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





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





Semiannual Regulatory Agenda

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

[[Page 57992]]


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

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


Current View
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

2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR