This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

9872 

Vol. 72, No. 43 

Tuesday, March 6, 2007 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Docket Number AMS–TM–06–0222; TM–04– 

07PR] 

RIN 0581–AC51 

National Organic Program, Sunset 

Review 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

amend the U.S. Department of 

Agriculture’s (USDA) National List of 

Allowed and Prohibited Substances 

(National List) regulations to reflect 

recommendations submitted to the 

Secretary of Agriculture (Secretary) by 

the National Organic Standards Board 

(NOSB) from November 17, 2005 

through October 19, 2006. The 

recommendations addressed in this 

proposed rule pertain to the continued 

exemption (use) and prohibition of 169 

substances in organic production and 

handling. Consistent with the 

recommendations from the NOSB, this 

proposed rule would renew 166 of the 

169 exemptions and prohibitions on the 

National List (along with any restrictive 

annotations), and remove 3 exemptions 

from the National List. 

DATES: Comments must be received by 

May 7, 2007. 

ADDRESSES: Interested persons may 

comment on this proposed rule using 

the following procedures: 

• Mail: Comments may be submitted 

by mail to: Toni Strother, Agricultural 

Marketing Specialist, National Organic 

Program, USDA–AMS–TMP–NOP, 1400 

Independence Ave., SW., Room 4008– 

So., Ag Stop 0268, Washington, DC 

20250. 

• Internet: www.regulations.gov. 

• Written comments on this proposed 

rule should be identified with the 

docket number TM–04–07. Commenters 

should identify the topic and section 

number of this proposed rule to which 

the comment refers. 

• Clearly indicate if you are for or 

against the proposed rule or some 

portion of it and your reason for it. 

Include recommended language changes 

as appropriate. 

• Include a copy of articles or other 

references that support your comments. 

Only relevant material should be 

submitted. 

It is our intention to have all 

comments to this proposed rule, 

whether submitted by mail, or Internet, 

available for viewing on the 

regulations.gov homepage. Comments 

submitted in response to this proposed 

rule will be available for viewing in 

person at USDA–AMS, Transportation 

and Marketing, Room 4008–South 

Building, 1400 Independence Ave., SW., 

Washington, DC, from 9 a.m. to 12 noon 

and from 1 p.m. to 4 p.m., Monday 

through Friday (except official Federal 

holidays). Persons wanting to visit the 

USDA South Building to view 

comments received in response to this 

proposed rule are requested to make an 

appointment in advance by calling (202) 

720–3252. 

FOR FURTHER INFORMATION CONTACT: Toni 

Strother, Agricultural Marketing 

Specialist, Telephone: (202) 720–3252; 

Fax: (202) 205–7808. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Organic Foods Production Act 

(OFPA), 7 U.S.C. 6501 et seq., 

authorizes the establishment of the 

National List of allowed and prohibited 

substances. The National List identifies 

synthetic substances (synthetics) that 

are exempted (allowed) and 

nonsynthetic substances (nonsynthetics) 

that are prohibited in organic crop and 

livestock production. The National List 

also identifies nonsynthetics and 

synthetics that are exempted for use in 

organic handling. 

The exemptions and prohibitions 

granted under the OFPA are required to 

be reviewed every 5 years by the NOSB. 

The Secretary of Agriculture has 

authority under the OFPA to renew 

such exemptions and prohibitions. If 

they are not reviewed by the NOSB 

within 5 years of their inclusion on the 

National List and renewed by the 

Secretary, their authorized use or 

prohibition expires. This means that a 

synthetic substance exempted for use on 

the National List in 2002 and currently 

allowed for use in organic production 

will no longer be allowed for use after 

October 21, 2007; a non-synthetic 

substance prohibited from use on the 

National List in 2002 and currently 

prohibited from use in organic 

production will be allowed after 

October 21, 2007; and a synthetic or 

nonsynthetic substance exempted for 

use on the National List and currently 

allowed for use in organic handling will 

be prohibited after October 21, 2007. 

In response to the sunset provisions 

in the OFPA, the Secretary published an 

Advanced Notice of Proposed 

Rulemaking (ANPR) (70 FR 35177) in 

the Federal Register on June 17, 2005, 

to announce the review of 174 

exemptions and prohibitions authorized 

under the National Organic Program 

regulations. This ANPR also requested 

public comment on the continued use or 

prohibition of such exemptions and 

prohibitions. The public comment 

period lasted 60 days. 

We received approximately 350 

comments. Comments were received 

from consumers, producers, certifying 

agents, trade associations, retailers, 

organic associations, animal welfare 

organizations, consumer groups, the 

NOSB, and various industry groups. 

In general, we received comments 

urging the current list to remain intact 

as it currently exists with many 

providing specific focused support for 

materials that they promoted, 

represented, or relied upon. One 

commenter strongly advocated for a 

careful review of the materials up for 

sunset review and not just a blanket 

approval. In particular, the commenter 

emphasized the need for additional 

technical review of the general 

categories of flavors, colors, vitamins 

and minerals used in handling; aquatic 

plant products, fish products, humic 

acid derivatives, antibiotics used in 

crops; and chlorine materials used as 

sanitizers in crops, livestock and 

handling. 

The NOSB reviewed the comments 

received on the ANPR and used the 

comments to make recommendations to 

the Secretary regarding the continued 

use and prohibition of the 169 

substances under review. Three 

meetings were held for the NOSB to 

deliberate and make recommendations 

to the Secretary. The first meeting was 

held on November 16–17, 2005, in 


cprice-sewell on PROD1PC67 with PROPOSALS
Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Proposed Rules 9873 

Washington, DC. The second meeting 

was held on April 19–20, 2006, in State 

College, PA. The third meeting was held 

on October 17–19, 2006, in Arlington, 

VA. All three meetings were open to the 

public and additional comments were 

received during the meetings. 

As a result of the November 2005, and 

2006 April and October NOSB meetings, 

the NOSB recommended that the 

Secretary renew 166 of the 169 

exemptions and prohibitions on the 

National List; and remove 3 exemptions 

from the National List. These 

recommendations are limited to those 

exemptions and prohibitions that were 

originally included on the National List 

on October 21, 2002. The Secretary is 

engaging in this proposed rulemaking to 

reflect the recommendations of the 

NOSB, from November 2005, April 

2006, and October 2006, and request 

public comment. 

Under the authority of the OFPA, as 

amended, (7 U.S.C. 6501 et seq.), the 

National List can be amended by the 

Secretary based on proposed 

amendments developed by the NOSB. 

Since established, the National List has 

been amended four times, October 31, 

2003 (68 FR 61987), November 3, 2003 

(68 FR 62215), October 21, 2005 (70 CFR 

61217) and September 11, 2006 (71 FR 

53299). 

II. Overview of Proposed Amendments 

From November 17, 2005, through 

October 19, 2006, the NOSB reviewed 

169 exemptions and prohibitions that 

are authorized on the National List and 

set to expire on October 21, 2007. [In the 

ANPR announcing this sunset review of 

substances (70 FR 35177, June 17, 2005), 

the original count of substances was 

quoted at 174 substances; however, 

there were a number of substances 

counted in technical error. As a result, 

the count has been corrected to reflect 

a total of 169 substances under review 

during this sunset process.] Using the 

evaluation criteria specified in the 

ANPR for sunset review, the NOSB 

reviewed these exemptions and 

prohibitions for continued authorization 

in organic agricultural production and 

handling. As a result of the NOSB’s 

review, the NOSB recommended that 

the Secretary renew 166 of the 169 

exemptions and prohibitions. In 

addition, the NOSB recommended that 

3 exemptions not be renewed. 

With respect to the criteria used to 

make recommendations regarding the 

continued authorization of exemptions 

and prohibitions, the NOSB agreed that 

decision making would be based on 

public comments and applicable 

supporting evidence that expressed a 

continued need for the use or 

prohibition of the substance(s). 

Concerning criteria used to make 

recommendations regarding the 

discontinuation of an authorized 

exempted synthetic substance or 

prohibited nonsynthetic substance, the 

NOSB agreed that decision making, for 

the exempted synthetic substance, 

would be based on public comments 

and applicable supporting evidence that 

demonstrated the currently authorized 

exempted or prohibited substance is (a) 

harmful to human health or the 

environment, (b) not necessary to the 

production of the agricultural products 

because of the availability of wholly 

nonsynthetic substitute products, or (c) 

inconsistent with organic farming and 

handling. 

In the case of recommendations to 

discontinue prohibitions of 

nonsynthetic substances, the NOSB 

agreed that decision making would be 

based on public comments and 

applicable supporting evidence 

demonstrating that the prohibited 

nonsynthetic substance is no longer 

harmful to human health or the 

environment and is consistent and 

compatible with organic practices. 

Renewals 

After considering all public comments 

and supporting evidence, the NOSB 

determined that 166 out of the 169 

exemptions and prohibitions 

demonstrated a continued need for 

authorization in organic agricultural 

production and handling. Based on the 

recommendations from the NOSB 

concerning substances identified for 

review under this sunset review 

process, this proposed rule would 

amend the USDA’s National regulations 

(7 CFR part 205) to renew exemptions 

and prohibitions of the following 

substances in organic agricultural 

production and handling (use categories 

and any restrictive annotations remain 

unchanged, but have been omitted from 

this overview): 

Section 205.601 Synthetic Substances 

Allowed for Use in Organic Crop 

Production 

1. Ethanol. 

2. Isopropanol. 

3. Calcium hypochlorite. 

4. Chlorine dioxide. 

5. Sodium hypochlorite. 

6. Hydrogen peroxide. 

7. Soap-based algicide/demossers. 

8. Herbicides, soap-based. 

9. Newspaper or other recycled paper, 

without glossy or colored inks. 

10. Plastic mulch and covers. 

11. Newspapers or other recycled 

paper, without glossy or colored inks. 

12. Soaps, ammonium. 

13. Ammonium carbonate. 

14. Boric acid. 

15. Elemental sulfur. 

16. Lime sulfur-including calcium 

polysulfide. 

17. Oils, horticultural-narrow range 

oils as dormant, suffocating, and 

summer oils. 

18. Soaps, insecticidal. 

19. Sticky traps/barriers. 

20. Pheromones. 

21. Sulfur dioxide. 

22. Vitamin D3. 

23. Copper hydroxide. 

24. Copper oxide. 

25. Copper oxychloride. 

26. Copper sulfate. 

27. Hydrated lime. 

28. Hydrogen peroxide. 

29. Lime sulfur. 

30. Oils, horticultural, narrow range 

oils as dormant, suffocating, and 

summer oils. 

31. Potassium bicarbonate. 

32. Elemental sulfur. 

33. Streptomycin. 

34. Tetracycline (oxytetracycline 

calcium complex). 

35. Aquatic plant extracts (other than 

hydrolyzed). 

36. Elemental sulfur. 

37. Humic acids. 

38. Lignin sulfonate. 

39. Magnesium sulfate. 

40. Soluble boron products. 

41. Sulfates. 

42. Carbonates. 

43. Oxides. 

44. Silicate of zinc. 

45. Silicate of copper. 

46. Silicate of iron. 

47. Silicate of manganese. 

48. Silicate of molybdenum. 

49. Silicate of selenium. 

50. Silicate of cobalt. 

51. Liquid fish products. 

52. Vitamin B1. 

53. Vitamin C. 

54. Vitamin E. 

55. Ethylene gas. 

56. Lignin sulfonate. 

57. Sodium silicate. 

58. EPA List 4-Inerts of Minimal 

Concern. 

Section 205.602 Nonsynthetic 

Substances Prohibited for Use in 

Organic Crop Production 

1. Ash from manure burning. 

2. Arsenic. 

3. Lead salts. 

4. Potassium chloride. 

5. Sodium fluoaluminate (mined). 

6. Sodium nitrate. 

7. Strychnine. 

8. Tobacco dust (nicotine sulfate). 

Section 205.603 Synthetic Substances 

Allowed for Use in Organic Livestock 

Production 

1. Ethanol. 


cprice-sewell on PROD1PC67 with PROPOSALS
9874 Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Proposed Rules 

2. Isopropanol. 

3. Aspirin. 

4. Vaccines. 

5. Chlorhexidine. 

6. Calcium hypochlorite. 

7. Chlorine dioxide. 

8. Sodium hypochlorite. 

9. Electrolytes. 

10. Glucose. 

11. Glycerine. 

12. Hydrogen peroxide. 

13. Iodine. 

14. Magnesium sulfate. 

15. Oxytocin. 

16. Ivermectin. 

17. Phosphoric acid. 

18. Copper sulfate. 

19. Iodine. 

20. Lidocaine. 

21. Lime, hydrated. 

22. Mineral oil. 

23. Procaine. 

24. Trace minerals. 

25. Vitamins. 

26. EPA List 4-Inerts of Minimal 

Concern. 

Section 205.604 Nonsynthetic 

Substances Prohibited for Use in 

Organic Livestock Production 

1. Strychnine. 

Section 205.605 Nonagricultural 

(Nonorganic) Substances Allowed as 

Ingredients In or On Processed Products 

Labeled As ‘‘Organic’’ or ‘‘Made With 

Organic (Specified Ingredients or Food 

Groups(s))’’

(a) Nonsynthetics allowed: 

1. Alginic acid. 

2. Citric acid. 

3. Lactic acid. 

4. Bentonite. 

5. Calcium carbonate. 

6. Calcium chloride. 

7. Carageenan. 

8. Dairy cultures. 

9. Diatomaceous earth. 

10. Enzymes. 

11. Flavors. 

12. Kaolin. 

13. Magnesium sulfate. 

14. Nitrogen-oil-free grades. 

15. Oxygen-oil-free grades. 

16. Perlite. 

17. Potassium chloride. 

18. Potassium iodide. 

19. Sodium bicarbonate. 

20. Sodium carbonate. 

21. Carnauba wax. 

22. Wood resin wax. 

23. Autolysate yeast. 

24. Bakers yeast. 

25. Brewers yeast. 

26. Nutritional yeast. 

27. Smoked yeast. 

(b) Synthetics allowed: 

1. Alginates. 

2. Ammonium bicarbonate. 

3. Ammonium carbonate. 

4. Ascorbic acid. 

5. Calcium citrate. 

6. Calcium hydroxide. 

7. Monobasic calcium phosphates. 

8. Dibasic calcium phosphates. 

9. Tribasic calcium phosphates. 

10. Carbon dioxide. 

11. Calcium hypochlorite. 

12. Chlorine dioxide. 

13. Sodium hypochlorite. 

14. Ethylene. 

15. Ferrous sulfate. 

16. Monoglycerides. 

17. Diglycerides. 

18. Glycerin. 

19. Hydrogen peroxide. 

20. Lecithin—bleached. 

21. Magnesium carbonate. 

22. Magnesium chloride. 

23. Magnesium stearate. 

24. Nutrient vitamins. 

25. Nutrient minerals. 

26. Ozone. 

27. Pectin (low-methoxy). 

28. Phosphoric acid. 

29. Potassium acid tartrate. 

30. Potassium carbonate. 

31. Potassium citrate. 

32. Potassium hydroxide. 

33. Potassium iodide. 

34. Potassium phosphate. 

35. Silicon dioxide. 

36. Sodium citrate. 

37. Sodium hydroxide. 

38. Sodium phosphates. 

39. Sulfur dioxide. 

40. Tocopherols. 

41. Xanthan gum. 

Section 205.606 Nonorganically 

Produced Agricultural Products 

Allowed as Ingredients In or On 

Processed Products Labeled as 

‘‘Organic’’

1. Cornstarch (native). 

2. Gums—water extracted only 

(arabic, guar, locust bean, carob bean). 

3. Kelp—for use only as a thickener 

and dietary supplement. 

4. Lecithin—unbleached. 

5. Pectin (high-methoxy). 

Nonrenewals 

Based on recommendations from the 

NOSB concerning substances identified 

for review under this sunset review 

process, this proposed rule would 

amend the USDA’s National List to 

remove exemptions (and any restrictive 

annotations) for the following 

substances in organic agricultural 

production and handling: 

Section 205.603 Synthetic Substances 

Allowed for Use in Organic Livestock 

Production 

Milk replacers without antibiotics, as 

emergency use only, no nonmilk 

products or products from BST treated 

animals. 

A milk replacer is a formula 

(powdered or liquid) designed to take 

the place of natural mother’s milk by 

supplying the nutritional needs of the 

baby animal during the critical, early 

nursing stage of its life. Milk replacers 

traditionally contain milk-based 

ingredients as their major source of 

protein. However, as more milk proteins 

are being used by the human food 

industry, milk proteins are becoming 

more and more expensive to source. 

The NOP regulations, at § 205.237(a), 

state that ‘‘The producer of an organic 

livestock operation must provide 

livestock with a total feed ration 

composed of agricultural products, 

including pasture and forage, that are 

organically produced and, if applicable, 

organically handled: Except, That, 

nonsynthetic substances and synthetic 

substances allowed under § 205.603 

may be used as feed additives and 

supplements.’’ In relation to this 

requirement, the National List, at 

§ 205.603(c), provides that nonorganic 

milk replacers, without antibiotics and 

not from nonmilk products or products 

from Bovine somatotropin treated 

animals may be used, for emergency use 

only, as a feed supplement in organic 

livestock production. Due to the 

concern for the commercial availability 

of organic milk at the time of 

publication of the NOP regulations 

(December 21, 2000), this exemption 

was considered necessary to protect the 

interests of organic livestock producers 

and the health of organic young calves. 

In reviewing public comments and 

evidence regarding the continued 

authorization of the use of milk 

replacers in organic agricultural 

livestock production, the NOSB 

determined that nonorganic milk 

replacers should no longer be permitted 

for use in organic livestock production. 

The NOSB based their decision on input 

and testimonies from organic livestock 

producers which stated that the use of 

such nonorganic agricultural feed 

supplements were not a necessity or 

widely utilized in organic livestock 

production. They also suggested that 

organic milk is commercially available 

and should be used to feed young 

animals that may need to be fed a milk 

replacer during their early stages of 

development. Since the full 

implementation of the NOP regulations 

and approximately four years of 

certified organic livestock production 

under such regulations, commenters 

expressed that there were not many 

emergency cases that justified the use of 

nonorganic milk replacers above organic 


cprice-sewell on PROD1PC67 with PROPOSALS
Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Proposed Rules 9875 

milk in the production of organic dairy 

animals. 

There were a few comments that 

suggested that nonorganic milk 

replacers should remain available for 

use in organic livestock production. 

Such comments provided that it would 

be more expensive to use organic milk 

as a milk replacer than nonorganic milk 

because organic milk is a highly valued 

commodity for human consumption. 

Therefore, it would present more of an 

economic challenge to farmers to feed 

saleable organic milk to an animal, 

rather than selling the milk for human 

consumption. 

After considering all input from the 

public and any applicable evidence, the 

NOSB maintained that nonorganic milk 

replacers should no longer be permitted 

as an authorized substance for use in 

organic livestock production, due to the 

availability of organic milk and the 

requirements in the regulations that 

require the feeding of organic 

agricultural feed to organically 

produced livestock. Therefore, the 

Secretary accepts the NOSB’s 

recommendation and proposes not to 

renew the exemption for the use of 

nonorganic milk replacers in 

§ 205.603(c) of the National List. 

Section 205.605 Nonagricultural 

(Nonorganic) Substances Allowed as 

Ingredients In or On Processed Products 

Labeled as ‘‘Organic’’ or ‘‘Made With 

Organic (Specified Ingredients or Food 

Groups(s))’’

Colors-nonsynthetic sources only. 

The NOSB voted not to renew the 

exemption to permit the use of 

nonsynthetic colors in organic handling. 

In considering whether to renew the 

exemption of nonsynthetic colors, many 

concerns were raised for the NOSB. 

First, the NOSB reflected on the fact that 

the OFPA states that the National List, 

established by the Secretary, shall be 

based upon a proposed National List or 

proposed amendments to the National 

List developed by the NOSB. In relation 

to that provision of the OFPA, the NOSB 

was made aware that nonsynthetic 

colors never received a formal 

recommendation by the NOSB to be 

included on the National List. 

Nonsynthetic colors were erroneously 

included in the final rule. As a result, 

the NOSB received several comments to 

remove the category of nonsynthetic 

colors from the National List, as 

nonsynthetic colors should be evaluated 

by the NOSB through the petition 

process. 

Secondly, the NOSB took comments 

into account that raised concern about 

how the broad category of 

‘‘nonsynthetic colors’’ produces 

difficulty in determining and verifying 

what colors are truly nonsynthetic 

versus synthetic and how such 

ambiguity could give rise to the use of 

inappropriate substances in organically 

handled products. 

In addition, the NOSB also 

deliberated on the historical fact that 

nonsynthetic colors had been permitted 

for use by the organic industry for over 

five years. As a result, commenters 

raised a general concern that removing 

nonsynthetic colors from the National 

List could cause a disruption in the 

manufacture of organic products in the 

organic handling sector. 

Taking all of these concerns into 

consideration, the NOSB decided that it 

would not affirm or deny the reauthorization of nonsynthetic colors on 

the National List at its April 2006 

meeting. Instead, the NOSB decided that 

it would provide the industry a window 

of opportunity to petition the addition 

of nonsynthetic colors on the National 

List before the finalization of the Sunset 

Review process. As of the October 2006 

meeting, nine individual and groups of 

colors had been petitioned for 

consideration as nonsynthetic on 

§ 205.605(a), and as agricultural, but not 

commercially available as organic, on 

§ 205.606, of the National List. In 

addition, the NOSB considered that in 

the absence of an initial 

recommendation from the NOSB to 

permit the addition of nonsynthetic 

colors as a broad category that they 

could not continue to permit the 

exemption of nonsynthetic colors on 

§ 205.605(a). As a result, the NOSB 

voted not to renew the exemption of 

nonsynthetic colors on § 205.605(a) and 

that they not be permitted for use in 

organic handling. Therefore, the 

Secretary accepts the NOSB’s 

recommendation and proposes not to 

renew the exemption for the use of 

colors, nonsynthetic on § 205.605(a) of 

the National List. 

Potassium tartrate made from tartaric 

acid. 

The NOSB recommended to remove 

‘‘Potassium tartrate made from tartaric 

acid’’ from § 205.605(b) of the National 

List. The NOP regulations, at 

§ 205.605(b), authorize the use of 

Potassium tartrate made from tartaric 

acid in organic handling. Comments 

were submitted concerning the 

continued need for this authorization. 

Based on information received through 

public comment, the NOSB learned that 

Potassium tartrate made from tartaric 

acid is not a term/substance formally 

recognized or authorized by the Food 

and Drug Administration (FDA) in food 

processing and is improperly identified 

on the National List. Comments 

suggested that the authorization for 

Potassium tartrate made from tartaric 

acid be removed from the National List 

and be properly referenced as 

‘‘Potassium acid tartrate,’’ (21 CFR 

184.1077), which is already an 

exempted substance on the National 

List. 

Research demonstrates that the 

original intent of the NOSB, in 1995, 

was to authorize the use of ‘‘Potassium 

tartrate’’ (also known as Potassium acid 

tartrate) in organic handling; however, 

when the NOSB made its 

recommendation to the Secretary, its 

recommendation included language 

suggesting the Secretary authorize the 

use of ‘‘Potassium acid tartrate (or 

potassium tartrate made from tartaric 

acid)’’ on the National List for organic 

handling. As a result of the NOSB 

recommendation, the NOP, when 

finalizing the National List in December 

2000, included both references of the 

substance (Potassium acid tartrate and 

Potassium tartrate made from tartaric 

acid) on the National List and created a 

situation of unnecessary duplication, as 

the terms were meant to be 

synonymous. Therefore, the inclusion of 

the term ‘‘Potassium tartrate made from 

tartaric acid’’ was included in technical 

error, considering the fact that the FDA 

regulations do not authorize its use, but, 

instead, authorize the use of ‘‘potassium 

acid tartrate’’. 

Accordingly, in response to the 

NOSB’s recommendation to remove 

‘‘Potassium tartrate made from tartaric 

acid’’ from the National List at 

§ 205.605(b), the Secretary accepts the 

NOSB’s recommendation and proposes 

not to renew the exemption. 

III. Related Documents 

One advanced notice of proposed 

rulemaking with request for comments 

was published in Federal Register 

Notice 70 FR 35177, June 17, 2005, to 

make the public aware that the 

allowance of 169 synthetic and nonsynthetic substances in organic 

production and handling will expire, if 

not reviewed by the NOSB and renewed 

by the Secretary. 

IV. Statutory and Regulatory Authority 

The OFPA, as amended (7 U.S.C. 6501 

et seq.), authorizes the Secretary to 

make amendments to the National List 

based on proposed amendments 

developed by the NOSB. Sections 

6518(k)(2) and 6518(n) of OFPA 

authorize the NOSB to develop 

proposed amendments to the National 

List for submission to the Secretary and 

establish a petition process by which 

persons may petition the NOSB for the 

purpose of having substances evaluated 


cprice-sewell on PROD1PC67 with PROPOSALS
9876 Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Proposed Rules 

for inclusion on or deletion from the 

National List. The National List petition 

process is implemented under § 205.607 

of the NOP regulations. The current 

petition process (65 FR 43259, July 13, 

200) can be accessed through the NOP 

Web site at http://www.ams.usda.gov/ 

nop. 

A. Executive Order 12866 

This action has been determined not 

significant for purposes of Executive 

Order 12866, and therefore, has not 

been reviewed by the Office of 

Management and Budget. 

B. Executive Order 12988 

Executive Order 12988 instructs each 

executive agency to adhere to certain 

requirements in the development of new 

and revised regulations in order to avoid 

unduly burdening the court system. 

This proposed rule is not intended to 

have a retroactive effect. 

States and local jurisdictions are 

preempted under § 2115 of the OFPA (7 

U.S.C. 6514) from creating programs of 

accreditation for private persons or State 

officials who want to become certifying 

agents of organic farms or handling 

operations. A governing State official 

would have to apply to USDA to be 

accredited as a certifying agent, as 

described in § 2115(b) of the OFPA (7 

U.S.C. 6514(b)). States are also 

preempted under §§ 2104 through 2108 

of the OFPA (7 U.S.C. 6503 through 

6507) from creating certification 

programs to certify organic farms or 

handling operations unless the State 

programs have been submitted to, and 

approved by, the Secretary as meeting 

the requirements of the OFPA. 

Pursuant to § 2108(b)(2) of the OFPA 

(7 U.S.C. 6507(b)(2)), a State organic 

certification program may contain 

additional requirements for the 

production and handling of organically 

produced agricultural products that are 

produced in the State and for the 

certification of organic farm and 

handling operations located within the 

State under certain circumstances. Such 

additional requirements must: (a) 

Further the purposes of the OFPA, (b) 

not be inconsistent with the OFPA, (c) 

not be discriminatory toward 

agricultural commodities organically 

produced in other States, and (d) not be 

effective until approved by the 

Secretary. 

Pursuant to § 2120(f) of the OFPA (7 

U.S.C. 6519(f)), this proposed rule 

would not alter the authority of the 

Secretary under the Federal Meat 

Inspection Act (21 U.S.C. 601 et seq.), 

the Poultry Products Inspections Act (21 

U.S.C. 451 et seq.), or the Egg Products 

Inspection Act (21 U.S.C. 1031 et seq.), 

concerning meat, poultry, and egg 

products, nor any of the authorities of 

the Secretary of Health and Human 

Services under the Federal Food, Drug 

and Cosmetic Act (21 U.S.C. 301 et 

seq.), nor the authority of the 

Administrator of EPA under the Federal 

Insecticide, Fungicide and Rodenticide 

Act (7 U.S.C. 136 et seq.). 

Section 2121 of the OFPA (7 U.S.C. 

6520) provides for the Secretary to 

establish an expedited administrative 

appeals procedure under which persons 

may appeal an action of the Secretary, 

the applicable governing State official, 

or a certifying agent under this title that 

adversely affects such person or is 

inconsistent with the organic 

certification program established under 

this title. The OFPA also provides that 

the U.S. District Court for the district in 

which a person is located has 

jurisdiction to review the Secretary’s 

decision. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601 et seq.) requires agencies 

to consider the economic impact of each 

rule on small entities and evaluate 

alternatives that would accomplish the 

objectives of the rule without unduly 

burdening small entities or erecting 

barriers that would restrict their ability 

to compete in the market. The purpose 

is to fit regulatory actions to the scale of 

businesses subject to the action. Section 

605 of the RFA allows an agency to 

certify a rule, in lieu of preparing an 

analysis, if the rulemaking is not 

expected to have a significant economic 

impact on a substantial number of small 

entities. 

Pursuant to the requirements set forth 

in the RFA, the Agricultural Marketing 

Service (AMS) performed an economic 

impact analysis on small entities in the 

final rule published in the Federal 

Register on December 21, 2000 (65 FR 

80548). The AMS has also considered 

the economic impact of this action on 

small entities. The impact on entities 

affected by this proposed rule would not 

be significant. The effect of this 

proposed rule would be to allow the 

continued use of most substances 

currently listed for use in organic 

agricultural production and handling. 

The AMS concludes that this action 

would have minimal economic impact 

on small agricultural service firms. 

Accordingly, USDA certifies that this 

rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Small agricultural service firms, 

which include producers, handlers, and 

accredited certifying agents, have been 

defined by the Small Business 

Administration (SBA) (13 CFR 121.201) 

as those having annual receipts of less 

than $6,500,000 and small agricultural 

producers are defined as those having 

annual receipts of less than $750,000. 

This proposed rule would have an 

impact on a substantial number of small 

entities. 

The U.S. organic industry at the end 

of 2001 included nearly 6,949 certified 

organic crop and livestock operations. 

These operations reported certified 

acreage totaling more than 2.09 million 

acres of organic farm production. Data 

on the numbers of certified organic 

handling operations (any operation that 

transforms raw product into processed 

products using organic ingredients) 

were not available at the time of survey 

in 2001; but they were estimated to be 

in the thousands. By the end of 2004, 

the number of certified organic crop, 

livestock, and handling operations 

totaled nearly 11,400 operations. Based 

on 2003 data, certified organic acreage 

increased to 2.2 million acres. 

The U.S. sales of organic food and 

beverages have grown from $1 billion in 

1990 to an estimated $12.2 billion in 

2004. Organic food sales were projected 

to reach $14.5 billion in 2005; total U.S. 

organic sales, including nonfood uses, 

were expected to reach $15 billion in 

2005. The organic industry is viewed as 

the fasting growing sector of agriculture, 

representing 2 percent of overall food 

and beverage sales. Since 1990, organic 

retail sales have historically 

demonstrated a growth rate between 20 

to 24 percent each year. This growth 

rate is projected to decline and fall to a 

rate of 5 to 10 percent in the future. 

In addition, USDA has accredited 95 

certifying agents provide certification 

services to producers and handlers. A 

complete list of names and addresses of 

accredited certifying agents may be 

found on the AMS NOP Web site, at 

http://www.ams.usda.gov/nop. AMS 

believes that most of these entities 

would be considered small entities 

under the criteria established by the 

SBA. 

D. Paperwork Reduction Act 

No additional collection or 

recordkeeping requirements are 

imposed on the public by this proposed 

rule. Accordingly, OMB clearance is not 

required by section 350(h) of the 

Paperwork Reduction Act of 1995, 44 

U.S.C. 3501, et seq., or OMB’s 

implementing regulations at 5 CFR part 

1320. 

The AMS is committed to compliance 

with the Government Paperwork 

Elimination Act (GPEA), which requires 

Government agencies in general to 

provide the public the option of 


cprice-sewell on PROD1PC67 with PROPOSALS
Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Proposed Rules 9877 

submitting information or transacting 

business electronically to the maximum 

extent possible. 

The AMS is committed to complying 

with the E-Government Act, to promote 

the use of the Internet and other 

information technologies to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

E. General Notice of Public Rulemaking 

This proposed rule reflects 

recommendations submitted to the 

Secretary by the NOSB for the 

continuation of 166 exemptions and 

prohibitions contained on the National 

List of Allowed and Prohibited 

Substances. This proposed rule also 

reflects recommendations by the NOSB 

to discontinue 3 exemptions contained 

on the National List. A 60-day period for 

interested persons to comment on this 

rule is provided. 

List of Subjects in 7 CFR Part 205 

Administrative practice and 

procedure, Agriculture, Animals, 

Archives and records, Imports, Labeling, 

Organically produced products, Plants, 

Reporting and recordkeeping 

requirements, Seals and insignia, Soil 

conservation. 

For the reasons set forth in the 

preamble, 7 CFR part 205, Subpart G is 

proposed to be amended as follows: 

PART 205—NATIONAL ORGANIC 

PROGRAM 

1. The authority citation for 7 CFR 

part 205 continues to read as follows: 

Authority: 7 U.S.C. 6501–6522. 

2. Section 205.603 is revised to read 

as follows: 

§ 205.603 Synthetic substances allowed 

for use in organic livestock production. 

In accordance with restrictions 

specified in this section the following 

synthetic substances may be used in 

organic livestock production: 

(a) As disinfectants, sanitizer, and 

medical treatments as applicable. 

(1) Alcohols. 

(i) Ethanol—disinfectant and sanitizer 

only, prohibited as a feed additive. 

(ii) Isopropanol—disinfectant only. 

(2) Aspirin—approved for health care 

use to reduce inflammation. 

(3) Biologics—Vaccines. 

(4) Chlorhexidine—Allowed for 

surgical procedures conducted by a 

veterinarian. Allowed for use as a teat 

dip when alternative germicidal agents 

and/or physical barriers have lost their 

effectiveness. 

(5) Chlorine materials—disinfecting 

and sanitizing facilities and equipment. 

Residual chlorine levels in the water 

shall not exceed the maximum residual 

disinfectant limit under the Safe 

Drinking Water Act. 

(i) Calcium hypochlorite. 

(ii) Chlorine dioxide. 

(iii) Sodium hypochlorite. 

(6) Electrolytes—without antibiotics. 

(7) Glucose. 

(8) Glycerine—Allowed as a livestock 

teat dip, must be produced through the 

hydrolysis of fats or oils. 

(9) Hydrogen peroxide. 

(10) Iodine. 

(11) Magnesium sulfate. 

(12) Oxytocin—use in postparturition 

therapeutic applications. 

(13) Paraciticides. Ivermectin—

prohibited in slaughter stock, allowed in 

emergency treatment for dairy and 

breeder stock when organic system 

plan-approved preventive management 

does not prevent infestation. Milk or 

milk products from a treated animal 

cannot be labeled as provided for in 

subpart D of this part for 90 days 

following treatment. In breeder stock, 

treatment cannot occur during the last 

third of gestation if the progeny will be 

sold as organic and must not be used 

during the lactation period for breeding 

stock. 

(14) Phosphoric acid—allowed as an 

equipment cleaner, Provided, That, no 

direct contact with organically managed 

livestock or land occurs. 

(b) As topical treatment, external 

parasiticide or local anesthetic as 

applicable. (1) Copper sulfate. 

(2) Iodine. 

(3) Lidocaine—as a local anesthetic. 

Use requires a withdrawal period of 90 

days after administering to livestock 

intended for slaughter and 7 days after 

administering to dairy animals. 

(4) Lime, hydrated—as an external 

pest control, not permitted to cauterize 

physical alterations or deodorize animal 

wastes. 

(5) Mineral oil—for topical use and as 

a lubricant. 

(6) Procaine—as a local anesthetic, 

use requires a withdrawal period of 90 

days after administering to livestock 

intended for slaughter and 7 days after 

administering to dairy animals. 

(c) As feed supplements. None. 

(d) As feed additives. 

(1) DL-Methionine, DL-Methioninehydroxy analog, and DL-Methioninehydroxy analog calcium—for use only 

in organic poultry production until 

October 21, 2008. 

(2) Trace minerals, used for 

enrichment or fortification when FDA 

approved. 

(3) Vitamins, used for enrichment or 

fortification when FDA approved. 

(e) As synthetic inert ingredients as 

classified by the Environmental 

Protection Agency (EPA), for use with 

nonsynthetic substances or a synthetic 

substances listed in this section and 

used as an active pesticide ingredient in 

accordance with any limitations on the 

use of such substances. 

(1) EPA List 4—Inerts of Minimal 

Concern. 

(2) [Reserved] 

(f) through (z) [Reserved] 

§ 205.605 [Amended] 

3. In § 205.605, the substance ‘‘colors, 

nonsynthetic sources only’’ is removed 

from paragraph (a) and the substance 

‘‘Potassium tartrate made from tartaric 

acid’’ is removed from paragraph (b). 

Dated: February 28, 2007. 

Lloyd C. Day, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. E7–3829 Filed 3–5–07; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2007–27359; Directorate 

Identifier 2006–NM–042–AD] 

RIN 2120–AA64 

Airworthiness Directives; Boeing 

Model 747–100, 747–100B, 747–200B, 

747–200C, 747–200F, 747–300, 747SR, 

and 747SP Series Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: The FAA proposes to adopt a 

new airworthiness directive (AD) for 

certain Boeing Model 747–100, 747–

100B, 747–200B, 747–200C, 747–200F, 

747–300, 747SR, and 747SP series 

airplanes. This proposed AD would 

require repetitive high frequency eddy 

current inspections for cracks of the 

fuselage skin at stringer 5 left and right 

between stations 340 and 350, and 

corrective actions if necessary. This 

proposed AD results from reports of 

fatigue cracks in the fuselage skin near 

stringer 5 between stations 340 and 350. 

We are proposing this AD to detect and 

correct fatigue cracking of the fuselage 

skin near stringer 5. Cracks in this area 

could join together and result in inflight depressurization of the airplane. 

DATES: We must receive comments on 

this proposed AD by April 20, 2007. 


cprice-sewell on PROD1PC67 with PROPOSALS