[Federal Register Volume 76, Number 2 (Tuesday, January 4, 2011)]
[Proposed Rules]
[Pages 288-291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-33138]
========================================================================
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.
========================================================================
Federal Register / Vol. 76, No. 2 / Tuesday, January 4, 2011 /
Proposed Rules
[[Page 288]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS-TM-07-0136; TM-07-14PR]
RIN 0581-AC77
National Organic Program (NOP); Sunset Review (2011)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would address recommendations submitted to
the Secretary of Agriculture (Secretary) by the National Organic
Standards Board (NOSB) on November 5, 2009, and April 29, 2010. The
recommendations addressed in this proposed rule pertain to the
continued exemption (use) of 12 substances in organic production and
handling. Consistent with the recommendations from the NOSB, this
proposed rule would continue the exemption (use) of 12 substances on
the U.S. Department of Agriculture's (USDA) National List of Allowed
and Prohibited Substances (National List) (along with any restrictive
annotations). These substances were originally added to the National
List on September 12, 2006.
DATES: Comments must be received by February 3, 2011.
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-NOP, 1400 Independence Ave., SW.,
Room 2646-So., Ag Stop 0268, Washington, DC 20250.
Internet: http://www.regulations.gov.
Written comments responding to this proposed rule should be
identified with the docket number AMS-TM-07-0136; TM-07-14. You should
clearly indicate your position to continue the allowance 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 for 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
(http://www.regulations.gov) Internet site. Comments submitted in
response to this proposed rule will also be available for viewing in
person at USDA-AMS, National Organic Program, 1400 Independence Ave.,
SW., Room 2646-South Building, 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: Melissa Bailey, Director, Standards
Division, Telephone: (202) 720-3252; Fax: (202) 205-7808.
SUPPLEMENTARY INFORMATION:
I. Background
The Organic Foods Production Act of 1990 (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 that may be used in organic production and nonsynthetic
(natural) substances that are prohibited in organic crop and livestock
production. The National List also identifies nonagricultural
nonsynthetic, nonagricultural synthetic and nonorganic agricultural
substances that may be used 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 Hydrogen chloride (CAS 7647-
01-0) and Ferric phosphate (CAS 10045-86-0), currently
allowed for use in organic crop production, will no longer be allowed
for use after the sunset date, September 12, 2011. This also means that
Egg white lysozyme (CAS 9001-63-2), L-Malic acid (CAS
97-67-6), Microorganisms, Activated charcoal (CAS s
7440-44-0; 64365-11-3), Cyclohexylamine (CAS 108-91-8),
Diethylaminoethanol (CAS 100-37-8), Octadecylamine (CAS
124-30-1), Peracetic acid/Peroxyacetic acid (CAS
79-21-0), Sodium acid pyrophosphate (CAS 7758-16-9), and
Tetrasodium pyrophosphate (CAS 7722-88-5), currently allowed
for use in organic handling, will no longer be allowed for use after
the sunset date, September 12, 2011.
In response to the sunset provisions in the OFPA, the Secretary
published an Advanced Notice of Proposed Rulemaking (ANPR) (73 FR
13795) in the Federal Register on March 14, 2008, to announce the
review of the 12 exemptions authorized under the National Organic
Program (NOP) regulations. This ANPR also requested public comment on
the continued use of such substances. The public comment period lasted
60 days.
We received 25 comments in response to the ANPR. Comments were
received from producers, handlers, certifying agents, trade
associations, organic associations, various industry groups, and a
university. Some comments addressed more than one substance. We
received general comments urging that the current listings remain as
they are currently stated, and one general comment insisting that no
chemicals should be allowed for use in organic products. Most
commenters provided specific support for substances that they promoted,
represented, or relied upon. Specific support was received for the
following substances: Hydrogen chloride, Ferric phosphate, Egg white
lysozyme, L-Malic acid, Microorganisms, Activated charcoal,
Cyclohexylamine, Diethylaminoethanol,
[[Page 289]]
Octadecylamine, Peracetic acid/Peroxyacetic acid, Sodium acid
pyrophosphate, and Tetrasodium pyrophosphate.
The NOSB received additional public comment concerning the pending
sunset of the 12 substances in response to three Federal Register
Notices announcing meetings of the NOSB and its planned deliberations
on recommendations involving Sunset 2011 substances. The three notices
were published in the Federal Register as follows: March 20, 2009 (74
FR 11904), September 9, 2009 (74 FR 46411), and March 17, 2010 (75 FR
12723). The NOSB received further written and oral testimony at these
public business meetings which occurred in Washington, DC on May 4-6,
2009, and November 3-5, 2009, and in Woodland, CA on April 26-29, 2010.
The written comments can be retrieved via http://www.regulations.gov by
searching for the document ID numbers: AMS-TM-09-0014 (May 2009
meeting); AMS-TM-09-0060 (November 2009 meeting); and AMS-NOP-10-0021
(April 2010). The oral comments were recorded in the meeting
transcripts which are available on the NOP Web site, http://www.ams.usda.gov/nop.
As a result of the May 2009, November 2009, and April 2010, NOSB
meetings, and in consideration of the comments received from the ANPR,
the NOSB recommended that the Secretary renew the 12 exemptions on the
National List (along with any restrictive annotations). The Secretary
is issuing this proposed rule to reflect the recommendations of the
NOSB, from November 2009 and April 2010, and to request public comment
on the continued exemption (use) of 12 substances on the National List.
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 fourteen 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), December 12, 2007 (72 FR 70479), September 18, 2008 (73
FR 54057), October 9, 2008 (73 FR 59479), July 6, 2010 (75 FR 38693),
August 24, 2010 (75 FR 51919), and December 13, 2010 (75 FR 77521).
Additionally, proposed amendments to the National List were published
on November 8, 2010 (75 FR 68505).
II. Overview of Proposed Renewals
From May 4, 2009, through April 29, 2010, the NOSB reviewed 12
exemptions that are authorized on the National List and set to expire
on September 12, 2011. Using the evaluation criteria specified in the
ANPR for sunset review, the NOSB reviewed these exemptions 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 12 exemptions.
With respect to the criteria used to make recommendations regarding
the continued authorization of exemptions and prohibitions, the NOSB's
decision 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, the NOSB's decision, 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.
Renewals
After considering all public comments and supporting evidence, the
NOSB determined that the 12 exemptions demonstrated a continued need
for authorization in organic agricultural production and handling. On
November 5, 2009, the NOSB finalized its recommendations on 11 of the
12 exemptions, and on April 29, 2010, the NOSB finalized its
recommendation on Ferric phosphate.
The Agricultural Marketing Service (AMS) has reviewed and concurs
with the NOSB recommendations. Accordingly, this proposed rule would
continue the exemptions at Sec. 205.601, along with any restrictive
annotations, for the following synthetic substances allowed for use in
organic crop production: Ferric phosphate (CAS 10045-86-0);
and Hydrogen chloride (CAS 7647-01-0). This proposed rule
would continue the exemptions at Sec. 205.605(a), along with any
restrictive annotations, for the following nonsynthetic,
nonagricultural (nonorganic) substances allowed as ingredients in or on
processed products labeled as ``organic'' or ``made with organic
(specified ingredients or food groups(s))'': Egg white lysozyme (CAS
9001-63-2); L-Malic acid (CAS 97-67-6); and
Microorganisms. This proposed rule would continue the exemptions at
Sec. 205.605(b), along with any restrictive annotations, for the
following synthetic, nonagricultural (nonorganic) substances allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food groups(s))'':
Activated charcoal (CAS s 7440-44-0; 64365-11-3);
Cyclohexylamine (CAS 108-91-8); Diethylaminoethanol (CAS
100-37-8); Octadecylamine (CAS 124-30-1); Peracetic
acid/Peroxyacetic acid (CAS 79-21-0); Sodium acid
pyrophosphate (CAS 7758-16-9); and Tetrasodium pyrophosphate
(CAS 7722-88-5).
III. Related Documents
One advanced notice of proposed rulemaking with request for
comments was published in Federal Register 73 FR 13795 on March 14,
2008, 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/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
[[Page 290]]
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. 601-612) 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 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 additional substances in agricultural
production and handling. The AMS concludes that the economic impact of
this addition of allowed substances, if any, would be minimal and
beneficial to 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 $7,000,000 and small agricultural
producers are defined as those having annual receipts of less than
$750,000.
According to USDA, Economic Research Service (ERS) data based on
information from USDA-accredited certifying agents, the number of
certified U.S. organic crop and livestock operations totaled nearly
13,000 and certified organic acreage exceeded 4.8 million acres in
2008.\1\ ERS, based upon the list of certified operations maintained by
the NOP, estimated the number of certified handling operations was
3,225 in 2007.\2\ AMS believes that most of these entities would be
considered small entities under the criteria established by the SBA.
---------------------------------------------------------------------------
\1\ U.S. Department of Agriculture, Economic Research Service.
2009. Data Sets: U.S. Certified Organic Farmland Acreage, Livestock
Numbers and Farm Operations, 1992-2008. http://www.ers.usda.gov/Data/Organic/.
\2\ U.S. Department of Agriculture, Economic Research Service,
2009. Data Sets: Procurement and Contracting by Organic Handlers:
Documentation. http://www.ers.usda.gov/Data/OrganicHandlers/Documentation.htm.
---------------------------------------------------------------------------
The U.S. sales of organic food and beverages have grown from $3.6
billion in 1997 to nearly $21.1 billion in 2008.\3\ The organic
industry is viewed as the fastest growing sector of agriculture,
representing over 3 percent of overall food sales in 2009. Between1990
and 2008, organic food sales have historically demonstrated a growth
rate between 15 to 24 percent each year. In 2009, organic food sales
grew 5.1%.\4\
---------------------------------------------------------------------------
\3\ Dimitri, C., and L. Oberholtzer. 2009. Marketing U.S.
Organic Foods: Recent Trends from Farms to Consumers, Economic
Information Bulletin No. 58, U.S. Department of Agriculture,
Economic Research Service, http://www.ers.usda.gov/Publications/EIB58.
\4\ Organic Trade Association's 2010 Organic Industry Survey,
http://www.ota.com.
---------------------------------------------------------------------------
In addition, USDA has 98 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 accredited certifying agents 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.
E. General Notice of Public Rulemaking
This proposed rule reflects recommendations submitted to the
Secretary by the NOSB for the continuation of 12 exemptions 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 is critical
to organic production, and this rulemaking should be completed before
September 12, 2011.
List of Subjects in 7 CFR Part 205
Administrative practice and procedure, Agriculture, Animals,
[[Page 291]]
Archives and records, Imports, Labeling, Organically produced products,
Plants, Reporting and recordkeeping requirements, Seals and insignia,
Soil conservation.
The authority citation for 7 CFR part 205 continues to read as
follows:
Authority: 7 U.S.C. 6501-6522.
Dated: December 22, 2010.
Rayne Pegg,
Administrator, Agricultural Marketing Service.
[FR Doc. 2010-33138 Filed 1-3-11; 8:45 am]
BILLING CODE 3410-02-P