EPA regulation of industrial nanomaterials: the good and the bad

Regarding EPA regulation of industrial nanomaterials ... let's take the good with the bad, shall we?

GOOD NEWS: According to Jim Alwood of EPA, its industrial chemical regulatory program (TSCA) has "regulated nearly all nanoengineered chemicals that it has reviewed" (as opposed to 10-15% of conventional chemistry submissions).

BAD NEWS: It takes 2-4x longer than a conventional review. 

GOOD NEWS: EPA has allowed most of the 160+ nano PMNs it has reviewed into the marketplace.

BAD NEWS: Beneficial uses are being delayed entry into the marketplace. perhaps due to EPA's conservative overestimate of risk when sufficient data is not submitted.
 
Do you have questions regarding submissions for nanoscale indsutrial chemicals, pesticides, biopesticides or antimicrobials?  Technical & Regulatory Services LLC can help!

EPA taking public comment on reducing # of inerts allowed in pesticides

Tomorrow, EPA will announce in the Federal Register that it is removing 72 of the currently allowable compounds used as inert ingredients in pesticide formulations.  The list of allowable inert substances is maintained by a specialized branch with the Office of Pesticide Program's Registration Division and any compound on this list may be used in a EPA-registered pesticide for non-food uses without any additional authorization.  (New inert ingredients will require approval from the branch in addition to new fees for such services levied under PRIA3.)

EPA undertook an analysis that determined that these 72 compounds are no longer used in pesticide formulations and will thus be removed from the list.  In order to be reinstated back on the list, a registrant would have to submit a petition "supported by data provided to and reviewed by the EPA as part of a new inert ingredient submission request."  (See more info on the process here.)  In addition, EPA is describing this action as "fulfilling a commitment as described in an EPA May 22, 2014 amended response to the petitioners" ... back in 2006, the Northwest Coalition for Alternatives to Pesticides and a group of State Attorney Generals petitioned EPA identified over 370 chemicals in pesticide formulations as hazardous and demanded that EPA disclose the presence of these compounds on the label.  It was this group of roughly 370 chemicals that EPA analyzed to identify the current batch of 72 that is no longer used.  There's more than you wanted to know on this sage here.  [It should also be noted that EPA revoked the tolerance of many inerts immediately following the submittal of the petitions, citing "insufficient evidence" on file to support a safety finding. This resulted in a large industry-led effort, the Joint Inerts Task Force, to develop these data to reinstate revoked tolerances.]

The Agency's revised May 2014 response to the petitioners and the list of 72 substances will be posted to regulations.gov at docket EPA-HQ-OPP-2014-0558 in the coming days.  Chances are if it is not posted by later afternoon tomorrow, you may be still able to obtain it directly from the EPA.

Both PESTICIDE REGISTRANTS and CHEMICAL MANUFACTURERS (particularly those that make proprietary inert formulations sold to registrants for inclusion in pesticide formulations) need to cross-check this list, when available, against their current portfolio.  If you need to reinstate an older inert, you may be facing some new data needs.  Technical & Regulatory Services LLC can help!

What lies ahead if EPA regulates strontium in drinking water?

EPA announced today that it made a "preliminary determination to regulate strontium in drinking water."  If this goes final, there's still an awful lot of work to do. What is involved?

The "preliminary determination" is being made under the Safe Drinking Water Act, which calls for the creation of a "candidates list" (a CCL) for regulation every five years (we are on CCL3). The latest batch of chemicals off CCL3 for which preliminary regulatory determinations were made identified strontium as the only chemical that potentially requires regulation. Following this action, a 60-day public comment period is planned, and assuming a final determination to regulate is made, then a rule is prepared (which likely would be published by the end of 2015).

To "regulate" strontium involves the derivation of both technology- and health-based allowable limits.  The former are called "maximum contaminant goals" are considered a "maximum permissible level of a contaminant in water delivered to users of a public water system."  The latter are more complicated to derive and is where the bulk of the remaining work lies.

To derive a health-based limit for a chemical that is protective of human health requires the derivation of a toxicity reference value (TRV), such as a "Reference Dose" (RfD). To do this, the Office of Water will request that the Office of Research & Development IRIS program establish a TRV.  Actually, the IRIS program has already done this, but the work is from 1992 and not reliable by today's risk and regulatory standards.  The Agency for Toxic Substances and Disease Registry has actually done a more up-to-date and thorough review of strontium toxicology and exposure (from 2004); however, it approached its derivation of a TRV differently -- despite using the exact same study as EPA.  

(ATSDR is a public health agency of the Department of Health & Human Services and mandated to serve specific functions by Congress: public health assessments of waste sites, health consultations concerning specific hazardous substances, health surveillance and registries, response to emergency releases of hazardous substances, applied research in support of public health assessments, information development and dissemination, and education and training concerning hazardous substances.)

WARNING!!  Tox Geek Alert!!  As one might imagine, there's not a ton of tox literature out there for strontium and the work that the current TRVs are based on were done in the 60s and 80s. Complicating the interpretation of the body work is the fact that it is naturally occurring, occurs in radioactive and radiostable forms, and has been used therapeutically in humans (to treat osteoporosis).  EPA IRIS based its RfD on rachitic bone effects observed in a 20-day oral study using young and adult female rats. ATSDR based its TRV (called a "minimal risk level") on the same study.  In both cases, a "no effects level" was interpreted from the study and combined with uncertainty factors to produce the TRV, and the differences are notable:

  • EPA defined the "no effects" level as 190 mg/kg-day and combined this with total UF of 300 to yield an RfD of 0.6 mg/kg-day.
  • ATSDR defined the "no effects" level as 140 and used a total UF of 90 to yield an MRL of 2 mg/kg-day (3x higher than EPA).  Additionally, it also set health limits based on its radioactivity (which is carcinogenic, as opposed to the radiostable versions which are not).

Given that this work is over 20 years old, a renewed TRV derivation will have to be done following the new IRIS procedures (which I have written about before).  This will involve "systematic review" of the available evidence, including any relevant human/clinical data which may have been reported in the intervening years.  This will also involve a long, laborious process that will have multiple comment periods, public meetings, etc and probably 3-5 years total.  

Once the IRIS process is successfully navigated, then there are additional SDWA mandates to follow.  For example, EPA has since introduced a policy where "lifetime health advisories" will be calculated for all SDWA contaminants. regardless of carcinogenicity status. The available evidence on the radiostable versions of strontium found in drinking water (such as strontium carbonate and strontium nitrate) shows it is not carcinogenic at the highest dose tested (263 mg/kg-day) following 3-year oral exposures in male adult rats.

If you use strontium in your manufacturing or laboratory processes, you may want to follow these proceedings and press EPA IRIS to use all available data and to use modern methods if it needs to derive a new TRV).  M³ Technical & Regulatory Services can help!

 

EPA OIG to investigate "misleading air toxics data" from California

Update from EPA's Office of the Inspector General :: October 14, 2014:

As a "result of a hotline complaint received by our office," the EPA Office of Inspector General has informed the California Air Resources Board (CARB) that it is"reviewing allegations that the ARB is reporting misleading air toxics data."  Furthermore, according to OIG, the purpose of the investigation is to "determine whether the ARB complied with applicable procurement requirements when purchasing the selected equipment and interrelated service contracts, and to determine whether ARB is following applicable requirements for testing and reporting air toxic data."

According to the letter sent to CARB, OIG is planning on initiating work with the State from a location in Sacramento in the next several weeks.  No reason was given other than stating that the investigation was the result of a "hotline tip."  

You should review the OIG letter and ensure you have the requested paperwork in order in case your region or state is next up on the "hotline."  M³ can help ensure your data and paperwork are compliant with EPA's standards. 

 

EPA Analysis Shows Little to No Benefit from Neonicotinoid Seed Treatments in U.S. Soybean Production

Presented below verbatim from this afternoon's EPA press release. I think you can almost guarantee that some of the currently registered uses of neonics will be discontinued upon completion of registration review (soybean insect control, for one) given the overall level of public concern coupled with the June 2014 Presidential Memorandum -- Creating a Federal Strategy to Promote the Health of Honey Bees and Other Pollinators.

 

FOR IMMEDIATE RELEASE
October 16, 2014 


EPA Finds Neonicotinoid Seed Treatments of Little or No Benefit to U.S. Soybean Production

Washington --- Today, the U.S. Environmental Protection Agency (EPA) released an analysis of the benefits of neonicotinoid seed treatments for insect control in soybeans. Neonicotinoid pesticides are a class of insecticides widely used on U.S. crops that EPA is reviewing with particular emphasis for their impact on pollinators. The analysis concluded that there is little or no increase in soybean yields using most neonicotinoid seed treatments when compared to using no pest control at all. A Federal Register notice inviting the public to comment on the analysis will publish in the near future.

“We have made the review of neonicotinoid pesticides a high priority,” said Jim Jones, assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention. “In our analysis of the economic benefits of this use we concluded that, on a national scale, U.S. soybean farmers see little or no benefit from neonicotinoid seed treatments.”

During the review of the neonicotinoids, EPA found that many scientific publications claim that treating soybean seeds has little value. Part of our assessment examined the effectiveness of these seed treatments for pest control and estimated the impacts on crop yields and quality, as well as financial losses and gains. The law requires EPA to consider the benefits of using pesticides as well as the risks.

The analysis concluded that: 

  • There is no increase in soybean yield using most neonicotinoid seed treatments when compared to using no pest control at all.
  • Alternative insecticides applied as sprays are available and effective.
  • All major alternatives are comparable in cost.
  • Neonicotinoid seed treatment could provide an insurance benefit against sporadic and unpredictable insect pests, but this potential benefit is not likely to be large or widespread throughout the United States.

This analysis is an important part of the science EPA will use to move forward with the assessment of the risks and benefits under registration review for the neonicotinoid pesticides.  Registration review --- the periodic re-evaluation of pesticides to determine if they continue to meet the safety standard --- can result in EPA discontinuing certain uses, placing limits on the pesticide registration, and requiring other label changes. 

Sign up for pesticide program updates to be notified by email when the EPA opens the docket and invites comment on its analysis of the benefits of neonicotinoid seed treatments on soybeans.

What if IRIS threw a party and nobody came?

Poor beleaguered IRIS ... that's the Integrated Risk Information System for those you not up to speed on your EPA acronyms. This EPA program has gotten such a bad rap for so long and it has earnestly tried to change in response to its critics so many times now that it resembles the classic David Byrne lyric (from the equally classic "Life During Wartime"): "I've changed my hairstyle so many times, I don't know what I look like."  During this week's public workshop (devoted to detailed discussion of the National Research Council Review of the IRIS Assessment Development Process), yet another change was announced that is worth mentioning. But first a little history.

IRIS was created in 1985 -- and currently housed within the National Center for Environmental Assessment within the Office of Research and Development -- without statutory authority to provide "consensus opinions about the health effects that may result from chronic exposure to various substances in the environment, and to provide these opinions in a database accessible across the Agency."  These consensus opinions take the form of a Toxicological Assessment (within which a "toxicity reference values" for subsequent risk assessment is proposed) for an individual substance (or sometimes related group of chemicals), results of which are posted online.  

The conclusions of the IRIS program (and the database) have come to be very heavily relied upon as "gold standard" risk assessment inputs by federal, regional and state regulators as well as by many other international experts and students.  If you want to know the best reference dose to put in your risk assessment, you go to IRIS. This is what every young risk analyst learns.

However, the program - since its inception - has basically never been been able to hit its production goals, the assessments it is able to complete take a long time, it no longer serves the needs of other EPA program offices (such as the Pesticides Office, who develop their own tox values for risk asseements) and as a result of all of the above, has been classified as a "high risk" federal program by the GAO which investigates certain wasteful government operations "due to their greater vulnerabilities to fraud, waste, abuse, and mismanagement or the need for transformation to address economy, efficiency, or effectiveness challenges." To quote from the GAO: 

"With regard to EPA’s IRIS program, the agency must demonstrate the ability to routinely complete timely, credible IRIS assessments. This will involve developing and achieving, over a sustained period of time, productivity goals for addressing its current backlog of assessments, routinely starting new assessments, and updating existing assessments. EPA must also fully address issues concerning the clarity and transparency of its development and presentation of draft IRIS assessments as well as issues regarding the availability and accuracy of current information to users of IRIS information on the status of IRIS assessments."

IRIS long targeted completion of 20 assessments per year, which it was never able to achieve, As a result of federal GAO scrutiny, NGO scrutiny (see this report from Rena Steinzor), Congressional scrutiny (such as this 2011 hearing or this 2014 hearing), and scrutiny from a seemingly unrelated NRC panel, many changes were put in place by now Director Ken Olden.

None of these changes have resulted in productivity gains to this point and appear to have made the whole public input aspect more complex.

In fact, GAO has been investigating IRIS since 2008:Chemical Assessments: Challenges Remain with EPA’s Integrated Risk Information System Program. GAO-12-42. Washington, D.C.: December 9, 2011.High-Risk Series: An Update. GAO-11-278. Washington, D.C…

In fact, GAO has been investigating IRIS since 2008:

Chemical Assessments: Challenges Remain with EPA’s Integrated Risk Information System Program. GAO-12-42. Washington, D.C.: December 9, 2011.

High-Risk Series: An Update. GAO-11-278. Washington, D.C.: February 2011.
Chemical Regulation: Observations on Improving the Toxic Substances Control Act. GAO-10-292T. Washington, D.C.: December 2, 2009.

EPA Chemical Assessments: Process Reforms Offer the Potential to Address Key Problems. GAO-09-774T. Washington, D.C.: June 11, 2009.

Chemical Regulation: Options for Enhancing the Effectiveness of the Toxic Substances Control Act. GAO-09-428T. Washington, D.C.: February 26, 2009.

High-Risk Series: An Update. GAO-09-271. Washington, D.C.: January 2009.

Toxic Chemicals: EPA’s New Assessment Process Will Increase Challenges EPA Faces in Evaluating and Regulating Chemicals. GAO-08-743T. Washington, D.C.: April 29, 2008.

Chemical Assessments: Low Productivity and New Interagency Review Process Limit the Usefulness and Credibility of EPA’s Integrated Risk Information System. GAO-08-440. Washington, D.C.: March 7, 2008.

So back to the change announced yesterday.  

Per EPA, the ongoing EPA Bimonthly Public Science Meetings "will be supplemented with independent scientific experts identified by the National Academies’ National Research Council ... [and] these independent experts will contribute to the scientific discussion of issues amongst EPA and public commenters." Furthermore, "EPA acknowledges concerns raised by the NRC committee regarding stakeholder participation and has noted that participation amongst stakeholder groups has been uneven during recent IRIS public science meetings.  To address the imbalance that has risen from an open registration to participate in IRIS Bimonthly Public Science Meetings, EPA has engaged the NRC to supplement the public discussions with scientific experts identified and assembled by the NRC.  These experts, who will be reviewed by the NRC for conflicts of interest and bias, will provide valuable, independent scientific input to these meetings.  The involvement of NRC experts will significantly contribute to broadening the range of perspectives represented at our public meetings."

A quick review of the handful of bimonthly public meetings will quickly show one that only industry appeared to have taken the call for public input.  The main reason for this is that EPA is taking technical comments on chemicals that industry spends a lot of money and time and effort researching, characterizing and testing.  NGOs never have and likely never will sponsor basic research and constructive input from them is often limited to policy comments and reviews of the open literature as mostly published by academics.  

NRC was justified in pointing out the imbalance in its May 2014 report, however, EPA is not justified in connecting this the open registration process. One may conclude that EPA is actually interfering in the public input process by "engaging" (i.e. contracting and PAYING) the NRC to select "independent" experts on behalf of the public and to promote a balanced discussion. Furthermore, Olden referred to the new approach as "not a change ... its an enhancement to invite scientists to participate in our bimonthly meetings." It is a change, and its fairly significant.

This author is fully in favor of open, transparent, balanced dialogues concerning regulation and science policy.  However, the government shouldn't step in to essentially subsidize independent experts if none rise to the challenge.  Perhaps the NGOs that spend the majority of their resources bringing litigation against the federal government should actually assist the government (and themselves in the process!) and spend some of that money more wisely by contracting the academics of their choice to provide technical input at the IRIS bimonthly meetings.

Just because you throw a party and nobody comes ... that doesn't mean you go out to the street and pay somebody to round up some attendees.  That might imply you were a bit of an egomaniac. Or desperate.  Time will tell for the IRIS program.  It clearly must adapt and evolve or die; however, it still does serve an important function to many a risk analyst.  Perhaps the lack of consistent progress at IRIS argues for some centralized agency ... or a distributed network of similar duties/mini-programs within the relevant federal agencies.

REACH compliance is poor among "Only Representatives" of non-EU manufacturers

Normally, I don't provide much info in this space on European regulations (usually confined to nanotechnology or pesticide policy); however, I saw this news and it shocked me a little.  The European Chemicals Agency has released the results of its 3rd "REACH Enforcement Project," which collected data from 528 company inspections in 2013 from 28 countries spanning over 3,000 chemicals. The "highest rate of non-compliance (43%) [was] found in the group of only representatives performing this one role only"  [as compared to importers (15%) and manufacturers (7%)].  Furthermore, large companies were found to be have a 6% non-compliance rate.  "Only representatives" (ORs) are authorized by Article 8(1) whereby "a natural or legal person established outside of the EU who manufactures substances (to be used on their own, in mixtures and/or to produce articles), formulates mixtures or produces articles, can nominate an only representative located within the EU to carry out the required registration of their substances that are imported."  Distributors cannot appoint an OR. 

The bottom line appears to be that ORs of non-EU companies do not understand or perhaps are unaware of the need for compliance with REACH.  Perhaps best summed up by CEFIC: "We need to provide much more communication and education to non-EU countries on what the real requirements are to bring products on the European market."  

SC Johnson and Clorox: Leaders in product ingredient disclosure

Last week, the major consumer packaged goods (CPG) company SC Johnson announced it would "expand its ingredient disclosure efforts by providing product-specific fragrance ingredient information" at the product level.  

SC Johnson is again mirroring the actions of its biggest competitor, Clorox, who has also been an industry leader in this area and was the first major CPG company to voluntarily disclose ingredients for its cleaning/disinfection and laundry products.  (Since then, Clorox has expanded these disclosures to preservatives, dyes and fragrances and, most recently, released a "Preferred Ingredient Calculator" intended "to help the company's product developers consider the sustainability profiles of different raw materials and formulations when making decisions about ingredients used in the company's cleaning products, including an analysis of human health, environmental health and sustainability metrics.")  In 2009, both companies established public databases and web sites to provide information on ingredients in some products SCJ started with cleaning and air care products).  SCJ also later expanded its disclosures to include other products in its portfolio, namely pest control products.

SCJ will first release ingredient information for its air care products (sprays, candles, oils and gels) in North America, with Europe to follow.  Typically, a "fragrance" is a complex of up to several hundred individual compounds, most of which have already been disclosed to the public (see the list maintained by the International Fragrance Association here).  However, the blending of these individual compounds into a proprietary mix is intellectual property that needs to be maintained and thus SCJ, Clorox and others will need to find that delicate balance between staying competitive in the marketplace and answering to the public call for transparency (i.e ingredient disclosure).  What is different about last week's move by SCJ is that it "represents the first attempt to disclose all fragrance ingredients on a product-by-product basis."  All parties will have to continue to work with the "fragrance houses" that supply the proprietary mixes and want to protect their intellectual property, which they have successfully done to date to provide all these disclosure data to the public.

 

 

USDA issues companion announcement regarding herbicide resistant management

Another post verbatim regarding today's regulatory announcement on Dow Agro's Enlist Duo. This one from USDA regarding herbicide resistant management. USDA will provide a well-informed and practical voice to the conversation surrounding stewardship plans and resistance management plans for these new tools being introduced to the farmer's toolbox. It great to see to the two agencies standing shoulder to shoulder on this very important issue. The USDA component is in great hands as the folks at the USDA Office of Pest Management Policy strive to take a practical yet protective approach to agricultural chemicals and their place in modern ag.

 

 

USDA Announces Measures to Help Farmers Diversify Weed Control Efforts

“WASHINGTON, Oct. 15, 2014 —Agriculture Secretary Tom Vilsack today announced several steps that the U.S. Department of Agriculture (USDA) is taking to address the increase of herbicide resistant weeds in U.S. agricultural systems.

“Weed control in major crops is almost entirely accomplished with herbicides today,” said Vilsack.  “USDA, working in collaboration with the Environmental Protection Agency, must continue to identify ways to encourage producers to adopt diverse tactics for weed management in addition to herbicide control.  The actions we are taking today are part of this effort.” 

Today USDA is announcing several of the steps it is taking to help farmers manage their herbicide resistant weed problems in a more holistic and sustainable way:  

USDA’s Natural Resource Conservation Service (NRCS) will offer financial assistance under its Environmental Quality Incentives Program (EQIP) for herbicide resistant weed control practices that utilize Integrated Pest Management plans and practices. 
 
Later this year NRCS will be soliciting proposals under the Conservation Innovation Grants (CIG) Program for innovative conservation systems that address herbicide resistant weeds.
 
USDA’s Animal and Plant Health Inspection Service (APHIS) will actively promote use of best management practices (BMPs) in design protocols for regulated authorized releases of genetically engineered (GE) crops and will include recommendations for BMPs with the authorization of field trials of HR crops.
 
USDA is partnering with the Weed Science Society of America (WSSA) and is providing funds to develop education and outreach materials for various stakeholders on managing herbicide–resistant weeds.  The Secretary has directed Dr. Sheryl Kunickis, Director of the USDA Office of Pest Management Policy, as the point person leading this effort with the USDA.
The issue of herbicide resistant weeds has become one of increasing importance for agriculture.  When herbicides are repeatedly used to control weeds, the weeds that survive herbicide treatment can multiply and spread. 

With EPA’s announcement today on the registration of new uses for herbicide mixtures containing the herbicides 2,4-D and glyphosate (in the Enlist® formulation) in conjunction with new genetically engineered crop varieties, farmers are being offered one more new tool to better manage emerging populations of herbicide-resistant weeds in corn and soybeans crops.  In its decision for 2,4-D use on genetically modified corn and soybean, EPA has outlined new requirements for registrants as part of a product stewardship program. 

The USDA Office of Pest Management Policy worked with EPA to address the issue of herbicide resistance through appropriate label language that will require registrants to develop a stewardship program for the herbicide, develop training and education on proper use of the product that includes diversifying weed management, investigate and report nonperformance, and develop and implement a remediation plan for suspected herbicide resistant weeds. 

EPA intends to require the same stewardship plans for all new applications for product registration on genetically modified crops with the goal being to encourage effective resistance management while maintaining needed flexibility for growers.

USDA recognizes that the problem of herbicide resistant weed control will not be solved solely through the application of new herbicides.  USDA has worked with the Weed Science Society of America for a number of years on identifying best management practices for farmers and on addressing impediments to adoption of those practices. 

USDA will continue to work to ensure that growers have the diverse tools they need to address the management of herbicide resistant weeds.

EPA Announces Final Decision to Register Enlist Duo, Herbicide Containing 2, 4-D and Glyphosate

This is taken verbatim from the EPA press release.  This has been a long time coming and evidently, is still not over yet.  EPA taking comments through November 14 as to whether or not to expand the use from the currently suggested 6 states to another 10 states.  This is odd, as the EPA can only allow the use of the new product in these additional states assuming it is able to perform the necessary ecological risk assessment work on endangered species in these states.  Comments from the public shouldn't impinge upon whether or not EPA has done the basic work to show the new use pattern on resistant crops is consistent with FIFRA's safety stamdard. If it hasn't done the basic work, then it is vulnerable to litigation.

 

EPA Announces Final Decision to Register Enlist Duo, Herbicide Containing 2, 4-D and Glyphosate

Risk assessment ensures protection of human health, including infants, children

WASHINGTON--The EPA is registering the herbicide, Enlist Duo with first-time ever restrictions to manage the problem of resistant weeds. The pesticide is for use in controlling weeds in corn and soybeans genetically-engineered (GE) to tolerate 2,4-D and glyphosate.  The agency’s decision reflects a large body of science and an understanding of the risk of pesticides to human health and the environment. 

The herbicides 2,4-D and glyphosate are two of the most widely used herbicides in the world for controlling weeds. Dozens of other countries including Canada, Mexico, Japan and 26 European Union Members have approved these pesticides for use on numerous crops and residential lawns. Last year, Canada approved the use of Enlist Duo for the same uses that EPA is authorizing.

EPA scientists used highly conservative and protective assumptions to evaluate human health and ecological risks for the new uses of 2,4-D in Enlist Duo. The assessments confirm that these uses meet the safety standards for pesticide registration and, as approved, will be protective of the public, agricultural workers, and non-target species, including endangered species. 

The agency evaluated the risks to all age groups, from infants to the elderly, and took into account exposures through food, water, pesticide drift, and as a result of use around homes. The decision meets the rigorous Food Quality Protection Act standard of "reasonable certainty of no harm" to human health. 

The approved formulation contains the choline salt of 2,4-D which is less prone to drift than the other forms of 2,4-D. The Agency has also put in place restrictions to avoid pesticide drift, including a 30-foot in-field “no spray” buffer zone around the application area, no pesticide application when the wind speed is over 15 mph, and only ground applications are permitted. This action provides an additional tool for the agricultural community to manage resistant weeds.

To ensure that weeds will not become resistant to 2,4-D and continue increased herbicide use, EPA is imposing a new, robust set of requirements on the registrant. These requirements include extensive surveying and reporting to EPA, grower education and remediation plans. The registration will expire in six years, allowing EPA to revisit the issue of resistance. In the future, the agency intends to apply this approach to weed resistance management for all existing and new herbicides used on herbicide tolerant crops.

This assessment is the third time in recent years that EPA has evaluated the safety of 2,4-D and the safety finding is consistent with past assessments that EPA has performed for 2,4-D. EPA comprehensively reviewed 2,4-D in 2005, and once more in 2012 and now again in 2014 in response to the current application.

EPA is registering the pesticide in six states:  Ill., Ind., Iowa, Ohio, SD., and Wis. The agency is accepting comments until Nov. 14, 2014 (30 days) on whether to register Enlist Duo in ten more states: Ark., Kan., La., Minn., Mo., Miss., Neb., Okla., Tenn., and ND.

PBPK Literature Visualization Project database now available

EPA has released an enormously useful tool to quickly find information regarding physiologically-based pharmacokinetic modeling (PBPK). The PBPK Literature Visualization Project has recently released a "second generation computational and informatics tools can be used to automatically organize and give rapid access to the body of PBPK modeling literature." The revised tool now houses about 3,000 references that address the toxicology, mode of action, etc. of many types of chemicals.  Take the revised tool for a test spin at http://pbpk.labworks.org.  You can learn more about the application of PBPK in risk assessment here.

 

EPA releases specifics of Drift Reduction Technology Program

EPA announced the release of the Drift Reduction Technology (DRT) Program in today's Federal Register.  EPA describes the DRT program as a "voluntary program based on this verification protocol to promote the use of technologies that have demonstrated their effectiveness in reducing the drift of agricultural pesticide spray application technologies." 

Under this program, equipment manufacturers would measure the the % drift that was reduced following use of certain technologies and then submit this study to the EPA for review.  These % reductions would be applied to the risk assessment for the pesticide product and will determine language than will then be placed in the final product label. Technologies that could be used to reduce drift include nozzle size, spray shields or even chemical adjuvants tank-mixed with the pesticide product.  A "star rating" will be applied to the label dependent on the amount of reduction demonstrated by the selected technology. For example, the maximum rating (4 stars) is achieved when one demonstrates 90+% reduction in spray drift.  

EPA intends to publicly post decisions made under the DRT on this web page (You may want to BOOKMARK this one!)  EPA claims that, eventually, one will be able to "search tables for DRT-rated technology for ground boom and aerial applications by manufacturer and system pressure (psi)."  

It is important to note that this is one component of an overall initiative by EPA to reduce spray drift from use of agricultural chemicals.  Earlier this year, two key guidance documents were issued for public comment, including a human health risk assessment policy document and
an updated method for estimating spray drift exposures. Also earlier this year, EPA made some "game changing" decisions regarding Dow Agro's Enlist Duo label (a formulation of 2,4-D and glyphosate intended for use on crops engineered to be resistant to both herbicides) when it comes to spray drift, including specific combinations of nozzle types and resultant droplet size that will be allowed to apply the product.  

The concept here is rather simple (increase droplet size to reduce the distance the chemicals travels from the site of application) yet requires massive amounts of information (air models, field deposition trials, wind tunnel studies) that could be misused in the developing EPA assessment procedures. Many smaller companies are likely to be put off by the combination of the data needed and the regulatory expertise needed to successfully get a sprayed pesticide on the market (or a new use).

 

 

NASA requests emergency exemption for novel pesticide

Here's something you don't see every day in the world of pesticide regulation: The National Aeronautics and Space Administration (NASA) has asked the EPA Office of Pesticide Programs for an emergency exemption from the federal pesticide law (FIFRA) to use the compound ortho-phthalaldehyde (OPA) to control the growth of "aerobic/microaerophilic water bacteria" in coolant water within several modules of the International Space Station.

Emergency exemptions are allowed under FIFRA Section 18 and EPA maintains a database of these emergency exemptions.  So far in 2014, over 100 emergency exemptions have been issued, mostly to deal with newer pests (like the use of bifenthrin and dinotefuran to control the Brown Marmorated Stink Bug) and/or to provide additional tools to deal with established pests (like the use of hop beta acids to control Varroa mite in honey bee hives).  Usually states are the requestors; however, other agencies will ask EPA for exemptions.  USDA commonly does this.

What is unique here, of course, is the request to approve a novel PESTICIDE (i.e. not yet registered with EPA) and the fact that EPA has allowed a mere 7 days for the public to comment on this action.  Emergency exemptions have a roughly 50-day time period, during which EPA will perform a risk assessment on the requested use (dietary, occupational, ecological and environmental risk assessment).  Novel pesticides pose a challenge her as they may not have data to feed into a risk model; however, in this case, OPA was approved by FDA in the 1990s for use as new disinfection & sterilization technique for medical devices. Given the closed environment in the Space Station, it is important to understand the toxicity to humans and, hopefully, this was done in the 50-day review process.

The comment period for this action is open until October 22. 

 

 

WOTUS rule comment period extended until November 14

The U.S. Environmental Protection Agency (EPA) and the U.S. Army Corps of Engineers (Corps) are extending the comment period for the proposed rule “Definition of `Waters of the United States' Under the Clean Water Act” published on April 21, 2014. 

Comments will now be taken until November 14. Visit docket EPA-HQ-OW-2011-0880 at www.regulations.gov to register your feedback.

Stan Meiburg to replace Bob Perciasepe as 2nd-in-command at EPA

The Hill is reporting that Stan Meiburg, who recently retired as deputy regional administrator for the EPA Region 4 office, replacing Acting Deputy Administrator Lisa Feldt.  Feldt worked for former Deputy Administrator Bob Perciasepe, who recently left EPA this past August to become President of the Center for Climate and Energy Solutions. (C2ES is the successor to the Pew Center on Global Climate Change.)

What makes this interesting is this quote from The Hill: "McCarthy did not say whether the White House would appoint Meiburg for the position, which would require Senate confirmation."  Is there another option McCarthy has to bring Meiburg back from retirement that doesn't need Congressional approval? Does the White House not want to see Meiburg caught up partisan bickering? <Magic 8 Ball says: "As I see it, yes.">

EPA's ChemView database now includes TSCA Consent Orders and SNURs

EPA issued a press release today describing changes made to its ChemView database, a "on stop shop" for information on chemicals regulated under the Toxic Substances Control Act. Today's press release outlines the "enhanced data functions [that] now include improved display and content," including links to information from the Toxics Release Inventory. To satisfy its desire for increased transparency, EPA has included TSCA Consent Orders and Significant New Use Rules in the ChemView database for the very first time. 

Regulatory tip of the day: Those companies who have been on the receiving end of a Consent Order and/or SNUR may want to check the accuracy of the info now found through ChemView.

Upcoming webinar on proposed changes to Worker Protection Standard for Agricultural Chemicals

I have teamed up with a company called AudioSolutionz to offer up an informative session on the proposed changes to Worker Protection Standard for Agricultural Chemicals.

Here's a summary of the 60-minute webinar scheduled for November 19, 2014 at 1 pm EST: 

The Environmental Protection Agency (EPA) has proposed changes to the agricultural Worker Protection Standard (WPS) to increase protections from pesticide exposure for agricultural workers. Proposed changes include increased frequency of mandatory trainings for farm workers, expanded mandatory posting of no-entry signs, minimum age requirement, and no-entry buffer areas surrounding pesticide-treated fields.

This presentation by Erik R. Janus will describe the recently proposed changes to the Worker Protection Standard (WPS) for Agricultural Pesticides, provide a critique of these changes and associated costs, and present the challenges and opportunities to industry with regard to compliance with and implementation of the revised WPS. In addition, it will provide helpful hints and resources to interact with the federal government during the rulemaking process.

This presentation will help you:

  • Identify the major revisions being proposed for the WPS for Agricultural Chemicals
  • Understand how the benefits described in the legislation are quantified
  • Identify some limitations of the technical and economic analysis in the proposed legislation
  • Have an increased awareness of the federal regulatory process
  • Have an increased awareness of how regulatory staff can interact with the government and others during the rulemaking process to effect positive change

Benefits of the session

  • Knowledge of proposed (and existing) legislation that impacts operations of agricultural companies and producers
  • Resources for understanding federal rulemaking
  • Resources to interact with the federal government during rulemaking
  • Tips and tools that companies (large and small) could use to enhance their regulatory affairs and compliance profile

Who should attend

  • Employees involved in compliance with US agricultural laws and regulations
  • Regulatory affairs
  • Compliance officers
  • Local and state government
  • Non-profit organizations concerned with federal agricultural policy and worker protection

 
Order Below or Call 1-800-223-8720 Today!

It’s getting harder and harder to use pesticides in California …

Conditions for pesticide use in California, already considered by industry to have the toughest operating conditions in the US, have just got that much tighter with additional restrictions to come.

First off, chlorpyrifos (CPF).  On September 26, officials at the California Department of Pesticide Regulation announced a proposal for public comment that would reclassify all products containing chlorpyrifos and used in agriculture as restricted use.  Restricted use pesticides are approved by the EPA and CDPR and as well as permitted by the county agricultural commissioner (who can impose additional, more stringent permit conditions).  According to CDPR, this proposal would entail about 30 currently sold products used on many dozens of crops of significant importance to California agriculture, such as walnuts (which are solely produced in California and worth over a billion dollars in exports in 2012).

The additional restrictions imposed by California come on top of a series of EPA pesticide policy changes over almost 15 years that have significantly reduced agricultural dependence on this organophosphate insecticide.  In the past, as EPA was determining the reregistration eligibility of CPF, residential & termiticide uses were eliminated, application rates for certain uses were reduced, and no-spray buffers around surface water bodies.   More recently, EPA reduced aerial application rates and imposed buffer zones for ground and aerial applications around “sensitive sites” (generally, occupied buildings or parks, etc.).  Finally, EPA issued a preliminary volatilization assessment in 2013 in response to a petition filed by the Natural Resources Defense Council (NRDC) and the Pesticide Action Network North America (PANNA), which requested that the agency ban all remaining uses of CPF.

There are more changes to come, most likely.  The legal actions brought by NRCD and PANNA continue.  For example, the groups filed a renewed petition for writ of mandamus the EPA on September 10 in an attempt to force EPA to make a final determination on a 2007 petition to revoke all tolerances and cancel all registrations.  The changes are also not restricted to active ingredients, but extend to certain pesticidal formulants as well.  CDPR recently announced that it would “likely not allow some pesticides that are high in Volatile Organic Compounds (VOCs) to be used in the San Joaquin Valley non-attainment area between May and October.”  The restrictions would be applied from May to October in both 2015 and 2016 and are needed in order to comply with the State Implementation Plan of the Clean Air Act (which specifies that DPR must publish an inventory of VOC emissions from pesticide use and achieve certain emission reductions). This spells yet more trouble for key California crops, such as tree nuts (almonds, walnuts), which are already prone to pest problems due to the continued drought.  Products that will be impacted could include abamectin (insecticide), CPF, gibberellins (plant growth regulator used in grapes) and oxyfluorfen (herbicide).

The proposal is out for public comment for 45 days, starting September 26. Find out more here.

EPA releases DDEF guidance for calculating uncertainty factors

EPA has released its "Guidance for Applying Quantitative 
Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies 
Extrapolation
” (DDEF Guidance). This guidance document describes methods for calculating interspecies and intraspecies uncertainty factors (UFs).  In the absence of chemical-specific data (such as toxicokinetic and/or toxicodynamic properties), default values for this variability are used which may be overly conservative.  This guidance now brings EPA methodology more in line with both the 2005 World Health Organization’s International Programme on Chemical Safety approach as well as a 2011 policy establishing "body weight scaling as the default method for the interspecies toxicokinetic extrapolation for orally encountered contaminants." 

Coalition of US House Reps sends (rather poorly researched) letter to EPA regarding neonics

On September 30, a group of 60 politicians sent a letter to EPA Administrator McCarthy, encouraging the Agency to follow the lead of the Fish & Wildlife Service (which cited a "precautionary approach" in its decision to prophylactically ban use of neonicotinoid insecticides on its lands) and providing a series of policy recommendations for EPA to "examine and consider." Unfortunately, this letter contains a number of inaccuracies and portrays an incomplete story.

The letter starts claiming commercial beekeepers in the US "experienced extremely high colony losses this past winter."  While it is true that managed honeybee overwintering losses have been very high since 2006 (and probably before that), the loss for 2013-2014 was ~ 22% (as compared to 2012-2013's 31% loss).  The reality is that last year's loss was much milder than the recent past.  These overwintering data are collected by the Bee Informed Partnership, which receives a majority of its funding from the National Institute of Food and Agriculture.  Native bumble bees have also "experienced sharp population declines at the national level" but this is not as well-studied as managed honey bee populations.

The letter goes on to attempt to associate the decline of the "iconic monarch butterfly" with the plight of the bees (in more than one spot).  Given that neonics are modern synthetic variants of previous nicotine compounds used as insecticides, it is reasonable to want to link declines in two insect species to an insecticide.  In both cases, however, a major reason for lack of these species thriving is lack of habitat.  In the case of the bees, lack of flowering habitat is the issue with some estimates of habitat loss as high as 87% over the last 20 years.  In the case of the Monarchs, it is lack of diverse habitat with sufficient milkweed that is the issue.  Insecticide use is unrelated to habitat loss for bees and butterflies.

The Congress cites the International Union for Conservation of Nature Task Force on Systemic Pesticides (identified incorrectly in the letter written by Congress) and the FWS decision as rationale for its assertions; however, the authors did not consider the findings and conclusions of the EPA and USDA. The Task Force's "official" IUCN page is here; however, much more information can be found the web site that the Task Force appears to have set up on its own.  In fact, the TF uses its own small communications company rather than use the IUCN staff and uses it web site to distribute the sill-incomplete series of reports called the Worldwide Integrated Assessment of the Impact of Systemic Pesticides on Biodiversity and Ecosystems (referred to in the letter).

EPA and USDA held a National Stakeholders Conference on Honey Bee Health in October 2012, which led to the release of a joint "comprehensive scientific report on honey bee health" in May 2013.  Here's some of the findings from that report:

  • "The parasitic Varroa mite is recognized as the major factor underlying colony loss in the U.S. and other countries."

  • "Nutrition has a major impact on individual bee and colony longevity. A nutrition-poor diet can make bees more susceptible to harm from disease and parasites...  Federal and state partners should consider actions affecting land management to maximize available nutritional forage to promote and enhance good bee health..." 

  • "There is a need for informed and coordinated communication between growers and beekeepers and effective collaboration between stakeholders on practices to protect bees from pesticides."

  • "The most pressing pesticide research questions relate to determining actual pesticide exposures and effects of pesticides to bees in the field and the potential for impacts on bee health and productivity of whole honey bee colonies."

he letter goes on to make some rather draconian policy suggestions, including suspension of the use of neonics on ornamental plants, rejecting applications for the use of "prophylactic insecticides," re-classify neonics as restricted use pesticides, and initiate consultations with the FWS (or National Marine Fisheries Service) under the Endangered Species Act for all registered neonics,  Finally, the letter make some policy suggestions that are of dubious origin, as they appear to be taken from recent NGO reports or are just incorrect.  For example, one policy suggestion involves phasing out conditional registrations - an option clearly allowed under FIFRA and well-documented by EPA, yet not to the liking of all stakeholders.  Another policy suggestion states that "[p]esticide seed treatments should be fully assessed ... [and] not exempted from federal pesticide regulations, as EPA currently allows."  This suggestion completely missed the fact checker unfortunately -- here's one example of a fee category to register a seed treatment pesticide at EPA.

While we should all be concerned with crashing bee populations (if substantiated), making expensive and labor-intensive policy decisions based on a selective and incomplete read of the scientific knowledge is probably not helpful in the long-run.