National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances per October 2018 NOSB Recommendations (Crops and Handling), 55866-55870 [2019-22639]
Download as PDF
<![CDATA[
55866
Proposed Rules
Federal Register
Vol. 84, No. 202
Friday, October 18, 2019
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS–NOP–19–0023;
NOP–19–01]
RIN 0581 AD83
National Organic Program; Proposed
Amendments to the National List of
Allowed and Prohibited Substances
per October 2018 NOSB
Recommendations (Crops and
Handling)
Agricultural Marketing Service,
USDA.
ACTION: Proposed rule.
AGENCY:
This proposed rule would
amend the National List of Allowed and
Prohibited Substances (National List)
section of the United States Department
of Agriculture’s (USDA’s) organic
regulations to implement
recommendations submitted to the
Secretary of Agriculture (Secretary) by
the National Organic Standards Board
(NOSB). This rule proposes to add blood
meal, made with sodium citrate, to the
National List as a soil fertilizer in
organic crop production; add natamycin
to the National List to prohibit its use
in organic crop production; and add
tamarind seed gum as a non-organic
agricultural substance for use in organic
handling when organic forms of
tamarind seed gum are not
commercially available.
DATES: Comments must be received by
December 17, 2019.
ADDRESSES: Interested persons may
comment on the proposed rule using the
following procedures:
SUMMARY:
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Mail: Robert Pooler, Standards
Division, National Organic Program,
USDA–AMS–NOP, 1400 Independence
Ave. SW, Room 2642–S., Ag Stop 0268,
Washington, DC 20250–0268.
Telephone: (202) 720–3252.
Instructions: All submissions received
must include the docket number AMS–
NOP–19–0023, NOP–19–01, and/or
Regulatory Information Number (RIN)
0581–AD83 for this rulemaking. When
submitting a comment, clearly indicate
the proposed rule topic and section
number to which the comment refers. In
addition, comments should clearly
indicate whether the commenter
supports the action being proposed and
also clearly indicate the reason(s) for the
position. Comments can also include
information on alternative management
practices, where applicable, that
support alternatives to the proposed
amendments. Comments should also
offer any recommended language
change(s) that would be appropriate to
the position. Please include relevant
information and data to support the
position such as scientific,
environmental, manufacturing,
industry, or impact information, or
similar sources. Only relevant material
supporting the position should be
submitted. All comments received will
be posted without change to https://
www.regulations.gov.
Document: To access the document
and read background documents, or
comments received, go to https://
www.regulations.gov. Comments
submitted in response to this proposed
rule will also be available for viewing in
person at USDA–AMS, National Organic
Program, Room 2642-South Building,
1400 Independence Ave. SW,
Washington, DC, from 9 a.m. to 12 noon
and from 1 p.m. to 4 p.m. Eastern Time,
Monday through Friday (except official
Federal holidays). Persons wanting to
visit the USDA South Building to view
comments received in response to this
proposed rule are requested to make an
appointment in advance by calling (202)
720–3252.
FOR FURTHER INFORMATION CONTACT:
Robert Pooler, Standards Division,
National Organic Program. Telephone:
(202) 720–3252.
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Secretary
established the National List within part
205 of the USDA organic regulations (7
CFR 205.600 through 205.607). The
National List identifies the synthetic
substance allowances and the
nonsynthetic substance prohibitions in
organic farming. The National List also
identifies synthetic and nonsynthetic
nonagricultural substances and
nonorganic agricultural substances that
may be used in organic handling.
The Organic Foods Production Act of
1990, as amended (7 U.S.C. 6501–6522)
(OFPA), and § 205.105 of the USDA
organic regulations 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 and any nonsynthetic
nonagricultural substance used in
organic handling be on the National
List. Under the authority of OFPA, the
National List can be amended by the
Secretary based on recommendations
presented by the NOSB. Since the final
rule establishing the National Organic
Program (NOP) became effective on
October 21, 2002, USDA’s Agricultural
Marketing Service (AMS) has published
multiple rules amending the National
List.
This proposed rule addresses three
NOSB recommendations to amend the
National List that were submitted to the
Secretary on October 26, 2018. Table 1
summarizes the proposed changes to the
National List based on these NOSB
recommendations.
TABLE 1—SUBSTANCES BEING ADDED TO THE NATIONAL LIST OR CURRENT LISTINGS BEING AMENDED
National list
section
Substance
Blood meal—made with Sodium citrate ...............................................................................................
Natamycin .............................................................................................................................................
Tamarind seed gum .............................................................................................................................
VerDate Sep<11>2014
16:07 Oct 17, 2019
Jkt 250001
PO 00000
Frm 00001
Fmt 4702
Sfmt 4702
E:\FR\FM\18OCP1.SGM
§ 205.601
§ 205.602
§ 205.606
18OCP1
Proposed rule action
Add to National List.
Add to National List.
Add to National List.
55867
Federal Register / Vol. 84, No. 202 / Friday, October 18, 2019 / Proposed Rules
II. Overview of Proposed Amendments
The following provides an overview
of the proposed amendments to
designated sections of the National List
regulations:
Blood Meal—Made With Sodium Citrate
The proposed rule would amend the
National List to add blood meal—made
with sodium citrate to § 205.601 as a
synthetic substance allowed for use in
crop production. Table 2 illustrates the
proposed listing.
TABLE 2—PROPOSED RULE ACTION
FOR BLOOD MEAL USING SODIUM
CITRATE
Current rule:
Proposed rule
action:
N/A
Add blood meal—made with
sodium citrate to
§ 205.601(j).
On July 20, 2016, AMS received a
petition 1 to add sodium citrate to the
National List as an anticoagulant for
spray dried blood products. The
addition of sodium citrate prevents the
blood from clotting and maintains the
blood in a liquid state while it is
processed to dried blood meal. In its
natural state, blood meal is a
nonsynthetic substance that may be
used in organic production as a soil
amendment.
The NOSB reviewed and considered
this petition at its public meeting on
October 26, 2018. At the conclusion of
meeting, the NOSB recommended to the
Secretary to add sodium citrate, for use
as an anticoagulant in the production of
blood meal, to the National List.2 In its
recommendation, the NOSB requested
that AMS review sodium citrate to
determine whether sodium citrate used
to process blood meal must be on the
National List in order for the resulting
blood meal to be allowed in organic
crop production.
AMS reviewed the NOSB’s sodium
citrate recommendation, the sodium
citrate petition, and the sodium citrate
technical report.3 AMS concurs with the
NOSB’s determination that sodium
citrate is a synthetic substance. Further,
AMS concludes that the use of sodium
citrate to manufacture blood meal
means that blood meal would not
1 Sodium citrate petition: https://
www.ams.usda.gov/sites/default/files/media/
Sodium%20Citrate%20Crops%20Pet.pdf.
2 NOSB recommendation for sodium citrate:
https://www.ams.usda.gov/sites/default/files/
media/CSSodiumCitratePetRecOct2018.pdf.
3 Technical Evaluation Report for sodium citrate
(for used in crop production): https://
www.ams.usda.gov/sites/default/files/media/
SodiumCitrateCropsTR20171218.pdf.
VerDate Sep<11>2014
16:07 Oct 17, 2019
Jkt 250001
qualify as a nonsynthetic substance.
AMS also concurs with the NOSB’s
determination that the construct of the
National List does not include
processing aids for crop production
substances; rather it includes the
generic crop production substance.
AMS determined that sodium citrate’s
use as an anticoagulant in the
production of blood meal is not
included within the production aid
categories specified in the OFPA (7
U.S.C. 6517(c)(1)(B)).
Therefore, to address the NOSB’s
recommendation to allow the use of
sodium citrate, AMS is proposing to add
blood meal produced with sodium
citrate to the National List. This
determination is consistent with the
current listing for liquid fish products
that are pH adjusted with sulfuric,
citric, or phosphoric acid and allowed
in organic crop production as a plant or
soil amendment (§ 205.601(j)(8)). In that
case, the addition of a synthetic
processing aid, i.e., the specified acids,
to a nonsynthetic substance, liquid fish
products, was resolved by listing as a
synthetic substance liquid fish products
that are pH adjusted with the specified
acids. The addition of the synthetic
substance, sodium citrate, in the
processing of blood meal means that the
final product is also synthetic and must
be on the National List for use in
organic crop production.4
In its recommendation to the
Secretary, the NOSB stated that there is
no concern with using sodium citrate to
make dried blood meal and noted that
sodium citrate is on the National List in
§ 205.605(b) as an allowed ingredient for
use in organic processing. This
proposed rule would amend the
National List by adding blood meal
made with sodium citrate to § 205.601(j)
as a plant or soil amendment.
§ 205.602 Nonsynthetic Substances
Prohibited for Use in Organic Crop
Production
This proposed rule would add
natamycin to § 205.602, Nonsynthetic
substances prohibited for use in organic
crop production.
Natamycin
The proposed rule would amend the
National List to add natamycin to
§ 205.602. Table 2 illustrates the
proposed listing.
4 Guidance on determining whether a substance
is synthetic or non-synthetic is described in
document NOP 5033–1, Guidance Decision Tree for
Classification of Materials as Synthetic or
Nonsynthetic: https://www.ams.usda.gov/sites/
default/files/media/NOP-Synthetic-NonSyntheticDecisionTree.pdf.
PO 00000
Frm 00002
Fmt 4702
Sfmt 4702
TABLE 3—PROPOSED RULE ACTION
FOR NATAMYCIN
Current rule:
Proposed rule
action:
N/A
Add natamycin to § 205.602.
On September 1, 2016, AMS received
a petition 5 to add natamycin as a
nonsynthetic substance allowed for use
in organic crop production as a postharvest treatment to control fungal
diseases. Natamycin is a naturally
occurring compound produced by soil
bacteria. Natamycin is used in
agriculture and in food processing for its
antifungal properties as either a
fungicide or fungistat. These properties
are effective over a wide pH range. To
enhance review of this petition, the
NOSB solicited a technical report on
natamycin.6 This report indicates that
natamycin is regulated by both the
Environmental Protection Agency (EPA)
and the Food and Drug Administration
(FDA). Commercial applications of
natamycin in crop, livestock, and food
production can be grouped into three
basic categories: Pre- or post-harvest
agricultural fungicide; livestock
medication; or as a preservative in
processed foods. For example,
natamycin may be used in mushroom
production to control fungal diseases
and in post-harvest handling treatment
of raw agricultural commodities, such as
fruits, to prevent spoilage. Natamycin is
also used in animal health for treating
ringworm and candidosis in horses and
cattle. Natamycin is approved as a
preservative in certain processed foods,
such as cheese, yogurt, and certain
beverages.
The 2016 natamycin petition is the
second natamycin petition received and
reviewed by the NOSB. In March 2007
the NOSB reviewed a petition on
natamycin for use as a nonsynthetic,
nonagricultural substance in organic
processing and handling, to prevent or
delay mold growth in packaged baked
goods. After reviewing the 2007
petition, the NOSB considered adding
natamycin to the National List in
§ 205.605(a), Nonagricultural
(nonorganic) substances allowed as
ingredients in or on processed products
labeled as ‘‘organic’’ or ‘‘made with
organic (specified ingredients or food
group(s)).’’ At the conclusion of the
March 2007 meeting, the NOSB did not
recommend adding natamycin to
5 Natamycin petition: https://www.ams.usda.gov/
sites/default/files/media/Natamycin%20NOP%20
Petition%20-%2001%20Sep%2016.pdf.
6 Natamycin Technical Evaluation Report,
November 2017: https://www.ams.usda.gov/sites/
default/files/media/NatamycinTR20171102.pdf.
E:\FR\FM\18OCP1.SGM
18OCP1
55868
Federal Register / Vol. 84, No. 202 / Friday, October 18, 2019 / Proposed Rules
§ 205.605(a). Some comments received
by the NOSB during the 2007 meeting
stated opposition to allowing natamycin
in organic handling because the
commenters believed that natamycin is
an antibiotic, and its use as a
preservative would not be compatible
with organic standards. In 2007, the
NOSB determined natamycin to be a
nonsynthetic substance and that its use,
as petitioned, was not compatible with
organic handling standards.
At its October 26, 2018, public
meeting, the NOSB considered the
second natamycin petition as a
nonsynthetic substance in organic crop
production and received public
comment. In its review, the NOSB also
considered a November 2, 2017,
technical evaluation report on
natamycin that described its
manufacture, industry uses, regulation,
and chemical properties.
After considering the petition,
technical report, and public comments,
the NOSB determined (1) that
natamycin is a nonsynthetic substance
and (2) that the use of natamycin as a
post-harvest treatment on harvested
crops met the OFPA criteria for
prohibitions on natural substances
because its use could negatively impact
human health by increasing fungal
resistance to natamycin. As such, its use
would not be consistent with organic
farming or handling. Therefore, the
NOSB recommended adding natamycin
to § 205.602 as a nonsynthetic substance
prohibited for use in organic crop
production.7
AMS has reviewed the NOSB
recommendation on natamycin and
agrees that natamycin meets the OFPA
criteria for listing as a prohibited
substance in organic crop production.
AMS proposes addressing this NOSB
recommendation through this proposed
rule. Consistent with the NOSB
recommendation, this proposed rule
would amend the National List by
adding natamycin to § 205.602 as a
prohibited nonsysthetic substance. This
action would prohibit any use of
natamycin in organic crop production,
including both pre-harvest and postharvest treatment.
§ 205.606 Nonorganically Produced
Agricultural Products Allowed as
Ingredients in or on Processed Products
Labeled as ‘‘Organic.’’
Tamarind Seed Gum
The proposed rule would amend the
National List to add tamarind seed gum
as a non-organic agricultural substance
7 NOSB natamycin recommendation: https://
www.ams.usda.gov/sites/default/files/media/
CSNatamycinPetRecOct2018.pdf.
VerDate Sep<11>2014
16:07 Oct 17, 2019
Jkt 250001
listed in § 205.606 for use in organic
handling.
TABLE 4—PROPOSED RULE ACTION
FOR TAMARIND SEED GUM
Current rule:
Proposed rule
action:
N/A
Add tamarind seed gum to
§ 205.606.
On February 13, 2017, AMS received
a petition 8 to add tamarind seed gum to
the National List in § 205.606 for use in
organic handling as a thickener,
stabilizer, or gelling agent in processed
foods. Tamarind seed gum is a plant
polysaccharide (polymer of
carbohydrate molecules) derived from
the kernel, or endosperm, of seeds of the
tamarind tree. Tamarind seed gum is
Generally Regarded as Safe (GRAS) for
several applications as a food additive—
specifically in foods such as cheese,
fruit preserves, sauces, and ice cream.
To enhance its review of this petition,
the NOSB solicited a technical report 9
on tamarind seed gum. This report
indicated that tamarind seed gum is
regulated by the FDA as a GRAS food
additive and specifically, as a stabilizer
and thickener as defined by 21 CFR
170.3.
At its October 26, 2018, public
meeting, the NOSB considered the
petition on adding tamarind seed gum
to the National List for use in organic
handling. As part of its review, the
NOSB considered a February 21, 2018,
technical report on tamarind seed gum
that described its manufacture, industry
uses, regulation, and chemical
properties. After considering the
petition, technical report, and public
comments on tamarind seed gum, the
NOSB determined that the allowance of
non-organic tamarind seed gum for use
as an ingredient in organic handling is
consistent with the OFPA evaluation
criteria for National List substances. The
NOSB’s evaluation also determined that
tamarind seed gum provides different
processing characteristics and texture
compared to the gums currently on the
National List. Subsequently, the NOSB
recommended 10 adding tamarind seed
gum to § 205.606 as a nonorganically
produced agricultural product allowed
as ingredients in or on processed
products labeled as ‘‘organic.’’
8 Tamarind seed gum petition: https://
www.ams.usda.gov/sites/default/files/media/
TamGumPetition.pdf.
9 Tamarind seed gum technical evaluation report,
February 2018: https://www.ams.usda.gov/sites/
default/files/media/TamarindSeedGum
TR2018221.pdf.
10 NOSB recommendation on tamarind seed gum:
https://www.ams.usda.gov/sites/default/files/
media/HSTamarindSeedGumPetRecOct2018.pdf.
PO 00000
Frm 00003
Fmt 4702
Sfmt 4702
AMS has reviewed the NOSB
recommendation on tamarind seed gum
and agrees that tamarind seed gum
satisfies the OFPA evaluation criteria for
an allowed substance on the National
List. Subsequently, AMS proposes
addressing this NOSB recommendation
through this proposed rule. Consistent
with the NOSB recommendation, this
proposed rule would amend the
National List by adding tamarind seed
gum to § 205.606 as a nonorganically
produced agricultural product allowed
as an ingredient in or on processed
products labeled as ‘‘organic.’’ This
action would require organic handlers
who use tamarind seed gum to source
an organic form of the ingredient before
using any nonorganic source of this
ingredient. If the organic form of the
ingredient is not commercially
available, the nonorganic form may be
used.11
III. Related Documents
On August 9, 2018, a document was
published in the Federal Register (83
FR 39376) announcing the fall 2018
NOSB meeting. One purpose of the
meeting was to deliberate on
recommendations on substances
petitioned as amendments to the
National List.
IV. Statutory and Regulatory Authority
The OFPA authorizes the Secretary to
make amendments to the National List
based on recommendations developed
by the NOSB. Sections 6518(k) and
6518(n) of the OFPA authorize the
NOSB to develop recommendations for
submission to the Secretary to amend
the National List and establish a process
by which persons may petition the
NOSB for the purpose of having
substances evaluated for inclusion on or
deletion from the National List. Section
205.607 of the USDA organic
regulations permits any person to
petition to add or remove a substance
from the National List and directs
petitioners to obtain the petition
procedures from USDA. The current
petition procedures published in the
Federal Register (81 FR 12680, March
10, 2016) for amending the National List
can be accessed through the NOP
Program Handbook on the NOP website
at https://www.ams.usda.gov/rulesregulations/organic/handbook.
A. Executive Orders 12866 and 13771,
and Regulatory Flexibility Act
This action falls within a category of
regulatory actions that the Office of
Management and Budget (OMB) has
11 See 7 CFR 205.606 and 7 CFR 205.2 for
definition of ‘‘Commercially available.’’
E:\FR\FM\18OCP1.SGM
18OCP1
Federal Register / Vol. 84, No. 202 / Friday, October 18, 2019 / Proposed Rules
exempted from Executive Order 12866.
Additionally, because this proposal
does not meet the definition of a
significant regulatory action, it does not
trigger the requirements contained in
Executive Order 13771. See OMB’s
Memorandum titled ‘‘Interim Guidance
Implementing Section 2 of the Executive
Order of January 30, 2017 titled
‘Reducing Regulation and Controlling
Regulatory Costs’ ’’ (February 2, 2017).
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.
The Small Business Administration
(SBA) sets size criteria for each industry
described in the North American
Industry Classification System (NAICS)
to delineate which operations qualify as
small businesses. The SBA has
classified small agricultural producers
that engage in crop and animal
production as those with average annual
receipts of less than $750,000. Handlers
are involved in a broad spectrum of food
production activities and fall into
various categories in the NAICS Food
Manufacturing sector. The small
business thresholds for food
manufacturing operations are based on
the number of employees and range
from 500 to 1,250 employees, depending
on the specific type of manufacturing.
Certifying agents fall under the NAICS
subsector, ‘‘All other professional,
scientific and technical services.’’ For
this category, the small business
threshold is average annual receipts of
less than $15 million.
AMS has considered the economic
impact of this proposed rulemaking on
small agricultural entities. Data
collected by the USDA National
Agricultural Statistics Service (NASS)
and the NOP indicate most of the
certified organic production operations
in the United States would be
considered small entities. According to
the 2017 Census of Agriculture, 18,166
organic farms in the United States
reported sales of organic products and
total farmgate sales in excess of $7.2
VerDate Sep<11>2014
16:07 Oct 17, 2019
Jkt 250001
billion.12 Based on that data, organic
sales average $400,000 per farm.
Assuming a normal distribution of
producers, we expect that most of these
producers would fall under the
$750,000 sales threshold to qualify as a
small business.
According to the NOP’s Organic
Integrity Database, there are 18,105
organic handlers that are certified under
the USDA organic regulations (10,184 of
these handlers are based in the U.S).13
The Organic Trade Association’s 2018
Organic Industry Survey has
information about employment trends
among organic manufacturers. The
reported data are stratified into three
groups by the number of employees per
company: Less than 5; 5 to 49; and 50
plus. These data are representative of
the organic manufacturing sector and
the lower bound (50) of the range for the
larger manufacturers is significantly
smaller than the SBA’s small business
thresholds (500 to 1,250). Therefore,
AMS expects that most organic handlers
would qualify as small businesses.
The USDA has 78 accredited
certifying agents who provide organic
certification services to producers and
handlers. The certifying agent that
reports the most certified operations,
nearly 3,500, would need to charge
approximately $4,200 in certification
fees in order to exceed the SBA’s small
business threshold of $15 million. The
costs for certification generally range
from $500 to $3,500, depending on the
complexity of the operation. Therefore,
AMS expects that most of the accredited
certifying agents would qualify as small
entities under the SBA criteria.
The economic impact on entities
affected by this rule would not be
significant. The effect of this rule, if
implemented as final, would be to allow
the use of two additional substances in
organic crop production and organic
handling. Adding two substances to the
National List would increase regulatory
flexibility and would give small entities
more tools to use in day-to-day
operations. This action would also
prohibit the use of natamycin in organic
crop production due to its possible
impact on human health. AMS reviewed
comments submitted to the NOSB
indicating that there is little to no use
of natamycin currently in organic crop
production. Therefore, AMS concludes
12 U.S. Department of Agriculture, National
Agricultural Statistics Service. 2017 Census of
Agriculture. https://www.nass.usda.gov/
Publications/AgCensus/2017/Full_Report/Volume_
1,_Chapter_1_US/. The number of organic farms
includes both certified and exempt farms.
13 Organic Integrity Database: https://
organic.ams.usda.gov/Integrity/. Accessed on June
7, 2019.
PO 00000
Frm 00004
Fmt 4702
Sfmt 4702
55869
that the economic impact of this
addition, if any, would be minimal
because there are other practices and
substances that provide effective fungal
control in organic crop production.
Accordingly, USDA certifies that this
rule would not have a significant
economic impact on a substantial
number of small entities.
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. Accordingly, to
prevent duplicative regulation, states
and local jurisdictions are preempted
under the OFPA from creating programs
of accreditation for private persons or
state officials who want to become
certifying agents of organic farms or
handling operations. A governing state
official would have to apply to USDA to
be accredited as a certifying agent, as
described in section 6514(b) of the
OFPA. States are also preempted under
sections 6503 through 6507 of the 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 the OFPA.
Pursuant to section 6507(b)(2) of the
OFPA, a state organic certification
program that has been approved by the
Secretary may, under certain
circumstances, contain additional
requirements for the production and
handling of agricultural products
organically produced in the state and for
the certification of organic farm and
handling operations located within the
state. Such additional requirements
must (a) further the purposes of the
OFPA, (b) not be inconsistent with the
OFPA, (c) not be discriminatory toward
agricultural commodities organically
produced in other States, and (d) not be
effective until approved by the
Secretary.
In addition, pursuant to section
6519(c)(6) of the OFPA, this proposed
rule would not supersede or 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, respectively,
nor any of the authorities of the
Secretary of Health and Human Services
under the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 301 et seq.), nor
the authority of the Administrator of the
E:\FR\FM\18OCP1.SGM
18OCP1
55870
Federal Register / Vol. 84, No. 202 / Friday, October 18, 2019 / Proposed Rules
EPA under the Federal Insecticide,
Fungicide and Rodenticide Act (7 U.S.C.
136 et seq.).
C. Paperwork Reduction Act
No additional collection or
recordkeeping requirements are
imposed on the public by this proposed
rule. Accordingly, OMB clearance is not
required by the Paperwork Reduction
Act of 1995, 44 U.S.C. 3501, Chapter 35.
D. Executive Order 13175
This proposed 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.
§ 205.602 Nonsynthetic substances
prohibited for use in organic crop
production.
*
*
*
*
*
(e) Natamycin.
*
*
*
*
*
■ 4. Amend § 205.606 by redesignating
paragraphs (s) through (w) as paragraphs
(t) through (x) and adding new
paragraph (s) to read as follows:
§ 205.606 Nonorganically produced
agricultural products allowed as ingredients
in or on processed products labeled as
‘‘organic.’’
*
*
*
*
*
(s) Tamarind seed gum.
*
*
*
*
*
Dated: October 11, 2019.
Bruce Summers,
Administrator, Agricultural Marketing
Service.
E. General Notice of Public Rulemaking
This proposed rule reflects
recommendations submitted by the
NOSB to the Secretary to add two
substances to the National List and
notify organic producers and certifying
agents of AMS’s decision not to add
sodium citrate to the National List. A
60-day period for interested persons to
comment on this rule is provided.
[FR Doc. 2019–22639 Filed 10–17–19; 8:45 am]
List of Subjects in 7 CFR Part 205
Administrative practice and
procedure, Agriculture, Animals,
Archives and records, Imports, Labeling,
Organically produced products, Plants,
Reporting and recordkeeping
requirements, Seals and insignia, Soil
conservation.
For the reasons set forth in the
preamble, 7 CFR part 205 is proposed to
be amended as follows:
RIN 0584–AE62
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.
2. Amend § 205.601 by redesignating
paragraphs (j)(2) through (11) as
paragraphs (j)(3) through (12) and
adding new paragraph (j)(2) to read as
follows:
■
§ 205.601 Synthetic substances allowed
for use in organic crop production.
*
*
*
*
*
(j) * * *
(2) Blood meal—made with sodium
citrate.
*
*
*
*
*
■ 3. Amend § 205.602 by redesignating
paragraphs (e) through (j) as paragraphs
(f) through (k) and adding new
paragraph (e) to read as follows:
VerDate Sep<11>2014
16:07 Oct 17, 2019
Jkt 250001
BILLING CODE 3410–02–P
DEPARTMENT OF AGRICULTURE
Food and Nutrition Service
7 CFR Part 273
[FNS–2018–0037]
Revision of Categorical Eligibility in
the Supplemental Nutrition Assistance
Program (SNAP); Reopening of
Comment Period
Food and Nutrition Service
(FNS), USDA.
ACTION: Proposed rule; reopening of
comment period.
AGENCY:
The Food and Nutrition
Service (FNS, or the Agency) proposed
to make changes to the Supplemental
Nutrition Asisstance Program (SNAP)
regulations to refine categorical
eligibility requirements based on receipt
of Temporary Assistance for Needy
Families (TANF) benefits. To aid the
public’s review of the rulemaking, FNS
is providing an informational analysis
regarding the potential impacts on
participants in the National School
Lunch Program and School Breakfast
Program. The agency is extending the
comment period to provide the public
an opportunity to review and provide
comment on this document as part of
the rulemaking record. Comments that
do not pertain to the issues referenced
in this additional document are not
germane to the extended comment
period and will not be accepted.
DATES: The comment period on the
proposed rule that published July 24,
SUMMARY:
PO 00000
Frm 00005
Fmt 4702
Sfmt 4702
2019 (84 FR 35570) is reopened. Written
comments must be received on or before
November 1, 2019 to be assured of
consideration.
The Food and Nutrition
Service, USDA, invites interested
persons to submit written comments on
this proposed rule. Comments may be
submitted in writing by the following
method:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov. Follow the
online instructions for submitting
comments.
• All written comments submitted in
response to this proposed rule will be
included in the record and will be made
available to the public. Please be
advised that the substance of the
comments and the identity of the
individuals or entities submitting the
comments will be subject to public
disclosure. FNS will make the written
comments publicly available on the
internet via https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Office of Policy Support, Food and
Nutrition Service, USDA, 3101 Park
Center Dr., Alexandria, VA 22302.
SUPPLEMENTARY INFORMATION: On July
24, 2019, FNS published in the Federal
Register (84 FR 35570) a proposed rule
to refine categorical eligibility
requirements based on receipt of TANF
benefits. Specifically, FNS proposed: (1)
To define ‘‘benefits’’ for categorical
eligibility to mean ongoing and
substantial benefits; and (2) to limit the
types of non-cash TANF benefits
conferring categorical eligibility to those
that focus on subsidized employment,
work supports and childcare. The
proposed rule would also require State
agencies to inform FNS of all non-cash
TANF benefits that confer categorical
eligibility. FNS has provided an
additional supplemental analysis on
www.regulations.gov regarding the
potential impacts on participants in the
National School Lunch Program and
School Breakfast Program. This
informational analysis, which was
prepared upon request after the
proposed rule was published, is being
posted to the docket in the interest of
public transparency. This analysis has
now been published on
www.regulations.gov as part of Docket
FNS–2018–0037. FNS is extending the
comment period to provide the public
an opportunity to review and provide
comment on this document as part of
the rulemaking record. This document
notifies the public FNS is reopening the
comment period. For additional
information, see the proposed rule
published July 24, 2019 (84 FR 35570).
ADDRESSES:
E:\FR\FM\18OCP1.SGM
18OCP1
]]>Agencies
[Federal Register Volume 84, Number 202 (Friday, October 18, 2019)]
[Proposed Rules]
[Pages 55866-55870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22639]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 84, No. 202 / Friday, October 18, 2019 /
Proposed Rules
[[Page 55866]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS-NOP-19-0023; NOP-19-01]
RIN 0581 AD83
National Organic Program; Proposed Amendments to the National
List of Allowed and Prohibited Substances per October 2018 NOSB
Recommendations (Crops and Handling)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would amend the National List of Allowed
and Prohibited Substances (National List) section of the United States
Department of Agriculture's (USDA's) organic regulations to implement
recommendations submitted to the Secretary of Agriculture (Secretary)
by the National Organic Standards Board (NOSB). This rule proposes to
add blood meal, made with sodium citrate, to the National List as a
soil fertilizer in organic crop production; add natamycin to the
National List to prohibit its use in organic crop production; and add
tamarind seed gum as a non-organic agricultural substance for use in
organic handling when organic forms of tamarind seed gum are not
commercially available.
DATES: Comments must be received by December 17, 2019.
ADDRESSES: Interested persons may comment on the proposed rule using
the following procedures:
Federal eRulemaking Portal: https://www.regulations.gov. Follow the
instructions for submitting comments.
Mail: Robert Pooler, Standards Division, National Organic Program,
USDA-AMS-NOP, 1400 Independence Ave. SW, Room 2642-S., Ag Stop 0268,
Washington, DC 20250-0268. Telephone: (202) 720-3252.
Instructions: All submissions received must include the docket
number AMS-NOP-19-0023, NOP-19-01, and/or Regulatory Information Number
(RIN) 0581-AD83 for this rulemaking. When submitting a comment, clearly
indicate the proposed rule topic and section number to which the
comment refers. In addition, comments should clearly indicate whether
the commenter supports the action being proposed and also clearly
indicate the reason(s) for the position. Comments can also include
information on alternative management practices, where applicable, that
support alternatives to the proposed amendments. Comments should also
offer any recommended language change(s) that would be appropriate to
the position. Please include relevant information and data to support
the position such as scientific, environmental, manufacturing,
industry, or impact information, or similar sources. Only relevant
material supporting the position should be submitted. All comments
received will be posted without change to https://www.regulations.gov.
Document: To access the document and read background documents, or
comments received, go to https://www.regulations.gov. Comments submitted
in response to this proposed rule will also be available for viewing in
person at USDA-AMS, National Organic Program, Room 2642-South Building,
1400 Independence Ave. SW, Washington, DC, from 9 a.m. to 12 noon and
from 1 p.m. to 4 p.m. Eastern Time, Monday through Friday (except
official Federal holidays). Persons wanting to visit the USDA South
Building to view comments received in response to this proposed rule
are requested to make an appointment in advance by calling (202) 720-
3252.
FOR FURTHER INFORMATION CONTACT: Robert Pooler, Standards Division,
National Organic Program. Telephone: (202) 720-3252.
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Secretary established the National List
within part 205 of the USDA organic regulations (7 CFR 205.600 through
205.607). The National List identifies the synthetic substance
allowances and the nonsynthetic substance prohibitions in organic
farming. The National List also identifies synthetic and nonsynthetic
nonagricultural substances and nonorganic agricultural substances that
may be used in organic handling.
The Organic Foods Production Act of 1990, as amended (7 U.S.C.
6501-6522) (OFPA), and Sec. 205.105 of the USDA organic regulations
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 and any nonsynthetic nonagricultural substance used in
organic handling be on the National List. Under the authority of OFPA,
the National List can be amended by the Secretary based on
recommendations presented by the NOSB. Since the final rule
establishing the National Organic Program (NOP) became effective on
October 21, 2002, USDA's Agricultural Marketing Service (AMS) has
published multiple rules amending the National List.
This proposed rule addresses three NOSB recommendations to amend
the National List that were submitted to the Secretary on October 26,
2018. Table 1 summarizes the proposed changes to the National List
based on these NOSB recommendations.
Table 1--Substances Being Added to the National List or Current Listings Being Amended
----------------------------------------------------------------------------------------------------------------
National list
Substance section Proposed rule action
----------------------------------------------------------------------------------------------------------------
Blood meal--made with Sodium citrate......... Sec. 205.601 Add to National List.
Natamycin.................................... Sec. 205.602 Add to National List.
Tamarind seed gum............................ Sec. 205.606 Add to National List.
----------------------------------------------------------------------------------------------------------------
[[Page 55867]]
II. Overview of Proposed Amendments
The following provides an overview of the proposed amendments to
designated sections of the National List regulations:
Blood Meal--Made With Sodium Citrate
The proposed rule would amend the National List to add blood meal--
made with sodium citrate to Sec. 205.601 as a synthetic substance
allowed for use in crop production. Table 2 illustrates the proposed
listing.
Table 2--Proposed Rule Action for Blood Meal Using Sodium Citrate
------------------------------------------------------------------------
Current rule: N/A
------------------------------------------------------------------------
Proposed rule action: Add blood meal--made with
sodium citrate to Sec.
205.601(j).
------------------------------------------------------------------------
On July 20, 2016, AMS received a petition \1\ to add sodium citrate
to the National List as an anticoagulant for spray dried blood
products. The addition of sodium citrate prevents the blood from
clotting and maintains the blood in a liquid state while it is
processed to dried blood meal. In its natural state, blood meal is a
nonsynthetic substance that may be used in organic production as a soil
amendment.
---------------------------------------------------------------------------
\1\ Sodium citrate petition: https://www.ams.usda.gov/sites/default/files/media/Sodium%20Citrate%20Crops%20Pet.pdf.
---------------------------------------------------------------------------
The NOSB reviewed and considered this petition at its public
meeting on October 26, 2018. At the conclusion of meeting, the NOSB
recommended to the Secretary to add sodium citrate, for use as an
anticoagulant in the production of blood meal, to the National List.\2\
In its recommendation, the NOSB requested that AMS review sodium
citrate to determine whether sodium citrate used to process blood meal
must be on the National List in order for the resulting blood meal to
be allowed in organic crop production.
---------------------------------------------------------------------------
\2\ NOSB recommendation for sodium citrate: https://www.ams.usda.gov/sites/default/files/media/CSSodiumCitratePetRecOct2018.pdf.
---------------------------------------------------------------------------
AMS reviewed the NOSB's sodium citrate recommendation, the sodium
citrate petition, and the sodium citrate technical report.\3\ AMS
concurs with the NOSB's determination that sodium citrate is a
synthetic substance. Further, AMS concludes that the use of sodium
citrate to manufacture blood meal means that blood meal would not
qualify as a nonsynthetic substance. AMS also concurs with the NOSB's
determination that the construct of the National List does not include
processing aids for crop production substances; rather it includes the
generic crop production substance. AMS determined that sodium citrate's
use as an anticoagulant in the production of blood meal is not included
within the production aid categories specified in the OFPA (7 U.S.C.
6517(c)(1)(B)).
---------------------------------------------------------------------------
\3\ Technical Evaluation Report for sodium citrate (for used in
crop production): https://www.ams.usda.gov/sites/default/files/media/SodiumCitrateCropsTR20171218.pdf.
---------------------------------------------------------------------------
Therefore, to address the NOSB's recommendation to allow the use of
sodium citrate, AMS is proposing to add blood meal produced with sodium
citrate to the National List. This determination is consistent with the
current listing for liquid fish products that are pH adjusted with
sulfuric, citric, or phosphoric acid and allowed in organic crop
production as a plant or soil amendment (Sec. 205.601(j)(8)). In that
case, the addition of a synthetic processing aid, i.e., the specified
acids, to a nonsynthetic substance, liquid fish products, was resolved
by listing as a synthetic substance liquid fish products that are pH
adjusted with the specified acids. The addition of the synthetic
substance, sodium citrate, in the processing of blood meal means that
the final product is also synthetic and must be on the National List
for use in organic crop production.\4\
---------------------------------------------------------------------------
\4\ Guidance on determining whether a substance is synthetic or
non-synthetic is described in document NOP 5033-1, Guidance Decision
Tree for Classification of Materials as Synthetic or Nonsynthetic:
https://www.ams.usda.gov/sites/default/files/media/NOP-Synthetic-NonSynthetic-DecisionTree.pdf.
---------------------------------------------------------------------------
In its recommendation to the Secretary, the NOSB stated that there
is no concern with using sodium citrate to make dried blood meal and
noted that sodium citrate is on the National List in Sec. 205.605(b)
as an allowed ingredient for use in organic processing. This proposed
rule would amend the National List by adding blood meal made with
sodium citrate to Sec. 205.601(j) as a plant or soil amendment.
Sec. 205.602 Nonsynthetic Substances Prohibited for Use in Organic
Crop Production
This proposed rule would add natamycin to Sec. 205.602,
Nonsynthetic substances prohibited for use in organic crop production.
Natamycin
The proposed rule would amend the National List to add natamycin to
Sec. 205.602. Table 2 illustrates the proposed listing.
Table 3--Proposed Rule Action For Natamycin
------------------------------------------------------------------------
Current rule: N/A
------------------------------------------------------------------------
Proposed rule action: Add natamycin to Sec.
205.602.
------------------------------------------------------------------------
On September 1, 2016, AMS received a petition \5\ to add natamycin
as a nonsynthetic substance allowed for use in organic crop production
as a post-harvest treatment to control fungal diseases. Natamycin is a
naturally occurring compound produced by soil bacteria. Natamycin is
used in agriculture and in food processing for its antifungal
properties as either a fungicide or fungistat. These properties are
effective over a wide pH range. To enhance review of this petition, the
NOSB solicited a technical report on natamycin.\6\ This report
indicates that natamycin is regulated by both the Environmental
Protection Agency (EPA) and the Food and Drug Administration (FDA).
Commercial applications of natamycin in crop, livestock, and food
production can be grouped into three basic categories: Pre- or post-
harvest agricultural fungicide; livestock medication; or as a
preservative in processed foods. For example, natamycin may be used in
mushroom production to control fungal diseases and in post-harvest
handling treatment of raw agricultural commodities, such as fruits, to
prevent spoilage. Natamycin is also used in animal health for treating
ringworm and candidosis in horses and cattle. Natamycin is approved as
a preservative in certain processed foods, such as cheese, yogurt, and
certain beverages.
---------------------------------------------------------------------------
\5\ Natamycin petition: https://www.ams.usda.gov/sites/default/files/media/Natamycin%20NOP%20Petition%20-%2001%20Sep%2016.pdf.
\6\ Natamycin Technical Evaluation Report, November 2017:
https://www.ams.usda.gov/sites/default/files/media/NatamycinTR20171102.pdf.
---------------------------------------------------------------------------
The 2016 natamycin petition is the second natamycin petition
received and reviewed by the NOSB. In March 2007 the NOSB reviewed a
petition on natamycin for use as a nonsynthetic, nonagricultural
substance in organic processing and handling, to prevent or delay mold
growth in packaged baked goods. After reviewing the 2007 petition, the
NOSB considered adding natamycin to the National List in Sec.
205.605(a), Nonagricultural (nonorganic) substances allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food group(s)).'' At the
conclusion of the March 2007 meeting, the NOSB did not recommend adding
natamycin to
[[Page 55868]]
Sec. 205.605(a). Some comments received by the NOSB during the 2007
meeting stated opposition to allowing natamycin in organic handling
because the commenters believed that natamycin is an antibiotic, and
its use as a preservative would not be compatible with organic
standards. In 2007, the NOSB determined natamycin to be a nonsynthetic
substance and that its use, as petitioned, was not compatible with
organic handling standards.
At its October 26, 2018, public meeting, the NOSB considered the
second natamycin petition as a nonsynthetic substance in organic crop
production and received public comment. In its review, the NOSB also
considered a November 2, 2017, technical evaluation report on natamycin
that described its manufacture, industry uses, regulation, and chemical
properties.
After considering the petition, technical report, and public
comments, the NOSB determined (1) that natamycin is a nonsynthetic
substance and (2) that the use of natamycin as a post-harvest treatment
on harvested crops met the OFPA criteria for prohibitions on natural
substances because its use could negatively impact human health by
increasing fungal resistance to natamycin. As such, its use would not
be consistent with organic farming or handling. Therefore, the NOSB
recommended adding natamycin to Sec. 205.602 as a nonsynthetic
substance prohibited for use in organic crop production.\7\
---------------------------------------------------------------------------
\7\ NOSB natamycin recommendation: https://www.ams.usda.gov/sites/default/files/media/CSNatamycinPetRecOct2018.pdf.
---------------------------------------------------------------------------
AMS has reviewed the NOSB recommendation on natamycin and agrees
that natamycin meets the OFPA criteria for listing as a prohibited
substance in organic crop production. AMS proposes addressing this NOSB
recommendation through this proposed rule. Consistent with the NOSB
recommendation, this proposed rule would amend the National List by
adding natamycin to Sec. 205.602 as a prohibited nonsysthetic
substance. This action would prohibit any use of natamycin in organic
crop production, including both pre-harvest and post-harvest treatment.
Sec. 205.606 Nonorganically Produced Agricultural Products Allowed as
Ingredients in or on Processed Products Labeled as ``Organic.''
Tamarind Seed Gum
The proposed rule would amend the National List to add tamarind
seed gum as a non-organic agricultural substance listed in Sec.
205.606 for use in organic handling.
Table 4--Proposed Rule Action For Tamarind Seed Gum
------------------------------------------------------------------------
Current rule: N/A
------------------------------------------------------------------------
Proposed rule action: Add tamarind seed gum to
Sec. 205.606.
------------------------------------------------------------------------
On February 13, 2017, AMS received a petition \8\ to add tamarind
seed gum to the National List in Sec. 205.606 for use in organic
handling as a thickener, stabilizer, or gelling agent in processed
foods. Tamarind seed gum is a plant polysaccharide (polymer of
carbohydrate molecules) derived from the kernel, or endosperm, of seeds
of the tamarind tree. Tamarind seed gum is Generally Regarded as Safe
(GRAS) for several applications as a food additive--specifically in
foods such as cheese, fruit preserves, sauces, and ice cream.
---------------------------------------------------------------------------
\8\ Tamarind seed gum petition: https://www.ams.usda.gov/sites/default/files/media/TamGumPetition.pdf.
---------------------------------------------------------------------------
To enhance its review of this petition, the NOSB solicited a
technical report \9\ on tamarind seed gum. This report indicated that
tamarind seed gum is regulated by the FDA as a GRAS food additive and
specifically, as a stabilizer and thickener as defined by 21 CFR 170.3.
---------------------------------------------------------------------------
\9\ Tamarind seed gum technical evaluation report, February
2018: https://www.ams.usda.gov/sites/default/files/media/TamarindSeedGumTR2018221.pdf.
---------------------------------------------------------------------------
At its October 26, 2018, public meeting, the NOSB considered the
petition on adding tamarind seed gum to the National List for use in
organic handling. As part of its review, the NOSB considered a February
21, 2018, technical report on tamarind seed gum that described its
manufacture, industry uses, regulation, and chemical properties. After
considering the petition, technical report, and public comments on
tamarind seed gum, the NOSB determined that the allowance of non-
organic tamarind seed gum for use as an ingredient in organic handling
is consistent with the OFPA evaluation criteria for National List
substances. The NOSB's evaluation also determined that tamarind seed
gum provides different processing characteristics and texture compared
to the gums currently on the National List. Subsequently, the NOSB
recommended \10\ adding tamarind seed gum to Sec. 205.606 as a
nonorganically produced agricultural product allowed as ingredients in
or on processed products labeled as ``organic.''
AMS has reviewed the NOSB recommendation on tamarind seed gum and
agrees that tamarind seed gum satisfies the OFPA evaluation criteria
for an allowed substance on the National List. Subsequently, AMS
proposes addressing this NOSB recommendation through this proposed
rule. Consistent with the NOSB recommendation, this proposed rule would
amend the National List by adding tamarind seed gum to Sec. 205.606 as
a nonorganically produced agricultural product allowed as an ingredient
in or on processed products labeled as ``organic.'' This action would
require organic handlers who use tamarind seed gum to source an organic
form of the ingredient before using any nonorganic source of this
ingredient. If the organic form of the ingredient is not commercially
available, the nonorganic form may be used.\11\
---------------------------------------------------------------------------
\10\ NOSB recommendation on tamarind seed gum: https://www.ams.usda.gov/sites/default/files/media/HSTamarindSeedGumPetRecOct2018.pdf.
\11\ See 7 CFR 205.606 and 7 CFR 205.2 for definition of
``Commercially available.''
---------------------------------------------------------------------------
III. Related Documents
On August 9, 2018, a document was published in the Federal Register
(83 FR 39376) announcing the fall 2018 NOSB meeting. One purpose of the
meeting was to deliberate on recommendations on substances petitioned
as amendments to the National List.
IV. Statutory and Regulatory Authority
The OFPA authorizes the Secretary to make amendments to the
National List based on recommendations developed by the NOSB. Sections
6518(k) and 6518(n) of the OFPA authorize the NOSB to develop
recommendations for submission to the Secretary to amend the National
List and establish a process by which persons may petition the NOSB for
the purpose of having substances evaluated for inclusion on or deletion
from the National List. Section 205.607 of the USDA organic regulations
permits any person to petition to add or remove a substance from the
National List and directs petitioners to obtain the petition procedures
from USDA. The current petition procedures published in the Federal
Register (81 FR 12680, March 10, 2016) for amending the National List
can be accessed through the NOP Program Handbook on the NOP website at
https://www.ams.usda.gov/rules-regulations/organic/handbook.
A. Executive Orders 12866 and 13771, and Regulatory Flexibility Act
This action falls within a category of regulatory actions that the
Office of Management and Budget (OMB) has
[[Page 55869]]
exempted from Executive Order 12866. Additionally, because this
proposal does not meet the definition of a significant regulatory
action, it does not trigger the requirements contained in Executive
Order 13771. See OMB's Memorandum titled ``Interim Guidance
Implementing Section 2 of the Executive Order of January 30, 2017
titled `Reducing Regulation and Controlling Regulatory Costs' ''
(February 2, 2017).
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.
The Small Business Administration (SBA) sets size criteria for each
industry described in the North American Industry Classification System
(NAICS) to delineate which operations qualify as small businesses. The
SBA has classified small agricultural producers that engage in crop and
animal production as those with average annual receipts of less than
$750,000. Handlers are involved in a broad spectrum of food production
activities and fall into various categories in the NAICS Food
Manufacturing sector. The small business thresholds for food
manufacturing operations are based on the number of employees and range
from 500 to 1,250 employees, depending on the specific type of
manufacturing. Certifying agents fall under the NAICS subsector, ``All
other professional, scientific and technical services.'' For this
category, the small business threshold is average annual receipts of
less than $15 million.
AMS has considered the economic impact of this proposed rulemaking
on small agricultural entities. Data collected by the USDA National
Agricultural Statistics Service (NASS) and the NOP indicate most of the
certified organic production operations in the United States would be
considered small entities. According to the 2017 Census of Agriculture,
18,166 organic farms in the United States reported sales of organic
products and total farmgate sales in excess of $7.2 billion.\12\ Based
on that data, organic sales average $400,000 per farm. Assuming a
normal distribution of producers, we expect that most of these
producers would fall under the $750,000 sales threshold to qualify as a
small business.
---------------------------------------------------------------------------
\12\ U.S. Department of Agriculture, National Agricultural
Statistics Service. 2017 Census of Agriculture. https://www.nass.usda.gov/Publications/AgCensus/2017/Full_Report/Volume_1,_Chapter_1_US/. The number of organic farms includes both
certified and exempt farms.
---------------------------------------------------------------------------
According to the NOP's Organic Integrity Database, there are 18,105
organic handlers that are certified under the USDA organic regulations
(10,184 of these handlers are based in the U.S).\13\ The Organic Trade
Association's 2018 Organic Industry Survey has information about
employment trends among organic manufacturers. The reported data are
stratified into three groups by the number of employees per company:
Less than 5; 5 to 49; and 50 plus. These data are representative of the
organic manufacturing sector and the lower bound (50) of the range for
the larger manufacturers is significantly smaller than the SBA's small
business thresholds (500 to 1,250). Therefore, AMS expects that most
organic handlers would qualify as small businesses.
---------------------------------------------------------------------------
\13\ Organic Integrity Database: https://organic.ams.usda.gov/Integrity/. Accessed on June 7, 2019.
---------------------------------------------------------------------------
The USDA has 78 accredited certifying agents who provide organic
certification services to producers and handlers. The certifying agent
that reports the most certified operations, nearly 3,500, would need to
charge approximately $4,200 in certification fees in order to exceed
the SBA's small business threshold of $15 million. The costs for
certification generally range from $500 to $3,500, depending on the
complexity of the operation. Therefore, AMS expects that most of the
accredited certifying agents would qualify as small entities under the
SBA criteria.
The economic impact on entities affected by this rule would not be
significant. The effect of this rule, if implemented as final, would be
to allow the use of two additional substances in organic crop
production and organic handling. Adding two substances to the National
List would increase regulatory flexibility and would give small
entities more tools to use in day-to-day operations. This action would
also prohibit the use of natamycin in organic crop production due to
its possible impact on human health. AMS reviewed comments submitted to
the NOSB indicating that there is little to no use of natamycin
currently in organic crop production. Therefore, AMS concludes that the
economic impact of this addition, if any, would be minimal because
there are other practices and substances that provide effective fungal
control in organic crop production. Accordingly, USDA certifies that
this rule would not have a significant economic impact on a substantial
number of small entities.
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. Accordingly, to prevent
duplicative regulation, states and local jurisdictions are preempted
under the OFPA from creating programs of accreditation for private
persons or state officials who want to become certifying agents of
organic farms or handling operations. A governing state official would
have to apply to USDA to be accredited as a certifying agent, as
described in section 6514(b) of the OFPA. States are also preempted
under sections 6503 through 6507 of the 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 the OFPA.
Pursuant to section 6507(b)(2) of the OFPA, a state organic
certification program that has been approved by the Secretary may,
under certain circumstances, contain additional requirements for the
production and handling of agricultural products organically produced
in the state and for the certification of organic farm and handling
operations located within the state. Such additional requirements must
(a) further the purposes of the OFPA, (b) not be inconsistent with the
OFPA, (c) not be discriminatory toward agricultural commodities
organically produced in other States, and (d) not be effective until
approved by the Secretary.
In addition, pursuant to section 6519(c)(6) of the OFPA, this
proposed rule would not supersede or 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, respectively, nor any of the authorities of
the Secretary of Health and Human Services under the Federal Food, Drug
and Cosmetic Act (21 U.S.C. 301 et seq.), nor the authority of the
Administrator of the
[[Page 55870]]
EPA under the Federal Insecticide, Fungicide and Rodenticide Act (7
U.S.C. 136 et seq.).
C. Paperwork Reduction Act
No additional collection or recordkeeping requirements are imposed
on the public by this proposed rule. Accordingly, OMB clearance is not
required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501,
Chapter 35.
D. Executive Order 13175
This proposed 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.
E. General Notice of Public Rulemaking
This proposed rule reflects recommendations submitted by the NOSB
to the Secretary to add two substances to the National List and notify
organic producers and certifying agents of AMS's decision not to add
sodium citrate to the National List. A 60-day period for interested
persons to comment on this rule is provided.
List of Subjects in 7 CFR Part 205
Administrative practice and procedure, Agriculture, Animals,
Archives and records, Imports, Labeling, Organically produced products,
Plants, Reporting and recordkeeping requirements, Seals and insignia,
Soil conservation.
For the reasons set forth in the preamble, 7 CFR part 205 is
proposed to be 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.
0
2. Amend Sec. 205.601 by redesignating paragraphs (j)(2) through (11)
as paragraphs (j)(3) through (12) and adding new paragraph (j)(2) to
read as follows:
Sec. 205.601 Synthetic substances allowed for use in organic crop
production.
* * * * *
(j) * * *
(2) Blood meal--made with sodium citrate.
* * * * *
0
3. Amend Sec. 205.602 by redesignating paragraphs (e) through (j) as
paragraphs (f) through (k) and adding new paragraph (e) to read as
follows:
Sec. 205.602 Nonsynthetic substances prohibited for use in organic
crop production.
* * * * *
(e) Natamycin.
* * * * *
0
4. Amend Sec. 205.606 by redesignating paragraphs (s) through (w) as
paragraphs (t) through (x) and adding new paragraph (s) to read as
follows:
Sec. 205.606 Nonorganically produced agricultural products allowed as
ingredients in or on processed products labeled as ``organic.''
* * * * *
(s) Tamarind seed gum.
* * * * *
Dated: October 11, 2019.
Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2019-22639 Filed 10-17-19; 8:45 am]
BILLING CODE 3410-02-P
