[Federal Register Volume 76, Number 136 (Friday, July 15, 2011)]
[Rules and Regulations]
[Pages 41687-41689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-17928]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2010-F-0103]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Hydroxypropyl Cellulose

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations for hydroxypropyl cellulose by lowering the 
minimum permitted viscosity from 145 centipoises (cPs) to 10 cPs and to 
permit its use as a binder in dietary supplements. This action is in 
response to a petition filed by Nisso America, Inc.

DATES: This rule is effective July 15, 2011. Submit either electronic 
or written objections and requests for a hearing by August 15, 2011. 
See section VII of this document for information on the filing of 
objections.

ADDRESSES: You may submit either electronic or written objections and 
requests for a hearing, identified by Docket No. FDA-2010-F-0103, by 
any of the following methods:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
     Fax: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2010-F-0103 for this rulemaking. All objections 
received will be posted without change to http://www.regulations.gov, 
including any personal information provided. For detailed instructions 
on submitting objections, see the ``Objections'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
objections received, go to http://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 Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Laura Dye, Center for Food Safety and 
Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740-3835, 240-402-1275.

SUPPLEMENTARY INFORMATION: 

I. Background

    In a notice published in the Federal Register of April 8, 2010 (75 
FR 17928), FDA announced that Nisso America Inc., 45 Broadway, Suite 
2120, New York, NY 10006, filed a food additive petition (FAP 0A4780). 
The petition proposed to amend the food additive regulations in Sec.  
172.870 (21 CFR 172.870), by lowering the minimum permitted viscosity 
of hydroxypropyl cellulose (HPC) identified in Sec.  172.870(a)(1) from 
145 cPs to 10 cPs and to permit its use as a binder in dietary 
supplements.
    Section 172.870 includes both high-substituted HPC, which contains 
not more than 4.6 hydroxypropyl groups per anhydroglucose unit (Sec.  
172.870(a)(1)), and low-substituted HPC, which contains on average 0.1 
to 0.4 hydroxypropyl groups per anhydroglucose unit (Sec.  
172.870(a)(2)). High-substituted HPC can be used, in accordance with 
good manufacturing practice, as an emulsifier, film former, protective 
colloid, stabilizer, suspending agent and thickener (Sec.  
172.870(b)(1)). Low-substituted HPC can be used, in accordance with 
good manufacturing practice, as a binder and disintegrator in tablets 
or wafers containing dietary supplements (Sec.  172.870(b)(2)). It is 
the high-substituted HPC regulated under Sec.  172.870(a)(1) and (b)(1) 
that is the subject of this petition.

II. Evaluation of Safety

    Under the general safety standard in section 409 of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348), a food 
additive cannot be approved for a particular use unless a fair 
evaluation of the data available to FDA establishes that the additive 
is safe for that use. FDA's food additive regulations (21 CFR 170.3(i)) 
define safe as ``a reasonable certainty in the minds of competent 
scientists that the substance is not harmful under the intended 
conditions of use.'' To establish with reasonable certainty that

[[Page 41688]]

a food additive is not harmful under its intended conditions of use, 
FDA considers the estimated human dietary intake of the additive, the 
additive's toxicological data, and other relevant information (such as 
published literature) available to the Agency.
    Both high-substituted HPC (the subject of this petition) and low-
substituted HPC are forms of cellulose and cellulose derivatives. The 
safety of cellulose and cellulose derivatives has been studied 
extensively in animals and humans. These studies show that cellulose 
and cellulose derivatives pass unchanged through the gastrointestinal 
tract and can be quickly detected in the feces of test animals and 
humans when consumed, confirming that the consumption of cellulose and 
cellulose derivatives at the proposed viscosity and use level will not 
result in toxicity. The Joint Food and Agriculture Organization and the 
World Health Organization (FAO/WHO) Expert Committee for Food Additives 
(JECFA) has evaluated the food uses of modified celluloses, including 
HPC, and has concluded that, as a group, modified celluloses are of 
very low toxicity at the levels of intake necessary to achieve the 
desired effect and do not pose a hazard to health (Ref. 1). Viscosity 
is not specified by the JECFA as a factor related to the safety of 
these additives.
    Although there is no available safety testing directly on HPC with 
a viscosity of < 145 cPs, there have been numerous studies on the 
viscosity related safety effect for other modified celluloses. Most of 
the safety studies we reviewed analyzed the use of cellulose and 
cellulose derivatives. All of these studies support the assertion that 
there is no safety effect arising from a change in viscosity. Because 
high-substituted HPC with a minimum viscosity of 10 cPs is not expected 
to have significantly different biological properties than those 
cellulose and cellulose derivatives which have been studied, or the 
high and low-substituted HPC currently permitted under Sec.  172.870, 
FDA concludes that the proposed use of high-substituted HPC with a 
minimum viscosity of 10 cPs is safe.
    Lastly, because high-substituted HPC with a minimum viscosity of 10 
cPs is intended to be used for the same purposes as are currently 
permitted for either high and low-substituted HPC, including as a 
binder in dietary supplements, FDA concludes that the proposed changes 
to Sec.  172.870 will not result in an increase in the combined overall 
daily intake of high-substituted and low-substituted HPC. Thus, 
permitting the use of high-substituted HPC with a minimum viscosity of 
10 cPs for use as a binder in dietary supplements will not result in an 
increased intake or harm to human health under the established 
conditions of use.

III. Conclusion

    FDA reviewed data in the petition and other available relevant 
material to evaluate the safety of the petitioned use of high-
substituted HPC with a minimum viscosity of 10 cPs as an emulsifier, 
film former, protective colloid, stabilizer, suspending agent, or 
thickener in food, and as a binder in dietary supplements. Based on 
this information, FDA concludes that the proposed use of the additive 
is safe and will achieve its intended technical effect under the 
proposed conditions of use. Therefore, the regulations in 21 CFR part 
172 should be amended as set forth in this document.

IV. Public Disclosure

    In accordance with Sec.  171.1(h) (21 CFR 171.1(h)), the petition 
and the documents that FDA considered and relied upon in reaching its 
decision to approve the petition will be made available for inspection 
at the Center for Food Safety and Applied Nutrition by appointment with 
the information contact person (see FOR FURTHER INFORMATION CONTACT). 
As provided in Sec.  171.1(h), the Agency will delete from the 
documents any materials that are not available for public disclosure 
before making the documents available for inspection.

V. Environmental Impact

    The Agency has previously considered the environmental effects of 
this rule as announced in the notice of filing for FAP 0A4780 (75 FR 
17928). No new information or comments have been received that would 
affect the Agency's previous determination that there is no significant 
impact on the human environment and that an environmental impact 
statement is not required.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VII. Objections

    Any person who will be adversely affected by this regulation may 
file with the Division of Dockets Management (see ADDRESSES) either 
electronic or written objections. Each objection shall be separately 
numbered, and each numbered objection shall specify with particularity 
the provisions of the regulation to which objection is made and the 
grounds for the objection. Each numbered objection on which a hearing 
is requested shall specifically so state. Failure to request a hearing 
for any particular objection shall constitute a waiver of the right to 
a hearing on that objection. Each numbered objection for which a 
hearing is requested shall include a detailed description and analysis 
of the specific factual information intended to be presented in support 
of the objection in the event that a hearing is held. Failure to 
include such a description and analysis for any particular objection 
shall constitute a waiver of the right to a hearing on the objection. 
It is only necessary to send one set of documents. It is no longer 
necessary to send three copies of all documents. Identify documents 
with the docket number found in brackets in the heading of this 
document. Any objections received in response to the regulation may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

VIII. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

    FDA's review of this petition was limited to section 409 of FD&C 
Act. This final rule is not a statement regarding compliance with other 
sections of the FD&C Act. For example, the Food and Drug Administration 
Amendments Act of 2007, which was signed into law on September 27, 
2007, amended the FD&C Act to, among other things, add section 301(ll) 
(21 U.S.C. 331(ll)). Section 301(ll) of the FD&C Act prohibits the 
introduction or delivery for introduction into interstate commerce of 
any food that contains a drug approved under section 505 of the FD&C 
Act (21 U.S.C. 355), a biological product licensed under section 351 of 
the Public Health Service Act (42 U.S.C. 262), or a drug or biological 
product for which substantial clinical investigations have been 
instituted and their existence has been made public, unless one of the 
exceptions in section 301(ll)(1) to (ll)(4) applies. In our review of 
this petition, FDA did not consider whether section 301(ll) of the FD&C 
Act or any of its exemptions apply to food containing this additive. 
Accordingly, this final rule should not be construed to be a statement 
that a food containing this additive, if introduced or delivered for 
introduction into interstate commerce, would not violate section 
301(ll) of the FD&C Act. Furthermore, this language is included in all 
food additive final rules and therefore should not be construed to be a 
statement of the likelihood that section 301(ll) of the FD&C Act 
applies.

[[Page 41689]]

IX. References

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has 
verified the Web site address, but FDA is not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register).
    1. Evaluations of the Joint FAO/WHO Expert Committee on Food 
Additives (JECFA), Hydroxypropyl Cellulose Toxicology Monograph 687, 
FAS 26-JECFA 35/85, 1989; http://apps.who.int/ipsc/database/evaluations/search.aspx.

List of Subjects in 21 CFR Part 172

    Food additives, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

0
1. The authority citation for 21 CFR part 172 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

0
2. Section 172.870 is amended by revising paragraphs (a)(1) and (b)(1) 
to read as follows:


Sec.  172.870  Hydroxypropyl cellulose.

* * * * *
    (a) * * *
    (1) A cellulose ether containing propylene glycol groups attached 
by an ether linkage that contains, on an anhydrous basis, not more than 
4.6 hydroxypropyl groups per anhydroglucose unit. The additive has a 
minimum viscosity of 10 centipoises for a 10 percent by weight aqueous 
solution at 25 degrees C.
* * * * *
    (b) * * *
    (1) The additive identified in paragraph (a)(1) of this section is 
used or intended for use as an emulsifier, film former, protective 
colloid, stabilizer, suspending agent, or thickener in food, in 
accordance with good manufacturing practice. The additive also may be 
used as a binder in dietary supplements, in accordance with good 
manufacturing practice.
* * * * *

    Dated: July 6, 2011.
Susan M. Bernard,
Acting Director, Office of Regulations, Policy and Social Sciences, 
Center for Food Safety and Applied Nutrition.
[FR Doc. 2011-17928 Filed 7-14-11; 8:45 am]
BILLING CODE 4160-01-P