➨

Blank Louisiana Fd 9 PDF Form

The Louisiana FD 9 form serves as an essential document for those seeking to register as bottled water distributors in the state. This form outlines the necessary steps and requirements to obtain a Certificate of Registration, ensuring that your bottled water products meet health and safety standards. Understanding the nuances of this form can streamline your application process and pave the way for successful distribution.

Access My Document Now

Navigation

The Louisiana FD-9 form is a crucial document for anyone looking to enter the bottled water distribution business in the state. This form serves as an application for a Certificate of Registration, which is mandatory for all bottled water distributors. To obtain this certificate, prospective importers must provide a variety of documentation, including a hydrogeological report and test results that confirm the safety and compliance of their water sources. The form outlines specific requirements based on different scenarios, such as new products or facilities, and emphasizes the importance of adhering to state and federal regulations. Additionally, it clarifies the process for registering distinct bottled water products, which can include various types like spring water, mineral water, and distilled water. Understanding the nuances of this form is essential for ensuring compliance and successfully navigating the registration process. If you have any questions or need further assistance, reaching out to the appropriate regulatory authority is highly encouraged.

Document Example

STATE OF LOUISIANA

DEPARTMENT OF HEALTH AND HOSPITALS

Dear Prospective Bottled Water Importer:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Attachments: PLEASE FIND THE FOLLOWING DOCUMENTS ATTACHED TO THIS GUIDE

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

TESTING REQUIREMENTS FOR BOTTLED WATER – SOURCE AND PRODUCT

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

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



Date					Registration No. (For Office Use Only)

Company Contact Person			Taxpayer ID		Telephone No.		Fax No.

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

Address			City		State		ZIP Code

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

Address			City		State		ZIP Code

Name of firm submitting application

Address (Mailing)			City		State		ZIP Code

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

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

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

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

1)	2)	3)

		FOR OFFICE USE ONLY
REGISTRATION YEAR	CHECK NUMBER		PROCESSED BY

SHEET NUMBER	CHECK DATE		CERTIFICATE TYPE

SHEET DATE

REGISTRATION NUMBER

Food and Drug Administration, HHS

Subpart A—General Provisions

§ 165.3 Definitions.

(a ) A lot i s :

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

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

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

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

Subpart B—Requirements for

Specific Standardized Beverages

§ 165.110 Bottled water.

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

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


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

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

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

§ 165.110

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

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

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

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

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

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

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

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

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

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

527

§ 165.110

21 CFR Ch. I (4–1–04 Edition)

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

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

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

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

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

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

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

d r a u l i c

c o n n e c t i o n

u s i n g

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

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


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

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

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

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

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

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

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


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

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

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

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

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

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

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

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

528

Food and Drug Administration, HHS

§ 165.110

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

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

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

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


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

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

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

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

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


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

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

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


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

	Substance	Concentration in
	Substance	milligrams per liter
		milligrams per liter

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

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

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

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

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

529

§ 165.110

21 CFR Ch. I (4–1–04 Edition)

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

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

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

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

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

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

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

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

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


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

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

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

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

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

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

TABLE 1

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

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

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

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

TABLE 2

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

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

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

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

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

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

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

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

		Concentration in milligrams
Contaminant		per liter
		(or as specified)

Antimony		.006.
Barium		2.
Beryllium		0.004.

530

Food and Drug Administration, HHS

§ 165.110

Concentration in milligrams

Contaminant

Concentration in

Contaminant

per liter

(CAS Reg. No.)

milligrams per liter

(or as specified)

Pentachlorophenol (87–86–5)

0.001

Cadmium

0.005.

PCB’s

(as

decachlorobiphenyl)

(1336–

Chromium

0.1.

36–3)

0.0005

Copper

1.0.

Picloram (1918–02–1)

0.5

Cyanide

0.2.

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

Simazine (122–34–9)

0.004

Lead

0.005.

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

2,3,7,8-TCDD (Dioxin) (1746–01–6)

.......

3×10¥8

Mercury

0.002.

Toxaphene (8001–35–2)

0.003

Nickel

0.1.

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

2,4,5-TP (Silvex) (93–72–1)

0.05

Nitrate

10 (as nitrogen).

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

Nitrite

1 (as nitrogen).

Total Nitrate and Nitrite ..

10 (as nitrogen).

(D )

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

l e v e l s

fo r

c e r t a i n

Selenium

0.05.

c h e m i c a l s

fo r

w h i c h

E P A

h a s

e s t a b -

Thallium

0.002.

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

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

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

l a t i o n s (40 CF R

p a r t

143) a r e a s

fo l l o w s :

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

(V OC’s )

a r e a s fo l -

l o w s :

Concentration in

Contaminant

milligrams per

Contaminant

Concentration in

liter

(CAS Reg. No.)

milligrams per liter

Aluminum

0.2

Benzene (71–43–2)

0.005

Silver

0.1

Carbon tetrachloride (56–23–5)

0.005

Sulfate 1

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

250.0

o- Dichlorobenzene (95–50–1)

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

0.6

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

p- Dichlorobenzene (106–46–7)

0.075

1,2-Dichloroethane (107–06–2)

0.005

tions are aesthetically based allowable levels and do not re-

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

late to a health concern.

1,1-Dichloroethylene (75–35–4)

0.007

cis-1,2-Dichloroethylene (156–59–2)

0.07

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

trans-1,2-Dichloroethylene (156–60–5)

0.1

a n c e

w i t h

t h e

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

o f

p a r a -

Dichloromethane (75–09–2)

0.005

1,2-Dichloropropane (78–87–5)

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

0.005

g r a p h

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

o f t h i s

s e c t i o n

s h a l l

Ethylbenzene (100–41–4)

0.7

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

Monochlorobenzene (108–90–7)

0.1

p l i c a b l e

m e t h o d

a n d

a p p l i c a b l e

r e v i -

Styrene (100–42–5)

0.1

Tetrachloroethylene (127–18–4)

0.005

s i o n s

t o

t h e

m e t h o d s

l i s t e d

i n

p a r a -

Toluene (108–88–3)

g r a p h s

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

t h r o u g h

1,2,4–Trichlorobenzene (120–82–1)

0.07

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

o f

t h i s

s e c t i o n

a n d

d e -

1,1,1-Trichloroethane (71–55–6)

0.20

1,1,2–Trichloroethane (79–00–5)

0.005

s c r i b e d ,

u n l e s s

o t h e r w i s e

n o t e d ,

i n

Trichloroethylene (79–01–6)

0.005

‘‘M e t h o d s

fo r

Ch e m i c a l

A n a l y s i s

o f

Vinyl chloride (75–01–4)

0.002

Wa t e r

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

Xylenes (1330–20–7)

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

o r a t o r y

(E M S L ),

Ci n c i n n a t i ,

45258

(E P A –600/4–79–020), M a r c h

1983, w h i c h i s

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

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

(S OC’s ) a r e a s fo l l o w s :

a n c e

w i t h

5 U . S . C.

552(a )

a n d

1 CF R

Contaminant

Concentration in

p a r t

51.

Co p i e s

o f

t h i s

p u b l i c a t i o n

a r e

(CAS Reg. No.)

milligrams per liter

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

Alachlor (15972–60–8)

0.002

I n fo r m a t i o n

S e r v i c e

(N T I S ),

U . S .

D e -

Atrazine (1912–24–9)

0.003

p a r t m e n t

o f

Co m m e r c e ,

5285

P o r t

Benzo(a)pyrene (50–32–8)

0.0002

R o y a l

R d . ,

S p r i n g fi e l d ,

V A

22161,

o r

Carbofuran (1563–66–2)

0.04

Chlordane (57–74–9)

0.002

m a y

b e

e x a m i n e d

a t

t h e

Ce n t e r

fo r

Dalapon (75–99–0)

0.2

F o o d

S a fe t y

a n d

A p p l i e d

N u t r i t i o n ’s

1,2-Dibromo-3-chloropropane (96–12–8)

0.0002

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

2,4-D (94–75–7)

0.07

t i o n ,

5100 P a i n t

B r a n c h

P k w y . ,

Co l l e g e

Di(2-ethylhexyl)adipate (103–23–1)

0.4

Dinoseb (88–85–7)

0.007

P a r k ,

M D

20740,

o r

a t

t h e

Offi c e

o f

t h e

Diquat (85–00–7)

0.02

F e d e r a l

R e g i s t e r ,

800

N o r t h

Ca p i t o l

Endothall (145–73–3)

0.1

S t r e e t

N W. ,

s u i t e

700,

Wa s h i n g t o n ,

D C.

Endrin (72–20–8)

0.002

Ethylene dibromide (106–93–4)

0.00005

(1) A n t i m o n y

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

Glyphosate (1071–53–6)

0.7

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

Heptachlor (76–44–8)

0.0004

(i)

M e t h o d

204. 2—‘‘A t o m i c

A b s o r p -

Heptachlor epoxide (1024–57–3)

0.0002

Hexachlorobenzene (118–74–4)

0.001

t i o n ;

fu r n a c e

t e c h n i q u e ,’’ w h i c h

i s

i n -

Hexachlorocyclopentadiene (77–47–4) ...

0.05

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

Lindane (58–89–9)

0.0002

w i t h

5 U . S . C. 552(a )

a n d

1 CF R

p a r t

51.

Methoxychlor (72–43–5)

0.04

Oxamyl (23135–22–0)

0.2

T h e

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

o f

t h i s

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

531

§ 165.110

21 CFR Ch. I (4–1–04 Edition)

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

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

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

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

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

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

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


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

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

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

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


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

532

Dos and Don'ts

When filling out the Louisiana FD-9 form, it's essential to follow specific guidelines to ensure a smooth application process. Here’s a helpful list of things you should and shouldn’t do:

Do read all instructions carefully before starting the form.
Do ensure that all required documents are attached to your application.
Do double-check that your payment method is included and correctly filled out.
Do provide accurate contact information for prompt communication.
Do submit your application well in advance of any deadlines.

Don't leave any sections of the form blank; every part must be completed.
Don't forget to sign the application; an unsigned form will be rejected.
Don't use outdated documents or forms; always use the most current version.
Don't assume that all products are considered distinct; clarify what qualifies.
Don't submit your application without verifying that all fees are correctly calculated.

Create Common Templates

Louisiana Amended Tax Return - Each transcript request must be accompanied by the student's signature.

For more details on completing the verification process, you can visit https://pdftemplates.info, where you will find resources that can assist you in filling out the California Employment Verification form correctly.

R-1048 Louisiana 2023 - Failure to adhere to the requirements could invalidate the exemption.

Detailed Instructions for Filling Out Louisiana Fd 9

Filling out the Louisiana FD-9 form is an essential step for those looking to register as a bottled-water distributor in the state. This process involves gathering necessary documentation and providing specific information about your company and products. Follow these steps carefully to ensure a smooth application process.

Obtain the FD-9(N) Application for a New Product Registration form.
Check the appropriate product type box at the top of the form (Food, Drug, Cosmetic, Prophylactic, Seafood, Milk/Dairy).
Enter the date and leave the registration number blank (for office use only).
Fill in your company name, contact person, taxpayer ID, telephone number, and fax number.
Provide the name of the manufacturer, distributor, packer, processor, or importer exactly as it appears on the label.
Complete the address section, including city, state, and ZIP code.
If applicable, list the name of the actual manufacturer for private-label/copacked products and provide their address.
Fill in the mailing address for the firm submitting the application.
Have the executive officer, proprietor, partner, or agent for service of process sign the form and provide their title.
Indicate the total number of products you intend to register. Multiply $20 by this number, or enter $200 if registering more than ten products.
Attach a catalog listing of all products intended for distribution in Louisiana along with proofs or specimen labels.
List the names and addresses of three brokers, warehousemen, or distributors handling your products. If none, indicate “SELF-DISTRIBUTION.”
Make a check or money order payable to DHH for the registration fee and attach it to the application.
Submit the completed FD-9 form and all required documents to the Louisiana Department of Health and Hospitals.

Documents used along the form

When applying for a Certificate of Registration as a bottled-water distributor in Louisiana, several additional forms and documents may be required alongside the Louisiana FD-9 form. Each of these documents plays a crucial role in ensuring compliance with state regulations.

Hydrogeological Report: This report must be prepared by a qualified geologist and detail the local geology and development of the water source. It includes assessments of the aquifer and potential contamination sources.
ATV Bill of Sale: This form serves as a formal record for transferring ownership of an all-terrain vehicle in Arizona, ensuring clarity in the sale process. For more information, visit arizonapdfs.com/atv-bill-of-sale-template/.
Testing Requirements Document: This outlines the specific contaminants that must be monitored in both source and product water. Compliance with these testing protocols is essential for registration.
Certificate/Inspection/License: A copy of the most recent document issued by the relevant state or local authority is necessary to confirm that the bottling facility meets all operational standards.
Specimen Labels: Labels for each distinct product must be submitted. They should comply with federal regulations, providing necessary information about the bottled water.
Product Registration Packet: This includes the completed FD-9(N) form, payment for registration fees, and proofs of labels for non-bulk products, ensuring that all products are registered correctly.
Approval Letter for New Sources: If a new source is utilized for an existing product, an approval letter from the Sanitarian Program Manager is required to confirm the source's compliance.
Monitoring Test Results: Recent test results verifying the quality of the water must be submitted to demonstrate compliance with health standards.

These documents collectively ensure that the bottled water products meet health and safety standards, paving the way for successful registration and distribution in Louisiana.

Your Questions, Answered

What is the Louisiana FD-9 form and why is it important?

The Louisiana FD-9 form is an application used to register bottled water products with the state. It is essential for any company looking to distribute bottled water in Louisiana. Completing this form correctly ensures compliance with state regulations and helps secure a Certificate of Registration. This registration is crucial for operating legally and maintaining consumer safety standards.

What documentation is required to register a new bottled water product?

To register a new bottled water product, you must provide several key documents:

A hydrogeological report from a certified professional geologist.
Recent test results showing the source water is monitored for specified contaminants.
Test results confirming that the product water meets the standards outlined in 21 CFR 165.110.
A copy of the latest certificate or inspection from the relevant state or local authority.
A completed FD-9(N) Application for a New Product Registration.
Specimen labels for each distinct product.
The appropriate fee of $20 per product, capped at $200 per DBA.

Once all documentation is reviewed, a Certificate of Registration will be issued if everything is in order.

What does "distinct product" mean in the context of bottled water?

The term "distinct product" refers to any bottled water that meets different standards of identity as specified in 21 CFR 165.110. For example, if you produce both distilled water and spring water, those are considered distinct products. Similarly, if you have Brand X and Brand Y distilled water, they also qualify as distinct products. Each distinct product must be registered, but you can register up to ten products for a maximum fee of $200.

How can I submit my hydrogeological report?

You can submit your hydrogeological report to the Sanitarian Program Manager for Bottled Water. This can be done via fax at (225) 342-7672 or by regular mail to Bin # 14, P.O. Box 4489, Baton Rouge, LA 70821-4489. Make sure the report is signed and certified by a qualified professional geologist or hydrogeologist and includes all required elements, such as regional geology and a watershed survey.

What monitoring is required for source and product water?

After constructing your well, you must conduct tests on samples taken from your source. The required monitoring includes:

Annual analysis for chemical, physical, and radiological contaminants.
Microbiological testing for coliform bacteria.

Public water sources must provide documentation proving compliance with National Primary Drinking Water Regulations. Always use a NELAP- or state-certified laboratory for these tests to ensure accuracy and compliance with health standards.

Common mistakes

Filling out the Louisiana FD-9 form can be a complex process, and many applicants make common mistakes that can delay their registration as bottled water distributors. One frequent error is incomplete documentation. Applicants often fail to include all required documents, such as the hydrogeological report or the recent test results. Ensuring that every piece of documentation is submitted is crucial for a smooth approval process.

Another common mistake is misunderstanding what constitutes a distinct product. Applicants sometimes register different brands of the same type of bottled water as separate products. However, if the water conforms to the same standard of identity, it should be registered as a single product. This misinterpretation can lead to unnecessary fees and complications.

Additionally, applicants may overlook the labeling requirements. Labels must meet specific criteria outlined in federal regulations, and failure to provide proper specimen labels can result in rejection. It is essential to verify that all labels contain the necessary information before submission.

Some applicants also neglect the importance of monitoring source and product water. After construction of a well, it is vital to perform required tests on the water sample. Failing to submit the proper testing documentation can lead to disapproval of the application. Regular monitoring is not just a recommendation; it is a requirement that must be adhered to.

Another mistake involves incorrect fee submission. Applicants sometimes miscalculate the registration fee based on the number of products they intend to register. Remember, the fee is capped at $200 for up to 10 products. Misunderstanding this can lead to delays in processing the application.

Lastly, some individuals fail to provide accurate contact information. This can hinder communication with the regulatory office. Providing a valid phone number and mailing address ensures that any questions or issues can be addressed promptly. By avoiding these common mistakes, applicants can facilitate a smoother registration process for their bottled water products in Louisiana.

Misconceptions

Understanding the Louisiana FD-9 form is crucial for anyone looking to distribute bottled water in the state. However, several misconceptions can lead to confusion. Here are ten common misunderstandings about the FD-9 form, along with clarifications:

The FD-9 form is only for new companies. Many believe that only new businesses need to fill out this form. In reality, existing companies must also register new products or sources using the FD-9 form.
Only large companies need a Certificate of Registration. This is false. Any entity distributing bottled water, regardless of size, must obtain a Certificate of Registration.
All bottled water products are treated the same. Different types of bottled water (e.g., spring water, distilled water) are considered distinct products and require separate registrations.
Submitting the FD-9 form guarantees approval. While the form is necessary, approval is contingent upon meeting all regulatory requirements, including documentation and testing results.
The registration fee is a one-time payment. This is misleading. Each distinct product requires a separate fee, and companies must pay for any new products they wish to register.
You can submit the FD-9 form without supporting documents. Incomplete submissions will delay the registration process. All required documentation must accompany the FD-9 form.
Labeling requirements are optional. This is incorrect. Labels must meet specific criteria outlined in federal regulations and must be submitted with the FD-9 form.
There is no limit on the number of products that can be registered. The fee structure caps the registration at ten products or $200 per DBA, meaning additional products will incur extra costs.
Once registered, products do not need further testing. Regular monitoring and testing of both source and product water are mandatory to maintain compliance.
The FD-9 form is only relevant to bottled water. While it primarily addresses bottled water, it also applies to other beverages if they meet certain criteria as outlined in the regulations.

By addressing these misconceptions, prospective bottled water distributors can better navigate the registration process and ensure compliance with Louisiana's regulations.

Document Attributes

Fact Name	Fact Description
Governing Authority	The Louisiana FD-9 form is governed by LSA R.S. 40:627 et seq.
Purpose	This form is used to apply for a Certificate of Registration as a bottled-water distributor in Louisiana.
Registration Fee	The fee for product registration is $20 per product, capped at a maximum of $200 per DBA.
Required Documentation	Applicants must submit a hydrogeological report, test results, and specimen labels among other documents.
Non-Bulk Product Registration	Non-bulk products (less than 3 gallons) must be registered with the state health department.
Distinct Products	A distinct product is defined by its compliance with different standards of identity as per 21 CFR 165.110.
Monitoring Requirements	Source and product water must be tested according to specified guidelines to ensure safety and compliance.
Submission Methods	Reports can be submitted via fax or regular mail to the Sanitarian Program Manager for Bottled Water.
Approval Process	Certificates of Registration are issued after all documentation is reviewed by the Sanitarian Program Manager.