U.S. Registration Requirements for Commercial Jet and Motor Vehicle Fuels

Among the regulations governing the development of renewable fuels are the various requirements in the U.S. and other countries around the world to have a new fuel certified or registered as appropriate for sale and use. In most countries, these regulations are distinct from more recently-enacted laws under which a fuel might be certified as “renewable” or to be sustainably produced – these regulations apply to all fuels and fuel additives, both traditional and renewable. The goal of these fuel certification regulations are to ensure that a new fuel has the appropriate chemical composition and that it is suitable for use in the range of engine types for which it is intended.

In this entry and in one to follow, I’ll briefly summarize the regulations or other requirements that are in place in the U.S. for different fuel types. Today’s post will describe testing and registration requirements for fuels intended for commercial (i.e. civilian) use, and the follow-up post will cover requirements for testing and certification of fuels for military use. I hope to cover regulations outside the U.S. in a subsequent post.

Generally, these regulatory regimes involve oversight over at least three distinct components. These are fuel composition (chemical make-up and physical/chemical properties); engine suitability and performance testing; and health effects of the emissions from fuel combustion. A fourth criteria which comes into play for novel aviation fuels is a consideration of the production pathway used to create the fuel, to ensure consistency and quality of the manufactured fuel product. Fuel composition and properties are often ascertained through the use of standard testing protocols to confirm that the fuel meets the accepted specification. Both the standards and the test protocols are often those certified by ASTM International or the equivalent standards issued by military branches or other international organizations. Engine testing may not be required in all cases, especially where the fuel has been shown to meet the applicable chemical specifications so as to be identical to a previously approved fuel, but where it is required the needed testing is often extensive. Similarly, assessment of health effects of emissions may be required under certain laws such as the U.S. Clean Air Act, but these requirements may be waived for fuels whose composition is identical to fuels currently on the market.

In the remainder of this post, I’ll describe the regulatory processes in place in the U.S. for motor vehicle (ground transportation) fuels for commercial use and jet fuels for commercial (civilian) aviation. In the post to follow, I’ll cover the requirements for motor vehicle fuels and aviation fuels for military use. There is some overlap between the different requirements: for example, although it is the Environmental Protection Agency that must certify all ground transportation fuels before they can be sold, a new fuel cannot be used by any branch of the U.S. military unless it has also undergone testing and certification by that branch. The same is true for aviation fuels: a new jet fuel that has undergone the needed testing and analysis to be cleared for use in commercial aviation must also pass muster with the applicable military branch, although in the case of jet fuels there is a greater degree of synergy between these two imperatives.

The following are the fuels I’ll cover in these two posts:

Fuel Type	Application	Agency/Military Branch
Ethanol, butanol, isobutanol	All (regulated as fuel additives)	EPA
Diesel, biodiesel, renewable diesel, renewable gasoline and other “drop-in” fuels	Civilian (auto, truck, nautical, small engines)	EPA
	Military (ground, nautical)	Navy (including Coast Guard and Marines)
Jet fuel	Civilian (commercial aviation)	FAA, through the ASTM standards process
Jet fuel	Military	Army*, Navy, Air Force

*Note: the U.S. Army uses jet fuel for its ground transportation needs.

Fuels for Civilian Use

Ethanol, butanol and isobutanol. All fuels and fuel additives must be certified by the U.S. EPA Office of Transportation and Air Quality (OTAQ), under EPA regulations found in 40 CFR Part 79 before they can be sold in the United States. The most common use for alcohols like ethanol and butanol is blending with gasoline, and when used in this way they are regulated as fuel additives, subject to blending limits specifying the maximum concentrations permitted in gasoline (for ethanol, the maximum is 15% for autos and light trucks of model year 2001 or later, and 10% for all other vehicles and motors; for butanol the limit is 12.5%). The approval process for ethanol additives is fairly simple and primarily requires conducting analytical testing to show that the additive meets the applicable ASTM standard (e.g. D-4806 for ethanol), and subscribing to publicly-available applicable health effects studies. There are additional requirements for approval of E15 ethanol, which I have described in an earlier blog post.

Diesel and gasoline for civilian use. These fuels also must be certified by EPA OTAQ under the Part 79 regulations, but the process for fuels is potentially more complicated than it is for well-known additives like ethanol, and may require more extensive testing. The following is a brief summary of the needed procedures.

The Part 79 regulations establish two families of conventional fuel (diesel and gasoline), as well as four families of alternative fuels, with each family being defined by the specifications of a base fuel (e.g., traditional diesel for the diesel family). Although the alternative families include methanol and ethanol when used as the main component of a fuel rather than as an additive, I won’t discuss those requirements here. Each of the two conventional families are further subdivided into three categories, referred to as “baseline”, “non-baseline” and “atypical”. Baseline fuels are those that contain no elements other than those permitted in the category’s base fuel, and which fully meet the accepted specifications for the base fuel. Non-baseline fuels also contain no elements other than those permitted in the category’s base fuel, but may deviate from one or more of the limitations in the base fuel specification. Atypical fuels contain elements other than those permitted in the base fuel specification, or otherwise do not meet the applicable standards.

The regulations specify different tiers of data which might be needed to support the registration of a new fuel. There are basic application requirements (found in 40 CFR Part 79.11), which include the name of the fuel, the results of analytical testing, etc., and basic registration data (40 CFR Part 79.59(b)) which includes projected production volumes and other information. Beyond that, there are three potential tiers of testing: Tier 1 (40 CFR Part 79.52) includes basic emissions characterization data plus a literature search of potential health effects of fuel emissions; Tier 2 (40 CFR Part 79.53) includes toxicity, carcinogenicity and other tests, and Tier 3 (40 CFR Part 79.54) includes other data EPA may require based on the results of data in the other tiers.

Although many manufacturers may need to submit the Tier 1 and Tier 2 data, there is a very important exemption available for small businesses (companies having less than $50 million in total annual sales for the three years prior to the application date). Small business companies proposing the registration of either a baseline or a non-baseline fuel are exempt from the need for any Tier 1 or Tier 2 testing; and companies proposing registration of an atypical fuel are exempt from Tier 2 requirements (but not Tier 1) if their annual sales are less than $10 million. Generally, if the proposed new fuel meets the applicable ASTM specifications for that fuel family (D-975 for diesel and D-4814 for gasoline), it would be considered either a baseline or a non-baseline fuel. So, if a small business entity can show compliance with the applicable specification, it would be exempt from the Tier 1 and 2 testing requirements. If an applicant does not qualify for this exemption, it may be possible for that company to obtain access to the required test data by subscribing to a pre-existing group that has generated the data to EPA’s satisfaction (e.g. in recent years, health effects data has been available for biodiesel through such a group).

Jet fuel for civilian use (commercial aviation). The regulatory agency for civilian aviation is the Federal Aviation Administration (FAA), but its approvals are not for the fuels per se — FAA approves aircraft, which are given “type certificates” as part of the certification process. Type certificates are given when the agency determines that the aircraft meets applicable regulations, and they usually specify the type design of the aircraft, its operating limitations, applicable regulations and the other approved conditions for which the aircraft can be used, including which fuel types are compatible with the plane’s engine. FAA regulations require that type certificate applicants identify the fuel grade or specifications that are to be used in their aircrafts. Upon approval, the specified fuels become part of the type certificate data sheet and the airplane flight manual.

FAA has historically relied on ASTM and equivalent standards, and the agency has stated that any fuel meeting ASTM standards D-1655, D-7566 or D-6615 would be acceptable for use in any engine certified for such fuels. (D-1655 is the specification for conventional petrochemical-derived Jet A fuel; D-7566 is a newer spec for jet fuels containing synthesized hydrocarbons, under which two annexes have been approved: one for fuels produced by the Fischer-Tropsch process, and another for “Hydroprocessed Esters and Fatty Acids” (HEFA) fuel derived from biomass feedstocks; D-6615 is the spec for Jet B). It is important to note that these ASTM standards are specific for feedstock and production process, so that a developer of a renewable or alternative jet fuel that is produced by a new process or feedstock will in all likelihood need to go through the ASTM process to have this fuel pathway certified for commercial aviation use.

ASTM International follows a standard-setting process which is uniform throughout the organization. This process is summarized in detail elsewhere, for example, here. Briefly, in order to create a new standard, or an annex to an existing standard, it is necessary to develop a body of testing data which would be evaluated by a task force within a standing ASTM committee or subcommittee. The ASTM subcommittee responsible for the evaluation and approval of new aviation fuels is Committee D.02, Petroleum and Lubricants, Subcommittee J. Those companies or other institutions proposing the inclusion of a new fuel would carry out the needed testing, and the results would be reviewed by the appropriate task force. The task force would then create a Research Report describing the results of the testing, which would be made available to the applicable subcommittee and committee members. After appropriate periods for review and comment, the standard must be adopted by balloting first at the subcommittee level and then at the full committee level. Ballot approvals must be unanimous, which requires that any objections raised at either the subcommittee or committee level be addressed, or the objections withdrawn, before the standard can be adopted.

The FAA, along with the Aerospace Industries Association (AIA), Airports Council International – North America (ACI-NA), and Airlines for America (A4A), co-sponsors the Commercial Aviation Alternative Fuels Initiative (CAAFI), as a multi-party organization to facilitate the testing and approval of alternative jet fuels. According to the CAAFI website, the organization’s long-term goal is to facilitate the development and deployment of alternative aviation fuels that will significantly reduce emissions associated with aviation operations in commercially meaningful quantities to improve price stability and supply security. Through its websites and meetings, CAAFI makes available a treasure trove of information useful to companies going through the process of having a new aviation fuel tested and certified for use in commercial aviation, through processes that are often also relevant to the potential use of the fuel for military purposes.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. Dr. Glass also serves as director of regulatory affairs for Joule Unlimited Technologies, Inc. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of Joule Unlimited Technologies, Inc. or any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

Pending Biofuel-Related Bills in Congress May 2013

In the first few months of the U.S. 113^th Congress there have been a number of bills introduced into the House of Representatives and the Senate that, if enacted, might affect the development of ethanol or other renewable fuels. The ones of most potential concern are those, all introduced by Republicans, that are meant to repeal or curtail existing programs that currently benefit the renewable fuels industry. I’ve written about several of these before, in previous Biofuel Policy Watch blog entries, but I thought it would be useful to summarize them here in a single place. There are also a number of bills pending in several state legislatures that would adversely affect development of ethanol or other biofuels, notably in Florida, New Hampshire and Maine, as well as helpful legislation in other states such as Minnesota. Previous entries of Biofuel Policy Watch have described these bills and their status.

Please bear in mind that this summary is a snapshot in time, and that new bills are likely to be introduced over time in both houses of the U.S. Congress. Please also bear in mind that these are all early legislative proposals, only one of which has progressed any farther than being referred to the appropriate committee. In most cases the committee has not yet held hearings or begun to consider any of these bills. Not only are they all at such an early stage, but it is safe to say that none of them stand any serious chance of passage in today’s divided political climate: while it is possible that some of the bills introduced in the House may well pass that Republican-controlled chamber, it seems highly unlikely that any would garner enough Democratic support to pass the Senate and be signed by President Obama (or that an Obama veto could be overridden in both houses). So, while these bills are a useful representation of where Congressional Republican sentiment lies regarding renewable fuels, it is very hard to see that any of these bills have any chance of becoming law.

In this summary, I’ve grouped the bills according to the policies they would introduce, or more appropriately which existing policies they would overturn or modify. All the hyperlinks below are links to www.govtrack.us, which is one of several sites at which you can find information on pending Congressional legislation. (Note: the bracketed information identifies each primary bill sponsor by party, state, and for members of the House, their congressional district).

Renewable Fuel Standard

H.R. 550: Phantom Fuel Reform Act of 2013
Sponsor: Rep. Gregg Harper [R-MS3]
Introduced: February 6, 2013, Referred to Committee: February 6, 2013
This bill is meant to address oil industry concerns over the way the EPA sets the annual volume mandate for cellulosic biofuels, since prior to this year there has been essentially no production of fuels qualifying as cellulosic fuels under the RFS. The bill would require the Energy Information Administration in each year to calculate the average monthly production of cellulosic fuels in all production plants, and then to apply that monthly average to all plants expected to be in production in the subsequent year, and for EPA to set the subsequent year’s cellulosic mandate at the exact level that is calculated. The bill would also require that, in any year in which the EPA reduces the applicable volume of cellulosic biofuel from the levels specified in the original RFS2 legislation, it must also reduce the applicable volume of renewable fuel and advanced biofuels required by the same amount. The renewable fuels industry opposes such an approach, because it views the law’s current requirement for escalating mandates as providing an incentive for growth that would not be provided if each year’s mandate were set at the exact level of production of the preceding year. First discussed in Biofuel Policy Watch, February 26, 2013.

S. 251: Phantom Fuel Reform Act
Sponsor: Sen. Jeff Flake [R-AZ]
Introduced: February 7, 2013, Referred to Committee: February 7, 2013
This is the companion bill to H.R. 550, with essentially identical provisions. First discussed in Biofuel Policy Watch, February 26, 2013.

H.R. 796: To require the Administrator of the Environmental Protection Agency to use the commercially available volume of cellulosic biofuel in setting requirements for the renewable fuel program under the Clean Air Act, and for other purposes.
Sponsor: Rep. James Sensenbrenner [R-WI5]
Introduced: February 15, 2013, Referred to Committee: February 15, 2013
Like H.R. 550 and S. 251, this bill would require EPA to base its annual cellulosic fuel volume mandates on actual production levels in the prior year, and to make corresponding reductions to the mandated volumes of renewable fuel and advanced biofuels. First discussed in Biofuel Policy Watch, February 26, 2013.

H.R. 1461: Renewable Fuel Standard Elimination Act
Sponsor: Rep. Bob Goodlatte [R-VA6]
Introduced: April 10, 2013, Referred to Committee: April 10, 2013
This bill would simply repeal the sections of the Clean Air Act that created the Renewable Fuel Standard. First discussed in Biofuel Policy Watch, April 18, 2013.

H.R. 1462: RFS Reform Act of 2013
Sponsor: Rep. Bob Goodlatte [R-VA6]
Introduced: April 10, 2013, Referred to Committee: April 10, 2013
This bill would revise the Renewable Fuel Standard in several ways: first, to reduce the annual volume mandates so that there would be no specified volume required for the category of “renewable fuels” that is today largely met by cornstarch-based ethanol; second to require that the annual mandates for cellulosic biofuel be based on actual production levels; and third, to prohibit EPA from approving for use in the U.S. any ethanol blend of greater than 10%, and to rescind any waivers or approvals the agency has already granted for E15 or other mid-level blends. First discussed in Biofuel Policy Watch, April 18, 2013.

H.R. 1469: Leave Ethanol Volumes at Existing Levels Act
Sponsor: Rep. Michael Burgess [R-TX26]
Introduced: April 10, 2013, Referred to Committee: April 10, 2013
According to a press release from the bill’s sponsor Rep. Burgess, the intent of this bill is to prohibit EPA from granting approvals for ethanol blends greater than 10% and to revoke any previously-granted waivers allowing such blends. However, the bill would also radically change the RFS by simplifying the definitions, removing the four current categories of fuels under the RFS, and instituting a single volume mandate for all renewable fuel, for all years, at 7.5 billion gallons. Presumably the point of this latter provision is that, by lowering the annual mandate to well below current production levels, the need for the nation’s gasoline pool to exceed 10% ethanol would disappear (i.e., essentially eliminating the “blend wall”).

H.R. 1482: Renewable Fuel Standard Amendments Act
Sponsor: Rep. Steve Womack [R-AR3]
Introduced: April 10, 2013, Referred to Committee: April 10, 2013
The provisions of this bill are nearly identical to one portion of the provisions of H.R. 1462, of which Rep. Womack is a cosponsor: like H.R. 1462, this bill would reduce the annual volume mandates so that there would be no specified volume required for the category called “renewable fuels” that is today largely met by cornstarch-based ethanol. This bill does not contain the other provisions of H.R. 1462. Since 1462 and 1482 were introduced on the same day by an overlapping set of cosponsors, presumably the cosponsors will elect to move forward with 1462, the broader based bill, thus superseding 1482, but that remains to be seen.

Ethanol Policies

H.R. 875: To provide for a comprehensive assessment of the scientific and technical research on the implications of the use of mid-level ethanol blends, and for other purposes.
Sponsor: Rep. James Sensenbrenner [R-WI5]
Introduced: February 27, 2013, Reported by Committee: April 11, 2013
This bill would repeal EPA’s granted waivers for E15, and would also require EPA to contract with the National Academy of Sciences to conduct a comprehensive assessment of available research on E15 and all “mid-level” ethanol blends. The bill would prohibit EPA from granting additional E15 waivers until the results of the NAS study were submitted to Congress. This bill was the subject of a hearing held by the House Committee on Science, Space and Technology Subcommittee on Environment on February 26, 2013, which was noteworthy because all the witnesses at this hearing represented groups critical of EPA’s E15 decision, with no witnesses from the renewable fuel industry. After this hearing, on April 11, 2013 the full Committee reported the bill out for action by the full House, which has not taken place as of this writing. First discussed in Biofuel Policy Watch, March 19, 2013.

H.R. 1214: Domestic Fuels Protection Act of 2013
Sponsor: Rep. John Shimkus [R-IL15]
Introduced: March 15, 2013, Referred to Committee: March 15, 2013
This bill is meant to address a concern that has been frequently voiced since EPA’s approval of E15 ethanol/gasoline blends. E15 is not approved for all vehicles out of concerns that engines of older cars may be damaged, and furthermore many critics believe that this blend will even be harmful to engines in the late-model vehicles for which use is approved. There are also concerns about the compatibility of E15 and other mid-level ethanol blends with infrastructure in place at gas stations (e.g. storage tanks, dispenser pumps). The goal of the bill is to ensure that service station owners, certain engine manufacturers and fuel producers are not held liable if damage or other liability results from the misuse of an EPA-approved fuel. Specifically, the bill would: exempt service stations from liability under EPA’s waste disposal laws and otherwise for damages caused by the incompatibility of underground storage tanks or dispensing equipment with E15 or other fuels; exempt service station owners from liability if a self-service gasoline purchaser uses ethanol blends in vehicles for which such blends are not improved, or if such action voids the warranty for the customer’s vehicle, except in the cases where the service station has not complied with EPA-approved misfueling requirements or in the case of intentional misfueling; relieve engine manufacturers, renewable fuel developers and others from any liability resulting from an individual’s misfueling.

H.R. 1462: RFS Reform Act of 2013
H.R. 1469: Leave Ethanol Volumes at Existing Levels Act
These two bills, discussed in detail above, would each limit EPA’s ability to approve ethanol blends of greater than 10%, while also amending certain aspects of the Renewable Fuel Standard.

S. 344: A bill to prohibit the Administrator of the Environmental Protection Agency from approving the introduction into commerce of gasoline that contains greater than 10-volume-percent ethanol, and for other purposes.
Sponsor: Sen. Roger Wicker [R-MS]
Introduced: February 14, 2013, Referred to Committee: February 14, 2013
This bill would prevent EPA from approving ethanol blends of greater than 10%, and would overturn EPA’s prior approvals of E15 blends. It would accomplish similar goals as H.R. 875, as discussed above. First discussed in Biofuel Policy Watch, February 26, 2013.

Tax Subsidies

H.R. 259: Energy Freedom and Economic Prosperity Act
Sponsor: Rep. Mike Pompeo [R-KS4]
Introduced: January 15, 2013, Referred to Committee: January 15, 2013
This bill would repeal a number of existing tax credits for renewable fuels, including the excise tax credits for alcohol fuel, biodiesel, and alternative fuel mixtures; the tax credits for the purchase of alternative motor vehicles and new qualified plug-in electric drive motor vehicles; the alternative fuel vehicle refueling property tax credit; the income tax credits for alcohol, biodiesel, and renewable diesel used as fuel; the tax credit for carbon dioxide sequestration; and others.

H.R. 1569: New Fair Deal Busting America’s Rigid Outdated & Needless Subsidies Act of 2013
Sponsor: Rep. Mike Pompeo [R-KS4]
Introduced: April 15, 2013, Referred to Committee: April 15, 2013
This bill is identical to H.R. 259 except that it contains a different list of cosponsors. Presumably this bill would supersede H.R. 259, both of which have been referred to the Ways and Means Committee.

State Regulation of Biomass Plantings (Florida and Mississippi)

In a previous blog entry, I discussed two recent articles (Quinn et al. 2013 and McCubbins et al. 2013) in which the authors proposed a new scheme for federal and state regulation for oversight over the potential use of noxious weeds or other invasive plant species as biofuel feedstocks. The scheme proposed in these articles would rely heavily on the states, and recommended that all 50 states modify their existing laws and regulations to adopt the most up-to-date scientific assessment tools to determine if a species proposed for planting within the state had noxious or invasive characteristics. These articles mentioned, essentially in passing, that at least two states (Florida and Mississippi) have provisions in their agricultural statutes to make them explicitly applicable to plants intended for use as biofuel feedstocks. In my blog entry, I noted that the Florida law is also broad enough to cover algae used to produce biofuels. In today’s post, I’d like to discuss and comment on these laws.

Let me first mention that, historically, a number of states have enacted laws or regulations for the regulation of biotechnology, and that those laws that are still in force may affect the use of either transgenic plants or modified microorganisms used in the production of biofuels or biobased chemicals. Other states have aquaculture laws that may cover industrial uses of algae. State biotechnology laws began to appear back in the 1980s, when the federal government was developing its biotechnology regulatory framework amidst criticism from some interest groups that there were “gaps” or other deficiencies in the federal approach. Over time, the primary target of these laws became the uses of biotechnology in agriculture and food, particularly covering the so-called “deliberate releases” into the environment of engineered plants and microorganisms, and there are a handful of states that still maintain such regulations in one form or another. (As an aside, I used to track these laws quite closely in the late 1980s and early 1990s, and have written summaries of such laws in the pre-Internet trade press, but I’m planning to devote a future blog entry to a broader summary of existing state laws that might affect the use of plants, microorganisms or algae in biofuel production).

Here are some comments on the Florida and Mississippi biomass planting laws and regulations.

Florida. Florida is one of the states that has had a biotechnology law on the books for some time. This law, Fla. Stat. § 581.083 to 211, required that anyone proposing to grow a “nonnative plant, including a genetically engineered plant or a plant that has been introduced, for purposes of fuel production or purposes other than agriculture in plantings greater in size than 2 contiguous acres” needed to obtain a permit from the Department of Agriculture and Consumer Services Division of Plant Industry (the original version of this law, before the 2012 amendments I’m about to describe, can be accessed here). Although this law is potentially broad, in covering all transgenic plants and any plant, whether engineered or not, used for energy production, I’m not aware of any controversy surrounding the law until the somewhat unexpected amendment that the legislature adopted last year. As part of a broader energy bill (HB 7117 of 2012), the legislature amended Subsection (4) of § 581.083, so that it now reads as follows (insertions shown in bold underline, deletions shown in ~~strikeout~~). Note: “blue-green algae” is another name for cyanobacteria.

A person may not cultivate a nonnative plant, algae, or blue-green algae, including a genetically engineered plant, algae, or blue-green algae or a plant that has been introduced, for purposes of fuel production or purposes other than agriculture in plantings greater in size than 2 contiguous acres, except under a special permit issued by the department through the division, which is the sole agency responsible for issuing such special permits.

It was reported at the time that this change originated with the Agriculture Department, where there was evidently concern within the Division of Plant Industry that large-scale industrial uses of algae were not being adequately regulated. But perhaps the only company that was immediately impacted by this change was Algenol, which at that time was building its first commercial plant for the manufacture of ethanol from cyanobacterial strains. Algenol, which had already been working extensively with the Agriculture Department’s Division on Aquaculture to obtain permits for its work under Florida aquaculture regulations, now found it needed to obtain an entirely different permit from the Division of Plant Industry (DPI), a different branch of the Agriculture Department. Algenol eventually worked out a solution that was satisfactory to the two different Ag Department divisions which didn’t require duplicative permit requirements for the company, but the situation attracted considerable attention in the spring of 2012 as it played out. You can follow the story in the Naples Daily News, in articles from March 13, 2012, March 19, 2012 and April 17, 2012.

The current version of the regulations implementing § 581.083 of the Florida Statutes, which is known as Rule 5B-57.011, was adopted in 2008 to expand the list of noxious species and to better specify the requirements for permits. These regulations require applicants to obtain a permit from the DPI for “biomass plantings” of greater than 2 acres, prohibit the granting of a permit for any species on the federal or state noxious weed list, and require permit holders to post a bond to cover the potential cost of removing the plants covered by the permit. The regulations specify that granted permits would contain requirements to institute measures to prevent the spread of the plants, including traps or filters to prevent spread through ditches, a fallow area surrounding the planting zone, and onsite decontamination of equipment. The regulations allow limited exemptions, e.g. for plants intended for use in agriculture or if the plant is judged to be non-invasive after consultation with the University of Florida.

Quinn et al. faults these regulations for not having a scientific base (in particular not requiring any assessment of weediness), and for imposing the same level of scrutiny to non-invasive plants as for invasive species. But again, I’m not aware of any criticism directed at the impact of these regulations on any company’s plans to cultivate bioenergy feedstocks in the state.

It happens that the Florida Agriculture Department DPI has recently proposed extensive revisions to these regulations (the proposed rule can also be accessed at the link for Rule 5B-57.011 shown above). The motivation for these revisions is not clear, although the stated reason is “to address the changes to Section 581.083 [i.e., as implemented in the 2012 legislative amendment] … [and] to improve the permitting process …”. Many of the revisions address administrative issues like introducing certain definitions and specifying procedures for applying for the permits, but the revisions would also expand the number of plant species listed by name on the noxious weed list. The revised regulations provide an apparently new procedure for a permit holder to petition to remove or reduce the level of the security bond that is required to be posted, and would also create a more extensive list of potential exemptions from the DPI permit requirement. Among the more important potential exemptions are a long list of plant species including energy cane and several Eucalyptus species, and a provision that aquatic plants, algae and blue-green algae could be exempt if grown in accordance with best management practices issued by the Agriculture Department’s Division of Aquaculture. This latter provision is important because it embodies what I understand to have been the compromise that allowed Algenol’s plans to go forward last year, and that it may also represent DPI’s intention for how future algae activities would be handled.

These proposed rules were published on February 25, 2013, and have been available for public comment. It is my understanding that there is not a formal comment period, as there is for federal rules, and that a public hearing would only be held if a member of the public requested one, which has not happened for this rule. I understand that the Agriculture Department is hoping to finalize the rules soon, but that they are still open to hear comments from interested parties, including industry.

I don’t know if these proposed revisions would address any of the concerns expressed by Quinn et al., who were writing before the revisions were proposed. I believe that the companies potentially affected by the proposed regulations are trying to understand their impact and decide if comments or proposed changes would be warranted. In my own review of the current and proposed regulations, what jumps out at me is that the stated requirements that would be imposed under any permit (Section 1(f) of the proposed revision to 5B-57.011, but also included in the current regulations) are written to apply primarily to terrestrial plants, and that many of these provisions don’t seem applicable to uses of algae or cyanobacteria. On the other hand, the revised regulations seem to embody the belief that uses of algae or cyanobacteria that fall under the rules would qualify for an exemption if used in compliance with the Best Management Practices of the Division of Aquaculture, so that these detailed permit conditions may not apply.

Mississippi. As noted in Quinn et al., in 2012, the state of Mississippi enacted a bill that included several amendments to its agricultural laws, one of which (Section 4 of House Bill No. 634) created new Section 69-25-10, which is entitled “Cultivation of certain nonnative plant species for purposes of fuel production without special permit prohibited.” The key provision of Section 69-25-10 is:

No individual or entity, commercial or noncommercial, may cultivate a nonnative plant species, including a genetically engineered plant, for purposes of fuel production or purposes other than agriculture, in plantings greater in size than one (1) acre, except under a special permit issued by the Department of Agriculture and Commerce. Requests for a permit authorized under this section may be denied if the department, in conjunction with specialists at Mississippi State University, determines that the plant is invasive or has potential to constitute a nuisance.

The law goes on to require that applicants requesting a permit put up a surety bond and provide certain information about the species to be cultivated, the location of the planting, and other information. The law specifies that all permits would have a one-year term. This law took effect on July 1, 2012, and later that year, on December 19, 2012, the state adopted regulations to implement the law (Sections 141.01 through 141.05, which can be found within Subpart 3, Chapter 01 of the state’s regulations). It is interesting to note that there are quite a few similarities between language in the Mississippi law and regulations and the language of the Florida law and regulations. Although much of the text of the Mississippi regulation mirrors that of the legislation, the regulation includes some other provisions, including a prohibition on granting permits for any species on the federal or state noxious weed list, and a limited list of plants for which a permit is not required (e.g. plants grown for food, plants determined not to pose a threat of invasiveness). The regulation includes a detailed list of six types of conditions that the permit may require of the applicant, primarily consisting of management or control measures that may reduce the likelihood of spread of the species beyond the area of cultivation.

The authors of Quinn et al. (whose comments are based on the legislation, not the regulations, which may not have been finalized at the time they were writing) took issue with the law, particularly the provision allowing the state Agriculture Department to deny a permit if the species were found to be “invasive,” but which did not include a definition of “invasive.” The regulation goes into more detail about permit conditions and the potential role of the Agriculture Department and Mississippi State University in determining whether to issue permits, but other than the reference to federal and state noxious weed lists, I don’t believe the regulations are any more specific about what “invasive” means. I have the added concern that the language of the legislation (and by extension, of the regulation as well) includes “a genetically engineered plant”, which could create the presumption that any transgenic plant would need a permit if intended for use in fuel production or “for purposes other than agriculture”. Since most such uses of transgenic plants would also require permits from the U.S. Department of Agriculture, this could create a duplicative permitting requirement that could be burdensome on applicants. I’m not aware of any proposed activities in Mississippi that would be, or have been, impacted by these regulations.

Comments on Proposed Regulatory Scheme for Use of Invasive Plant Species as Biofuel Feedstocks

Recently published articles from a team at the University of Illinois (including its Energy Biosciences Institute) and Virginia Tech (Quinn et al. 2013 and McCubbins et al. 2013, full citations below) discussed whether existing federal and state regulations are sufficient to ensure that noxious or invasive plant species are not grown for large-scale biofuel production. The authors concluded that the existing framework was in fact not sufficient for this purpose, and instead they have suggested a regulatory plan of their own, which would require coordinated action by state legislatures to strengthen individual state noxious weed laws, coupled with strengthened provisions to hold companies liable for environmental damage resulting from introduction of invasive species.

Specifically, the articles point out the inconsistencies seen in most states between the state’s official noxious weed list, which often forms the basis for regulation, and the lists of potential invasive plant species created by two types of organizations that are found in many states: “invasive plant councils” (IPCs) which are maintained by nongovernmental entities, and “invasive species councils” (ISCs), which are government agencies or advisory bodies. The authors found that, on average, official state noxious weed lists contained only about 20% of the species that are considered invasive by the state’s IPC and/or ISC. Because a plant species would only be regulated if it were found on a federal or state noxious weed list, the authors feel this potentially creates a gap in the regulatory system that could allow invasive species to be grown as an energy crop. The authors suggest a new regulatory regime where each state’s ISCs would be given authority to add species to that state’s noxious weed list, based on assessments of invasiveness using a recently-developed USDA screening tool. This would result in assigning nonnative species to different tiers based on potential invasiveness, requiring different levels of caution corresponding to such potential. The articles further call for industry to adopt a set of good practices to ensure that noxious or invasive species are not developed for use in bioenergy or other applications, coupled with provisions to ensure that companies would have liability for any adverse events or effects arising from their use of an invasive species.

This issue has real-world implications, in view of the current interest in using Arundo donax, also known as “giant reed”, as a feedstock for cellulosic ethanol production. At least one commercial ethanol plant that would utilize Arundo as a feedstock is under construction, and the EPA is currently reviewing the desirability of accepting a pathway of producing ethanol from Arundo under the Renewable Fuel Standard (an excellent recent summary of the pros and cons of the use of Arundo donax can be found here). Although EPA has been reviewing this proposed pathway for some time, the agency recently decided to omit this pathway from its 2013 rule-making proposal, opting for further study of the issues (this issue was briefly discussed in an earlier post on Biofuel Policy Watch).

These articles raise several questions, including the following:

Is the existing regulatory regime adequate, and if not, how should it be fixed?

The articles raise some good points from a scientific perspective, because (speaking in the abstract) it makes sense for new plant species to be screened for their invasiveness potential before they are cultivated on a large scale. Plant species that are found to have the potential to be invasive should not be used on a large scale as energy crops, unless suitable controls or management protocols are in place to prevent adverse environmental effects. In addition, proposals to genetically modify such species might raise additional concerns, although these would be reviewed and assessed when permits for field tests or expanded field use are reviewed, for example under USDA’s biotechnology regulations. In either case, the remedy should be a requirement to use a safe management protocol rather than an outright prohibition on use of the crop, except in unusual circumstances.

However, without an intimate knowledge of all the species on the various lists, it is hard to know what number of the 80-plus percent of species found on ISC lists but not noxious weed lists present a risk. It is also possible, especially in large states, that a species found on an ISC or IPC list may only be invasive in specific regions or ecological zones within the state, and may not have invasive characteristics if grown elsewhere. So, the concern raised by the authors may only be a hypothetical one, and it may be that, in most or all states, the species found on the lists that trigger regulation are indeed the ones that are the most invasive or otherwise problematic.

What is the role for the federal government vs. the states? Should invasiveness be a criterion considered in EPA decisions such as approving new RFS pathways?

On the one hand, invasiveness must certainly be evaluated on a site-specific basis, since a species invasive in one state may not be invasive or at all problematic in another. On the other hand, development of useful energy crops may be hindered if it is governed by a patchwork of state laws, which argues for some federal role. The short answer is that both levels of regulation will likely come into play. In addition to the applicability of state laws, a federal role may emerge if the proposed use of a biofuel feedstock species entails a “major federal action” such as a regulatory decision or the use of federal grant or contract funds. In those cases, the relevant federal agency must conduct an environmental assessment under the National Environmental Policy Act (NEPA) that would necessarily take invasiveness or noxiousness into account. This may be one factor in EPA’s ongoing review of the proposed Arundo donax pathway under the RFS (although EPA actions don’t trigger NEPA reviews per se, but are considered by law to afford the equivalent environmental assessment); and it would certainly be the case for a genetically modified plant of a potentially invasive species that might be subject to USDA’s biotechnology regulations. Should this be the case for any proposed use, it is hoped that adequate communication and coordination between federal and state regulators would avoid duplicative or conflicting requirements.

The articles also raise another point, which is that certain states (Florida and Mississippi) have explicit provisions in their agricultural statutes to make them applicable to plants used as biofuel feedstocks. The Florida law, in fact, is also broad enough to cover algae used to produce biofuels. This is an interesting topic that is worth exploring at length, and I intend to discuss these laws in a future blog post.

Are safe growth management practices possible or feasible? Can industry utilize voluntary compliance/management schemes rather than submit to mandatory regulation?

Yes – companies might decide to adopt such a plan voluntarily, or be required to utilize such a plan for certain species as a condition of whatever regulatory approval may be needed for a given project. The University of North Carolina Biofuels Center has developed a growth management plan for Arundo, and there are no doubt other examples. Such plans could be adopted and would be expected to be effective, certainly for smaller-scale energy crop plantations, although one must be aware of the possibility that such plans could be harder to implement successfully at larger scale. It seems that use of growth management practices is more desirable than outright prohibitions, particularly since novel energy feedstocks would usually be developed for commercial use only gradually, beginning with small outdoor plots or field tests, so that any ecological issues could be detected before the species is grown at large scale.

Is the authors’ suggested regulatory scheme desirable and feasible?

The authors make a good case that the current system of state regulation is a patchwork that may not ensure adequate, consistent protection against inappropriate use of invasive species. However, finding the path towards standardizing or coordinating 50 different state policies seems quite implausible. It also seems quite unlikely that all 50 state legislatures could revise their regulatory schemes to be more reliant on cutting-edge science (especially in today’s political climate!). It’s also worth noting that different states have different concerns – for example island states or territories like Hawaii and Puerto Rico are unusually sensitive about encroachment of nonnative species, so there will inevitably be differences between states, although this may not matter from the authors’ perspective. So, the authors’ proposal has little likelihood of being enacted in the real world, as they themselves acknowledge in the papers.

The authors also suggest a stronger liability standard for companies developing invasive species as energy feedstocks, in the event their actions lead to environmental harm. Since I’m not a lawyer and not conversant with the laws of environmental liability, I can’t comment in detail on this aspect of the proposal, but I would imagine that existing laws would provide some remedy in the event that significant environmental damage were caused by a company’s negligent activities. I’d also observe that overly stringent liability provisions, with the possibility of hefty financial penalties, could serve as a strong deterrent to the development of novel energy feedstocks, and so any revision to current liability provisions should balance this consideration against the need for adequate environmental protection.

Conclusions

These articles clearly raise issues that are deserving of discussion, and the authors have done a service in calling attention to the issues. At the end of the day, I don’t think the authors’ proposed approach of a 50-state solution is politically or realistically feasible (which they themselves acknowledge). Short of such a regulatory overhaul, the best approach would be for energy crop developers to consult with appropriate state regulators at an early stage, to ensure that the species, or the method in which it is to be grown, does not pose environmental (or regulatory) problems, and for companies to voluntarily adopt best practices for growth and management of potentially invasive species. Finally, the fact that the large-scale use of such plant species will often encounter some federal government involvement means that in most cases the possible environmental impacts of the use of the species will be considered as part of an overall environmental assessment.

Citations for the articles:

L.D. Quinn, et al. (2013) “Navigating the “Noxious” and “Invasive” Regulatory Landscape: Suggestions for Improved Regulation” Bioscience 63(2): 124-131.

J.S.N. McCubbins, et al. (2013) “Frayed Seams in the Patchwork Quilt of American Federalism: An Empirical Analysis of Invasive Plant Species Regulation”) Environmental Law 43(1): 35-81.

International Regulation of Microorganisms for Biofuel or Chemical Production: Europe, Asia and Australia

In two blog entries in 2010, I described the possible regulatory regimes that might affect the use of genetically modified microorganisms or plants in the production of biofuels or bio-based chemicals, focusing on Canada and Europe. In a post last week, I briefly summarized several countries in North America, South America and Africa having explicit biotechnology laws with reasonably clear applicability to uses of GMO microbes in contained manufacturing ( “contained use” or “confined use”). In today’s entry, I’ll describe regulatory regimes for contained uses of modified microorganisms in Europe and Australia, and in selected countries in Asia.

As explained in the earlier posts, biotechnology regulations might apply to either of two strategies for the use of advanced biotechnology in biofuel or chemical production, that is, the development either of genetically modified microorganisms or modified plants. Many countries in the world that have adopted a biotechnology regulatory framework that conforms with the provisions of the Cartagena Biosafety Protocol under the Convention on Biological Diversity, and such regulations may often cover proposed uses of either engineered microorganisms or transgenic plants. Under such regulatory schemes, the use of GMO microorganisms in contained manufacturing will likely face a fairly straightforward regulatory process, because using a GMO in “contained” conditions in a manufacturing process will generally pose far fewer hypothetical concerns about environmental or public health impacts. In today’s post I’ll focus on the regulation of modified microorganisms for the manufacture of biofuels or bio-based chemicals. I won’t explicitly the discuss regulation of transgenic plants, although I hope to eventually do so in a subsequent post on the blog.

Europe

The European Union has adopted a directive governing the “contained uses” of GMOs (Directive 2009/41/EC). Briefly, this directive would require applicants to assign a risk level to its organisms, to adopt containment measures appropriate for that risk level, and to notify a designated national agency before beginning operations. However, specific requirements in any given EU nation would be governed by national legislation or regulation adopted in conformance with the EU directive, so that national requirements in any given country may differ from, and may even exceed, the requirements of the EU directive.

The definition of “contained use” in Article 2 of Directive 2009/41/EC reads as follows:

‘contained use’ means any activity in which micro-organisms are genetically modified or in which such GMMs [genetically modified microorganisms] are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment.

This definition appears to give an applicant proposing to use a GMM in Europe (called a “user” in the directive) would have a fair amount of leeway in determining that a system or process is “contained”, and what level of containment measures are called for.

Article 4 of the directive requires the user to carry out a risk assessment of the GMM, using considerations set forth in Annex III of the directive. As a result of this assessment, the user would determine which of four containment levels is appropriate for the organism, after which the user would have the requirement to adopt appropriate containment measures in accordance with Annex IV of the directive. These requirements are similar to the U.S. NIH Guidelines and other international biosafety guidelines, and most microorganisms used for fuel or chemical production would qualify to be included within the lowest level of containment, “Containment Level 1”.

Article 6 of the directive requires users to notify the “competent” national authority (i.e., the government agency designated in national legislation as having jurisdiction to enforce the contained use directive) before a facility is to be used with GMMs for the first time. Annex V specifies the information required to be submitted with such notifications, and for Class 1 organisms, the necessary information is fairly minimal.

The EU Contained Use Directive should be viewed as providing general guidance and baseline requirements for member state governments to adopt national regulations for oversight There is at least one recent (and very comprehensive) summary of national legislation under this directive available online – it is a report published in January 2011 by the Netherlands Commission on Genetic Modification – it can be downloaded from this site. One example of a national law adopted in conformance with the EU Contained Use Directive is the law adopted in the United Kingdom, described in the portal site accessible here. Briefly, the UK law requires advance notice to the relevant agency before any work with modified microorganisms is to begin, as well as the submission of a risk assessment for the agency’s review.

Asia

Indonesia has ratified the Cartagena Protocol, and adopted Law Number 21 of 2004, followed by Government Regulation Number 21 of 2005 to implement its responsibilities under the Protocol. These regulations, although largely focusing on agricultural uses of GMOs, appear to require an environmental risk assessment for the importation of any GMO, even for contained use. The gist of the regulations is that any GMO either created in the country or imported into Indonesia must undergo a risk assessment to ascertain environmental safety, food safety, or animal feed safety. The Ministry of Environment appears to be the main contact for GMOs, and is listed with the Cartagena Protocol as the “Competent National Authority”.

In addition, Law 21 required the formation of a Biosafety Commission of Genetically Engineered Products (Indonesian acronym KKH), and this was apparently not established until 2010. The commission is under the responsibility of the President of Indonesia and is assigned to assist relevant agencies in giving recommendations about biosafety, in conducting control over importation and use of genetically engineered products, as well as in the scientific evaluation of applications and reports. The commission has the authority to assign the Biosafety Technical Team for Genetic Engineered Product in the conduct of evaluation and technical assessment of biosafety of GMO products.

It appears that importation of a GMO into Indonesia, even for a contained use, requires government review. For example, Article 13 of Government Regulation 21 reads: “Any person who imports any [GMO] of the same type from abroad for the first time, shall submit an application to the competent Minister or Head of Non-Departmental Agency”, and goes on to say that the application must include a risk assessment document attesting to environmental, food, and animal feed safety. The regulation and other background documents provide some guidance as to what information must be submitted. Presumably, applications for production of fuels or chemicals would be submitted to the Ministry of the Environment, but would be reviewed by the Biosafety Commission. Advance consultation with the Ministry would certainly seem prudent.

Japan is a signatory to the Cartagena Protocol, and it has adopted Law 97 of 2003, entitled “Law Concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms,” to place Japanese law in conformance with the Protocol. (Note: this law and other documents referenced here can be downloaded in English from the Japan Biosafety Clearing House website). Law 97 forms the basis for Japan’s biotechnology regulatory regime. Among the defined terms of Law 97 are definitions of two categories of use of Living Modified Organisms (LMOs). “Type 1” Uses correspond to what is typically called “deliberate releases”, while “Type 2” Uses are “contained uses”, which are both defined in Article 2 of the Law as follows:

5. In this Law, “Type 1 Use” shall mean use not subject to taking the measures provided for in the following paragraph.

6. In this Law, “Type 2 Use” shall mean use undertaken with the intention of preventing the dispersal of living modified organisms into the air, water or soil outside facilities, equipment or other structures (hereinafter “Facilities”) in accordance with measures specifying this fact or other measures stipulated in the ordinance of the competent ministries.

The provisions governing Type 2 Uses are covered in Chapter 2, Section 2 (Articles 12-15) of Law No. 97. These articles contain general provisions specifying that appropriate containment procedures must be put in place, and specifying procedures to be implemented in the event of an accidental release of an organism.

To implement Law 97, the government adopted “Regulations related to the Enforcement of the Law concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms”. Article 40(3) of these Regulations specify which “competent ministers” have responsibility for Type 2 Uses, either for R&D or commercial purposes. Jurisdiction for R&D is more clear: under subparagraph (i) of this Article, either the Minister of Education, Science and Technology or the Minister of the Environment would have jurisdiction over Type 2 R&D Uses. Subparagraph (ii) of this Article covers activities other than R&D, and specifies that the competent minister depends on who “has jurisdiction over the undertakings performed by persons who make of the Type 2 Use, along with the Minister of the Environment”. Presumably this means that the Minister with jurisdiction would be the Minister ordinarily responsible for the type of commercial activity to which biotechnology is to be applied, with additional responsibility assigned to the Minister of the Environment.

Japanese regulatory law is structured via a series of hierarchical regulations, such that the procedures applicable to commercial Type 2 Uses are further governed by another document, “The Ministerial Ordinance Providing Containment Measures to Be Taken in the Industrial Use of Type 2 Use of Living Modified Organisms” (there is also an equivalent document for Type 2 R&D Uses). The “Ministerial Ordinance” goes into more specific detail about appropriate containment provisions for microorganisms, plants and animals. For microorganisms, the procedures required for the lowest risk category generally correspond to Good Industrial Large Scale Practice (GILSP). The Ministerial Ordinance also includes the application form needed to be submitted to the competent minister. This is “Form 1”, which asks for information about the LMO and its properties and the measures to be adopted to ensure containment. These data provisions appear to be equivalent to those in place in other countries around the world.

It is not clear whether there have been any Type 2 Use applications in Japan for commercial activities outside of the pharmaceutical field. While the applicable procedures and data requirements appear straightforward, given the intricacies of the Japanese legal and regulatory system, it would naturally be advisable for foreign companies to work with a Japanese partner and/or attorney, and to hold early discussions with the applicable regulatory agencies in advance of any submission.

India has an existing regulatory framework, although it is based on a 27-year-old law that the government has been trying to update. This law is the Environmental Protection Act of 1986, whose provisions are implemented by the 1989 “Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms and Cells” (both the law and the rules can be downloaded from the government’s biotechnology website. The two primary regulatory bodies under this regime are the Department of Biotechnology (DBT) within the Ministry of Science and Technology and the Genetic Engineering Approval Committee (GEAC) within the Ministry of Environment and Forestry. The DBT has developed recombinant DNA guidelines, and the GEAC has developed guidelines for field testing and food use of GMOs. Under the Act and the Rules, all uses of genetically engineered organisms, including “production in which genetically engineered organisms or cells or micro-organisms are generated or used” require advance approval of the GEAC (although the final section of the Rules gives the Environment Ministry the power to grant exemptions from this requirement). In relying on a single regulatory committee with representatives from various government agencies, the Indian system embodies a regulatory regime that is better suited for R&D applications than for commercial uses, but which reflects the prevailing practice at the time the law was adopted.

The Indian government has been trying to revise these regulations to create a stronger framework since 2007. Under a National Biotechnology Strategy issued in that year, the Ministry of Science and Technology and the DBT have created drafts of a proposed “Biotechnology Regulatory Authority of India Bill”. The first version of this bill was proposed in 2008, with a subsequent version proposed in 2012 following inter-agency consultations and stakeholder feedback. The bill would create a unified National Biotechnology Regulatory Authority, with individual branches having responsibility for different commercial and R&D uses of biotechnology: for example, under the original 2008 proposal, the “Industrial and Environmental Applications Branch” would have responsibility for “application[s] in industrial production or manufacturing processes”, and so if this regime is implemented, that Branch would presumably have responsibility for review of uses of engineered microorganisms in fuel production.

It appears from online sources that the government has not made much progress in passing this new legislation, and that it has engendered opposition from many fronts. Not least of the opposition has come from India’s state governments, which are concerned that the new law might pre-empt authority they currently maintain to play a significant role in regulating certain biotechnology products. There has been opposition from segments of the public as well. At this writing it does not look likely that this law will be implemented in the near future, and so the status quo under the 1986 Act and 1989 Rules remains in effect. Although not an ideal regulatory regime, it has the advantage of providing applicants with fairly straightforward requirements. Companies seeking to use genetically modified microorganisms for fuel or chemical production would likely need to gain approval from the GEAC.

Australia

Australia has a Gene Technology Act of 2000, implemented by the Gene Technology Regulations of 2011, which would dictate whether the use of modified microorganisms for biofuel production would require a license. The Act and regulations established the Gene Technology Regulator (GTR) as the central office that administers the Act. The GTR plays the key role in assessing, regulating and licensing GMOs and enforcing license conditions. The Gene Technology Act defines gene technology as any technique for the modification of genes or other genetic material, although there is an exception for “homologous recombination” that appears quite narrow.

The most important features of the Gene Technology Regulations are the clarification of procedures for licensing certain uses of GMOs (activities involving GMOs are referred to by the term “Dealings”). Of the dealings requiring a license, a distinction is made between those involving a deliberate release of a GMO into the environment, and those that do not, with the latter being referred to as a DNIR (“dealing not involving release”). Applicants for either type of license are required to submit certain information to the GTR, which is then used to prepare a risk assessment and risk management plan, which forms the basis for the GTR’s decision.

Procedures for DNIR license applications are similar to those for deliberate releases, except that the time period for the government’s decision is shorter for DNIRs (90 working days as opposed to 150-255 working days for release applications), and that public involvement may not be required for DNIR applications as they are for deliberate releases. Another feature of all license applications is that they must first be reviewed and approved by an Institutional Biosafety Committee (IBC). The law and regulations specify requirements for such committees, and it appears that to meet such requirements, applicants would need to use an IBC in Australia.

It appears that any proposed use of a modified microorganism in contained manufacturing of a fuel or chemical would require a permit from the GTR. The GTR website has links to the application forms, and the form for application for a DNIR license can be downloaded here. The application form is quite detailed, although the scientific information it requires is similar to the information that would be submitted to the U.S. EPA in a Microbial Commercial Activity Notice, which were summarized in one of my 2010 posts.

I’ll admit that the two posts in this series represent a somewhat arbitrary selection of countries, particularly in South America and Asia. I’d be happy to answer questions about regulations in other countries not mentioned in either post, either through Comments on this post, or by contacting me offline.

International Regulation of Microorganisms for Biofuel or Chemical Production: North and South America and Africa

As explained in my 2010 posts, biotechnology regulations might apply to either of two strategies for the use of advanced biotechnology in biofuel or chemical production, that is, the development either of genetically modified microorganisms or modified plants. In either case, some government review or permitting will likely be needed, and in many countries such oversight would be governed by the provisions of a single law. As I described in a previous post, many countries in the world that have adopted a biotechnology regulatory framework have done so to conform with the provisions of the Cartagena Biosafety Protocol under the Convention on Biological Diversity. National laws that are based on the Cartagena Protocol often feature unified provisions for government review of any biotechnology proposal, although in most cases the driving force for the creation of such rules was the desire for adequate oversight over agricultural and food uses of modified crop species.

The use of genetically modified microorganisms (GMOs) in manufacturing will likely face a fairly straightforward regulatory process in most countries, because such “contained” uses will generally pose far fewer hypothetical concerns about environmental or public health impacts. In contrast, the use of genetically modified plants as improved biofuel feedstocks will entail the field testing and ultimately the outdoor cultivation of modified plants, and may trigger a more rigorous review of potential environmental impacts. In many cases, national biotechnology laws cover both potential applications, but in today’s post I’ll focus on the regulation of modified microorganisms for the manufacture of biofuels or bio-based chemicals. I won’t explicitly the discuss regulation of transgenic plants in today’s post, although I hope to eventually do so in a subsequent post on the blog.

The following are brief summaries of several countries in North America, South America and Africa having explicit biotechnology laws with reasonably clear applicability to uses of GMO microbes in contained manufacturing ( “contained use” or “confined use”). I’ll cover countries elsewhere in the world in a subsequent post.

North America

Mexico is a signatory to the Cartagena Protocol and has a Bio-Safety Law adopted in 2005. The Bio-Safety Law assigned primary responsibility for biotechnology regulation to three agencies: the Secretariat of Agriculture, Livestock, Rural Development, Fisheries and Food (SAGARPA), the Secretariat of Environment and Natural Resources (SEMARNAT), and the Secretariat of Health (SALUD), and specified each agency’s jurisdiction. The Inter-Ministerial Commission on Biosecurity and Genetically Modified Organisms (CIBIOGEM) coordinates Mexico’s biotechnology oversight activities. The government has issued regulations (known by the Spanish title Reglamento) under the Bio-Safety Law, with the most recent version being issued in March 2008. The Reglamento provides detailed requirements for the use of GMOs outside containment, or for food use, human use, or bioremediation.

The Reglamento ostensibly also provided for a notification scheme for contained uses, but this does not appear to have been fully fleshed out until April 2011, when the government published notice of an agreement between SAGARPA and SEMARNAT regarding a unified approach to notifications for confined uses of GMOs. This notice is available here, apparently only in Spanish. Part of this notice is a lengthy “Annex” containing the proposed unified format for notifications. This notification form requires submission of a good deal of information describing the GMO, how it is proposed to be used, as well as information pertaining to a risk assessment for the proposed use. The amount and type of information required is of a similar scope to what would be required in the U.S. (e.g. in a Microbial Commercial Activity Notice under EPA regulations), but the information would of course need to be submitted in Spanish (EPA’s data requirements are discussed in my previous blog entries from 2010). The form can be a little difficult to understand, in that it specifies that different sections are to be completed for each of several different permit types, and so advance consultation with the relevant regulatory agency would be recommended.

Canada’s regulatory approach resembles that of the U.S., in that existing laws and regulations are used to regulate biotechnology in a product-specific way. Therefore, many products of biotechnology would be regulated in Canada under existing federal laws. In November 1997, Environment Canada (EC) issued biotechnology regulations under the Canadian Environmental Protection Act (CEPA), that are similar in scope and approach to the U.S. EPA’s TSCA biotechnology regulations, and which are meant to cover biotechnology products or microorganisms that are new to commerce in Canada and which are not regulated by other federal agencies. Among products that could fall under this law’s scope would be microbial strains used for biofuel or bio-based chemical production, or for manufacture of enzymes for use in biofuel production. My 2010 post described these regulations in detail, but the following is a brief summary and update.

EC considers microorganisms as being potentially subject to these “New Substance Notification” (NSN) regulations if they meet the definition of “new substance”. The law defines a “new substance” as one intended for introduction into commerce that is not on the Domestic Substance List (DSL) as having been used in commerce between January 1, 1984 and December 31, 1986. The DSL for microorganisms includes about 70 naturally-occurring species, identified by ATCC accession numbers. Thus, if a microorganism on this list was used in commerce from 1984-86 in a way such that “its entry into the environment was unrestricted”, it is exempt from reporting; but all other microorganisms, regardless of make-up, are subject to reporting. In this way, the Canadian CEPA regulations are broader than those of the U.S. EPA, in subjecting a larger class of microorganisms to regulation, and it is important to note that the regulations are broad enough to include naturally occurring or classically mutated strains, if such strains had never previously been used in commerce.

Under the NSN regulations, any person who manufactures or imports substances subject to notification must provide a notification package to EC, which contains certain information specified in the regulations. EC uses this information to conduct a risk assessment prior to entry into commerce. The required information is generally similar to the information the U.S. EPA requests in MCAN submissions under its TSCA regulations (EPA’s requirements are discussed in my previous blog entries from 2010). Information on the Canadian biotechnology rule is available at the biotechnology home page, and the New Substance regulations themselves can be found here. A Guidelines document that is similar to EPA’s “Points to Consider document” can be accessed here. CEPA published a fact sheet specific for biofuels, which is accessible here.

CEPA has reviewed and approved a number of notifications for industrial uses of new microorganisms. These have been described in my 2010 blog post on the Canadian regulations, which includes links to the various decision documents. There do not appear to have been any published decision documents or risk assessments in the time since my earlier blog post.

South America

Colombia is a signatory to the Cartagena Protocol, and has adopted laws and regulations to ensure compliance. These include Act 740 of 2002 and Decree 4525 of 2005, which implements Act 740, and establishes which agencies would have authority for which types of activities (note: these links will lead to the original Spanish versions of these documents). These agencies are: the Ministry of Agriculture and Rural Development, with responsibility for agricultural, livestock, fisheries, forest plantations and agribusiness; the Ministry of Environment, Housing and Territorial Development, with responsibility for organisms intended solely for use in the environment; and the Ministry of Social Protection, with responsibilities for uses in health or foods. Decree 4525 appears to require at least a notification to the appropriate government agency prior to any intent to import a GMO into Colombia for use in contained R&D, accompanied by a suitable risk assessment of the proposed use. The law and the implementing regulations do not explicitly state the requirements for commercial use of a GMO in contained manufacturing, and so consultation with the government, likely the Ministry of the Environment, would be advised.

Chile has signed the Cartagena Protocol, but it has not been ratified, with no set timetable for ratification. The country has no national biosafety law, but the National Commission of the Environment (CONAMA) worked with the United Nations Environmental Project (UNEP) in 2005 to develop a document that proposed the fundamentals for a national biosafety framework for Chile that would be consistent with the Cartagena Protocol, but no action on such a proposal has yet taken place. In spite of the lack of a national law, the government has reviewed requests for field use of transgenic plants under existing agricultural regulations. Responsibility for such reviews within the Ministry of Agriculture was given to the Advisory Committee for the Release of Transgenes (known by the Spanish acronym CALT), which has reviewed and approved a large number of applications for field growth of transgenic plants since 1992. On the microorganism side, there are guidelines for laboratory use of GMOs but apparently no laws that would clearly cover proposed uses such as use of a GMO in a contained manufacturing process. It is probably advisable for companies planning activities in Chile to consult either with the Ministry of the Environment or with the CALT committee.

Brazil has ratified the Cartagena Protocol and has been active in oversight over agricultural and industrial biotechnology. Brazil has a national biosafety law (Law No. 11,105 of March 24, 2005, available here in either English or Portuguese). The law creates a national regulatory framework administered by the Biosafety National Technical Committee (Comissão Técnica Nacional de Biossegurança, known by its Portuguese acronym CTNBio), and the National Biosafety Council (CNBS), with the involvement of the Ministries of Health, Environment and Agriculture, the Special Secretariat of Agriculture and Fishery, and other agencies. The CTNBio website, in Portuguese but with some links to English pages, can be found here. The Law and its regulations require that companies wishing to conduct commercial activities using GMOs or to test or use GM plants in the environment must seek the approval of CTNBio. Specifically, the Law requires approval for any activities involving the “cultivation, production, handling, transport, transfer, commercialization, import, export, storage, consumption, release and disposal of GMOs and their derivatives for commercial purposes.” Thus, unlike some national regulatory frameworks that are largely restricted to covering outdoor use of GMO plants, it is clear that the Law covers not only contained manufacturing but also the importation of GMO strains into Brazil.

There are precedents in Brazil for prior approvals for industrial biotechnology activities. These are two applications that were filed by Amyris for the use of genetically modified strains of S. cerevisiae (yeast) for the production of farnesene for fuel and chemical use. These applications appear to have been approved by CTNBio within a review period of several months, following submission by the company of a fairly detailed dossier describing the organisms, their construction and proposed use, and a risk assessment of the proposed commercial application.

Africa

South Africa adopted the Genetically Modified Organisms Act of 1997, which was amended in 2006 after the country ratified the Cartagena Protocol. The regulations and any required permit applications would be administered by the Ministry of Agriculture. Regulations were first established in 1999, but apparently implementation of these regulations was problematic with regard to permit applications and public access to decision-making documents, so there was pressure to revise the regulations. An Amendment to the Genetically Modified Organisms Act was adopted in 2006, in part to overcome these problems, and this version is in effect at this time. There is a website that is the gateway to downloading permit applications, and from the list of applications shown on this site, it appears that the following three applications might need to be submitted for a proposed biofuel or bio-based chemical plant which uses GMOs.

Application for authorization to import GMOs into South Africa that are destined for contained use
Application for contained use of GMOs
Application to register a facility for activities involving genetic modification

The “contained use” application generally asks for the sorts of information one would expect, including a description of the organism, the facility, and the process, and is guided by a list of issues to address. The contained use application also requires submission of a risk assessment in a format set out in an appendix to the application, which is similar to, but not identical to, the risk assessment format set out in the Cartagena Protocol: it appears that the South Africa form is longer and asks for more data than the risk assessment format that is contained in Annex III of the Protocol.

International Regulation of Microorganisms for Biofuel or Chemical Production: the Cartagena Protocol

In two blog entries in 2010, I described the possible regulatory regimes that might affect the use of genetically modified microorganisms or plants in the production of biofuels or bio-based chemicals, focusing on Canada and Europe. In a forthcoming series of posts, I’ll be updating information on the regulation of genetically modified microorganisms and extending it to a broader group of countries. In preparation for doing so, today’s post will briefly describe an international standard on which many national biotechnology laws are based, particularly in the developing world. That is the Cartagena Protocol on Biosafety, which is an annex to UNEP’s Convention on Biological Diversity.

Overview

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international agreement which was enacted to ensure the safe handling, transport and use of genetically modified organisms (which the Protocol calls “living modified organisms”, or LMOs) resulting from modern biotechnology that may have adverse effects on biological diversity, and possible risks to human health. The Protocol was adopted on January 29, 2000 as a supplementary agreement to the Convention on Biological Diversity and took effect on September 11, 2003. Considerable detail on the history of the Protocol and its development can be found on the Biosafety Clearing-House website, which is a site established under the Protocol to be a repository of information from various countries regarding compliance.

The Protocol is intended to ensure that national authorities are notified of proposed deliberate releases or transboundary movement of LMOs in their countries, and to ensure that information about uses of LMOs is provided to the public and to other countries and interested parties. Another important goal of the Protocol is to ensure that rules are in place for the transboundary export of LMOs, particularly those to be used for food or feed. Specifically, the Protocol requires there to be “Advance Informed Agreements” (AIA) when LMOs are shipped across national boundaries, to ensure that the recipient nation is notified of the proposed shipment, and to allow the recipient nation to conduct needed risk assessments. The Protocol specifies that each party to the Convention designate one or more government agencies as the “competent national authority” having responsibility for oversight over activities that are subject to the Protocol.

Signatories to the Convention need to adopt national laws, or amend existing laws, to establish procedures that conform to the provisions of the Protocol. Although such national laws based on the Protocol sometimes feature unified provisions for government review of any biotechnology proposal, in most cases the driving force for the creation of such legislation or regulation has been the desire for adequate oversight over agricultural and food uses of modified crop species, particularly the so-called “deliberate release” of modified crop plants. Therefore, in countries having national biotechnology laws that were enacted to implement the provisions of the Protocol, the best-defined provisions are those that apply to LMOs intended for agricultural and/or food use. Although these are clearly the most widely applicable portions of the Protocol, I won’t describe these provisions any further here, because the focus of today’s post is the impact of the Protocol on contained use of LMOs in commercial manufacturing.

Applicability to Contained Uses of Modified Microorganisms

In the Protocol and often in national laws, the provisions that might apply to “contained” or “confined” uses of microorganisms, for example in a commercial manufacturing process, are not well defined. In fact, although the Protocol contains detailed provisions governing the Advanced Informed Agreements required for transboundary shipments of LMOs, there is an exemption from the AIA procedures for shipments of GMOs intended solely for contained use. Specifically, Article 6(2) of the Protocol reads as follows (emphasis added; note that the term “Party” refers to a country that is a party to the Convention on Biological Diversity):

Notwithstanding Article 4 and without prejudice to any right of a Party to subject all living modified organisms to risk assessment prior to decisions on import and to set standards for contained use within its jurisdiction, the provisions of this Protocol with respect to the advance informed agreement procedure shall not apply to the transboundary movement of living modified organisms destined for contained use undertaken in accordance with the standards of the Party of import.

“Contained Use” is defined in Article 3 as follows:

(b) “Contained use” means any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment

It’s important to note that Article 6(2) requires that the contained use must be “undertaken in accordance with the standards of the Party of import.” Therefore, what Article 6(2) says is that transboundary shipments solely for contained uses do not necessarily require AIAs under the Protocol, although individual countries are free to set their own standards for contained use and to require and carry out whatever risk assessments or other regulatory requirements they feel are appropriate. This might include not only a review of the proposed importation of the LMO, but also review and possible permitting of the proposed contained use itself. So, for example, in the European Union, where each member state has regulations governing “contained uses” in accordance with the EU contained biotechnology directive, the use of an LMO sent to an EU member state via a transboundary shipment would have to comply with EU or national law, even if the Protocol does not require there to be an AIA.

The Protocol does, however, set some labeling standards for transboundary shipments of GMOs. Article 18(2)(b) reads as follows:

2. Each Party shall take measures to require that documentation accompanying:

… (b) Living modified organisms that are destined for contained use clearly identifies them as living modified organisms; and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the living modified organisms are consigned

Note that the definition of “contained use” in the Protocol does not distinguish between research uses and commercial uses. This ambiguity carries forward to a number of national laws that I’ve reviewed, sometimes making it unclear whether any there might be any permit requirements for commercial “contained uses” over and above the notification and labeling requirements under the Protocol.

Implications for Use of GMO Microorganisms in Biofuel or Biobased Chemical Production

The Protocol can be viewed as establishing minimum requirements for applicants proposing to use LMOs in contained commercial manufacturing, with the understanding that national laws may impose additional requirements in certain countries. Applicants should therefore consider taking steps such as documenting that the intended use in the country of importation is indeed “contained” in accordance with the definition in Article 3 of the Protocol; documenting in writing that the intended recipients understand that an LMO is to be shipped, and abiding by the labeling requirements for all shipments of the LMO into the country. It would also be advisable to identify the relevant agency(ies) that are the “competent national authority” for the activity to be undertaken, and to consult with that agency in advance. It is possible that national law or regulations or common practice in any given country might be to require a risk assessment even for proposed contained uses of LMOs, and if so, such a risk assessment might need to be carried out in conformance with the Protocol, e.g. as specified in its Annex III. Several of the national laws that I’ll describe in the forthcoming posts will indeed require a risk assessment and sometimes a permit application as part of the review of proposed uses of LMOs in contained manufacturing.

This has been a brief, and highly selective discussion of the Cartagena Protocol and its requirements, and there are many aspects that I’ve omitted here as not necessarily relevant to contained uses of microorganisms. There are a myriad of sources for additional information about the Protocol available online, including some of the sites referenced above (see also a 2003 guide published by IUCN – The World Conservation Union, available here).

Advanced Biotechnology for Biofuels

Discussing how advanced biotechnology is being used to improve the production of renewable fuels