National Organic Program (NOP); Sunset 2016 Amendments to the National List, 51075-51079 [2016-18108]
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51075
Rules and Regulations
Federal Register
Vol. 81, No. 149
Wednesday, August 3, 2016
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
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REGISTER issue of each week.
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS–NOP–15–0052;
NOP–15–12]
RIN 0581–AD43
National Organic Program (NOP);
Sunset 2016 Amendments to the
National List
Agricultural Marketing Service,
USDA.
ACTION: Final rule.
AGENCY:
This final rule addresses
recommendations submitted to the
Secretary of Agriculture (Secretary) by
the National Organic Standards Board
(NOSB) following their April 2015
meeting. These recommendations
pertain to the 2016 sunset review of
substances on the U.S. Department of
Agriculture’s (USDA) National List of
Allowed and Prohibited Substances
(National List). Consistent with the
recommendations from the NOSB, this
final rule removes five nonorganic
nonagricultural substances from the
National List for use in organic
handling: Egg white lysozyme,
cyclohexylamine, diethylaminoethanol,
octadecylamine, and tetrasodium
pyrophosphate when their use
exemptions (allowances) expire on
September 12, 2016.
DATES: Effective Date: This rule is
effective on September 12, 2016.
FOR FURTHER INFORMATION CONTACT: Paul
Lewis, Ph.D., Director, Standards
Division, Telephone: (202) 720–3252;
Fax: (202) 260–9151.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Background
The National Organic Program (NOP)
is authorized by the Organic Foods
Production Act of 1990 (OFPA), as
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amended (7 U.S.C. 6501–6522). The
USDA Agricultural Marketing Service
(AMS) administers the NOP. Final
regulations implementing the NOP, also
referred to as the USDA organic
regulations, were published December
21, 2000 (65 FR 80548), and became
effective on October 21, 2002. Through
these regulations, the AMS oversees
national standards for the production,
handling, and labeling of organically
produced agricultural products. Since
becoming effective, the USDA organic
regulations have been frequently
amended, mostly for changes to the
National List in 7 CFR 205.601–205.606.
This National List identifies the
synthetic substances that may be used
and the nonsynthetic substances that
may not be used in organic production.
The National List also identifies
synthetic, nonsynthetic nonagricultural,
and nonorganic agricultural substances
that may be used in organic handling.
The OFPA and the USDA organic
regulations, as indicated in § 205.105,
specifically prohibit the use of any
synthetic substance in organic
production and handling unless the
synthetic substance is on the National
List. Section 205.105 also requires that
any nonorganic agricultural substance
and any nonsynthetic nonagricultural
substance used in organic handling
appear on the National List.
As stipulated by the OFPA, the NOSB
develops recommendations to amend
the National List. The NOSB operates in
accordance with the Federal Advisory
Committee Act (5 U.S.C. App. 2 et seq.),
to assist in the evaluation of substances
to be used or not used in organic
production and handling, and to advise
the Secretary on the USDA organic
regulations. The OFPA also requires a
sunset review of all substances included
on the National List within five years of
their addition to or renewal on the list.
If a listed substance is not reviewed by
the NOSB and renewed by the USDA
within the five year period, its
allowance or prohibition on the
National List is no longer in effect.
Under the authority of the OFPA, the
Secretary can amend the National List
through rulemaking based upon
proposed amendments recommended by
the NOSB.
The NOSB’s recommendations to
continue existing exemptions and
prohibitions include consideration of
public comments and applicable
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supporting evidence that express a
continued need for the use or
prohibition of the substance(s) as
required by the OFPA.
Recommendations to either continue or
discontinue an authorized exempted
synthetic substance (7 U.S.C. 6517(c)(1))
are determined by the NOSB’s
evaluation of technical information,
public comments, and supporting
evidence that demonstrate that the
substance is: (a) Harmful to human
health or the environment; (b) no longer
necessary for organic production due to
the availability of alternative wholly
nonsynthetic substitute products or
practices; or (c) inconsistent with
organic farming and handling practices.
In accordance with the sunset review
process published in the Federal
Register on September 16, 2013 (78 FR
61154), this final rule would amend the
National List to reflect
recommendations submitted to the
Secretary by the NOSB on April 30,
2015, to amend the National List to
remove five substances allowed as
ingredients in or on processed products
labeled as ‘‘organic.’’ The exemptions of
each substance appearing on the
National List for use in organic
production and handling are evaluated
by the NOSB using the evaluation
criteria specified on the OFPA (7 U.S.C.
6517–6518).
II. Overview of Amendments
Nonrenewals
After considering public comments
and supporting documents, the NOSB
determined that one substance allowed
on § 205.605(a) and four substances
allowed on § 205.605(b) of the National
List are no longer necessary or essential
for organic handling. The NOSB
concluded that practices and other
substances are suitable alternatives to
egg white lysozyme, cyclohexylamine,
diethylaminoethanol, octadecylamine,
and tetrasodium pyrophosphate. AMS
has reviewed and accepts the five NOSB
recommendations for removal. Based
upon these NOSB recommendations,
this action amends the National List to
remove the exemptions for egg white
lysozyme, cyclohexylamine,
diethylaminoethanol, octadecylamine,
and tetrasodium pyrophosphate when
their use exemptions expire on
September 12, 2016.
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Egg white lysozyme
The USDA organic regulations
include an exemption on the National
List for egg white lysozyme as a
nonsynthetic ingredient for use in
organic processed products at
§ 205.605(a) as follows: Egg white
lysozyme (CAS # 9001–63–2). In 2004,
egg white lysozyme was petitioned for
addition to § 205.605 because it was
considered to be an essential processing
aid/preservative for controlling bacteria
that survived the pasteurization process
of milk that is used for cheese
manufacture. As recommended by the
NOSB, egg white lysozyme was added
to the National List on September 12,
2006 (71 FR 53299). The NOSB
recommended the renewal of egg white
lysozyme during their 2011 sunset
review and the listing was renewed in
a final rule published on August 3, 2011
(76 FR 46595). The NOSB completed the
2016 sunset review for the allowance of
egg white lysozyme at their April 2015
meeting.
AMS published two notices of the
NOSB public meetings covering the
2016 sunset review, in Federal Register
on September 8, 2014 (79 FR 53162) and
on March 12, 2015 (80 FR 12975) with
requests for comments. Their purpose
was to notify the public that the
allowance for egg white lysozyme
would expire on September 12, 2016, if
not reviewed by the NOSB and renewed
by the Secretary. During their sunset
review deliberation, the NOSB
considered written comments received
prior to and during the public meetings
on all substances included in the 2016
sunset review. These written comments
can be viewed at https://
www.regulations.gov by searching for
the documents: AMS–NOP–14–0063
(October 2014 NOSB public meeting)
and AMS–NOP–15–0002 (April 2015
NOSB public meeting). The NOSB also
considered oral comments received
during these public meetings which are
included in the meeting transcripts
available on the AMS Web site at https://
www.ams.usda.gov/nop. During their
sunset review of egg white lysozyme the
NOSB considered two technical reports
on enzymes that were requested by and
developed for the NOSB in 2011 and
2003, which are also available for
review on the AMS Web site.
Public comments provided the NOSB
with information about the availability
of practice-based alternatives to the use
of egg white lysozyme. Such comments
provided limited information to support
the continued need for egg white
lysozyme in organic processed products.
Based on those public comments, the
NOSB determined that the allowance for
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egg white lysozyme on the National List
in § 205.605(a) is no longer necessary or
essential for organic processed products.
Subsequently, the NOSB recommended
removal of egg white lysozyme from the
National List at their April 2015 public
meeting.
A proposed rule to remove egg white
lysozyme from the National List was
published on December 16, 2015 (80 FR
78150). AMS received comments that
egg white lysozyme is used in the
organic processing of beer, wine and
hard cheeses. The prevalence of use in
organic processing could not be
ascertained from the public comments.
Further, the comments did not assert
that egg white lysozyme is essential in
organic processing. Therefore,
consistent with the NOSB
recommendation, this final rule amends
§ 205.605(a) by removing the allowance
for egg white lysozyme. This
amendment is effective on egg white
lysozyme’s sunset date, September 12,
2016. After that date, egg white
lysozyme will be prohibited in organic
processing.
Cyclohexylamine, Diethylaminoethanol
and Octadecylamine
The USDA organic regulations
include allowances on the National List
for cyclohexylamine,
diethylaminoethanol and octadcylamine
as processing aids for use in organic
processing at § 205.605(b) as follows:
Cyclohexylamine (CAS # 108–91–8)—
for use only as a boiler water additive
for packaging sterilization.
Diethylaminoethanol (CAS # 100–37–
8)—for use only as a boiler water
additive for packaging sterilization.
Octadecylamine (CAS # 124–30–1)—
for use only as a boiler water additive
for packaging sterilization.
Cyclohexylamine,
diethylaminoethanol and octadcylamine
were added to the National List on
September 12, 2006 (71 FR 53299). The
NOSB recommended the renewal of
cyclohexylamine, diethylaminoethanol
and octadcylamine during their 2011
sunset review. AMS published a notice
renewing the allowances for
cyclohexylamine, diethylaminoethanol
and octadcylamine the National List on
August 3, 2011 (76 FR 46595).
Subsequently, the NOSB considered
the allowances for cyclohexylamine,
diethylaminoethanol, and
octadcylamine during the 2016 sunset
review. AMS published two notices in
the Federal Register announcing the
NOSB public meetings and requesting
public comments on September 8, 2014
(79 FR 53162) and on March 12, 2015
(80 FR 12975). Their purpose was to
notify the public that the allowances for
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cyclohexylamine, diethylaminoethanol
and octadcylamine would expire on
September 12, 2016, if not reviewed by
the NOSB and renewed by the
Secretary. During their 2016 sunset
review deliberation, the NOSB
considered written comments received
prior to and during the public meetings
on all substances included in the 2016
sunset review. These written comments
can be viewed at https://
www.regulations.gov by searching for
the document: AMS–NOP–14–0063
(October 2014 NOSB meeting) and
AMS–NOP–15–0002 (April 2015 NOSB
meeting). The NOSB also considered
oral comments received during these
public meetings which are included in
the meeting transcripts available on the
AMS Web site at https://
www.ams.usda.gov/nop. During their
2016 sunset review, the NOSB
considered technical reports on
cyclohexylamine, diethylaminoethanol,
and octadcylamine that were requested
by and developed for the NOSB in 2001;
these are available for review on the
AMS Web site.
The September 2014 and April 2015
NOSB meeting notices requested
information on the continued use of
cyclohexylamin, diethylaminoethanol,
or octadcylamine as boiler water
additives in organic processing. Public
comment in response to these requests
informed the NOSB that organic
processors are phasing out these
materials. The comments provided
limited information supporting the
continued need for the use of
cyclohexylamine, diethylaminoethanol,
or octadcylamine as boiler water
additives. The NOSB cited information
from public comments and the potential
for adverse human health and
environmental impacts in their
conclusion that the allowances for
cyclohexylamine, diethylaminoethanol,
or octadcylamine on § 205.605(b) are no
longer necessary or essential in organic
processing. Therefore, the NOSB
recommended that cyclohexylamine,
diethylaminoethanol, and
octadcylamine be removed from the
National List.
AMS published a proposed rule with
a request for comments on December 16,
2015 (80 FR 78150). No public
comments were received supporting the
continued use of cyclohexylamine,
diethylaminoethanol, and
octadcylamine in organic processing.
Consistent with the NOSB
recommendation, this final rule amends
§ 205.605(b) by removing the allowances
for cyclohexylamine,
diethylaminoethanol, and
octadcylamine. This amendment is
effective on cyclohexylamine,
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diethylaminoethanol, and
octadcylamine’s current sunset date,
September 12, 2016. After that date,
these substances are prohibited in
organic processing.
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Tetrasodium Pyrophosphate
The USDA organic regulations
include an exemption on the National
List for tetrasodium pyrophosphate as
an ingredient for use in organic
processed products at § 205.605(b) as
follows: Tetrasodium pyrophosphate
(CAS # 7722–88–5)—for use only in
meat analog products. In December
2001, tetrasodium pyrophosphate was
petitioned for addition onto § 205.605
for use as an ingredient in organic food
processing facilities. As recommended
by the NOSB, tetrasodium
pyrophosphate was added to the
National List on September 12, 2006 (71
FR 53299). In the 2011 sunset review,
the NOSB recommended renewing the
allowance for tetrasodium
pyrophosphate. Consistent with the
NOSB recommendation, AMS published
a notice in the Federal Register
renewing the tetrasodium
pyrophosphate exemption on the
National List on August 3, 2011 (76 FR
46595).
For the 2016 sunset review, AMS
published two notices in Federal
Register announcing the NOSB public
meetings and requesting comments on
September 8, 2014 (79 FR 53162) and on
March 12, 2015 (80 FR 12975). The
notices informed the public that the
tetrasodium pyrophosphate exemption
would expire on September 12, 2016, if
not reviewed by the NOSB and renewed
by the Secretary and to request
information on the necessity of
tetrasodium pyrophosphate as an
ingredient in organic food processing.
During their 2016 sunset review
deliberation, the NOSB considered
written comments received prior to and
during the public meetings on all
substance exemptions included in the
2016 sunset review. These written
comments can be viewed at https://
www.regulations.gov by searching for
the document: AMS–NOP–14–0063
(October 2014 public meeting) and
AMS–NOP–15–0002 (April 2015 public
meeting). The NOSB also considered
oral comments received during these
public meetings which are included in
the meeting transcripts available on the
AMS Web site at https://
www.ams.usda.gov/nop. In addition,
during their 2016 sunset review, the
NOSB considered two technical reports
on tetrasodium pyrophosphate that were
requested by and developed for the
NOSB in 2014 and 2002; these are
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available for review on the AMS Web
site.
Public comment to the NOSB did not
support a continued need for
tetrasodium pyrophosphate in the
production of organic processed
products and informed that various
alternative substances are available.
Based on public comments and
information in the 2014 technical report
on tetrasodium pyrophosphate, the
NOSB determined that there are
alternatives to this substances that may
be more compatible with organic
production. Therefore, the NOSB
determined that the allowance for
tetrasodium pyrophosphate on
§ 205.605(b) is no longer necessary or
essential for organic processed products
and recommended that tetrasodium
pyrophosphate be removed from the
National List.
A proposed rule with a request for
comments was published on December
16, 2015 (80 FR 78150), and no public
comments were received supporting the
continued use of tetrasodium
pyrophosphate in processed organic
products. Consistent with the NOSB
recommendation, this final rule amends
§ 205.605(b) by removing the substance
exemption for tetrasodium
pyrophosphate. This amendment is
effective on tetrasodium
pyrophosphate’s current sunset date,
September 12, 2016. After that date,
tetrasodium pyrophosphate will be
prohibited in organic processing.
III. Related Documents
Two notices of public meetings with
request for comments were published in
Federal Register on September 8, 2014
(79 FR 53162) and on March 12, 2015
(80 FR 12975) to notify the public that
substances included in the 2016 sunset
review would expire on September 12,
2016, if not reviewed by the NOSB and
renewed by the Secretary. The listings
for egg white lysozyme,
cyclohexylamine, diethylaminoethanol,
octadecylamine, and tetrasodium
pyrophosphate were added to the
National List on September 12, 2006 (71
FR 53299). The proposed rule to remove
the allowance for the use of these
substances in organic handling was
published on December 16, 2015 (80 FR
78150).
IV. Statutory and Regulatory Authority
OFPA, as amended (7 U.S.C. 6501–
6522), authorizes the Secretary to make
amendments to the National List based
on proposed recommendations
developed by the NOSB. Sections
6518(k)(2) and 6518(n) of OFPA
authorize the NOSB to develop
proposed amendments to the National
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51077
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 § 205.607
of the USDA organic regulations. The
National List Petition Guidelines (NOP
3011) are published in the NOP
Handbook which is available on the
AMS Web site, https://
www.ams.usda.gov/nop. This describes
the information to be included for all
types of petitions submitted to amend
the National List.1 AMS published a
revised sunset review process in the
Federal Register on September 16, 2013
(78 FR 56811).
A. Executive Order 12866
This action has been determined to be
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 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 section
6514(b) of OFPA. States are also
preempted under sections 6503 through
6507 of OFPA 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 OFPA.
Pursuant to section 6507(b)(2) of
OFPA, 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
1 These guidelines supersede the ‘‘Submission of
Petitions of Substances for Inclusion on or Removal
From the National List of Substances Allowed and
Prohibited in Organic Production and Handling,’’
published January 18, 2007 in the Federal Register
(72 FR 2167), which is now obsolete.
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purposes of OFPA, (b) not be
inconsistent with 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 section 6519(f) of OFPA,
this proposed rule would not alter the
authority of the Secretary under the
Federal Meat Inspection Act (21 U.S.C.
601–624), the Poultry Products
Inspection Act (21 U.S.C. 451–471), or
the Egg Products Inspection Act (21
U.S.C. 1031–1056), 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.
301–399), nor the authority of the
Administrator of EPA under the Federal
Insecticide, Fungicide, and Rodenticide
Act (7 U.S.C. 136–136(y)).
Section 6520 of OFPA 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. 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
of the RFA 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, 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). 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 prohibit the
use of five nonorganic nonagricultural
substances that have limited public
support and may no longer be used
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since nonorganic nonagricultural
alternatives to these substances have
been developed and implemented by
food processors. AMS concludes that
the economic impact of removing the
nonorganic nonagricultural substance,
egg white lysozyme, cyclohexylamine,
diethylaminoethanol, octadecylamine,
and tetrasodium pyrophosphate would
be minimal to small agricultural firms
since alternative practices and
nonagricultural products may be
commercially available. As such, these
substances are proposed to be removed
from the National List under this rule.
Accordingly, AMS 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, National
Agricultural Statistics Service (NASS),
certified organic acreage exceeded 3.6
million acres in 2014.2 According to
NOP’s Accreditation and International
Activities Division, the number of
certified U.S. organic crop and livestock
operations totaled over 19,470 in 2014.
The list of certified operations is
available on the NOP Web site at https://
apps.ams.usda.gov/nop/. AMS believes
that most of these entities would be
considered small entities under the
criteria established by the SBA. U.S.
sales of organic food and non-food have
grown from $1 billion in 1990 to $39.1
billion in 2014, an 11.3 percent growth
over 2013 sales.3 In addition, the USDA
has 80 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 Web site, at https://
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. Certifying agents report 31,020
certified operations worldwide in 2015.4
2 U.S. Department of Agriculture, National
Agricultural Statistics Service. September 2015.
2014 Certified Organic Productions Survey.
3 Organic Trade Association. 2014. Organic
Industry Survey. www.ota.com.
4 USDA, AMS, National Organic Program,
Organic INTEGRITY Database, https://
apps.ams.usda.gov/integrity/.
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D. Paperwork Reduction Act
No additional collection or
recordkeeping requirements are
imposed on the public by this rule.
Accordingly, OMB clearance is not
required by the Paperwork Reduction
Act of 1995, 44 U.S.C. 3501, Chapter 35.
E. Executive Order 13175
This rule has been reviewed in
accordance with the requirements of
Executive Order 13175, Consultation
and Coordination with Indian Tribal
Governments. The review reveals that
this regulation will not have substantial
and direct effects on Tribal governments
and will not have significant Tribal
implications.
F. Comments Received on Proposed
Rule AMS–NOP–15–0052; NOP–15–12
AMS received nine comments from
two consumers, one certifying agent,
and six manufacturers (of organic
products and ingredients used in
organic products) on proposed rule
AMS–NOP–15–0052. These written
comments can be viewed at https://
www.regulations.gov by searching for
the document: AMS–NOP–15–0052.
One comment presented general
concerns about organic inspections that
are not within the scope of this rule.
One comment stated general opposition
to all chemicals in organic production
and agreed with the proposal to remove
five nonorganic, nonagricultural
substances from the National List.
Changes Requested But Not Made
The comments of a certifying agent
and six manufacturers opposed the
proposal to remove the allowance for
egg white lysozyme in organic
processing. These comments indicated
that egg white lysozyme is used in the
production of wine, beer and hard
cheeses. The comments did not specify
the prevalence of egg white lysozyme in
organic processing or provide
compelling information to explain why
this substance is essential in organic
processing. Therefore, AMS is
implementing the NOSB
recommendation to remove this
substance from the National List.
No comments addressed the proposed
removal of cyclohexylamine,
diethylaminoethanol, octadecylamine,
and tetrasodium pyrophosphate.
Consistent with the NOSB
recommendations, this final rule
amends § 205.605 by removing egg
white lysozyme, cyclohexylamine,
diethylaminoethanol, octadecylamine,
and tetrasodium pyrophosphate.
This amendment is effective on the
current sunset date, September 12, 2016.
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After that date, these substances will be
prohibited in organic processing.
List of Subjects in 7 CFR Part 205
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 is 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.
§ 205.605
[Amended]
2. Amend § 205.605 by:
A. In paragraph (a), remove the
substance ‘‘Egg white lysozyme (CAS #
9001–63–2)’’.
■ B. In paragraph (b), remove the
substances ‘‘Cyclohexylamine (CAS #
108–91–8)—for use only as a boiler
water additive for packaging
sterilization’’; ‘‘Diethylaminoethanol
(CAS # 100–37–8)—for use only as a
boiler water additive for packaging
sterilization’’; ‘‘Octadecylamine (CAS #
124–30–1)—for use only as a boiler
water additive for packaging
sterilization’’; and ‘‘Tetrasodium
pyrophosphate (CAS # 7722–88–5)—for
use only in meat analog products’’.
■
■
Dated: July 26, 2016.
Elanor Starmer,
Administrator, Agricultural Marketing
Service.
[FR Doc. 2016–18108 Filed 8–2–16; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Parts 13 and 406
[Docket No. FAA–2016–7004 Amdt. Nos. 13–
38, 406–10]
RIN 2120–AK90
Revisions to the Civil Penalty Inflation
Adjustment Tables; Correction
Federal Aviation
Administration (FAA), DOT.
ACTION: Interim final rule; correction.
rmajette on DSK2TPTVN1PROD with RULES
AGENCY:
The FAA is correcting an
interim final rule titled ‘‘Revisions to
the Civil Penalty Inflation Adjustment
Tables’’ that it published in the Federal
Register on July 5, 2016. That interim
final rule was the catch-up inflation
SUMMARY:
VerDate Sep<11>2014
14:12 Aug 02, 2016
Jkt 238001
adjustment to civil penalty amounts that
may be imposed for violations of
Federal Aviation Administration (FAA)
regulations, as required by the Federal
Civil Penalties Inflation Adjustment Act
Improvements Act of 2015. In that
document, there were several errors that
need to be corrected before the rule
becomes effective. This document
addresses those errors.
DATES: This correction is effective on
August 5, 2016.
FOR FURTHER INFORMATION CONTACT: Cole
R. Milliard, Attorney, Office of the Chief
Counsel, Enforcement Division, AGC–
300, Federal Aviation Administration,
800 Independence Avenue SW.,
Washington, DC 20591; telephone (202)
267–3452; email Cole.Milliard@faa.gov.
SUPPLEMENTARY INFORMATION: Prior to
the July 5 final rule’s publication, the
Pipeline and Hazardous Materials Safety
Administration (PHMSA), the
Department of Transportation (DOT)
agency primarily responsible for
developing and enforcing hazardous
materials regulations, published its
catch-up adjustments for civil penalties,
including those for violations of 49
U.S.C. 5123(a)(3). The FAA is amending
its catch-up adjustment for 49 U.S.C.
5123(a)(3) to harmonize it with
PHMSA’s.
Background
On July 5, 2016, the FAA published
an interim final rule titled ‘‘Revisions to
the Civil Penalty Inflation Adjustment
Tables’’ (81 FR 43463). The intent of
that rule is to implement the Federal
Civil Penalties Inflation Adjustment Act
of 1990 (FCPIAA), Public Law (Pub. L.)
101–410, as amended by the Debt
Collection Improvement Act (DCIA) of
1996, Pub. L. 104–134, and the Federal
Civil Penalties Inflation Adjustment Act
Improvements Act of 2015 (2015 Act),
Pub. L. 114–74, codified at 28 U.S.C.
2461 note.
The FCPIAA, DCIA, and the 2015 Act
require Federal agencies to adjust
minimum and maximum civil penalty
amounts for inflation to preserve their
deterrent impact. The 2015 Act
amended the formula and frequency of
inflation adjustments. It required an
initial catch-up adjustment in the form
of an interim final rule, followed by
annual adjustments of penalty amounts.
The amount of the adjustment must be
made using a strict statutory formula
that was discussed in the final rule and
is corrected as indicated below.
As mentioned above, the FAA’s
interim final rule was published on July
5, 2016, and included an inflation
adjustment for civil penalties associated
with hazardous materials training
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
51079
violations under 49 U.S.C. 5123(a)(3).
On June 29, 2016, prior to the FAA’s
civil penalty inflation adjustment
publication, the Pipeline and Hazardous
Materials Safety Administration
(PHMSA), the DOT agency primarily
responsible for developing and
enforcing hazardous materials
regulations, also published its catch-up
adjustments for civil penalties,
including those for violations of 49
U.S.C. 5123(a)(3). PHMSA, however,
came up with a different adjustment to
the minimum penalty for training than
the FAA. PHMSA read technical
amendments made to section 5123(a)(3)
in 2012 to be adjusting the minimum
penalty back down from a 2009 PHMSA
inflation adjustment. See Moving Ahead
for Progress in the 21st Century Act
(MAP–21), Pub. L. 112–141, 33010, 126
Stat. 405, 837, (2012); 74 FR 68701 (Dec.
29, 2009). It therefore concluded that
2012 was the year the minimum penalty
was established or adjusted. FAA
concluded that 2005 was the correct
year upon which to base adjustments
because Congress established the $450
minimum that year and did not change
it in its 2012 amendments. Compare
Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for
Users (SAFETEA–LU), Pub. L. 109–59,
7120, 119 Stat. 1144, 1905 (2005) with
MAP–21, 126 Stat. at 837. Because
PHMSA is the primary DOT agency in
the area of hazardous materials safety,
and because its calculation is
reasonable, the FAA is correcting its
catch-up adjustment to harmonize it
with PHMSA’s.
The FAA is also making technical
corrections to its interim final rule.
First, it is correcting the effective date
noted in the table included in 14 CFR
13.301(c), to reflect the correct effective
date of August 5, 2016 (not August 1,
2016). Second, the word ‘‘established’’
is replacing the word ‘‘set’’ when used
in reference to the ‘‘catch-up
adjustment’’ formula provided by the
2015 Act to make the text of the interim
final rule consistent with the statutory
text of the 2015 Act. Finally, the FAA
is correcting the reference to ‘‘section
5123’’ in the hazmat adjustment
example for 49 U.S.C. 5123(a)(1),
provided in the background section of
the interim final rule, to specifically
reference section 5123(a)(1).
Correction
In FR Doc. 2016–7004, beginning on
page 43463 in the Federal Register of
July 5, 2016, make the following
corrections:
1. On page 43464, in the second
column, under the heading
‘‘Background’’, in the second paragraph,
E:\FR\FM\03AUR1.SGM
03AUR1
]]>Agencies
[Federal Register Volume 81, Number 149 (Wednesday, August 3, 2016)]
[Rules and Regulations]
[Pages 51075-51079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18108]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 /
Rules and Regulations
[[Page 51075]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS-NOP-15-0052; NOP-15-12]
RIN 0581-AD43
National Organic Program (NOP); Sunset 2016 Amendments to the
National List
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule addresses recommendations submitted to the
Secretary of Agriculture (Secretary) by the National Organic Standards
Board (NOSB) following their April 2015 meeting. These recommendations
pertain to the 2016 sunset review of substances on the U.S. Department
of Agriculture's (USDA) National List of Allowed and Prohibited
Substances (National List). Consistent with the recommendations from
the NOSB, this final rule removes five nonorganic nonagricultural
substances from the National List for use in organic handling: Egg
white lysozyme, cyclohexylamine, diethylaminoethanol, octadecylamine,
and tetrasodium pyrophosphate when their use exemptions (allowances)
expire on September 12, 2016.
DATES: Effective Date: This rule is effective on September 12, 2016.
FOR FURTHER INFORMATION CONTACT: Paul Lewis, Ph.D., Director, Standards
Division, Telephone: (202) 720-3252; Fax: (202) 260-9151.
SUPPLEMENTARY INFORMATION:
I. Background
The National Organic Program (NOP) is authorized by the Organic
Foods Production Act of 1990 (OFPA), as amended (7 U.S.C. 6501-6522).
The USDA Agricultural Marketing Service (AMS) administers the NOP.
Final regulations implementing the NOP, also referred to as the USDA
organic regulations, were published December 21, 2000 (65 FR 80548),
and became effective on October 21, 2002. Through these regulations,
the AMS oversees national standards for the production, handling, and
labeling of organically produced agricultural products. Since becoming
effective, the USDA organic regulations have been frequently amended,
mostly for changes to the National List in 7 CFR 205.601-205.606.
This National List identifies the synthetic substances that may be
used and the nonsynthetic substances that may not be used in organic
production. The National List also identifies synthetic, nonsynthetic
nonagricultural, and nonorganic agricultural substances that may be
used in organic handling. The OFPA and the USDA organic regulations, as
indicated in Sec. 205.105, specifically prohibit the use of any
synthetic substance in organic production and handling unless the
synthetic substance is on the National List. Section 205.105 also
requires that any nonorganic agricultural substance and any
nonsynthetic nonagricultural substance used in organic handling appear
on the National List.
As stipulated by the OFPA, the NOSB develops recommendations to
amend the National List. The NOSB operates in accordance with the
Federal Advisory Committee Act (5 U.S.C. App. 2 et seq.), to assist in
the evaluation of substances to be used or not used in organic
production and handling, and to advise the Secretary on the USDA
organic regulations. The OFPA also requires a sunset review of all
substances included on the National List within five years of their
addition to or renewal on the list. If a listed substance is not
reviewed by the NOSB and renewed by the USDA within the five year
period, its allowance or prohibition on the National List is no longer
in effect. Under the authority of the OFPA, the Secretary can amend the
National List through rulemaking based upon proposed amendments
recommended by the NOSB.
The NOSB's recommendations to continue existing exemptions and
prohibitions include consideration of public comments and applicable
supporting evidence that express a continued need for the use or
prohibition of the substance(s) as required by the OFPA.
Recommendations to either continue or discontinue an authorized
exempted synthetic substance (7 U.S.C. 6517(c)(1)) are determined by
the NOSB's evaluation of technical information, public comments, and
supporting evidence that demonstrate that the substance is: (a) Harmful
to human health or the environment; (b) no longer necessary for organic
production due to the availability of alternative wholly nonsynthetic
substitute products or practices; or (c) inconsistent with organic
farming and handling practices.
In accordance with the sunset review process published in the
Federal Register on September 16, 2013 (78 FR 61154), this final rule
would amend the National List to reflect recommendations submitted to
the Secretary by the NOSB on April 30, 2015, to amend the National List
to remove five substances allowed as ingredients in or on processed
products labeled as ``organic.'' The exemptions of each substance
appearing on the National List for use in organic production and
handling are evaluated by the NOSB using the evaluation criteria
specified on the OFPA (7 U.S.C. 6517-6518).
II. Overview of Amendments
Nonrenewals
After considering public comments and supporting documents, the
NOSB determined that one substance allowed on Sec. 205.605(a) and four
substances allowed on Sec. 205.605(b) of the National List are no
longer necessary or essential for organic handling. The NOSB concluded
that practices and other substances are suitable alternatives to egg
white lysozyme, cyclohexylamine, diethylaminoethanol, octadecylamine,
and tetrasodium pyrophosphate. AMS has reviewed and accepts the five
NOSB recommendations for removal. Based upon these NOSB
recommendations, this action amends the National List to remove the
exemptions for egg white lysozyme, cyclohexylamine,
diethylaminoethanol, octadecylamine, and tetrasodium pyrophosphate when
their use exemptions expire on September 12, 2016.
[[Page 51076]]
Egg white lysozyme
The USDA organic regulations include an exemption on the National
List for egg white lysozyme as a nonsynthetic ingredient for use in
organic processed products at Sec. 205.605(a) as follows: Egg white
lysozyme (CAS # 9001-63-2). In 2004, egg white lysozyme was petitioned
for addition to Sec. 205.605 because it was considered to be an
essential processing aid/preservative for controlling bacteria that
survived the pasteurization process of milk that is used for cheese
manufacture. As recommended by the NOSB, egg white lysozyme was added
to the National List on September 12, 2006 (71 FR 53299). The NOSB
recommended the renewal of egg white lysozyme during their 2011 sunset
review and the listing was renewed in a final rule published on August
3, 2011 (76 FR 46595). The NOSB completed the 2016 sunset review for
the allowance of egg white lysozyme at their April 2015 meeting.
AMS published two notices of the NOSB public meetings covering the
2016 sunset review, in Federal Register on September 8, 2014 (79 FR
53162) and on March 12, 2015 (80 FR 12975) with requests for comments.
Their purpose was to notify the public that the allowance for egg white
lysozyme would expire on September 12, 2016, if not reviewed by the
NOSB and renewed by the Secretary. During their sunset review
deliberation, the NOSB considered written comments received prior to
and during the public meetings on all substances included in the 2016
sunset review. These written comments can be viewed at https://www.regulations.gov by searching for the documents: AMS-NOP-14-0063
(October 2014 NOSB public meeting) and AMS-NOP-15-0002 (April 2015 NOSB
public meeting). The NOSB also considered oral comments received during
these public meetings which are included in the meeting transcripts
available on the AMS Web site at https://www.ams.usda.gov/nop. During
their sunset review of egg white lysozyme the NOSB considered two
technical reports on enzymes that were requested by and developed for
the NOSB in 2011 and 2003, which are also available for review on the
AMS Web site.
Public comments provided the NOSB with information about the
availability of practice-based alternatives to the use of egg white
lysozyme. Such comments provided limited information to support the
continued need for egg white lysozyme in organic processed products.
Based on those public comments, the NOSB determined that the allowance
for egg white lysozyme on the National List in Sec. 205.605(a) is no
longer necessary or essential for organic processed products.
Subsequently, the NOSB recommended removal of egg white lysozyme from
the National List at their April 2015 public meeting.
A proposed rule to remove egg white lysozyme from the National List
was published on December 16, 2015 (80 FR 78150). AMS received comments
that egg white lysozyme is used in the organic processing of beer, wine
and hard cheeses. The prevalence of use in organic processing could not
be ascertained from the public comments. Further, the comments did not
assert that egg white lysozyme is essential in organic processing.
Therefore, consistent with the NOSB recommendation, this final rule
amends Sec. 205.605(a) by removing the allowance for egg white
lysozyme. This amendment is effective on egg white lysozyme's sunset
date, September 12, 2016. After that date, egg white lysozyme will be
prohibited in organic processing.
Cyclohexylamine, Diethylaminoethanol and Octadecylamine
The USDA organic regulations include allowances on the National
List for cyclohexylamine, diethylaminoethanol and octadcylamine as
processing aids for use in organic processing at Sec. 205.605(b) as
follows:
Cyclohexylamine (CAS # 108-91-8)--for use only as a boiler water
additive for packaging sterilization.
Diethylaminoethanol (CAS # 100-37-8)--for use only as a boiler
water additive for packaging sterilization.
Octadecylamine (CAS # 124-30-1)--for use only as a boiler water
additive for packaging sterilization.
Cyclohexylamine, diethylaminoethanol and octadcylamine were added
to the National List on September 12, 2006 (71 FR 53299). The NOSB
recommended the renewal of cyclohexylamine, diethylaminoethanol and
octadcylamine during their 2011 sunset review. AMS published a notice
renewing the allowances for cyclohexylamine, diethylaminoethanol and
octadcylamine the National List on August 3, 2011 (76 FR 46595).
Subsequently, the NOSB considered the allowances for
cyclohexylamine, diethylaminoethanol, and octadcylamine during the 2016
sunset review. AMS published two notices in the Federal Register
announcing the NOSB public meetings and requesting public comments on
September 8, 2014 (79 FR 53162) and on March 12, 2015 (80 FR 12975).
Their purpose was to notify the public that the allowances for
cyclohexylamine, diethylaminoethanol and octadcylamine would expire on
September 12, 2016, if not reviewed by the NOSB and renewed by the
Secretary. During their 2016 sunset review deliberation, the NOSB
considered written comments received prior to and during the public
meetings on all substances included in the 2016 sunset review. These
written comments can be viewed at https://www.regulations.gov by
searching for the document: AMS-NOP-14-0063 (October 2014 NOSB meeting)
and AMS-NOP-15-0002 (April 2015 NOSB meeting). The NOSB also considered
oral comments received during these public meetings which are included
in the meeting transcripts available on the AMS Web site at https://www.ams.usda.gov/nop. During their 2016 sunset review, the NOSB
considered technical reports on cyclohexylamine, diethylaminoethanol,
and octadcylamine that were requested by and developed for the NOSB in
2001; these are available for review on the AMS Web site.
The September 2014 and April 2015 NOSB meeting notices requested
information on the continued use of cyclohexylamin,
diethylaminoethanol, or octadcylamine as boiler water additives in
organic processing. Public comment in response to these requests
informed the NOSB that organic processors are phasing out these
materials. The comments provided limited information supporting the
continued need for the use of cyclohexylamine, diethylaminoethanol, or
octadcylamine as boiler water additives. The NOSB cited information
from public comments and the potential for adverse human health and
environmental impacts in their conclusion that the allowances for
cyclohexylamine, diethylaminoethanol, or octadcylamine on Sec.
205.605(b) are no longer necessary or essential in organic processing.
Therefore, the NOSB recommended that cyclohexylamine,
diethylaminoethanol, and octadcylamine be removed from the National
List.
AMS published a proposed rule with a request for comments on
December 16, 2015 (80 FR 78150). No public comments were received
supporting the continued use of cyclohexylamine, diethylaminoethanol,
and octadcylamine in organic processing. Consistent with the NOSB
recommendation, this final rule amends Sec. 205.605(b) by removing the
allowances for cyclohexylamine, diethylaminoethanol, and octadcylamine.
This amendment is effective on cyclohexylamine,
[[Page 51077]]
diethylaminoethanol, and octadcylamine's current sunset date, September
12, 2016. After that date, these substances are prohibited in organic
processing.
Tetrasodium Pyrophosphate
The USDA organic regulations include an exemption on the National
List for tetrasodium pyrophosphate as an ingredient for use in organic
processed products at Sec. 205.605(b) as follows: Tetrasodium
pyrophosphate (CAS # 7722-88-5)--for use only in meat analog products.
In December 2001, tetrasodium pyrophosphate was petitioned for addition
onto Sec. 205.605 for use as an ingredient in organic food processing
facilities. As recommended by the NOSB, tetrasodium pyrophosphate was
added to the National List on September 12, 2006 (71 FR 53299). In the
2011 sunset review, the NOSB recommended renewing the allowance for
tetrasodium pyrophosphate. Consistent with the NOSB recommendation, AMS
published a notice in the Federal Register renewing the tetrasodium
pyrophosphate exemption on the National List on August 3, 2011 (76 FR
46595).
For the 2016 sunset review, AMS published two notices in Federal
Register announcing the NOSB public meetings and requesting comments on
September 8, 2014 (79 FR 53162) and on March 12, 2015 (80 FR 12975).
The notices informed the public that the tetrasodium pyrophosphate
exemption would expire on September 12, 2016, if not reviewed by the
NOSB and renewed by the Secretary and to request information on the
necessity of tetrasodium pyrophosphate as an ingredient in organic food
processing. During their 2016 sunset review deliberation, the NOSB
considered written comments received prior to and during the public
meetings on all substance exemptions included in the 2016 sunset
review. These written comments can be viewed at https://www.regulations.gov by searching for the document: AMS-NOP-14-0063
(October 2014 public meeting) and AMS-NOP-15-0002 (April 2015 public
meeting). The NOSB also considered oral comments received during these
public meetings which are included in the meeting transcripts available
on the AMS Web site at https://www.ams.usda.gov/nop. In addition, during
their 2016 sunset review, the NOSB considered two technical reports on
tetrasodium pyrophosphate that were requested by and developed for the
NOSB in 2014 and 2002; these are available for review on the AMS Web
site.
Public comment to the NOSB did not support a continued need for
tetrasodium pyrophosphate in the production of organic processed
products and informed that various alternative substances are
available. Based on public comments and information in the 2014
technical report on tetrasodium pyrophosphate, the NOSB determined that
there are alternatives to this substances that may be more compatible
with organic production. Therefore, the NOSB determined that the
allowance for tetrasodium pyrophosphate on Sec. 205.605(b) is no
longer necessary or essential for organic processed products and
recommended that tetrasodium pyrophosphate be removed from the National
List.
A proposed rule with a request for comments was published on
December 16, 2015 (80 FR 78150), and no public comments were received
supporting the continued use of tetrasodium pyrophosphate in processed
organic products. Consistent with the NOSB recommendation, this final
rule amends Sec. 205.605(b) by removing the substance exemption for
tetrasodium pyrophosphate. This amendment is effective on tetrasodium
pyrophosphate's current sunset date, September 12, 2016. After that
date, tetrasodium pyrophosphate will be prohibited in organic
processing.
III. Related Documents
Two notices of public meetings with request for comments were
published in Federal Register on September 8, 2014 (79 FR 53162) and on
March 12, 2015 (80 FR 12975) to notify the public that substances
included in the 2016 sunset review would expire on September 12, 2016,
if not reviewed by the NOSB and renewed by the Secretary. The listings
for egg white lysozyme, cyclohexylamine, diethylaminoethanol,
octadecylamine, and tetrasodium pyrophosphate were added to the
National List on September 12, 2006 (71 FR 53299). The proposed rule to
remove the allowance for the use of these substances in organic
handling was published on December 16, 2015 (80 FR 78150).
IV. Statutory and Regulatory Authority
OFPA, as amended (7 U.S.C. 6501-6522), authorizes the Secretary to
make amendments to the National List based on proposed recommendations
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 USDA organic regulations. The National List Petition
Guidelines (NOP 3011) are published in the NOP Handbook which is
available on the AMS Web site, https://www.ams.usda.gov/nop. This
describes the information to be included for all types of petitions
submitted to amend the National List.\1\ AMS published a revised sunset
review process in the Federal Register on September 16, 2013 (78 FR
56811).
---------------------------------------------------------------------------
\1\ These guidelines supersede the ``Submission of Petitions of
Substances for Inclusion on or Removal From the National List of
Substances Allowed and Prohibited in Organic Production and
Handling,'' published January 18, 2007 in the Federal Register (72
FR 2167), which is now obsolete.
---------------------------------------------------------------------------
A. Executive Order 12866
This action has been determined to be 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 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 section
6514(b) of OFPA. States are also preempted under sections 6503 through
6507 of OFPA 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 OFPA.
Pursuant to section 6507(b)(2) of OFPA, 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
[[Page 51078]]
purposes of OFPA, (b) not be inconsistent with 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 section 6519(f) of OFPA, this proposed rule would not
alter the authority of the Secretary under the Federal Meat Inspection
Act (21 U.S.C. 601-624), the Poultry Products Inspection Act (21 U.S.C.
451-471), or the Egg Products Inspection Act (21 U.S.C. 1031-1056),
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. 301-399), nor the authority of the
Administrator of EPA under the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136-136(y)).
Section 6520 of OFPA 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. 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 of
the RFA 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, 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). 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 prohibit the
use of five nonorganic nonagricultural substances that have limited
public support and may no longer be used since nonorganic
nonagricultural alternatives to these substances have been developed
and implemented by food processors. AMS concludes that the economic
impact of removing the nonorganic nonagricultural substance, egg white
lysozyme, cyclohexylamine, diethylaminoethanol, octadecylamine, and
tetrasodium pyrophosphate would be minimal to small agricultural firms
since alternative practices and nonagricultural products may be
commercially available. As such, these substances are proposed to be
removed from the National List under this rule. Accordingly, AMS
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, National Agricultural Statistics Service (NASS),
certified organic acreage exceeded 3.6 million acres in 2014.\2\
According to NOP's Accreditation and International Activities Division,
the number of certified U.S. organic crop and livestock operations
totaled over 19,470 in 2014. The list of certified operations is
available on the NOP Web site at https://apps.ams.usda.gov/nop/. AMS
believes that most of these entities would be considered small entities
under the criteria established by the SBA. U.S. sales of organic food
and non-food have grown from $1 billion in 1990 to $39.1 billion in
2014, an 11.3 percent growth over 2013 sales.\3\ In addition, the USDA
has 80 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 Web site, at
https://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. Certifying agents report 31,020 certified
operations worldwide in 2015.\4\
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\2\ U.S. Department of Agriculture, National Agricultural
Statistics Service. September 2015. 2014 Certified Organic
Productions Survey.
\3\ Organic Trade Association. 2014. Organic Industry Survey.
www.ota.com.
\4\ USDA, AMS, National Organic Program, Organic INTEGRITY
Database, https://apps.ams.usda.gov/integrity/.
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D. Paperwork Reduction Act
No additional collection or recordkeeping requirements are imposed
on the public by this rule. Accordingly, OMB clearance is not required
by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, Chapter 35.
E. Executive Order 13175
This rule has been reviewed in accordance with the requirements of
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments. The review reveals that this regulation will not have
substantial and direct effects on Tribal governments and will not have
significant Tribal implications.
F. Comments Received on Proposed Rule AMS-NOP-15-0052; NOP-15-12
AMS received nine comments from two consumers, one certifying
agent, and six manufacturers (of organic products and ingredients used
in organic products) on proposed rule AMS-NOP-15-0052. These written
comments can be viewed at https://www.regulations.gov by searching for
the document: AMS-NOP-15-0052.
One comment presented general concerns about organic inspections
that are not within the scope of this rule. One comment stated general
opposition to all chemicals in organic production and agreed with the
proposal to remove five nonorganic, nonagricultural substances from the
National List.
Changes Requested But Not Made
The comments of a certifying agent and six manufacturers opposed
the proposal to remove the allowance for egg white lysozyme in organic
processing. These comments indicated that egg white lysozyme is used in
the production of wine, beer and hard cheeses. The comments did not
specify the prevalence of egg white lysozyme in organic processing or
provide compelling information to explain why this substance is
essential in organic processing. Therefore, AMS is implementing the
NOSB recommendation to remove this substance from the National List.
No comments addressed the proposed removal of cyclohexylamine,
diethylaminoethanol, octadecylamine, and tetrasodium pyrophosphate.
Consistent with the NOSB recommendations, this final rule amends
Sec. 205.605 by removing egg white lysozyme, cyclohexylamine,
diethylaminoethanol, octadecylamine, and tetrasodium pyrophosphate.
This amendment is effective on the current sunset date, September
12, 2016.
[[Page 51079]]
After that date, these substances will be prohibited in organic
processing.
List of Subjects in 7 CFR Part 205
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 is
amended as follows:
PART 205--NATIONAL ORGANIC PROGRAM
0
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]
0
2. Amend Sec. 205.605 by:
0
A. In paragraph (a), remove the substance ``Egg white lysozyme (CAS #
9001-63-2)''.
0
B. In paragraph (b), remove the substances ``Cyclohexylamine (CAS #
108-91-8)--for use only as a boiler water additive for packaging
sterilization''; ``Diethylaminoethanol (CAS # 100-37-8)--for use only
as a boiler water additive for packaging sterilization'';
``Octadecylamine (CAS # 124-30-1)--for use only as a boiler water
additive for packaging sterilization''; and ``Tetrasodium pyrophosphate
(CAS # 7722-88-5)--for use only in meat analog products''.
Dated: July 26, 2016.
Elanor Starmer,
Administrator, Agricultural Marketing Service.
[FR Doc. 2016-18108 Filed 8-2-16; 8:45 am]
BILLING CODE 3410-02-P
