[Federal Register Volume 72, Number 43 (Tuesday, March 6, 2007)]
[Proposed Rules]
[Pages 9872-9877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3829]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 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.
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  Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / 
Proposed Rules  

[[Page 9872]]



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.

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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

[[Page 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.

[[Page 9874]]

    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 Sec.  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 Sec.  205.603 may be used as feed additives and 
supplements.'' In relation to this requirement, the National List, at 
Sec.  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

[[Page 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 Sec.  
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 re-authorization 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 Sec.  205.605(a), and as 
agricultural, but not commercially available as organic, on Sec.  
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 Sec.  
205.605(a). As a result, the NOSB voted not to renew the exemption of 
nonsynthetic colors on Sec.  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 Sec.  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 Sec.  205.605(b) of the National List. The NOP 
regulations, at Sec.  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 Sec.  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 
non-synthetic 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

[[Page 9876]]

for inclusion on or deletion from the National List. The National List 
petition process is implemented under Sec.  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 Sec.  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 Sec.  2115(b) of the OFPA (7 U.S.C. 6514(b)). States are 
also preempted under Sec. Sec.  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 Sec.  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 Sec.  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

[[Page 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:


Sec.  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-Methionine-hydroxy analog, and DL-Methionine-
hydroxy 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]


Sec.  205.605  [Amended]

    3. In Sec.  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