↝

Blank Louisiana Fd 9 Form

The Louisiana FD-9 form is an application used by bottled water distributors to obtain a Certificate of Registration 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 standards. Understanding the FD-9 form is essential for anyone looking to enter the bottled water market in Louisiana.

Outline

The Louisiana FD-9 form serves as a crucial document for businesses seeking to distribute bottled water within the state. This form outlines the necessary steps and requirements for obtaining a Certificate of Registration, which is essential for any bottled water importer. Key aspects of the FD-9 include the submission of a hydrogeological report prepared by a qualified geologist, recent test results to ensure compliance with safety standards, and various documentation related to the water source and bottling facility. Each distinct bottled water product must be registered, with a fee structure that caps at $200 for up to ten products. Additionally, the form emphasizes the importance of ongoing monitoring of both source and product water to adhere to health regulations. By following the guidelines set forth in the FD-9, businesses can navigate the regulatory landscape effectively and ensure their bottled water products meet the stringent standards required by the Louisiana Department of Health and Hospitals.

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

Click for PDF

Form Information

Fact Name	Description
Governing Law	The Louisiana FD-9 form operates under LSA R.S. 40:627 et seq., which governs the registration of bottled water distributors in Louisiana.
Required Documentation	To obtain a Certificate of Registration, applicants must submit various documents, including a hydrogeological report, test results, and the FD-9(N) application.
Registration Fee	The fee for registering bottled water products is $20 per product, capped at a maximum of $200 per DBA (Doing Business As).
Product Distinction	Each distinct bottled water product must be registered separately. Different types, such as spring water and distilled water, are considered distinct products.

Detailed Guide for Filling Out Louisiana Fd 9

Filling out the Louisiana FD-9 form is an essential step for those looking to register bottled water products in the state. The process requires careful attention to detail and the inclusion of specific documentation. Once the form is completed, it will be submitted along with the necessary fees and supporting documents to the appropriate regulatory authority.

Obtain the FD-9(N) Application for a New Product Registration form. This can be found in the attached documents or requested from the Louisiana Department of Health and Hospitals.
Fill in the Company Information section with the name, address, and contact details of the manufacturer, distributor, or importer. Ensure that the name matches exactly as it appears on the product label.
If applicable, provide the name and address of the actual manufacturer for private-label or co-packed products.
Complete the Contact Person section with the taxpayer ID, telephone number, and fax number of the company representative.
Indicate the Product Type by checking the appropriate box (Food, Drug, Cosmetic, etc.).
In the Registration Fee section, calculate the total fee based on the number of products you intend to register. The fee is $20 per product, capped at a maximum of $200 per DBA.
List the names and addresses of three brokers, warehousemen, or distributors who will handle your products in Louisiana. If none are available, indicate “SELF-DISTRIBUTION.”
Sign the form in the designated area, ensuring that the signature belongs to an executive officer, proprietor, partner, or agent for service of process.
Attach the required documents, including specimen labels for each product, the hydrogeological report (if applicable), and any test results as specified in the guidelines.
Submit the completed FD-9 form, along with the registration fee and all supporting documentation, to the Office of Public Health at the address provided on the form.

Obtain Answers on Louisiana Fd 9

What is the Louisiana FD-9 form?
The Louisiana FD-9 form is an application used to register bottled water products and distribution facilities in the state of Louisiana. This form is essential for businesses seeking to obtain a Certificate of Registration as a bottled-water distributor.
What documentation is required for new product registration?
To register a new product, you must provide several key documents:
- A hydrogeological report prepared by a professional geologist.
- Recent test results showing that the source water is monitored for specific contaminants.
- Test results confirming that the product water complies with the standard of identity in 21 CFR 165.110.
- A copy of the latest certificate or inspection license from the relevant regulatory authority.
- A completed FD-9(N) Application for a New Product Registration.
- Specimen labels for each distinct product.
- The registration fee of $20 per product, capped at $200 per DBA.
How do I submit the required hydrogeological report?
The hydrogeological report must be submitted to the Sanitarian Program Manager for Bottled Water. You can send it via fax at (225) 342-7672 or by regular mail to:

Bin # 14, P.O. Box 4489, Baton Rouge, LA 70821-4489.
What does "distinct product" mean in the context of bottled water?
A "distinct product" refers to any bottled water that meets a different standard of identity as specified in 21 CFR 165.110. For example, if you produce both distilled water and spring water, those are considered distinct products. However, variations of the same product under different brand names do count as separate products for registration purposes.
Are there any specific testing requirements for source and product water?
Yes, there are specific testing and monitoring requirements. Once your well construction is complete, you must conduct tests on water samples taken from your source. The required testing regimen is outlined in the Testing Requirements for Bottled Water document. Ensure compliance with the National Primary Drinking Water Regulations if using public sources.
What is the registration fee structure for the FD-9 form?
The registration fee is $20 per product, with a maximum of $200 for up to 10 products. If you are registering more than 10 products, you will still pay a maximum of $200. Each product must be listed on the FD-9 form or an attached document, along with a label.
How do I ensure my product labels meet the necessary criteria?
Product labels must contain all the basic information as outlined in 21 CFR 101 et seq. You will need to submit proofs or specimen copies of these labels along with your FD-9 application. Ensure that the labels are accurate and meet federal regulations to avoid delays in your registration.
What happens after I submit my application and documentation?
Once you have submitted all necessary documentation, the Sanitarian Program Manager for Bottled Water will review your application. If everything is in order, you will receive a Certificate of Registration for your bottled water products. For new facilities, the issuance of a certificate may depend on corporate policies.

Common mistakes

Filling out the Louisiana FD-9 form can be a straightforward process, but many people make common mistakes that can delay their application. One frequent error is failing to include all required documentation. Applicants must provide a hydrogeological report, recent test results, and a completed FD-9(N) application. Missing any of these documents can lead to rejection.

Another mistake is not understanding what constitutes a "distinct product." Many applicants mistakenly think that different brands of the same type of water count as separate products. In reality, each product must meet different standards of identity. Therefore, if you have multiple brands of distilled water, they are considered distinct products and must be registered separately.

Some applicants overlook the importance of accurate labeling. Labels must contain all the necessary information as outlined in 21 CFR 101. Failing to adhere to these guidelines can result in the rejection of the application. It’s essential to double-check that all labels are compliant before submission.

In addition, applicants sometimes miscalculate the registration fees. The fee is $20 per product, with a maximum of $200 for up to ten products. If you attempt to register more than ten products, you must still pay only $200. Understanding this limit helps avoid unnecessary overpayment.

Another common error is neglecting to provide the correct contact information. This includes ensuring that the name of the manufacturer or distributor matches exactly as it appears on the label. If there are discrepancies, it can cause confusion and delay the processing of your application.

Some individuals fail to submit their hydrogeological report to the right office or in the correct format. This report must be sent to the Sanitarian Program Manager for Bottled Water and must be signed by a qualified professional. Submitting it to the wrong office or without proper certification can lead to rejection.

Additionally, applicants sometimes forget to include a catalog listing of all products they intend to distribute. This listing is crucial for the approval process. Without it, the application may be deemed incomplete, causing further delays.

Finally, many people do not keep copies of their submitted documents. Having a record of what was sent can be helpful if any issues arise. If the office requests additional information or documentation, you will have what you need readily available.

Documents used along the form

The Louisiana FD-9 form is a crucial document for anyone looking to register as a bottled water distributor in the state. However, there are several other forms and documents that often accompany the FD-9 to ensure compliance with state regulations. Understanding these additional documents can streamline the registration process and facilitate the establishment of your bottled water business.

Hydrogeological Report: This report, prepared by a qualified geologist, outlines the geology of the water source area. It includes details on the aquifer's extent and construction methods, ensuring that the source is safe and sustainable for bottled water production.
Testing Requirements for Bottled Water: This document specifies the testing protocols for both source and product water. It ensures that the water meets safety standards set by health authorities, addressing potential contaminants and compliance with federal regulations.
Product Labels: Specimen labels for each distinct product must be submitted. These labels provide essential information about the bottled water, including its source, and must comply with federal labeling requirements.
Certificate/Inspection/License: A copy of the most recent certificate or inspection report from the relevant state or local authority is necessary. This document verifies that the bottling facility meets health and safety standards.
Approval Letter for New Sources: If you are using a new source for an existing product, an approval letter from the Sanitarian Program Manager is required. This letter confirms that the new source meets safety and quality standards.

Having these documents ready can significantly enhance the efficiency of your registration process. Each form plays a vital role in demonstrating compliance with health and safety regulations, ultimately contributing to the success of your bottled water business in Louisiana.

Similar forms

The Louisiana FD-9 form is essential for bottled water distributors in Louisiana. Several other documents share similarities with the FD-9 form, primarily in their purpose of ensuring compliance with health and safety regulations. Below is a list of documents that are comparable to the FD-9 form:

FD-9(N) Application for a New Product Registration: This form is specifically for registering new bottled water products, similar to the FD-9 in that both require detailed information about the product and its source.
21 CFR 165.110 Standard of Identity for Bottled Water: This regulation outlines the definitions and standards for bottled water, akin to the FD-9, which also requires adherence to specific quality standards.
Testing Requirements for Bottled Water – Source and Product: This document details the testing protocols for water sources and products, paralleling the FD-9’s emphasis on safety and compliance through testing.
Hydrogeological Report: Required for new water sources, this report must be prepared by a professional geologist, similar to the FD-9's requirement for comprehensive documentation to ensure safety.
Certificate of Inspection/License: This certificate is required for bottling plants, much like the FD-9, which necessitates proof of regulatory compliance for product registration.
Application for Registration with the Office of Public Health: This application is similar to the FD-9 in that it is a formal request for approval to distribute bottled water, requiring specific documentation and fees.
Specimen Labels Submission: The requirement to submit labels for bottled water products is a component of both the FD-9 and other registration forms, ensuring that all products meet labeling standards.
Approval Letter for New Sources: Similar to the FD-9 process, this letter is issued for new sources of water, ensuring compliance with health regulations before product distribution.

Dos and Don'ts

When filling out the Louisiana FD-9 form, there are important guidelines to follow. Here’s a list of things you should and shouldn’t do:

Do ensure all required documentation is complete and accurate.
Do include a hydrogeological report certified by a professional geologist.
Do submit specimen labels for each distinct product you are registering.
Do pay the appropriate registration fee of $20 per product, up to a maximum of $200.
Don’t submit incomplete applications; missing documents can delay your registration.
Don’t forget to check if your water source meets the required testing standards.
Don’t assume that multiple sizes of the same product count as distinct products.

Following these guidelines will help ensure a smoother application process for your bottled water registration in Louisiana.

Misconceptions

Here are 10 common misconceptions about the Louisiana FD 9 form:

Only large companies need to register. Many believe that only large companies must complete the FD 9 form. In reality, any bottled water distributor, regardless of size, must register.
Registration is optional. Some think that registration is optional for bottled water distributors. This is incorrect; registration is a legal requirement in Louisiana.
All water sources are automatically approved. It's a common misconception that any water source can be used without approval. Each source must undergo a specific approval process.
Only the product label needs to be submitted. Many assume that submitting the product label is sufficient. However, a complete registration packet, including various documents, is required.
Fees are a one-time payment. Some believe that the registration fee is a one-time charge. In fact, fees must be paid for each distinct product, with a maximum cap per business name.
Hydrogeological reports are optional. There is a misconception that hydrogeological reports can be bypassed. These reports are mandatory for new water sources and products.
All products can be registered under one label. Many think they can register multiple products under a single label. Each distinct product requires its own registration.
Testing requirements are the same for all water sources. Some believe that testing requirements are uniform across all sources. In reality, requirements vary based on whether the source is public or private.
New facilities always get a Certificate of Registration. There is a belief that new facilities automatically receive a Certificate of Registration. This is not true; it depends on corporate policy and approval.
Once registered, there’s no need for ongoing compliance. Some think that registration means they can operate without further oversight. Continuous compliance with testing and monitoring is essential.

Key takeaways

Here are some key takeaways about filling out and using the Louisiana FD-9 form:

Understand the Purpose: The FD-9 form is used to obtain a Certificate of Registration as a bottled-water distributor in Louisiana.
Required Documentation: To register a new product or facility, you must submit several documents, including a hydrogeological report and test results for contaminants.
Registration Fee: Each product registration costs $20, with a maximum fee of $200 for up to ten products.
Distinct Products: Each type of bottled water that meets different standards must be registered as a distinct product, even under different brand names.
Monitoring Requirements: Water sources must undergo regular testing for contaminants, and specific protocols must be followed for both private and public water supplies.
Submission Process: Documentation should be submitted to the Sanitarian Program Manager via fax or regular mail, ensuring all items are complete and certified as required.
Approval Letters: New sources or facilities may receive an approval letter instead of a Certificate of Registration, depending on corporate policies and compliance.