[Federal Register Volume 85, Number 152 (Thursday, August 6, 2020)]
[Notices]
[Pages 47797-47798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17169]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1099]


Inorganic Arsenic in Rice Cereals for Infants: Action Level; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a final guidance for industry entitled ``Inorganic 
Arsenic in Rice Cereals for Infants: Action Level.'' The guidance 
identifies for industry an action level for inorganic arsenic in rice 
cereals for infants that is intended to help protect public health and 
is achievable with the use of current good manufacturing practices. It 
also describes our intended sampling and enforcement approach. Thus, 
the guidance finalizes the approach presented in the draft guidance 
issued in 2016.

DATES: The announcement of the guidance is published in the Federal 
Register on August 6, 2020.

ADDRESSES: You may submit either electronic or written comments on FDA 
guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-1099 for ``Inorganic Arsenic in Rice Cereals for Infants: 
Action Level; Guidance for Industry.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, 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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to 
Division of Plant Products and Beverages, Office of Food Safety, Center 
for Food Safety and Applied Nutrition, Food and Drug Administration 
(HFS-317), 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Eileen Abt, Center for Food Safety and 
Applied Nutrition (HFS-317), Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-1529.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Inorganic Arsenic in Rice Cereals for Infants: Action 
Level.'' We are issuing this guidance consistent with our good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on this topic. It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

[[Page 47798]]

    In the Federal Register of April 6, 2016 (81 FR 19976), we made 
available a draft guidance for industry entitled ``Inorganic Arsenic in 
Rice Cereals for Infants: Action Level.'' We also announced the 
availability of two related scientific documents: a document entitled 
``Supporting Document for Action Level for Inorganic Arsenic in Rice 
Cereals for Infants'' (supporting document), and a risk assessment 
entitled ``Arsenic in Rice and Rice Products Risk Assessment: Report'' 
(the risk assessment report). We gave interested parties an opportunity 
to submit comments by July 5, 2016, and later extended the comment 
period to July 19, 2016 (see 81 FR 42714 (June 30, 2016)).
    This guidance finalizes FDA's action level for inorganic arsenic in 
rice cereals for infants of 100 micrograms per kilogram ([micro]g/kg) 
or 100 parts per billion (ppb) and identifies FDA's intended sampling 
and enforcement approach. The basis for the action level is set forth 
in the revised supporting document. The revised supporting document as 
well as the risk assessment report originally made available on April 
6, 2016 (81 FR 19976), can be accessed at www.regulations.gov. The 
revised supporting document reviews data on inorganic arsenic levels in 
rice cereals for infants, health effects, and achievability and 
explains FDA's rationale for identifying an action level of 100 
[micro]g/kg for inorganic arsenic in rice cereals for infants.
    Arsenic is present in the environment as a naturally occurring 
substance or as a result of contamination from human activity. In 
foods, arsenic may be present as inorganic arsenic (the primary toxic 
form of arsenic) or organic arsenic. Exposure to inorganic arsenic is 
associated with adverse human health effects including cancer and 
neurodevelopmental effects. Rice and rice products are common in the 
American diet, and FDA sampling data have demonstrated that rice and 
rice products have higher levels of inorganic arsenic than other foods. 
Furthermore, rice and rice products are a greater potential source of 
dietary inorganic arsenic exposure for infants and children than for 
adults, because the dietary patterns of infants and children are often 
less varied than those of adults, and because infants and children 
consume more food relative to their body weight than do adults. We 
expect that that the 100 [micro]g/kg action level, though non-binding, 
will help protect the public health, by encouraging manufacturers to 
reduce levels of inorganic arsenic in rice cereals for infants, and we 
also expect that this level is achievable by industry with the use of 
current good manufacturing practices. We intend to consider the action 
level of 100 [micro]g/kg or 100 ppb inorganic arsenic as an important 
source of information for determining whether infant rice cereal is 
adulterated within the meaning of section 402(a)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1)).
    Comments on the draft guidance requested that we consider 
establishing action levels for rice-based foods other than infant 
cereal, lower the action level under 100 ppb, and questioned the 
achievability of the action level of 100 ppb for inorganic arsenic in 
infant rice cereals. However, we did not receive new data from the 
comments supporting establishment of either lower or higher action 
levels. We determined that we should prioritize efforts to reduce 
infant exposure to inorganic arsenic from rice because rice intake, 
primarily through infant rice cereal, is about three times greater for 
infants than adults in relation to body weight (Ref. 1), and 
epidemiologic data show that early life exposure to inorganic arsenic, 
including dietary exposure, can result in a child's decreased 
performance on certain developmental tests that measure learning (Ref. 
1). Thus, the guidance finalizes the approach presented in the draft 
guidance.
    Other comments suggested modifications to the risk assessment 
report. We note that the risk assessment report underwent extensive 
interagency review and external peer review before we made it available 
to the public. None of these comments supported a determination that 
the risk assessment report needs to be modified. We will continue to 
monitor research developments on non-cancer adverse health effects, 
such as neurodevelopmental effects, cardiovascular disease, and 
diabetes, to determine if new data support changes to the risk 
assessment report or guidance.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act is not required.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

IV. References

    The following references are on display at the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

    1. FDA, ``Arsenic in Rice and Rice Products Risk Assessment: 
Report,'' 2016, https://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm485278.htm.

    Dated: July 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17169 Filed 8-5-20; 8:45 am]
BILLING CODE 4164-01-P


