81 FR 19976 - Inorganic Arsenic in Rice Cereals for Infants: Action Level; Draft Guidance for Industry; Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants; Arsenic in Rice and Rice Products Risk Assessment: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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 66 (April 6, 2016)

Page Range		19976-19978
FR Document		2016-07840

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Inorganic Arsenic in Rice Cereals for Infants: Action Level,'' a supporting document entitled ``Supporting Document for Action Level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 The draft guidance, when finalized, will identify for industry an action level for inorganic arsenic in rice cereals for infants that will help protect public health and is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.

Federal Register, Volume 81 Issue 66 (Wednesday, April 6, 2016)

[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Notices]
[Pages 19976-19978]
From the Federal Register Online [www.thefederalregister.org]
[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Draft Guidance for Industry; Supporting Document for Action Level for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

19978 Federal Register / Vol. 81, No. 66 / Wednesday, April 6, 2016 / Notices

FoodborneIllnessContaminants/Metals/ EMDAC@fda.hhs.gov, or FDA Advisory Evaluation and Research, Food and
UCM352467.pdf). Committee Information Line, 1–800– Drug Administration, 10903 New
4. U.S. Food and Drug Administration, 741–8138 (301–443–0572 in the Hampshire Ave., Bldg. 31, Rm. 2417,
‘‘Analytical Results from Inorganic Arsenic Washington, DC area). Please call the Silver Spring, MD 20993–0002, 301–
in Rice Cereals for Infants, Non-rice Infant
Cereal and Other Foods Commonly Eaten by
Information Line for up-to-date 796–9001, email: BRUDAC@fda.hhs.gov.
Infants and Toddlers,’’ 2016, (http:// information on this meeting. SUPPLEMENTARY INFORMATION: Pursuant
www.fda.gov/Food/FoodScienceResearch/ SUPPLEMENTARY INFORMATION: In the to 41 CFR 102–3.65 and approval by the
RiskSafetyAssessment/ucm485278.htm). Federal Register of March 17, 2016 (81 Department of Health and Human
5. U.S. Food and Drug Administration, FR 14448), FDA announced that a Services pursuant to 45 CFR part 11 and
‘‘Arsenic in Rice and Rice Products Risk meeting of the Endocrinologic and by the General Services Administration,
Assessment: Report,’’ 2016, (http:// Metabolic Drugs Advisory Committee FDA is announcing the renewal of the
www.fda.gov/Food/FoodScienceResearch/
would be held on May 25, 2016. On Bone, Reproductive and Urologic Drugs
RiskSafetyAssessment/ucm485278.htm).
6. U.S. Food and Drug Administration, page 14449, in the first column, the Date Advisory Committee. The committee is
‘‘External Peer Review Report. Arsenic in and Time portion of the document is a discretionary Federal advisory
Rice and Rice Products Risk Assessment: changed to read as follows: committee established to provide advice
Draft Report, Addendum, and Model,’’ 2015, Date and Time: The meeting will be to the Commissioner. The Bone,
(http://www.fda.gov/downloads/Food/ held on May 24, 2016, from 8 a.m. to 5 Reproductive and Urologic Drugs
FoodScienceResearch/RiskSafetyAssessment/ p.m. Advisory Committee advises the
UCM486544.pdf). This notice is issued under the Commissioner or designee in
7. U.S. Food and Drug Administration, Federal Advisory Committee Act (5 discharging responsibilities as they
‘‘FDA’s Response to External Peer Review on U.S.C. app. 2) and 21 CFR part 14,
FDA’s Arsenic in Rice and Rice Products
relate to helping to ensure safe and
relating to the advisory committees. effective drugs for human use and, as
Risk Assessment: Draft Report (July 2015),
Addendum to FDA’s Arsenic in Rice and Dated: April 1, 2016. required, any other product for which
Rice Products Risk Assessment, and Arsenic Jill Hartzler Warner, the Food and Drug Administration has
in Rice and Rice Products Risk Assessment Associate Commissioner for Special Medical regulatory responsibility. The
Cancer Model,’’ 2016, (http://www.fda.gov/ Programs. Committee reviews and evaluates data
downloads/Food/FoodScienceResearch/ on the safety and effectiveness of
[FR Doc. 2016–07906 Filed 4–5–16; 8:45 am]
RiskSafetyAssessment/UCM487230.pdf). marketed and investigational human
BILLING CODE 4164–01–P
Dated: April 1, 2016. drug products for use in the practice of
Leslie Kux, osteoporosis and metabolic bone
Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND disease, obstetrics, gynecology, urology
[FR Doc. 2016–07840 Filed 4–5–16; 8:45 am] HUMAN SERVICES and related specialties, and makes
BILLING CODE 4164–01–P
appropriate recommendations to the
Food and Drug Administration Commissioner of Food and Drugs.
The Committee shall consist of a core
[Docket No. FDA–2016–N–0001]
DEPARTMENT OF HEALTH AND of 11 voting members including the
HUMAN SERVICES Advisory Committee; Bone, Chair. Members and the Chair are
Reproductive and Urologic Drugs selected by the Commissioner or
Food and Drug Administration Advisory Committee, Renewal designee from among authorities
knowledgeable in the fields of
[Docket No. FDA–2016–N–0001] AGENCY: Food and Drug Administration, osteoporosis and metabolic bone
Endocrinologic and Metabolic Drugs HHS. disease, obstetrics, gynecology, urology,
Advisory Committee; Amendment of ACTION:Notice; renewal of advisory pediatrics, epidemiology, or statistics
Notice committee. and related specialties. Members will be
invited to serve for overlapping terms of
AGENCY: Food and Drug Administration, SUMMARY: The Food and Drug up to 4 years. Almost all non-Federal
HHS. Administration (FDA) is announcing the members of this committee serve as
ACTION: Notice. renewal of the Bone, Reproductive and Special Government Employees. The
Urologic Drugs Advisory Committee by core of voting members may include one
SUMMARY: The Food and Drug the Commissioner of Food and Drugs technically qualified member, selected
Administration (FDA) is announcing an (the Commissioner). The Commissioner by the Commissioner or designee, who
amendment to the notice of a meeting of has determined that it is in the public is identified with consumer interests
the Endocrinologic and Metabolic Drugs interest to renew the Bone, and is recommended by either a
Advisory Committee. This meeting was Reproductive and Urologic Drugs consortium of consumer-oriented
announced in the Federal Register of Advisory Committee for an additional 2 organizations or other interested
March 17, 2016. The amendment is years beyond the charter expiration persons. In addition to the voting
being made to reflect a change in the date. The new charter will be in effect members, the Committee may include
Date and Time portion of the document. until March 23, 2018. one non-voting member who is
The Date of the meeting is changed to DATES: Authority for the Bone, identified with industry interests.
May 24, 2016. There are no other Reproductive and Urologic Drugs Further information regarding the
asabaliauskas on DSK3SPTVN1PROD with NOTICES

changes. Advisory Committee will expire on most recent charter and other
FOR FURTHER INFORMATION CONTACT: March 23, 2018, unless the information can be found at http://
LaToya Bonner, Center for Drug Commissioner formally determines that www.fda.gov/AdvisoryCommittees/
Evaluation and Research, Food and renewal is in the public interest. CommitteesMeetingMaterials/Drugs/
Drug Administration, 10903 New FOR FURTHER INFORMATION CONTACT: ReproductiveHealthDrugsAdvisory
Hampshire Ave., Bldg.31, Rm. 2417, Kalyani Bhatt, Division of Advisory Committee/ucm107572.htm or by
Silver Spring, MD 20993–0002, 301– Committee and Consultant contacting the Designated Federal
796–9001, FAX: 301–847–8533, Management, Center for Drug Officer (see FOR FURTHER INFORMATION

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Document Created: 2018-02-07 13:51:42
Document Modified: 2018-02-07 13:51:42

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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.
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.
FR Citation		81 FR 19976

81 FR 19976 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 66 (April 6, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration