The Louisiana FD-9 form is a crucial document required for anyone looking to register as a bottled water distributor in Louisiana. This form outlines the necessary steps and documentation needed to obtain a Certificate of Registration for bottled water products. If you are planning to enter this industry, it’s essential to fill out the form accurately and completely; take action now by clicking the button below.
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 distributor. Key components include the approval of new water sources, products, and bottling plants. For instance, businesses must provide a hydrogeological report, recent test results for contaminants, and compliance documentation with federal standards. Additionally, the form specifies the registration process for distinct bottled water products, emphasizing the importance of labeling and adherence to safety regulations. It also addresses monitoring requirements for both source and product water, ensuring that public health standards are met. By carefully following the guidelines set forth in the Fd 9 form, prospective bottled water importers can navigate the regulatory landscape and achieve compliance with Louisiana's health and safety laws.
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
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
Name of firm submitting application
Address (Mailing)
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
‘‘s e l t ze r
w a t e r ,’’ ‘‘s o d a
‘‘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
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
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
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
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
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 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
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>
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 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 ,
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 ’’
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
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
(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
(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
‘‘d i s -
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 ,
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
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
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 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
milligrams per liter
Arsenic
0.05
Chloride1
250.0
Iron1
0.3
Manganese1
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
(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),
‘‘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
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
N W. , s u i t e 700, Wa s h i n g t o n
D C, o r
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)
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 ;’’
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 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
40
s u b p a r t C, a p p e n d i x C;
(4)
I I :
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 i )(A ) B o t t l e d
w a t e r p a c k a g e d i n
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-
centration in mil-
peratures (°F)
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
1.7
1.5
1.3
1.2
1.0
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 ),
(b )(4)(i i i )(G )
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
Filling out the Louisiana FD-9 form is a crucial step in the process of registering your bottled water product in the state. This form collects essential information about your company and the products you intend to distribute. Ensuring that you complete it accurately will help streamline the approval process and avoid potential delays.
After submitting your application, it will be reviewed by the appropriate authorities. They will reach out if any additional information is needed. Once everything is in order, you will receive your Certificate of Registration, allowing you to distribute your bottled water products in Louisiana.
The Louisiana FD-9 form is an application used to obtain a Certificate of Registration as a bottled-water distributor in the state of Louisiana. This form is essential for businesses that intend to distribute bottled water products, ensuring compliance with state regulations.
To register a new bottled water product, you must submit several documents, including:
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 a company produces both distilled and spring water, these are considered distinct products. Additionally, products under different brand names or private labels are also distinct. However, multiple sizes of the same product do not qualify as distinct and may be registered as one product.
The hydrogeological report must be submitted to the Sanitarian Program Manager for Bottled Water. You can send it via fax to (225) 342-7672 or by regular mail to Bin # 14, P.O. Box 4489, Baton Rouge, LA 70821-4489. The report should include detailed geological information and must be signed by a credentialed professional geologist or hydrogeologist.
Yes, specific testing requirements must be followed. After well construction, samples from the water source must be tested for chemical, physical, and microbiological contaminants. This testing should be conducted by a NELAP- or state-certified laboratory. Public water sources may provide documentation to verify compliance with National Primary Drinking Water Regulations.
The registration fee for each product is $20, capped at a maximum of $200 per DBA. If you plan to register more than ten products, you will still pay a maximum fee of $200. Each distinct product must be listed on the FD-9 form, and the fee must accompany the application.
If you have questions regarding the FD-9 form or the registration process, you should contact the Sanitarian Program Manager for Bottled Water. The office can be reached at (225) 342-7517 for assistance.
Incomplete Information: Many applicants forget to fill out all required fields on the FD-9 form, leading to delays in processing.
Incorrect Fees: Submitting the wrong registration fee can result in rejection. Make sure to calculate the fee based on the number of products accurately.
Missing Documentation: Failing to include essential documents, such as hydrogeological reports or test results, can halt the application process.
Label Issues: Labels must meet specific criteria. Submitting labels that do not comply with 21 CFR 101 can lead to rejections.
Using Incorrect Product Names: Applicants sometimes use names that do not accurately describe the product, which can cause confusion and compliance issues.
Not Specifying Distinct Products: Some people fail to identify what constitutes a distinct product, leading to incorrect registrations.
Ignoring Submission Guidelines: Not following the submission guidelines for sending in the application can result in delays or loss of documents.
Failure to Update Contact Information: If contact information changes, not updating it can lead to missed communications from the Department of Health.
Not Consulting the Guidelines: Skipping the review of attached guidelines can lead to mistakes that could have been easily avoided.
Missing Signatures: Omitting the required signature from the executive officer or responsible party can invalidate the application.
The Louisiana FD-9 form is an essential document for bottled water distributors seeking to obtain a Certificate of Registration in Louisiana. Along with the FD-9 form, several other forms and documents are often required to ensure compliance with state regulations. Below is a list of related documents that are commonly used in conjunction with the FD-9 form.
Each of these documents plays a crucial role in the registration process for bottled water distributors in Louisiana. Ensuring that all necessary forms are completed accurately and submitted on time can facilitate a smoother approval process.
The Louisiana FD-9 form shares similarities with the FDA Form 2541, which is used for food product registration. Both forms require detailed information about the product, including its source and manufacturing process. The FDA Form 2541 specifically asks for labeling information and compliance with federal regulations, similar to the FD-9's requirements for specimen labels and adherence to 21 CFR standards. Both forms aim to ensure that products meet safety and quality standards before they can be distributed to consumers.
Another document comparable to the FD-9 is the FDA Form 3500, which is a reporting form for adverse events related to food products. Like the FD-9, this form is crucial for maintaining consumer safety. It requires detailed information about the product and its manufacturer. The FD-9 focuses on registration and compliance, while Form 3500 emphasizes monitoring and reporting issues that may arise post-distribution. Both are essential for regulatory oversight in the food industry.
The USDA Food Safety and Inspection Service (FSIS) Form 7000 is also similar to the FD-9. This form is used for the inspection and approval of meat and poultry products. Both documents require comprehensive information about the source and production processes. While the FD-9 is specific to bottled water, the FSIS Form 7000 serves a broader category of food products. Both forms are designed to ensure that the products meet safety and quality standards before reaching consumers.
In addition, the State of Louisiana’s Application for Food Establishment Permit bears resemblance to the FD-9. This application is necessary for any food business operating in Louisiana and requires similar documentation, such as proof of compliance with health regulations. Both forms aim to protect public health by ensuring that food products are safe for consumption. The FD-9 focuses specifically on bottled water, while the food establishment permit covers a wider range of food products.
The FDA's Form 3331, which is used for food facility registration, is another document that parallels the FD-9. Both forms require information about the facility's location, ownership, and operations. While the FD-9 is specific to bottled water distributors, Form 3331 serves all types of food facilities. The goal of both forms is to facilitate regulatory oversight and ensure that food products are produced in safe environments.
The FDA Form 2579, which is used for dietary supplement registration, also shares similarities with the FD-9. Both forms require detailed information about the product, including its ingredients and manufacturing practices. While the FD-9 pertains specifically to bottled water, the Form 2579 is focused on dietary supplements. Both documents aim to ensure that products meet safety and efficacy standards before they can be marketed to consumers.
The Environmental Protection Agency (EPA) Form 5700-54 is another comparable document, primarily used for the registration of pesticide products. Similar to the FD-9, this form requires extensive information about the product's composition and intended use. Both forms serve to protect public health and the environment by ensuring that products meet established safety standards. While the FD-9 is focused on bottled water, the EPA Form 5700-54 addresses a different category of products.
The FDA Form 2253, which is used for the submission of advertising and promotional labeling for drugs, also exhibits similarities with the FD-9. Both forms require information about the product and its intended use. While the FD-9 is specific to bottled water registration, Form 2253 focuses on ensuring that drug promotions comply with regulatory standards. Both documents are crucial for maintaining transparency and safety in their respective industries.
Lastly, the FDA's Form 2632, which is used for the registration of food contact substances, is another document that resembles the FD-9. Both forms require detailed information about the product and its intended use. While the FD-9 focuses on bottled water, Form 2632 is concerned with substances that come into contact with food. Both forms aim to ensure that products are safe for consumer use and comply with relevant regulations.
When filling out the Louisiana FD-9 form, there are several important dos and don’ts to keep in mind. Following these guidelines can help ensure a smooth application process.
Understanding the Louisiana FD-9 form is essential for anyone looking to distribute bottled water in the state. However, several misconceptions can lead to confusion. Below are six common misunderstandings regarding this form:
This is not true. While the FD-9 form is essential for new applicants, existing businesses must also use it when registering new products or changing their operations.
In reality, any entity, regardless of size, that intends to distribute bottled water in Louisiana must complete the FD-9 form. Small businesses and individual distributors are equally required to comply.
Approval is not automatic. The submitted documentation must be thoroughly reviewed by the Sanitarian Program Manager, and only after meeting all requirements will a Certificate of Registration be issued.
The fee structure is based on the number of distinct products being registered. While the fee is $20 per product, it caps at $200 for up to ten products. This means that businesses with more than ten products will not pay more than $200.
This is misleading. Continuous monitoring and testing of the source and product water are mandatory to ensure compliance with safety standards. Regular testing is crucial for maintaining the validity of the registration.
In addition to the FD-9 form, applicants must submit several other documents, including hydrogeological reports and product labels. Each piece of documentation plays a critical role in the approval process.
When filling out and using the Louisiana FD-9 form, keep these key takeaways in mind:
By following these guidelines, you can navigate the registration process more smoothly and ensure compliance with state regulations.