[Federal Register Volume 87, Number 31 (Tuesday, February 15, 2022)]
[Notices]
[Pages 8592-8593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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CPGs because they have become outdated or have been superseded by 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 https://www.regulations.gov 
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 https://www.regulations.gov.

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


