Small Entity Compliance Guide: Bottled Water: Residual Disinfectants and Disinfection Byproducts; Availability, 26252 [E9-12671]

Download as PDF 26252 Federal Register / Vol. 74, No. 103 / Monday, June 1, 2009 / Notices others by written request to terminate or modify the agreement. [FR Doc. E9–12676 Filed 5–29–09; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0224] Small Entity Compliance Guide: Bottled Water: Residual Disinfectants and Disinfection Byproducts; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Bottled Water: Residual Disinfectants and Disinfection Byproducts—Small Entity Compliance Guide’’ for a direct final rule published in the Federal Register of March 28, 2001. This small entity compliance guide (SECG) is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation. DATES: Submit written or electronic comments on the SECG at any time. ADDRESSES: Submit written comments on the SECG to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments on the SECG to https://www.regulations.gov. Submit written requests for single copies of the SECG to the Division of Plant and Dairy Food Safety (HFS–317), Office of Food Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or fax your request to 301–436–2651. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the SECG. FOR FURTHER INFORMATION CONTACT: Lauren Posnick Robin, Center for Food Safety and Applied Nutrition (HFS– 317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–1639. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of March 28, 2001 (66 FR 16858), FDA issued a direct final rule amending its bottled water VerDate Nov<24>2008 15:29 May 29, 2009 Jkt 217001 quality standard regulations by establishing allowable levels for three residual disinfectants (chloramine, chlorine, and chlorine dioxide) and three types of disinfection byproducts (DBPs) (bromate, chlorite, and haloacetic acids (HAA5)), and by revising the existing allowable level for the DBP total trihalomethanes (TTHM). FDA also revised, for the three residual disinfectants and four types of DBPs only, the monitoring requirement for source water found in the current good manufacturing practice (CGMP) regulations for bottled water. On July 5, 2001 (66 FR 35373), FDA issued a technical amendment to correct an editorial error and confirmed the effective date of January 1, 2002. FDA examined the economic implications of the direct final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601–612) and determined that the rule would have a significant economic impact on a substantial number of small entities. In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104–121), FDA is making available this SECG stating in plain language the legal requirements of the March 28, 2001, direct final rule set forth in 21 CFR parts 129 and 165 concerning the allowable levels and monitoring requirements for the three residual disinfectants (chloramine, chlorine, and chlorine dioxide) and four types of DBPs (bromate, chlorite, HAA5, and TTHM). FDA is issuing this SECG as level 2 guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG represents the agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this SECG. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The SECG and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 III. Electronic Access Persons with access to the Internet may obtain the document at https:// www.cfsan.fda.gov/guidance.html or https://www.regulations.gov. Dated: May 22, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–12671 Filed 5–29–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS–2009–0079] The National Infrastructure Advisory Council AGENCY: Directorate for National Protection and Programs, Department of Homeland Security. ACTION: Committee Management; Notice of Federal Advisory Council Meeting SUMMARY: The National Infrastructure Advisory Council (NIAC) will meet on Tuesday July 14, 2009 at the J.W. Marriott’s Salons E and F, 1331 Pennsylvania Avenue, Washington, DC 20004. DATES: The National Infrastructure Advisory Council will meet Tuesday July 14, 2009 from 12:30 p.m. to 3:30 p.m. Please note that the meeting may close early if the committee has completed its business. For additional information, please consult the NIAC Web site, https:// www.dhs.gov/niac, or contact Matthew Sickbert by phone at 703–235–2888 or by e-mail at Matthew.Sickbert@associates.dhs.gov. ADDRESSES: The meeting will be held at the J.W. Marriott’s Salons E and F, 1331 Pennsylvania Avenue, Washington, DC 20004. While we will be unable to accommodate oral comments from the public, written comments may be sent to Nancy J. Wong, Department of Homeland Security, Directorate for National Protection and Programs, Washington, DC 20528. Written comments should reach the contact person listed no later than July 7, 2009. Comments must be identified by DHS– 2009–0079 and may be submitted by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • E-mail: matthew.sickbert@associates.dhs.gov. Include the docket number in the subject line of the message. • Fax: 703–235–3055 E:\FR\FM\01JNN1.SGM 01JNN1

Agencies

[Federal Register Volume 74, Number 103 (Monday, June 1, 2009)]
[Notices]
[Page 26252]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-12671]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0224]


Small Entity Compliance Guide: Bottled Water: Residual 
Disinfectants and Disinfection Byproducts; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Bottled Water: 
Residual Disinfectants and Disinfection Byproducts--Small Entity 
Compliance Guide'' for a direct final rule published in the Federal 
Register of March 28, 2001. This small entity compliance guide (SECG) 
is intended to set forth in plain language the requirements of the 
regulation and to help small businesses understand the regulation.

DATES: Submit written or electronic comments on the SECG at any time.

ADDRESSES: Submit written comments on the SECG to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
on the SECG to https://www.regulations.gov. Submit written requests for 
single copies of the SECG to the Division of Plant and Dairy Food 
Safety (HFS-317), Office of Food Safety, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or fax your request to 301-436-2651. 
Send one self-addressed adhesive label to assist that office in 
processing your request. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the SECG.

FOR FURTHER INFORMATION CONTACT: Lauren Posnick Robin, Center for Food 
Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1639.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 28, 2001 (66 FR 16858), FDA issued 
a direct final rule amending its bottled water quality standard 
regulations by establishing allowable levels for three residual 
disinfectants (chloramine, chlorine, and chlorine dioxide) and three 
types of disinfection byproducts (DBPs) (bromate, chlorite, and 
haloacetic acids (HAA5)), and by revising the existing allowable level 
for the DBP total trihalomethanes (TTHM). FDA also revised, for the 
three residual disinfectants and four types of DBPs only, the 
monitoring requirement for source water found in the current good 
manufacturing practice (CGMP) regulations for bottled water. On July 5, 
2001 (66 FR 35373), FDA issued a technical amendment to correct an 
editorial error and confirmed the effective date of January 1, 2002.
    FDA examined the economic implications of the direct final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and 
determined that the rule would have a significant economic impact on a 
substantial number of small entities. In compliance with section 212 of 
the Small Business Regulatory Enforcement Fairness Act (Public Law 104-
121), FDA is making available this SECG stating in plain language the 
legal requirements of the March 28, 2001, direct final rule set forth 
in 21 CFR parts 129 and 165 concerning the allowable levels and 
monitoring requirements for the three residual disinfectants 
(chloramine, chlorine, and chlorine dioxide) and four types of DBPs 
(bromate, chlorite, HAA5, and TTHM).
    FDA is issuing this SECG as level 2 guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG 
represents the agency's current thinking on this topic. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this SECG. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The SECG and received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
https://www.cfsan.fda.gov/guidance.html or https://www.regulations.gov.

    Dated: May 22, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12671 Filed 5-29-09; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.