83_FR_58213 83 FR 57991 - Semiannual Regulatory Agenda, Fall 2018

83 FR 57991 - Semiannual Regulatory Agenda, Fall 2018

DEPARTMENT OF AGRICULTURE
Office of the Secretary

Federal Register Volume 83, Issue 222 (November 16, 2018)

Page Range57991-57996
FR Document2018-24141

This agenda provides summary descriptions of the significant and not significant regulatory and deregulatory actions being developed in agencies of the U.S. Department of Agriculture (USDA) in conformance with Executive Orders (E.O.) 12866, ``Regulatory Planning and Review,'' 13771, ``Reducing Regulation and Controlling Regulatory Costs,'' 13777, ``Enforcing the Regulatory Reform Agenda,'' and 13563, ``Improving Regulation and Regulatory Review.'' The agenda also describes regulations affecting small entities as required by section 602 of the Regulatory Flexibility Act, Public Law 96-354. This agenda also identifies regulatory actions that are being reviewed in compliance with section 610(c) of the Regulatory Flexibility Act. We invite public comment on those actions as well as any regulation consistent with Executive Order 13563. USDA has attempted to list all regulations and regulatory reviews pending at the time of publication except for minor and routine or repetitive actions, but some may have been inadvertently missed. There is no legal significance to the omission of an item from this listing. Also, the dates shown for the steps of each action are estimated and are not commitments to act on or by the date shown. USDA's complete regulatory agenda is available online at www.reginfo.gov. Because publication in the Federal Register is mandated for the regulatory flexibility agendas required by the Regulatory Flexibility Act (5 U.S.C. 602), USDA's printed agenda entries include only: (1) Rules that are likely to have a significant economic impact on a substantial number of small entities; and (2) Rules identified for periodic review under section 610 of the Regulatory Flexibility Act. For this edition of the USDA regulatory agenda, the most important regulatory and deregulatory actions are summarized in a Statement of Regulatory Priorities that is included in the Regulatory Plan, which appears in both the online regulatory agenda and in part II of the Federal Register that includes the abbreviated regulatory agenda.

Federal Register, Volume 83 Issue 222 (Friday, November 16, 2018)
[Federal Register Volume 83, Number 222 (Friday, November 16, 2018)]
[Unknown Section]
[Pages 57991-57996]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-24141]



[[Page 57991]]

Vol. 83

Friday,

No. 222

November 16, 2018

Part III





 Department of Agriculture





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Semiannual Regulatory Agenda

Federal Register / Vol. 83 , No. 222 / Friday, November 16, 2018 / 
Unified Agenda

[[Page 57992]]


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DEPARTMENT OF AGRICULTURE

Office of the Secretary

2 CFR Subtitle B, Ch. IV

5 CFR Ch. LXXIII

7 CFR Subtitle A; Subtitle B, Chs. I-XI, XIV-XVIII, XX, XXV-
XXXVIII, XLII

9 CFR Chs. I-III

36 CFR Ch. II

48 CFR Ch. 4


Semiannual Regulatory Agenda, Fall 2018

AGENCY: Office of the Secretary, USDA.

ACTION: Semiannual regulatory agenda.

-----------------------------------------------------------------------

SUMMARY: This agenda provides summary descriptions of the significant 
and not significant regulatory and deregulatory actions being developed 
in agencies of the U.S. Department of Agriculture (USDA) in conformance 
with Executive Orders (E.O.) 12866, ``Regulatory Planning and Review,'' 
13771, ``Reducing Regulation and Controlling Regulatory Costs,'' 13777, 
``Enforcing the Regulatory Reform Agenda,'' and 13563, ``Improving 
Regulation and Regulatory Review.'' The agenda also describes 
regulations affecting small entities as required by section 602 of the 
Regulatory Flexibility Act, Public Law 96-354. This agenda also 
identifies regulatory actions that are being reviewed in compliance 
with section 610(c) of the Regulatory Flexibility Act. We invite public 
comment on those actions as well as any regulation consistent with 
Executive Order 13563.
    USDA has attempted to list all regulations and regulatory reviews 
pending at the time of publication except for minor and routine or 
repetitive actions, but some may have been inadvertently missed. There 
is no legal significance to the omission of an item from this listing. 
Also, the dates shown for the steps of each action are estimated and 
are not commitments to act on or by the date shown.
    USDA's complete regulatory agenda is available online at 
www.reginfo.gov. Because publication in the Federal Register is 
mandated for the regulatory flexibility agendas required by the 
Regulatory Flexibility Act (5 U.S.C. 602), USDA's printed agenda 
entries include only:
    (1) Rules that are likely to have a significant economic impact on 
a substantial number of small entities; and
    (2) Rules identified for periodic review under section 610 of the 
Regulatory Flexibility Act.
    For this edition of the USDA regulatory agenda, the most important 
regulatory and deregulatory actions are summarized in a Statement of 
Regulatory Priorities that is included in the Regulatory Plan, which 
appears in both the online regulatory agenda and in part II of the 
Federal Register that includes the abbreviated regulatory agenda.

FOR FURTHER INFORMATION CONTACT: For further information on any 
specific entry shown in this agenda, please contact the person listed 
for that action. For general comments or inquiries about the agenda, 
please contact Michael Poe, Office of Budget and Program Analysis, U.S. 
Department of Agriculture, Washington, DC 20250, (202) 720-3257.

    Dated: September 4, 2018.
Michael Poe,
Legislative and Regulatory Staff.

            Agricultural Marketing Service--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
183.......................  National Bioengineered             0581-AD54
                             Food Disclosure Standard
                             (Reg Plan Seq No. 2).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


     Animal and Plant Health Inspection Service--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
184.......................  Removal of Emerald Ash             0579-AE42
                             Borer Domestic Quarantine
                             Regulations.
------------------------------------------------------------------------


      Animal and Plant Health Inspection Service--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
185.......................  Scrapie in Sheep and Goats         0579-AC92
186.......................  Plant Pest Regulations;            0579-AC98
                             Update of General
                             Provisions.
187.......................  Bovine Spongiform                  0579-AD10
                             Encephalopathy and
                             Scrapie; Importation of
                             Small Ruminants and Their
                             Germplasm, Products, and
                             Byproducts.
188.......................  Lacey Act Implementation           0579-AD44
                             Plan: De Minimis
                             Exception.
189.......................  Branding Requirements for          0579-AE38
                             Bovines Imported Into the
                             United States From Mexico.
------------------------------------------------------------------------


      Animal and Plant Health Inspection Service--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
190.......................  Importation of Fresh               0579-AD95
                             Citrus Fruit From the
                             Republic of South Africa
                             Into the Continental
                             United States.
------------------------------------------------------------------------


[[Page 57993]]


      Animal and Plant Health Inspection Service--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
191.......................  Phytophthora Ramorum;              0579-AB82
                             Quarantine and
                             Regulations.
192.......................  Establishing a Performance         0579-AD71
                             Standard for Authorizing
                             the Importation and
                             Interstate Movement of
                             Fruits and Vegetables.
193.......................  Animal Welfare;                    0579-AD99
                             Establishing De Minimis
                             Exemptions From Licensing.
194.......................  VSTA Records and Reports           0579-AE11
                             Specific to International
                             Standards for
                             Pharmacovigilance.
195.......................  Conditions for Payment of          0579-AE14
                             Highly Pathogenic Avian
                             Influenza Indemnity
                             Claims.
------------------------------------------------------------------------


          Food Safety and Inspection Service--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
196.......................  Elimination of Trichina            0583-AD59
                             Control Regulations and
                             Consolidation of
                             Thermally Processed,
                             Commercially Sterile
                             Regulations.
------------------------------------------------------------------------


    Office of Procurement and Property Management--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
197.......................  Designation of Biobased            0599-AA27
                             Product Categories for
                             Federal Procurement,
                             Round 11.
------------------------------------------------------------------------


DEPARTMENT OF AGRICULTURE (USDA)

Agricultural Marketing Service (AMS)

Final Rule Stage

183. National Bioengineered Food Disclosure Standard

    Regulatory Plan: This entry is Seq. No. 2 in part II of this issue 
of the Federal Register.
    RIN: 0581-AD54

BILLING CODE 3410-02-P

DEPARTMENT OF AGRICULTURE (USDA)

Animal and Plant Health Inspection Service (APHIS)

Proposed Rule Stage

184. Removal of Emerald Ash Borer Domestic Quarantine Regulations

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 7 U.S.C. 7701 to 7772; 7 U.S.C. 7781 to 7786
    Abstract: This rulemaking would remove the domestic quarantine 
regulations for the plant pest emerald ash borer. This action would 
discontinue the domestic regulatory component of the emerald ash borer 
program as a means to more effectively direct available resources 
toward management and containment of the pest. Funding previously 
allocated to the implementation and enforcement of these domestic 
quarantine regulations would instead be directed to a non-regulatory 
option of research into, and deployment of, biological control agents 
for emerald ash borer, which would serve as the primary tool to 
mitigate and control the pest.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/19/18  83 FR 47310
NPRM Comment Period End.............   11/19/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Robyn Rose, National Policy Manager, PPQ, 
Department of Agriculture, Animal and Plant Health Inspection Service, 
4700 River Road, Unit 26, Riverdale, MD 20737-1231, Phone: 301 851-
2283.
    RIN: 0579-AE42

DEPARTMENT OF AGRICULTURE (USDA)

Animal and Plant Health Inspection Service (APHIS)

Final Rule Stage

185. Scrapie in Sheep and Goats

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 7 U.S.C. 8301 to 8317
    Abstract: This rulemaking would amend the scrapie regulations by 
changing the risk groups and categories established for individual 
animals and for flocks. It would simplify, reduce, or remove certain 
recordkeeping requirements. This action would provide designated 
scrapie epidemiologists with more alternatives and flexibility when 
testing animals in order to determine flock designations under the 
regulations. It would also make the identification and recordkeeping 
requirements for goat owners consistent with those for sheep owners. 
These changes would affect sheep and goat producers and State 
governments.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/10/15  80 FR 54659
NPRM Comment Period End.............   11/09/15  .......................
NPRM Comment Period Reopened........   11/16/15  80 FR 70718
NPRM Comment Period Reopened End....   12/09/15  .......................
Final Rule..........................   11/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Diane Sutton, Sheep, Goat, Cervid, and Equine 
Health Center; Surveillance, Preparedness, and Response Services, VS, 
Department of Agriculture, Animal and Plant Health Inspection Service, 
4700 River Road, Unit 43, Riverdale, MD 20737-1235, Phone: 301 851-
3509.
    RIN: 0579-AC92

186. Plant Pest Regulations; Update of General Provisions

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 7 U.S.C. 450; 7 U.S.C. 2260; 7 U.S.C. 7701 to 
7772; 7 U.S.C. 7781 to 7786; 7 U.S.C. 8301 to 8817; 21 U.S.C. 111; 21 
U.S.C. 114a; 21 U.S.C.

[[Page 57994]]

136 and 136a; 31 U.S.C. 9701; 42 U.S.C. 4331 and 4332
    Abstract: We are revising our regulations regarding the movement of 
plant pests. We are establishing criteria regarding the movement and 
environmental release of biological control organisms, and establishing 
regulations to allow the importation and movement in interstate 
commerce of certain types of plant pests without restriction by 
granting exceptions from permitting requirements for those pests. We 
are also revising our regulations regarding the movement of soil. This 
action clarifies the factors that would be considered when assessing 
the risks associated with the movement of certain organisms and 
facilitates the movement of regulated organisms and articles in a 
manner that also protects U.S. agriculture.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Notice of Intent To Prepare an         10/20/09  74 FR 53673
 Environmental Impact Statement.
Notice Comment Period End...........   11/19/09  .......................
NPRM................................   01/19/17  82 FR 6980
NPRM Comment Period Extended........   02/13/17  82 FR 10444
NPRM Comment Period End.............   04/19/17  .......................
Final Rule..........................   11/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Colin Stewart, Assistant Director, Pests, 
Pathogens, and Biocontrol Permits, PPQ, Department of Agriculture, 
Animal and Plant Health Inspection Service, 4700 River Road, Unit 133, 
Riverdale, MD 20737-1236, Phone: 301 851-2237.
    RIN: 0579-AC98

187. Bovine Spongiform Encephalopathy and Scrapie; Importation of Small 
Ruminants and Their Germplasm, Products, and Byproducts

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 7 U.S.C. 450; 7 U.S.C. 1622; 7 U.S.C. 7701 to 
7772; 7 U.S.C. 7781 to 7786; 7 U.S.C. 8301 to 8317; 21 U.S.C. 136 and 
136a; 31 U.S.C. 9701
    Abstract: This rulemaking amends the bovine spongiform 
encephalopathy (BSE) and scrapie regulations regarding the importation 
of live sheep, goats, and wild ruminants and their embryos, semen, 
products, and byproducts. The scrapie revisions regarding the 
importation of sheep, goats, and susceptible wild ruminants for other 
than immediate slaughter are similar to those recommended by the World 
Organization for Animal Health in restricting the importation of such 
animals to those from scrapie-free regions or certified scrapie-free 
flocks.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/18/16  81 FR 46619
NPRM Comment Period End.............   09/16/16  .......................
Final Rule..........................   11/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Alexandra MacKenzie, Veterinary Medical Officer, 
Animal Permitting and Negotiating Services, NIES, VS, Department of 
Agriculture, Animal and Plant Health Inspection Service, 4700 River 
Road, Unit 39, Riverdale, MD 20737, Phone: 301 851-3300.
    RIN: 0579-AD10

188. Lacey Act Implementation Plan: De Minimis Exception

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 16 U.S.C. 3371 et seq.
    Abstract: The Food, Conservation, and Energy Act of 2008 amended 
the Lacey Act to provide, among other things, that importers submit a 
declaration at the time of importation for certain plants and plant 
products. The declaration requirements of the Lacey Act became 
effective on December 15, 2008, and enforcement of those requirements 
is being phased in. We are proposing to establish an exception to the 
declaration requirement for products containing a minimal amount of 
plant materials.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   06/30/11  76 FR 38330
ANPRM Comment Period End............   08/29/11  .......................
NPRM................................   07/09/18  83 FR 31697
NPRM Comment Period End.............   09/07/18  .......................
Final Rule..........................   09/00/19  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Robert Baca, Assistant Director, Compliance and 
Environmental Coordination, PPQ, Department of Agriculture, Animal and 
Plant Health Inspection Service, 4700 River Road, Unit 150, Riverdale, 
MD 20737, Phone: 301 851-2347.
    RIN: 0579-AD44

189. Branding Requirements for Bovines Imported Into the United States 
From Mexico

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 7 U.S.C. 1622; 7 U.S.C. 8301 to 8317; 21 U.S.C. 
136 and 136a; 31 U.S.C. 9701
    Abstract: This rulemaking would amend the regulations regarding the 
branding of bovines imported into the United States from Mexico.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/12/18  83 FR 15756
NPRM Comment Period End.............   06/11/18  .......................
Final Rule..........................   11/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Betzaida Lopez, Senior Staff Veterinarian, National 
Import Export Services, VS, Department of Agriculture, Animal and Plant 
Health Inspection Service, 4700 River Road, Unit 39, Riverdale, MD 
20737, Phone: 301 851-3300.
    RIN: 0579-AE38

DEPARTMENT OF AGRICULTURE (USDA)

Animal and Plant Health Inspection Service (APHIS)

Long-Term Actions

190. Importation of Fresh Citrus Fruit From the Republic of South 
Africa Into the Continental United States

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 7 U.S.C. 450; 7 U.S.C. 7701 to 7772; 7 U.S.C. 7781 
to 7786; 21 U.S.C. 136 and 136a
    Abstract: This rulemaking will amend the fruits and vegetables 
regulations to allow the importation of several varieties of fresh 
citrus fruit, as well as citrus hybrids, into the continental United 
States from areas in the Republic of South Africa where citrus black 
spot has been known to occur. As a condition of entry, the fruit will 
have to be produced in accordance with a systems approach that includes 
shipment traceability, packinghouse registration and procedures, and 
phytosanitary treatment. The fruit will also be required to be imported 
in commercial consignments and accompanied by a phytosanitary 
certificate issued by the national plant protection organization of the 
Republic of South Africa with an additional declaration confirming that 
the fruit has been produced in accordance with the systems approach. 
This action will

[[Page 57995]]

allow for the importation of fresh citrus fruit, including citrus 
hybrids, from the Republic of South Africa while continuing to provide 
protection against the introduction of plant pests into the United 
States.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/28/14  79 FR 51273
NPRM Comment Period End.............   10/27/14  .......................
Next Action Undetermined............  .........  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Tony Rom[aacute]n, Phone: 301 851-2242.
    RIN: 0579-AD95

DEPARTMENT OF AGRICULTURE (USDA)

Animal and Plant Health Inspection Service (APHIS)

Completed Actions

191. Phytophthora Ramorum; Quarantine and Regulations

    E.O. 13771 Designation: Not subject to, not significant.
    Legal Authority: 7 U.S.C. 7701 to 7772; 7 U.S.C. 7781 to 7786
    Abstract: The interim rule amended the Phytophthora ramorum 
regulations to make the regulations consistent with a Federal Order 
issued by APHIS in December 2004 that established restrictions on the 
interstate movement of nursery stock from nurseries in nonquarantined 
counties in California, Oregon, and Washington. This action also 
updated conditions for the movement of regulated articles of nursery 
stock from quarantined areas, as well as restricted the interstate 
movement of all other nursery stock from nurseries in quarantined 
areas. We also updated the list of plants regulated because of P. 
ramorum and the list of areas that are quarantined for P. ramorum and 
made other miscellaneous revisions to the regulations. This action was 
superseded by 0579-AE30.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   07/16/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Prakash Hebbar, Phone: 301 734-5717.
    RIN: 0579-AB82

192. Establishing a Performance Standard for Authorizing the 
Importation and Interstate Movement of Fruits and Vegetables

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 7 U.S.C. 450; 7 U.S.C. 7701 to 7772; 7 U.S.C. 7781 
to 7786; 21 U.S.C. 136 and 136(a)
    Abstract: This rulemaking will amend our regulations governing the 
importations of fruits and vegetables by broadening our existing 
performance standard to provide for consideration of all new fruits and 
vegetables for importation into the United States using a notice-based 
process. Rather than authorizing new imports through proposed and final 
rules and specifying import conditions in the regulations, the notice-
based process uses Federal Register notices to make risk analyses 
available to the public for review and comment, with authorized 
commodities and their conditions of entry subsequently being listed on 
the internet. It also will remove the region- or commodity-specific 
phytosanitary requirements currently found in these regulations. 
Likewise, we are proposing an equivalent revision of the performance 
standard in our regulations governing the interstate movements of 
fruits and vegetables from Hawaii and the U.S. territories (Guam, 
Northern Mariana Islands, Puerto Rico, and the U.S. Virgin Islands) and 
the removal of commodity-specific phytosanitary requirements from those 
regulations. This action will allow for the consideration of requests 
to authorize the importation or interstate movement of new fruits and 
vegetables in a manner that enables a more flexible and responsive 
regulatory approach to evolving pest situations in both the United 
States and exporting countries. It will not, however, alter the 
science-based process in which the risk associated with importation or 
interstate movement of a given fruit or vegetable is evaluated or the 
manner in which risks associated with the importation or interstate 
movement of a fruit or vegetable are mitigated.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Rule..........................   09/14/18  83 FR 46627
Final Action Effective..............   10/15/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Benjamin Kaczmarski, Phone: 301 851-2127.
    RIN: 0579-AD71

193. Animal Welfare; Establishing de Minimis Exemptions From Licensing

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 7 U.S.C. 2131 to 2159
    Abstract: We are amending the Animal Welfare Act (AWA) regulations 
to implement amendments to the Act that broadened the scope of the 
exemptions from the licensing requirements for dealers and exhibitors. 
Specifically, we are broadening the licensing exemption for any person 
who maintains four or fewer breeding female dogs, cats, and/or small 
exotic or wild mammals and only sells the offspring of these animals 
for pets or exhibition to include additional types of pet animals and 
domesticated farm-type animals. In addition, we are adding a new 
licensing exemption for any person who maintains eight or fewer pet 
animals, small exotic or wild animals, and/or domesticated farm-type 
animals for exhibition. These actions will allow the Agency to focus 
its limited resources on situations that pose a higher risk to animal 
welfare and public safety. Finally, we are making conforming changes to 
the definitions of dealer and exhibitor to reflect the amendments to 
the Act and making several miscellaneous changes to the regulations for 
consistency and to remove redundant and obsolete requirements.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Rule..........................   06/04/18  83 FR 25549
Final Rule Effective................   06/04/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Kay Carter-Corker, Phone: 301 851-3748.
    RIN: 0579-AD99

194. VSTA Records and Reports Specific to International Standards for 
Pharmacovigilance

    E.O. 13771 Designation: Not subject to, not significant.
    Legal Authority: 21 U.S.C. 151 to 159
    Abstract: We are amending the Virus-Serum-Toxin Act regulations 
concerning records and reports. This change requires veterinary 
biologics licensees and permittees to record and submit reports 
concerning adverse events associated with the use of biological 
products they produce or distribute. The information that must be 
included in the adverse event reports submitted to the Animal and Plant 
Health Inspection Service (APHIS) will be provided in separate guidance 
documents. These records and reports

[[Page 57996]]

will help ensure that APHIS can provide complete and accurate 
information to consumers regarding adverse reactions or other problems 
associated with the use of licensed biological products.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Rule..........................   05/17/18  83 FR 22832
Final Rule Effective................   06/18/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Donna L. Malloy, Phone: 301 851-3426.
    RIN: 0579-AE11

195. Conditions for Payment of Highly Pathogenic Avian Influenza 
Indemnity Claims

    E.O. 13771 Designation: Other.
    Legal Authority: 7 U.S.C. 8301 to 8317
    Abstract: We are adopting as a final rule, with changes, an interim 
rule that amended the regulations pertaining to certain diseases of 
livestock and poultry to specify conditions for payment of indemnity 
claims for highly pathogenic avian influenza (HPAI). The interim rule 
provided a formula allowing us to split such payments between poultry 
and egg owners and parties with which the owners enter into contracts 
to raise or care for the eggs or poultry based on the proportion of the 
production cycle completed. That action was necessary to ensure that 
all contractors are compensated appropriately. The interim rule also 
clarified an existing policy regarding the payment of indemnity for 
eggs destroyed due to HPAI and required a statement from owners and 
contractors, unless specifically exempted, indicating that at the time 
of detection of HPAI in their facilities, they had in place and were 
following a biosecurity plan aimed at keeping HPAI from spreading to 
commercial premises.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Rule..........................   08/15/18  83 FR 40433
Final Action Effective..............   08/15/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Troy Bigelow, Phone: 515 284-4121.
    RIN: 0579-AE14

BILLING CODE 3410-34-P

DEPARTMENT OF AGRICULTURE (USDA)

Food Safety and Inspection Service (FSIS)

Completed Actions

196. Elimination of Trichina Control Regulations and Consolidation of 
Thermally Processed, Commercially Sterile Regulations

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 21 U.S.C. 601 et seq.; 21 U.S.C. 451 et seq.
    Abstract: The Food Safety and Inspection Service (FSIS) proposed to 
amend the Federal meat inspection regulations to eliminate the 
requirements for both ready-to-eat (RTE) and not-ready-to-eat (NRTE) 
pork and pork products to be treated to destroy trichina (Trichinella 
spiralis) because the regulations are inconsistent with the Hazard 
Analysis and Critical Control Point (HACCP) regulations, and these 
prescriptive regulations are no longer necessary.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Action........................   05/31/18  83 FR 25302
Final Action Effective..............   07/30/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Matthew Michael, Phone: 202 720-0345, Fax: 202 690-
0486, Email: [email protected].
    RIN: 0583-AD59

BILLING CODE 3410-DM-P

DEPARTMENT OF AGRICULTURE (USDA)

Office of Procurement and Property Management (OPPM)

Completed Actions

197. Designation of Biobased Product Categories for Federal 
Procurement, Round 11

    E.O. 13771 Designation: Not subject to, not significant.
    Legal Authority: Pub. L. 113-79
    Abstract: On January 13, 2017, Departmental Management (DM) 
published a proposed rule in the Federal Register (82 FR 4206) to amend 
the BioPreferred Program (Program) Guidelines at 7 CFR 3201 to add 12 
sections that designate product categories within which biobased 
products will be afforded Federal procurement preference by Federal 
agencies and their contractors. This final rule will add 12 sections 
that designate the following product categories: Intermediates--Plastic 
Resins; Intermediates--Chemicals; Intermediates--Paint and Coating 
Components; Intermediates--Textile Processing Materials; 
Intermediates--Foams; Intermediates--Fibers and Fabrics; 
Intermediates--Lubricant Components; Intermediates--Binders; 
Intermediates--Cleaner Components; Intermediates--Personal Care Product 
Components; Intermediates--Oils, Fats, and Waxes; and Intermediates--
Rubber Materials.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   01/13/17  82 FR 4206
NPRM Comment Period End.............   03/14/17  .......................
Final Action........................   07/10/18  83 FR 31841
Final Action Effective..............   08/09/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Karen Zhang, Office of Procurement and Property 
Management, Department of Agriculture, Office of Procurement and 
Property Management, 1400 Independence Avenue SW, Washington, DC 20250, 
Phone: 202 401-4747, Email: [email protected].
    RIN: 0599-AA27

[FR Doc. 2018-24141 Filed 11-15-18; 8:45 am]
 BILLING CODE 3410-TX-P



                                                                                                     Vol. 83                           Friday,
                                                                                                     No. 222                           November 16, 2018




                                                                                                     Part III


                                                                                                     Department of Agriculture
                                                                                                     Semiannual Regulatory Agenda
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                                                57992                      Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Unified Agenda

                                                DEPARTMENT OF AGRICULTURE                                            ‘‘Enforcing the Regulatory Reform                                     602), USDA’s printed agenda entries
                                                                                                                     Agenda,’’ and 13563, ‘‘Improving                                      include only:
                                                Office of the Secretary                                              Regulation and Regulatory Review.’’                                     (1) Rules that are likely to have a
                                                                                                                     The agenda also describes regulations                                 significant economic impact on a
                                                2 CFR Subtitle B, Ch. IV                                             affecting small entities as required by                               substantial number of small entities;
                                                                                                                     section 602 of the Regulatory Flexibility                             and
                                                5 CFR Ch. LXXIII                                                     Act, Public Law 96–354. This agenda                                     (2) Rules identified for periodic
                                                                                                                     also identifies regulatory actions that are                           review under section 610 of the
                                                7 CFR Subtitle A; Subtitle B, Chs. I–XI,                             being reviewed in compliance with                                     Regulatory Flexibility Act.
                                                XIV–XVIII, XX, XXV–XXXVIII, XLII                                     section 610(c) of the Regulatory                                        For this edition of the USDA
                                                                                                                     Flexibility Act. We invite public                                     regulatory agenda, the most important
                                                9 CFR Chs. I–III                                                     comment on those actions as well as any                               regulatory and deregulatory actions are
                                                                                                                     regulation consistent with Executive                                  summarized in a Statement of
                                                36 CFR Ch. II                                                        Order 13563.                                                          Regulatory Priorities that is included in
                                                                                                                        USDA has attempted to list all                                     the Regulatory Plan, which appears in
                                                48 CFR Ch. 4                                                                                                                               both the online regulatory agenda and in
                                                                                                                     regulations and regulatory reviews
                                                                                                                                                                                           part II of the Federal Register that
                                                Semiannual Regulatory Agenda, Fall                                   pending at the time of publication
                                                                                                                                                                                           includes the abbreviated regulatory
                                                2018                                                                 except for minor and routine or
                                                                                                                                                                                           agenda.
                                                                                                                     repetitive actions, but some may have
                                                AGENCY:      Office of the Secretary, USDA.                          been inadvertently missed. There is no                                FOR FURTHER INFORMATION CONTACT:      For
                                                ACTION:     Semiannual regulatory agenda.                            legal significance to the omission of an                              further information on any specific
                                                                                                                     item from this listing. Also, the dates                               entry shown in this agenda, please
                                                SUMMARY:  This agenda provides
                                                                                                                     shown for the steps of each action are                                contact the person listed for that action.
                                                summary descriptions of the significant
                                                                                                                     estimated and are not commitments to                                  For general comments or inquiries about
                                                and not significant regulatory and
                                                                                                                     act on or by the date shown.                                          the agenda, please contact Michael Poe,
                                                deregulatory actions being developed in
                                                                                                                        USDA’s complete regulatory agenda is                               Office of Budget and Program Analysis,
                                                agencies of the U.S. Department of
                                                                                                                                                                                           U.S. Department of Agriculture,
                                                Agriculture (USDA) in conformance                                    available online at www.reginfo.gov.
                                                                                                                                                                                           Washington, DC 20250, (202) 720–3257.
                                                with Executive Orders (E.O.) 12866,                                  Because publication in the Federal
                                                ‘‘Regulatory Planning and Review,’’                                  Register is mandated for the regulatory                                 Dated: September 4, 2018.
                                                13771, ‘‘Reducing Regulation and                                     flexibility agendas required by the                                   Michael Poe,
                                                Controlling Regulatory Costs,’’ 13777,                               Regulatory Flexibility Act (5 U.S.C.                                  Legislative and Regulatory Staff.

                                                                                                     AGRICULTURAL MARKETING SERVICE—FINAL RULE STAGE
                                                                                                                                                                                                                                      Regulation
                                                  Sequence No.                                                                                     Title                                                                             Identifier No.

                                                183 ....................   National Bioengineered Food Disclosure Standard (Reg Plan Seq No. 2) ...................................................                                     0581–AD54
                                                   References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register.

                                                                                      ANIMAL AND PLANT HEALTH INSPECTION SERVICE—PROPOSED RULE STAGE
                                                                                                                                                                                                                                      Regulation
                                                  Sequence No.                                                                                     Title                                                                             Identifier No.

                                                184 ....................   Removal of Emerald Ash Borer Domestic Quarantine Regulations ................................................................                                0579–AE42


                                                                                          ANIMAL AND PLANT HEALTH INSPECTION SERVICE—FINAL RULE STAGE
                                                                                                                                                                                                                                      Regulation
                                                  Sequence No.                                                                                     Title                                                                             Identifier No.

                                                185 ....................   Scrapie in Sheep and Goats ............................................................................................................................      0579–AC92
                                                186 ....................   Plant Pest Regulations; Update of General Provisions ...................................................................................                     0579–AC98
                                                187 ....................   Bovine Spongiform Encephalopathy and Scrapie; Importation of Small Ruminants and Their Germplasm,                                                            0579–AD10
                                                                             Products, and Byproducts.
                                                188 ....................   Lacey Act Implementation Plan: De Minimis Exception ..................................................................................                       0579–AD44
                                                189 ....................   Branding Requirements for Bovines Imported Into the United States From Mexico ......................................                                         0579–AE38
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                                                                                        ANIMAL AND PLANT HEALTH INSPECTION SERVICE—LONG-TERM ACTIONS
                                                                                                                                                                                                                                      Regulation
                                                  Sequence No.                                                                                     Title                                                                             Identifier No.

                                                190 ....................   Importation of Fresh Citrus Fruit From the Republic of South Africa Into the Continental United States ......                                                0579–AD95




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                                                                           Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Unified Agenda                                                                 57993

                                                                                       ANIMAL AND PLANT HEALTH INSPECTION SERVICE—COMPLETED ACTIONS
                                                                                                                                                                                                                      Regulation
                                                  Sequence No.                                                                            Title                                                                      Identifier No.

                                                191 ....................   Phytophthora Ramorum; Quarantine and Regulations ....................................................................................        0579–AB82
                                                192 ....................   Establishing a Performance Standard for Authorizing the Importation and Interstate Movement of Fruits                                        0579–AD71
                                                                             and Vegetables.
                                                193 ....................   Animal Welfare; Establishing De Minimis Exemptions From Licensing ..........................................................                 0579–AD99
                                                194 ....................   VSTA Records and Reports Specific to International Standards for Pharmacovigilance ...............................                           0579–AE11
                                                195 ....................   Conditions for Payment of Highly Pathogenic Avian Influenza Indemnity Claims ..........................................                      0579–AE14


                                                                                             FOOD SAFETY AND INSPECTION SERVICE—COMPLETED ACTIONS
                                                                                                                                                                                                                      Regulation
                                                  Sequence No.                                                                            Title                                                                      Identifier No.

                                                196 ....................   Elimination of Trichina Control Regulations and Consolidation of Thermally Processed, Commercially                                           0583–AD59
                                                                              Sterile Regulations.


                                                                                 OFFICE OF PROCUREMENT AND PROPERTY MANAGEMENT—COMPLETED ACTIONS
                                                                                                                                                                                                                      Regulation
                                                  Sequence No.                                                                            Title                                                                      Identifier No.

                                                197 ....................   Designation of Biobased Product Categories for Federal Procurement, Round 11 .......................................                         0599–AA27



                                                DEPARTMENT OF AGRICULTURE                                       deployment of, biological control agents                      and flexibility when testing animals in
                                                (USDA)                                                          for emerald ash borer, which would                            order to determine flock designations
                                                                                                                serve as the primary tool to mitigate and                     under the regulations. It would also
                                                Agricultural Marketing Service (AMS)
                                                                                                                control the pest.                                             make the identification and
                                                Final Rule Stage                                                  Timetable:                                                  recordkeeping requirements for goat
                                                                                                                                                                              owners consistent with those for sheep
                                                183. National Bioengineered Food                                        Action                Date           FR Cite          owners. These changes would affect
                                                Disclosure Standard
                                                                                                                                                                              sheep and goat producers and State
                                                  Regulatory Plan: This entry is Seq.                           NPRM ..................     09/19/18      83 FR 47310
                                                                                                                NPRM Comment                11/19/18
                                                                                                                                                                              governments.
                                                No. 2 in part II of this issue of the                                                                                           Timetable:
                                                                                                                 Period End.
                                                Federal Register.
                                                  RIN: 0581–AD54                                                                                                                     Action                Date          FR Cite
                                                                                                                  Regulatory Flexibility Analysis
                                                BILLING CODE 3410–02–P                                          Required: Yes.                                                NPRM ..................     09/10/15    80 FR 54659
                                                                                                                  Agency Contact: Robyn Rose, National                        NPRM Comment                11/09/15
                                                                                                                Policy Manager, PPQ, Department of                              Period End.
                                                DEPARTMENT OF AGRICULTURE                                       Agriculture, Animal and Plant Health                          NPRM Comment                11/16/15    80 FR 70718
                                                (USDA)                                                          Inspection Service, 4700 River Road,                            Period Re-
                                                                                                                Unit 26, Riverdale, MD 20737–1231,                              opened.
                                                Animal and Plant Health Inspection                              Phone: 301 851–2283.                                          NPRM Comment                12/09/15
                                                Service (APHIS)                                                   RIN: 0579–AE42                                                Period Re-
                                                                                                                                                                                opened End.
                                                Proposed Rule Stage                                                                                                           Final Rule ............     11/00/18
                                                184. Removal of Emerald Ash Borer
                                                                                                                DEPARTMENT OF AGRICULTURE                                       Regulatory Flexibility Analysis
                                                Domestic Quarantine Regulations
                                                                                                                (USDA)                                                        Required: Yes.
                                                  E.O. 13771 Designation: Deregulatory.                                                                                         Agency Contact: Diane Sutton, Sheep,
                                                  Legal Authority: 7 U.S.C. 7701 to                             Animal and Plant Health Inspection                            Goat, Cervid, and Equine Health Center;
                                                7772; 7 U.S.C. 7781 to 7786                                     Service (APHIS)                                               Surveillance, Preparedness, and
                                                  Abstract: This rulemaking would                               Final Rule Stage                                              Response Services, VS, Department of
                                                remove the domestic quarantine                                                                                                Agriculture, Animal and Plant Health
                                                regulations for the plant pest emerald                          185. Scrapie in Sheep and Goats
                                                                                                                                                                              Inspection Service, 4700 River Road,
                                                ash borer. This action would                                      E.O. 13771 Designation: Deregulatory.                       Unit 43, Riverdale, MD 20737–1235,
                                                discontinue the domestic regulatory                               Legal Authority: 7 U.S.C. 8301 to 8317                      Phone: 301 851–3509.
                                                component of the emerald ash borer                                Abstract: This rulemaking would                               RIN: 0579–AC92
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                                                program as a means to more effectively                          amend the scrapie regulations by
                                                direct available resources toward                               changing the risk groups and categories                       186. Plant Pest Regulations; Update of
                                                management and containment of the                               established for individual animals and                        General Provisions
                                                pest. Funding previously allocated to                           for flocks. It would simplify, reduce, or                       E.O. 13771 Designation: Deregulatory.
                                                the implementation and enforcement of                           remove certain recordkeeping                                    Legal Authority: 7 U.S.C. 450; 7 U.S.C.
                                                these domestic quarantine regulations                           requirements. This action would                               2260; 7 U.S.C. 7701 to 7772; 7 U.S.C.
                                                would instead be directed to a non-                             provide designated scrapie                                    7781 to 7786; 7 U.S.C. 8301 to 8817; 21
                                                regulatory option of research into, and                         epidemiologists with more alternatives                        U.S.C. 111; 21 U.S.C. 114a; 21 U.S.C.


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                                                57994                     Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Unified Agenda

                                                136 and 136a; 31 U.S.C. 9701; 42 U.S.C.                   susceptible wild ruminants for other                    189. Branding Requirements for
                                                4331 and 4332                                             than immediate slaughter are similar to                 Bovines Imported Into the United States
                                                  Abstract: We are revising our                           those recommended by the World                          From Mexico
                                                regulations regarding the movement of                     Organization for Animal Health in                         E.O. 13771 Designation: Deregulatory.
                                                plant pests. We are establishing criteria                 restricting the importation of such                       Legal Authority: 7 U.S.C. 1622; 7
                                                regarding the movement and                                animals to those from scrapie-free                      U.S.C. 8301 to 8317; 21 U.S.C. 136 and
                                                environmental release of biological                       regions or certified scrapie-free flocks.               136a; 31 U.S.C. 9701
                                                control organisms, and establishing                         Timetable:                                              Abstract: This rulemaking would
                                                regulations to allow the importation and                                                                          amend the regulations regarding the
                                                movement in interstate commerce of                               Action                 Date         FR Cite      branding of bovines imported into the
                                                certain types of plant pests without                                                                              United States from Mexico.
                                                restriction by granting exceptions from                   NPRM ..................   07/18/16     81 FR 46619        Timetable:
                                                permitting requirements for those pests.                  NPRM Comment              09/16/16
                                                We are also revising our regulations                        Period End.                                                    Action            Date        FR Cite
                                                                                                          Final Rule ............   11/00/18
                                                regarding the movement of soil. This
                                                action clarifies the factors that would be                                                                        NPRM ..................   04/12/18   83 FR 15756
                                                                                                            Regulatory Flexibility Analysis                       NPRM Comment              06/11/18
                                                considered when assessing the risks
                                                                                                          Required: Yes.                                            Period End.
                                                associated with the movement of certain                                                                           Final Rule ............   11/00/18
                                                organisms and facilitates the movement                      Agency Contact: Alexandra
                                                of regulated organisms and articles in a                  MacKenzie, Veterinary Medical Officer,                    Regulatory Flexibility Analysis
                                                manner that also protects U.S.                            Animal Permitting and Negotiating                       Required: Yes.
                                                agriculture.                                              Services, NIES, VS, Department of                         Agency Contact: Betzaida Lopez,
                                                  Timetable:                                              Agriculture, Animal and Plant Health                    Senior Staff Veterinarian, National
                                                                                                          Inspection Service, 4700 River Road,                    Import Export Services, VS, Department
                                                       Action               Date           FR Cite        Unit 39, Riverdale, MD 20737, Phone:                    of Agriculture, Animal and Plant Health
                                                                                                          301 851–3300.                                           Inspection Service, 4700 River Road,
                                                Notice of Intent           10/20/09     74 FR 53673         RIN: 0579–AD10
                                                  To Prepare an                                                                                                   Unit 39, Riverdale, MD 20737, Phone:
                                                  Environmental                                           188. Lacey Act Implementation Plan:                     301 851–3300.
                                                  Impact State-                                                                                                     RIN: 0579–AE38
                                                                                                          De Minimis Exception
                                                  ment.
                                                Notice Comment             11/19/09                         E.O. 13771 Designation: Deregulatory.
                                                  Period End.                                               Legal Authority: 16 U.S.C. 3371 et seq.
                                                NPRM ..................    01/19/17     82 FR 6980                                                                DEPARTMENT OF AGRICULTURE
                                                NPRM Comment               02/13/17     82 FR 10444         Abstract: The Food, Conservation,                     (USDA)
                                                  Period Ex-                                              and Energy Act of 2008 amended the
                                                                                                          Lacey Act to provide, among other                       Animal and Plant Health Inspection
                                                  tended.
                                                                                                          things, that importers submit a                         Service (APHIS)
                                                NPRM Comment               04/19/17
                                                  Period End.                                             declaration at the time of importation                  Long-Term Actions
                                                Final Rule ............    11/00/18                       for certain plants and plant products.
                                                                                                          The declaration requirements of the                     190. Importation of Fresh Citrus Fruit
                                                  Regulatory Flexibility Analysis                         Lacey Act became effective on                           From the Republic of South Africa Into
                                                Required: Yes.                                            December 15, 2008, and enforcement of                   the Continental United States
                                                  Agency Contact: Colin Stewart,                          those requirements is being phased in.                     E.O. 13771 Designation: Deregulatory.
                                                Assistant Director, Pests, Pathogens, and                 We are proposing to establish an                           Legal Authority: 7 U.S.C. 450; 7 U.S.C.
                                                Biocontrol Permits, PPQ, Department of                    exception to the declaration                            7701 to 7772; 7 U.S.C. 7781 to 7786; 21
                                                Agriculture, Animal and Plant Health                      requirement for products containing a                   U.S.C. 136 and 136a
                                                Inspection Service, 4700 River Road,                      minimal amount of plant materials.                         Abstract: This rulemaking will amend
                                                Unit 133, Riverdale, MD 20737–1236,                                                                               the fruits and vegetables regulations to
                                                                                                            Timetable:
                                                Phone: 301 851–2237.                                                                                              allow the importation of several
                                                  RIN: 0579–AC98                                                 Action                 Date         FR Cite      varieties of fresh citrus fruit, as well as
                                                                                                                                                                  citrus hybrids, into the continental
                                                187. Bovine Spongiform                                                                                            United States from areas in the Republic
                                                                                                          ANPRM ...............     06/30/11     76 FR 38330
                                                Encephalopathy and Scrapie;                               ANPRM Comment             08/29/11                      of South Africa where citrus black spot
                                                Importation of Small Ruminants and                          Period End.                                           has been known to occur. As a
                                                Their Germplasm, Products, and                            NPRM ..................   07/09/18     83 FR 31697      condition of entry, the fruit will have to
                                                Byproducts                                                NPRM Comment              09/07/18                      be produced in accordance with a
                                                                                                            Period End.
                                                  E.O. 13771 Designation: Deregulatory.                                                                           systems approach that includes
                                                                                                          Final Rule ............   09/00/19
                                                  Legal Authority: 7 U.S.C. 450; 7 U.S.C.                                                                         shipment traceability, packinghouse
                                                1622; 7 U.S.C. 7701 to 7772; 7 U.S.C.                                                                             registration and procedures, and
                                                7781 to 7786; 7 U.S.C. 8301 to 8317; 21                     Regulatory Flexibility Analysis                       phytosanitary treatment. The fruit will
                                                U.S.C. 136 and 136a; 31 U.S.C. 9701                       Required: Yes.                                          also be required to be imported in
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                                                  Abstract: This rulemaking amends the                      Agency Contact: Robert Baca,                          commercial consignments and
                                                bovine spongiform encephalopathy                          Assistant Director, Compliance and                      accompanied by a phytosanitary
                                                (BSE) and scrapie regulations regarding                   Environmental Coordination, PPQ,                        certificate issued by the national plant
                                                the importation of live sheep, goats, and                 Department of Agriculture, Animal and                   protection organization of the Republic
                                                wild ruminants and their embryos,                         Plant Health Inspection Service, 4700                   of South Africa with an additional
                                                semen, products, and byproducts. The                      River Road, Unit 150, Riverdale, MD                     declaration confirming that the fruit has
                                                scrapie revisions regarding the                           20737, Phone: 301 851–2347.                             been produced in accordance with the
                                                importation of sheep, goats, and                            RIN: 0579–AD44                                        systems approach. This action will


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                                                                          Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Unified Agenda                                                      57995

                                                allow for the importation of fresh citrus                      192. Establishing a Performance                         193. Animal Welfare; Establishing de
                                                fruit, including citrus hybrids, from the                      Standard for Authorizing the                            Minimis Exemptions From Licensing
                                                Republic of South Africa while                                 Importation and Interstate Movement                        E.O. 13771 Designation: Deregulatory.
                                                continuing to provide protection against                       of Fruits and Vegetables                                   Legal Authority: 7 U.S.C. 2131 to 2159
                                                the introduction of plant pests into the                                                                                  Abstract: We are amending the
                                                United States.                                                    E.O. 13771 Designation: Deregulatory.
                                                                                                                                                                       Animal Welfare Act (AWA) regulations
                                                   Timetable:                                                     Legal Authority: 7 U.S.C. 450; 7 U.S.C.              to implement amendments to the Act
                                                                                                               7701 to 7772; 7 U.S.C. 7781 to 7786; 21                 that broadened the scope of the
                                                       Action                 Date              FR Cite        U.S.C. 136 and 136(a)                                   exemptions from the licensing
                                                                                                                  Abstract: This rulemaking will amend                 requirements for dealers and exhibitors.
                                                NPRM ..................     08/28/14         79 FR 51273       our regulations governing the
                                                NPRM Comment                10/27/14                                                                                   Specifically, we are broadening the
                                                                                                               importations of fruits and vegetables by                licensing exemption for any person who
                                                  Period End.
                                                Next Action Unde-         ................
                                                                                                               broadening our existing performance                     maintains four or fewer breeding female
                                                  termined.                                                    standard to provide for consideration of                dogs, cats, and/or small exotic or wild
                                                                                                               all new fruits and vegetables for                       mammals and only sells the offspring of
                                                  Regulatory Flexibility Analysis                              importation into the United States using                these animals for pets or exhibition to
                                                Required: Yes.                                                 a notice-based process. Rather than                     include additional types of pet animals
                                                                                                               authorizing new imports through                         and domesticated farm-type animals. In
                                                  Agency Contact: Tony Román, Phone:
                                                                                                               proposed and final rules and specifying                 addition, we are adding a new licensing
                                                301 851–2242.
                                                                                                               import conditions in the regulations, the               exemption for any person who
                                                  RIN: 0579–AD95
                                                                                                               notice-based process uses Federal                       maintains eight or fewer pet animals,
                                                                                                               Register notices to make risk analyses                  small exotic or wild animals, and/or
                                                                                                               available to the public for review and                  domesticated farm-type animals for
                                                DEPARTMENT OF AGRICULTURE                                      comment, with authorized commodities                    exhibition. These actions will allow the
                                                (USDA)                                                         and their conditions of entry                           Agency to focus its limited resources on
                                                                                                               subsequently being listed on the                        situations that pose a higher risk to
                                                Animal and Plant Health Inspection
                                                                                                               internet. It also will remove the region-               animal welfare and public safety.
                                                Service (APHIS)
                                                                                                               or commodity-specific phytosanitary                     Finally, we are making conforming
                                                Completed Actions                                              requirements currently found in these                   changes to the definitions of dealer and
                                                                                                               regulations. Likewise, we are proposing                 exhibitor to reflect the amendments to
                                                191. Phytophthora Ramorum;
                                                                                                               an equivalent revision of the                           the Act and making several
                                                Quarantine and Regulations
                                                                                                               performance standard in our regulations                 miscellaneous changes to the
                                                   E.O. 13771 Designation: Not subject                         governing the interstate movements of                   regulations for consistency and to
                                                to, not significant.                                           fruits and vegetables from Hawaii and                   remove redundant and obsolete
                                                   Legal Authority: 7 U.S.C. 7701 to                           the U.S. territories (Guam, Northern                    requirements.
                                                7772; 7 U.S.C. 7781 to 7786                                    Mariana Islands, Puerto Rico, and the                      Completed:
                                                   Abstract: The interim rule amended                          U.S. Virgin Islands) and the removal of
                                                the Phytophthora ramorum regulations                           commodity-specific phytosanitary                              Reason               Date        FR Cite
                                                to make the regulations consistent with                        requirements from those regulations.
                                                                                                               This action will allow for the                          Final Rule ............   06/04/18   83 FR 25549
                                                a Federal Order issued by APHIS in
                                                                                                               consideration of requests to authorize                  Final Rule Effec-         06/04/18
                                                December 2004 that established                                                                                           tive.
                                                restrictions on the interstate movement                        the importation or interstate movement
                                                of nursery stock from nurseries in                             of new fruits and vegetables in a manner
                                                                                                                                                                         Regulatory Flexibility Analysis
                                                nonquarantined counties in California,                         that enables a more flexible and
                                                                                                                                                                       Required: Yes.
                                                Oregon, and Washington. This action                            responsive regulatory approach to
                                                                                                                                                                         Agency Contact: Kay Carter-Corker,
                                                also updated conditions for the                                evolving pest situations in both the
                                                                                                                                                                       Phone: 301 851–3748.
                                                movement of regulated articles of                              United States and exporting countries. It                 RIN: 0579–AD99
                                                nursery stock from quarantined areas, as                       will not, however, alter the science-
                                                well as restricted the interstate                              based process in which the risk                         194. VSTA Records and Reports
                                                movement of all other nursery stock                            associated with importation or interstate               Specific to International Standards for
                                                from nurseries in quarantined areas. We                        movement of a given fruit or vegetable                  Pharmacovigilance
                                                also updated the list of plants regulated                      is evaluated or the manner in which                        E.O. 13771 Designation: Not subject
                                                because of P. ramorum and the list of                          risks associated with the importation or                to, not significant.
                                                areas that are quarantined for P.                              interstate movement of a fruit or                          Legal Authority: 21 U.S.C. 151 to 159
                                                ramorum and made other miscellaneous                           vegetable are mitigated.                                   Abstract: We are amending the Virus-
                                                revisions to the regulations. This action                         Completed:                                           Serum-Toxin Act regulations
                                                was superseded by 0579–AE30.                                                                                           concerning records and reports. This
                                                   Completed:                                                        Reason                  Date         FR Cite      change requires veterinary biologics
                                                                                                                                                                       licensees and permittees to record and
                                                      Reason                  Date              FR Cite        Final Rule ............   09/14/18     83 FR 46627      submit reports concerning adverse
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                                                                                                               Final Action Effec-       10/15/18
                                                                                                                                                                       events associated with the use of
                                                Withdrawn ...........       07/16/18                             tive.
                                                                                                                                                                       biological products they produce or
                                                                                                                                                                       distribute. The information that must be
                                                  Regulatory Flexibility Analysis                                Regulatory Flexibility Analysis                       included in the adverse event reports
                                                Required: Yes.                                                 Required: Yes.                                          submitted to the Animal and Plant
                                                  Agency Contact: Prakash Hebbar,                                Agency Contact: Benjamin                              Health Inspection Service (APHIS) will
                                                Phone: 301 734–5717.                                           Kaczmarski, Phone: 301 851–2127.                        be provided in separate guidance
                                                  RIN: 0579–AB82                                                 RIN: 0579–AD71                                        documents. These records and reports


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                                                57996                     Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Unified Agenda

                                                will help ensure that APHIS can provide                     RIN: 0579–AE14                                          Legal Authority: Pub. L. 113–79
                                                complete and accurate information to                      BILLING CODE 3410–34–P                                    Abstract: On January 13, 2017,
                                                consumers regarding adverse reactions                                                                            Departmental Management (DM)
                                                or other problems associated with the                                                                            published a proposed rule in the
                                                use of licensed biological products.                                                                             Federal Register (82 FR 4206) to amend
                                                  Completed:                                              DEPARTMENT OF AGRICULTURE
                                                                                                          (USDA)                                                 the BioPreferred Program (Program)
                                                      Reason                Date           FR Cite                                                               Guidelines at 7 CFR 3201 to add 12
                                                                                                          Food Safety and Inspection Service                     sections that designate product
                                                Final Rule ............    05/17/18     83 FR 22832       (FSIS)                                                 categories within which biobased
                                                Final Rule Effec-          06/18/18                       Completed Actions                                      products will be afforded Federal
                                                  tive.                                                                                                          procurement preference by Federal
                                                                                                          196. Elimination of Trichina Control
                                                                                                          Regulations and Consolidation of                       agencies and their contractors. This
                                                  Regulatory Flexibility Analysis                                                                                final rule will add 12 sections that
                                                Required: Yes.                                            Thermally Processed, Commercially
                                                                                                          Sterile Regulations                                    designate the following product
                                                  Agency Contact: Donna L. Malloy,
                                                                                                                                                                 categories: Intermediates—Plastic
                                                Phone: 301 851–3426.                                         E.O. 13771 Designation: Deregulatory.               Resins; Intermediates—Chemicals;
                                                  RIN: 0579–AE11                                             Legal Authority: 21 U.S.C. 601 et seq.;
                                                                                                                                                                 Intermediates—Paint and Coating
                                                                                                          21 U.S.C. 451 et seq.
                                                195. Conditions for Payment of Highly                                                                            Components; Intermediates—Textile
                                                                                                             Abstract: The Food Safety and
                                                Pathogenic Avian Influenza Indemnity                      Inspection Service (FSIS) proposed to                  Processing Materials; Intermediates—
                                                Claims                                                    amend the Federal meat inspection                      Foams; Intermediates—Fibers and
                                                   E.O. 13771 Designation: Other.                         regulations to eliminate the                           Fabrics; Intermediates—Lubricant
                                                   Legal Authority: 7 U.S.C. 8301 to 8317                 requirements for both ready-to-eat (RTE)               Components; Intermediates—Binders;
                                                   Abstract: We are adopting as a final                   and not-ready-to-eat (NRTE) pork and                   Intermediates—Cleaner Components;
                                                rule, with changes, an interim rule that                  pork products to be treated to destroy                 Intermediates—Personal Care Product
                                                amended the regulations pertaining to                     trichina (Trichinella spiralis) because                Components; Intermediates—Oils, Fats,
                                                certain diseases of livestock and poultry                 the regulations are inconsistent with the              and Waxes; and Intermediates—Rubber
                                                to specify conditions for payment of                      Hazard Analysis and Critical Control                   Materials.
                                                indemnity claims for highly pathogenic                    Point (HACCP) regulations, and these
                                                                                                                                                                    Timetable:
                                                avian influenza (HPAI). The interim rule                  prescriptive regulations are no longer
                                                provided a formula allowing us to split                   necessary.                                                      Action            Date        FR Cite
                                                such payments between poultry and egg                        Completed:
                                                owners and parties with which the                                                                                NPRM ..................   01/13/17   82 FR 4206
                                                owners enter into contracts to raise or                         Reason                 Date         FR Cite
                                                                                                                                                                 NPRM Comment              03/14/17
                                                care for the eggs or poultry based on the                                                                          Period End.
                                                                                                          Final Action .........   05/31/18     83 FR 25302
                                                proportion of the production cycle                        Final Action Effec-      07/30/18                      Final Action .........    07/10/18   83 FR 31841
                                                completed. That action was necessary to                     tive.                                                Final Action Effec-       08/09/18
                                                ensure that all contractors are                                                                                    tive.
                                                compensated appropriately. The interim                       Regulatory Flexibility Analysis
                                                rule also clarified an existing policy                    Required: Yes.                                           Regulatory Flexibility Analysis
                                                regarding the payment of indemnity for                       Agency Contact: Matthew Michael,                    Required: Yes.
                                                eggs destroyed due to HPAI and                            Phone: 202 720–0345, Fax: 202 690–
                                                required a statement from owners and                      0486, Email: matthew.michael@                            Agency Contact: Karen Zhang, Office
                                                contractors, unless specifically                          fsis.usda.gov.                                         of Procurement and Property
                                                exempted, indicating that at the time of                     RIN: 0583–AD59                                      Management, Department of
                                                detection of HPAI in their facilities, they                                                                      Agriculture, Office of Procurement and
                                                                                                          BILLING CODE 3410–DM–P
                                                had in place and were following a                                                                                Property Management, 1400
                                                biosecurity plan aimed at keeping HPAI                                                                           Independence Avenue SW, Washington,
                                                from spreading to commercial premises.                                                                           DC 20250, Phone: 202 401–4747, Email:
                                                   Completed:                                             DEPARTMENT OF AGRICULTURE                              karen.zhang@dm.usda.gov.
                                                                                                          (USDA)
                                                                                                                                                                   RIN: 0599–AA27
                                                      Reason                Date           FR Cite        Office of Procurement and Property                     [FR Doc. 2018–24141 Filed 11–15–18; 8:45 am]
                                                                                                          Management (OPPM)
                                                Final Rule ............    08/15/18     83 FR 40433                                                              BILLING CODE 3410–TX–P
                                                Final Action Effec-        08/15/18                       Completed Actions
                                                  tive.
                                                                                                          197. Designation of Biobased Product
                                                  Regulatory Flexibility Analysis                         Categories for Federal Procurement,
                                                Required: Yes.                                            Round 11
                                                  Agency Contact: Troy Bigelow, Phone:                      E.O. 13771 Designation: Not subject
                                                515 284–4121.                                             to, not significant.
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Document Created: 2018-11-16 07:22:39
Document Modified: 2018-11-16 07:22:39
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionSemiannual regulatory agenda.
ContactFor further information on any specific entry shown in this agenda, please contact the person listed for that action. For general comments or inquiries about the agenda, please contact Michael Poe, Office of Budget and Program Analysis, U.S. Department of Agriculture, Washington, DC 20250, (202) 720-3257.
FR Citation83 FR 57991 
CFR Citation36
Title 36 CFR Chapter II
48
Title 48 CFR Chapter 4
5
Title 5 CFR Chapter LXXIII

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