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.

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

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:

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:

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. 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:

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:

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:

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:

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 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:

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Tony Román, 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:

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:

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:

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 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:

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:

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Troy Bigelow, Phone: 515 284-4121.

RIN: 0579-AE14

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:

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Matthew Michael, Phone: 202 720-0345, Fax: 202 690-0486, Email: matthew.michael@fsis.usda.gov.

RIN: 0583-AD59

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:

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: karen.zhang@dm.usda.gov.

RIN: 0599-AA27