[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]
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Proposed Rules
Federal Register
________________________________________________________________________
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