[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Notices]
[Pages 19976-19978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07840]


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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; 
Draft Guidance for Industry; Supporting Document for Action Level for 
Inorganic Arsenic in Rice Cereals for Infants; Arsenic in Rice and Rice 
Products Risk Assessment: Report; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``Inorganic 
Arsenic in Rice Cereals for Infants: Action Level,'' a supporting 
document entitled ``Supporting Document for Action Level for Inorganic 
Arsenic in Rice Cereals for Infants'' (the supporting document), and a 
risk assessment report entitled ``Arsenic in Rice and Rice Products 
Risk Assessment: Report'' (the risk assessment report). The draft 
guidance, when finalized, will identify for industry an action level 
for inorganic arsenic in rice cereals for infants that will help 
protect public health and is achievable with the use of current good 
manufacturing practice. It also will describe our intended sampling and 
enforcement approach. The risk assessment report includes a 
quantitative component (a mathematical model) that estimates occurrence 
of lung cancer and bladder cancer from long-term exposure to inorganic 
arsenic in rice and rice products, and a qualitative component that 
describes our review and evaluation of the scientific literature of 
certain non-cancer health risks, in certain susceptible life stages, 
from inorganic arsenic in rice and rice products.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on this draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance, the 
supporting document, or the risk assessment report by July 5, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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; Draft Guidance for Industry; Supporting Document for 
Action Level for Inorganic Arsenic in Rice Cereals for Infants; Arsenic 
in Rice and Rice Products Risk Assessment: Report; Availability.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     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.'' The Agency will 
review this copy, including the claimed confidential information, in 
its 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the

[[Page 19977]]

docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance and 
the supporting document to the Division of Plant Products and 
Beverages, Office of Food Safety, Center for Food Safety and Applied 
Nutrition (HFS-317), Food and Drug Administration, 5100 Paint Branch 
Pkwy., 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 draft guidance, 
supporting document, and risk assessment report.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Center for Food Safety 
and Applied Nutrition (HFS-24), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION: 

I. Background

    Arsenic is present in the environment as a naturally occurring 
substance or as a result of contamination from human activity. It is 
found in water, air (e.g., in dust or particulates), soil, and foods. 
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 many adverse human health effects, including 
cancer. FDA has been monitoring the levels of total arsenic in foods 
for decades, as part of our Total Diet Study, an ongoing survey and 
analysis of the average American diet (Ref. 1), and our Toxic Elements 
in Food and Foodware and Radionuclides in Food Program (Ref. 2), but 
only in recent years has methodology been available to FDA laboratories 
to readily distinguish between inorganic and organic arsenic in a large 
number and variety of food samples. Arsenic is inadvertently taken up 
by plants through pathways for essential or beneficial nutrients, and, 
compared to other cereals, such as oat, wheat, and barley, rice is much 
more efficient at arsenic accumulation. In 2011, we increased our 
testing for arsenic in certain foods. In 2012 and 2013, we released 
analytical results for approximately 1,300 samples of rice and rice 
products as part of a major effort to understand and manage arsenic-
related risks associated with the consumption of these foods in the 
United States (Ref. 3). More recently, in April 2016 we released the 
results of our analysis of inorganic arsenic in 526 samples collected 
in 2014; the samples included rice cereals for infants, as well as non-
rice infant cereal and other foods commonly eaten by infants and 
toddlers (Ref. 4).
    We have focused on rice and rice products because evidence from 
FDA's Total Diet Study revealed that arsenic levels, although varying, 
tend to be higher in these foods than in others, and rice products are 
common in the average American diet. Collectively, our sampling 
indicates that the presence of inorganic arsenic varies widely among 
and within different categories of rice grain and products made from 
rice grain, ranging from <1 to 545 parts per billion (ppb) inorganic 
arsenic.
    We are announcing the availability of three documents: (1) A draft 
guidance for industry entitled ``Inorganic Arsenic in Rice Cereals for 
Infants: Action Level;'' (2) a supporting document referenced in the 
draft guidance entitled ``Supporting Document for Action Level for 
Inorganic Arsenic in Rice Cereals for Infants;'' and (3) a risk 
assessment referenced in the draft guidance entitled ``Arsenic in Rice 
and Rice Products Risk Assessment: Report.''
    In the risk assessment report, we provide quantitative estimates of 
lung and bladder cancer risk presented by long-term exposure to 
inorganic arsenic in rice and rice products. We qualitatively address 
certain non-cancer health risks of exposure to inorganic arsenic in 
rice and rice products during pregnancy, infancy, and early childhood, 
periods of high susceptibility to those risks. We also used the 
mathematical cancer risk model to evaluate the impact of potential 
mitigation options to reduce the risk. We conducted this risk 
assessment in consultation with other Federal Agencies, including the 
National Institute of Environmental Health Science, the FDA National 
Center for Toxicological Research, and the Environmental Protection 
Agency. External expert peer review of the risk assessment was 
conducted; the risk assessment report and peer review documents are 
available online (Refs. 5, 6, and 7).
    The draft guidance identifies an action level for inorganic arsenic 
in rice cereals for infants of 100 micrograms/kilogram ([micro]g/kg) or 
100 parts per billion (ppb), and identifies FDA's intended sampling and 
enforcement approach. The 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 for inorganic arsenic in rice cereals for infants of 100 
[micro]g/kg.
    We conclude that the 100 [micro]g/kg action level will help protect 
the public health and is achievable with the use of current good 
manufacturing practice, but we especially welcome comments and 
information bearing on the achievability and public health benefits and 
risks of 100 [micro]g/kg, as compared with other potential action 
levels (including no action level). If the guidance is finalized 
consistent with the draft, we intend to consider the action level of 
100 [micro]g/kg or 100 ppb inorganic arsenic, in addition to other 
factors, when considering whether to bring enforcement action in a 
particular case.
    We are issuing the draft guidance consistent with our good guidance 
practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of the 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 alternate approach if it 
satisfies the requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
and the supporting document at either http://www.fda.gov/FoodGuidances 
or http://www.regulations.gov. Use the FDA Web site listed in the 
previous sentence to find the most current version of the guidance. 
Persons with access to the Internet may obtain the risk assessment 
report at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm485278.htm.

III. References

    The following references are on display in the Division of Dockets 
Management (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 http://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

    1. U.S. Food and Drug Administration, ``Total Diet Study,'' 
2016, (http://www.fda.gov/Food/FoodScienceResearch/TotalDietStudy/ucm2006799.htm).
    2. U.S. Food and Drug Administration, ``Toxic Elements in Food 
and Foodware and Radionuclides in Food Program,'' 2016, (http://www.fda.gov/downloads/Food/ComplianceEnforcement/ucm073204.pdf).
    3. U.S. Food and Drug Administration, ``Analytical Results from 
Inorganic Arsenic in Rice and Rice Products Sampling,'' 2013, 
(http://www.fda.gov/downloads/Food/

[[Page 19978]]

FoodborneIllnessContaminants/Metals/UCM352467.pdf).
    4. U.S. Food and Drug Administration, ``Analytical Results from 
Inorganic Arsenic in Rice Cereals for Infants, Non-rice Infant 
Cereal and Other Foods Commonly Eaten by Infants and Toddlers,'' 
2016, (http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm485278.htm).
    5. U.S. Food and Drug Administration, ``Arsenic in Rice and Rice 
Products Risk Assessment: Report,'' 2016, (http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm485278.htm).
    6. U.S. Food and Drug Administration, ``External Peer Review 
Report. Arsenic in Rice and Rice Products Risk Assessment: Draft 
Report, Addendum, and Model,'' 2015, (http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM486544.pdf).
    7. U.S. Food and Drug Administration, ``FDA's Response to 
External Peer Review on FDA's Arsenic in Rice and Rice Products Risk 
Assessment: Draft Report (July 2015), Addendum to FDA's Arsenic in 
Rice and Rice Products Risk Assessment, and Arsenic in Rice and Rice 
Products Risk Assessment Cancer Model,'' 2016, (http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM487230.pdf).

    Dated: April 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07840 Filed 4-5-16; 8:45 am]
 BILLING CODE 4164-01-P