(Interim Report)

1.4

(NATIONAL ORGANIC
PROGRAM;NOP)

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7:
205
(NATIONAL ORGANIC PROGRAM)
(Subpart ADefinitions)
205.1 (Meaning of words.)
205.2 (Terms defined.)
2H

3H

(Subpart BApplicability)
205.100
205.101
205.102
205.103
205.104 []
205.105

205.106-205.199 []
4H

5H

6H

7H

(Subpart COrganic Production and Handling Requirements)

205.200
205.201
205.202
205.203
205.204
205.205
205.206
205.207
205.208-205.235 []
205.236
205.237
205.238
205.239
8H

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205.240-205.269 []
205.270
205.271
205.272
205.273-205.289 []
205.290
205.291-205.299 []
9H

10H

1H

(Labels, Labeling, and Market

Information)
205.300
205.301
205.302
205.303 100
205.304 ()
205.305
70
205.306
205.307
100
( )
205.308
100
205.309
()
205.310
205.311 USDA
205.312-205.399 []
12H

13H

14H

15H

16H

17H

18H

19H

20H

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205.1


205.2
(Accreditation)


(Act) ..1990
(7U.S.C.6501 et.seq.)
(Action level)
(Food and Drug Administration)

(Administrator)

(Agricultural inputs)

(Agricultural product)

(Agricultural Marketing Service/AMS)

(Allowed synthetic)

AMDUCA . . 1994 (Pub. L. 103396)

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(Animal drug) 201

(21 U.S.C. 321)

(Annual seedling)

(Area of operation) :

(Audit trail)
100
(
)
70
(Biodegradable)

(Biologics)
, , ,
, ,

(Breeder stock)
(Buffer zone)

(Bulk)

(Certification or certified)

(Certified operation)

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(Certifying agent)

(Certifying agent's operation)

(Claims)

100
()
70

(Commercially available)

(Commingling)

(Compost)

: 25:1 40:1
(in-vessel system) (static aerated pile system)
131 F -170 F 3
(windrow system) 131 F -170 F 5
5
(Control)

(Crop)

(Crop residues)


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(Crop rotation)

(Perennial cropping system)

(Crop year)
(Cultivation)

(Cultural methods)



(Detectable residue)

(Disease vectors)

(Drift)

(Emergency pest or Disease treatment

Program)

(Employee)
(Excipients)

( ) fillers,
extenders, diluents, wetting agents solvents, emulsifiers, preservatives, flavors, absorption
enhancers, sustained-release matrics

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(Excluded methods)

Cell
Fusion,
Microencapsulation, (recombinant DNA technology) gene
deletion, gene doubling, introducing a foreign gene
conjugation,
fermentation, hybridization, (tissue culture)
(Feed)
() ( )

(Feed additives)

(Feed supplement)

(1)
(2)
(3)
(Fertilizer)

(Field)

(Forage)
( )
(Governmental entity)

(Handle)

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(Handler)

(Handling operation)

(
)

(Immediate family)





(Inert ingredient) (
[Environmental Protection Agency])

(40CFR
152.3(m))
(Information panel)

(Ingredient)

(Ingredient statement)

(Inspection)

(Inspector)


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 (Interim Report)

(Label)



(Labeling)

(Livestock)
(Fiber) ;
;
(Fiber)
(Lot)

(Manure)

(Market information)

(Mulch)


(Narrow range oils)
(paraffinic) (naphthenic) 50 . ( 10 )
415 440
(National list)

(National Organic Program, NOP)

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 (Interim Report)

(National Organic Standard Board, NOSB)

7 U.S.C. 6518

(Natural resources of the operation)

(Nonagricultural substance)

(Nonsynthetic (Natural))
6502(21)
7 U.S.C. 6502(21)

(Nonretail container)


(Nontoxic)

(Organic)

(Organic matter)
(Organic production)

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(Organic system plan)

C
(Pasture)

(Peer review panel)

(Administrator)

(Person)
(Pesticide)

2(U) 7 U.S.C. 136(u)

(Petition)

(Planting stock)

(Practice standard)

(Principal display panel)

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(Private entity)

(Processing)

(Processing aid)
(1)

(2)


(3)


(Producer)

(Production lot number/identifier)

(Prohibited substance)

(Records)


(Residue testing)

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(Responsible connected)
10

(Retail food establishment)

(Routine use of parasiticide)

(Secretary)

(Sewage sludge)

(Slaughter stock)

(Soil and water quality)

(Split operation)


(State)

(State certifying agent)

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(State organic program, SOP)

6506


(State organic programs governing State official)

(Synthetic)

(Tolerance)

(Transplant)

(Unavoidable residual
environmental contamination, UREC)


(Wild crop)

[65 FR 80637 21 2000, 72 FR 12 2007)

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(Applicability)
205.100 (What has to be certified)
(a) 205.101



100 ()
E

(b)

1

18
20 2001
(c)
(1)
3.91(b)(1)(xxxvii)
(2)

1001 18
[65 FR 80637, Dec. 21, 2000, 70 FR 29579, May 24, 2005]
205.101 (Exemptions and exclusions from
certification)
(a) (1)

5,000 E
205.201

205.310

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 (Interim Report)

(2)

(3)
70
()
(i)
205.272

(ii) 205.305 205.310;

(iii) (c)
(4)
(Information panel)

(i)
205.272

(ii) 205.305 205.310;

(iii) (c)
(b) (1)

205.272

100
()
(i)

(ii)

(2)

100 ( )


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 (Interim Report)

(i)
205.272
(ii) 205.310;
(c)
(1) (a)(3) (a)(4)
;
(i)

(ii)
(2) 3

205.102 (Use of the term, organic.)

100
( )
(a) 205.101 205.202 205.207
205.236 205.239 205
(b) 205.101 205.270 205.272
205
205.103 (Recordkeeping by
certified operations)
(a)

100
()
(b) ;
(1)
(2)

(3) 5 ;

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(4)

(c)

205.104 []
205.105

(Allowed and prohibited substances, methods, and

ingredients in organic production and handling)
100
( )

(a) 205.601
205.603
(b) 205.602 205.604
(c)

205.605
(d)
205.606
(e)
205.600 (a)
(f) FDA 21 CFR
179.26;
(g)
205.106-205.199 []

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(Organic
Production and Handling Requirements)
205.200 (General)

100
()



205.201 (Organic production
and handling system plan)
(a)
205.101
100 (
)

(1)

(2)

(3)

(4)
205.103
(5)

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 (Interim Report)

(6)

(b)


205.202 (Land requirements)


(a) 205.203 205.206;
(b) 205.105 3

(c)

205.203 (Soil fertility

and crop nutrient management practice standard)
(a)

(b)

(c)


(1) ;
(i)
(ii) 120

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 (Interim Report)

(iii) 90

(2)
(i) C:N 25:1 40:1
(ii) 137 oF 170 oF 3
(in-vessel system) (static aerated pile system)
(iii) 137 oF 170 oF 5
(windrow system) 5
(3)
(d)

;
(1)

(2)
(3)

(4) (e)

(5)

205.601
(e) ;
(1)

(2) ( Biosolids) 40 CFR 503

(3)

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205.204 (Seeds and planting stock

practice standard)
(a)

(1)

(2)

(3)

(temporary
variance)

205.290(a)(2);
(4)

1
(5)

(b) []
205.205 (Crop rotation practice standard)

(Catch crops) ;
(a)
(b)
(c)

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(d)
205.206 (Crop pest, weed, and disease
management practice standard)
(a)
(1)
205.203 205.205
(2)

(3) (Cultural methods)


(b)
(1)
(2)
(3)
(c)
(1)
(2)
(3)
(4)
(5)
(6)

(d)
(1)
(2)

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(e) (a) (d)

(organic system plan)
(f) (arsenate)

205.207 (Wild-crop harvesting practice standard)

(a)
205.105 3

(b)

205.208-205.235 []
205.236 (Origin of livestock)
(a)
3 ()

(1) (Poultry)
2
(2) (Dairy animals)
1

(i) 3

12
(ii)

9 2007: (a) 9

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 (Interim Report)

80
(b)
205.237 3
(iii)
3 ()
(3)

3()
(b)
(1)


(2)
3 ()

(c)

[65 FR 80637, Dec. 21, 2000, as amended at 71 FR 32807, June 7, 2006]

205.237 (Livestock feed)
(a)


205.603

(b) ;
(1)

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(2)

(3)
(4)
(5)
(6)
(Federal Food, Drug, and Cosmetic Act)
205.238 (Livestock health care practice standard)
(a)
(1)

(2)
/ (
)
(3)

(4)

(5)

(6)
(b)

205.603 205.603 ;
(1) 3 ()

(2) 90

(c) ;

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 (Interim Report)

(1)

205.603
205.604
(2)
(3)
(4)
(5)
(6)
(Federal Food, Drug, and Cosmetic Act)
(7)

205.239 (Livestock living conditions)

a)

(1)


(2)
(3)
205.237
(4)
(i)
(ii)
(iii)
b)

(1)

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 (Interim Report)

(2)
(3)
(4)
c)

205.240-205.269 []
205.270 (Organic handling requirements)
(a)





(b) 205.605
205.606 ;
(1)
205.301(b)

(2)
() 205.301(c)
(c)
100
()

(1) (e) (f) 205.105

(2)
205.605
()

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205.271 (Facility pest management practice

standard)
(a)

(1)
(2)
(3)

(b)
(1)
(2)

(c) (a) (b)

(d) (a), (b) (c)

(e)

(f) (a), (b), (c) (d)

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205.272
(Commingling and contact with prohibited substance prevention practice standard)
(a)

(b)
D
(1)

(2)



205.273-205.289 []
205.290 (Temporary variances)
(a) 205.203 205.207, 205.236
205.239, 205.270 205.272
(1)
(2)

(3)

(b)
C

(a)
(c)

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 (Interim Report)

(d)

(e)
205.105
205.291-205.299 [Reserved]
D
205.300 (Use of the term, organic)
(a)

(b)

205.307 (c)
(c)
E D
(d)
205.307(c)
205.301 (Product composition)
(a) 100

100 % (
) 100%
205.303
(b)

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 (Interim Report)

(
)
95


G
205.303
(c) (
)

() (
)
70 C
(f)(1), (2),
(3) 205.301
(f)(4), (5), (6), (7) 205.301
205.304
(d) 70

( )
70 C

70
205.305
(e)
(1)
100

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 (Interim Report)

100 (
)
(2)
205.237
(f) 1 00 %

(1)
(2)
(3)
(4)

201.105 (e)
201.105(f)
201.105(g)

G
100 %

(5)

(6)

(7)
205.302 (Calculating the percentage
of organically produced ingredients)
(a)
1 00 % (
)
(1) ()
()
(2) ()
()

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(3)
(
) ()
(b)

(c)

205.303 100 % (Packaged

products labeled 100 percent organic or organic.)
(a) 205.301(a) (b)


(1) 100
(2)
(

(3)
100
(4) USDA /
(5)

USDA
(b) 205.301(a) (b)

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 (Interim Report)

(1)

(2)
***


205.304 (
) (Packaged products labeled made with organic (specified ingredients or food
group(s)).)
21H

(a) 205.301(c)

(1) :
(i) ( )
3
(ii) ( )
3



(iii)

(2)

(3)
(b) 205.301(c)
(1)


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(2)
***


(c) 205.301(c)
USDA
205.305
70 (Multi-ingredient packaged products with less than 70 percent
organically produced ingredients)
(a) 70
;
(1)

(2)

(b) 70

(1) USDA
(2)

205.306 (Labeling of livestock feed)

(a) 205.301(e)(1) (e)(2)
;
(1) 100

(2) USDA

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(3)

USDA
(4)

(b) 205.301(e)(1) (e)(2)

(1)
***


(2)

205.307
100 %
() (Labeling of nonretail
containers used for only shipping or storage of raw or processed agricultural products
labeled as 100 percent organic, organic, or made with organic (specified
ingredients or food group(s)).)
(a)

(1)

(2)
(3)
(4) USDA
(5)

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(b)

(c)

205.101
205.308
100% (Agricultural
products in other than packaged form at the point of retail sale that are sold, labeled, or
represented as 100 percent organic or organic.)
(a)
100


(b)
;
(1) USDA
(2)

USD

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205.309
(
) (Agricultural products in other than packaged form at the point of retail sale
that are sold, labeled, or represented as made with organic (specified ingredients or
food group(s)).)
2H

(a)
70 95 (
)

(1)
3

(2)

(b)
()


205.310
(Agricultural products produced on an exempt or excluded operation)
(a)

(1) USDA


(2)

(b)

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(c) (a) 205.300, (f)(1)
(f)(7) 205.301
205.311 USDA (USDA Seal)
(a) USDA (b) (c)
(a), (b), (e)(1), (e)(2)
205.301
(b) USDA 1

(1) USDA


(2) USDA

(3) 4

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E (Certification)
205.400

(a)

(b)

205.200;

(c)

205.403;
(d) 5

205.104;
(e) ;
(f)
(1)

(2)

205.401 (Application for certification)

(a) 205.200;
(b) ;
;

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(c) ; ;
;
;

(d)

205.402 (Review of application)

(a)
(1) 205.401;
(2)
C ;
(3)

205.405

205.405(e);
(4)

C
(b)
(1)
(2)

(3)
(c)

205.403 (On-site inspections)

(a) (1)


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(2) (i)

(ii)

(iii)

(b) (Scheduling) (1)

C 6


(2)

(c) (Verification of information)

;
(1)

(2)
205.401, 205.406 205.200

;
(3)
; ; ; ;
; ;

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(d) Exit interview exit interview

(e) (1)

(2)

205.404 (Granting certification)

(a)

(b) ;
(1) ;
(2)
(3)

(4)
(c)

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 (Interim Report)

205.405 (Denial of certification)

(a) 205.402
205.404

(1)
(2)
(3)

(b)
(1)

(2)
:

;
(3)

(c) ;
(1)

; (i)

205.404; (ii)

(2)

(3) 205.501(a)(14)
(d) ;
(1) 205.401 205.405(e)
(2) 205.663

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(3) 205.681

(e)
205.401
205.405 (e)

(f)

205.402
(g) (a)

(c)(1)(ii)

205.406 (Continuation of certification)

(a)

;
(1) ;
(i)

;
(ii)
205.200
(2) 205.401(b)
(3)

(4)

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 (Interim Report)

(b) (a)

205.403

12 :
205.403
6

(c)
205.404

205.662
(d)

205.404(b)
205.407- 205.499 []
G (administrative)
23H

(The National List of Allowed and

Prohibited Substances)
205.600
(Evaluation criteria for allowed and prohibited substances,
methods, and ingredients)

:

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 (Interim Report)

(a)

(7 U.S.C. 6517 6518)
(b)

(1)
(2)

(3)

(4)

(5) (FDA)
(GRAS)GMP(Good Manufacturing Practice) FDA
FDA
(6)
(c)
(7 U.S.C. 6517 6518)
205.601 (Synthetic substances
allowed for use in organic crop production)

:
(disinfectant)
(Sanitizer) (a) (c) (j) (k) (l)
205.206(a) (d)

(a) (algicide) (disinfectant) (sanitizer)

(1)
(ii)

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 (Interim Report)

(iii)
(2)

(i)
(ii)
(iii)
(3) 1
24

(2)

(5)
(6)

(7)
(b)
(1) (
(right of way) )
(2)
(i)
(ii)
(c)

(d)

(e) ( )
(1)

(2)
(3)
1 24

(4)

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(5)
(6) (Narrow range oils as dormant)
suffocating, summer oils
(7)
(8)
(9) (CAS# s 42922 -74-7; 58064-47-4)

(f)
(g)
(1) ()
(2) 3
(h) (CAS# 10045-86-0)
(i)
(1)
EPA

(2)
(3)
(4)
(5)
(6) suffocating, summer oils
(7) fire blight
(8)
(9)
(10)
(11) ( )
(j)
(1) ()

(2)
(3)
(4) (chelating agent)

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(5)
(6) (micronutrient)

(i)
(ii)

(7) pH
pH3 .5
(8) 1
(k)
(l)
(1)
(2)
(m) inert ingredient


(1) 4 (EPA list 4) inert

(2) 3 (EPA list 3) inert

(i) ( ) (CAS #s 37220 -82-9) 31

2006
(ii) inert passive
(n) (CAS #s 7647-01-0)

(o) (z)

[]

(65 FR 80637, 21 2000 68 FR 61992, 31 2003; 71

FR 53302, 11 2006; 72 FR 69572, 10 2007)

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205.602 (Nonsynthetic
substances prohibited for use in organic crop production)

(a)
(b)
(c)

(d)
(e)

(f) ()
(g) 20
; (unrestricted)
21 2005
(h)
(i) ()
(j) (z)
[]
68 FR 61992, 31 2003
205.603 (Synthetic
substances allowed for use in organic livestock production)

(a)
(1)
(i)
(ii)
(2)
(3) (CAS# -51-55-8)

.. 1994 (AMDUCA) 21 FCR
530 (FDA) 7 FCR 205
( Organic Agricultural Program)
(i)

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(ii) 56
12

(4)
(5) (CAS# -42408-82-2)

.. 1994 (AMDUCA) 21 FCR
530 (FDA) 7 FCR 205
( Organic Agricultural Program)
(i)
(ii) 42
8

(6)
/

(7)

(i)
(ii)
(iii)
(8)
(9) (CAS#-38677-85-9) ;
7 CFR 205
2 FDA
(10) (CAS#-54-31-9);
7 CFR 205
2 FDA
(11)
(12)

(13)
(14)

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(15) (CAS# -1309-42-8)

.. 1994 (AMDUCA) 21
FCR 530 (FDA) 7
FCR 205 ( Organic Agricultural
Program)
(16)
(17)
(18)


D
90
()

(19) / (CAS# -79-21-0)

(20)

(21) (CAS#-9003-11-6) 7 CFS 205
(NOP)
(22) (CAS#-59-98-3)

.. 1994 (AMDUCA) 21 FCR
530 (FDA) 7 FCR
205 ( Organic Agricultural Program)
(i)
(ii)
(iii) 8
4

(23) (CAS#-7361-61-7)

.. 1994 (AMDUCA) 21 FCR

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 (Interim Report)

(b)

(c)
(d)

(e)

530 (FDA) 7 FCR

205 ( Organic Agricultural Program)
(i)
(ii)
(iii) 8
4


(1)
(2)
(3) 90

7
(4)

(5)
(6) 90

7
(7) (CAS#-42922-74-4; 58064-47-4)

(feed supplements)
(feed additives)
(1) - - -
(CAS#-59-51-8); 63-68-3; 348-67-4)
1 2010
(2)
FDA
(3) FDA

(inert ingredient) (EPA)

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(1) 4 (EPA list 4) inert

(2) []
(f) (Excipients)
: FDA ; FDA
FDA
(New Animal Drug Application or New Drug Application)
(g) (z)
[]
(72 FR 70484, 12 2007 73 FR 54059, 18 2008)
205.604 (Nonsynthetic
substances prohibited for use in organic livestock production)

(a)
(b) - (z) []
24H

205.605
()

() [Nonagricultural (nonorganic) substances
allowed as ingredients in or on processed products labeled as organic or made with
organic (specified ingredients or food group(s))]

()
(a)
(; ;
)

(Animal enzymes) (Rennet) ;

(catalase) ; ; ;

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(Carrageenan)


(CAS#-9001-63-2)

(Flavors)
carrier system
- (Glucono delta-lactone) -

(CAS#-97-67-6)

( )

(Autolysate; Bakers; Brewers; Nutritional; and Smoked
)
(b)
(CAS#-7440-44-0; 64365-11-3)

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(
)

(
)

(; ;
)
(CAS#-108-91-8) (Sterilization)

(CAS#-100-37-8)

(Sterilization)

()
(mono di)

(
)

(
)
21 CFS 104.20
(National Quality Guidelines for Foods)
(CAS#-124-30-1) (Sterilization)

()
/ (CAS#-79-21-0) /
(rinse) FDA



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IQF (Individually Quality Frozen)
(
)
(
)

(CAS#-7758-16-9)

100

(CAS#-7722-88-5)

Xanthomonas (Xanthan gum)
(c) - (z)
[]
(68 FR 61993, 31 2003; 68 FR 62217, 3
2003; 71 FR 53302, 11 2006; 72 FR 58473, 16 2007; 73 FR 59481, 9
2008)
205.606
[Nonorganically
produced agricultural products allowed as ingredients in or on processed products
labeled as organic.]



(a)
(b)
(c) (Chia or Salvia hispanica L.)
25H

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(d)
(1) (annatto) (CAS#1393-63-1)

(2) (beet juice) (CAS#7659-95-2)

(3) (CAS#1393-63-1)
(4) (CAS# s: 528-58-5: 528-53-0: 643-84-5: 13401-0: 1429-30-7: 134-04-3)
(5) / ( CAS #'s: 528585, 528530, 643845,
134010, 1429307, 134043)
(6) ( CAS #'s: 528585, 528530, 643845, 134
010, 1429307, 134043)
(7) ( CAS # 1393631)
(8) ( CAS #'s: 528585, 528530, 643845, 134010,
1429307, 134043)
(9) ( CAS #'s: 528585, 528530, 64384
5, 134010, 1429307, 134043)
(10) ( CAS #'s: 528585, 528530, 643845,
134010, 1429307, 134043)
(11) ( CAS #'s: 528585, 528530, 643845, 134010,
1429307, 134043)
(12) ( CAS #'s: 528585, 528530, 643845, 134
010, 1429307, 134043)
(13) (CAS # 68917782)
(14) ( CAS # 127402)
(15) ( CAS #'s: 528585, 528530, 643845, 134
010, 1429307, 134043)
(16) (CAS #'s: 528585, 528530, 643845,
134010, 1429307, 134043)
(17) ( CAS #'s: 528585, 528530, 643845,
134010, 1429307, 134043)
(18) ( CAS # 1393631)
(19) (CAS # 458377)
(e) (CAS # 8006755)

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(f) ( CAS #'s: 10417944, 25167628)

205.605
205.606
(g) (CAS # 308066662)
(h)
(i) (CAS # 9000708)
(j) (; ; ; )
(k) (Humulus luplus)
(l) (CAS # 9005805)
(m)
(n) CAS # 37220170)
(o)
(p)
(q) (CAS # 9000593)
(r) ()
(s) (Chipotle chile)
(t)
(1)
(2) (CAS # 977000080)
21 2009
(3)
(u) (Turkish bay leaves)
(v) (Undaria pinnatifida)
(w)
(72 FR 35140, 27 2007)
205.607 (Amending the National List)
(a) (National Organic
Standard Board)

(b)
USDA 205.607 (c)

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(c)
USAD/AMS/TMP/ NOP, 1400 4008 0268
20250
(65 FR 80637, 21 2000; 68 FR 61993, 31
2003)
205.608-205.619 []
26H

(State Organic Programs)

205.620 (Requirements of State organic
programs)
(a)

(b)

(c)

(d)

(e)

205.621
(Submission and determination of proposed
State organic programs and amendments to approved State organic programs)
(a)

(1)




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(2)

(b) 6


(c)

205.622 (Review of approved
State organic programs)
1 5

6
205.623-205.639 []
27H

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