[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Rules and Regulations]
[Pages 12490-12491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 112, 117, and 507

[Docket Nos. FDA-2011-N-0920, FDA-2011-N-0921, and FDA-2011-N-0922]
RIN 0910-AG10, 0910-AG35, and 0910-AG36


Implementing the Food and Drug Administration Food Safety 
Modernization Act; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
correcting with technical amendments two final rules that published in 
the Federal Register of September 17, 2015, and one final rule that 
published in the Federal Register of November 27, 2015. The final rules 
published with editorial and inadvertent errors. This document corrects 
those errors.

DATES: Effective April 2, 2019.

FOR FURTHER INFORMATION CONTACT: Sylvia Kim, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, 301-796-7599.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 17, 
2015 (80 FR 55908 and 80 FR 56170), FDA published the final rules 
``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Human Food'' and ``Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food 
for Animals'' with editorial and inadvertent errors in the regulatory 
text. In the Federal Register of November 27, 2015 (80 FR 74354), FDA 
published the final rule ``Standards for the Growing, Harvesting, 
Packing, and Holding of Produce for Human Consumption'' with editorial 
and inadvertent errors in the regulatory text. This action is being 
taken to correct those editorial and inadvertent errors.

List of Subjects

21 CFR Part 112

    Foods, fruits and vegetables, Incorporation by reference, Packaging 
and containers, Recordkeeping requirements, Safety.

21 CFR Part 117

    Food packaging, Foods.

21 CFR Part 507

    Animal foods, Labeling, Packaging and containers, Reporting and 
recordkeeping requirements.

PART 112--STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND 
HOLDING OF PRODUCE FOR HUMAN CONSUMPTION

0
1. The authority citation for part 112 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 
264, 271.

0
2. In Sec.  112.4, revise paragraph (a) to read as follows:


Sec.  112.4  Which farms are subject to the requirements of this part?

    (a) Except as provided in paragraph (b) of this section, a farm or 
farm mixed-type facility with an average annual monetary value of 
produce (as ``produce'' is defined in Sec.  112.3) sold during the 
previous 3-year period of more than $25,000 (on a rolling basis), 
adjusted for inflation using 2011 as the baseline year for calculating 
the adjustment, is a ``covered farm'' subject to this part. Covered 
farms subject to this part must comply with all applicable requirements 
of this part when conducting a covered activity on covered produce.
* * * * *

0
3. In Sec.  112.5, revise paragraphs (a)(1) and (2) to read as follows:


Sec.  112.5   Which farms are eligible for a qualified exemption and 
associated modified requirements based on average monetary value of all 
food sold and direct farm marketing?

    (a) * * *
    (1) During the previous 3-year period preceding the applicable 
calendar year, the average annual monetary value of the food (as 
defined in Sec.  112.3) the farm sold directly to qualified end-users 
(as defined in Sec.  112.3) during such period exceeded the average 
annual monetary value of the food the farm sold to all other buyers 
during that period; and
    (2) The average annual monetary value of all food (as defined in 
Sec.  112.3) the farm sold during the 3-year period preceding the 
applicable calendar year

[[Page 12491]]

was less than $500,000, adjusted for inflation.
* * * * *

0
4. In Sec.  112.161, revise paragraph (b) to read as follows:


Sec.  112.161   What general requirements apply to records required 
under this part?

* * * * *
    (b) Records required under Sec. Sec.  112.7(b), 112.30(b), 
112.50(b)(2), (4), and (6), 112.60(b)(2), 112.140(b)(1) and (2), and 
112.150(b)(1), (4), and (6), must be reviewed, dated, and signed, 
within a reasonable time after the records are made, by a supervisor or 
responsible party.

PART 117--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND 
RISK-BASED PREVENTIVE CONTROS FOR HUMAN FOOD

0
5. The authority citation for part 117 continues to read as follows:

    Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 
371, 374; 42 U.S.C. 243, 264, 271.

0
6. In Sec.  117.126, revise paragraph (b)(5) to read as follows:


Sec.  117.126  Food safety plan.

* * * * *
    (b) * * *
    (5) The written procedures for monitoring the implementation of the 
preventive controls as required by Sec.  117.145(a);
* * * * *

PART 507--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND 
RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS

0
7. The authority citation for part 507 continues to read as follows:

    Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 
371, 374; 42 U.S.C. 243, 264, 271.

0
8. In Sec.  507.31, revise paragraph (c)(5) to read as follows:


Sec.  507.31   Food safety plan.

* * * * *
    (c) * * *
    (5) The written procedures for monitoring the implementation of the 
preventive controls as required by Sec.  507.40(a);
* * * * *

0
9. In Sec.  507.130, revise paragraph (c)(2)(ii) to read as follows:


Sec.  507.130   Conducting supplier verification activities for raw 
materials and other ingredients.

* * * * *
    (c) * * *
    (2) * * *
    (ii) A statement that the facility is in compliance with State, 
local, county, tribal, or other applicable non-Federal food safety 
laws, including relevant laws and regulations of foreign countries.
* * * * *

    Dated: March 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06141 Filed 4-1-19; 8:45 am]
 BILLING CODE 4164-01-P


