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Free Louisiana Fd 9 Template

The Louisiana FD-9 form is your key to becoming a registered bottled-water distributor in Louisiana. It offers a comprehensive guide to ensuring your water source, products, and bottling plants meet the state's requirements, thereby enabling you to distribute non-bulk water products effectively. To start the process of obtaining your Certificate of Registration and ensure compliance with Louisiana's Department of Health, click the button below.

Fill Out Louisiana Fd 9 Here

Structure

Navigating the intricacies of registering as a bottled-water distributor in Louisiana requires a thorough understanding of the FD-9 form, an essential document that outlines the procedural roadmap for prospective importers. This form, provided by the Louisiana Department of Health and Hospitals, serves as a cornerstone for ensuring compliance with both state and federal regulations concerning the distribution of bottled water. Prospective importers are guided through a series of critical steps, starting from the validation of water sources, product types, and bottling facilities to the adherence to stringent testing requirements for source and product water. The document highlights the necessity for detailed hydrogeological reports, inspection certificates, and appropriate labeling, underscoring the state's commitment to public health and safety. Furthermore, it introduces a financial aspect by detailing the fee structure for product registration, thereby encapsulating the multifaceted process of obtaining a Certificate of Registration for bottled-water distribution. This all-encompassing approach not only facilitates regulatory compliance but also fosters an environment of transparency and accountability within the bottled water industry in Louisiana.

Form Example

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

Free Louisiana Fd 9 PDF

Document Breakdown

Fact Number	Description
1	The FD-9 form is specifically designed for companies seeking to register as bottled water distributors in Louisiana.
2	Applicants must ensure their water source is approved, requiring a hydrogeological report and test results on source water for contaminants.
3	Registration of new water products or facilities requires submission of FD-9(N), with a fee of $20 per product, capped at $200 per DBA.
4	Distinct products, defined by water type (e.g., distilled vs. spring water) or brand, each require separate registration.
5	The Louisiana Department of Health and Hospitals, Office of Public Health, manages the bottled water registration process.
6	Source and product water must be monitored and tested according to specific requirements laid out in the provided Testing Requirements for Bottled Water document.
7	The governing law for bottled water registration in Louisiana is LSA R.S. 40: 627 et seq., overseeing packaged food, drug, cosmetic, or prophylactic devices distribution.

Instructions on Filling in Louisiana Fd 9

Securing a Certificate of Registration as a bottled-water distributor in Louisiana involves a multifaceted process tailored to various scenarios like new products, bottling plants, or water sources. It's crucial for applicants to meticulously gather the required documents, including a hydrogeological report and test results for confirmation of compliance with established standards. Furthermore, differentiation of products plays a significant role in the registration fee calculation. Let’s walk through the essential steps to fill out the Louisiana FD-9 form effectively.

Start by reading all the provided documents to fully understand the requirements for obtaining a Certificate of Registration. This step is fundamental in preparing the necessary documentation for submission.
Identify whether your submission is for a new product, facility, or source to determine the specific documents needed. This includes a hydrogeological report, test results, a recent certificate from regulatory authorities, and labels for your product.
Complete the FD-9(N) Application for a New Product Registration Form. Ensure to fill out all fields accurately to avoid delays. This includes selecting the product type, providing company and contact information, and specifying the name as it appears on the label.
Calculate the registration fee based on the number of distinct products you are registering, making sure not to exceed the maximum fee of $200 per DBA. This is critical for keeping your application within the financial guidelines.
Prepare a catalog listing all products intended for distribution in Louisiana, including proofs or specimen labels for each product. This is a crucial step to demonstrate compliance with Louisiana law.
Write a check or prepare a money order payable to DHH for the calculated registration fee. This financial step is essential for processing your application.
List the names and addresses of three brokers, warehousemen, or distributors handling your products in Louisiana. If applicable, note "SELF-DISTRIBUTION."
Gather all required documents, including the completed FD-9(N) form, registration fee payment, catalog of products, and labels. Double-check to ensure all information is accurate and complete.
Submit the completed packet to Brian R. Warren, Program Manager for Product Registration, via fax to (225) 342-7672 or through regular mail at Bin # 14, P.O. Box 4489, Baton Rouge, LA 70821-4489. Submission through the correct channel is vital for the timely processing of your application.
Lastly, ensure to keep copies of all documents and correspondence for your records. This step is critical for future reference and confirms your proactive approach in the registration process.

Following these steps diligently will streamline the process of obtaining a Certificate of Registration as a bottled-water distributor in Louisiana. Remember, the key to a smooth process is thorough preparation and careful attention to the specific requirements outlined in the guidelines.

Listed Questions and Answers

What is the Louisiana FD-9 form?

The Louisiana FD-9 form is an application required for companies seeking to distribute bottled water products within the state of Louisiana. It's part of the process for obtaining a Certificate of Registration as a bottled water distributor. This certificate indicates that the product, source, and facility meet the state's required health standards.

Who needs to fill out the FD-9 form?

The form must be completed by businesses aiming to distribute bottled water, including new brands or products, in Louisiana. This includes manufacturers, distributors, packers, processors, or importers whose names appear on the product labels.

What documents are required alongside the FD-9 form for a new water product or facility?

Applicants must provide:

A hydrogeological report signed by a professional geologist.
Recent test results for the source water and product water, demonstrating compliance with specified standards.
A copy of the most recent certificate/inspection/license of the bottling plant.
Specimen labels for each distinct product.
The appropriate registration fee.

How much is the registration fee when applying with the FD-9 form?

The registration fee is $20 per product, with a maximum fee of $200 per Doing Business As (DBA) name. If registering more than 10 products, the maximum cap of $200 applies.

What is considered a "distinct product" in the context of bottled water registration?

A "distinct product" refers to bottled water products that have different characteristics, such as being from different sources (e.g., spring water vs. distilled water) or being marketed under different brand names, even if the water type is the same. Each variant that meets these criteria needs to be registered separately.

How are new sources for an existing product treated?

New sources used by existing products and facilities need to submit a hydrogeological report and recent test results on the source water. Approval for new sources will be given in the form of a letter from the Sanitarian Program Manager for Bottled Water.

What are the steps for registering a new facility that produces a previously-registered product?

For such facilities, the required documentation includes:

The most recent certificate/inspection/license for the bottling plant.
Test results proving that the product water complies with the standard of identity.

A Certificate of Registration or an approval letter will be issued based on these submissions.

Where should the hydrogeological report and other documents be sent?

Documents should be submitted to the Sanitarian Program Manager for Bottled Water either by fax at (225) 342-7672 or through regular mail at Bin # 14, P.O. Box 4489, Baton Rouge, LA 70821-4489.

What if I plan to use a public water source?

If your water source is public, you must provide documents showing full compliance with the National Primary Drinking Water Regulations. This demonstrates the water's safety and quality for being used as bottled water.

Are there specific laboratories where the water testing should be done?

Yes, water samples must be analyzed by laboratories certified either by NELAP (The NELAC Institute) or the state for drinking water chemistry. For routine weekly microbiological testing, an in-house laboratory may be used, but annual tests must be performed by a certified laboratory.

Common mistakes

Filling out the Louisiana FD 9 form, essential for registering as a bottled water distributor, requires close attention to specific details to avoid common errors. Here are six mistakes often made during this process:

Incorrect Identification of Product Type: Applicants sometimes check the wrong product type box, leading to confusion about the nature of the product being registered.
Incomplete Manufacturer Information: A frequent oversight is not providing complete details for the manufacturer, distributor, packer, processor, or importer as exactly as it appears on the label.
Omission of the Actual Manufacturer for Private-Label Products: For private-label or copacked products, failing to list the actual manufacturer’s name and address is a common mistake.
Insufficient Specimen Labels: Not submitting a specimen or proof of each label for every distinct product is a critical error. Labels must meet the criteria outlined in 21 CFR 101 and should be included for each distinct product manufactured.
Miscalculated Registration Fee: Applicants often incorrectly calculate the registration fee. It is essential to multiply $20 by the number of products intended to be registered, up to a maximum of $200 per DBA.
Failure to Attach Required Documentation: The most crucial step is to attach all necessary documents, including the hydrogeological report, recent test results for source water and product water, and the certificate/inspection/license of the bottling plant, when applicable.

Each of these mistakes can delay the registration process or result in the denial of the Certificate of Registration. Careful review of the FD-9(N) Application for a New Product Registration Form, adherence to the guidelines provided, and comprehensive preparation of the required documentation can help ensure a smooth and successful registration process.

Documents used along the form

When preparing to register as a bottled-water distributor in Louisiana, there's a comprehensive process to ensure compliance with state regulations. The Louisiana FD-9 form is central to this process, but it is often accompanied by additional forms and documents that are crucial for a successful application. Understanding these forms and their purposes can streamline the application process and help avoid delays.

Hydrogeological Report: Prepared by a professional geologist, this report outlines the regional and local geology of the water source. It includes details on the aquifer, contamination sources, and construction methods for water collection.
Test Results for Bottled Water – Source and Product: Recent test results that demonstrate the water meets the state’s standards for contaminants and identity. It's vital for both new sources and products.
State or Local Regulatory Authority Certificate/Inspection/License: A document from the regulatory authority having jurisdiction over the bottling plant, ensuring the facility meets all required standards.
FD-9(N) Application for a New Product Registration: A form used to apply for the registration of a new bottled water product, detailing product specifics and the associated fee.
Specimen Labels: Labels for each product that need to comply with the criteria outlined in 21 CFR 101, ensuring all required information is presented clearly.
Application Fee: A fee payment, capped at $200 for ten products, required as part of the product registration process.
NELAP- and/or State-Certified Laboratory Results: Results from an authorized lab that has conducted annual, quadrennial, and triennial analysis of the water for chemical, physical, and radiological contaminants.
21 CFR 165.110 Standard of Identity for Bottled Water: A document that defines the standard of identity bottled water must meet, essential for ensuring product compliance.
NELAC Institute Current List of Certified Laboratories: Contact information for laboratories certified to analyze bottled water, important for ongoing compliance with testing requirements.

Collectively, these documents support the Louisiana FD-9 form in providing a comprehensive overview of a bottled water product’s compliance with regulatory standards. Keeping accurate and up-to-date records, as well as understanding each document’s role in the registration process, facilitates a smoother application experience. It is recommended to consult with professionals or regulatory bodies if there are any uncertainties, ensuring that all materials meet the required standards for approval.

Similar forms

The Louisiana FD 9 form is similar to various other documents used across different states for the purpose of product registration, particularly for items that require health department approval. One such document is the California Department of Public Health's Food and Drug Branch (FDB) Product Registration form. Both the Louisiana FD 9 and the California Product Registration forms serve the purpose of registering new food, drug, or cosmetic products within their respective states. They require similar information from applicants, such as details about the product, the manufacturer, and labeling specifications. Both forms are crucial for ensuring public safety and compliance with state regulations concerning the distribution and sale of consumable goods.

Another document with similarities to the Louisiana FD 9 form is the Federal Drug Administration's (FDA) Food Facility Registration form. This federal-level form is used for facilities that manufacture, process, pack, or hold food products intended for consumption in the United States. Both the Louisiana FD 9 and the FDA form facilitate a regulatory oversight process, aiming to protect public health by ensuring that products meet specific safety and quality standards. Though the FDA's form has a broader scope, applying to facilities nationwide, both documents are integral to a comprehensive system of food safety regulation.

Dos and Don'ts

Filling out the Louisiana FD-9 form is an important step for becoming a registered bottled-water distributor in the state. To ensure your application is processed smoothly, here are some do's and don'ts:

Do carefully review the guideline documents provided by the Department of Health and Hospitals before starting your application. This will give you a clear understanding of the requirements.
Do ensure that your water source will be approved for use before submitting the application. A hydrogeological report and recent test results are critical components of this step.
Do compile all required documentation, including hydrogeological reports, test results, certificates, licenses from regulatory authorities, and product labels, before filling out the form.
Do include the appropriate fee with your application, keeping in mind the cap per DBA (Doing Business As).
Do make sure your product labels meet the specifications outlined in 21 CFR 101 et seq., as they need to be submitted with your application.
Don't forget to register each distinct product that your firm manufactures, as each requires an entry on the FD-9 form or an attached document, along with a label for each.
Don't overlook the importance of submitting your application and documents to the correct department and official, as outlined in the instructions.
Don't underestimate the role of ensuring your water source and product comply with the Testing Requirements for Bottled Water – Product and Source, as well as the 21 CFR 165.110 standard of identity for bottled water.
Don't hesitate to contact the office with any questions immediately after reviewing the application materials. It's better to clarify any doubts beforehand.

Adhering to these guidelines will facilitate a smoother application process for obtaining your Certificate of Registration as a bottled-water distributor in Louisiana.

Misconceptions

Understanding the Louisiana FD-9 form, specifically designed for bottled water distributors, often leads to several misconceptions. To provide clarity, here are ten common misunderstandings and the facts that dispel them:

The FD-9 form is only for new bottled water products. Fact: The FD-9 form is required for new water sources, products, bottling plants, and even new facilities producing a previously-registered product.
Registration with the FD-9 form guarantees immediate approval. Fact: Approval is granted after the submitted documentation is reviewed and found satisfactory by the Sanitarian Program Manager for Bottled Water.
A hydrogeological report is not necessary for source approval. Fact: A detailed hydrogeological report is essential for the approval of new water sources to ensure safety and compliance.
All facilities manufacturing a particular product require separate Certificates of Registration (CoRs). Fact: CoRs are generally issued to the corporate owner of the manufacturing facilities, not each facility, unless corporate policies require otherwise.
Label registration is optional. Fact: Labels for all non-bulk products (sizes below 3 gallons) must be submitted for registration, ensuring they meet specified criteria.
Registration fees are per facility. Fact: Fees are per product, with a cap of $200 per Doing Business As (DBA), emphasizing the focus on product registration rather than facility registration.
Annual testing doesn't require a specific laboratory. Fact: Annual tests must be performed by a NELAP- and/or state-certified laboratory for drinking water chemistry to ensure quality and safety standards are met.
Distilled water and spring water under the same brand are considered a single product. Fact: They are regarded as two distinct products because they conform to different standards of identity as specified in the guidelines.
Testing requirements are the same for all products. Fact: Testing requirements vary based on whether the source is new for an existing product, a new product is being introduced, or a new facility is being used for a previously-registered product.
Every bottled water product requires a new FD-9 form. Fact: Multiple sizes of the same product do not constitute distinct products and can be registered as a single product, simplifying the process.

Dispelling these misconceptions ensures proper understanding and compliance with the Louisiana Department of Health's requirements for bottled water distributors, aiding in the streamlined registration and approval process.

Key takeaways

Understanding the process and requirements for obtaining a Certificate of Registration as a bottled-water distributor in Louisiana is essential for prospective applicants. The State of Louisiana Department of Health and Hospitals has outlined a specific procedure to ensure that water sources, products, and bottling plants meet the necessary criteria for public safety and compliance. Here are seven key takeaways for successfully filling out and using the Louisiana FD-9 form.

Initially, applicants must ensure that their water source will be approved for use. This involves submitting a hydrogeological report prepared by a professional geologist, alongside a recent set of test results documenting monitoring for specified contaminants.
The Louisiana FD-9(N) Application for a New Product Registration form is crucial for new products or facilities entering the market. This form, along with required documentation like test results, certificate of inspection, specimen labels, and the appropriate fee, forms the core of the application process.
Understanding the definition of a "distinct product" is key for registration. Distinct products are defined by their standard identity under 21 CFR 165.110 or if they are produced under different brand names or labels, which may require separate registrations.
Product registration fees in Louisiana are structured so that each distinct product incurs a $20 fee, up to a maximum of $200 per doing business as (DBA), facilitating cost planning for applicants.
For facilities utilizing a new source for an existing approved product, or for new facilities producing a previously registered product, different documentation requirements apply, streamlined to reflect their established compliance.
Source and product water monitoring is a continuous obligation, with specifics outlined in the attached Testing Requirements for Bottled Water – Source and Product document. This includes the necessity for testing by NELAP and/or state-certified laboratories.
All labels for non-bulk products (below 3 gallons) must include basic information meeting the criteria outlined in 21 CFR 101 et seq. and are to be submitted for review alongside the FD-9(N) application, ensuring compliance with federal standards.

Adherence to these guidelines ensures that applicants can navigate the regulatory landscape efficiently, securing their Certificate of Registration and maintaining compliance. Each step, from the initial hydrogeological report to ongoing water source monitoring, is designed to protect public health and uphold the quality standards of bottled water distributed within Louisiana.

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