The Louisiana FD-9 form is a crucial document for anyone looking to register as a bottled-water distributor in the state of Louisiana. This form outlines the necessary steps and documentation required to obtain a Certificate of Registration, ensuring compliance with state health regulations. If you're ready to start the registration process, click the button below to fill out the form.
Irp Application Form - Specific guidelines for hazardous materials transport are included in the safety regulations section.
A Power of Attorney form is a legal document that authorizes one person to act on behalf of another in either specific or general legal matters. It's a powerful tool that can grant authority over financial, legal, or medical decisions. This makes understanding the form’s details and implications vital for anyone considering its use, and further information can be found at UsaLawDocs.com.
Healthy Louisiana Plan - Timeliness in submitting the request will contribute to smooth transitions in service provision.
Completing the Louisiana FD-9 form is essential for obtaining a Certificate of Registration as a bottled water distributor in Louisiana. The following steps will guide you through the process of filling out the form accurately and efficiently.
After submitting the FD-9 form, the Louisiana Department of Health and Hospitals will review your application. Upon approval, you will receive your Certificate of Registration, allowing you to distribute bottled water in the state. Ensure that all accompanying documentation is accurate and complete to avoid delays in processing.
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
(CAS Reg. No.)
Pentachlorophenol (87–86–5)
Cadmium
0.005.
PCB’s
(as
decachlorobiphenyl)
(1336–
Chromium
0.1.
36–3)
0.0005
Copper
1.0.
Picloram (1918–02–1)
0.5
Cyanide
0.2.
.............................
Simazine (122–34–9)
0.004
Lead
..............................
2,3,7,8-TCDD (Dioxin) (1746–01–6)
.......
3×10¥8
Mercury
0.002.
Toxaphene (8001–35–2)
0.003
Nickel
.........................
2,4,5-TP (Silvex) (93–72–1)
Nitrate
10 (as nitrogen).
....................
Nitrite
1 (as nitrogen).
Total Nitrate and Nitrite ..
(D )
T h e a l l o w a b l e
l e v e l s
c e r t a i n
Selenium
0.05.
c h e m i c a l s
E P A
e s t a b -
Thallium
l i s h e d s e c o n d a r y m a x i m u m c o n t a m i -
(B ) T h e a l l o w a b l e l e v e l s fo r v o l a t i l e
n a n t l e v e l s i n i t s d r i n k i n g w a t e r r e g u -
l a t i o n s (40 CF R
143) a r e a s
o r g a n i c c h e m i c a l s
(V OC’s )
a r e a s fo l -
l o w s :
milligrams per
liter
Aluminum
0.2
Benzene (71–43–2)
0.005
Silver
0.1
Carbon tetrachloride (56–23–5)
Sulfate 1
.....................................................
o- Dichlorobenzene (95–50–1)
................
0.6
1 Mineral water is exempt from allowable level. The exemp-
p- Dichlorobenzene (106–46–7)
0.075
1,2-Dichloroethane (107–06–2)
tions are aesthetically based allowable levels and do not re-
...............
late to a health concern.
1,1-Dichloroethylene (75–35–4)
0.007
cis-1,2-Dichloroethylene (156–59–2)
0.07
(E ) A n a l y s e s t o d e t e r m i n e c o m p l i -
trans-1,2-Dichloroethylene (156–60–5)
a n c e
w i t h
p a r a -
Dichloromethane (75–09–2)
1,2-Dichloropropane (78–87–5)
g r a p h
o f t h i s
s e c t i o n
s h a l l
Ethylbenzene (100–41–4)
0.7
b e c o n d u c t e d i n a c c o r d a n c e w i t h a n a p -
Monochlorobenzene (108–90–7)
p l i c a b l e
m e t h o d
a p p l i c a b l e
r e v i -
Styrene (100–42–5)
Tetrachloroethylene (127–18–4)
s i o n s
t o
m e t h o d s
Toluene (108–88–3)
1
g r a p h s
(b )(4)(i i i )(E )(1)
1,2,4–Trichlorobenzene (120–82–1)
(b )(4)(i i i )(E )(13)
t h i s
1,1,1-Trichloroethane (71–55–6)
0.20
1,1,2–Trichloroethane (79–00–5)
s c r i b e d ,
u n l e s s
o t h e r w i s e
n o t e d ,
Trichloroethylene (79–01–6)
Vinyl chloride (75–01–4)
0.002
Wa t e r
a n d Wa s t e s ,’’ U . S . E P A E n v i r o n -
Xylenes (1330–20–7)
10
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 -
(C) T h e a l l o w a b l e l e v e l s fo r p e s t i c i d e s
o r a t o r y
(E M S L ),
Ci n c i n n a t i ,
OH
45258
(E P A –600/4–79–020), M a r c h
1983, w h i c h i s
a n d o t h e r s y n t h e t i c o r g a n i c c h e m i c a l s
i n c o r p o r a t e d b y r e fe r e n c e i n a c c o r d -
(S OC’s ) a r e a s fo l l o w s :
5 U . S . C.
552(a )
1 CF R
Co p i e s
p u b l i c a t i o n
a v a i l a b l e fr o m t h e N a t i o n a l T e c h n i c a l
Alachlor (15972–60–8)
I n fo r m a t i o n
S e r v i c e
(N T I S ),
U . S .
D e -
Atrazine (1912–24–9)
p a r t m e n t
Co m m e r c e ,
5285
P o r t
Benzo(a)pyrene (50–32–8)
0.0002
R o y a l
R d . ,
S p r i n g fi e l d ,
V A
22161,
Carbofuran (1563–66–2)
0.04
Chlordane (57–74–9)
e x a m i n e d
a t
Ce n t e r
Dalapon (75–99–0)
F o o d
S a fe t y
1,2-Dibromo-3-chloropropane (96–12–8)
L i b r a r y , F o o d a n d D r u g A d m i n i s t r a -
2,4-D (94–75–7)
t i o n ,
5100 P a i n t
P k w y . ,
Co l l e g e
Di(2-ethylhexyl)adipate (103–23–1)
0.4
Dinoseb (88–85–7)
P a r k ,
M D
Offi c e
Diquat (85–00–7)
0.02
800
N o r t h
Endothall (145–73–3)
S t r e e t
N W. ,
D C.
Endrin (72–20–8)
Ethylene dibromide (106–93–4)
0.00005
(1) A n t i m o n y
s h a l l b e m e a s u r e d u s i n g
Glyphosate (1071–53–6)
t h e fo l l o w i n g m e t h o d s :
Heptachlor (76–44–8)
0.0004
(i)
M e t h o d
204. 2—‘‘A t o m i c
A b s o r p -
Heptachlor epoxide (1024–57–3)
Hexachlorobenzene (118–74–4)
t i o n ;
fu r n a c e
t e c h n i q u e ,’’ w h i c h
i n -
Hexachlorocyclopentadiene (77–47–4) ...
c o r p o r a t e d b y r e fe r e n c e i n a c c o r d a n c e
Lindane (58–89–9)
5 U . S . C. 552(a )
Methoxychlor (72–43–5)
Oxamyl (23135–22–0)
a v a i l a b i l i t y
i n c o r p o r a t i o n
531
b y r e fe r e n c e i s g i v e n i n p a r a g r a p h (b )(4)(i i i )(E ) o f t h i s s e c t i o n .
(ii) M e t h o d 200. 8—‘‘D e t e r m i n a t i o n o f T r a c e E l e m e n t s i n Wa t e r a n d Wa s t e s b y I n d u c t i v e l y Co u p l e d P l a s m a -M a s s S p e c t r o m e t r y ,’’ R e v . 4. 4, A p r i l 1991, U . S . E P A , E M S L . T h e r e v i s i o n i s c o n - t a i n e d i n t h e m a n u a l e n t i t l e d ‘‘M e t h - o d s fo r t h e D e t e r m i n a t i o n o f M e t a l s i n E n v i r o n m e n t a l S a m p l e s ,’’ Offi c e o f R e - s e a r c h a n d D e v e l o p m e n t , Wa s h i n g t o n , D C 20460, (E P A /600/4–91/010), J u n e 1991, w h i c h i s i n c o r p o r a t e d b y r e fe r e n c e i n
a c c o r d a n c e w i t h 5
U . S . C.
552(a ) a n d 1
CF R p a r t 51. Co p i e s
a r e a v a i l a b l e fr o m t h e N a t i o n a l T e c h - n i c a l I n fo r m a t i o n S e r v i c e , U . S . D e p a r t -
m e n t
o f Co m m e r c e ,
S p r i n g fi e l d , V A
e x a m i n e d a t t h e Ce n t e r fo r F o o d S a fe t y a n d A p p l i e d N u t r i t i o n ’s L i b r a r y , F o o d a n d D r u g A d m i n i s t r a t i o n , 5100 P a i n t B r a n c h P k w y . , Co l l e g e P a r k , M D 20740, o r a t t h e Offi c e o f t h e F e d e r a l R e g i s t e r , 800 N o r t h Ca p i t o l S t r e e t N W. , s u i t e 700, Wa s h i n g t o n , D C.
(iii) M e t h o d 200. 9—‘‘D e t e r m i n a t i o n o f T r a c e E l e m e n t s b y S t a b i l i ze d T e m p e r a - t u r e G r a p h i t e F u r n a c e A t o m i c A b s o r p -
t i o n
S p e c t r o m e t r y ,’’ R e v .
1. 2, A p r i l
1991,
U . S . E P A ,
E M S L . T h e r e v i s i o n
c o n t a i n e d
m a n u a l
e n t i t l e d
D e t e r m i n a t i o n
M e t a l s i n
E n v i r o n m e n t a l S a m p l e s ,’’ Of-
fi c e o f R e s e a r c h a n d D e v e l o p m e n t ,
Wa s h i n g t o n , D C 20460,
(E P A /600/4–91/
010), J u n e 1991, w h i c h i s
i n c o r p o r a t e d
b y r e fe r e n c e i n a c c o r d a n c e w i t h 5 U . S . C. 552(a ) a n d 1 CF R p a r t 51. T h e a v a i l a b i l i t y o f t h i s i n c o r p o r a t i o n b y
r e fe r e n c e
g i v e n
p a r a g r a p h
(b )(4)(i i i )(E )(1)(ii) o f t h i s
s e c t i o n .
(iv )
D –3697–92—‘‘S t a n d a r d
T e s t
M e t h o d fo r
A n t i m o n y
i n Wa t e r ,’’
c o n t a i n e d i n t h e A n n u a l B o o k o f A S T M S t a n d a r d s , v o l s . 11. 01 a n d 11. 02, 1995, A m e r i c a n S o c i e t y fo r T e s t i n g a n d M a -
t e r i a l s , 100 B a r r
H a r b o r
D r . ,
We s t
Co n s h o h o c k e n , P A
19428,
i s i n -
c o r p o r a t e d b y r e fe r e n c e i n a c c o r d a n c e w i t h 5 U . S . C. 552(a ) a n d 1 CF R p a r t 51. Co p i e s o f t h i s p u b l i c a t i o n a r e a v a i l a b l e fr o m A m e r i c a n S o c i e t y fo r T e s t i n g a n d
M a t e r i a l s , 100 B a r r H a r b o r
Co n s h o h o c k e n , P A 19428, o r
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 p p l i e d N u t r i t i o n ’s L i b r a r y , F o o d
D r u g A d m i n i s t r a t i o n , 5100 P a i n t
B r a n c h P k w y . , Co l l e g e P a r k , M D 20740,
o r a t t h e Offi c e o f t h e F e d e r a l R e g i s t e r , 800 N o r t h Ca p i t o l S t r e e t N W. , s u i t e 700, Wa s h i n g t o n , D C.
(2) B a r i u m s h a l l b e m e a s u r e d u s i n g t h e fo l l o w i n g m e t h o d s :
208. 2—‘‘A t o m i c A b s o r p -
t e c h n i q u e ,’’ w h i c h i s i n -
5 U . S . C. 552(a ) a n d 1 CF R
p a r t 51,
(ii)
M e t h o d 208. 1—‘‘A t o m i c
t i o n ; d i r e c t a s p i r a t i o n ,’’ w h i c h
i s i n c o r -
p o r a t e d b y r e fe r e n c e i n a c c o r d a n c e w i t h 5 U . S . C. 552(a ) a n d 1 CF R p a r t 51. T h e a v a i l a b i l i t y o f t h i s i n c o r p o r a t i o n b y r e fe r e n c e i s g i v e n i n p a r a g r a p h (b )(4)(i i i )(E ) o f t h i s s e c t i o n .
(iii) M e t h o d 200. 7—‘‘D e t e r m i n a t i o n o f M e t a l s a n d T r a c e E l e m e n t s i n Wa t e r a n d Wa s t e s b y I n d u c t i v e l y Co u p l e d
P l a s m a -A t o m i c E m i s s i o n S p e c t r o m - e t r y ,’’ R e v . 3. 3, A p r i l 1991, U . S . E P A , E M S L . T h e r e v i s i o n i s c o n t a i n e d i n t h e m a n u a l e n t i t l e d ‘‘M e t h o d s fo r t h e D e - t e r m i n a t i o n o f M e t a l s i n E n v i r o n -
m e n t a l
S a m p l e s ,’’ Offi c e
o f R e s e a r c h
a n d D e v e l o p m e n t , Wa s h i n g t o n , D C
20460,
(E P A /600/4–91/010),
J u n e 1991,
w h i c h i s i n c o r p o r a t e d b y
r e fe r e n c e i n
a c c o r d a n c e w i t h 5 U . S . C. 552(a ) a n d 1 CF R p a r t 51. T h e a v a i l a b i l i t y o f t h i s i n - c o r p o r a t i o n b y r e fe r e n c e i s g i v e n i n
p a r a g r a p h (b )(4)(i i i )(E )(1)(ii) o f
t h i s s e c -
t i o n .
(3) B e r y l l i u m s h a l l b e m e a s u r e d u s i n g
210. 2—‘‘A t o m i c
F u r n a c e
T e c h n i q u e ,’’ w h i c h i s i n -
c o r p o r a t e d b y r e fe r e n c e i n a c c o r d a n c e w i t h 5 U . S . C. 552(a ) a n d 1 CF R p a r t 51. T h e a v a i l a b i l i t y o f t h i s i n c o r p o r a t i o n b y r e fe r e n c e i s g i v e n i n p a r a g r a p h (b )(4)(i i i )(E ) o f t h i s s e c t i o n .
(ii) M e t h o d 200. 7—‘‘D e t e r m i n a t i o n o f M e t a l s a n d T r a c e E l e m e n t s i n Wa t e r a n d Wa s t e s b y I n d u c t i v e l y Co u p l e d
w h i c h i s i n c o r p o r a t e d b y r e fe r e n c e i n a c c o r d a n c e w i t h 5 U . S . C. 552(a ) a n d 1 CF R p a r t 51. T h e a v a i l a b i l i t y o f t h i s i n - c o r p o r a t i o n b y r e fe r e n c e i s g i v e n i n
532
Misconception 1: The FD-9 form is only for new bottled water companies.
This is not true. While the FD-9 form is essential for new companies seeking to register their products, existing companies also need to use this form when they introduce new products or sources. Any changes in product offerings require compliance with registration protocols.
Misconception 2: All bottled water products are considered the same.
In reality, the term "distinct product" is crucial. Different types of bottled water, like spring water and distilled water, must be registered separately. Even variations of the same type under different brand names are considered distinct products and require individual registrations.
Misconception 3: You can submit the FD-9 form without any supporting documents.
Submitting the FD-9 form alone is insufficient. Accompanying documents, such as hydrogeological reports and test results, are mandatory for approval. Without these, your application may face delays or outright rejection.
Misconception 4: There is no limit to the number of products you can register with the FD-9 form.
This is incorrect. The registration fee is capped at $200 for up to ten products. If you wish to register more than ten, you will still only pay for ten products. Each additional product beyond that requires a separate registration process.
Misconception 5: Once registered, a product does not need to be monitored again.
This is a critical misunderstanding. Ongoing monitoring of both source and product water is essential. Regular testing must continue to ensure compliance with health standards, even after initial registration is granted.
Misconception 6: You can use any laboratory for testing your water samples.
Not all laboratories are acceptable. Testing must be conducted by NELAP- or state-certified laboratories. Using non-certified labs could lead to issues with compliance and jeopardize your registration status.
The Louisiana FD-9 form is a crucial document for those seeking to register as bottled-water distributors in the state. However, several other forms and documents are often utilized alongside the FD-9 to ensure compliance with state regulations. Each of these documents serves a specific purpose in the registration process, helping to streamline the approval of bottled water products and facilities.
Understanding the role of these documents in conjunction with the FD-9 form is vital for anyone looking to navigate the regulatory landscape of bottled water distribution in Louisiana. Each document contributes to a comprehensive assessment of safety, compliance, and quality assurance in the bottled water industry.