80 FR 77231 - National Organic Program (NOP); Sunset 2015 Amendments to the National List
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service Federal Register Volume 80, Issue 239 (December 14, 2015)
Agricultural Marketing Service
Federal Register Volume 80, Issue 239 (December 14, 2015)
| Page Range | 77231-77234 | |
| FR Document | 2015-31413 |
[Federal Register Volume 80, Number 239 (Monday, December 14, 2015)] [Rules and Regulations] [Pages 77231-77234] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31413] ======================================================================== 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. 80, No. 239 / Monday, December 14, 2015 / Rules and Regulations [[Page 77231]] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS-NOP-15-0015; NOP-15-07] RIN 0581-AD39 National Organic Program (NOP); Sunset 2015 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 October 2014 meeting. These recommendations pertain to the 2015 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 two nonorganic agricultural substances from the National List for use in organic handling, fortified cooking wines--marsala wine and sherry wine. This final rule also removes two listings for synthetic substances allowed for use in organic crop production on the National List, streptomycin and tetracycline, as their use exemptions expired on October 21, 2014. DATES: Effective Date: This final rule is effective on December 14, 2015. FOR FURTHER INFORMATION CONTACT: Robert Pooler, Standards Division, National Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW., Room 2642-So., Ag Stop 0268, Washington, DC 20250-0268. Telephone: (202) 720-3252; Fax: (202) 205-7808. 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, recommendations to propose amendment of the National List are developed by the NOSB, operating under 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 as 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. This rule removes the expired listings of two substances, streptomycin and tetracycline, as their National List exemptions expired on October 21, 2014. After this expiration date, the use of streptomycin and tetracycline in organic production is prohibited. While USDA accredited certifying agents are enforcing the prohibition of streptomycin and tetracycline, delisting of these substances from the National List reduces the likelihood of noncompliant use by organic producers. Following their October 2014 public meeting, the NOSB submitted their 2015 Sunset Review recommendations to the Secretary. This rule amends the National List to implement two NOSB recommendations to remove the substances, marsala wine and sherry wine, allowed as ingredients in or on processed products labeled as ``organic'' in Sec. 205.606. The National List exemptions of these substances for use in organic production and handling that were considered by the NOSB during the 2015 Sunset Review process were evaluated according to the evaluation criteria specified on the OFPA (7 U.S.C. 6517-6518). II. Overview of Amendments The following provides an overview of the amendments made to designated sections of the National List regulations: [[Page 77232]] Sec. 205.601 Synthetic Substances Allowed for Use in Organic Crop Production This final rule amends Sec. 205.601 of the National List regulations by removing (1) the expired substance exemption for streptomycin, for fire blight control in apples and pears only until October 21, 2014, in Sec. 205.601(i)(11), and (2) the expired substance exemption for tetracycline, for fire blight control in apples and pears only until October 21, 2014, in Sec. 205.601(i)(12). Streptomycin This rule amends Sec. 206.601 of the National List by removing the expired exemption for streptomycin, for fire blight control in apples and pears only until October 21, 2014. In 1995, streptomycin was recommended by the NOSB for addition as a plant disease control to the National List. The NOSB recommendation was accepted by the Secretary and streptomycin was included, as a plant disease control, in the initial final rule establishing the NOP that was published on December 21, 2000 (65 FR 80548). The listing for streptomycin was amended, as recommended by the NOSB, on June 6, 2012 (77 FR 33290) to add an expiration date to the streptomycin annotation: Streptomycin, for fire blight control in apples and pears only until October 21, 2014. This rule removes the listing for streptomycin that expired on October 21, 2014 from Sec. 205.601. Since the prohibition against the use of streptomycin has been effective since October 21, 2014, removal of this exempted substance from the National List has no new regulatory effect. Tetracycline This rule amends Sec. 206.601 of the National List by removing the expired exemption for tetracycline, for fire blight control in apples and pears only until October 21, 2014. Tetracycline was considered by the NOSB at their October 31-November 4, 1995, meeting. The NOSB recommendation was accepted by the Secretary and tetracycline was included, as a plant disease control, in the initial final rule establishing the NOP that was published on December 21, 2000 (65 FR 80548). Subsequently, as recommended by the NOSB, the listing for tetracycline was amended on August 2, 2012 (77 FR 45903) to add an expiration date to the tetracycline annotation: Tetracycline, for fire blight control in apples and pears only until October 21, 2014. This rule removes the exempted listing for tetracycline from Sec. 205.601 that expired on October 21, 2014. Since the prohibition against the use of tetracycline has been effective since October 21, 2014, the removal of this exempted substance from the National List has no new regulatory effect. Sec. 205.606 Nonorganically Produced Agricultural Products Allowed as Ingredients In or On Processed Products Labeled as ``Organic'' This final rule amends Sec. 205.606 of the National List by removing two substance exemptions listed in Sec. 205.606(g): Fortified cooking wines, (1) marsala, (2) sherry. This rule implements two NOSB recommendations from their 2015 Sunset review that were submitted to the Secretary on October 30, 2014. During their 2015 Sunset Review, the NOSB determined that two substance exemptions for marsala wine and sherry wine included on Sec. 205.606 of the National List are no longer necessary for organic handling. Marsala Wine The USDA organic regulations have included an exemption on the National List for fortified cooking wines as an ingredient for use in organic processed products at Sec. 205.606(g) as follows: Fortified cooking wines, (1) Marsala. In 2007, marsala wine was petitioned for addition to Sec. 205.606 because it was considered a key flavor ingredient that was not commercially available in organic form and quantity. As required by the OFPA, the exemption for marsala wine was considered during the NOSB's 2015 sunset review. During their sunset review deliberation, the NOSB received no public comments supporting the continued need for the use of nonorganic marsala wine in organic processed products. In addition, the NOSB considered evidence that only a few operations use marsala wine as an ingredient in organic processed products. Based upon this information, the NOSB determined that the exemption for marsala wine on Sec. 205.606 is no longer necessary or essential for organic processed products and voted for the removal of marsala wine from the National List, effective on December 14, 2015. Sherry Wine The USDA organic regulations have included an exemption on the National List for fortified cooking wine, sherry wine, as an ingredient for use in organic processed products at Sec. 205.606(g) as follows: Fortified cooking wines, (2) Sherry. In 2007, sherry wine was petitioned for addition to Sec. 205.606 because it was considered a key flavor ingredient that was not commercially available in organic form or quantity. As required by the OFPA, the exemption for sherry wine was considered during the NOSB's 2015 sunset review. During their sunset review deliberation, the NOSB received no public comments supporting the continued need for the use of nonorganic sherry wine in organic processed products. In addition, the NOSB considered evidence that only a few operations use sherry wine as an ingredient in organic processed products. Based upon this information, the NOSB determined that the exemption for sherry wine as listed on Sec. 205.606 is no longer necessary or essential for organic processed products and voted for the removal of sherry wine from the National List, effective on December 14, 2015. This rule amends Sec. 205.606 by redesignating paragraphs (h) through (z) as (g) through (y), respectively. III. Related Documents Two notices of public meeting with request for comments were published in Federal Register on March 10, 2014 (79 FR 13272) and on September 8, 2014 (79 FR 53162) to notify the public that the 2015 sunset review listings discussed in this proposed rule would expire on December 14, 2015, if not reviewed by the NOSB and renewed by the Secretary. The listing for both streptomycin and tetracycline was added to the National List by the final rule (65 FR 80548) published in the Federal Register on December 21, 2000. Subsequently, an expiration date of October 21, 2014 was added to the streptomycin and tetracycline annotations on June 6, 2012 (77 FR 33290) and on August 2, 2012 (77 FR 45903). The proposal to address the substances in this final rule was published in the Federal Register on July 30, 2015 (80 FR 45499). 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 current petition process was published on January 18, 2007 (72 FR 2167) and [[Page 77233]] can be accessed through the NOP Web site at http://www.ams.usda.gov/nop. 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 final 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 2115(b) of OFPA (7 U.S.C. 6514(b)). States are also preempted under section 2104 through 2108 of OFPA (7 U.S.C. 6503-6507) from creating certification programs to certify organic farms or handling operations unless the State programs have been submitted to, and approved by, the Secretary as meeting the requirements of OFPA. Pursuant to section 2108(b)(2) of OFPA (7 U.S.C. 6507(b)(2)), a State organic certification program may contain additional requirements for the production and handling of organically produced agricultural products that are produced in the State and for the certification of organic farm and handling operations located within the State under certain circumstances. Such additional requirements must: (a) Further the purposes of 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 2120(f) of OFPA (7 U.S.C. 6519(f)), this 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 2121 of OFPA (7 U.S.C. 6520) provides for the Secretary to establish an expedited administrative appeals procedure under which persons may appeal an action of the Secretary, the applicable governing State official, or a certifying agent under this title that adversely affects such person or is inconsistent with the organic certification program established under this title. 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 rule would not be significant. The effect of this rule would be to prohibit the use of two nonorganic agricultural products that may be available in organic form for use in organic processed products. AMS concludes that the economic impact of removing the nonorganic agricultural products, marsala wine and sherry wine, would be minimal to small agricultural firms since organic form of these agricultural products or organic forms of alternative agricultural products may be commercially available and, as such, their nonorganic forms 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 3.5 million acres in 2011.\1\ 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.\2\ 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 NOP Web site, at http://www.ams.usda.gov/services/organic-certification/certifying-agents. AMS believes that most of these accredited certifying agents would be considered small entities under the criteria established by the SBA. Certifying agents reported 27,810 certified operations worldwide in 2014. --------------------------------------------------------------------------- \1\ U.S. Department of Agriculture, National Agricultural Statistics Service. October 2012. 2011 Certified Organic Productions Survey. \2\ Organic Trade Association. 2014. Organic Industry Survey. www.ota.com. --------------------------------------------------------------------------- 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 section 350(h) of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, Chapter 35, or OMB's implementing regulations at 5 CFR part 1320. 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. [[Page 77234]] F. Comments Received on Proposed Rule AMS-NOP-15-0015; NOP-15-07 AMS received two comments on proposed rule AMS-NOP-15-0015. Only one comment from a consumer addressed the 2015 Sunset review amendments to remove marsala and sherry wines from the National List. The second comment was from a California apple producer and it addressed removing the expired listings, streptomycin and tetracycline, from the National List. The consumer who commented on removing marsala and sherry wines from the National List agreed with the proposed amendment to prohibit the use of these nonorganic ingredients in foods labeled as organic. During their sunset review of marsala and sherry, the NOSB did not receive comments supporting the continued use of these wines as nonorganic ingredients in organic products. Additionally, since no comments were received opposing the removal of marsala and sherry wines from the National List, AMS is finalizing these amendments as proposed through this final rule. Additionally, the consumer who supported the removal of marsala and sherry wines also added that nonorganic ingredients should not be used in organic foods. AMS has considered this comment. The USDA organic regulations, in Sec. 205.301(b), requires that a raw or processed agricultural product sold, labeled, or represented as ``organic'' must contain not less than 95 percent organically produced raw or processed agricultural products. Any remaining product ingredients must be organically produced, unless not commercially available in organic form, or must be nonagricultural substances as listed in Sec. 205.605, or nonorganic agricultural products as listed in Sec. 205.606 on the National List. In essence, the USDA organic regulations requires organic producers or organic handlers to maximize organic ingredients before using nonorganic nonagricultural or nonorganic agricultural that are included on the National List. Changes Requested But Not Made The commenter on the proposed removal of expired listings for streptomycin and tetracycline did not agree with this action and did not agree with the prohibition against the use of these antibiotics to control fire blight infestation in apple production. This commenter stated that the prohibition of streptomycin and tetracycline for use in apple production has had a significant impact on organic apple growers in California's central valley. According to this commenter, the alternatives to the use of streptomycin and tetracycline researched in the Pacific Northwest are ineffective in controlling fire blight in California's central valley. The commenter claims the amendment to prohibit the use of these antibiotics to control fire blight created a significant economic advantage for apple growers in the Pacific Northwest. The removal of the expired listings for streptomycin and tetracycline in the proposed rule is essentially a notice of a technical correction since the prohibition on the use of these two substances in organic crop production is already in effect. The final rule that established the effective date of streptomycin's expiration date as listed in Sec. 205.601(i)(11) was published in the Federal Register (77 FR 33290) on June 6, 2012. This final rule addressed comments received on the proposed rule to list streptomycin with an expiration date, including comments in support of or in opposition to the expiration date. AMS also addressed comments on commercially viable alternatives, including the efficacy of these alternatives, and addressed additional factors considered by the NOSB during their determination. Since the prohibition against the use of streptomycin has been in effect since October 22, 2014, AMS is finalizing this correction as noted in the proposed rule. Organic producers who have determined that there are no commercially available alternatives to streptomycin in controlling fire blight in apples or pear production for their region can submit a petition (http://www.ams.usda.gov/rules-regulations/organic/national-list/filing-petition) to add streptomycin back onto the National List. The final rule that established the effective date of tetracycline's expiration date as listed in Sec. 205.601(i)(12) was published in the Federal Register (77 FR 45903) on August 2, 2012. This final rule addressed comments received on the proposed rule to list tetracycline with an expiration date, including comments in support of or in opposition to the expiration date. AMS also addressed comments on commercially viable alternatives, including the efficacy of these alternatives, and addressed additional factors considered by the NOSB during their determination. Since the prohibition against the use of tetracycline has been in effect since October 22, 20014, AMS is finalizing this correction as noted in the proposed rule. Organic producers who have determined that there are no commercially available alternatives to tetracycline in controlling fire blight in apples or pear production for their region can submit a petition (http://www.ams.usda.gov/rules-regulations/organic/national-list/filing-petition) to add tetracycline back onto the National List. List of Subjects in 7 CFR Part 205 Administrative practice and procedure, Agricultural commodities, Imports, Labeling, Livestock, Reporting and recordkeeping requirements, 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. 205.601 [Amended] 0 2. Section 205.601 is amended by removing paragraphs (i)(11) and (12). Sec. 205.606 [Amended] 0 3. Section 205.606 is amended by removing paragraph (g) and redesignating paragraphs (h) through (z) as (g) through (y). Dated: December 8, 2015. Rex A. Barnes, Associate Administrator, Agricultural Marketing Service. [FR Doc. 2015-31413 Filed 12-11-15; 8:45 am] BILLING CODE 3410-02-P
![77231
Rules and Regulations Federal Register
Vol. 80, No. 239
Monday, December 14, 2015
This section of the FEDERAL REGISTER SUPPLEMENTARY INFORMATION: through rulemaking based upon
contains regulatory documents having general proposed amendments as recommended
applicability and legal effect, most of which I. Background
by the NOSB.
are keyed to and codified in the Code of The National Organic Program (NOP)
Federal Regulations, which is published under The NOSB’s recommendations to
is authorized by the Organic Foods continue existing exemptions and
50 titles pursuant to 44 U.S.C. 1510.
Production Act of 1990 (OFPA), as
prohibitions include consideration of
The Code of Federal Regulations is sold by amended (7 U.S.C. 6501–6522). The
public comments and applicable
the Superintendent of Documents. Prices of USDA Agricultural Marketing Service
supporting evidence that express a
new books are listed in the first FEDERAL (AMS) administers the NOP. Final
continued need for the use or
REGISTER issue of each week. regulations implementing the NOP, also
prohibition of the substance(s) as
referred to as the USDA organic
regulations, were published December required by the OFPA.
DEPARTMENT OF AGRICULTURE 21, 2000 (65 FR 80548), and became Recommendations to either continue or
effective on October 21, 2002. Through discontinue an authorized exempted
Agricultural Marketing Service these regulations, the AMS oversees synthetic substance (7 U.S.C. 6517(c)(1))
national standards for the production, are determined by the NOSB’s
7 CFR Part 205 handling, and labeling of organically evaluation of technical information,
[Document Number AMS–NOP–15–0015; produced agricultural products. Since public comments, and supporting
NOP–15–07] becoming effective, the USDA organic evidence that demonstrate that the
regulations have been frequently substance is: (a) Harmful to human
RIN 0581–AD39 health or the environment; (b) no longer
amended, mostly for changes to the
National List in 7 CFR 205.601–205.606. necessary for organic production due to
National Organic Program (NOP);
This National List identifies the the availability of alternative wholly
Sunset 2015 Amendments to the
synthetic substances that may be used nonsynthetic substitute products or
National List
and the nonsynthetic substances that practices; or (c) inconsistent with
AGENCY: Agricultural Marketing Service, may not be used in organic production. organic farming and handling practices.
USDA. The National List also identifies This rule removes the expired listings
ACTION: Final rule. synthetic, nonsynthetic nonagricultural, of two substances, streptomycin and
and nonorganic agricultural substances tetracycline, as their National List
SUMMARY: This final rule addresses that may be used in organic handling. exemptions expired on October 21,
recommendations submitted to the The OFPA and the USDA organic 2014. After this expiration date, the use
Secretary of Agriculture (Secretary) by regulations, as indicated in § 205.105, of streptomycin and tetracycline in
the National Organic Standards Board specifically prohibit the use of any organic production is prohibited. While
(NOSB) following their October 2014 synthetic substance in organic USDA accredited certifying agents are
meeting. These recommendations production and handling unless the enforcing the prohibition of
pertain to the 2015 Sunset Review of synthetic substance is on the National streptomycin and tetracycline, delisting
substances on the U.S. Department of List. Section 205.105 also requires that of these substances from the National
Agriculture’s (USDA) National List of any nonorganic agricultural substance List reduces the likelihood of
Allowed and Prohibited Substances and any nonsynthetic nonagricultural noncompliant use by organic producers.
(National List). Consistent with the substance used in organic handling
recommendations from the NOSB, this Following their October 2014 public
appear on the National List.
final rule removes two nonorganic meeting, the NOSB submitted their 2015
As stipulated by the OFPA,
agricultural substances from the Sunset Review recommendations to the
recommendations to propose
National List for use in organic Secretary. This rule amends the
amendment of the National List are
handling, fortified cooking wines— National List to implement two NOSB
developed by the NOSB, operating
marsala wine and sherry wine. This under the Federal Advisory Committee recommendations to remove the
final rule also removes two listings for Act (5 U.S.C. App. 2 et seq.), to assist substances, marsala wine and sherry
synthetic substances allowed for use in in the evaluation of substances to be wine, allowed as ingredients in or on
organic crop production on the National used or not used in organic production processed products labeled as ‘‘organic’’
List, streptomycin and tetracycline, as and handling, and to advise the in § 205.606. The National List
their use exemptions expired on Secretary on the USDA organic exemptions of these substances for use
October 21, 2014. regulations. The OFPA also requires a in organic production and handling that
DATES: Effective Date: This final rule is sunset review of all substances included were considered by the NOSB during
effective on December 14, 2015. on the National List within five years of the 2015 Sunset Review process were
FOR FURTHER INFORMATION CONTACT: their addition to or renewal on the list. evaluated according to the evaluation
mstockstill on DSK4VPTVN1PROD with RULES
Robert Pooler, Standards Division, If a listed substance is not reviewed by criteria specified on the OFPA (7 U.S.C.
National Organic Program, USDA– the NOSB and renewed by the USDA 6517–6518).
AMS–NOP, 1400 Independence Ave. within the five year period, its II. Overview of Amendments
SW., Room 2642–So., Ag Stop 0268, allowance or prohibition on the
Washington, DC 20250–0268. National List is no longer in effect. The following provides an overview
Telephone: (202) 720–3252; Fax: (202) Under the authority of the OFPA, the of the amendments made to designated
205–7808. Secretary can amend the National List sections of the National List regulations:
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![77234 Federal Register / Vol. 80, No. 239 / Monday, December 14, 2015 / Rules and Regulations
F. Comments Received on Proposed California’s central valley. According to tetracycline in controlling fire blight in
Rule AMS–NOP–15–0015; NOP–15–07 this commenter, the alternatives to the apples or pear production for their
AMS received two comments on use of streptomycin and tetracycline region can submit a petition (http://
proposed rule AMS–NOP–15–0015. researched in the Pacific Northwest are www.ams.usda.gov/rules-regulations/
Only one comment from a consumer ineffective in controlling fire blight in organic/national-list/filing-petition) to
addressed the 2015 Sunset review California’s central valley. The add tetracycline back onto the National
amendments to remove marsala and commenter claims the amendment to List.
sherry wines from the National List. The prohibit the use of these antibiotics to
control fire blight created a significant List of Subjects in 7 CFR Part 205
second comment was from a California Administrative practice and
economic advantage for apple growers
apple producer and it addressed procedure, Agricultural commodities,
in the Pacific Northwest. The removal of
removing the expired listings, Imports, Labeling, Livestock, Reporting
the expired listings for streptomycin
streptomycin and tetracycline, from the and recordkeeping requirements, Soil
and tetracycline in the proposed rule is
National List. conservation.
essentially a notice of a technical
The consumer who commented on
correction since the prohibition on the For the reasons set forth in the
removing marsala and sherry wines
use of these two substances in organic preamble, 7 CFR part 205 is amended as
from the National List agreed with the
crop production is already in effect. follows:
proposed amendment to prohibit the The final rule that established the
use of these nonorganic ingredients in effective date of streptomycin’s PART 205—NATIONAL ORGANIC
foods labeled as organic. During their expiration date as listed in PROGRAM
sunset review of marsala and sherry, the § 205.601(i)(11) was published in the
NOSB did not receive comments Federal Register (77 FR 33290) on June ■ 1. The authority citation for 7 CFR
supporting the continued use of these 6, 2012. This final rule addressed part 205 continues to read as follows:
wines as nonorganic ingredients in comments received on the proposed Authority: 7 U.S.C. 6501–6522.
organic products. Additionally, since no rule to list streptomycin with an
comments were received opposing the expiration date, including comments in § 205.601 [Amended]
removal of marsala and sherry wines support of or in opposition to the
from the National List, AMS is ■ 2. Section 205.601 is amended by
expiration date. AMS also addressed removing paragraphs (i)(11) and (12).
finalizing these amendments as comments on commercially viable
proposed through this final rule. alternatives, including the efficacy of § 205.606 [Amended]
Additionally, the consumer who these alternatives, and addressed
supported the removal of marsala and ■ 3. Section 205.606 is amended by
additional factors considered by the
sherry wines also added that nonorganic removing paragraph (g) and
NOSB during their determination. Since
ingredients should not be used in redesignating paragraphs (h) through (z)
the prohibition against the use of
organic foods. AMS has considered this as (g) through (y).
streptomycin has been in effect since
comment. The USDA organic October 22, 2014, AMS is finalizing this Dated: December 8, 2015.
regulations, in § 205.301(b), requires correction as noted in the proposed rule. Rex A. Barnes,
that a raw or processed agricultural Organic producers who have Associate Administrator, Agricultural
product sold, labeled, or represented as determined that there are no Marketing Service.
‘‘organic’’ must contain not less than 95 commercially available alternatives to [FR Doc. 2015–31413 Filed 12–11–15; 8:45 am]
percent organically produced raw or streptomycin in controlling fire blight in BILLING CODE 3410–02–P
processed agricultural products. Any apples or pear production for their
remaining product ingredients must be region can submit a petition (http://
organically produced, unless not www.ams.usda.gov/rules-regulations/ DEPARTMENT OF TRANSPORTATION
commercially available in organic form, organic/national-list/filing-petition) to
or must be nonagricultural substances as add streptomycin back onto the Federal Aviation Administration
listed in § 205.605, or nonorganic National List.
agricultural products as listed in The final rule that established the 14 CFR Part 71
§ 205.606 on the National List. In effective date of tetracycline’s expiration
essence, the USDA organic regulations date as listed in § 205.601(i)(12) was [Docket No. FAA–2015–3321; Airspace
requires organic producers or organic Docket No. 15–ANM–17]
published in the Federal Register (77
handlers to maximize organic FR 45903) on August 2, 2012. This final Establishment of Class E Airspace,
ingredients before using nonorganic rule addressed comments received on Neah Bay, WA
nonagricultural or nonorganic the proposed rule to list tetracycline
agricultural that are included on the with an expiration date, including AGENCY: Federal Aviation
National List. comments in support of or in opposition Administration (FAA), DOT.
to the expiration date. AMS also ACTION: Final rule.
Changes Requested But Not Made
addressed comments on commercially
The commenter on the proposed viable alternatives, including the SUMMARY: This action establishes Class
removal of expired listings for efficacy of these alternatives, and E airspace at U. S. Coast Guard Station
streptomycin and tetracycline did not addressed additional factors considered Neah Bay Heliport, Neah Bay, WA, to
agree with this action and did not agree by the NOSB during their accommodate a new Standard
mstockstill on DSK4VPTVN1PROD with RULES
with the prohibition against the use of determination. Since the prohibition Instrument Approach Procedure
these antibiotics to control fire blight against the use of tetracycline has been developed at the heliport. Controlled
infestation in apple production. This in effect since October 22, 20014, AMS airspace is necessary for the safety and
commenter stated that the prohibition of is finalizing this correction as noted in management of Instrument Flight Rules
streptomycin and tetracycline for use in the proposed rule. Organic producers (IFR) operations at the heliport.
apple production has had a significant who have determined that there are no DATES: Effective 0901 UTC, February 4,
impact on organic apple growers in commercially available alternatives to 2016. The Director of the Federal
VerDate Sep<11>2014 16:45 Dec 11, 2015 Jkt 238001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\14DER1.SGM 14DER1](https://thefederalregister.org/doc/80_FR_77470/page/4.svg)
Document Created: 2015-12-14 13:46:56
Document Modified: 2015-12-14 13:46:56
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Contact | Robert Pooler, Standards Division, National Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW., Room 2642-So., Ag Stop 0268, Washington, DC 20250-0268. Telephone: (202) 720-3252; Fax: (202) 205-7808. | |
| FR Citation | 80 FR 77231 | |
| RIN Number | 0581-AD39 | |
| CFR Associated | Administrative Practice and Procedure; Agricultural Commodities; Imports; Labeling; Livestock; Reporting and Recordkeeping Requirements and Soil Conservation |
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