[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 http://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 http://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 http://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 http://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 http://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 http://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, http://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 http://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 
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. 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/.
---------------------------------------------------------------------------

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 http://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