[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