[Federal Register: July 14, 2008 (Volume 73, Number 135)]
[Proposed Rules]
[Page 40194-40197]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy08-11]
========================================================================
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.
========================================================================
[[Page 40194]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Docket Number AMS-TM-07-0124; TM-07-12PR]
RIN 0581-AC76
National Organic Program (NOP); Sunset Review (2008)
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) on November 30, 2007, and May 22, 2008. The
recommendations addressed in this proposed rule pertain to the
continued exemption (use) and prohibition of 12 substances in organic
production and handling. Consistent with the recommendations from the
NOSB, this proposed rule would renew the 11 exemptions and 1
prohibition on the National List (along with any restrictive
annotations) and correct the Tartaric acid listings by adding
annotations originally recommended to the Secretary on November 1,
1995.
DATES: Comments must be received by August 13, 2008.
ADDRESSES: Interested persons may submit written comments on this
proposed rule using the following addresses:
Mail: 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 responding to this proposed rule should be
identified with the docket number AMS-TM-07-0124. You should clearly
indicate your position to continue the allowance or prohibition of the
substances identified in this proposed rule and the reasons for your
position. You should include relevant information and data to support
your position (e.g., scientific, environmental, manufacturing, industry
impact information, etc.). You should also supply information on
alternative substances or alternative management practices, where
applicable, that support a change from the current exemption or
prohibition of the substance. Only the supporting material relevant to
your position will be considered.
It is our intention to have all comments concerning this proposed
rule, including, names and addresses when provided, whether submitted
by mail or internet available for viewing on the Regulations.gov
(www.regulations.gov) Internet site. Comments submitted in response to
this proposed rule will also be available for viewing in person at
USDA-AMS, Transportation and Marketing Programs, National Organic
Program, 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: Richard H. Mathews, Chief, Standards
Development and Review Branch, Telephone: (202) 720-3252; Fax: (202)
205-7808.
SUPPLEMENTARY INFORMATION:
I. Background
The OFPA, 7 U.S.C. 6501 et seq., authorizes the establishment of
the National List of exempted 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 National Organic Standards Board
(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 synthetic substances Copper sulfate, Ozone gas, Peracetic
acid, and EPA List 3 Inerts, currently allowed for use in organic crop
production, will no longer be allowed for use after November 3, 2008.
Calcium chloride currently prohibited from use in organic crop
production, except as a foliar spray to treat a physiological disorder
associated with calcium uptake, will be allowed after November 3, 2008.
This also means that Agar-agar, Carrageenan, and Tartaric acid,
currently allowed for use in organic handling, will be prohibited after
November 3, 2008. Finally, Animal enzymes, Calcium sulfate, Glucono
delta lactone, and Cellulose, currently allowed for use in organic
handling, will no longer be allowed for use after November 4, 2008.
In response to the sunset provisions in the OFPA, the Secretary
published an Advanced Notice of Proposed Rulemaking (ANPR) (72 FR
73667) in the Federal Register on December 28, 2007, to announce the
review of 11 exemptions and 1 prohibition authorized under the National
Organic Program regulations. This ANPR also requested public comment on
the continued use or prohibition of such exemptions and prohibition.
The public comment period lasted 30 days.
We received 35 comments. Comments were received from producers,
handlers, certifying agents, trade associations, organic associations,
various industry groups, and a university. We received six comments
urging that the current listings remain as they are currently stated.
Most commenters provided specific support for substances that they
promoted, represented, or relied upon. Specific support was received
for the following substances (the number in parenthesis represents the
number of specific support comments): Agar-agar (7), animal enzymes
(2), calcium chloride (1), calcium sulfate (1), carrageenan (15),
cellulose (10), List 3 inert ingredients in passive pheromone
dispensers (1), ozone gas (3), and peracetic acid (1). One commenter
[[Page 40195]]
stated that they have found the standard of identity for passive
pheromone dispenser to be undefined. As a result they requested, if the
allowance for List 3 inerts in passive pheromone dispensers is renewed,
that the AMS and the NOSB reexamine and clarify the meaning of
``passive pheromone dispensers.'' The AMS is unaware of any problems
with passive pheromone dispensers.
Six of the commenters supported relisting DL-Methionine, DL-
Methionine-hydroxyl analog, and DL-Methionine-hydroxyl analog calcium
(CAS --59-51-8; 63-68-3; 348-67-4). These substances were
added to the National List on November 3, 2003, for use in organic
poultry production. Initially these substances carried an expiration
date of October 21, 2005. Effective October 22, 2005, the expiration
date was amended to October 1, 2008. Because these substances have an
expiration date recommended by the NOSB and established by rulemaking,
they are not included in this sunset review.
The Methionine Task Force, a commenter to the ANPR, submitted a
petition on December 17, 2007, to amend Sec. 205.603(d)(1) by removing
the annotation date of October 1, 2008. Rulemaking on this request is
handled through a separate rulemaking action.
The NOSB met November 27-30, 2007, in Arlington, VA, where they
finalized recommendations to continue the listing of 11 of the 12
substances due to sunset. The NOSB met again May 20-22, 2008, in
Baltimore, MD, where they finalized their recommendations to continue
the listings for Tartaric acid. The NOSB also recommended correcting
the Tartaric acid listings by adding annotations originally recommended
to the Secretary on November 1, 1995. Having reviewed the comments
received on the ANPR, the NOSB also at the May meeting reaffirmed their
recommendations from November 30, 2007. Both meetings were open to the
public and additional comments were received during the meetings.
As a result of the November 2007 and May 2008 NOSB meetings, and in
consideration of the ANPR comments, the NOSB recommended that the
Secretary renew the 11 exemptions and 1 prohibition on the National
List (along with any restrictive annotations) and correct the Tartaric
acid listings by adding annotations originally recommended to the
Secretary on November 1, 1995. These recommendations are limited to the
prohibition and exemptions originally included on the National List on
November 3 and 4, 2003. The Secretary is engaging in this proposed
rulemaking to reflect the recommendations of the NOSB, from November
2007 and May 2008, and to 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 nine times, October 31, 2003 (68 FR
61987), November 3, 2003 (68 FR 62215), October 21, 2005 (70 FR 61217),
June 7, 2006 (71 FR 32803), September 11, 2006 (71 FR 53299), June, 27,
2007 (72 FR 35137), October 16, 2007 (72 FR 58469), December 10, 2007
(72 FR 69569), and December 12, 2007 (72 FR 70479).
II. Overview of Proposed Amendments
From November 27, 2007, through May 22, 2008, the NOSB reviewed 11
exemptions and 1 prohibition that are authorized on the National List
and set to expire on November 3 and 4, 2007. Using the evaluation
criteria specified in the ANPR for sunset review, the NOSB reviewed
these exemptions and prohibition for continued authorization in organic
agricultural production and handling. As a result of the NOSB's review,
the NOSB recommended that the Secretary renew the 11 exemptions and 1
prohibition on the National List (along with any restrictive
annotations) and correct the Tartaric acid listings by adding
annotations originally recommended to the Secretary on November 1,
1995.
With respect to the criteria used to make recommendations regarding
the continued authorization of exemptions and prohibitions, that
decision making is based on public comments and applicable supporting
evidence that expresses 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, that decision making, for the
exempted synthetic substance, is based on public comments and
applicable supporting evidence that demonstrates the currently
authorized exempted 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, that decision making is 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 the 11 exemptions and 1 prohibition demonstrated a
continued need for authorization in organic agricultural production and
handling. On May 22, 2008, the NOSB finalized its recommendation on
Tartaric acid and reaffirmed its recommendations of November 30, 2007,
on the other 11 substances.
In addition to recommending the continued listing of Tartaric acid
in paragraphs (a) and (b) of Sec. 205.605, the NOSB recommended that
the listings be corrected to include the annotations originally
recommended by the NOSB on November 1, 1995. The NOSB recommended that
the listing for Tartaric acid at Sec. 205.605(a) be corrected to read,
``Tartaric acid--made from organic grape wine.'' The NOSB recommended
that the listing for tartaric acid at Sec. 205.605(b) be corrected to
read, ``Tartaric acid--made from malic acid.'' These annotations were
inadvertently left out of the rulemaking which added Tartaric acid to
the National List on October 31, 2003 (68 FR 61987).
The Agricultural Marketing Service (AMS) has reviewed and concurs
with the NOSB recommendations. Accordingly, this proposed rule would
continue the 11 exemptions and 1 prohibition in 7 CFR 205.601, 205.602,
and 205.605 of the following substances in organic agricultural
production and handling and amend the USDA's national regulations (7
CFR part 205) to add annotations to the Tartaric acid listings of Sec.
205.605:
Section 205.601 Synthetic Substances Allowed for Use in Organic Crop
Production
(a) As algicide, disinfectants, and sanitizer, including irrigation
system cleaning systems.
(3) Copper sulfate--for use as an algicide in aquatic rice systems,
is limited to one application per field during any 24-month period.
Application rates are limited to those which do not increase baseline
soil test values for copper over a timeframe agreed upon by the
producer and accredited certifying agent.
(5) Ozone gas--for use as an irrigation system cleaner only.
[[Page 40196]]
(6) Peracetic acid--for use in disinfecting equipment, seed, and
asexually propagated planting material.
(e) As insecticides (including acaricides or mite control).
(3) Copper Sulfate--for use as tadpole shrimp control in aquatic
rice production, is limited to one application per field during any 24-
month period. Application rates are limited to levels which do not
increase baseline soil test values for copper over a timeframe agreed
upon by the producer and accredited certifying agent.
(i) As plant disease control.
(7) Peracetic acid--for use to control fire blight bacteria.
(m) As synthetic inert ingredients as classified by the
Environmental Protection Agency (EPA), for use with nonsynthetic
substances or synthetic substances listed in this section and used as
an active pesticide ingredient in accordance with any limitations on
the use of such substances.
(2) EPA List 3--Inerts of unknown toxicity allowed:
(ii) Inerts used in passive pheromone dispensers.
Section 205.602 Nonsynthetic Substances Prohibited for Use in Organic
Crop Production
(c) Calcium chloride, brine process is natural and prohibited for
use except as a foliar spray to treat a physiological disorder
associated with calcium uptake.
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 Group(s))''
(a) Nonsynthetics allowed:
Agar-agar.
Animal enzymes--(Rennet--animals derived; Catalase--bovine liver;
Animal lipase; Pancreatin; Pepsin; and Trypsin).
Calcium sulfate--mined.
Carrageenan.
Glucono delta-lactone--production by the oxidation of D-glucose
with bromine water is prohibited.
Tartaric acid--made from organic grape wine.
(b) Synthetics allowed:
Cellulose--for use in regenerative casings, as an anti-caking agent
(non-chlorine bleached) and filtering aid.
Tartaric acid--made from malic acid.
Nonrenewals
The NOSB determined that the 11 exemptions and 1 prohibition
demonstrated a continued need for authorization. Accordingly there are
no nonrenewals.
Technical Correction
This proposed rule would amend Sec. 205.605(a) by changing
``Carageenan'' to ``Carrageenan'' to correct the spelling of this
allowed substance.
III. Related Documents
One advanced notice of proposed rulemaking with request for
comments was published in Federal Register Notice 72 FR 73667, December
28, 2007, to make the public aware that the allowance of 12 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 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 (72 FR
2167, January 18, 2007) can be accessed through the NOP Web site at:
http://www.ams.usda.gov/AMSv1.0/
getfile?dDocName=STELPRDC5048809&acct=nopgeninfo.
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 the OFPA 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
[[Page 40197]]
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 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 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 2005, the number of U.S. certified organic crop,
livestock, and handling operations totaled about 8,500. Based on 2005
USDA, Economic Research Service, data from USDA-accredited certifying
agents, U.S. certified organic acreage increased to 4 million acres.
The U.S. sales of organic food and beverages have grown from $1
billion in 1990 to nearly $17 billion in 2006. The organic industry is
viewed as the fastest growing sector of agriculture, representing
almost 3 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, including a 22 percent increase in
2006.
In addition, USDA has 95 accredited certifying agents who 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 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 11 exemptions and 1
prohibition contained on the National List of Allowed and Prohibited
Substances. A 30-day period for interested persons to comment on this
rule is provided. Thirty days is deemed appropriate because the
expiration of these 12 substances has been widely publicized, their
continued use or prohibition is critical to organic production, and
this rulemaking should be completed before November 3, 2008.
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.
Sec. 205.605 [Amended]
2. Section 205.605(a) is amended by removing ``Carageenan'' and
adding ``Carrageenan'' in its place, and by removing ``Tartaric acid''
and adding ``Tartaric acid--made from grape wine'' in its place.
3. Section 205.605(b) is amended by removing ``Tartaric acid'' and
adding ``Tartaric acid--made from malic acid'' in its place.
Dated: July 1, 2008.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
[FR Doc. E8-15389 Filed 7-11-08; 8:45 am]
BILLING CODE 3410-02-P