subject to April 18, 2016, the following corrections
relevant laws and regulations of a Code.
are made:
country whose food safety system FDA On page 22524, in the third column, DATES: Effective Date: These regulations
has officially recognized as comparable remove amendatory instructions 35 and are effective on April 28, 2016.
or determined to be equivalent to that of 36. Applicability Date: For date of
the United States). applicability see § 301.6708–1(i).
* * * * * List of Subjects in 21 CFR Part 524
FOR FURTHER INFORMATION CONTACT:
(c) * * * Animal drugs. Hilary March, (202) 317–5406 (not a
(1) * * * Accordingly, 21 CFR part 524 is toll-free number).
(i) Except as specified in paragraph corrected by making the following SUPPLEMENTARY INFORMATION:
(c)(1)(iii) of this section, in approving correcting amendments:
your foreign suppliers, you must Paperwork Reduction Act
evaluate the applicable FDA food safety PART 524—OPHTHALMIC AND The collection of information
regulations and information relevant to TOPICAL DOSAGE FORM NEW contained in these final regulations has
the foreign supplier’s compliance with ANIMAL DRUGS been reviewed and approved by the
those regulations, including whether the Office of Management and Budget in
foreign supplier is the subject of an FDA ■ 1. The authority citation for part 524
continues to read as follows: accordance with the Paperwork
warning letter, import alert, or other Reduction Act of 1995 (44 U.S.C.
FDA compliance action related to food Authority: 21 U.S.C. 360b. 3507(d)) under control number 1545–
safety, and document the evaluation. 2245.
§ 524.1193 [Amended]
* * * The collection of information in the
* * * * * ■ 2. In paragraph (b)(2) of § 524.1193, final regulations is in § 301.6708–
remove ‘‘000859’’ and in its place add 1(c)(3)(ii). This information is required
Dated: April 21, 2016. ‘‘016592’’.
Leslie Kux, for the IRS to determine whether good
§ 524.1484k [Amended] cause exists to allow a person affected
Associate Commissioner for Policy.
■ 3. In § 524.1484k, revise the section by these regulations an extension of the
[FR Doc. 2016–09784 Filed 4–27–16; 8:45 am]
heading to read: Neomycin and legislatively established 20-business-day
BILLING CODE 4164–01–P
prednisolone suspension. period to furnish a lawfully requested
list to the IRS. The collection of
Dated: April 22, 2016. information is voluntary to obtain a
DEPARTMENT OF HEALTH AND Tracey Forfa, benefit. The likely respondents are
HUMAN SERVICES Acting Director, Center for Veterinary persons (individuals and entities) who
Medicine. qualify as material advisors, as defined
Food and Drug Administration
[FR Doc. 2016–09865 Filed 4–27–16; 8:45 am] in section 6111, who are unable to
21 CFR Part 524 BILLING CODE 4164–01–P respond to a valid and statutorily
authorized section 6112 list request
[Docket No. FDA–2016–N–0002] within the statutory period of time
DEPARTMENT OF THE TREASURY provided by section 6708.
New Animal Drugs; Approval of New An agency may not conduct or
Animal Drug Applications; Changes of Internal Revenue Service sponsor, and a person is not required to
Sponsorship; Correction respond to, a collection of information
AGENCY: Food and Drug Administration, 26 CFR Part 301 unless it displays a valid control
HHS. [TD 9764] number.
asabaliauskas on DSK3SPTVN1PROD with RULES

Final rule; technical
ACTION: Books and records relating to a
RIN 1545–BF39 collection of information must be
amendment; correcting amendments.
retained as long as their contents might
Section 6708 Failure To Maintain List
SUMMARY: The Food and Drug become material in the administration
of Advisees With Respect to
Administration (FDA) published a of any internal revenue law. Generally,
Reportable Transactions
document in the Federal Register of tax returns and tax return information
April 18, 2016 (81 FR 22520), amending AGENCY: Internal Revenue Service (IRS), are confidential, as required by section
the animal drug regulations to reflect Treasury. 6103 of the Internal Revenue Code.

VerDate Sep<11>2014 16:16 Apr 27, 2016 Jkt 238001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\28APR1.SGM 28APR1

Document Created: 2016-04-28 01:05:14
Document Modified: 2016-04-28 01:05:14

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule; technical amendment.
Dates		Effective April 28, 2016.
Contact		Brian Pendleton, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4614, email: [email protected]
FR Citation		81 FR 25326
RIN Number		0910-AG64
CFR Associated		Cosmetics; Drugs; Exports; Food Labeling; Imports; Labeling and Reporting and Recordkeeping Requirements

81 FR 25326 - Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 82 (April 28, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration