House Farm Bill and GMOs

The House version of the Farm Bill (H.R.6083) includes some provisions about biotechnology that has incited some concerns¹. Unfortunately, the articles expressing those concerns haven’t included the language of interest or links to the language. The purpose of this post is simply to provide the current language in hopes that we might have a conversation about it.

The text shown here is from 11 July 2012. Please note that the language will likely change². It has gone through committee markup, but still needs to pass the full House, likely with many amendments, and then needs to go through conference where it will be reconciled with the vastly different Senate Farm Bill (S.3240, which does not mention biotechnology at all). The House Agriculture Committee (26 R and 20 D) vote was 11 Nay (4 R, 7 D) and 35 Yea (22 R, 13 D) – so there doesn’t seem to be any extreme partisan issues here, despite all of the other things happening in this bill besides biotechnology.

Only one section actually mentions biotechnology (10014), but there are three other sections that are likely relevant to biotechnology regulation (sections 10011, 10012, and 10013). These sections are all located in Title X: Horticulture. There were no amendments proposed for these sections.

Links to relevant US Code and footnotes were added. Note that some of the legal citations are confusing (at least they were to me before I did some research) because they cite both the legislation and the law. Also, et seq. means in sequence, so when that phrase is used, such as 7 U.S.C. 136 et seq., they mean 136a, 136b, and so on. If they mean a specific section then they mention it specifically.

SEC. 10014. REPORT TO CONGRESS ON REGULATION OF BIOTECHNOLOGY.

Not later than one year after the date of the enactment of this section, the Secretary, in consultation with the Secretary of Health and Human Services and the Administrator of the Environmental Protection Agency, shall submit to Congress a report on the measures taken and proposed to be taken by the Secretaries and the Administrator to provide for balanced and appropriate regulatory oversight of agricultural biotechnology products, by–

1. reducing regulatory burdens on research conducted by academic institutions, small businesses, and public entities in developing lower-cost plant and animal sources of food, feed, fuel, and fiber developed through biotechnology, with special emphasis on minor use crops, orphan crops, and sources of protein;
2. identifying categories of products developed through biotechnology for which a history of safe use has been established and providing with respect to such products reduced data requirements, expedited review periods, exemptions from regulation, and other measures, as appropriate, based on sound science; and
3. developing and implementing a cohesive national policy for the low-level presence of agronomic biotechnology material in crops, including grain and other commodity crops, for food, feed, and processing.

SEC. 10011. PETITIONS TO DETERMINE ORGANISM NOT A PLANT PEST.

(a) Petition to Determine Organism Not a Plant Pest- The Plant Protection Act is amended by inserting after section 411 (7 U.S.C. 7711) the following new section:

`SEC. 411A. PETITION TO DETERMINE ORGANISM NOT A PLANT PEST.
`(a) Petition- A person may petition the Secretary for a determination that an organism that is subject to regulation by the Secretary as a plant pest under this Act is not a plant pest for purposes of this Act.
`(b) Review of Petition-
`(1) ASSESSMENT AND ANALYSIS REQUIRED- In reviewing a petition submitted under subsection (a), the Secretary shall conduct the following with respect to an organism that is the subject of the petition:
`(A) PLANT PEST RISK ASSESSMENT- An assessment of the likelihood that such organism is a plant pest.
`(B) ENVIRONMENTAL ANALYSIS- An analysis of any likely adverse effects of such organism on the soil, water, air quality, non-target organisms, and listed threatened and endangered species and the critical habitat of such species for the environment in which such organism is likely to be grown or otherwise used under the conditions specified in such petition.
`(2) DETERMINATION- The Secretary shall issue a determination that an organism is not a plant pest for purposes of this Act if the Secretary determines, based on sound science and the plant pest risk assessment conducted under paragraph (1)(A), that an organism is not likely to be a plant pest.
`(3) REVIEW PERIOD-
`(A) INITIAL REVIEW PERIOD- Not later than one year after the date on which the Secretary determines that a petition submitted under subsection (a) is complete, the Secretary shall complete the plant pest risk assessment and the environmental analysis required under paragraph (1) and issue a determination with respect to such petition under paragraph (2).
`(B) EXTENSION- The Secretary may extend the one-year review period referred to in subparagraph (A) for a petition for one additional period of not more than 180 days if the Secretary determines that additional review is necessary. The Secretary shall notify the person who submitted the petition, in writing, of the reasons for the extension and an estimate of the time period necessary to complete the review.
`(4) EFFECT OF FAILURE TO MEET TIME PERIOD- Notwithstanding any other provision of law, if after completing the plant pest risk assessment, but not the environmental analysis, required under paragraph (1), the Secretary finds that there is no reason to believe that an organism is a plant pest and does not grant or deny a petition submitted under subsection (a) with respect to such organism within the time period required under paragraph (3), such organism shall be deemed not to be a plant pest for purposes of this Act.
`(5) EFFECT ON PESTICIDE REGISTRATION- In the case of an organism containing a plant-incorporated protectant³ (as defined in section 174.3 of title 40, Code of Federal Regulations, or any successor regulation) with respect to which an application for registration of the plant-incorporated protectant is pending under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a et seq.), a determination made under paragraph (2) that an organism is not a plant pest or the deeming that an organism is not a plant pest under paragraph (4) shall not be effective until the registration of the plant-incorporated protectant contained in such organism is approved under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a et seq.). If such registration is not approved, a determination made under paragraph (2) that an organism is not a plant pest or a deeming that an organism is not a plant pest under paragraph (4) shall not become effective.
`(6) SUBSEQUENT AUTHORITY TO REGULATE- Notwithstanding a determination that an organism is not a plant pest under paragraph (2) or that such organism has been deemed not to be a plant pest under paragraph (4), the Secretary may issue a determination, based on information discovered after the date of such determination or the date on which the organism was so deemed and sound science, that an organism is a plant pest for purposes of this Act.
`(7) PUBLIC NOTICE-
`(A) NOTICE- The Secretary shall publish notice in the Federal Register of–
`(i) the grant or denial of a petition submitted under subsection (a) with respect to an organism; or
`(ii) the deeming that such organism is not a plant pest under paragraph (4).
`(B) RISK ASSESSMENTS AND ENVIRONMENTAL ANALYSIS- The Secretary shall provide to the person who submitted a petition under subsection (a), and make available to the public, the risk assessment and environmental analysis prepared under paragraph (1) with respect to such petition.
`(c) Applicability of Environmental Analysis Conducted for Petition to Determine Organism Not a Plant Pest-
`(1) EXCLUSIVE ANALYSIS PERFORMED- Notwithstanding any other provision of law, the environmental analysis required under subsection (b)(1) and as specifically described in such subsection shall be the only analysis or procedure regarding the effects on the environment of an organism that is the subject of a petition submitted under subsection (a) required or authorized by law with respect to reviewing and taking action on such a petition.
`(2) PROHIBITION ON USE OF FUNDS FOR OTHER ANALYSES- No funds made available by any Act shall be obligated, expended, or used for any analysis or procedure regarding the effects on the environment of an organism conducted for purposes of this section other than the environmental analysis required under subsection (b)(1).
`(3) PROHIBITION ON SOLICITATION OF FUNDS FOR ENVIRONMENTAL ANALYSIS- The Secretary shall not require or solicit any financial assistance from a person submitting a petition under subsection (a) for any analysis or procedure regarding the effects on the environment of an organism or for any other analysis or procedure not specifically authorized by subsection (b)(1).
`(d) Use of Data From Permits for Purposes of Petition for a Determination That an Organism Not a Plant Pest- Notwithstanding any other provision of law, the Secretary shall use data collected under a permit issued by the Secretary under section 411(a) with respect to an organism, among other relevant data, for purposes of the review of a petition submitted under subsection (a) with respect to such organism.’.

(b) Authority of Review for and Environmental Analysis Applicable to Permits- Section 411 of the Plant Protection Act (7 U.S.C. 7711) is amended–
(1) by redesignating subsections (c), (d), and (e) as subsections (e), (f), and (g), respectively; and
(2) by inserting after subsection (b), the following new subsections:
`(c) Limitation on Analyses and Procedures for Permits- Notwithstanding any other provision of law, the analyses or procedures required under the regulations issued by the Secretary under the Federal Plant Pest Act and continued in effect in accordance with section 438(c) shall be the only analyses or procedures required or authorized by law with respect to reviewing and taking action on an application for a permit submitted under subsection (a).
`(d) Environmental Analysis Applicable to Certain Permits- Notwithstanding any other provision of law, in reviewing an application for a permit submitted under subsection (a) that is not excluded from environmental review under regulations issued by the Secretary in effect on the date of the enactment of this subsection (or any successor regulations), the Secretary shall conduct an environmental analysis described in section 411A(b)(1)(B). Such analysis shall be the only environmental analysis or procedure required or authorized by law with respect to reviewing and taking action on such an application.’.
(c) Transitional Provisions-
(1) COMPLETENESS-
(A) COMPLETENESS OF PETITIONS- Notwithstanding any other provision of law, including section 411A of the Plant Protection Act (as added by subsection (a)), if the Secretary of Agriculture determined that a petition submitted before the date of the enactment of this section under section 340.6 of title 7, Code of Federal Regulations, for a determination that an organism is not a plant pest was complete before such date, the Secretary shall consider such petition to be complete and maintain the status such petition had in the process for the review of such petition on such date under section 340.6 of title 7, Code of Federal Regulations.
(B) COMPLETENESS OF APPLICATIONS FOR PERMITS- Notwithstanding any other provision of law, including subsection (c) of section 411 of the Plant Protection Act (7 U.S.C. 7711) (as amended by subsection (b)), if the Secretary of Agriculture determined that an application for a permit submitted under subsection (a) of such section (7 U.S.C. 7711) before the date of the enactment of this section was complete before such date, the Secretary shall consider such application to be complete and maintain the status such application had in the process for the review of such application on such date under subsection (a) of such section.
(2) USE OF ENVIRONMENTAL ANALYSIS-
(A) USE OF ENVIRONMENTAL ANALYSIS FOR PETITIONS- Notwithstanding any other provision of law, the Secretary of Agriculture shall use any environmental analysis conducted for purposes of a petition submitted under section 340.6 of title 7, Code of Federal Regulations, before the date of the enactment of this section with respect to an organism to the greatest extent possible to complete the environmental analysis conducted under section 411A of the Plant Protection Act (as added by subsection (a)) for purposes of a petition submitted under subsection (a) of such section with respect to such organism.
(B) USE OF ENVIRONMENTAL ANALYSIS FOR APPLICATIONS FOR PERMITS- Notwithstanding any other provision of law, the Secretary of Agriculture shall use any environmental analysis conducted for purposes of an application for a permit submitted under subsection (a) of section 411 of the Plant Protection Act (7 U.S.C. 7711) before the date of the enactment of this section with respect to such organism to the greatest extent possible to complete the environmental analysis conducted under subsection (d) of such section (as amended by subsection (b)) with respect to such organism.
(3) SPECIAL CONSIDERATION FOR REVIEW OF CERTAIN PETITIONS-
(A) PENDING PETITIONS WITHOUT A COMPLETED PLANT PEST RISK ASSESSMENT- Notwithstanding section 411A(b)(2) of the Plant Protection Act (as added by subsection (a)), the Secretary of Agriculture shall determine the length of the period for the review of petitions submitted under section 340.6 of title 7, Code of Federal Regulations, before the date of the enactment of this section for which a plant pest risk assessment has not been completed on or before such date of enactment.
(B) PENDING PETITIONS WITH A COMPLETED PLANT PEST RISK ASSESSMENT-
(i) DEEMING OF CERTAIN PETITIONS- Notwithstanding any other provision of law, with respect to each covered petition, if the Secretary finds that there is no reason to believe that the organism that is the subject of such covered petition is a plant pest and the Secretary does not grant or deny such covered petition not later than 90 days after the date of the enactment of this section, such organism shall be deemed not to be a plant pest for purposes of the Plant Protection Act (7 U.S.C. 7701 et seq.).
(ii) COVERED PETITION DEFINED- In this subparagraph, the term `covered petition’ means a petition submitted before the date of the enactment of this section under section 340.6 of title 7, Code of Federal Regulations, for a determination that an organism is not a plant pest for which a plant pest risk assessment and an environmental assessment have been published and a notice and comment period on each assessment has been completed as of such date of enactment.
(4) REGULATIONS- Not later than 180 days after the date of the enactment of this section, the Secretary of Agriculture shall issue such regulations as the Secretary considers necessary to carry out the amendments made by this section.

SEC. 10012. CONSOLIDATION OF PLANT PEST AND DISEASE MANAGEMENT AND DISASTER PREVENTION PROGRAMS.

(a) Relocation of Legislative Language Relating to National Clean Plant Network- Section 420 of the Plant Protection Act (7 U.S.C. 7721) is amended–
(1) by redesignating subsection (e) as subsection (f); and
(2) by inserting after subsection (d) the following new subsection:
`(e) National Clean Plant Network-
`(1) IN GENERAL- The Secretary shall establish a program to be known as the `National Clean Plant Network’ (referred to in this subsection as the `Program’).
`(2) REQUIREMENTS- Under the Program, the Secretary shall establish a network of clean plant centers for diagnostic and pathogen elimination services–
`(A) to produce clean propagative plant material; and
`(B) to maintain blocks of pathogen-tested plant material in sites located throughout the United States.
`(3) AVAILABILITY OF CLEAN PLANT SOURCE MATERIAL- Clean plant source material produced or maintained under the Program may be made available to–
`(A) a State for a certified plant program of the State; and
`(B) private nurseries and producers.
`(4) CONSULTATION AND COLLABORATION- In carrying out the Program, the Secretary shall–
`(A) consult with–
`(i) State departments of agriculture; and
`(ii) land-grant colleges and universities and NLGCA Institutions (as those terms are defined in section 1404 of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3103)); and
`(B) to the extent practicable and with input from the appropriate State officials and industry representatives, use existing Federal or State facilities to serve as clean plant centers.’.
(b) Funding- Subsection (f) of section 420 of the Plant Protection Act (7 U.S.C. 7721) (as so redesignated) is amended–
(1) in paragraph (3), by striking `and’ at the end;
(2) in paragraph (4), by striking `and each fiscal year thereafter.’ and inserting `; and’; and
(3) by adding at the end the following new paragraph:
`(5) $71,500,000 for fiscal year 2013 and each fiscal year thereafter.’.
(c) Repeal of Existing Provision- Section 10202 of the Food, Conservation, and Energy Act of 2008 (7 U.S.C. 7761) is repealed.
(d) Clarification of Use of Funds for Technical Assistance- Section 420 of the Plant Protection Act (7 U.S.C. 7721) (as amended by subsection (a)) is amended by adding at the end the following new subsection:
`(g) Relationship to Other Law- The use of Commodity Credit Corporation funds under this section to provide technical assistance shall not be considered an allotment or fund transfer from the Commodity Credit Corporation for purposes of the limit on expenditures for technical assistance imposed by section 11 of the Commodity Credit Corporation Charter Act (15 U.S.C. 714i).’.

SEC. 10013. AUTHORITY FOR REGULATION OF PLANTS.

(a) Regulation of Plants Under Plant Protection Act- Subject to subsection (b), any living stage of a plant, including any nucleic acid or other genetic material as contained in such plant, shall be exclusively subject to regulation under statutes under which the Secretary of Agriculture is authorized to issue regulations with respect to plants, including the Plant Protection Act (7 U.S.C. 7701 et seq.).
(b) Regulation of Certain Pesticidal Substances Under Federal Insecticide, Fungicide, and Rodenticide Act- A pesticidal substance contained in a plant shall be subject to regulation as a plant-incorporated protectant³ (as defined in section 174.3 of title 40, Code of Federal Regulations, or any successor regulation) under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.).
(c) Requirements for Regulation of Certain Pesticidal Substances Under Federal Insecticide, Fungicide, and Rodenticide Act- The regulations issued by the Administrator of the Environmental Protection Agency with respect to plant-incorporated protectants under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), including section 3(c)(1)(C) of such Act (7 U.S.C. 136a(c)(1)(C)), section 3(c)(2)(A) of such Act (7 U.S.C. 136a(c)(2)(A)), section 7 of such Act (7 U.S.C. 136e), section 8 of such Act (7 U.S.C. 136f), section 9 of such Act (7 U.S.C. 136g), and section 17 of such Act (7 U.S.C. 136o), shall–
(1) be based on sound science;
(2) use the least burdensome requirements; and
(3) provide for exemptions from the requirements otherwise applicable to pesticides that are not plant-incorporated protectants.
(d) Definitions- In this section:
(1) PLANT- The term `plant’ has the meaning given such term in section 403 of the Plant Protection Act (7 U.S.C. 7702).
(2) PESTICIDAL SUBSTANCE- The term `pesticidal substance’ means a substance or a mixture of substances that–
(A) is contained in any living stage of a plant that–
(i) as of the date of the enactment of this subsection, is subject to part 340 of title 7, Code of Federal Regulations; or
(ii) has been determined not to be a plant pest under section 411A(b)(2) or deemed not to be a plant pest under section 411A(b)(4); and
(B) is intended for preventing, destroying, repelling, or mitigating any pest.

¹ This isn’t the first time that people have misunderstood legislation and gotten really upset over nothing. For example, the Global Food Security Act of 2009. Do you remember any other examples? Let us know in the comments!
² For a quick refresher of how legislation becomes law (with a little more detail than School House Rock ), see Government 101: How a Bill Becomes Law by Project Vote Smart.
³ The definition of plant-incorporated protectants from CFR Title 40 174.3 is: Plant-incorporated protectant means a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance. It also includes any inert ingredient contained in the plant, or produce thereof.

A big thank you to the Legal Information Institute of Cornell Law School (@LIICornell) for providing the US Code in an easy to find format!