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Free Louisiana Fd 9 Form

The Louisiana FD-9 form serves as an application for obtaining a Certificate of Registration for bottled water distributors in the state of Louisiana. This form outlines the necessary documentation and requirements for both new products and facilities, ensuring compliance with health and safety regulations. For those interested in entering the bottled water market, completing this form is a crucial first step; click the button below to begin the process.

Open Louisiana Fd 9 Editor Here

Open Louisiana Fd 9 Editor Here

Structure

The Louisiana FD 9 form serves as a crucial document for businesses seeking to distribute bottled water in the state. This form guides prospective bottled water importers through the necessary steps to obtain a Certificate of Registration. A variety of requirements must be met to ensure compliance with state regulations. Applicants must provide documentation related to new water sources, products, or bottling plants. Key items include hydrogeological reports prepared by licensed professionals, test results confirming water quality, and proof of regulatory compliance. Additionally, the form outlines registration fees and the definition of distinct products, emphasizing the importance of accurate labeling and monitoring of both source and product water. Understanding these requirements is essential for any company aiming to navigate the complexities of bottled water distribution in Louisiana.

Sample - Louisiana Fd 9 Form

STATE OF LOUISIANA

DEPARTMENT OF HEALTH AND HOSPITALS

Dear Prospective Bottled Water Importer:

I am pleased to provide you with the attached documents as a guideline to the steps necessary in order to obtain a Certificate of Registration as a bottled-water distributor in the state of Louisiana. Please read the following information carefully, and if you have any questions immediately after reviewing it, please contact my office.

1.Required Items for Approval of New Water Sources, Products, and/or Bottling Plants:Your first step in obtaining a Certificate of Registration for your water product is to ensure that your water source will be approved for this use. Below you will find several different scenarios for various permutations of new products, bottling plants, or sources. Please review the following information to determine which of these scenarios best characterizes your activities.

For a new product [that has never previously been registered] and/or a new facility, we require the following documentation: a hydrogeological report prepared by a professional geologist detailing the regional and local geology, as well as the development of catchment facilities; a recent set of test results documenting that the source water is being monitored for the contaminants specified in the attached Testing Requirements for Bottled Water – Product and Source, a recent set of test results verifying that product water is compliant with the standard of identity found in 21 CFR 165.110, a copy of the most recent certificate/inspection/license issued by the state or local regulatory authority having jurisdiction over the bottling plant, a completed FD-9(N) Application for a New Product Registration, specimen labels for each distinct product, and the appropriate fee of $20 per product up to a maximum of $200 per DBA.

New products will be issued a Certificate of Registration once all documentation has been received and reviewed by the Sanitarian Program Manager for Bottled Water. New facilities may be issued a Certificate of Registration at the discretion of the management of the corporate owner of the facility.

Note that it is not our standard practice to issue CoR documents to each facility manufacturing a particular product; the CoR is intended to be issued once to the corporate owner of the facility or facilities that manufacture said product. However, we will accommodate corporate policies that may require each plant to have a certificate.

For a new source utilized by an existing product and an approved facility, we require the following information: a hydrogeological report as described below and a recent set of test results documenting that the source water is being monitored for the contaminants specified in the attached Testing Requirements for Bottled Water – Product and Source. New sources will be issued an approval letter by the Sanitarian Program Manager for Bottled Water.

For new facilities producing a previously-registered product and an approved source, we require the following documentation: a copy of the most recent certificate/inspection/license issued by the state or local regulatory authority having jurisdiction over the bottling plant and test results verifying that the product water (from this specific plant) is compliant with the standard of identity found in 21 CFR 165.110. As indicated above, new facilities may be issued a Certificate of Registration if

corporate policy requires it; otherwise, a new facility will receive an approval letter from the Sanitarian Program Manager for Bottled Water.

Submission of Hydrogeological Report on Source to Program Manager: The report is to be submitted to the Sanitarian Program Manager for Bottled Water for review at (225) 342-7672 [fax] or regular mail at Bin # 14, P.O. Box 4489, Baton Rouge, LA 70821-4489. The report must include the following items (at a minimum) and it must be signed and certified by a credentialed professional geologist or hydrogeologist:

a)a report on the regional geology and the specific site geology of the source area, including a description of the vertical and horizontal extent of the source aquifer using existing data;

b)a report detailing the development of the source, the method of construction including spring design, well installation, surface catchment and intake structures, and transmission facilities as appropriate;

c)a watershed survey of the recharge area or zone of influence of subject source that identifies and evaluates actual and potential sources of contamination;

d)and, based on the findings of Section (c) above, a plan for special monitoring of any significant contaminant source and for taking restrictive preventive or corrective measures as appropriate to protect the source and product water.

2.Product Registration: Your non-bulk products (any sizes below 3 gallons) must be registered with this office. Therefore, you must submit proofs or specimen copies of labels containing all of the basic information provided in and meeting the criteria outlined in 21 CFR 101 et seq. (not provided—this document is available from the Food and Drug Administration). Labels must be submitted to the Program Manager for Product Registration, currently Brian R. Warren, at (225)

342-7672 [fax] or regular mail at Bin # 14, P.O. Box 4489, Baton Rouge, LA 70821-4489. Assemble a registration packet consisting of the attached FD-9(N) Application for a New Product Registration Form, a check or money order for $20 per distinct product, and specimens or proofs of each label.

Clarification of “Distinct Product” and What It Means in the Bottled Water Industry: An additional

note on registration: the term “distinct product” as it applies to bottled water may mean several things. If your firm will manufacture a distilled water product and a spring water product, these are two distinct products. However, if your firm will produce a Brand X distilled water and a Brand Y distilled water, these are also two distinct products. So, the rule of thumb to follow here is this: if the water conforms to a different standard of identity as specified in 21 CFR 165.110 (Bottled water), it is a distinct product, and if you manufacture said product under different brand names or private labels, each of those constitutes a separate product as well. You must register each product that your firm manufactures (meaning that it must be listed on the FD-9 form or an attached document and a label must be provided), but the registration fee is capped at 10 products or $200. Please note that multiple sizes (12 oz., 16 oz., 1 gallon) of the same product are not considered distinct products and may be registered as a single product.

3.Source And Product Water Monitoring: Once construction is complete on your well, if you are relying on a private water supply, you will need to perform tests on a sample taken from your sample tap. The required testing and monitoring regimen is outlined in the attached Testing Requirements for Bottled Water – Source and Product document. Public water sources may submit documents verifying that the source is fully compliant with the National Primary Drinking Water Regulations (40 CFR 141—not provided, this document may be obtained from the Environmental Protection Agency).

Once a source sample is collected (according to the guidelines of and using the sample container provided by the testing laboratory), you may submit the sample to a NELAP- and/or state-certified laboratory for drinking water chemistry for the performance of annual, quadrennial, and triennial analysis for chemical, physical, and radiological contaminants and/or a NELAP- or state-certified laboratory for drinking water microbiology for the coliform analysis. An in-house laboratory may conduct the routine weekly microbiological testing, but annual tests must be performed by a NELAP- or state-certified laboratory for drinking water chemistry. Contact the NELAC Institute for a current listing of NELAP-certified laboratories in your area and your state environmental quality or public health agency (depending on which agency oversees laboratory certification) for a list of state-certified laboratories for drinking water chemistry and microbiology.

Attachments: PLEASE FIND THE FOLLOWING DOCUMENTS ATTACHED TO THIS GUIDE

FD-9(N) APPLICATION FOR A NEW PRODUCT REGISTRATION FORM 21 CFR 165.110 STANDARD OF IDENTITY FOR BOTTLED WATER

TESTING REQUIREMENTS FOR BOTTLED WATER – SOURCE AND PRODUCT

APPLICATION	DEPARTMENT OF HEALTH AND HOSPITALS
FOR REGISTRATION	OFFICE OF PUBLIC HEALTH
FD-9 (N)	FOOD AND DRUG UNIT
Rev. (10/2008)	628 N. 4th ST./P.O. BOX 4489
	BATON ROUGE, LA 70821-4489
	PHONE: (225) 342-7517 * FAX: (225) 342-7672

NEW COMPANY INITIAL APPLICATION
Check the appropriate product type below:
FOOD	DRUG	COSMETIC		PROPHYLACTIC		SEAFOOD	MILK/DAIRY



Date					Registration No. (For Office Use Only)

Company Contact Person			Taxpayer ID		Telephone No.		Fax No.

Name of Manufacturer, Distributor, Packer, Processor, or Importer (exactly as it appears on the label)

Address			City		State		ZIP Code

If this is a private-label/copacked product, list the name of the actual manufacturer here

Address			City		State		ZIP Code

Name of firm submitting application

Address (Mailing)			City		State		ZIP Code

Signature of Executive Officer, Proprietor, Partner, or Agent for Service of Process					Title

APPLICATION IS HEREBY MADE BY THE ABOVE-REFERENCED INDIVIDUALS/COMPANIES TO SELL OR OTHERWISE DISTRIBUTE PACKAGED FOOD, DRUG, COSMETIC, OR PROPHYLACTIC DEVICES IN THE STATE OF LOUISIANA, IN ACCORDANCE WITH LSA R.S. 40: 627 ET SEQ. APPLICATION IS BEING MADE IN THE NAME OF THE RESPONSIBLE PARTY FOR THE AFOREMENTIONED PRODUCTS, WHOSE NAME AND ADDRESS APPEAR ON THE LABELS, AS REQUIRED BY STATE AND FEDERAL LAW. BY SIGNING IN THE SPACE PROVIDED, I ACKNOWLEDGE THAT I HAVE ATTACHED A CATALOG LISTING OF ALL PRODUCTS I INTEND TO DISTRIBUTE IN LOUISIANA ALONG WITH PROOFS OR SPECIMEN LABELS FOR ALL SUCH PRODUCTS IN PAPER OR ELECTRONIC FORM, AS REQUIRED BY LOUISIANA LAW.

REGISTRATION FEE: THE FEE FOR PRODUCT REGISTRATION IS $20 PER PRODUCT UP TO A MAXIMUM
PER DBA OF $200. MULTIPLY $20 BY THE NUMBER OF PRODUCTS YOU INTEND TO REGISTER OR 10 IF	Total number of products to register:
THE NUMBER IS GREATER THAN 10, AND ENTER THAT NUMBER IN THE LINE TO THE RIGHT. NOTE
THAT IF YOU ARE REGISTERING MORE THAN ONE DBA, YOU MUST USE MORE THAN ONE FD-9(N).	Fee attached
MAKE ALL CHECKS AND MONEY ORDERS PAYABLE TO DHH.

List below the names and addresses of three brokers, warehousemen, or distributors who will be handling your products in the state. If you do not currently have any distributors, indicate “SELF-DISTRIBUTION” in the first space below.

1)	2)	3)

		FOR OFFICE USE ONLY
REGISTRATION YEAR	CHECK NUMBER		PROCESSED BY

SHEET NUMBER	CHECK DATE		CERTIFICATE TYPE

SHEET DATE

REGISTRATION NUMBER

Food and Drug Administration, HHS

Subpart A—General Provisions

§ 165.3 Definitions.

(a ) A lot i s :

(1) F o r p u r p o s e s o f d e t e r m i n i n g q u a l - i t y fa c t o r s r e l a t e d t o m a n u fa c t u r e , p r o c e s s i n g , o r p a c k i n g , a c o l l e c t i o n o f p r i m a r y c o n t a i n e r s o r u n i t s o f t h e s a m e s i ze , t y p e , a n d s t y l e p r o d u c e d u n d e r c o n d i t i o n s a s n e a r l y u n i fo r m a s p o s s i b l e a n d u s u a l l y d e s i g n a t e d b y a c o m m o n c o n t a i n e r c o d e o r m a r k i n g , o r i n t h e a b s e n c e o f a n y c o m m o n c o n - t a i n e r c o d e o r m a r k i n g , a d a y ’s p r o d u c - t i o n .

(2) F o r p u r p o s e s o f d e t e r m i n i n g q u a l - i t y fa c t o r s r e l a t e d t o d i s t r i b u t i o n a n d s t o r a g e , a c o l l e c t i o n o f p r i m a r y c o n - t a i n e r s o r u n i t s t r a n s p o r t e d , s t o r e d , o r h e l d u n d e r c o n d i t i o n s a s n e a r l y u n i - fo r m a s p o s s i b l e .

(b ) A sa m p le c o n s i s t s o f 10 s u b s a m p l e s (c o n s u m e r u n i t s ), o n e t a k e n fr o m e a c h o f 10 d i ffe r e n t r a n d o m l y c h o s e n s h i p - p i n g c a s e s t o b e r e p r e s e n t a t i v e o f a g i v e n l o t , u n l e s s o t h e r w i s e s p e c i fi e d i n a s p e c i fi c s t a n d a r d i n t h i s p a r t .

(c ) A n a n a ly t ica l u n it i s t h e p o r t i o n (s ) o f fo o d t a k e n fr o m a s u b s a m p l e o f a s a m p l e fo r t h e p u r p o s e o f a n a l y s i s .

Subpart B—Requirements for

Specific Standardized Beverages

§ 165.110 Bottled water.

(a ) I d en t it y —(1) D escrip t ion . B o t t l e d

w a t e r i s w a t e r t h a t i s i n t e n d e d fo r h u m a n c o n s u m p t i o n a n d t h a t i s s e a l e d i n b o t t l e s o r o t h e r c o n t a i n e r s w i t h n o a d d e d i n g r e d i e n t s e x c e p t t h a t i t m a y o p t i o n a l l y c o n t a i n s a fe a n d s u i t a b l e a n t i m i c r o b i a l a g e n t s . F l u o r i d e m a y b e o p t i o n a l l y a d d e d w i t h i n t h e l i m i t a t i o n s e s t a b l i s h e d i n § 165. 110(b )(4)(i i ). B o t t l e d w a t e r m a y b e u s e d a s a n i n g r e d i e n t i n b e v e r a g e s (e . g . , d i l u t e d j u i c e s , fl a v o r e d b o t t l e d w a t e r s ). I t d o e s n o t i n c l u d e t h o s e fo o d i n g r e d i e n t s t h a t a r e d e -


c l a r e d	i n	i n g r e d i e n t		l a b e l i n g		a s
‘‘w a t e r ,’’		‘‘c a r b o n a t e d		w a t e r ,’’ ‘‘d i s -
i n fe c t e d		w a t e r ,’’	‘‘fi l t e r e d		w a t e r ,’’
‘‘s e l t ze r	w a t e r ,’’ ‘‘s o d a			w a t e r ,’’	‘‘s p a r -
k l i n g w a t e r ,’’ a n d			‘‘t o n i c w a t e r . ’’			T h e

p r o c e s s i n g a n d b o t t l i n g o f b o t t l e d w a t e r s h a l l c o m p l y w i t h a p p l i c a b l e r e g -

u l a t i o n s i n p a r t 129		o f t h i s c h a p t e r .
(2)	N om en cla t u re.	T h e n a m e o f t h e
fo o d	i s ‘‘b o t t l e d	w a t e r ,’’ ‘‘d r i n k i n g

§ 165.110

w a t e r ,’’ o r a l t e r n a t i v e l y o n e o r m o r e o f t h e fo l l o w i n g t e r m s a s a p p r o p r i a t e :

(i ) T h e n a m e o f w a t e r fr o m a w e l l t a p p i n g a c o n fi n e d a q u i fe r i n w h i c h t h e w a t e r l e v e l s t a n d s a t s o m e h e i g h t

a b o v e t h e t o p	o f t h e a q u i fe r i s	‘‘a r t e -
s i a n w a t e r ’’ o r	‘‘a r t e s i a n w e l l	w a t e r . ’’

A r t e s i a n w a t e r m a y b e c o l l e c t e d w i t h t h e a s s i s t a n c e o f e x t e r n a l fo r c e t o e n - h a n c e t h e n a t u r a l u n d e r g r o u n d p r e s - s u r e . On r e q u e s t , p l a n t s s h a l l d e m - o n s t r a t e t o a p p r o p r i a t e r e g u l a t o r y o ffi - c i a l s t h a t t h e w a t e r l e v e l s t a n d s a t s o m e h e i g h t a b o v e t h e t o p o f t h e a q u i - fe r .

(i i ) T h e n a m e o f w a t e r fr o m a s u b - s u r fa c e s a t u r a t e d zo n e t h a t i s u n d e r a p r e s s u r e e q u a l t o o r g r e a t e r t h a n a t - m o s p h e r i c p r e s s u r e i s ‘‘g r o u n d w a t e r . ’’ G r o u n d w a t e r m u s t n o t b e u n d e r t h e d i - r e c t i n fl u e n c e o f s u r fa c e w a t e r a s d e - fi n e d i n 40 CF R 141. 2.

(i i i ) T h e n a m e o f w a t e r c o n t a i n i n g n o t l e s s t h a n 250 p a r t s p e r m i l l i o n (p p m ) t o t a l d i s s o l v e d s o l i d s (T D S ), c o m i n g fr o m a s o u r c e t a p p e d a t o n e o r m o r e b o r e h o l e s o r s p r i n g s , o r i g i n a t i n g fr o m a g e o l o g i c a l l y a n d p h y s i c a l l y p r o - t e c t e d u n d e r g r o u n d w a t e r s o u r c e , m a y b e ‘‘m i n e r a l w a t e r . ’’ M i n e r a l w a t e r s h a l l b e d i s t i n g u i s h e d fr o m o t h e r t y p e s o f w a t e r b y i t s c o n s t a n t l e v e l a n d r e l - a t i v e p r o p o r t i o n s o f m i n e r a l s a n d t r a c e e l e m e n t s a t t h e p o i n t o f e m e r g e n c e fr o m t h e s o u r c e , d u e a c c o u n t b e i n g t a k e n o f t h e c y c l e s o f n a t u r a l fl u c t u a - t i o n s . N o m i n e r a l s m a y b e a d d e d t o t h i s w a t e r .

(i v ) T h e n a m e o f w a t e r t h a t h a s b e e n p r o d u c e d b y d i s t i l l a t i o n , d e i o n i za t i o n , r e v e r s e o s m o s i s , o r o t h e r s u i t a b l e p r o c - e s s e s a n d t h a t m e e t s t h e d e fi n i t i o n o f ‘‘p u r i fi e d w a t e r ’’ i n t h e U n i t e d S t a t e s P h a r m a c o p e i a , 23d R e v i s i o n , J a n u a r y 1, 1995, w h i c h i s i n c o r p o r a t e d b y r e fe r e n c e i n a c c o r d a n c e w i t h 5 U . S . C. 551(a ) a n d 1 CF R p a r t 51. (Co p i e s m a y b e o b t a i n e d fr o m t h e U n i t e d S t a t e s P h a r m a c o p i a l

Co n v e n t i o n , I n c . , 12601 T w i n b r o o k P k w y . , R o c k v i l l e , M D 20852 a n d m a y b e e x a m i n e d a t t h e Ce n t e r fo r F o o d S a fe t y

a n d A p p l i e d N u t r i t i o n ’s L i b r a r y ,						5100
P a i n t B r a n c h P k w y . , Co l l e g e P a r k , M D
20740,	o r a t t h e Offi c e			o f t h e F e d e r a l
R e g i s t e r ,		800 N o r t h	Ca p i t o l		S t . N W. ,
s u i t e	700,	Wa s h i n g t o n ,		D C),	m a y	b e
‘‘p u r i fi e d		w a t e r ’’	o r	‘‘d e m i n e r a l i ze d

w a t e r . ’’ A l t e r n a t i v e l y , t h e w a t e r m a y b e c a l l e d ‘‘d e i o n i ze d w a t e r ’’ i f t h e

527

§ 165.110

21 CFR Ch. I (4–1–04 Edition)

w a t e r	h a s	b e e n	p r o c e s s e d	b y
d e i o n i za t i o n ,		‘‘d i s t i l l e d	w a t e r ’’ i f i t	i s
p r o d u c e d	b y	d i s t i l l a t i o n , ‘‘r e v e r s e		o s -

m o s i s w a t e r ’’ i f t h e w a t e r h a s b e e n p r o c e s s e d b y r e v e r s e o s m o s i s , a n d

‘‘ d r i n k i n g w a t e r ’’ w i t h t h e b l a n k b e i n g fi l l e d i n w i t h o n e o f t h e d e fi n e d t e r m s d e s c r i b i n g t h e w a t e r i n t h i s

p a r a g r a p h (e . g . , ‘‘p u r i fi e d		d r i n k i n g
w a t e r ’’ o r	‘‘d e i o n i ze d d r i n k i n g	w a t e r ’’).
(v ) T h e	n a m e o f w a t e r t h a t , a ft e r

t r e a t m e n t a n d p o s s i b l e r e p l a c e m e n t o f c a r b o n d i o x i d e , c o n t a i n s t h e s a m e a m o u n t o f c a r b o n d i o x i d e fr o m t h e s o u r c e t h a t i t h a d a t e m e r g e n c e fr o m t h e s o u r c e m a y b e ‘‘s p a r k l i n g b o t t l e d w a t e r . ’’

(v i ) T h e n a m e o f w a t e r d e r i v e d fr o m a n u n d e r g r o u n d fo r m a t i o n fr o m w h i c h w a t e r fl o w s n a t u r a l l y t o t h e s u r fa c e o f t h e e a r t h m a y b e ‘‘s p r i n g w a t e r . ’’

S p r i n g w a t e r s h a l l b e c o l l e c t e d o n l y a t
t h e s p r i n g o r t h r o u g h a b o r e h o l e t a p -
p i n g t h e u n d e r g r o u n d fo r m a t i o n fe e d -
i n g t h e s p r i n g . T h e r e s h a l l b e a n a t u r a l
fo r c e c a u s i n g t h e w a t e r t o fl o w t o	t h e
s u r fa c e t h r o u g h a n a t u r a l o r i fi c e . T h e
l o c a t i o n o f t h e s p r i n g s h a l l b e i d e n t i -
fi e d . S p r i n g w a t e r c o l l e c t e d w i t h	t h e
u s e o f a n e x t e r n a l fo r c e s h a l l b e fr o m
t h e s a m e u n d e r g r o u n d s t r a t u m a s	t h e
s p r i n g , a s s h o w n b y a m e a s u r a b l e	h y -

d r a u l i c

c o n n e c t i o n

u s i n g

h y d r o g e o l o g i c a l l y v a l i d m e t h o d b e - t w e e n t h e b o r e h o l e a n d t h e n a t u r a l s p r i n g , a n d s h a l l h a v e a l l t h e p h y s i c a l p r o p e r t i e s , b e fo r e t r e a t m e n t , a n d b e o f t h e s a m e c o m p o s i t i o n a n d q u a l i t y , a s t h e w a t e r t h a t fl o w s n a t u r a l l y t o t h e s u r fa c e o f t h e e a r t h . I f s p r i n g w a t e r i s c o l l e c t e d w i t h t h e u s e o f a n e x t e r n a l fo r c e , w a t e r m u s t c o n t i n u e t o fl o w n a t - u r a l l y t o t h e s u r fa c e o f t h e e a r t h t h r o u g h t h e s p r i n g ’s n a t u r a l o r i fi c e . P l a n t s s h a l l d e m o n s t r a t e , o n r e q u e s t , t o a p p r o p r i a t e r e g u l a t o r y o ffi c i a l s , u s i n g a h y d r o g e o l o g i c a l l y v a l i d m e t h - o d , t h a t a n a p p r o p r i a t e h y d r a u l i c c o n - n e c t i o n e x i s t s b e t w e e n t h e n a t u r a l o r i - fi c e o f t h e s p r i n g a n d t h e b o r e h o l e .

(v i i ) T h e n a m e o f w a t e r t h a t m e e t s


t h e	r e q u i r e m e n t s			u n d e r	‘‘S t e r i l i t y
T e s t s ’’ < 71>		i n	t h e U n i t e d		S t a t e s P h a r -
m a c o p e i a ,		23d	R e v i s i o n ,		J a n u a r y 1,
1995, w h i c h		i s i n c o r p o r a t e d b y r e fe r e n c e
i n a c c o r d a n c e w i t h				5 U . S . C. 552(a ) a n d 1
CF R	51. (Co p i e s m a y b e o b t a i n e d fr o m
t h e U n i t e d S t a t e s P h a r m a c o p e i a l Co n -
v e n t i o n , I n c . ,			12601	T w i n b r o o k P k w y . ,

R o c k v i l l e , M D 20852 a n d m a y b e e x a m - i n e d a t t h e Ce n t e r fo r F o o d S a fe t y a n d

A p p l i e d	N u t r i t i o n ’s	L i b r a r y , 5100 P a i n t
B r a n c h	P k w y . , Co l l e g e P a r k , M D 20740,
o r a t t h e Offi c e o f t h e F e d e r a l R e g i s t e r ,
800 N o r t h Ca p i t o l		S t . N W. ,	s u i t e 700,
Wa s h i n g t o n , D C),		m a y b e	‘‘s t e r i l e

w a t e r . ’’ A l t e r n a t i v e l y , t h e w a t e r m a y b e c a l l e d ‘‘s t e r i l i ze d w a t e r . ’’

(v i i i ) T h e n a m e o f w a t e r fr o m a h o l e b o r e d , d r i l l e d , o r o t h e r w i s e c o n s t r u c t e d i n t h e g r o u n d w h i c h t a p s t h e w a t e r o f a n a q u i fe r m a y b e ‘‘w e l l w a t e r . ’’

(3) O t h er la bel st a t em en t s. (i ) I f t h e

T D S c o n t e n t o f m i n e r a l w a t e r i s b e l o w


500 p p m ,		o r i f i t i s	g r e a t e r t h a n		1,500
p p m ,	t h e	s t a t e m e n t	‘‘l o w m i n e r a l		c o n -
t e n t ’’	o r	t h e s t a t e m e n t		‘‘h i g h m i n e r a l
c o n t e n t ’’,		r e s p e c t i v e l y ,		s h a l l a p p e a r o n

t h e p r i n c i p a l d i s p l a y p a n e l fo l l o w i n g t h e s t a t e m e n t o f i d e n t i t y i n t y p e s i ze a t l e a s t o n e -h a l f t h e s i ze o f t h e s t a t e - m e n t o f i d e n t i t y b u t i n n o c a s e o f l e s s t h a n o n e -s i x t e e n t h o f a n i n c h . I f t h e

T D S	o f m i n e r a l w a t e r i s b e t w e e n 500
a n d	1,500 p p m , n o a d d i t i o n a l s t a t e m e n t
n e e d a p p e a r .
(i i ) Wh e n b o t t l e d w a t e r c o m e s fr o m a

c o m m u n i t y w a t e r s y s t e m , a s d e fi n e d i n 40 CF R 141. 2, e x c e p t w h e n i t h a s b e e n

t r e a t e d t o m e e t t h e d e fi n i t i o n s i n p a r a -
g r a p h s (a )(2)(i v ) a n d	(a )(2)(v i i ) o f t h i s
s e c t i o n a n d i s l a b e l e d	a s s u c h , t h e l a b e l

s h a l l s t a t e ‘‘fr o m a c o m m u n i t y	w a t e r
s y s t e m ’’ o r , a l t e r n a t i v e l y , ‘‘fr o m	a m u -

n i c i p a l s o u r c e ’’ a s a p p r o p r i a t e , o n t h e p r i n c i p a l d i s p l a y p a n e l o r p a n e l s . T h i s s t a t e m e n t s h a l l i m m e d i a t e l y a n d c o n - s p i c u o u s l y p r e c e d e o r fo l l o w t h e n a m e o f t h e fo o d w i t h o u t i n t e r v e n i n g w r i t - t e n , p r i n t e d , o r g r a p h i c m a t t e r , o t h e r t h a n s t a t e m e n t s r e q u i r e d b y p a r a g r a p h (c ) o f t h i s s e c t i o n , i n t y p e s i ze a t l e a s t o n e -h a l f t h e s i ze o f t h e s t a t e m e n t o f i d e n t i t y b u t i n n o c a s e o f l e s s t h a n o n e - s i x t e e n t h o f a n i n c h .

(i i i ) Wh e n t h e l a b e l o r l a b e l i n g o f a b o t t l e d w a t e r p r o d u c t s t a t e s o r i m p l i e s (e . g . , t h r o u g h l a b e l s t a t e m e n t s o r v i - g n e t t e s w i t h r e fe r e n c e s t o i n fa n t s ) t h a t t h e b o t t l e d w a t e r i s fo r u s e i n fe e d i n g i n fa n t s , a n d t h e p r o d u c t i s n o t c o m - m e r c i a l l y s t e r i l e u n d e r § 113. 3(e )(3)(i ) o f t h i s c h a p t e r , t h e p r o d u c t ’s l a b e l s h a l l b e a r c o n s p i c u o u s l y a n d o n t h e p r i n - c i p a l d i s p l a y p a n e l t h e s t a t e m e n t ‘‘N o t s t e r i l e . U s e a s d i r e c t e d b y p h y s i c i a n o r b y l a b e l i n g d i r e c t i o n s fo r u s e o f i n fa n t fo r m u l a . ’’

528

Food and Drug Administration, HHS

§ 165.110

(4) L a bel d ecla ra t ion . E a c h o f t h e i n -

g r e d i e n t s u s e d i n t h e fo o d s h a l l b e d e - c l a r e d o n t h e l a b e l a s r e q u i r e d b y t h e

a p p l i c a b l e s e c t i o n s	o f p a r t s	101 a n d 130
o f t h i s c h a p t e r .
(b ) Q u a lit y . T h e	s t a n d a r d	o f q u a l i t y

fo r b o t t l e d w a t e r , i n c l u d i n g w a t e r fo r u s e a s a n i n g r e d i e n t i n b e v e r a g e s (e x - c e p t t h o s e d e s c r i b e d i n t h e l a b e l i n g a s


‘‘w a t e r ,’’		‘‘c a r b o n a t e d		w a t e r ,’’		‘‘d i s -
i n fe c t e d		w a t e r ,’’	‘‘fi l t e r e d		w a t e r ,’’
‘‘s e l t ze r		w a t e r ,’’ ‘‘s o d a		w a t e r ,’’	‘‘s p a r -
k l i n g	w a t e r ,’’ a n d		‘‘t o n i c w a t e r ’’),			i s a s
fo l l o w s :
(1)	D ef in it ion s.		(i ) T rih a lom et h a n e

(T H M ) m e a n s o n e o f t h e fa m i l y o f o r - g a n i c c o m p o u n d s , n a m e d a s d e r i v a t i v e s o f m e t h a n e , w h e r e i n t h r e e o f t h e fo u r h y d r o g e n a t o m s i n m e t h a n e a r e e a c h s u b s t i t u t e d b y a h a l o g e n a t o m i n t h e m o l e c u l a r s t r u c t u r e .

(i i ) T ot a l t rih a lom et h a n es (T T H M )

m e a n s t h e s u m o f t h e c o n c e n t r a t i o n i n

m i l l i g r a m s p e r l i t e r o f t h e t r i h a l o m e t h a n e c o m p o u n d s (t r i c h l o r o -


m e t h a n e ,	d i b r o m o c h l o r o m e t h a n e ,
b r o m o d i c h l o r o m e t h a n e ,		a n d

t r i b r o m o m e t h a n e ), r o u n d e d t o t w o s i g - n i fi c a n t fi g u r e s .

(i i i ) H a loa cet ic a cid s (fi v e ) (H A A 5) m e a n s t h e s u m o f t h e c o n c e n t r a t i o n s i n m i l l i g r a m s p e r l i t e r o f t h e h a l o a c e t i c


a c i d	c o m p o u n d s	(m o n o c h l o r o a c e t i c
a c i d ,	d i c h l o r o a c e t i c		a c i d ,

t r i c h l o r o a c e t i c a c i d , m o n o b r o m o a c e t i c a c i d , a n d d i b r o m o a c e t i c a c i d ), r o u n d e d t o t w o s i g n i fi c a n t fi g u r e s a ft e r a d d i - t i o n .

(2) M icrobiologica l qu a lit y . B o t t l e d

w a t e r s h a l l , w h e n a s a m p l e c o n s i s t i n g o f a n a l y t i c a l u n i t s o f e q u a l v o l u m e i s e x a m i n e d b y t h e m e t h o d s d e s c r i b e d i n a p p l i c a b l e s e c t i o n s o f ‘‘S t a n d a r d M e t h - o d s fo r t h e E x a m i n a t i o n o f Wa t e r a n d Wa s t e w a t e r ,’’ 15t h E d . (1980), A m e r i c a n P u b l i c H e a l t h A s s o c i a t i o n , w h i c h i s i n - c o r p o r a t e d b y r e fe r e n c e i n a c c o r d a n c e w i t h 5 U . S . C. 552(a ) a n d 1 CF R p a r t 51 (c o p i e s m a y b e o b t a i n e d fr o m t h e A m e r i c a n P u b l i c H e a l t h A s s o c i a t i o n ,

800 I S t . N W. , Wa s h i n g t o n , D C 20001, o r
a c o p y	m a y b e	e x a m i n e d a t t h e Offi c e
o f t h e	F e d e r a l	R e g i s t e r , 800 N o r t h Ca p -
i t o l S t . , N W. ,		s u i t e 700, Wa s h i n g t o n ,

D C, o r a t t h e Ce n t e r fo r F o o d S a fe t y

a n d	A p p l i e d N u t r i t i o n ’s	L i b r a r y , 200 C
S t . ,	S W. , Wa s h i n g t o n ,	D C), m e e t t h e

fo l l o w i n g s t a n d a r d s o f m i c r o b i o l o g i c a l q u a l i t y :

(i ) M u lt ip le-t u be f erm en t a t ion m et h od .

N o t m o r e t h a n o n e o f t h e a n a l y t i c a l u n i t s i n t h e s a m p l e s h a l l h a v e a m o s t p r o b a b l e n u m b e r (M P N ) o f 2. 2 o r m o r e c o l i fo r m o r g a n i s m s p e r 100 m i l l i l i t e r s a n d n o a n a l y t i c a l u n i t s h a l l h a v e a n M P N o f 9. 2 o r m o r e c o l i fo r m o r g a n i s m s p e r 100 m i l l i l i t e r s ; o r

(i i ) M em bra n e f ilt er m et h od . N o t m o r e

t h a n o n e o f t h e a n a l y t i c a l u n i t s i n t h e s a m p l e s h a l l h a v e 4. 0 o r m o r e c o l i fo r m o r g a n i s m s p e r 100 m i l l i l i t e r s a n d t h e a r i t h m e t i c m e a n o f t h e c o l i fo r m d e n - s i t y o f t h e s a m p l e s h a l l n o t e x c e e d o n e c o l i fo r m o r g a n i s m p e r 100 m i l l i l i t e r s .

(3) P h y sica l qu a lit y . B o t t l e d w a t e r

s h a l l , w h e n a c o m p o s i t e o f a n a l y t i c a l u n i t s o f e q u a l v o l u m e fr o m a s a m p l e i s e x a m i n e d b y t h e m e t h o d d e s c r i b e d i n a p p l i c a b l e s e c t i o n s o f ‘‘S t a n d a r d M e t h - o d s fo r t h e E x a m i n a t i o n o f Wa t e r a n d Wa s t e w a t e r ,’’ 15t h E d . (1980), w h i c h i s i n c o r p o r a t e d b y r e fe r e n c e (t h e a v a i l - a b i l i t y o f t h i s i n c o r p o r a t i o n b y r e f- e r e n c e i s g i v e n i n p a r a g r a p h (b )(2) o f t h i s s e c t i o n ), m e e t t h e fo l l o w i n g s t a n d - a r d s o f p h y s i c a l q u a l i t y :

(i ) T h e t u r b i d i t y s h a l l n o t e x c e e d 5 u n i t s .

(i i ) T h e c o l o r s h a l l n o t e x c e e d 15 u n i t s . 1

(i i i ) T h e o d o r s h a l l n o t e x c e e d t h r e s h - o l d o d o r N o . 3. 1

(4) Ch em ica l qu a lit y . (i )(A ) B o t t l e d w a t e r s h a l l , w h e n a c o m p o s i t e o f a n a - l y t i c a l u n i t s o f e q u a l v o l u m e fr o m a s a m p l e i s e x a m i n e d b y t h e m e t h o d s d e - s c r i b e d i n p a r a g r a p h (b )(4)(i )(B ) o f t h i s s e c t i o n , m e e t s t a n d a r d s o f c h e m i c a l q u a l i t y a n d s h a l l n o t c o n t a i n c h e m i c a l s u b s t a n c e s i n e x c e s s o f t h e fo l l o w i n g c o n c e n t r a t i o n s :

	Substance	Concentration in
	Substance	milligrams per liter
		milligrams per liter

	Arsenic	0.05
	Chloride1	250.0
	Iron1	0.3
	Manganese1	0.05
	Phenols	0.001
	Total dissolved solids1	500.0
	Zinc 1	5.0

1Mineral water is exempt from allowable level. The exemp- tions are aesthetically based allowable levels and do not re- late to a health concern.

1 M i n e r a l w a t e r i s e x e m p t fr o m a l l o w a b l e

l e v e l .	T h e e x e m p t i o n s a r e a e s t h e t i c a l l y
b a s e d	a l l o w a b l e l e v e l s a n d d o n o t r e l a t e t o a

h e a l t h c o n c e r n .

529

§ 165.110

21 CFR Ch. I (4–1–04 Edition)

(B ) A n a l y s e s c o n d u c t e d t o d e t e r m i n e c o m p l i a n c e w i t h p a r a g r a p h (b )(4)(i )(A )

o f t h i s s e c t i o n s h a l l b e	m a d e i n a c c o r d -
a n c e w i t h t h e m e t h o d s	d e s c r i b e d i n t h e

a p p l i c a b l e s e c t i o n s o f ‘‘S t a n d a r d M e t h - o d s fo r t h e E x a m i n a t i o n o f Wa t e r a n d

Wa s t e w a t e r ,’’		15t h	E d .	(1980),	o r
‘‘M e t h o d s	fo r	Ch e m i c a l		A n a l y s i s	o f
Wa t e r a n d	Wa s t e s ,’’		E n v i r o n m e n t a l

M o n i t o r i n g a n d S u p p o r t L a b o r a t o r y (E M S L ), E P A –600/4–79–020, M a r c h 1983, U . S . E n v i r o n m e n t a l P r o t e c t i o n A g e n c y (E P A ), b o t h o f w h i c h a r e i n c o r p o r a t e d b y r e fe r e n c e i n a c c o r d a n c e w i t h 5

U . S . C. 552(a ) a n d 1 CF R p a r t	51.
(C) A n a l y s e s fo r o r g a n i c	s u b s t a n c e s

s h a l l b e d e t e r m i n e d b y t h e a p p r o p r i a t e m e t h o d s s e t fo r t h b e l o w . T h e m e t h o d s i n p a r a g r a p h s (b )(4)(i ) (C)(1) a n d (C)(2) o f t h i s s e c t i o n a r e i n c o r p o r a t e d b y r e f- e r e n c e i n a c c o r d a n c e w i t h 5 U . S . C.

552(a ) a n d	1 CF R p a r t 51 a n d	a r e	d e -
s c r i b e d i n	‘‘S t a n d a r d M e t h o d s	fo r	E x -
a m i n a t i o n	o f Wa t e r a n d Wa s t e w a t e r ,’’
15t h E d . (1980). Co p i e s m a y b e		o b t a i n e d

fr o m t h e A m e r i c a n P u b l i c H e a l t h A s s o -


c i a t i o n , 800 I S t . N W. ,	Wa s h i n g t o n		D C
20001, a n d e x a m i n e d a t	t h e Offi c e o f t h e
F e d e r a l R e g i s t e r , 800 N o r t h		Ca p i t o l	S t . ,
N W. , s u i t e 700, Wa s h i n g t o n		D C, o r	t h e

Ce n t e r fo r F o o d S a fe t y a n d A p p l i e d N u - t r i t i o n ’s L i b r a r y , 200 C S t . N W. , Wa s h - i n g t o n D C. T h e m e t h o d s i n p a r a g r a p h s

(b )(4)(i )(C)(3) a n d		(C)(4)	a r e	c r o s s -r e f-
e r e n c e d	i n 40 CF R	p a r t	141,	s u b p a r t C,
a p p e n d i x C.
(1) ‘‘M e t h o d s fo r		Or g a n o c h l o r i n e P e s -
t i c i d e s i n I n d u s t r i a l E ffl u e n t s ;’’
(2)	‘‘M e t h o d s	fo r	Ch l o r i n a t e d

P h e n o x y A c i d H e r b i c i d e s i n I n d u s t r i a l

E ffl u e n t s ,’’ N o v e m b e r 28, 1973;
(3)	‘‘P a r t	I :		T h e	A n a l y s i s		o f
T r i h a l o m e t h a n e s i n F i n i s h e d Wa t e r s b y
t h e P u r g e a n d		T r a p M e t h o d ;’’ w h i c h i s
c r o s s -r e fe r e n c e d			i n	40	CF R	p a r t	141,
s u b p a r t C, a p p e n d i x C;
(4)	‘‘P a r t	I I :		T h e	A n a l y s i s		o f
T r i h a l o m e t h a n e s i n D r i n k i n g Wa t e r b y
L i q u i d /L i q u i d		E x t r a c t i o n ,’’				w h i c h	i s
c r o s s -r e fe r e n c e d			i n	40	CF R	p a r t	141,
s u b p a r t C, a p p e n d i x C;
(i i )(A ) B o t t l e d			w a t e r p a c k a g e d i n				t h e

U n i t e d S t a t e s t o w h i c h n o fl u o r i d e i s a d d e d s h a l l n o t c o n t a i n fl u o r i d e i n e x - c e s s o f t h e l e v e l s i n T a b l e 1 a n d t h e s e l e v e l s s h a l l b e b a s e d o n t h e a n n u a l a v - e r a g e o f m a x i m u m d a i l y a i r t e m p e r a - t u r e s a t t h e l o c a t i o n w h e r e t h e b o t t l e d w a t e r i s s o l d a t r e t a i l .

TABLE 1

	Annual average of maximum daily air tem-	Fluoride con-
	Annual average of maximum daily air tem-	centration in mil-
	peratures (°F)	centration in mil-
	peratures (°F)	ligrams per liter
		ligrams per liter

	53.7 and below	2.4
	53.8–58.3	2.2
	58.4–63.8	2.0
	63.9–70.6	1.8
	70.7–79.2	1.6
	79.3–90.5	1.4

(B ) I m p o r t e d b o t t l e d w a t e r t o w h i c h n o fl u o r i d e i s a d d e d s h a l l n o t c o n t a i n fl u o r i d e i n e x c e s s o f 1. 4 m i l l i g r a m s p e r l i t e r .

(C) B o t t l e d w a t e r p a c k a g e d i n t h e U n i t e d S t a t e s t o w h i c h fl u o r i d e i s a d d e d s h a l l n o t c o n t a i n fl u o r i d e i n e x - c e s s o f l e v e l s i n T a b l e 2 a n d t h e s e l e v - e l s s h a l l b e b a s e d o n t h e a n n u a l a v e r - a g e o f m a x i m u m d a i l y a i r t e m p e r a - t u r e s a t t h e l o c a t i o n w h e r e t h e b o t t l e d w a t e r i s s o l d a t r e t a i l .

TABLE 2

	Annual average of maximum daily air tem-	Fluoride con-
	Annual average of maximum daily air tem-	centration in mil-
	peratures (°F)	centration in mil-
	peratures (°F)	ligrams per liter
		ligrams per liter

	53.7 and below	1.7
	53.8–58.3	1.5
	58.4–63.8	1.3
	63.9–70.6	1.2
	70.7–79.2	1.0
	79.3–90.5	0.8

(D ) I m p o r t e d b o t t l e d w a t e r t o w h i c h fl u o r i d e i s a d d e d s h a l l n o t c o n t a i n fl u o - r i d e i n e x c e s s o f 0. 8 m i l l i g r a m p e r l i t e r .

(i i i ) H a v i n g c o n s u l t e d w i t h E P A a s r e q u i r e d b y s e c t i o n 410 o f t h e F e d e r a l F o o d , D r u g , a n d Co s m e t i c A c t , t h e F o o d a n d D r u g A d m i n i s t r a t i o n h a s d e - t e r m i n e d t h a t b o t t l e d w a t e r , w h e n a c o m p o s i t e o f a n a l y t i c a l u n i t s o f e q u a l v o l u m e fr o m a s a m p l e i s e x a m i n e d b y

t h e m e t h o d s		l i s t e d	i n p a r a g r a p h s
(b )(4)(i i i )(E )	t h r o u g h		(b )(4)(i i i )(F ),	a n d
(b )(4)(i i i )(G )	o f	t h i s s e c t i o n , s h a l l		n o t

c o n t a i n t h e fo l l o w i n g c h e m i c a l c o n - t a m i n a n t s i n e x c e s s o f t h e c o n c e n t r a -

t i o n s s p e c i fi e d i n p a r a g r a p h s

(b )(4)(i i i )(A )	t h r o u g h (b )(4)(i i i )(D ) o f
t h i s s e c t i o n .
(A ) T h e a l l o w a b l e l e v e l s fo r i n o r g a n i c
s u b s t a n c e s a r e a s fo l l o w s :

		Concentration in milligrams
Contaminant		per liter
		(or as specified)

Antimony		.006.
Barium		2.
Beryllium		0.004.

530

Food and Drug Administration, HHS

§ 165.110

Concentration in milligrams

Contaminant

Concentration in

Contaminant

per liter

(CAS Reg. No.)

milligrams per liter

(or as specified)

Pentachlorophenol (87–86–5)

0.001

Cadmium

0.005.

PCB’s

(as

decachlorobiphenyl)

(1336–

Chromium

0.1.

36–3)

0.0005

Copper

1.0.

Picloram (1918–02–1)

0.5

Cyanide

0.2.

.............................

Simazine (122–34–9)

0.004

Lead

0.005.

..............................

2,3,7,8-TCDD (Dioxin) (1746–01–6)

.......

3×10¥8

Mercury

0.002.

Toxaphene (8001–35–2)

0.003

Nickel

0.1.

.........................

2,4,5-TP (Silvex) (93–72–1)

0.05

Nitrate

10 (as nitrogen).

....................

Nitrite

1 (as nitrogen).

Total Nitrate and Nitrite ..

10 (as nitrogen).

(D )

T h e a l l o w a b l e

l e v e l s

fo r

c e r t a i n

Selenium

0.05.

c h e m i c a l s

fo r

w h i c h

E P A

h a s

e s t a b -

Thallium

0.002.

l i s h e d s e c o n d a r y m a x i m u m c o n t a m i -

(B ) T h e a l l o w a b l e l e v e l s fo r v o l a t i l e

n a n t l e v e l s i n i t s d r i n k i n g w a t e r r e g u -

l a t i o n s (40 CF R

p a r t

143) a r e a s

fo l l o w s :

o r g a n i c c h e m i c a l s

(V OC’s )

a r e a s fo l -

l o w s :

Concentration in

Contaminant

milligrams per

Contaminant

Concentration in

liter

(CAS Reg. No.)

milligrams per liter

Aluminum

0.2

Benzene (71–43–2)

0.005

Silver

0.1

Carbon tetrachloride (56–23–5)

0.005

Sulfate 1

.....................................................

250.0

o- Dichlorobenzene (95–50–1)

................

0.6

1 Mineral water is exempt from allowable level. The exemp-

p- Dichlorobenzene (106–46–7)

0.075

1,2-Dichloroethane (107–06–2)

0.005

tions are aesthetically based allowable levels and do not re-

...............

late to a health concern.

1,1-Dichloroethylene (75–35–4)

0.007

cis-1,2-Dichloroethylene (156–59–2)

0.07

(E ) A n a l y s e s t o d e t e r m i n e c o m p l i -

trans-1,2-Dichloroethylene (156–60–5)

0.1

a n c e

w i t h

t h e

r e q u i r e m e n t s

o f

p a r a -

Dichloromethane (75–09–2)

0.005

1,2-Dichloropropane (78–87–5)

...............

0.005

g r a p h

(b )(4)(i i i )(A )

o f t h i s

s e c t i o n

s h a l l

Ethylbenzene (100–41–4)

0.7

b e c o n d u c t e d i n a c c o r d a n c e w i t h a n a p -

Monochlorobenzene (108–90–7)

0.1

p l i c a b l e

m e t h o d

a n d

a p p l i c a b l e

r e v i -

Styrene (100–42–5)

0.1

Tetrachloroethylene (127–18–4)

0.005

s i o n s

t o

t h e

m e t h o d s

l i s t e d

i n

p a r a -

Toluene (108–88–3)

g r a p h s

(b )(4)(i i i )(E )(1)

t h r o u g h

1,2,4–Trichlorobenzene (120–82–1)

0.07

(b )(4)(i i i )(E )(13)

o f

t h i s

s e c t i o n

a n d

d e -

1,1,1-Trichloroethane (71–55–6)

0.20

1,1,2–Trichloroethane (79–00–5)

0.005

s c r i b e d ,

u n l e s s

o t h e r w i s e

n o t e d ,

i n

Trichloroethylene (79–01–6)

0.005

‘‘M e t h o d s

fo r

Ch e m i c a l

A n a l y s i s

o f

Vinyl chloride (75–01–4)

0.002

Wa t e r

a n d Wa s t e s ,’’ U . S . E P A E n v i r o n -

Xylenes (1330–20–7)

m e n t a l M o n i t o r i n g a n d S u p p o r t L a b -

o r a t o r y

(E M S L ),

Ci n c i n n a t i ,

45258

(E P A –600/4–79–020), M a r c h

1983, w h i c h i s

a n d o t h e r s y n t h e t i c o r g a n i c c h e m i c a l s

i n c o r p o r a t e d b y r e fe r e n c e i n a c c o r d -

(S OC’s ) a r e a s fo l l o w s :

a n c e

w i t h

5 U . S . C.

552(a )

a n d

1 CF R

Contaminant

Concentration in

p a r t

51.

Co p i e s

o f

t h i s

p u b l i c a t i o n

a r e

(CAS Reg. No.)

milligrams per liter

a v a i l a b l e fr o m t h e N a t i o n a l T e c h n i c a l

Alachlor (15972–60–8)

0.002

I n fo r m a t i o n

S e r v i c e

(N T I S ),

U . S .

D e -

Atrazine (1912–24–9)

0.003

p a r t m e n t

o f

Co m m e r c e ,

5285

P o r t

Benzo(a)pyrene (50–32–8)

0.0002

R o y a l

R d . ,

S p r i n g fi e l d ,

V A

22161,

o r

Carbofuran (1563–66–2)

0.04

Chlordane (57–74–9)

0.002

m a y

b e

e x a m i n e d

a t

t h e

Ce n t e r

fo r

Dalapon (75–99–0)

0.2

F o o d

S a fe t y

a n d

A p p l i e d

N u t r i t i o n ’s

1,2-Dibromo-3-chloropropane (96–12–8)

0.0002

L i b r a r y , F o o d a n d D r u g A d m i n i s t r a -

2,4-D (94–75–7)

0.07

t i o n ,

5100 P a i n t

B r a n c h

P k w y . ,

Co l l e g e

Di(2-ethylhexyl)adipate (103–23–1)

0.4

Dinoseb (88–85–7)

0.007

P a r k ,

M D

20740,

o r

a t

t h e

Offi c e

o f

t h e

Diquat (85–00–7)

0.02

F e d e r a l

R e g i s t e r ,

800

N o r t h

Ca p i t o l

Endothall (145–73–3)

0.1

S t r e e t

N W. ,

s u i t e

700,

Wa s h i n g t o n ,

D C.

Endrin (72–20–8)

0.002

Ethylene dibromide (106–93–4)

0.00005

(1) A n t i m o n y

s h a l l b e m e a s u r e d u s i n g

Glyphosate (1071–53–6)

0.7

t h e fo l l o w i n g m e t h o d s :

Heptachlor (76–44–8)

0.0004

(i)

M e t h o d

204. 2—‘‘A t o m i c

A b s o r p -

Heptachlor epoxide (1024–57–3)

0.0002

Hexachlorobenzene (118–74–4)

0.001

t i o n ;

fu r n a c e

t e c h n i q u e ,’’ w h i c h

i s

i n -

Hexachlorocyclopentadiene (77–47–4) ...

0.05

c o r p o r a t e d b y r e fe r e n c e i n a c c o r d a n c e

Lindane (58–89–9)

0.0002

w i t h

5 U . S . C. 552(a )

a n d

1 CF R

p a r t

51.

Methoxychlor (72–43–5)

0.04

Oxamyl (23135–22–0)

0.2

T h e

a v a i l a b i l i t y

o f

t h i s

i n c o r p o r a t i o n

531

§ 165.110

21 CFR Ch. I (4–1–04 Edition)

b y r e fe r e n c e i s g i v e n i n p a r a g r a p h (b )(4)(i i i )(E ) o f t h i s s e c t i o n .

(ii) M e t h o d 200. 8—‘‘D e t e r m i n a t i o n o f T r a c e E l e m e n t s i n Wa t e r a n d Wa s t e s b y I n d u c t i v e l y Co u p l e d P l a s m a -M a s s S p e c t r o m e t r y ,’’ R e v . 4. 4, A p r i l 1991, U . S . E P A , E M S L . T h e r e v i s i o n i s c o n - t a i n e d i n t h e m a n u a l e n t i t l e d ‘‘M e t h - o d s fo r t h e D e t e r m i n a t i o n o f M e t a l s i n E n v i r o n m e n t a l S a m p l e s ,’’ Offi c e o f R e - s e a r c h a n d D e v e l o p m e n t , Wa s h i n g t o n , D C 20460, (E P A /600/4–91/010), J u n e 1991, w h i c h i s i n c o r p o r a t e d b y r e fe r e n c e i n

a c c o r d a n c e w i t h 5	U . S . C.	552(a ) a n d 1
CF R p a r t 51. Co p i e s	o f t h i s	p u b l i c a t i o n

a r e a v a i l a b l e fr o m t h e N a t i o n a l T e c h - n i c a l I n fo r m a t i o n S e r v i c e , U . S . D e p a r t -

m e n t	o f Co m m e r c e ,	5285	P o r t	R o y a l
R d . ,	S p r i n g fi e l d , V A	22161,	o r	m a y b e

e x a m i n e d a t t h e Ce n t e r fo r F o o d S a fe t y a n d A p p l i e d N u t r i t i o n ’s L i b r a r y , F o o d a n d D r u g A d m i n i s t r a t i o n , 5100 P a i n t B r a n c h P k w y . , Co l l e g e P a r k , M D 20740, o r a t t h e Offi c e o f t h e F e d e r a l R e g i s t e r , 800 N o r t h Ca p i t o l S t r e e t N W. , s u i t e 700, Wa s h i n g t o n , D C.

(iii) M e t h o d 200. 9—‘‘D e t e r m i n a t i o n o f T r a c e E l e m e n t s b y S t a b i l i ze d T e m p e r a - t u r e G r a p h i t e F u r n a c e A t o m i c A b s o r p -


t i o n	S p e c t r o m e t r y ,’’ R e v .				1. 2, A p r i l
1991,	U . S . E P A ,		E M S L . T h e r e v i s i o n			i s
c o n t a i n e d		i n	t h e	m a n u a l	e n t i t l e d
‘‘M e t h o d s		fo r	t h e	D e t e r m i n a t i o n		o f
M e t a l s i n		E n v i r o n m e n t a l S a m p l e s ,’’ Of-

fi c e o f R e s e a r c h a n d D e v e l o p m e n t ,

Wa s h i n g t o n , D C 20460,	(E P A /600/4–91/
010), J u n e 1991, w h i c h i s	i n c o r p o r a t e d

b y r e fe r e n c e i n a c c o r d a n c e w i t h 5 U . S . C. 552(a ) a n d 1 CF R p a r t 51. T h e a v a i l a b i l i t y o f t h i s i n c o r p o r a t i o n b y


r e fe r e n c e		i s	g i v e n	i n	p a r a g r a p h
(b )(4)(i i i )(E )(1)(ii) o f t h i s				s e c t i o n .
(iv )	M e t h o d		D –3697–92—‘‘S t a n d a r d
T e s t	M e t h o d fo r		A n t i m o n y		i n Wa t e r ,’’

c o n t a i n e d i n t h e A n n u a l B o o k o f A S T M S t a n d a r d s , v o l s . 11. 01 a n d 11. 02, 1995, A m e r i c a n S o c i e t y fo r T e s t i n g a n d M a -

t e r i a l s , 100 B a r r	H a r b o r	D r . ,	We s t
Co n s h o h o c k e n , P A	19428,	w h i c h	i s i n -

c o r p o r a t e d b y r e fe r e n c e i n a c c o r d a n c e w i t h 5 U . S . C. 552(a ) a n d 1 CF R p a r t 51. Co p i e s o f t h i s p u b l i c a t i o n a r e a v a i l a b l e fr o m A m e r i c a n S o c i e t y fo r T e s t i n g a n d

M a t e r i a l s , 100 B a r r H a r b o r	D r . ,	We s t
Co n s h o h o c k e n , P A 19428, o r	m a y	b e e x -

a m i n e d a t t h e Ce n t e r fo r F o o d S a fe t y

a n d	A p p l i e d N u t r i t i o n ’s L i b r a r y , F o o d
a n d	D r u g A d m i n i s t r a t i o n , 5100 P a i n t

B r a n c h P k w y . , Co l l e g e P a r k , M D 20740,

o r a t t h e Offi c e o f t h e F e d e r a l R e g i s t e r , 800 N o r t h Ca p i t o l S t r e e t N W. , s u i t e 700, Wa s h i n g t o n , D C.

(2) B a r i u m s h a l l b e m e a s u r e d u s i n g t h e fo l l o w i n g m e t h o d s :

(i)	M e t h o d	208. 2—‘‘A t o m i c A b s o r p -
t i o n ;	fu r n a c e	t e c h n i q u e ,’’ w h i c h i s i n -

c o r p o r a t e d b y r e fe r e n c e i n a c c o r d a n c e

w i t h	5 U . S . C. 552(a ) a n d 1 CF R	p a r t 51,
o r
(ii)	M e t h o d 208. 1—‘‘A t o m i c	A b s o r p -
t i o n ; d i r e c t a s p i r a t i o n ,’’ w h i c h		i s i n c o r -

p o r a t e d b y r e fe r e n c e i n a c c o r d a n c e w i t h 5 U . S . C. 552(a ) a n d 1 CF R p a r t 51. T h e a v a i l a b i l i t y o f t h i s i n c o r p o r a t i o n b y r e fe r e n c e i s g i v e n i n p a r a g r a p h (b )(4)(i i i )(E ) o f t h i s s e c t i o n .

(iii) M e t h o d 200. 7—‘‘D e t e r m i n a t i o n o f M e t a l s a n d T r a c e E l e m e n t s i n Wa t e r a n d Wa s t e s b y I n d u c t i v e l y Co u p l e d

P l a s m a -A t o m i c E m i s s i o n S p e c t r o m - e t r y ,’’ R e v . 3. 3, A p r i l 1991, U . S . E P A , E M S L . T h e r e v i s i o n i s c o n t a i n e d i n t h e m a n u a l e n t i t l e d ‘‘M e t h o d s fo r t h e D e - t e r m i n a t i o n o f M e t a l s i n E n v i r o n -

m e n t a l	S a m p l e s ,’’ Offi c e	o f R e s e a r c h
a n d D e v e l o p m e n t , Wa s h i n g t o n , D C
20460,	(E P A /600/4–91/010),	J u n e 1991,
w h i c h i s i n c o r p o r a t e d b y		r e fe r e n c e i n

a c c o r d a n c e w i t h 5 U . S . C. 552(a ) a n d 1 CF R p a r t 51. T h e a v a i l a b i l i t y o f t h i s i n - c o r p o r a t i o n b y r e fe r e n c e i s g i v e n i n

p a r a g r a p h (b )(4)(i i i )(E )(1)(ii) o f			t h i s s e c -
t i o n .
(3) B e r y l l i u m s h a l l b e m e a s u r e d u s i n g
t h e fo l l o w i n g m e t h o d s :
(i)	M e t h o d	210. 2—‘‘A t o m i c	A b s o r p -
t i o n ;	F u r n a c e	T e c h n i q u e ,’’ w h i c h i s i n -

c o r p o r a t e d b y r e fe r e n c e i n a c c o r d a n c e w i t h 5 U . S . C. 552(a ) a n d 1 CF R p a r t 51. T h e a v a i l a b i l i t y o f t h i s i n c o r p o r a t i o n b y r e fe r e n c e i s g i v e n i n p a r a g r a p h (b )(4)(i i i )(E ) o f t h i s s e c t i o n .

(ii) M e t h o d 200. 7—‘‘D e t e r m i n a t i o n o f M e t a l s a n d T r a c e E l e m e n t s i n Wa t e r a n d Wa s t e s b y I n d u c t i v e l y Co u p l e d

m e n t a l	S a m p l e s ,’’ Offi c e	o f R e s e a r c h
a n d D e v e l o p m e n t , Wa s h i n g t o n , D C
20460,	(E P A /600/4–91/010),	J u n e 1991,

w h i c h i s i n c o r p o r a t e d b y r e fe r e n c e i n a c c o r d a n c e w i t h 5 U . S . C. 552(a ) a n d 1 CF R p a r t 51. T h e a v a i l a b i l i t y o f t h i s i n - c o r p o r a t i o n b y r e fe r e n c e i s g i v e n i n

532

↓ Louisiana Fd 9 File

Form Characteristics

Fact Name	Description
Governing Law	The Louisiana FD-9 form is governed by LSA R.S. 40:627 et seq., which outlines the regulations for bottled water distribution in Louisiana.
Registration Fee	The fee for product registration is $20 per product, with a maximum fee of $200 per DBA.
Required Documentation	To register a new product, a hydrogeological report, test results, and the FD-9(N) application must be submitted.
Approval Process	New products receive a Certificate of Registration after all required documents are reviewed by the Sanitarian Program Manager.
Distinct Products	A distinct product refers to variations that meet different standards of identity, such as spring water versus distilled water.
Monitoring Requirements	Water sources must be monitored for contaminants as outlined in the Testing Requirements for Bottled Water document.

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