Comments Submitted on Evaluation of Existing Regulations

May 15, 2017

U.S. Environmental Protection Agency
Office of Regulatory Policy and Management
Office of Policy
Via:  http://www.regulations.gov

RE: Comments on Docket ID No. EPA–HQ–OA–2017–0190; Evaluation of Existing Regulations

The National Cotton Council (NCC) is the central organization of the United States cotton industry.  Its members include growers, ginners, cottonseed processors and merchandisers, merchants, cooperatives, warehousers and textile manufacturers.  A majority of the industry is concentrated in 17 cotton-producing states stretching from California to Virginia. U.S. cotton growers cultivate between 9 and 12 million acres of cotton with production averaging 12 to 18 million 480-lb bales annually. The downstream manufacturers of cotton apparel and home furnishings are located in virtually every state. Farms and businesses directly involved in the production, distribution and processing of cotton employ more than 125,000 workers and produce direct business revenue of more than $21 billion.  Annual cotton production is valued at more than $5.5 billion at the farm gate, the point at which the grower markets the crop.  Accounting for the ripple effect of cotton through the broader economy, direct and indirect employment surpasses 280,000 workers with economic activity of almost $100 billion. In addition to the cotton fiber, cottonseed products are used for livestock feed, and cottonseed oil is used as an ingredient in food products as well as being a premium cooking oil.

The NCC appreciates the opportunity to provide these comments and desires to work with EPA to facilitate a better understanding of our industry and to create workable solutions for a safer and healthier environment.

General Comments:

The safe protection of U.S. agricultural commodities is dependent upon EPA (Agency) regulation and registration procedures under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  The Office of Pesticide Programs (OPP) is one of the most beneficial of EPA offices and programs to agriculture, and in the past agriculture stakeholders could be assured that EPA would work to try to ensure a continued flow of safe products to help U.S. agriculture remain competitive in the production of safe and affordable food, fiber, and fuel.  In the past, OPP has used a risk-benefit regulation process in compliance with FIFRA, but in recent years there has been a growing shift away from statutory language requiring that process.   In the last several years, the EPA regulatory process has shifted toward a decision process that appeared to discourage new products from coming to the market by requiring additional needs justification and systematically eliminated proven chemistries.  Examples of issues created by this process shift include:

1. Lack of Consistency
   1. The Agency has moved toward accepting studies from other organizations that do not meet the same Good Laboratory Practices (GLP) required of registrants and that do not include the raw data necessary for independent evaluation by EPA and other stakeholders.  The Agency recently gave more weight to such a study even though the study’s summarized results were contrary to approximately 40 years of GLP, data-evaluated studies as mandated by the Agency.  That study, the Columbia University (CU) epidemiology (epi) study of Chlorpyrifos, an organophosphate (OP), implied a correlation, but did not demonstrate a “cause-effect,” and contradicted the known mode of action of Chlorpyrifos.  In addition, the Agency moved a step beyond the data boundaries to use the study to claim, with no supporting evidence, that similar correlations existed for all OPs.  The use of such epi studies greatly weakens the Agency’s reliance on credible scientific data.

2. It is understandable that the Agency has concerns that need to be addressed during pesticide registration reviews, however the Agency often dismisses scientifically credible registrant-submitted studies and then requests additional studies without developing the protocol necessary to produce Agency-acceptable data.  This confusing process raises the cost of product registration and greatly reduces the incentive for product development unless the product has global potential.  Potential products better suited for certain geographic areas or certain targeted pests but without global economic returns potential may either be forced to be developed for a broader than desired set of uses leading to higher risk of resistance development, or are unlikely to be pursued for development due to high regulatory costs with only limited market potential.

3. EPA has provided conflicting messages to growers.  For example, the Agency has lost message consistency in the regulatory process regarding pollinators.  On one hand, the Agency extols the virtues of pollinator habitat around field edges but on the other hand, the Agency tells growers to keep fields and margins free of weeds for the purpose of managing herbicide resistance.  In another example, the Agency continuously tells growers to utilize multiple modes of action to prevent resistance and then gives no credit to the value of modes of action when addressing Section 18 requests or registration review of pesticides, thereby forcing growers to rely on fewer modes of action.

2. Lack of transparency
   1. There are new label restrictions on 76 pesticides to protect pollinators.  This action was taken without any chemical-specific pollinator risk assessments being completed for those pesticides and without review or comment from registrants or growers.

2. We question Agency risk assessments based on EPA’s current calculation methods.   'Risk' is a function of (equals) 'Hazard' (toxicity) and 'Exposure' (known contact).  In its new pollinator risk assessment, the Agency has assumed full exposure and has substituted a new "calculation" that implies that Risk is a function of Hazard (toxicity of product) and Hazard (forced contact with product).  In other words, the Agency assumes absolute exposure without a legitimate exposure component that looks at probability of contact.  An example can be found in the recent Clothianidin and Thiamethoxam pollinator risk assessments where the data shows the total number of managed honey bee colonies in the U.S. is not sufficient to occupy the combined acreage of cotton, corn, and soybeans so there cannot be as much risk as the Agency assumed.  Even human risk assessments do not assume exposure is absolute.  The new Agency forced contact assumption may result in denying many growers needed crop protection products based on unsubstantiated claims of bee presence.

3. Based on the CU epi study the Agency buried a major shift in policy (i.e. to apply FQPA safety factors within individual organophosphate dockets) within the chlorpyrifos and other OP dockets, with no notification of the new policy to stakeholders.  Using a similar strategy, the Agency then released the draft pollinator risk assessments of two neonicotinoid insecticides (clothianidin and thiamethoxam) and noted in the release that the Agency had used a different methodology than the previous neonicotinoid release (imidacloprid) and was also taking comments on the new methodology.  Methodology should be understood and shared prior to use, and should not be an announcement imbedded within a risk assessment release.

4. Another example of the lack of transparency by EPA includes docket releases that mask numerous different products.  For example, the docket release announcing 22 Sulfonyl Urea pesticides included one Insect Growth Regulator and several OP pesticides.  Such announcements suggest the Agency desires to conceal certain products imbedded in the release.

3. Avoiding due process for registrants and stakeholders
   1. The Agency asked the Ninth Circuit Court to vacate a registration in lieu of established requirements for proposing label changes (Enlist Duo).

2. The Agency proposed revoking tolerances under the Federal Food, Drug and Cosmetic Act instead of cancellation under FIFRA where registrants and other stakeholders have clear process rights (chlorpyrifos).

3. Lack of EPA coordination with USDA Office of Pest Management Policy (EPA release of report claiming no economic benefit from soybean seed treatments).

4. Subtle but strong movements away from risk-based assessments and toward a hazard-based analysis
   1. The Agency is moving away from toxicology studies and toward epidemiology studies that had previously only been used as a basis for requiring additional studies or further investigation.  In at least one case (the CU epi study), this shift has been based on data that registrants and other stakeholders have not been allowed to review and that the Agency, per their own statement, does not have in their possession (chlorpyrifos).  The Agency would never grant such weight and leniency to registrants without data and multiple supporting third party verifications.

2. The Agency has proposed eliminating chemistries based on rudimentary and overly conservative drinking water models (chlorpyrifos).

3. The Agency is rejecting real sample data and is relying on overly conservative water model data (flubendiamide).

4. The Agency has created computer model simulations to assist in risk assessment.  Models are powerful tools to help identify areas of concern, but models contain many human assumptions and should not be viewed as absolute predictors.  For example, the Agency’s water model has repeatedly identified contamination while real world monitoring data contradicted the model results.  Unfortunately, the Agency dismisses real data in preference of the model assumptions.  A specific example can be found in the review of the chemical Terbufos, in which EPA’s water division initiated a water monitoring study that showed no detects.  The water division deemed Terbufos as a “chemical of no concern”.  However, OPP dismissed the monitoring data and used model estimates in order to refuse a Section 18 use of the material.

5. The Agency refuses to accept relevant studies conducted by multiple university scientists that demonstrate the in-field safety of neonic products with honey bee hives present, but gives substantial weight to force feeding studies with excessive doses that are not field equivalents.  These studies fail to include the nature of honey bees blending multiple food sources that further dilutes any potential toxicant and therefore exaggerates product effects.

5.  Litigation is reshaping the regulatory process with less emphasis on FIFRA
   1. Sulfoxaflor case: the court ignored benefits of the product and ruled solely on presumed risks.  The Agency did not defend the FIFRA process and its own scientists.

2. In a recent seed treatment litigation, plaintiffs asked the court to require EPA to regulate bags of seed if the seed had been treated with a pesticide, potentially duplicating the regulation of the pesticide applied to the seed as already required by law.

3. The Endangered Species Act (ESA) consultation process among EPA and the U.S. Fish and Wildlife Service/ National Marine Fisheries Service (the Services) has not yet been clarified due to conflicting statutes (FIFRA vs ESA).  The process is slowing down registration of products and repeatedly results in lawsuits.

4. Commodity groups are more frequently becoming engaged in litigation in order to emphasize agriculture’s needs and protect the ability of growers to continue to utilize crop protection products.

6. Unsustainable Conflict with ESA

The Agency has worked for multiple years with the Services in an attempt to meet the legal obligations for both.  However, the process is not working and continues to serve as a platform for legal action by activist groups.  The Tiered approach has developed Tier 1 and Tier II agreements, but the Tier III agreement– which is the most critical – has not been developed and threatens to delay registrations and provide for continual legal action against federal agencies.

7. Interpretation that “Resistance” is an adverse effect.

The Agency has recently announced intentions to begin implementing “Resistance Management” for all pesticide products, claiming authority under FIFRA as an “adverse effect.”  The action contains multiple concerns both from liability and interpretation issues under FIFRA.  Resistance can be viewed as survival of the fittest.  The extent to which a product is adopted increases selection for individuals already carrying the resistant gene.  Resistance management attempts to delay the rate at which that gene becomes prominent in a population, but does not claim “prevention”.  Resistance is a biological process, with some plants resistant prior to the introduction of the chemistry.  Further, resistance does not necessarily alter the risk-benefits analysis, because the analysis varies with which species developed the resistant population and whether that species is of significant economic concern.  Resistance management is an academic concept, greatly debated, and difficult to prove.  Resistance will develop…it is a matter of time and a function of fitness of resistant individuals.  Resistance management also varies by geographic areas in the country.  EPA is encouraged to re-evaluate its position on resistance management and to encourage state agencies and universities to expand the concept, education, and training appropriate for their state.  EPA is urged to review the history of the transgenic Bt trait in crops and the challenge with the limited pest species-focus for the trait.  The challenges included pest population variation in regions, unequal regulations within 5 miles of each other, the resulting confusion those unequal regulations caused, and the non-compliance due to the confusion.  And still, resistance developed.

Specific Comments:

Pesticide Registration-Reviews

1. Chlorpyrifos

1. The CU study was used to set regulatory endpoints up to 1,833-fold lower than current endpoints.  Data from the study was/is deemed to be privately owned by CU, therefore EPA stated they have not seen the data, and neither has the regulated community.  This lack of transparency has blocked the stakeholders from being able to assess or comment on the background data that EPA was recently basing their decisions on.  In addition, the EPA’s Science Advisory Panel refuted the study stating at one point that the study did not carry the merit for EPA to base regulatory decisions, but nevertheless, EPA used the study to institute an additional 10x safety factor on Chlorpyrifos.  The Agency then went further and used this study, meant only for Chlorpyrifos, to institute a 10x safety factor on all Ops.

2. EPA recently announced it would not revoke all tolerances for the product as petitioned, but would instead continue with the normal registration review process which should be final in a few years.  We appreciate EPA's decision to revert to the normal scientific process.

Request:  If the Agency plans to use the CU epi study for chlorpyrifos then EPA and stakeholders should be granted full access to the raw data, and have time to review it.  The results of EPA's review of the study should not be used for any pesticide products other than the one the study is based on.  Also, EPA should be reminded that the FIFRA statute is not a precautionary principle-based law.  EPA should release its own critique of the study, which notes multiple flaws and confounding factors comments, the same as it releases statements of concern raised by the study.

2. Malathion

1. Malathion is an OP that is being reviewed for a new label.  It now subject to the additional10x safety factor imposed by EPA due to the CU study with the comment period closed last December.

2. Malathion is of overriding importance to the Boll Weevil Eradication Program for the cotton industry.  It is the only viable insecticide used in the program.  The U.S. cotton industry in partnership with federal and state governments has made over $3 billion in investments in recent decades to successfully eradicate the boll weevil from nearly 100% of the Cotton Belt.  The NCC cannot stress enough to EPA that this product’s registration must be continued in its existing form to ensure continued control, ultimate eradication and the prevention of re-infestation from Mexico of the boll weevil in the future.  It is critically necessary to protect the tremendous financial investment made in the program and the positive environmental impacts resulting from the reduced number of pesticide applications where the Boll Weevil has been eradicated.

3. Malathion has a long standing history as one of the safest pest control options for multiple uses.  If not for the unprecedented move to impose a study with questionable conclusions and implications (specifically—no known cause to directly relate malathion to other OP’s), malathion would not have the new artificially inflated concern levels.

Request:  Keep the use of Malathion as is for the Boll Weevil Eradication Program.

3. Dicrotophos

Another OP that had an additional 10x safety factor applied.  Without this artificial inflation factor, which has no known direct linkage, there would be no concern.  The additional safety factor resulted in the Agency unilaterally proposing to ban aerial applications to reduce Agency-required buffer zones without seeking stakeholder input.  Other proposed restrictions include: ground applications may have as small as a 100-ft buffer; use rates will be drastically reduced; early season use will remain but with a reduced rate; and the field reentry restriction interval will be doubled to 28 days.

Request:  Remove the artificially imposed 10X safety factor.  Some of the proposed restrictions may render the product useless to the cotton industry.  EPA should seek stakeholder input to understand the ramifications of their proposals to determine if alternative, acceptable techniques can be agreed upon.  The CU epi study should not apply to this product.

4. Tribufos

Yet another OP that had an additional 10x safety factor applied.  The EPA risk model defaults to requiring a closed system & maximum Personal Protective Equipment (PPE), but with the additional 10x safety factor applied, the simulated risk is so great that even one drop is considered toxic.  Residential/bystander spray drift (under FQPA) requires 300 plus-ft buffer and droplet sizes and boom heights will be adjusted.  Use rates will be reduced by half, likely allowing only one use per season.

Request:  Remove the artificially imposed 10X safety factor.  Once again EPA should have consulted with the cotton industry before proposing restrictions that render the product ineffective.  The CU epi study should not apply to this product.

5. Sulfoxaflor

EPA stated “Sulfoxaflor is a sulfoximine, a new insecticide class, and is safer for bees and other pollinators. It works against pests that are becoming resistant to carbamate, neonicotinoid, organophosphate, and pyrethroid insecticides.”  Cotton was originally on the label and then withdrawn by court decree due to an alleged risk to bees.  EPA then stated there would be a Section 3 label that included cotton at lower use rates however, the October 2016 registration did not include cotton.

Request:  EPA should be able to defend their science successfully in court instead of continually suffering court defeats that delay and/or stop pesticide registrations and reviews.  EPA must add cotton use back to the label for Sulfoxaflor to ensure growers have access to all the tools necessary for crop protection, especially newer products such as this, to help prevent resistance.  EPA has been provided clear evidence of the benefit and need of this product for cotton pest control.

6. Neonicitinoids (neonics)

1. EPA has required pollinator risk assessments for all neonic products.  As part of the assessments, EPA has introduced a new methodology that has not been explained to industry or reviewed.  Also, EPA continues to use and defend a water model that suggests pesticide residues in water that far exceed actual monitoring data.

2. Why has the Agency introduced a new methodology and not let outside stakeholders review it?  Why does EPA continue to defend a water model that doesn’t reflect real-world results?   EPA needs to use sound science in its review process and ensure modeling results are consistent with real world data.

Request:  If the Agency insists on trying to use new methodology then EPA should allow the new methodology to be published for public comment and review prior to implementation into multiple assessments.  EPA should also have to explain why their model doesn't agree with sampling data and allow for review as well.  These actions should be completed before the risk assessments are allowed to move forward.

‘Waters of the US’ (WOTUS) Rule
(80 Fed. Reg. 37054, June 29, 2015; 40 CFR 230.3)

President Trump's February Executive Order (EO) 13778 directed the EPA to review the WOTUS rule and to publish a proposal rescinding or revising it.  There is no need to belabor the point that the cotton industry disagrees with the WOTUS rule and supports the Administration's efforts to correct this mistake.We support the President’s EO and urge EPA to pursue this effort aggressively.While the Agency is involved in the rewrite of the rule we must also urge that the Agency look at the overreach involved in the past several years by stretching the definitions of "normal farming practices" (§404(f) of the Clean Water Act 33 CFR 323.4) and "prior converted cropland"[33 CFR. 328.3(b)].

Request:  We recommend that the Agency repeal the existing rule (80 Fed. Reg. 37054) and, in a separate rulemaking, propose a revised rule that more closely adheres to the language of the Clean Water Act and Supreme Court decisions in Riverside Bayview, SWANCC and Rapanos.  We request that any new rule provides clarity and simplicity, and common sense to the regulated community.  Furthermore, we request that the Agency (and the U.S. Army Corp of Engineers) continue to adhere to the historic definitions for "normal farming practices" and "prior converted cropland".

Worker Protection Standards (WPS) rule (40 CFR 170)

In the September 2015 WPS rule, EPA included a provision that permits anyone claiming to be a ‘designated representative’ to gain access to a farmer’s proprietary records relating to pesticide use.  This provision provides farmers with no protection from fraudulent or counterfeit claims; violates the farmer's privacy and business confidentiality; does not assure that records released by the farmer will actually be shared with workers; and imposes no constraints on what the designated representative may do with documentation once it is obtained.  EPA has never cited any data or facts that demonstrate that such a provision would improve worker safety and the regulation imposes an unnecessary regulatory burden and cost, while exposing farmers to legal liability, with no discernible benefit.

 

No justifiable explanation identifies how the designated representative reduces potential worker exposure to pesticides, provides additional educational training of working around pesticides, or serves to decontaminate should exposure occur, which is the purpose for WPS.  The designated representative clause awkwardly stands out as having no measure to reduce the chance of pesticide exposure and should be eliminated from the Worker Protection Standards.

Request:  EPA should repeal 40 CFR 170.311(b)(9) and related provisions.

Oil Pollution Prevention; 40 CFR 112 Spill Prevention, Control, and Countermeasure (SPCC) Rule

SPCC regulates aboveground storage tanks of oils and fuels.   Originally written for the transportation and heavy industries, in the early 2000’s it was unwisely applied to agriculture.  After multiple iterations both regulatory and legislative, the latest version of the regulation is still not completed for agriculture.

Many growers and cotton ginners have attempted to comply, spending thousands to tens of thousands of dollars in compliance costs only to have the rule change repeatedly.

This rule is unjustified by the Agency’s own Regulatory Impact Analysis (RIA).  EPA examined the Clean Water Act violation data from 2001 to 2006.  In over 10,000 violations in that time period, only 292 involved oil spills of any type, and only one of those involved a farm.  EPA then moved to place a costly and burdensome rule on the agricultural industry with no data to show a risk justifying the cost.

Many other estimates in the RIA were incorrect as well. EPA estimated an approximate figure of 152,000 affected farms based on USDA numbers.  Nowhere did EPA mention the USDA numbers presented in the 2005 round of proposals that numbered potentially affected farms closer to 400,000.

EPA generated their estimates based in part on assumptions plugged into complex calculations.  One assumption, that 1997 and 2002 “total fuel expenditures by farms was identical” ignored the fact that farms sometimes used less fuel as prices increase, and that expenditures were not an appropriate indicator of volume of fuel used since prices fluctuate.

Another incorrect assumption is “that all gasoline and diesel storage is aboveground.”

EPA states, “The best federal source of on-farm fuel storage data is the 1982 U.S. Census of Agriculture...”.  That source, as represented in a chart, records approximately 1,124,000 million farms in 1982.  EPA then used a negative growth rate developed from 1996 to 2005 farm data to predict a medium estimate of only 151,000 SPCC-regulated farms.  However, the Agency then stated that 2002 data shows over 2 million farms storing fuel, based on the 2002 fuel oils expenditures multiplied by the ratio of diesel expenditure to total fuel oil expenditure in 1997.  EPA’s numbers do not add up and appear to underestimate the farming community that will be regulated by this rule.

EPA included other incorrect assumptions to bolster the cost-savings analysis.  They estimated a savings of $3.6 million due to exempting pesticide application equipment but that cost was only based on a report from one state.  They estimated $2,000+ savings from not regulating home heating oil tanks but those tanks were exempted in the original 1973 rule and no one has ever applied SPCC to those tanks anyway.

Request:  The SPCC regulation for agriculture has proved to be practically unenforceable, unwieldy, costly and thus needs to be repealed.

Conclusion:

First we thank EPA for their recent decision to continue with the registration-review process for Chlorpyrifos.   Second we also applaud the Agency's work so far on the repeal and replacement of WOTUS.  Lastly we also applaud EPA's most recent decisions not only to review the makeup of the Science Advisory Boards but also to delay the Certification and Training Rule so that the new administration may review it.

These comments represent only a part of the regulatory burden that has been placed on the U.S. cotton industry and the rest of agriculture.  As you can see, many of our issues deal with the potential loss of pesticide products used by the industry.  Even if cotton is kept on a pesticide label but such onerous restrictions are placed on its use that it is realistically impractical to use, then that product is lost as surely as if cotton had been removed from the label.  These issues can be addressed, and probably corrected acceptably to all involved, if the industry can work with EPA as a partner to address risk and policy-based issues as they arise.  This requires the Agency to act in a transparent and cooperative manner and to adhere to the requirements of FIFRA.  The cotton industry believes that we can continue to use many products in a safe and environmentally friendly manner if we are able to work with EPA up front to address the Agency's concerns in a cooperative manner.

Aside from pesticide issues, we must continue to work on regulations such as SPCC and WOTUS and WPS that create regulatory and resource burdens that are not balanced by commensurate environmental or health and safety protections.  We therefore ask the Agency to review our comments on these regulations as well.  The industry needs clarity and common sense in many environmental areas including air, water, pollution prevention, training and worker safety.

Thank you for opening the docket regarding current regulations and giving us the opportunity to offer comments.  If you have any questions, please don't hesitate to contact me at (202) 745-7805.

Respectfully submitted,                                         

Steve Hensley
Senior Scientist, Regulatory and Environmental Issues