Notice2022-03224
Compliance Policy Guide Sec. 510.800 Beverages-Serving Size Labeling; Compliance Policy Guide Sec. 540.420 Raw Breaded Shrimp-Microbiological Criteria for Evaluating Compliance With Current Good Manufacturing Practice Regulations; and Compliance Policy Guide Sec. 562.800 Vending Machine Food-Labeling; Withdrawal of Guidances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 15, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the withdrawal of three compliance policy guides (CPG) entitled "Compliance Policy Guide Sec. 510.800 Beverages--Serving Size Labeling," "Compliance Policy Guide Sec. 540.420 Raw Breaded Shrimp-- Microbiological Criteria for Evaluating Compliance with Current Good Manufacturing Practice Regulations," and "Compliance Policy Guide Sec. 562.800 Vending Machine Food--Labeling." We are withdrawing these CPGs because they have become outdated or have been superseded by subsequent FDA actions.
Full Text
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<title>Federal Register, Volume 87 Issue 31 (Tuesday, February 15, 2022)</title>
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[Federal Register Volume 87, Number 31 (Tuesday, February 15, 2022)]
[Notices]
[Pages 8592-8593]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03224]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2010-D-0575 and FDA-2021-N-0764]
Compliance Policy Guide Sec. 510.800 Beverages--Serving Size
Labeling; Compliance Policy Guide Sec. 540.420 Raw Breaded Shrimp--
Microbiological Criteria for Evaluating Compliance With Current Good
Manufacturing Practice Regulations; and Compliance Policy Guide Sec.
562.800 Vending Machine Food--Labeling; Withdrawal of Guidances
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
withdrawal of three compliance policy guides (CPG) entitled
``Compliance Policy Guide Sec. 510.800 Beverages--Serving Size
Labeling,'' ``Compliance Policy Guide Sec. 540.420 Raw Breaded Shrimp--
Microbiological Criteria for Evaluating Compliance with Current Good
Manufacturing Practice Regulations,'' and ``Compliance Policy Guide
Sec. 562.800 Vending Machine Food--Labeling.'' We are withdrawing these
CPGs because they have become outdated or have been superseded by
subsequent FDA actions.
DATES: The withdrawal is applicable February 15, 2022.
ADDRESSES: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
and insert docket number FDA-2010-D-0575 for ``Compliance Policy Guide
Sec. 510.800 Beverages--Serving Size Labeling'' or FDA-2021-N-0764 for
``Compliance Policy Guide Sec. 540.420 Raw Breaded Shrimp--
Microbiological Criteria for Evaluating Compliance with Current Good
Manufacturing Practice Regulations'' and ``Compliance Policy Guide Sec.
562.800 Vending Machine Food--Labeling'' into the ``Search'' box and
follow the prompts and/or go to the Dockets Management Staff, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Kevin Kwon, Office of Compliance (HFS-
605), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-4597;
or Alexandra Jurewitz, Office of Regulations and Policy (HFS-024),
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the withdrawal of three CPGs entitled
``Compliance Policy Guide Sec. 510.800 Beverages--Serving Size
Labeling,'' ``Compliance Policy Guide Sec. 540.420 Raw Breaded Shrimp--
Microbiological Criteria for Evaluating Compliance with Current Good
Manufacturing Practice Regulations,'' and ``Compliance Policy Guide
Sec. 562.800 Vending Machine Food--Labeling.''
CPG Sec. 510.800 entitled ``Beverages--Serving Size Labeling'' was
first issued in December 2010. This CPG provided guidance for FDA staff
and industry as to when we would typically consider not taking
enforcement action in connection to a ``12 [fluid ounce] (360
[milliliter])'' labeled serving size on specific types of beverages
larger than 20 fluid ounces. On May 27, 2016, FDA issued a final rule
entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be
Consumed at One Eating Occasion; Dual-Column Labeling; Updating,
Modifying, and Establishing Certain Reference Amounts Customarily
Consumed; Serving Size for Breath Mints; and Technical Amendments'' (81
FR 34000). The final rule amended the Reference Amounts Customarily
Consumed (RACCs) that are used by manufacturers to determine serving
sizes for certain foods, including certain beverages. Our regulations,
at 21 CFR 101.12(b), table 2, lists the categories for each type of
food product and each category's current RACC. Due to the updated RACCs
for certain beverages, CPG Sec. 510.800 is now obsolete, and the
enforcement discretion provided in this CPG is no longer applicable.
Therefore, CPG Sec. 510.800 is being withdrawn.
CPG Sec. 540.420 entitled ``Raw Breaded Shrimp--Microbiological
Criteria for Evaluating Compliance with Current Good Manufacturing
Practice Regulations'' was first issued in August 1983. This CPG used
data collected in fiscal year 1978 and listed an outdated sampling and
compliance structure. The compliance criteria and the methodology used
in the CPG have become outdated and are no longer useful. This CPG is
superseded by the
[[Page 8593]]
Seafood Hazard Analysis Critical Control Point regulation in 21 CFR
part 123. Seafood processors must prevent food safety hazards using
critical controls and appropriate verification activities, such as end-
product and in-process testing (21 CFR part 123). This CPG is also
superseded by FDA's Fish and Fishery Products Hazards and Controls
Guidance (Ref. 1), which describes controls for food safety hazards
related to breaded shrimp. For these reasons, CPG Sec. 540.420 is now
obsolete and is being withdrawn.
CPG 562.800 entitled ``Vending Machine Food--Labeling'' was first
issued in September 1976. This CPG provided guidance for FDA staff and
industry regarding certain mandatory label information for foods and
beverages dispensed in vending machines after movement in interstate
commerce.
On March 23, 2010, President Obama signed the Patient Protection
and Affordable Care Act of 2010 (ACA; Pub, L, 111-148) into law.
Section 4205 of the ACA amended section 403(q) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343(q)) and section 403A
of the FD&C Act (21 U.S.C. 343-1), which governs Federal preemption of
State and local food labeling requirements. Section 4205 of the ACA
added section 403(q)(5)(H)(viii) to the FD&C Act to require that if an
article of food is sold from a vending machine that (1) does not permit
a prospective purchaser to examine the Nutrition Facts Panel before
purchasing the article or does not otherwise provide visible nutrition
information at the point of purchase; and (2) is operated by a person
who is engaged in the business of owning or operating 20 or more
vending machines, then the vending machine operator must provide a sign
in close proximity to each article of food or the selection button that
includes a clear and conspicuous statement disclosing the number of
calories contained in the article of food.
In the Federal Register of December 1, 2014 (79 FR 71259), we
issued a final rule to implement these labeling requirements; the
regulations are codified at 21 CFR 101.8. With this regulatory change,
CPG 562.800 is now obsolete and is being withdrawn.
II. Reference
The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
1. FDA, ``Fish and Fishery Products Hazards and Controls Guidance,
4th Edition,'' June 2021.
Dated: February 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03224 Filed 2-14-22; 8:45 am]
BILLING CODE 4164-01-P
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