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Revisions to USDA-APHIS 7 CFR Part 340 Regulations Governing The United States Revisions to USDA-APHIS 7 CFR part Department of Agriculture 340 Regulations Governing the Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Animal and Plant Organisms Health Inspection Service Draft Programmatic Environmental Impact Statement – May, 2019 Revisions to USDA-APHIS 7 CFR part 340 Regulations Governing the Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms Draft Programmatic Environmental Impact Statement May, 2019 Agency Contact: Cindy Eck Biotechnology Regulatory Services 4700 River Road USDA, APHIS Riverdale, MD 20737 Fax: (301) 734-8669 i Non‐Discrimination Policy In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident. To File a Program Complaint To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD‐3027, found online at How to File a Program Discrimination Complaint and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632‐9992. Submit your completed form or letter to USDA by: (1) mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue, SW, Washington, D.C. 20250‐9410; (2) fax: (202) 690‐7442; or (3) email: [email protected]. Persons with Disabilities Persons with disabilities who require alternative means of communication for program information (e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720‐2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877‐8339. Additionally, program information may be made available in languages other than English. USDA is an equal opportunity provider, employer, and lender. ii TABLE OF CONTENTS EXECUTIVE SUMMARY..................................................................................................................... ES‐1 1 PURPOSE AND NEED ................................................................................................................... 1‐1 OVERVIEW .................................................................................................................................. 1‐1 APHIS STATUTORY AUTHORITY UNDER THE PPA AND IMPLEMENTING REGULATIONS ................................. 1‐1 RECOMMENDED REVISIONS TO APHIS’ BIOTECHNOLOGY REGULATORY PROGRAM ..................................... 1‐2 HISTORY OF REVISIONS TO 7 CFR PART 340 ....................................................................................... 1‐3 SUMMARY OF PROPOSED REVISIONS TO 7 CFR PART 340 ..................................................................... 1‐4 BACKGROUND ON THE REGULATION OF GENETICALLY ENGINEERED ORGANISMS ........................................ 1‐4 1.6.1 FEDERAL OVERSIGHT UNDER THE COORDINATED FRAMEWORK ................................................................. 1‐6 NEPA ANALYSIS OF PROPOSED REVISIONS TO 7 CFR PART 340 ............................................................. 1‐7 1.7.1 PUBLIC INVOLVEMENT ........................................................................................................................ 1‐8 2 PROPOSED PROGRAM ALTERNATIVES ......................................................................................... 2‐1 PROGRAM ALTERNATIVE 1: NO ACTION ............................................................................................ 2‐1 2.1.1 OVERVIEW ........................................................................................................................................ 2‐1 2.1.2 REGULATORY SCOPE ........................................................................................................................... 2‐2 2.1.3 AUTHORIZATION OF IMPORTS, INTERSTATE MOVEMENTS, AND ENVIRONMENTAL RELEASES ........................... 2‐5 2.1.3.1 Importation and Interstate Movement .................................................................................... 2‐8 2.1.3.2 Environmental Release ............................................................................................................. 2‐9 2.1.4 COMPLIANCE, ENFORCEMENT, AND REMEDIATION .................................................................................. 2‐9 2.1.5 DETERMINATIONS OF REGULATORY STATUS ......................................................................................... 2‐10 PROGRAM ALTERNATIVE 2: PREFERRED ALTERNATIVE – IMPLEMENT PROPOSED RULE .............................. 2‐11 2.2.1 OVERVIEW OF THE PROPOSED REGULATORY FRAMEWORK ...................................................................... 2‐12 ALTERNATIVES CONSIDERED BUT DISMISSED FROM FURTHER CONSIDERATION ........................................ 2‐20 2.3.1 REGULATION TO FACILITATE COEXISTENCE ........................................................................................... 2‐20 2.3.2 WITHDRAW 7 CFR PART 340 AND REGULATE PLANT PESTS UNDER PART 330, AND NOXIOUS WEEDS UNDER PART 360 2‐24 2.3.3 REVISE THE REGULATORY FRAMEWORK IN 7 CFR PART 340 THAT DESCRIBES APHIS’S ABILITY TO DETERMINE A GE ORGANISM AS A PLANT PEST, BUT KEEP NOTIFICATIONS ............................................................................... 2‐25 2.3.4 REGULATE BASED ON THE CONCEPT OF “NOVELTY” ............................................................................... 2‐26 SUMMARY: COMPARISON OF ALTERNATIVES CONSIDERED IN REVISION OF 7 CFR PART 340 ....................... 2‐26 3 AFFECTED ENVIRONMENT ........................................................................................................... 3‐1 iii ESTIMATES OF MAJOR LAND USES IN THE UNITED STATES ..................................................................... 3‐1 MAJOR LAND USES IN THE UNITED STATES ........................................................................................ 3‐2 3.2.1 LAND IN FARMS ................................................................................................................................. 3‐3 3.2.1.1 Historic and Projected Trends .................................................................................................. 3‐3 3.2.2 AGRICULTURAL LAND USES .................................................................................................................. 3‐6 3.2.2.1 Principal Crops .......................................................................................................................... 3‐7 3.2.3 FOREST USE LANDS ............................................................................................................................ 3‐8 3.2.3.1 Current and Projected Uses ..................................................................................................... 3‐8 3.2.4 REGIONAL AGRICULTURAL AND FORESTRY LAND USES IN THE UNITED STATES ............................................ 3‐10 3.2.4.1 Land Resource Regions and Agricultural Activities in the United States, Caribbean, and Pacific Basin 3‐11 GENETICALLY ENGINEERED ORGANISMS IN AGRICULTURE, FORESTRY, AND INDUSTRY ............................... 3‐16 3.3.1 PERMITS AND NOTIFICATIONS UNDER 7 CFR PART 340 .......................................................................... 3‐17 3.3.2 AUTHORIZATION OF INTERSTATE MOVEMENT AND IMPORT OF GE ORGANISMS ......................................... 3‐17 3.3.3 ENVIRONMENTAL RELEASES OF GE ORGANISMS IN THE UNITED STATES AND U.S. TERRITORIES .................... 3‐19 3.3.3.1 GE Plants ................................................................................................................................. 3‐24 3.3.3.2 GE Microorganisms ................................................................................................................ 3‐26 3.3.3.3 GE Insects and Invertebrates ................................................................................................. 3‐28 3.3.3.4 GE Organisms Developed for Pharmaceutical and Industrial Purposes ................................ 3‐28 3.3.4 COMPLIANCE AND ENFORCEMENT ACTIONS ......................................................................................... 3‐29 3.3.5 PETITION AND DETERMINATION OF NONREGULATED STATUS UNDER 7 CFR PART 340 ............................... 3‐30 3.3.6 DETERMINATION OF NONREGULATED STATUS AND ADOPTION OF GE CROPS ............................................. 3‐31 3.3.7 GE TRAITS, AND CURRENT AND FUTURE GE ORGANISMS ....................................................................... 3‐34 GENETICALLY ENGINEERED ORGANISMS AND THE ENVIRONMENT .......................................................... 3‐38 3.4.1 GE CROP PLANTS ............................................................................................................................
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