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 |
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BATON ROUGE, LA 70821-4489 |
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PHONE: (225) 342-7517 * FAX: (225) 342-7672 |
NEW COMPANY INITIAL APPLICATION |
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Check the appropriate product type below: |
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FOOD |
DRUG |
COSMETIC |
PROPHYLACTIC |
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SEAFOOD |
MILK/DAIRY |
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Registration No. (For Office Use Only) |
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Company Contact Person |
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Name of Manufacturer, Distributor, Packer, Processor, or Importer (exactly as it appears on the label) |
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If this is a private-label/copacked product, list the name of the actual manufacturer here |
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Signature of Executive Officer, Proprietor, Partner, or Agent for Service of Process |
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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 |
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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 |
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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. |
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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.
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FOR OFFICE USE ONLY |
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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 -
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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 ,’’ |
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‘‘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 |
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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
§ 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 |
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
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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
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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 . ’’
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 . |
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(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
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‘‘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 : |
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(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 -
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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
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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 |
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milligrams per liter |
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Arsenic |
0.05 |
|
Chloride1 |
250.0 |
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Iron1 |
0.3 |
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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 .
§ 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 -
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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. |
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(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; |
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(3) |
‘‘P a r t |
I : |
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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; |
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(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; |
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(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- |
|
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
|
Annual average of maximum daily air tem- |
Fluoride con- |
|
centration in mil- |
|
peratures (°F) |
|
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. |
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) |
|
|
1 |
|
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) |
|
|
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 : |
|
|
|
|
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 |
|
|
|
§ 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 -
|
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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
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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 |
|
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(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 . |
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(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
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
Food and Drug Administration, HHS |
§ 165.110 |
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 .
(iii) 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. 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 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 -
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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 . |
(4) Ca d m 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 |
213. 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
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 . |
|
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(5) Ch r o m 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 |
218. 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. 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
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 .
(6) Co p p e r s h a l l b e m e a s u r e d a s t o t a l r e c o v e r a b l e m e t a l w i t h o u t fi l t r a t i o n
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 |
220. 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 220. 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 e s e 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
§ 165.110 |
21 CFR Ch. I (4–1–04 Edition) |
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 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. 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 .
(v ) 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 -
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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
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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 . |
(7) Cy a n i d e 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 : |
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(i) |
M e t h o d |
335. 1—‘‘T i t r i m e t r i c ; |
S p e c t r o p h o t o m e t r i c ’’ 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 |
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(ii) |
M e t h o d |
335. 2—‘‘T i t r i m e t r i c ; |
S p e c t r o p h o t o m e t r i c ’’ 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 |
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(iii) |
M e t h o d 335. 3—‘‘Co l o r i m e t r i c , |
A u t o m a t e d U V ,’’ 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 e s e i n c o r p o r a t i o n b y
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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 . |
|
(iv ) |
M e t h o d |
D –2036–91—‘‘S t a n d a r d |
T e s t |
M e t h o d s fo r Cy a n i d e s |
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 , 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. |
|
(8) L e a d s h a l l b e m e a s u r e d a s t o t a l |
r e c o v e r a b l e m e t a l w i t h o u t fi l t r a t i o n 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 |
239. 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. 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. 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. 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 .
(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 -
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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 . |
(9) M e r c u r y 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 |
245. 1—‘‘M a n u a l c o l d v a p o r |
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 |
Food and Drug Administration, HHS |
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§ 165.110 |
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. |
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 |
552(a ) a n d 1 CF R p a r t 51, o r |
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1991, |
U . S . E P A , E M S L . T h e |
r e v i s i o n |
i s |
(ii) |
M e t h o d |
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245. 2—‘‘A u t o m a t e d |
c o l d |
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 |
v a p o r |
t e c h n i q u e ,’’ |
w h i c h |
|
i s |
|
i n c o r - |
‘‘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 |
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 |
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- |
w i t h |
5 U . S . C. 552(a ) |
a n d |
1 CF R |
p a r t |
51. |
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 , |
T h e a v a i l a b i l i t y |
o f t h e s e |
i n c o r p o r a t i o n |
Wa s h i n g t o n , |
D C |
20460, |
(E P A /600/4–91/ |
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 |
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 )(4)(i i i )(E ) o f t h i s s e c t i o n . |
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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 |
(10) |
N i c k e l |
s h a l l |
b e |
m e a s u r e d |
u s i n g |
U . S . C. 552(a ) |
a n d 1 |
CF R |
p a r t |
51. T h e |
t h e fo l l o w i n g m e t h o d s : |
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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 |
(i) |
M e t h o d |
|
249. 1—‘‘A t o m i c |
A b s o r p - |
r e fe r e n c e |
|
i s |
g i v e n |
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i n p a r a g r a p h |
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 - |
(b )(4)(i i i )(E )(1)(ii) o f t h i s |
s e c t i o n . |
|
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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 |
(11) N i t r a t e a n d /o r n i t r i t e s h a l l b e |
w i t h |
5 U . S . C. 552(a ) |
a n d |
1 CF R |
p a r t |
51, |
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 : |
o r |
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(i) M e t h o d 300. 0—‘‘T h e D e t e r m i n a t i o n |
(ii) |
M e t h o d |
249. 2—‘‘A t o m i c |
A b s o r p - |
o f I n o r g a n i c |
A n i o n s |
i n |
Wa t e r |
b y I o n |
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 - |
Ch r o m a t o g r a p h y —M e t h o d |
300. 0,’’ |
E P A , |
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 |
E M S L |
(E P A –600/4–84–017), |
M a r c h |
1984, |
w i t h |
5 U . S . C. 552(a ) |
a n d |
1 CF R |
p a r t |
51. |
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 |
T h e a v a i l a b i l i t y |
o f |
t h e s e |
i n c o r p o r a t i o 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 |
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 |
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 |
(b )(4)(i i i )(E ) o f t h i s s e c t i o n . |
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a r e a v a i l a b l e |
fr o m |
N T I S , |
U . S . D e p a r t - |
(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 n t |
o f |
Co m m e r c e , |
5285 |
P o r t |
R o y a l |
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 |
R d . , S p r i n g fi e l d , |
V A |
22161, |
o r |
m a y |
b e |
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 |
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 |
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 - |
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 |
e t r y ,’’ R e v . |
3. 3, |
A p r i l |
1991, |
U . S . |
E P A , |
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 |
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 |
B r a n c h |
P k w y . , Co l l e g e |
P a r k , M D |
20740, |
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 - |
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 , |
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 - |
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, |
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 |
Wa s h i n g t o n , D C. |
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a n d |
D e v e l o p m e n t , |
Wa s h i n g t o n , |
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D C |
(ii) |
|
M e t h o d |
353. 1—‘‘Co l o r i m e t r i c , |
20460, |
(E P A /600/4–91/010), |
J u n e |
|
1991, |
a u t o m a t e d , |
h y d r a zi n e |
r e d u c t i o n ,’’ |
fo r |
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 |
n i t r a t e o n l y , w h i c h i s i n c o r p o r a t e d b y |
a c c o r d a n c e |
w i t h |
5 |
U . S . C. 552(a ) |
a n d 1 |
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. |
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 - |
552(a ) a n d 1 CF R p a r t |
51, o r |
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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 |
(iii) |
|
M e t h o d |
353. 2—‘‘Co l o r i m e t r i c , |
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 - |
a u t o m a t e d , |
c a d m i u m |
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r e d u c t i o n ,’’ |
fo r |
t i o n . |
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b o t h n i t r a t e a n d n i t r i t e , w h i c h i s i n - |
(iv ) |
M e t h o d |
200. 8—‘‘D e t e r m i n a t i o n |
o f |
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 |
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 |
w i t h |
5 U . S . C. 552(a ) a n d |
1 CF R |
p a r t |
51, |
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 |
o r |
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S p e c t r o m e t r y ,’’ |
R e v . |
4. 4, |
A p r i l |
|
1991, |
(iv ) |
|
M e t h o d |
353. 3—‘‘S p e c t r o p h o t o - |
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 - |
m e t r i c , |
c a d m i u m |
r e d u c t i o n ,’’ |
fo r |
b o t h |
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 - |
n i t r a t e |
a n d n i t r i t e , |
|
w h i c h |
i s |
i n c o r - |
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 |
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 |
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 - |
w i t h |
5 U . S . C. 552(a ) |
a n d |
1 CF R |
p a r t |
51, |
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 , |
o r |
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D C 20460, |
(E P A /600/4–91/010), |
J u n e |
1991, |
(12) |
|
S e l e n i u m |
s h a l l |
b e |
m e a s u r 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 |
u s i n g t h e fo l l o w i n g m e t h o d s : |
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a c c o r d a n c e |
w i t h |
5 |
U . S . C. 552(a ) |
a n d 1 |
(i) |
M e t h o d |
270. 2—‘‘A t o m i c |
A b s o r p - |
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 - |
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 i o n b y r e fe r e n c e i s g i v e n 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 |
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 - |
w i t h |
5 U . S . C. 552(a ) |
a n d |
1 CF R |
p a r t |
51, |
t i o n . |
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o r |
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(v ) |
M e t h o d |
200. 9—‘‘D e t e r m i n a t i o n |
o f |
(ii) |
M e t h o d |
270. 3—‘‘A t o m i c |
A b s o r p - |
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 i o n ; |
g a s e o u s |
h y d r i d e ,’’ w h i c h |
i s |
i n c o r - |
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 - |
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 |
§ 165.110 |
21 CFR Ch. I (4–1–04 Edition) |
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 .
(13) T h a 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 |
279. 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. 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. 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. 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 .
(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 -
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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 . |
(F ) 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 - 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 - g r a p h s (b )(4)(i i i )(B ) a n d (b )(4)(i i i )(C) o f t h i s s e c t i o n s h a l l 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 p l i c a b l e m e t h o d o r a p p l i c a b l e r e v i 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 g r a p h s |
(b )(4)(i i i )(F )(1) |
t h r o u g h |
(b )(4)(i i i )(F )(20) |
o f t h i s s e c t i o n |
a n d d e 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 ‘‘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 |
Or g a n i c |
Co m p o u n d s i n |
D r i n k i n g |
Wa t e r ,’’ |
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 , |
E M S L , |
E P A /600/4–88/039, D e - |
c e m b e r 1988, o r i n |
‘‘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 Or g a n i c Co m p o u n d s i n D r i n k i n g Wa t e r , S u p p l e m e n t 1,’’ 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 , E M S L , E P A /600/4–90/020, J u l y 1990, 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. Co p i e s o f t h e s e p u b l i c a t i o n s a r e |
a v a i l a b l e fr o m N T I S , 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
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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 . N W. , s u i t e 700, |
Wa s h i n g t o n , D C. |
|
|
(1) |
M e t h o d |
502. 1—‘‘V o l a t i l e |
H a l o - |
g e n a t e d Or g a n i c Co m p o u n d s i n Wa t e r |
b y P u r g e a n d T r a p G a s Ch r o m a - |
t o g r a p h y ,’’ R e v . 2. 0, 1989, |
(a p p l i c a b l e t o |
V OC’s ), w h i c h |
i s 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, o r
(2) M e t h o d 502. 2—‘‘V o l a t i l e Or g a n i c Co m p o u n d s i n Wa t e r b y P u r g e a n d T r a p Ca p i l l a r y Co l u m n G a s Ch r o m a - t o g r a p h y w i t h P h o t o i o n i za t i o n a n d E l e c t r o l y t i c Co n d u c t i v i t y D e t e c t o r s i n
S e r i e s ,’’ |
R e v . |
2. 0, |
1989, (a p p l i c a b l e |
t o |
V OC’s ), |
w h i c h |
i s |
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, o r
(3) M e t h o d 503. 1—‘‘V o l a t i l e A r o m a t i c a n d U n s a t u r a t e d Or g a n i c Co m p o u n d s i n Wa t e r b y P u r g e a n d T r a p G a s Ch r o - m a t o g r a p h y ,’’ R e v . 2. 0, 1989, (a p p l i c a b l e t o V OC’s ), w h i c h i s 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, o r
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(4) M e t h o d |
524. 1—‘‘M e a s u r e m e n t |
o f |
P u r g e a b l e Or g a n i c |
Co m p o u n d s |
i n |
Wa t e r b y P a c k e d Co l u m n G a s Ch r o m a - |
t o g r a p h y /M a s s |
S p e c t r o m e t r y ,’’ R e v . |
3. 0, 1989, (a p p l i c a b l e |
t o V OC’s ), 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 |
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(5) |
M e t h o d |
524. 2—‘‘M e a s u r e m e n t |
o f |
P u r g e a b l e |
Or g a n i c |
Co m p o u n d s |
i n |
Wa t e r b y Ca p i l l a r y Co l u m n G a s Ch r o - |
m a t o g r a p h y /M a s s S p e c t r o m e t r y ,’’ R e v . 3. 0, 1989, (a p p l i c a b l e t o V OC’s ), 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 |
Food and Drug Administration, HHS |
§ 165.110 |
(6) M e t h o d 504—‘‘1,2–D i b r o m o e t h a n e
(E D B ) a n d |
1,2–D i b r o m o -3-Ch l o r o p r o - |
p a n e (D B CP ) i n Wa t e r b y M i c r o e x t r a c - |
t i o n |
a n d |
G a s Ch r o m a t o g r a p h y ,’’ R e v . |
2. 0, |
1989, |
(a p p l i c a b l e |
t o d i b r o m o c h l o r o - |
p r o p a n e |
|
(D B CP ) |
a n d |
e t h y l e n e |
d i b r o m i d e |
(E D B )), |
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 |
|
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(7) |
M e t h o d |
505—‘‘A n a l y s i s |
o f |
Or g a n o h a l i d e P e s t i c i d e s a n d Co m m e r - c i a l P o l y c h l o r i n a t e d B i p h e n y l (P CB ) P r o d u c t s i n Wa t e r b y M i c r o e x t r a c t i o n
a n d |
G a s Ch r o m a t o g r a p h y ,’’ |
R e v . 2. 0, |
1989, |
(a p p l i c a b l e t o a l a c h l o r , |
a t r a zi n e , |
c h l o r d a n e , h e p t a c h l o r , h e p t a c h l o r e p -
o x i d e , l i n d a n e , m e t h o x y c h l o r , t o x a p h e n e , e n d r i n , h e x a c h l o r o b e n ze n e ,
h e x a c h l o r o c y c l o p e n t a d i e n e , s i m a zi n e , a n d a s a s c r e e n fo r P CB ’s ), 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 |
|
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(8) |
M e t h o d 506—‘‘D e t e r m i n a t i o n |
o f |
P h t h a l a t e a n d A d i p a t e E s t e r 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 o r L i q u i d -S o l i d E x t r a c t i o n a n d G a s Ch r o m a t o g r a p h y w i t h P h o t o i o n i za t i o n D e t e c t i o n ,’’ a p p l i c a b l e t o d i (2-e t h y l - h e x y l ) a d i p a t 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
(9) M e t h o d 507—‘‘D e t e r m i n a t i o n o f N i t r o g e n - a n d P h o s p h o r u s -Co n t a i n i n g P e s t i c i d e s i n Wa t e r b y G a s Ch r o m a - t o g r a p h y w i t h a N i t r o g e n -P h o s p h o r u s
D e t e c t o r ,’’ R e v . 2. 0, |
1989, (a p p l i c a b l e t o |
a l a c h l o r , |
a t r a zi n e , |
a n d |
s i m a zi n 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 |
|
(10) M e t h o d 508—‘‘D e t e r m i n a t i o n |
o f |
Ch l o r i n a t e d P e s t i c i d e s i n Wa t e r b y G a s |
Ch r o m a t o g r a p h y w i t h a n E l e c t r o n Ca p - |
t u r e D e t e c t o r ,’’ R e v . 3. 0, 1989, (a p p l i c a - |
b l e t o c h l o r d a n e , h e p t a c h l o r , h e p t a - c h l o r e p o x i d e , l i n d a n e , m e t h o x y c h l o r , t o x a p h e n e , e n d r i n , h e x a c h l o r o b e n ze n e , a n d a s a s c r e e n fo r P CB ’s ), 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 |
|
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(11) |
M e t h o d |
508A —‘‘S c r e e n i n g |
fo r |
P o l y c h l o r i n a t e d |
B i p h e n y l s |
b y |
P e r - |
c h l o r i n a t i o n |
a n d |
G a s |
Ch r o m a - |
t o g r a p h y ,’’ R e v . 1. 0, |
1989, |
(u s e d |
t o |
q u a n t i t a t e |
|
P CB ’s |
|
a s |
d e c a c h l o r o b i p h e n y l |
i f |
d e t e c t e d |
i n |
m e t h o d s 505 |
o r |
508 i n p a r a g r a p h |
(b )(4)(i i i )(F )(7) |
o r |
(b )(4)(i i i )(F )(9) o f t h i s |
s e c t i o n , r e s p e c t i v e l y , 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 |
|
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(12) M e t h o d 515. 1—‘‘D e t e r m i n a t i o n |
o f |
Ch l o r i n a t e d A c i d s i n Wa t e r b y G a s |
Ch r o m a t o g r a p h y w i t h a n E l e c t r o n Ca p - |
t u r e |
D e t e c t o r ,’’ R e v . 5. 0, 1991, |
(a p p l i c a - |
b l e |
t o 2,4–D , |
2,4,5–T P |
(S i l v e x ), |
p e n t a c h l o r o p h e n o l , d a l a p o n , d i n o s e b , a n d p i c l o r a m ), 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
(13) |
M e t h o d 525. 1—‘‘D e t e r m i n a t i o n o f |
Or g a n i c Co m p o u n d s i n D r i n k i n g Wa t e r |
b y L i q u i d -S o l i d E x t r a c t i o n a n d Ca p - |
i l l a r y Co l u m n G a s Ch r o m a t o g r a p h y / |
M a s s |
S p e c t r o m e t r y ,’’ R e v . |
2. 2, M a y |
1991, |
(a p p l i c a b l e t o a l a c h l o r , |
a t r a zi n e , |
c h l o r d a n e , h e p t a c h l o r , h e p t a c h l o r e p -
o x i d e , |
l i n d a n e , |
m e t h o x y c h l o r , |
p e n t a c h l o r o p h e n o l , |
b e n zo (a )p y r e n e , |
d i (2-e t h y l h e x y l ) |
a d i p a t e , |
e n d r i n , |
h e x a c h l o r o b e n ze n e , |
h e x a c h l o r o c y c l o - |
p e n t a d i e n e , a n d s i m a zi n 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 |
|
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(14) |
M e t h o d 531. 1—‘‘M e a s u r e m e n t |
o f |
N -M e t h y l c a r b a m o y l o x i m e s |
a n d |
N - |
M e t h y l c a r b a m a t e s i n Wa t e r b y D i r e c t |
A q u e o u s I n j e c t i o n H P L C w i t h P o s t Co l - |
u m n |
D e r i v a t i za t i o n ,’’ R e v . |
3. 0, 1989, |
(a p p l i c a b l e t o c a r b o fu r a n a n d o x a m y l (v y d a t e )), w h i c h i s 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, o r
(15) M e t h o d 547—‘‘D e t e r m i n a t i o n o f G l y p h o s a t e i n D r i n k i n g Wa t e r b y D i -
r e c t -A q u e o u s -I n j e c t i o n H P L C, P o s t - Co l u m n D e r i v a t i za t i o n , a n d F l u o r e s -
c e n c e D e t e c t i o n ,’’ (a p p l i c a b l e t o g l y p h o s a t 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
(16) M e t h o d 548—‘‘D e t e r m i n a t i o n o f E n d o t h a l l i n D r i n k i n g Wa t e r b y A q u e - o u s D e r i v a t i za t i o n , L i q u i d -S o l i d E x - t r a c t i o n , a n d G a s Ch r o m a t o g r a p h y w i t h E l e c t r o n -Ca p t u r e D e t e c t i o n ,’’ (a p - p l i c a b l e t o e n d o t h a l l ), 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 |
|
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(17) |
M e t h o d 549—‘‘D e t e r m i n a t i o n |
o f |
D i q u a t |
a n d P a r a q u a t |
i n D r i n k i n g |
Wa t e r b y L i q u i d -S o l i d E x t r a c t i o n a n d
§ 165.110 |
21 CFR Ch. I (4–1–04 Edition) |
H P L C w i t h U l t r a v i o l e t D e t e c t i o n ,’’ (a p - p l i c a b l e t o d i q u a t ), 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 |
|
|
(18) |
M e t h o d 550—‘‘D e t e r m i n a t i o n |
o f |
P o l y c y c l i c A r o m a t i c H y d r o c a r b o n 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 a n d H P L C w i t h Co u p l e d U l t r a - v i o l e t a n d F l u o r e s c e n c e D e t e c t i o n ,’’ (a p p l i c a b l e t o b e n zo (a )p y r e n e a n d o t h e r p o l y n u c l e a r a r o m a t i c h y d r o c a r b o n s ), 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 |
|
(19) M e t h o d 550. 1—‘‘D e t e r m i n a t i o n |
o f |
P o l y c y c l i c A r o m a t i c H y d r o c a r b o n s i n D r i n k i n g Wa t e r b y L i q u i d -S o l i d E x - t r a c t i o n a n d H P L C w i t h Co u p l e d U l t r a - v i o l e t a n d F l u o r e s c e n c e D e t e c t i o n ,’’ (a p p l i c a b l e t o b e n zo (a )p y r e n e a n d o t h e r p o l y n u c l e a r a r o m a t i c h y d r o c a r b o n s ), 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 e s e |
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
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p a r a g r a p h |
(b )(4)(i i i )(F ) o f t h i s s e c t i o n . |
(20) M e t h o d 1613—‘‘T e t r a - |
t h r o u g h |
Oc t a - Ch l o r i n a t e d D i o x i n s a n d F u r a n s |
b y I s o t o p e |
D i l u t i o n |
H R G C/H R M S ,’’ |
R e v . A , 1990, E P A , Offi c e o f Wa t e r R e g - |
u l a t i o n s |
a n d |
S t a n d a r d s , |
I n d u s t r i a l |
T e c h n o l o g y D i v i s i o n , (a p p l i c a b l e t o |
2,3,7,8–T CD D (D i o x i 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
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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 |
U S E P A –OS T , |
S a m p l e |
Co n t r o l |
Ce n t e r , |
P . O. B o x |
1407, A l e x a n d r i a , V A |
22313, |
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 . N W. , s u i t e 700, Wa s h i n g t o n , D C.
(G ) 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 - 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 - g r a p h (b )(4)(i i i )(D ) o f t h i s s e c t i o n s h a l l 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 - 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 - 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 -
g r a p h s |
(b )(4)(i i i )(G )(1) |
t h r o u g h |
(b )(4)(i i i )(G )(3) o f t h i s s e c t i o n |
a n d d e - |
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 |
‘‘M e t h o d s |
o f 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 ,’’ 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 .
(1) A l u m i n 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 |
202. 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 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 |
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(ii) |
M e t h o d |
202. 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. 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 ).
(iii) M e t h o d 200. 7—‘‘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 -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 ,’’ 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 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. 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 .
(v ) 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 -
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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/
Food and Drug Administration, HHS |
§ 165.110 |
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
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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 . |
(2) S i l v e r 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 |
272. 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 |
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 |
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(ii) |
M e t h o d |
272. 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. 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 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 ,’’ 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 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. 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 .
(v ) 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 -
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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 e s e 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) S u l fa t e 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 300. 0—‘‘T h e D e t e r m i n a t i o n o f I n o r g a n i c A n i o n s i n Wa t e r b y I o n
Ch r o m a t o g r a p h y —M e t h o d |
300. 0,’’ |
E P A , |
E M S L (E P A –600/4–84–017), |
M a r c h |
1984, |
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 )(11)(i) o f t h i s s e c - |
t i o n . |
|
(ii) M e t h o d |
375. 1—‘‘Co l o r i m e t r i c , |
A u t o m a t e d , Ch l o r a n i l a t 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 |
|
(iii) |
M e t h o d 375. 3—‘‘G r a v i m e t r i c ,’’ |
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
(iv ) M e t h o d 375. 4—‘‘T u r b i d i m e t r i c ,’’ 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 e s e |
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 .
(H ) T h e a l l o w a b l e l e v e l s fo r r e s i d u a l d i s i n fe c t a n t s a n d d i s i n fe c t i o n b y p r o d - u c t s a r e a s fo l l o w s :
|
Substance |
Concentration in |
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milligrams per liter |
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Disinfection byproducts |
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Bromate |
0.010 |
|
Chlorite |
1.0 |
|
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Haloacetic acids (five) (HAA5) |
0.060 |
|
Total Trihalomethanes (TTHM) |
0.080 |
|
Residual disinfectants |
|
|
|
Chloramine |
4.0 |
(as Cl2) |
|
Chlorine |
4.0 |
(as Cl2) |
|
Chlorine dioxide |
0.8 |
(as ClO2) |
|
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(I ) A n a l y s i s 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 t h e r e q u i r e m e n t s o f p a r a g r a p h (b )(4)(i i i )(H ) o f t h i s s e c t i o n s h a l l 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 p l i - c a b l e m e t h o d l i s t e d i n p a r a g r a p h s
(b )(4)(i i i )(I )(1) t h r o u g h |
(b )(4)(i i i )(I )(7) o f |
t h i s |
s e c t i o n a n d d e s c r i b e d i n |
‘‘M e t h o d |
300. 1, |
D e t e r m i n a t i o n |
o f |
I n o r g a n i c |
§ 165.110 |
21 CFR Ch. I (4–1–04 Edition) |
A n i o n s i n D r i n k i n g Wa t e r b y I o n Ch r o -
m a t o g r a p h y ,’’ R e v . 1. 0, U . S . |
E P A , |
1997, |
E P A /600/R –98/118; ‘‘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 I n o r g a n i c S u b s t a n c e s i n E n v i r o n m e n t a l S a m p l e s ,’’ U . S . E P A , A u g u s t 1993, E P A /600/R –93/100; ‘‘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 Or g a n i c Co m p o u n d s i n D r i n k i n g Wa t e r -S u p p l e -
m e n t |
I I ,’’ U . S . E P A , |
A u g u s t |
1992, E P A / |
600/R –92/129; ‘‘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 Or g a n i c Co m p o u n d s i n |
D r i n k i n g Wa t e r -S u p p l e m e n t |
I I I ,’’ U . S . |
E P A , |
A u g u s t |
1995, |
E P A /600/R –95/131; |
‘‘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 ,’’ 19t h |
E d . , 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 , 1995; a n d ‘‘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 . |
11. 01, |
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 , |
1996, |
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. Co p i e s o f t h e fo l l o w i n g |
p u b l i c a t i o n 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 (N T I S ): E P A /600/R –95/131 (N T I S n u m b e r P B 95–261616), E P A /600/R –92/129 (N T I S n u m b e r P B 92–207703), E P A /600/R –93/100 (N T I S n u m b e r P B 94–121811), a n d E P A / 600/R –98/118 (N T I S n u m b e r P B 98–169196). N T I S c a n b e c o n t a c t e d a t N T I S , 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, 1–800–
553–6847 o r 703–605–6000, |
w w w . n t i s . g o v . |
Co p i e s |
o f t h e |
p u b l i c a t i o n |
E P A /600/R –98/ |
118 a r e |
a l s o |
a v a i l a b l e fr o m t h e Ch e m - |
i c a l E x p o s u r e R e s e a r c h B r a n c h , M i c r o - b i o l o g i c a l a n d Ch e m i c a l E x p o s u r e A s - s e s s m e n t R e s e a r c h D i v i s i o n , N a t i o n a l E x p o s u r e R e s e a r c h L a b o r a t o r y , U . S . E P A , Ci n c i n n a t i , OH 45268, 513–569–7757, (F A X ) 513–569–7757. Co p i e 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 ,’’ 19t h E d . , a r e a v a i l - a b l e 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 , |
1015 15t h |
S t r e e t , |
N W. , |
Wa s h i n g t o n , |
D C 20005. A l l |
o f t h e |
p u b l i - |
c a t i o n s c i t e d |
i n p a r a g r a p h (b )(4)(i i i )(I ) |
o f t h i s s e c t i o n 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 , 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. Co p i e s o f ‘‘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 ,’’ |
1996, |
v o l . |
11. 01, a r e |
a v a i l a b l e |
fr o m |
t h e |
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 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 |
Offi c e o f t h e F e d e r a l R e g i s t e r . Co p i e s o f t h e m e t h o d s 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 p a r a g r a p h (b )(4)(i i i )(I ) o f t h i s s e c t i o n m a y a l s o 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. |
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(1) B r o m a t e 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 : |
M e t h o d 300. |
1— |
‘‘D e t e r m i n a t i o n o f I n o r g a n i c A n i o n s |
i n |
D r i n k i n g |
Wa t e r |
b y |
I o n |
Ch r o m a - |
t o g r a p h y ,’’ |
R e v . |
1. 0, U . S . E P A , 1997, |
E P A /600/R –98/118, 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 )(I ) o f t h i s |
s e c t i o n . |
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(2) Ch l o r i t e 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 : |
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(i) M e t h o d |
300. 0—‘‘D e t e r m i n a t i o n |
o f |
I n o r g a n i c A n i o n s b y I o n Ch r o m a - |
t o g r a p h y ,’’ |
R e v . |
2. 1. |
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 |
I n - |
o r g a n i c S u b s t a n c e s i n E n v i r o n m e n t a l S a m p l e s ,’’ U . S . E P A , A u g u s t 1993, E P A / 600/R –93/100, 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 f-
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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 )(4)(i i i )(I ) o f t h i s s e c t i o n . |
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(ii) |
M e t h o d 300. 1—‘‘D e t e r m i n a t i o n |
o f |
I n o r g a n i c A n i o n s i n D r i n k i n g Wa t e r b y |
I o n |
Ch r o m a t o g r a p h y ,’’ |
R e v . |
1. 0, U . S . |
E P A , |
1997, |
E P A /600/R –98/118, |
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 )(I ) o f t h i s |
s e c t i o n . |
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(3) H A A 5 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 : |
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(i) M e t h o d |
552. 1—‘‘D e t e r m i n a t i o n |
o f |
H a l o a c e t i c |
A c i d s a n d |
D a l a p o n |
i n |
D r i n k i n g Wa t e r b y I o n E x c h a n g e L i q - u i d -S o l i d E x t r a c t i o n a n d G a s Ch r o m a - t o g r a p h y w i t h E l e c t r o n Ca p t u r e D e t e c -
t i o n ,’’ |
R e v . 1. 0. 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 Or g a n i c Co m p o u n d s i n D r i n k i n g Wa t e r -S u p p l e - m e n t I I ,’’ U . S . E P A , A u g u s t 1992, E P A / 600/R –92/129, 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.
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Food and Drug Administration, HHS |
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§ 165.110 |
552(a ) |
a n d |
1 |
CF R |
p a r t |
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51. |
T h e a v a i l - |
a c c o r d a n c e |
w i t h |
5 U . S . C. 552(a ) |
a n d 1 |
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- |
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 - |
e r e n c e |
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i s |
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g i v e n |
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i n |
p a r a g r a p h |
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 |
(b )(4)(i i i )(I ) o f t h i s |
s e c t i o n . |
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p a r a g r a p h (b )(4)(i i i )(I ) o f t h i s |
s e c t i o n . |
(ii) |
M e t h o d |
552. 2—‘‘D e t e r m i n a t i o n o f |
(iii) |
M e t h o d |
551. 1—‘‘D e t e r m i n a t i o n |
o f |
H a l o a c e t i c |
A c i d s |
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a n d D a l a p o n |
i n |
Ch l o r i n a t i o n D i s i n fe c t i o n B y p r o d u c t s , |
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 - |
Ch l o r i n a t e d S o l v e n t s , a n d H a l o g e n a t e d |
t r a c t i o n , D e r i v a t i za t i o n a n d G a s Ch r o - |
P e s t i c i d e s /H e r b i c i d e s |
|
i n |
D r i n k i n g |
m a t o g r a p h y w i t h E l e c t r o n Ca p t u r e D e - |
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 a n d |
t e c t i o n ,’’ R e v . |
1. 0. |
T h e |
|
r e v i s i o n i s c o n - |
G a s |
Ch r o m a t o g r a p h y |
w i t h |
E l e c t r 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 - |
Ca p t u r e D e t e c t i o n ,’’ R e v . 1. 0. |
T h e r e v i - |
o d s fo r t h e D e t e r m i n a t i o n o f Or g a n i c |
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 - |
Co m p o u n d s i n |
D r i n k i n g |
Wa t e r -S u p p l e - |
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 n t |
I I I ,’’ U . S . E P A , A u g u s t |
1993, E P A / |
Or g a n i c Co m p o u n d s i n D r i n k i n g Wa t e r - |
600/R –95/131, |
w h i c h |
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i s |
i n c o r p o r a t e d |
b y |
S u p p l e m e n t |
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I I I ,’’ |
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U . S . |
E P A , |
A u g u s t |
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. |
1993, |
E P A /600/R –95/131, w h i c h |
i s |
i n c o r - |
552(a ) |
a n d |
1 |
CF R |
p a r t |
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51. |
T h e a v a i l - |
p o r a t e d |
b y |
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r e fe r e n c e |
i n a c c o r d a n c e |
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- |
w i t h |
5 U . S . C. 552(a ) |
a n d |
1 CF R |
p a r t |
51. |
e r e n c e |
|
i s |
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g i v e n |
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i n |
p a r a g r a p h |
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 )(4)(i i i )(I ) o f t h i s s e c t i o n . |
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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 |
(iii) M e t h o d 6251 B —‘‘D i s i n fe c t i o n |
B y - |
(b )(4)(i i i )(I ) o f t h i s s e c t i o n . |
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P r o d u c t s : |
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H a l o a c e t i c |
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A c i d s |
a n d |
(5) Co m p l i a n c e w i t h t h e c h l o r a m i n e |
T r i c h l o r o p h e n o l ,’’ |
w h i c h |
i s |
c o n t a i n e d |
s t a n d a r d |
c a n |
b e |
d e t e r m i n e d |
b y |
m e a s - |
i n t h e |
b o o k |
e n t i t l e d ‘‘S t a n d a r d M e t h - |
u r i n g |
c o m b i n e d |
o r |
t o t a l c h l o r i n e . T h e |
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 |
fo l l o w i n g m e t h o d s s h a l l b e u s e d t o |
Wa s t e w a t e r ,’’ |
19t h |
E d . , |
w h i c h |
i s i n c o r - |
m e a s u r e c h l o r a m i n e : |
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p o r a t e d |
b y |
r e fe r e n c e |
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i n |
a c c o r d a n c e |
(i) |
A S T M |
M e t h o d |
D 1253-86—‘‘S t a n d - |
w i t h |
5 U . S . C. 552(a ) |
a n d |
|
1 CF R |
p a r t |
51. |
a r d |
T e s t |
M e t h o d |
fo r R e s i d u a l |
Ch l o r i n 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 |
i n |
Wa t e r ,’’ |
w h i c h |
i s |
c o n t a i n e d i n t h e |
b y r e fe r e n c e |
i s |
g i v e n |
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i n |
p a r a g r a p h |
b o o k |
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e n t i t l e d |
‘‘A n n u a l |
B o o k |
o f A S T M |
(b )(4)(i i i )(I ) o f t h i s |
s e c t i o n . |
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S t a n d a r d s ,’’ 1996, v o l . |
11. 01, w h i c h |
i s |
i n - |
(4) T T H M s h a l l b e m e a s u r e d u s i n g |
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 |
t h e fo l l o w i n g m e t h o d s : |
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w i t h |
5 U . S . C. 552(a ) |
a n d |
1 CF R |
p a r t |
51. |
(i) |
M e t h o d |
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502. 2—‘‘V o l a t i l e |
Or g a n i c |
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 |
Co m p o u n d s i n Wa t e r b y P u r g e a n d |
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 |
T r a p Ca p i l l a r y |
Co l u m n |
G a s |
Ch r o m a - |
(b )(4)(i i i )(I ) o f t h i s s e c t i o n . |
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t o g r a p h y |
w i t h |
P h o t o i o n i za t i o n |
a n d |
(ii) |
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M e t h o d |
4500-Cl |
D —‘‘A m p e r o - |
E l e c t r o l y t i c |
Co n d u c t i v i t y D e t e c t o r s i n |
m e t r i c |
T i t r a t i o n |
M e t h o d ,’’ |
w h i c h |
i s |
S e r i e s ,’’ |
R e v . |
2. 1. |
T h e |
r e v i s i o n i s c o n - |
c o n t a i n e d i n |
t h e |
b o o k |
e n t i t l e d |
‘‘S t a n d - |
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 - |
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 |
o d s fo r |
t h e |
D e t e r m i n a t i o n |
o f Or g a n i c |
Wa t e r |
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a n d |
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Wa s t e w a t e r ,’’ |
19t h |
E d . , |
Co m p o u n d s i n D r i n k i n g Wa t e r -S u p p l 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 |
m e n t |
I I I ,’’ U . S . E P A , A u g u s t |
1993, E P A / |
a c c o r d a n c e |
w i t h |
5 U . S . C. 552(a ) |
a n d 1 |
600/R –95/131, |
w h i c h |
|
i s |
i n c o r p o r a t e d |
b y |
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 - |
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. |
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 |
552(a ) |
a n d |
1 |
CF R |
p a r t |
|
51. |
T h e a v a i l - |
p a r a g r a p h (b )(4)(i i i )(I ) o f t h i s s e c t i o n . |
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- |
(iii) |
M e t h o d |
4500-Cl |
F —‘‘D P D |
F e r r o u s |
e r e n c e |
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i s |
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g i v e n |
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i n |
p a r a g r a p h |
T i t r i m e t r i c |
M e t h o d ,’’ |
w h i c h |
i s c o n - |
(b )(4)(i i i )(I ) o f t h i s |
s e c t i o n . |
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t a i n e d |
i n |
t h e |
b o o k |
e n t i t l e d ‘‘S t a n d a r d |
(ii) |
M e t h o d |
524. 2—‘‘M e a s u r e m e n t |
o f |
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 |
P u r g e a b l e |
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Or g a n i c |
Co m p o u n d s |
i n |
a n d Wa s t e w a t e r ,’’ 19t h E d . , w h i c h |
i s i n - |
Wa t e r b y Ca p i l l a r y Co l u m n G a s Ch r o - |
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 |
m a t o g r a p h y /M a s s S p e c t r o m e t r y ,’’ R e v . |
w i t h |
5 U . S . C. 552(a ) |
a n d |
1 CF R |
p a r t |
51. |
1. 0. 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 |
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 |
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 - |
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 |
t e r m i n a t i o n |
o f Or g a n i c |
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Co m p o u n d s i n |
(b )(4)(i i i )(I ) o f t h i s s e c t i o n . |
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D r i n k i n g |
Wa t e r -S u p p l e m e n t |
I I I ,’’ U . S . |
(iv ) |
M e t h o d |
4500-Cl |
G —‘‘D P D Co l o r i - |
E P A , |
A u g u s t |
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1993, |
E P A /600/R –95/131, |
m e t r i c |
M e t h o d ,’’ w h i c h |
i s c o n t a i n e d |
i 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 |
t h e |
b o o k |
e n t i t l e d |
‘‘S t a n d a r d |
M e t h o d s |
§ 165.110 |
21 CFR Ch. I (4–1–04 Edition) |
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 ,’’ 19t h 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 p a r a g r a p h
(b )(4)(i i i )(I ) o f t h i s s e c t i o n . |
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(v ) M e t h o d |
4500-Cl E —‘‘L o w -L e v e l |
A m p e r o m e t r i c |
T i t r a t i o n |
M e t h o d ,’’ |
w h i c h i s c o n t a i n e d i n t h e b o o k e n t i t l e d
‘‘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 ,’’ 19t h |
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
p a r a g r a p h |
(b )(4)(i i i )(I ) o f t h i s s e c t i o n . |
(v i) |
M e t h o d |
4500-Cl |
I —‘‘I o d o m e t r i c |
E l e c t r o d e |
T e c h n i q u e ,’’ |
w h i c h i s c o n - |
t a i n e d |
i n |
t h e |
b o o k e n t i t l e d ‘‘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 ,’’ 19t h 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 p a r a g r a p h (b )(4)(i i i )(I ) o f t h i s s e c t i o n .
(6) Co m p l i a n c e w i t h t h e c h l o r i n e s t a n d a r d c a n b e d e t e r m i n e d b y m e a s - u r i n g fr e e o r t o t a l c h l o r i n e . T h e fo l - l o w i n g m e t h o d s s h a l l b e u s e d t o m e a s - u r e c h l o r i n e :
(i) A S T M M e t h o d D 1253-86—‘‘S t a n d - a r d T e s t M e t h o d fo r R e s i d u a l Ch l o r i n e
i n Wa t e r ,’’ w h i c h i s c o n t a i n e d |
i n |
t h e |
b o o k e n t i t l e d ‘‘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 ,’’ 1996, v o l . 11. 01, 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
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s e c t i o n . |
(ii) |
M e t h o d |
4500-Cl D —‘‘A m p e r o - |
m e t r i c |
T i t r a t i o n |
M e t h o d ,’’ w h i c h i s |
c o n t a i n e d i n t h e |
b o o k e n t i t l e d ‘‘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 ,’’ 19t h 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 p a r a g r a p h (b )(4)(i i i )(I ) o f t h i s s e c t i o n .
(iii) M e t h o d 4500-Cl F —‘‘D P D F e r r o u s T i t r i m e t r i c M e t h o d ,’’ w h i c h i s c o n - t a i n e d i n t h e b o o k e n t i t l e d ‘‘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 ,’’ 19t h 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 p a r a g r a p h (b )(4)(i i i )(I ) o f t h i s s e c t i o n .
(iv ) M e t h o d 4500-Cl G —‘‘D P D Co l o r i - m e t r i c M e t h o d ,’’ w h i c h i s c o n t a i n e d i n t h e b o o k e n t i t l e d ‘‘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 ,’’ 19t h 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 p a r a g r a p h
(b )(4)(i i i )(I ) o f t h i s s e c t i o n . |
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(v ) M e t h o d |
4500-Cl E —‘‘L o w -L e v e l |
A m p e r o m e t r i c |
T i t r a t i o n |
M e t h o d ,’’ |
w h i c h i s c o n t a i n e d i n t h e b o o k e n t i t l e d
‘‘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 ,’’ 19t h |
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
p a r a g r a p h |
(b )(4)(i i i )(I ) o f t h i s s e c t i o n . |
(v i) |
M e t h o d |
4500-Cl |
I —‘‘I o d o m e t r i c |
E l e c t r o d e |
T e c h n i q u e ,’’ |
w h i c h i s c o n - |
t a i n e d |
i n |
t h e |
b o o k e n t i t l e d ‘‘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 ,’’ 19t h 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 p a r a g r a p h
(b )(4)(i i i )(I ) o f t h i s |
s e c t i o n . |
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(v ii) |
M e t h o d |
4500-Cl |
H — |
‘‘S y r i n g a l d a zi n e |
(F A CT S ) M e t h o d ,’’ |
w h i c h i s c o n t a i n e d i n t h e b o o k e n t i t l e d
‘‘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 ,’’ 19t h |
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 p a r a g r a p h (b )(4)(i i i )(I ) o f t h i s s e c t i o n .
(7) Ch l o r i n e d i o x i d e 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 : |
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(i) M e t h o d |
4500-Cl O2 D —‘‘D P D M e t h - |
o d ,’’ w h i c h i s |
c o n t a i n e d i n |
t h e |
b o o k |
e n - |
t i t l e d ‘‘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 ,’’ |
19t h 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 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. 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 )(4)(i i i )(I ) o f t h i s s e c t i o n . |
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(ii) |
M e t h o d |
4500-Cl O2E —‘‘A m p e r o - |
m e t r i c |
M e t h o d |
I I ,’’ w h i c h |
i s c o n t a i n e d |
i n t h e |
b o o k e n t i t l e d |
‘‘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
Food and Drug Administration, HHS |
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§ 165.110 |
Wa s t e w a t e r ,’’ 19t h E d . , |
w h i c h i s i n 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 - |
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 |
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 |
w i t h 5 U . S . C. |
552(a ) a n d |
1 CF R p a r t 51. |
P k w y . , Co l l e g e P a r k , M D . |
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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 |
(A ) Co m b i n e d r a d i u m -226/-228 s h a l l |
b e |
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 |
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 : |
(b )(4)(i i i )(I ) o f t h i s s e c t i o n . |
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(1) |
M e t h o d |
7500–R a |
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B —‘‘P r e c i p i t a t i o n |
(5) |
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R a d iologica l |
qu a lit y . |
(i ) |
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B o t t l e d |
M e t h o d ,’’ |
w h i c h |
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i s |
c o n t a i n e d |
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i n |
w a t e r |
s h a l l , |
w h e n |
a |
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c o m p o s i t e |
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o f |
a n a - |
‘‘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 - |
l y t i c a l |
u n i t s |
o f |
e q u a l |
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v o l u m e |
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fr o m a |
t i o n |
o f |
Wa t e r |
a n d |
Wa s t e w a t e r ,’’ |
20t h |
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 - |
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 |
s c r i b e d |
i n |
p a r a g r a p h |
(b )(5)(i i ) |
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o f |
t h i s |
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 |
s e c t i o n , |
m e e t |
s t a n d a r d s |
o f |
r a d i o l o g i c a l |
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 - |
q u a l i t y a s fo l l o w s : |
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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 t h e |
(A ) |
T h e |
b o t t l e d |
w a t e r |
s h a l l |
n o t |
c o n - |
i n t r o d u c t o r y |
t e x t o f p a r a g r a p h |
(b )(5)(i i ) |
t a i n |
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a |
c o m b i n e d |
r a d i u m -226 |
a n d |
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r a - |
o f t h i s s e c t i o n . |
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d i u m -228 |
a c t i v i t y |
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i n e x c e s s |
o f |
5 |
(2) |
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M e t h o d |
7500–R a |
D —‘‘S e q u e n t i a l |
p i c o c u r i e s p e r |
l i t e r o f w a t e r . |
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P r e c i p i t a t i o n |
M e t h o d ,’’ |
w h i c h |
i s |
c o n - |
(B ) |
T h e |
b o t t l e d |
w a t e r |
s h a l l |
n o t |
c o n - |
t a i n e d |
i n |
‘‘S t a n d a r d |
M e t h o d s |
fo r |
t h e |
t a i n a g r o s s a l p h a p a r t i c l e a c t i v i t y (i n - |
E x a m i n a t i o n o f Wa t e r a n d Wa s t e - |
c l u d i n g |
r a d i u m -226, |
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b u t |
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e x c l u d i n g |
w a t e r ,’’ 20t h |
E d . , w h i c h |
i s |
i n c o r p o r a t e d |
r a d o n a n d u r a n i u m ) i n e x c e s s o f 15 |
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 |
p i c o c u r i e s p e r |
l i t e r o f w a t e r . |
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U . S . C. 552(a ) |
a n d |
1 |
CF R |
p a r t |
51. |
T h e |
(C) |
T h e |
b o t t l e d |
w a t e r |
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s h a l l |
n o t |
c o n - |
a v a i l a b i l i t y |
o f |
t h i s |
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i n c o r p o r a t i o n |
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b y |
t a i n b e t a p a r t i c l e a n d p h o t o n r a d i o a c - |
r e fe r e n c e i s g i v e n i n t h e i n t r o d u c t o r y |
t i v i t y fr o m |
m a n m a d e |
r a d i o n u c l i d e s |
i n |
t e x t |
o f p a r a g r a p h |
(b )(5)(i i ) o f |
t h i s |
s e c - |
e x c e s s o f t h a t w h i c h w o u l d p r o d u c e a n |
t i o n . |
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a n n u a l d o s e e q u i v a l e n t t o t h e t o t a l |
(B ) G r o s s a l p h a p a r t i c l e r a d i o a c t i v i t y |
b o d y o r a n y i n t e r n a l o r g a n o f 4 |
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 i l l i r e m s |
p e r |
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y e a r |
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c a l c u l a t e d |
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o n |
t h e |
m e t h o d : M e t h o d 7110 |
C—‘‘Co p r e c i p i t a - |
b a s i s o f a n i n t a k e o f 2 l i t e r s o f t h e |
t i o n M e t h o d fo r G r o s s A l p h a R a d i o a c - |
w a t e r |
p e r |
d a y . I f |
t w o |
o r |
m o r e |
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b e t a |
o r |
t i v i t y |
i n |
D r i n k i n g |
Wa t e r ,’’ |
w h i c h |
i s |
p h o t o n -e m i t t i n g |
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r a d i o n u c l i d e s |
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a r e |
c o n t a i n e d |
i n |
‘‘S t a n d a r d |
M e t h o d s |
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fo r |
p r e s e n t , t h e s u m o f t h e i r a n n u a l d o s e |
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 - |
e q u i v a l e n t |
t o |
t h e |
t o t a l |
b o d y |
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o r |
t o |
a n y |
w a t e r ,’’ 20t h |
E d . , w h i c h |
i s |
i n c o r p o r a t e d |
i n t e r n a l o r g a n s h a l l n o t |
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e x c e e d 4 |
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 |
m i l l i r e m s p e r |
y e a r . |
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U . S . C. 552(a ) |
a n d |
1 |
CF R |
p a r t |
51. |
T h e |
(D ) T h e b o t t l e d w a t e r s h a l l n o t c o n - |
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 |
t a i n |
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u r a n i u m |
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i n |
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e x c e s s |
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o f |
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r e fe r e n c e i s g i v e n i n t h e i n t r o d u c t o r y |
m i c r o g r a m s p e r |
l i t e r |
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o f w a t e r . |
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t e x t |
o f p a r a g r a p h |
(b )(5)(i i ) o f |
t h i s |
s e c - |
(i i ) 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 |
t i o n . |
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c o m p l i 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 |
(C) B e t a |
p a r t i c l e |
a n d p h o t o n |
r a d i o a c - |
p a r a g r a p h |
(b )(5)(i ) |
o f |
t h i s |
s e c t i o n s h a l l |
t i v i t y |
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 - |
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 - |
l o w i n g m e t h o d s : |
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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 |
(1) |
M e t h o d |
7500–S r |
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B —‘‘P r e c i p i t a t i o n |
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 - |
M e t h o d ,’’ |
w h i c h |
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i s |
c o n t a i n e d |
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i n |
t i o n |
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o f |
Wa t e r |
a n d |
Wa s t e w a t e r ,’’ |
20t h |
‘‘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 - |
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 |
t i o n |
o f |
Wa t e r |
a n d |
Wa s t e w a t e r ,’’ |
20t h |
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 |
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 |
CF R |
p a r t 51. Co p i e s o f ‘‘S t a n d a r d M e t h - |
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 |
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 |
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 - |
Wa s t e w a t e r ,’’ |
|
20t h |
|
E d . , |
m a y |
|
b e |
|
o b - |
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 |
t h e |
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 |
i n t r o d u c t o r y |
t e x t o f p a r a g r a p h |
(b )(5)(i i ) |
H e a l t h |
A s s o c i a t i o n , |
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1015 |
15t h |
S t . N W. , |
o f t h i s s e c t i o n . |
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Wa s h i n g t o n , |
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D C |
20005. |
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Co p i e s |
|
o f |
t h e |
(2) |
M e t h o d |
7500–3H |
B —‘‘L i q u i d S c i n - |
m e t h o d 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 |
t i l l a t i o n |
S p e c t r o m e t r i c |
|
M e t h o d ,’’ |
t h i s p a r a g r a p h |
(b )(5)(i i ) m a y |
a l s o b e |
e x - |
w h i c h |
i s c o n t a i n e d |
i n |
‘‘S t a n d a r d M e t h - |
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 |
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 |
R E G I S T E R , |
800 |
N o r t h |
Ca p i t a l |
S t . N W. , |
Wa s t e w a t e r ,’’ 20t h |
E d . , |
w h i c h |
i s i n c o r - |
s u i t e |
700, |
Wa s h i n g t o n , |
D C, |
o r |
|
a t |
t h e |
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 |
Pt. 166 |
21 CFR Ch. I (4–1–04 Edition) |
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 t h e i n t r o d u c -
t o r y t e x t o f p a r a g r a p h |
(b )(5)(i i ) |
o f |
t h i s |
s e c t i o n . |
|
|
|
|
(3) |
M e t h o d |
7120 |
B —‘‘G a m m a |
S p e c t r o s c o p i c M e t h o d ,’’ w h i c h |
i s |
c o n - |
t a i n e d |
i n ‘‘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 ,’’ 20t h 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 t h e i n t r o d u c t o r y
t e x t o f p a r a g r a p h (b )(5)(i i ) o f t h i s |
s e c - |
t i o n . |
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(D ) U r a n 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 : |
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(1) M e t h o d 7500–U B —‘‘R a d i o c h e m i c a l |
M e t h o d ’’ |
w h i c h |
i s |
c o n t a i n e d |
i n |
‘‘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 ,’’ |
20t h |
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 t h e i n t r o d u c t o r y t e x t o f p a r a g r a p h (b )(5)(i i ) o f t h i s s e c t i o n .
(2) M e t h o d 7500–U C—‘‘I s o t o p i c M e t h - o d ’’ w h i c h i s c o n t a i n e d i n ‘‘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 ,’’ 20t h 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 t h e i n t r o d u c -
t o r y t e x t o f p a r a g r a p h (b )(5)(i i ) |
o f t h i s |
s e c t i o n . |
|
(c ) L a bel st a t em en t s. Wh e n t h e |
m i c r o - |
b i o l o g i c a l , p h y s i c a l , c h e m i c a l , o r r a d i o - l o g i c a l q u a l i t y o f b o t t l e d w a t e r i s b e l o w t h a t p r e s c r i b e d b y p a r a g r a p h s (b )(2) t h r o u g h (b )(5), o f t h i s s e c t i o n , t h e l a b e l s h a l l b e a r t h e s t a t e m e n t o f s u b - s t a n d a r d q u a l i t y s p e c i fi e d i n § 130. 14(a ) o f t h i s c h a p t e r e x c e p t t h a t , a s a p p r o -
p r i a t e , i n s t e a d o f o r i n a d d i t i o n t o |
t h e |
s t a t e m e n t s p e c i fi e d i n § 130. 14(a ) |
t h e |
fo l l o w i n g s t a t e m e n t (s ) s h a l l b e u s e d : |
(1) ‘‘Co n t a i n s E x c e s s i v e B a c t e r i a ’’ i f t h e b o t t l e d w a t e r fa i l s t o m e e t t h e r e - q u i r e m e n t s o f p a r a g r a p h (b )(2) o f t h i s s e c t i o n .
(2) ‘‘E x c e s s i v e l y T u r b i d ’’, ‘‘A b n o r m a l Co l o r ’’, a n d /o r ‘‘A b n o r m a l Od o r ’’ i f t h e b o t t l e d w a t e r fa i l s t o m e e t t h e r e q u i r e - m e n t s o f p a r a g r a p h (b )(3) (i ), (i i ), o r (i i i ), r e s p e c t i v e l y , o f t h i s s e c t i o n .
(3) ‘‘Co n t a i n s E x c e s s i v e,’’ w i t h t h e b l a n k fi l l e d i n w i t h t h e n a m e o f t h e c h e m i c a l fo r w h i c h a m a x i m u m c o n - t a m i n a n t l e v e l i n p a r a g r a p h (b )(4) o f t h i s s e c t i o n i s e x c e e d e d (e . g . , ‘‘Co n t a i n s
E x c e s s i v e |
A r s e n i c ,’’ |
‘‘Co n t a i n s |
E x c e s - |
s i v e T r i h a l o m e t h a n e s ’’) e x c e p t |
t h a t |
‘‘Co n t a i n s |
E x c e s s i v e |
Ch e m i c a l |
S u b - |
s t a n c e s ’’ m a y b e u s e d i f t h e b o t t l e d
w a t e r i s n o t m i n e r a l w a t e r . |
|
|
(4) ‘‘E x c e s s i v e l y |
R a d i o a c t i v e ’’ i f |
t h e |
b o t t l e d w a t e r fa i l s t o m e e t |
t h e r e q u i r e - |
m e n t s o f p a r a g r a p h (b )(5) |
o f t h i s |
s e c - |
t i o n . |
|
|
|
(d ) A d u lt era t ion . |
B o t t l e d |
w a t e r |
c o n - |
t a i n i n g a s u b s t a n c e a t a l e v e l c o n s i d - e r e d i n j u r i o u s t o h e a l t h u n d e r s e c t i o n 402(a )(1) o f t h e a c t i s d e e m e d t o b e a d u l t e r a t e d , r e g a r d l e s s o f w h e t h e r o r n o t t h e w a t e r b e a r s a l a b e l s t a t e m e n t o f s u b s t a n d a r d q u a l i t y p r e s c r i b 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 .
[60 F R 57124, N o v . 13, 1995; 60 F R 66495, D e c .
22, 1995, |
a s |
a m e n d e d a t 61 F R 13264, M a r . 26, |
1996; |
61 |
F R |
14480, |
A p r . 2, 1996; 63 F R 25769, |
M a y 11, 1998; 66 F R |
16865, M a r . 28, 2001; 66 F R |
17359, |
M a r . 30, 2001; 66 F R 35373, J u l y 5, 2001; |
66 F R |
56035, N o v . 6, 2001; 58 F R 15355, M a r . 31, |
2003; 68 F R 9881, M a r . 3, 2003]
PART 166—MARGARINE
Subpart A—General Provisions
S e c .
166.40 L a b e l i n g o f m a r g a r i n e .
Subpart B—Requirements for Specific
Standardized Margarine
166. 110 M a r g a r i n e .
A U T H OR I T Y : 21 U . S . C. 321, 341, 343, 347, 348, 371, 379e .
Subpart A—General Provisions
§ 166.40 Labeling of margarine.
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 w a s a m e n d e d |
b y |
P u b . L . 459, |
81s t Co n g r e s s (64 S t a t . |
20) |
o n c o l o r e d |
o l e o m a r g a r i n e o r m a r g a r i n e b y a d d i n g t h e r e t o a n e w s e c t i o n n u m b e r e d 407. A m o n g o t h e r t h i n g s , t h i s s e c t i o n r e - q u i r e s t h a t t h e r e a p p e a r o n t h e l a b e l o f
t h e p a c k a g e t h e |
w o r d ‘‘o l e o m a r g a r i n e ’’ |
o r ‘‘m a r g a r i n e ’’ |
i n t y p e o r l e t t e r i n g a t |
l e a s t a s l a r g e a s a n y o t h e r t y p e o r l e t - t e r i n g o n t h e l a b e l , a n d a fu l l a n d a c c u - r a t e s t a t e m e n t o f a l l t h e i n g r e d i e n t s c o n t a i n e d i n s u c h o l e o m a r g a r i n e o r
