[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR129.35]
[Page 284-285]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 129 PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER--Table of Contents
Subpart B Buildings and Facilities
Sec. 129.35 Sanitary facilities.
Each plant shall provide adequate sanitary facilities including, but
not limited to, the following:
(a) Product water and operations water--(1) Product water. The
product water supply for each plant shall be from an approved source
properly located, protected, and operated and shall be easily
accessible, adequate, and of a safe, sanitary quality which shall be in
conformance at all times with the applicable laws and regulations of the
government agency or agencies having jurisdiction.
(2) Operations water. If different from the product water supply,
the operations water supply shall be obtained from an approved source
properly located, protected, and operated and shall be easily
accessible, adequate, and of a safe, sanitary quality which shall be in
conformance at all times with the applicable laws and regulations of the
government agency or agencies having jurisdiction.
(3) Product water and operations water from approved sources. (i)
Samples of source water are to be taken and analyzed by the plant as
often as necessary, but at a minimum frequency of once each year for
chemical contaminants and once every 4 years for radiological
contaminants. Additionally, source water obtained from other than a
public water system is to be sampled and analyzed for microbiological
contaminants at least once each week. This sampling is in addition to
any performed by government agencies having jurisdiction. Records of
approval of the source water by government agencies having jurisdiction
and of sampling and analyses for which the plant is responsible are to
be maintained on file at the plant.
(ii) Test and sample methods shall be those recognized and approved
by the government agency or agencies having jurisdiction over the
approval of the water source, and shall be consistent with the minimum
requirements set forth in Sec. 165.110(b) of this chapter.
(iii) Analysis of the sample may be performed for the plant by
competent commercial laboratories (e.g., Environmental Protection Agency
(EPA) and State-certified laboratories).
[[Page 285]]
(4) Source water testing exemptions. (i) Firms that use a public
water system for source water may substitute public water system testing
results, or certificates showing full compliance with all provisions of
EPA National Primary and Secondary Drinking Water Regulations pertaining
to chemical contaminants (40 CFR parts 141 and 143), for the testing
requirements of Sec. 129.35(a)(3).
(ii) Firms that do not use a public water system as the source of
their water may reduce the frequency of their testing of that source, as
well as the number of chemical contaminants for which they test the
source water, if they can document that such reduction is consistent
with a State-issued waiver under EPA regulations (40 CFR parts 141 and
143).
(iii) Firms that do not use a public water system as the source of
their water and whose source water has not been treated with a chlorine-
based disinfectant or ozone do not have to test their source water for
the residual disinfectants and DBP's listed in Sec.
165.110(b)(4)(iii)(H) of this chapter. Firms that do not use a public
water system as the source of their water but whose source water has
been treated with a chlorine-based disinfectant or ozone must test their
source water for the residual disinfectants and the DBP's listed in
Sec. 165.110(b)(4)(iii)(H) that are likely to result from such
treatment.
(iv) The finished bottled water must comply with bottled water
quality standards (21 CFR 165.110(b)) and section 402(a)(1) of the act
dealing with adulterated foods.
(b) Air under pressure. Whenever air under pressure is directed at
product water or a product water-contact surface, it shall be free of
oil, dust, rust, excessive moisture, and extraneous materials; shall not
affect the bacteriological quality of the water; and should not
adversely affect the flavor, color, or odor of the water.
(c) Locker and lunchrooms. When employee locker and lunchrooms are
provided, they shall be separate from plant operations and storage areas
and shall be equipped with self-closing doors. The rooms shall be
maintained in a clean and sanitary condition and refuse containers
should be provided. Packaging or wrapping material or other processing
supplies shall not be stored in locker or lunchrooms.
[42 FR 14355, Mar. 15, 1977, as amended at 44 FR 12175, Mar. 6, 1979; 60
FR 57123, Nov. 13, 1995; 66 FR 16865, Mar. 28, 2001]
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