
[Federal Register Volume 81, Number 82 (Thursday, April 28, 2016)]
[Rules and Regulations]
[Pages 25326-25328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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: brian.pendleton@fda.hhs.gov.

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


