 Introduction

EPA published a Notice of Intent to Delete the Jasco Chemical Corporation Superfund Site ("Jasco Site") in the Federal Register on May 26, 2020 (85 FR 31427). EPA published the notice to inform the public that EPA planned to delete the Jasco Site from the National Priorities List (NPL) and to provide a 30-day public comment period on the proposed deletion, which ended on June 25, 2020.

EPA received eight submissions each containing multiple comments opposing the deletion. These comments were carefully considered in EPA's final decision to delete the Jasco Site from the NPL.

One email contained several comments that are outside the scope of this deletion, including opinions about the U.S. President, EPA's Administrator, and fossil fuels. We do not consider these comments to be relevant or germane to this action and therefore we do not consider these comments as being against this action. Also, these comments do not address a specific regulation or provision in question or recommend a different action on the proposed deletion.
We are finalizing our action to delete as originally proposed, addressing all relevant comments contained within the eight submissions in the Responsiveness Summary below.
Thank you, commenters, for submitting comments and sharing your concerns with the agency.

 Responsiveness Summary

This Responsiveness Summary provides a response to all relevant comments submitted to EPA during a 30-day public comment period regarding the Notice of Intent to Delete the Jasco Site from the NPL (85 FR 31427). Original comments are available at http://www.regulations.gov, Docket ID No. EPA-HQ-SFUND-1989-0011, with the supporting materials under document type "Public Submissions." Comments have been summarized and paraphrased below and grouped with similar comments.

 Summary of Comments

Comment 1:
Why does the Jasco Superfund site need to be removed from the National Priorities List? Would it not be wise to leave the site under Superfund, allowing more oversight and funding?

Response 1:
EPA is proposing to delete the Jasco Site because it meets the official criteria for site deletion. The National Oil and Hazardous Substances Pollution Contingency Plan establishes criteria that EPA uses to delete sites from the NPL, at 40 CFR 300.425(e). To delete a site from the NPL, EPA must determine, in consultation with the state, that one of those criteria has been met. In consultation with the California Department of Toxic Substances Control (DTSC), EPA determined that the following criterion for delisting the Jasco Site has been met: the responsible party, Jasco Chemical Corporation (or "Jasco"), has implemented all appropriate response actions required for the Jasco Site.

This means that no further response action is necessary, and the Jasco Site is eligible for deletion.

EPA identified site deletions as a priority in its 2017 Superfund Task Force Recommendations. The Jasco Site was a clear candidate for delisting, as its 2012 Five-Year Review found that the remedy was protective of human health and the environment, concluding that the remedy had been successfully implemented and no waste was left in place at the Jasco Site.

Once a site is deleted from the NPL, the Comprehensive Environmental Response, Compensation, and Liability Act ("CERCLA" or Superfund) allows EPA to take future actions, as appropriate, to protect human health and the environment if future conditions require action. 42 USC 9605(e); 40 CFR § 300.425(e)(3). In addition:

 Deletion of the site from the NPL does not allow responsible parties to escape legal liability for future response actions at the Jasco Site that may become necessary to protect human health and the environment. 40 CFR § 300.425(b)(4).
 All releases of contamination from deleted NPL sites are eligible for further remedial actions if warranted. 40 CFR § 300.425(e)(3).
 In the event there is a significant release from the Jasco Site, EPA can restore it to the NPL without application of the hazard ranking system. 40 CFR § 300.425(e)(3).

In summary, deleting the Jasco Site from the NPL does not preclude regulatory oversight or cut off access to funding if additional response actions are needed at the Jasco Site in the future to protect human health and the environment.

Useful Documents
 EPA's 2011 Office of Solid Waste and Emergency Response Close Out Procedures for National Priorities List Sites guidance document.
 US EPA 2019 Final Close Out Report for the Jasco Chemical Company Superfund Site
 Remedial Action Completion Report
 US EPA 2012 Five-Year Review for the Jasco Chemical Corporation Superfund Site

Comment 2:
The site is still contaminated with perchloroethylene (PCE), which likely causes cancer in humans. Is EPA risking the health of future residents at the apartment complex being built at the Jasco Site by deleting the site from the NPL?

Response 2:
The Jasco Site, which is defined by the contamination that originated from the JASCO Chemical Corporation does not have any PCE contamination. However, an offsite PCE plume was discovered at the JASCO site around 1995. After rigorous study, EPA concluded that the plume did not originate from Jasco and was therefore not a part of the Jasco site or the Superfund cleanup process. This PCE plume is referred to as the Villa Street PCE plume.

Potential risks to future residents from the Villa Street PCE plume at the Jasco Site are being managed independently of the CERCLA or Superfund cleanup process.  A "Covenant and Environmental Restriction on Property" (or "deed restriction") on the Jasco property requires the California Regional Water Quality Control Board (RWQCB) and EPA to oversee the Jasco Site's future reuse and ensure soil and groundwater is managed according to a soil management plan that prevents any human exposure to PCE and other contaminants of concern.

Under the deed restriction, EPA and the RWQCB will:
 Ensure no wells are drilled at the site except for purposes of investigating or cleaning up contamination.
 Approve a soil management plan to ensure that people do not contact potentially contaminated soil, groundwater or dust at the site.
 Continue to sample site soil and groundwater, as it is transported offsite, to assure protection of human health and environment.
 Approve plans to install a vapor mitigation system under the building; and
 Oversee confirmatory pre-occupancy indoor air sampling to verify the efficacy of the system.
 The deed restriction's requirement to involve EPA and the RWQCB also applies to any future soil or groundwater disturbance.

Discussion of Potential Risks
When evaluating potential risks posed to human health by chemicals in the environment, it is important to understand the exposure pathway, or the way in which a chemical enters the human body from the environment. Exposure can come from breathing chemical vapors, accidental eating of contaminated soil, drinking contaminated water, or when a chemical passes through skin and reaches the blood stream.
There is no risk of drinking contaminated water originating from the Jasco Site or in the surrounding neighborhood because there are no groundwater supply wells near the Jasco Site. The City of Mountain View provides drinking water to homes in the Shoreline West neighborhood; most of this water comes from snowmelt in the Sierra Nevada Mountains and less than 2% is sourced from local groundwater wells not near the Jasco site.
There is also no risk of exposure from accidentally eating or breathing in dust generated from PCE-contaminated soil to PCE-contaminated soil at the Jasco Site because PCE was detected in only one isolated area in relatively low concentrations up to 16 mg/kg, or parts per million. Out of hundreds of soil samples collected between 1988 and 2000, only eight had results slightly above the Jasco Site's cleanup level of 7 mg/kg. The area where PCE was present in soil was excavated and treated onsite using bioremediation, a cleanup method that uses bacteria to break down harmful contaminants into less harmful ones. Sampling conducted after bioremediation confirmed that soil cleanup levels for the Jasco Site were reached. Additionally, excavation of the Jasco Site's soil for residential development is subject to a RWQCB-approved soil management plan, and only clean fill soil will be used near the surface.
Vapor intrusion occurs when chemicals in groundwater or soil vapor, or soil gas release gases that travel through the ground and enter homes through utility pathways or cracks and gaps in the building's foundation. Soil vapors may contain a mixture of gases that come from chemicals in groundwater and soil and remain in a gaseous state in between particles of soil. A human health risk assessment was conducted in 2003 using groundwater and soil vapor sampling data to assess the risks posed by the Villa Street PCE plume through the vapor intrusion exposure pathway to construction workers and future residents at the Jasco Site. The report concluded that risks posed were minimal and resulted in an increased cancer risk of less than one in one million using the best available science at the time. Nevertheless, EPA and the RWQCB required Jasco to record a deed restriction to ensure future construction workers and occupants of the property would not be harmed by vapor intrusion or by contact with contaminated groundwater. Due to the limits imposed by the deed restriction, the new apartment complex will have a waterproofing and vapor barrier installed beneath areas of the building that are in contact with soil and groundwater. This will protect the occupants of the building against vapor intrusion. The two-story garage under the building will be equipped with a ventilation system to prevent buildup of harmful gases inside the building and will serve as an added buffer. Confirmation samples of soil vapor, groundwater, and indoor air will be collected prior to the apartment complex being occupied to ensure future residents are protected.
The deed restriction includes a requirement that the developer must create and maintain an operations, maintenance, and monitoring plan as one of the vapor intrusion controls approved by the RWQCB and EPA under the deed restriction. This plan is based on an action level for PCE. If samples collected under the plan exceed the action level, the developer must take actions to reduce the level of PCE in indoor air, until PCE is reduced below the action level.
It is likely that the potential risks posed by the Villa Street PCE plume will be further reduced by construction currently underway at the Jasco Site. Construction plans, which were submitted under the deed restriction, call for the expected extraction and treatment of 200 million gallons of groundwater as well as the removal of around 62,000 cubic yards of soil (equal to about 6,200 dump trucks). These actions will likely reduce concentrations of PCE in soil vapor and groundwater at the Jasco Site.
Since construction began at the new apartment complex at 1710 Villa Street, additional sampling under the soil management plan required by the deed restriction has been done. Eleven soil boring profiles were drilled in October 2019, and soil samples were collected at depths of 1, 2, 5, 10, and 20 feet below grade from each boring and analyzed for a variety of different contaminants, including PCE.  Sampling results were well below the Regional Water Quality Control Board's Residential Environmental Screening Level of 80 ppb (parts per billion). Sampling of surface water runoff during stormwater events has taken place under a Stormwater Pollution Prevention Plan administered by the RWQCB. So far, all results have shown that no toxic chemicals are entering storm drains on the perimeter of the site and that the owner and developer, Prometheus Group is in compliance with the requirements of its Stormwater Pollution Prevention Plan. Additionally, groundwater that is pumped to the surface and treated with a water treatment system is sampled before it is discharged into the nearby Permanente Creek under a National Pollutant Discharge Elimination System permit administered by the RWQCB. To date, sampling results for the effluent discharged into Permanente Creek have shown that the treatment system is properly functioning and groundwater is being treated to levels safe to discharge into the environment.
Useful Documents
 2010 Covenant and Environmental Restriction on Property (or "deed restriction")
 2003 Human Health Risk Assessment
 For more information about the redevelopment of the Jasco Site and the protection of future residents, please see the Regional Water Quality Control Board's GeoTracker database: https://geotracker.waterboards.ca.gov/profile_report?global_id=T0608592706
 City of Mountain View Water Quality Report 2019 https://www.mountainview.gov/depts/pw/services/water/water_quality_report.asp
Comment 3:
Does the PCE plume threaten the health of other residents in the surrounding neighborhood?

Response 3:
As discussed in Response 2, there is no risk of drinking water contamination at the Jasco Site or in the neighborhood. There is also no risk of contact with contaminated soil from the Jasco Site, because there was limited soil contamination to begin with and it has been cleaned up. EPA has been unable to locate the source of the Villa Street PCE plume, so it is possible that some PCE-contaminated soil exists outside of the Jasco Site. EPA's investigations concluded that the most likely sources of the PCE contamination were in areas that have since been redeveloped.
The soil that is currently being excavated due to construction of the new apartment complex is being managed under a soil management plan required by the deed restriction, which ensures that people do not come into contact with contaminated soil. This includes preventive measures such as sampling soil prior to excavation to characterize it for proper disposal offsite and covering trucks carrying soil offsite. An environmental field representative with hazardous waste training is onsite to monitor conditions at the Jasco Site. A perimeter air monitoring program is in place to ensure that dust or toxic chemicals, including PCE, do not leave the Jasco Site through the air and impact the surrounding community.
More groundwater and soil vapor sampling is needed to better understand the current boundaries of the Villa Street PCE plume and the potential for PCE to move through the vapor intrusion exposure pathway. While EPA is confident that potential risks to future residents of redevelopment at the Jasco Site are being appropriately managed, EPA lacks information about the potential risk from the Villa Street PCE plume to residents on surrounding properties. The RWQCB has agreed to lead the investigation and oversight of the Villa Street PCE plume. EPA formally referred the Villa Street PCE plume to the RWQCB in a letter dated September 16[th], 2020. RWQCB will evaluate groundwater and soil vapor quality data to be collected after the construction activities are completed at the Jasco Site to better understand current site conditions. The RWQCB will direct a potentially responsible party (a former owner of 1350 Villa Street) to develop a workplan to investigate soil vapor and groundwater quality in the vicinity of 1350 Villa Street. This data will be used to determine if additional investigation or remedial actions are needed in respect to the Villa Street PCE plume. The RWQCB will be working on this investigation over the next year (2021) to assess the nature and extent of the Villa Street PCE plume.

Comment 4:
I do not believe deletion should occur until the new apartments, under construction at the site, are verified to have been designed and built to meet vapor intrusion mitigation requirements that would ensure the safety of future building occupants. I have asked the Water Board to a) develop a contingency plan if sampling during construction shows exceedances above remedial objectives; b) provide assurances that the ventilation in the parking garage will be adequate to prevent unacceptable PCE exposure and ensure mitigation systems for elevators and stairwells are designed to prevent preferential migration; and c) require that prospective residents be notified of the property's environmental history and response to date. EPA should not delete the site from the NPL before such actions are taken. Deletion now would be misleading to the public, particularly those who may choose to rent the apartments that are now under construction.
Response 4:
EPA and RWQCB agree that a contingency plan, adequate ventilation in the parking garage, blocking preferential vapor migration pathways and public notices to prospective residents are all important and we are using our authority under the deed restriction to ensure that these issues are addressed.  A preferential vapor migration pathway is an opening by which soil vapor can enter the apartment complex such as utility connections, elevator shafts and stairways.
Response to part a) contingency plan:
The RWQCB is requiring the owner and developer, Prometheus Group, to develop a contingency plan for remedial action if any indoor air samples are above the action level specified in the vapor intrusion mitigation system operations, maintenance, and monitoring plan. The RWQCB and EPA will review the contingency plan to make sure the proposed mitigation measures adequately address any potential levels of PCE in indoor air found at the new apartment complex. The vapor intrusion mitigation system has been designed so that it can be switched easily from passive to active mode if needed.
Response to part b) adequate ventilation in the parking garage and preventing preferential migration.
The deed restriction requires a vapor intrusion mitigation system to be installed. The developer submitted a proposal; EPA and RWQCB provided technical comments on it to address concerns of adequate ventilation in the parking garage and protection against preferential migration pathways such as elevator shafts, utility corridors and stairwells. RWQCB and EPA have not yet received a revised design report for the system but will make sure that these issues are addressed in the final design.
Response to part c) notice to prospective residents:
The deed restriction requires that the following notice must be contained in all purchase agreements or leases relating to the property:
   The land described herein contains hazardous materials in soils and in the groundwater under the property, and is subject to a Covenant and Environmental Restriction on Property dated as of February 24, 2010, and recorded on March 29, 2010, in the Official Records of Santa Clara County, California, as Document No. 20659469, which Covenant and Environmental Restriction imposes certain covenants, conditions, and restrictions on usage of the property described herein. This statement is not a declaration that a hazard exists.
Additionally, the deed restriction must be incorporated in and attached to all deeds and leases of any portion of the property. The developer and EPA are currently working together to draft additional language to be a part of all leases, which will include:
 A description of the vapor intrusion mitigation system
 Contacts for more information or to report problems with the mitigation system
 Websites where residents can find more information about the Jasco Site, including EPA's website: https://www.epa.gov/superfund/jascottps://cumulis.epa.gov/supercpad/cursites/csitinfo.cfm?id=0901126, and the RWQCB's GeoTracker database, https://geotracker.waterboards.ca.gov/profile_report?global_id=T0608592706.
Keeping the Jasco Site on the Superfund list because the Villa Street PCE plume exists would imply that EPA is using its Superfund authority to address the contaminated Villa Street PCE plume, which might mislead the public into thinking that EPA will investigate or address the Villa Street PCE plume. That is not the case; EPA is not using its Superfund authority to address the Villa Street PCE plume. Once EPA determined that the source of the plume was offsite, it required Jasco to record the deed restriction to address any potential exposure at the Jasco Site. In addition to the deed restriction, EPA worked with state agencies to determine which agency would be the appropriate regulatory lead to address the Villa Street PCE plume. In 2012, DTSC agreed to take responsibility for the Villa Street PCE plume, but DTSC did not complete any work. In 2020, the RWQCB agreed to take responsibility for investigation and oversight of the Villa Street PCE plume. The RWQCB is planning to review the results for post construction groundwater and soil vapor data that will be collected at the Jasco Site in order to determine if additional investigation or remedial actions are needed with respect to the Villa Street PCE plume. It is anticipated that such actions would be conducted by the current or previous landowners.
Comment 5:
According to the City of Mountain View, "An environmental deed restriction for the site requires the RWQCB and EPA to oversee its development and re-use. The agencies' oversight will ensure soil or groundwater is managed according to a soil management plan that prevents any human exposure to the chemical." As you know, a 226-unit apartment complex is being developed at this location, and we do not want to see future residents there, as well as current construction workers and nearby residents, put at any health risks that can be avoided through proper and complete application of the Superfund and Regional Water Quality Control Board (RWQCB) program.

Response 5:
This comment has been addressed primarily above, but EPA is concerned that the commenter may be under the impression that the deed restriction will expire with the Jasco Site's deletion. This is not the case. The deed restriction, titled Covenant and Environmental Restriction on Property, recorded March 29, 2010, will remain in place and continue to subject the property at 1710 Villa Street to restrictions on its use. As explained in EPA's 2012 Explanation of Significant Differences (ESD):
      "The deed restriction, though necessary and protective, is addressing a release that is not part of the site. Therefore, this ESD clarifies that the deed restriction is no longer a component of the CERCLA remedy for the Jasco Site."
Because the Covenant and Environmental Restriction on Property is not a component of the CERCLA remedy for the Jasco Site, it is not affected by the removal of the Jasco Site from the NPL. The deed restriction's terms apply to the land no matter who owns or occupies it, and the restriction must be incorporated into all deeds and leases of any portion of the property.
Specifically, the deed restriction:
 prohibits drilling of wells into and/or extraction of groundwater for any use other than remediation or monitoring.
 requires prior approval by the RWQCB and EPA before any use of the property results in:
 Any excavation of soil that is saturated with groundwater or is part of any aquifer or perched zone for any use other than remediation or monitoring;
 Use, removal, or modification of existing groundwater monitoring or extraction wells;
 Constructing any underground structure without engineering controls to adequately control buildup of vapors in occupied spaces and prevent intrusion of groundwater;
 Soil disturbance (excavating, grading, removal, trenching, filling, earthmoving, or mining).
The apartment complex being developed at this location is subject to these restrictions, and the RWQCB and EPA have reviewed and approved the developer's plans submitted thus far.
Comment 6:
Why didn't EPA clean up the PCE plume at the site? I do not believe deletion should occur until current sampling shows that the original remedial action objectives have been met. The most recent data shows unacceptable levels of PCE in the soil gas and groundwater. The conclusion that the PCE did not originate on site appears to have been first put forward by consultants for JASCO; it's possible, but I do not find the evidence persuasive. I consider corporate self-reporting unreliable, and in this case my organization received a report in the 1980s that someone from JASCO was conducting "midnight dumping." Regulators should also consider preferential pathways in evaluating potential sources of PCE contamination. No one has explained the extremely high levels of PCE in soil gas; in particular, the reported levels of groundwater contamination are not high enough to explain the presence of PCE in soil gas at 45,000 micrograms per cubic meter. I strongly oppose the claim that the contamination in this site is from an outside source therefore the site can be removed from NPL. This claim must be thoroughly investigated.

Response 6:
EPA did not address the Villa Street PCE plume because it determined that the plume did not originate at the Jasco Site. Under CERCLA, EPA does not hold parties responsible for contaminated groundwater under their site that originated elsewhere (discussed in more detail in the Response 8 below).
Confirmation sampling indicates that cleanup levels for all contaminants that originated from the Jasco Site in soil and groundwater were reached in 2002. Though Jasco met the cleanup goals for contaminants identified as coming from Jasco's operations, two volatile organic compounds, perchloroethylene (PCE) and trichloroethylene (TCE), remain in groundwater. After significant investigation, PCE and its breakdown compound TCE, were determined to be from an unknown offsite source, not Jasco. EPA completed a rigorous independent evaluation to confirm that the PCE plume under the Jasco Site did not originate from site activities at Jasco.
EPA's evaluation used the following data to conclude that the Villa Street PCE plume was not from Jasco:
 Jasco's contractor reports (or self-reporting) that PCE was not used at the Jasco Site;
 An analysis of more than 300 soil samples from 100+ different locations, 112 soil borings, 44 Hydropunch samples included in the revised PCE investigation report; and
 a close examination of groundwater quality reports.
   This data was also used to delineate the boundaries of the PCE plume and assess its origins.
   In 2011, EPA completed a Final Expert Technical Assistance Report. This report included a comprehensive review of hydrogeological groundwater monitoring, soil sampling data, and soil vapor data at the Jasco Site to confirm that Jasco was not responsible for the Villa Street PCE plume.
   Multiple lines of evidence support the conclusion that the Villa Street plume is not related to Jasco, including the following:
 Out of hundreds of soil samples and soil boring cores collected over decades, PCE was detected in only eight soil samples at relatively low concentrations, suggesting that no source of PCE existed at the Jasco Site.
 During the Remedial Investigation of the late 1980s, PCE was found in eight shallow surface soil samples in the drainage swale at the Northwest corner of the Jasco Site, which received runoff waste from several other properties. Concentrations ranged from 0.21 to 16 parts per million. These low concentrations in soil are not consistent with being a source for the much higher concentrations of PCE found in groundwater under other parts of the Jasco Site.
 Additionally, groundwater at the Jasco Site flows north, meaning that the drainage swale is downgradient of the PCE hotspot near monitoring well V-10A. It is not possible for the low levels of PCE found in soil in the drainage swale to have traveled against the prevailing direction of groundwater flow and have caused a much higher concentration of PCE in groundwater.
 PCE was first identified in groundwater near well V-4. After remediation started and groundwater was being pumped at the Jasco Site, PCE began to appear in high concentrations at well V-10A.
 Two distinct fingerprints have been observed through the history of groundwater monitoring at the Jasco site: Fingerprint A, with 1,1,1-TCA -- 1,1-DCA -- 1,1-DCE, which was observed primarily during the early remedial history of the site (mainly before 1998), with most contaminant concentrations decreasing through time; and Fingerprint B, with PCE -- TCE -- cis-1,2-DCE, which has been observed almost exclusively after 1995, with contaminant concentrations increasing at most locations over time. The two parent compounds (1,1,1-TCA and PCE) and their daughter products are not related by any degradation scheme, and these parent-daughter combinations of compounds are well established in the technical literature. The composition of each fingerprint, along with the differing temporal and spatial patterns, lends confidence to the idea that the two fingerprints represent separate contamination plumes and separate contamination sources. The PCE plume appears to have arrived later and from a contaminant source not on the Jasco site, based on the very extensive soil sampling performed at all potential on-site source areas.
 PCE was first detected in the Jasco Site's groundwater in 1995 after the groundwater cleanup was underway. Its distribution at the Jasco Site is not consistent with historic contaminant presence and distribution at the Jasco Site from known source areas.
 City of Mountain View Fire Department and Jasco records and correspondence
         indicate that PCE has not been stored, used, or distributed at the Jasco Site.
 The highest concentrations of PCE detected during the investigation were at locations
         on property to the east of the Jasco Site, and PCE has been detected at elevated
         levels at sampling points upgradient of the Jasco Site.
 The property immediately east of the Jasco facility had been previously occupied
         by companies whose industrial activities typically would have used solvents.
After EPA concluded that Jasco was not responsible for the Villa Street plume in 2012, EPA met with DTSC and the RWQCB to determine which agency should have oversight of the Villa Street PCE plume, and DTSC accepted responsibility for addressing it. See Explanation of Significant Differences at the Jasco Chemical Company Superfund Site, Appendix A (Sept. 26, 2012).

DTSC did not undertake any sampling or investigation efforts to address the Villa Street PCE plume. The RWQCB has now accepted responsibility for investigating the Villa Street PCE plume and EPA will work with the RWQCB to ensure that the RWQCB's investigation work continues.  See Response 7 below for details on how the RWQCB will address the Villa Street PCE plume in the future.

The most recent groundwater sampling data is from 2010 and the most recent soil vapor data was collected in 2002. Sampling results from these efforts revealed that PCE levels in groundwater ranged from 0.5-190 parts per billion (ppb), which were above the federal Maximum Contaminant Level of 5 ppb. As discussed in Response 2, groundwater at the Jasco Site is not used as drinking water source. Unlike groundwater, there is no Maximum Contaminant Level for PCE in soil vapor because the vapor intrusion exposure pathway is influenced by several variables that change for different exposure scenarios including the depth to groundwater, concentration of the contaminant in groundwater, the type of building, and indoor air ventilation systems. The highest recorded soil vapor concentration of 45,000 μg/m[3] near well V-10A, is consistent with soil vapor levels observed at other sites with comparable concentrations of PCE in groundwater. Because PCE is a volatile organic compound and has a large Henry's Constant, it is transported more easily from the liquid to the gaseous phase. Henry's Law is a law in chemistry that states that the amount of gas disolved in a liquid is proportional to the partial pressure of the gas above the liquid. A large Henry's Constant implies that a substance is not very soluble in a liquid, which means it is more likely to go into the gaseous phase. Under certain conditions, 1ppb of PCE can create a 500 ug/m[3] in soil vapor. While PCE naturally attenuates in groundwater, it does not degrade as easily in soil vapor, which explains why it is thought to have a 500-1000x multiplier effect in soil vapor as compared to groundwater. This explains the high concentrations of PCE in soil vapor relative to groundwater concentrations at the Jasco Site.
Useful Documents
 Final Expert Technical Assistance Report (2011)
 Explanation of Significant Differences (2012)
 Revised 2000 PCE Investigation Report
 ATSDR Toxic Substances Portal-Tetrachloroethylene (PCE)
https://www.atsdr.cdc.gov/phs/phs.asp?id=263&tid=48
 Letter referring Villa Street PCE Plume to DTSC (2012)
 The Jasco Site administrative record is available on EPA's website: https://cumulis.epa.gov/supercpad/SiteProfiles/index.cfm?fuseaction=second.ars&id=0901126&doc=Y&colid=65129&region=09&type=AR

Comment 7:
The site should continue to be on the NPL list until it meets acceptable health standards, and the source should be identified and appropriately dealt with. Some agency needs to take responsibility for cleaning up the remaining PCE, until this has been done, it should remain on the Superfund's National Priorities List. Nothing has been done by the California Department of Toxic Substances Control to identify an off-site responsible party or address the property as an orphan site.

Response 7:
The determination that the Villa Street PCE plume was from an offsite source not related to Jasco was carefully reviewed over a span of 12 years using data from hundreds of surface soil, soil boring, soil vapor, and groundwater samples and several historical records. Response 6 details why EPA concluded that the Villa Street PCE plume did not originate from activities at the Jasco Site.
EPA has determined that it is appropriate to proceed with the deletion because all response actions at the Jasco Site are complete and the criteria for deletion have been met. The decision to delete the Jasco Site from the NPL is not determined by the presence or absence of the Villa Street PCE plume, because the Villa Street PCE plume is not part of the Jasco Site. After careful consideration of the facts available to and gathered by the agency, EPA determined that the PCE plume was coming from offsite, and subsequently EPA discussed the situation with DTSC and the RWQCB to identify the most appropriate agency to regulate the offsite PCE plume. DTSC, in consultation with the RWQCB, identified itself as the appropriate regulatory agency, and in 2012, EPA formally referred the Villa Street PCE plume to DTSC for further investigation and oversight. DTSC does not have the resources to address the Villa Street PCE plume as an "orphan site." An orphan site is defined as a site without a responsible party to conduct or pay for the investigation or cleanup of the pollution.
Additionally, a deed restriction is in place to ensure that the Villa Street PCE plume does not pose a risk to future residents of the apartment complex currently under construction at the Jasco Site. Response 2 gives more details on the deed restriction and how it protects human health and the environment. The RWQCB and EPA are requiring additional sampling of PCE (and other contaminants) in groundwater, soil vapor, and indoor air after construction is completed, and before anyone occupies the new apartment complex. This sampling will inform our understanding of current Jasco Site conditions, the Villa Street PCE plume, and identify any potential risks to future residents.
EPA acknowledges that the current potential risk from the offsite Villa Street PCE plume to occupants of neighboring properties is unknown. After receiving comments on the proposed deletion of the Jasco Site indicating the public's concern that DTSC was not taking action, EPA met with DTSC to discuss the Villa Street PCE plume. DTSC has not addressed the Villa Street PCE plume since they agreed to take over the investigation in 2012. The RWQCB agreed to take over the investigation and oversight of the PCE plume and this decision was documented in a formal referral letter dated September 16, 2020. The RWQCB will evaluate groundwater and soil vapor quality data to be collected after the construction activities are completed at the Jasco Site to better understand current site conditions. The RWQCB will direct a potentially responsible party (a former owner of 1350 Villa Street) to develop a workplan to investigate soil vapor and groundwater quality in the vicinity of 1350 Villa Street. This data will be used to determine if additional investigation or remedial actions are needed in respect to the Villa Street PCE plume. The RWQCB will be working on its investigation over the next year (2021) to assess potential risks to human health and the environment associated with the Villa Street PCE plume.
Additionally, the State of California, through the appropriate state regulatory agencies including the RWQCB and/or DTSC, could request that US EPA evaluate the Villa Street Plume using the hazard ranking system to see if the Villa Street Plume would score high enough to qualify to be listed on the National Priorities List. The State of California has the discretion to request listing or otherwise seek assistance from EPA under its CERCLA authorities in the future if it determines it to be necessary. At that point, the Villa Street Plume would undergo an evaluation under the Superfund Site Assessment Process to see whether it qualifies to be added to the National Priorities List (Superfund List).
Useful Documents:
Final Expert Technical Assistance Report (2011)
Superfund Site Assessment Process
https://www.epa.gov/superfund/superfund-site-assessment-process

Comment 8:
The conclusion that PCE did not originate on site seems inconsistent with the Superfund principle of Strict, Joint, and Several Liability. If a party is responsible for any portion of a site's contamination, it can be held responsible for all of it. In other words, NPL listing is based upon the site and the hazard it poses, not the source. Why would EPA walk away from such a site?

Response 8:
Jasco was the owner and operator of the Jasco Chemical Corporation Superfund Site; this means that Jasco is liable for costs of cleanup of the Jasco Site under CERCLA at 42 USC 9607(a). The Villa Street PCE plume was contaminating the Jasco Site; therefore, the principle of strict, joint, and several liability would ordinarily apply to require Jasco pay for the cleanup of the Villa Street PCE plume. EPA has a longstanding policy, established in 1995, which states EPA's position towards owners of property containing contaminated aquifers. Under the policy, if contamination has spread to a property solely as the result of migration in groundwater from a source outside the property, EPA will not take enforcement action against the owner to require cleanup or payment for cleanup of the contaminated groundwater. Because Jasco's cleanup of its contamination in the groundwater was underway when PCE was first detected, and there was no evidence that Jasco had released PCE, EPA applied the principle behind the policy and did not require Jasco to clean up the Villa Street PCE plume.
Useful Document
 EPA's Final Policy Toward Owners of Property Containing Contaminated Aquifers (1995) https://www.epa.gov/sites/production/files/2013-09/documents/contamin-aqui-rpt.pdf.
Comment 9:
According to this notice all groundwater and soil monitoring was stopped in 2012. The site is under active development and a large amount of soil is being removed daily for the housing complex. It seems prudent to continue to do further monitoring, especially since the last time monitoring was performed there were indeed high levels of PCE and TCE found. No recent subsurface sampling has been conducted at the site. There needs to be current subsurface sampling at the mentioned site showing acceptable levels of tetrachloroethylene or perchloroethylene (PCE) in the soil gas and groundwater.

Response 9:
Groundwater was last monitored at the Jasco Site in 2010 and soil vapor was last sampled in 2002. However, the current owner collected subsurface soil samples in 2019, prior to excavation and grading at the construction site of the new apartment complex. Samples were collected at 11 locations at depths of 1, 2, 5, 10, and 20 feet below ground surface. PCE was not detected in any of these recent soil samples at levels above the California Regional Water Quality Control Board's residential environmental screening level.

It is likely that any potential risks posed by the Villa Street PCE plume will be further reduced by construction underway at the Jasco Site. The construction plans, which were required to be submitted under the deed restriction, call for the expected extraction and treatment of 200 million gallons of groundwater as well as the removal of around 62,000 cubic yards of soil. These actions will likely reduce concentrations of PCE in soil vapor and groundwater at the Jasco Site.
The deed restriction as outlined in Response 2 requires numerous protections to ensure that people do not contact contaminated soil or groundwater at the Jasco Site. As part of the Jasco Site's current redevelopment, groundwater is being pumped to the surface and treated with a portable water filtration system and discharged into surface waters under a permit issued by EPA (referred to in Response 2). Soil excavated during construction is sampled for proper offsite disposal. A perimeter dust and air monitoring program ensures that no dust or dust that might contain PCE leaves the Jasco Site boundary and impacts the surrounding neighborhood. Prior to the apartment complex being occupied, indoor air samples will be taken to confirm that there are no vapor intrusion issues at the Jasco Site. If the samples exceed the action level specified in the vapor intrusion mitigation system operations, maintenance, and monitoring plan, mitigation measures will be applied until the action level is met.
As discussed in the Responses 3 and 7, more recent groundwater and soil vapor data would be helpful in determining the current boundaries of the Villa Street PCE plume and its impact to the surrounding neighborhood. The RWQCB is planning to issue a letter requiring a potentially responsible party to submit a work plan to assess the nature and extent of PCE in soil vapor and groundwater associated with the Villa Street plume. However, more recent data is not needed to protect the health of future residents at the Jasco Site.
Comment 10:
The Notice of Intent to Delete was not written in simple and accessible language in accordance with the Plain Writing Act of 2010.

Response 10:
Thank you for bringing this matter to our attention. We used EPA's standard Federal Register notice templates for deleting sites from the NPL at https://www.epa.gov/superfund/superfund-npl-deletion-federal-register-templates. The rule-making process for NPL deletions is undergoing substantial changes at the present time and we will review and consider modification of this language in new future rulemakings in consultation with General Counsel and the Federal Register staff in the Office of Policy.
As a result of your comment, we made several improvements in this responsiveness summary. Specifically, we:
 Used simpler explanations
 Limited our use of acronyms
 Included a list of acronyms and defined terms used in the responsiveness summary (Appendix A)
We hope you will see and benefit from these changes in understanding our responses and commit to writing in plainer language in the future.

                                  Appendix A

Acronyms
DTSC 		California Department of Toxic Substances Control
CERCLA 	Comprehensive Environmental Response, Compensation, and Liability Act (Superfund)
EPA 		U.S. Environmental Protection Agency
NPL		National Priorities List
PCE 		Perchloroethylene
PPB		Parts per billion
RWQCB 	Regional Water Quality Control Board
TCE		trichloroethylene
Terms and Definitions
Aquifer - a body of permeable rock and/or soil that can contain or transport groundwater. Groundwater is not an underground lake, it is stored in between the individual particles of rock, gravel, sand, clay or soil.
Release -  Defined in CERCLA as "any spilling, leaking, pumping, pouring, emitting, emptying, discharging, injecting, escaping, leaching, dumping, or disposing into the environment (including the abandonment or discarding of barrels, containers, and other closed receptacles containing any hazardous substance or pollutant or contaminant)," subject to some exclusions not relevant for purposes of this responsiveness summary. 42 U.S.C. § 9601(22).

Remedy  -  Defined in CERCLA as "those actions consistent with permanent remedy taken instead of or in addition to removal actions in the event of a release or threatened release of a hazardous substance into the environment, to prevent or minimize the release of hazardous substances so that they do not migrate to cause substantial danger to present or future public health or welfare or the environment. The term includes, but is not limited to, such actions at the location of the release as storage, confinement, perimeter protection using dikes, trenches, or ditches, clay cover, neutralization, cleanup of released hazardous substances and associated contaminated materials, recycling or reuse, diversion, destruction, segregation of reactive wastes, dredging or excavations, repair or replacement of leaking containers, collection of leachate and runoff, onsite treatment or incineration, provision of alternative water supplies, and any monitoring reasonably required to assure that such actions protect the public health and welfare and the environment. The term includes the costs of permanent relocation of residents and businesses and community facilities where the President determines that, alone or in combination with other measures, such relocation is more cost-effective than and environmentally preferable to the transportation, storage, treatment, destruction, or secure disposition offsite of hazardous substances, or may otherwise be necessary to protect the public health or welfare; the term includes offsite transport and offsite storage, treatment, destruction, or secure disposition of hazardous substances and associated contaminated materials." 42 U.S.C. § 9601(24).

Soil Vapor or Vapor - Soil vapor consists of gases that come from chemicals in groundwater and soil and remain in a gaseous state in between particles of soil.

Vapor Intrusion - chemicals in groundwater or soil vapor release gases that travel through the ground and enter homes through utility corridors or cracks and gaps in the building's foundation.


[Federal Register: May 25, 2011 (Volume 76, Number 101)]
[Notices]
[Page 30342]
[DOCID:fr25my11-67]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. TS11-3-000]

Gulf South Pipeline Company, LP; Notice of Request for Waiver

    Take notice that on April 29, 2011, pursuant to section 358.1(d) of
the Commission's regulations, 18 CFR 358.1(d) (2010), Gulf South
Pipeline Company, LP (Gulf South) requests a waiver of part 358 of the
Commission's Regulations, Standards of Conduct for Transmission
Providers (Standards of Conduct) adopted by the Commission in Order No.
717.\1\
---------------------------------------------------------------------------

    \1\ Standards of Conduct for Transmission Providers, FERC Stats.
& Regs.  31,280 (2008) (Order No 717), order on reh'g, FERC
Stats. & Regs. ] 31,297 (2009) (Order No. 717-A, order on reh'g, 129
FERC ]61,123 (2009) (Order No. 717B), order on reh'g, 131 FERC
61,045 (Order No. 717-C (Order No. 717-D), order on reh'g,
135 FERC ] 61,017 (2011).
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    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.
    Intervention and Protest Date: 5 p.m. Eastern Time on Thursday,
June 2, 2011.

    Dated: May 19, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-12889 Filed 5-24-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Notices]
[Pages 56908-56909]
[FR Doc No: 2018-24849]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2018-0019]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of denials.

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SUMMARY: FMCSA announces its decision to deny applications from 77
individuals who requested an exemption from the vision standard in the
Federal Motor Carrier Safety Regulations (FMCSRs) to operate a CMV in
interstate commerce.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2018-0019, in the keyword box, and
click ``Search.'' Next, click the ``Open Docket Folder'' button and
choose the document to review. If you do not have access to the
internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9
a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    FMCSA received applications from 77 individuals who requested an
exemption from the vision standard in the FMCSRs. FMCSA has evaluated
the eligibility of these applicants and concluded that granting these
exemptions would not provide a level of safety that would be equivalent
to or greater than, the level of safety that would be obtained by
complying with the regulation 49 CFR 391.41(b)(10).

III. Basis for Exemption Determination

    Under 49 U.S.C.31136 (e) and 31315, FMCSA may grant an exemption if
it finds such an exemption would likely achieve a level of safety that
is equivalent to, or greater then, the level that would be achieved
absent such an exemption.
    The Agency's decision regarding these exemption applications is
based on the eligibility criteria, the terms and conditions for Federal
exemptions, and an individualized assessment of each applicant's
medical information provided by the applicant.

IV. Conclusion

    The Agency has determined that these applicants do not satisfy the
criteria eligibility or meet the terms and conditions of the Federal
exemption and granting these exemptions would not provide a level of
safety that would be equivalent to or greater than, the level of safety
that would be obtained by complying with the regulation 49 CFR
391.41(b)(10). Therefore, the 77 applicants in this notice have been
denied exemptions from the physical qualification standards in 49 CFR
391.41(b)(10).
    Each applicant has, prior to this notice, received a letter of
final disposition regarding his/her exemption request. Those decision
letters fully outlined the basis for the denial and constitute final
action by the Agency. This notice summarizes the Agency's recent
denials as required under 49 U.S.C. 31315(b)(4) by periodically
publishing names and reasons for denial.
    The following three applicants did not have sufficient driving
experience over the past three years under normal highway operating
conditions:

Sallie R. Brenner (TX); Kenneth R. Jordan (IL); and Jackie R. Karst
(MS)

    The following 36 applicants had no experience operating a CMV:

Scott A. Allnutt (KY)
Linas Brock (LA)
Landon M. Brown (CA)
Shaletta C. Buford (TN)
Jackueline D. Bullock (TX)
Peter K. Chege (MN)
Christopher J. Dantoni (PA)
Catherine Davis (IL)
Davidson Dorce (FL)
Jimi L. Engler (OH)
Kevin Ezell (CA)
Darrien W. Ferrell (IL)
Terrence H. Flick (IL)
Lonnie R. Gale (MD)
Liliana Gonzalez (IL)
Raheel Hameed (IL)
Jemminson R. Homesombath (CA)
Billy M. Lamb (MI)
Brian J. Loch (MN)
Eli Mast (ND)
Israel W. McAfee (VA)
Lamar P. Moore (IL)
Amanda M. Morse (IL)
Nicolas R. Motta (NC)
Bryan C. Pratt (PA)
Harold B. Rainwater (MO)
Ashley L. Reed (AR)
Keith G. Roberts (OH)
Sinisa Sabljic (NV)
Selemani A. Said (VA)
Joseph E. Saint Jean (NY)
Allen D. Sedwick (AR)
Ronald W. Smith (TX)
Ryan J. Smith (PA)
Kip R. Stringer (OR)
Jerred L. Thomas (OK)

    The following 11 applicants did not have three years of experience
driving a CMV on public highways with their vision deficiencies:

Bruce Banwell (IA)
Anthony C. Bears (MO)
Donald D. Brown (NC)
Ray E. Caldwell (WA)
Robert Evans (NH)
Harold J. Hughes (FL)
David E. Nelson (ID)
Perry E. Principi (MS)
Peter J. Urlacher (WA)

John A. Valusek (ND)
Owen W. Witmer (PA)

    The following eight applicants did not have three years of recent
experience driving a CMV on public highways with their vision
deficiencies:

Monte L. Albrecht (CO)
Gary J. Bouchard (ME)
Henry Darden (MD)
Mark P. Gilbert (MT)
Charles W. McClister (PA)
Jason J. Oaks (SD)
James L. Ross (TX)
Mark J. Simmer (MA)

    The following five applicants did not have sufficient driving
experience over the past three years under normal highway operating
conditions (gaps in driving record):

Robert J. Campbell (ND)
Timothy V. Compton (CA)
Jordan D. Mahoney (MN)
Gale L. O'Neil (PA)
Gary Peach (IN)

    The following applicant, Christopher T. Sides (ME), contributed to
accident(s) in which the applicant was operating a CMV, which is a
disqualifying offense.
    The following applicant, Keith Hauenstein (PA), did not have an
optometrist or ophthalmologist willing to make a statement that they
are able to operate a commercial vehicle from a vision standpoint.
    The following seven applicants were denied for multiple reasons:

McVay Chambers (LA)
Narciso L. Ferreira (ID)
Nicholas Piscitelli (NJ)
Louis J. Scheele (IN)
Terry A. Smith (IA)
James H. Ward (NC)
Dana J. York (PA)

    The following two applicants have not had stable vision for the
preceding three-year period:

Plynie A. Deen (GA); and Bret A. Herbolsheimer (WA)

    The following three applicants drove interstate while restricted to
intrastate driving:

Raul Alcalde (CA); Joseph N. Fulton (SC); and Heriberto R. Perez (TX)

    Issued on: November 5, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-24849 Filed 11-13-18; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 82, Number 230 (Friday, December 1, 2017)]
[Notices]
[Page 57015]
[FR Doc No: 2017-26103]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

FEDERAL REGISTER CITATION OF PREVIOUS ANNOUNCEMENT: 82 FR 56089,
November 27, 2017.

PREVIOUSLY ANNOUNCED TIME AND DATE OF THE MEETING: Friday, December 1,
2017.

CHANGES IN THE MEETING: The following matter will also be considered
during the 12 p.m. Closed Meeting scheduled for Friday, December 1,
2017: Formal orders of investigation.

CONTACT PERSON FOR MORE INFORMATION: For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact the Office of the Secretary at<PHONE_NUMBER>.

    Dated: November 29, 2017.
Brent J. Fields,
Secretary.
[FR Doc. 2017-26103 Filed 11-29-17; 4:15 pm]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 131 (Monday, July 9, 2018)]
[Notices]
[Pages 31760-31762]
[FR Doc No: 2018-14537]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0545]

Revised Recommendations for Reducing the Risk of Zika Virus
Transmission by Blood and Blood Components; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Revised
Recommendations for Reducing the Risk of Zika Virus Transmission by
Blood and Blood Components; Guidance for Industry.'' The guidance
document provides blood establishments that collect Whole Blood and
blood components with revised recommendations to reduce the risk of
transmission of Zika virus (ZIKV) by blood and blood components. The
guidance does not apply to the collection of Source Plasma. The
guidance announced in this notice supersedes the document of the same
title dated August 2016 (August 2016 Guidance).

DATES: The announcement of the guidance is published in the Federal
Register on July 9, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted,

such as medical information, your or anyone else's Social Security
number, or confidential business information, such as a manufacturing
process. Please note that if you include your name, contact
information, or other information that identifies you in the body of
your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-0545 for ``Revised Recommendations for Reducing the Risk of
Zika Virus Transmission by Blood and Blood Components; Guidance for
Industry.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled ``Revised
Recommendations for Reducing the Risk of Zika Virus Transmission by
Blood and Blood Components; Guidance for Industry.'' The guidance
provides blood establishments that collect Whole Blood and blood
components with revised recommendations to reduce the risk of
transmission of ZIKV by blood and blood components. The guidance does
not apply to the collection of Source Plasma. This guidance supersedes
the August 2016 Guidance.
    In the August 2016 Guidance, FDA recognized ZIKV as a relevant
transfusion-transmitted infection under 21 CFR 630.3(h) and recommended
universal individual donation nucleic acid testing (ID NAT) for ZIKV or
the use of an FDA-approved pathogen reduction device. Since 2016, the
number of ZIKV disease cases in the U.S. States and territories has
decreased considerably. In addition, FDA has licensed a nucleic acid
screening test(s) for the detection of ZIKV in individual or pooled
samples. Considering the changing epidemiology of ZIKV in the United
States and the availability of licensed screening tests, FDA is
revising the recommendations contained in the August 2016 Guidance. In
this guidance FDA explains that, in order to comply with the testing
requirements in 21 CFR 610.40(a)(3), blood establishments must test all
donations collected in the United States and its territories with a
licensed nucleic acid test for ZIKV, using either ID NAT or minipool
(MP) NAT. The guidance explains the basis for FDA's determination that
universal MP NAT screening, with certain conditions identified to
trigger ID NAT when local mosquito-borne ZIKV transmission is presumed
in a collection area, provides an adequate and appropriate safeguard
against the current and future risk of ZIKV transmission through blood
transfusion. Alternatively, blood establishments can use an FDA-
approved pathogen reduction device. The revised recommendations are
less burdensome for blood establishments because fewer tests will be
performed when donations are tested by MP NAT compared to ID NAT.
However, the recommendations are consistent with public health
considering the changing course of the ZIKV epidemic in the United
States and the sensitivity of the licensed test(s) to detect ZIKV in
blood donation.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). FDA is issuing this guidance for
immediate implementation in accordance with 21 CFR 10.115(g)(2) without
initially seeking prior comment because the Agency has determined that
prior public participation is not feasible or appropriate.
Specifically, we are not seeking comments because the guidance presents
a less burdensome policy for reducing the risk of transfusion-
transmitted ZIKV that is consistent with public health. The guidance
represents the current thinking of FDA on recommendations for reducing
the risk of Zika virus transmission by blood and blood components. It
does not establish

any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR parts 601 and 640, and Form FDA
356h have been approved under OMB control number 0910-0338; and the
collections of information in 21 CFR parts 606 and 630 have been
approved under OMB control number 0910-0116.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: June 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14537 Filed 7-6-18; 8:45 am]
 BILLING CODE 4164-01-P


FILE NAME:   62719.wpt   (12/29/2005) (xml)

Template Number P25

ATTENTION:

All commodity terms must comply with the Food and Feed Commodity
Vocabulary database (http://www.epa.gov/pesticides/foodfeed/).

All text in blue font (instructions for preparing the document), should
be removed prior to sending the document to the Federal Register Staff.
Instructional text and prompts in green font should also be removed.

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

(1/1/2005)

EPA Registration Division contact: [James A. Tompkins<PHONE_NUMBER>]

TEMPLATE:

[Glyphosate dimethylammonium salt or dimethylamine (DMA) salt of
–(phosphonomethyl)glycine]  to the existing list of tolerances
established  for residues of glyphosate (n-phosphomethyl)glycine)
resulting from the application of glyphosate, the isopropylamine salt of
glyphosate, the ethanolamine salt of glyphosate, the ammonium salt of
glyphosate and the potassium of glyphosate in or on the currently EPA
approved  raw agricultural commodities as listed in 40 CFR part 180.364.
 EPA has determined that the petition contains data or information
regarding the elements set forth in section 408(d)(2) of the FFDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the petition.
 Additional data may be needed before EPA rules on the petition.

. [Adequate enforcement methods are  available for analysis of residues
of glyphosate in or on plant commodities.  These methods include gas
liquid chromathography (GLC) (Method I in Pesticides Analytical Manual
(PAM) II; the limit of detection is 0.05 ppm) and High Performance
Liquid Chromatography (HPLC) with fluorometric detection. The HPLC
procedure has undergone successful Agency validation, and was
recommended for inclusion in PAM II. A gas chromatography/mass
spectrometry (GC/MS) method for glyphosate crops has also been validated
by EPA’s Analytical Chemistry Laboratory (ACL).  The proposed revision
in the tolerance regulation does not change the residue to be analyzed,
which remains as glyphosate per se.]

. [Adequate data concerning glyphosate residues on RACs has previously
been submitted to the Agency.  Accordingly, the available residue data
for glyphosate support the proposed revision of the tolerance expression
for glyphosate.  As noted above, the proposed revision will permit
glyphosate residues from the application of glyphosate in the form of
its dimethylammonium salt.   In addition, any secondary residues
occurring in liver or kidney of cattle, goats, horses  and sheep,
meat-by-products of poultry and eggs, will be covered by existing
tolerances.  Any residues occurring in harvestable aquatic species will
be covered by existing glyphosate tolerances for fish and shellfish.]

.  [EPA has previously evaluated the available toxicity data and
considered its validity, completeness and reliability, as well as the
relationship of the results of the studies to human risk.  EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.

The table below compares the acute toxicity results of glyphosate
(–phosphonomethyl glycine) against toxicity results of glyphosate DMA
salt as in GF-1667, demonstrating the lower toxicity of the glyphosate
DMA salt.

	Glyphosate

GF-1667 Glyphosate DMA Salt

Test

Result

Category

Result

Category

Acute Oral (Rat)

Technical: > 4320 mg/kg

III

> 5000 mg/kg

IV

Acute Dermal (rabbit)

Technical: > 2 g/kg

III

(Rats) > 5000 mg/kg

IV

Acute Inhalation

Technical: Not required

N/A

(4 hr) LC50 > 5.21 mg/L

IV

Eye Irritation

MP: mid irritation, clear in 7 days

III

slight iritis and conjunctival irritation, cleared < 72 hr

III

Dermal Irritation

MP: Slight irritation

IV

Irritation cleared < 48 hr

III

Skin Sensitization

MP: negative

N/A

Negative

N/A

MP: Manufacturing Products .]

.  [In vitro rec-assay with B. Subtilis H17 (rec+) and M45 (rec-) and
reverse mutation assay using E. Coli WP2 hcr and S. Typhimurium strains:
 There was no evidence of genotoxicity up to the limit dose or
cytotoxicity in the presence or absence of metabolic activation.

In vitro reverse gene mutation assay in S. Typhimurium bacteria:  There
was no evidence of induced mutant colonies over background in Salmonella
strains TA 98, TA 100, TA 1535, and TA 1537 both in the presence and
absence of metabolic activation, at doses up to cytoxic levels or the
limit dose.

In vitro gene mutation assay in Chinese hamster ovary cells/HGPRT:
There was no evidence of genotoxicity up to cytotoxic levels in the
presence or absence of metabolic activation.

Bone marrow chromosome aberrations assay:   There was no significant
increase in the frequency of chromosome aberrations in bone marrow at
the limit dose of 1,000 mg/kg in both sexes of Sprague-Dawley rats.]

.  [i.  Prenatal developmental toxicity in rats:

Maternal NOAEL = 1,000 mg/kg/day day based on mortality, LOAEL = 3,000
mg/kg/day based on mortality, increased clinical signs, and reduced body
weight gain. Developmental NOAEL = 1,000 mg/kg/day based on decreases in
total implantations/dam and nonviable fetuses /dam, increased number of
litters and fetuses with unossified sternebrae, and decreased fetal body
weight.

ii.  Prenatal developmental toxicity in rabbits:  Maternal NOAEL = 175
mg/kg/day, LOAEL = 350 mg/kg/day based on mortality, and clinical signs.
 Developmental NOAEL = 175 mg/kg/day, LOAEL = 350 mg/kg/day
(insufficient litters available to assess developmental toxicity).

[i.  90-Day oral study toxicity in rats:  NOAEL less than 50 milligrams
(mg) / kilogram (kg) / day for both sexes.  LOAEL = 50 mg/kg/day based
on increased phosphorus and potassium in both sexes

ii.  90-Day oral toxicity in mice:  NOAEL = 1,500 mg/kg/day in both
sexes LOAEL = 7,500 mg/kg/day in both sexes based on decreased body
weight gain in both sexes.

iii.  28-day dermal study 21/28-Day dermal toxicity in rabbits:  NOAEL =
1,000 mg/kg/day for males and 5,000 mg/kg/day for females.  LOAEL =
5,000 mg/kg/day in males based on decreased food consumption .]

. [i. Chronic toxicity in dogs: NOAEL= 500 mg/kg/day highest does
tested).   LOAEL greater than 500 mg/kg/day.

ii.  Combined Chronic Toxicity/Carinogenicity in rats:  NOAEL = 362
mg/kg/day in males and 457 mg/kg/day in females.  LOAEL = 940 mg/kg/day
in males and 1,183 mg/kg/day in females based on decreased weight gain
in females, and increased incidence of cataracts and lens abnormalities,
decreased urinary pH, increased absolute liver weight, and increased
relative liver weight/brain weight in males.  There was no evidence of
carcinogenicity.

. [Metabolism in rats:  Following a single oral dose, 30-36% was
absorbed and less than 0,27% was eliminated as CO2.  Urine and feces
contained 97.5% as parent. Aminomethylphosphonic acid (AMPA) was only
metabolite found at 0.2-0.3% of administered dose. Less than 1.0% of the
absorbed dose remained in tissues and organs, primarily in the bone.]

.  [The EPA does not consider AMPA a metabolite of concern, and is not
included in the risk assessment.  AMPA is slightly hazardous to rats
given a single oral dose, with an LD50 of 8300 mg/kg of body weight
(WHO, 1996).  In a 90-day study of toxicity in rats receiving AMPA, the
NOAEL was 400 mg/kg of body weight per day.  In a 90-day study of
toxicity in dogs receiving AMPA, the NOAEL was 300 mg/kg of body weight
per day.  No indication of genotoxic activity was seen in studies of
gene mutation in bacteria, of DNA repair in bacteria and mammalian cells
in vitro or of micronucleus formation in vivo.  No assays for gene
mutation were performed in mammalian cells in vitro, but the structural
similarity of AMPA to glyphosate and the lack of genotoxicity of
glyphosate, including in an assay for gene mutation in mammalian cells
in vitro, indicate that such an assay with AMPA would be redundant.

The NOAEL for developmental toxicity was 400 mg/kg of body weight per
day.  AMPA did not induce dermal or ocular irritation in rabbits.  No
long-term study of the toxicity or carcinogenicity of AMPA has been
carried out, but in the more recent of two such studies with
technical-grade glyphosate in rats at dietary levels of 0.2, 0.8 or 2%,
the AMPA content of the test compound was given, namely 0.68%. The NOAEL
for technical-grade glyphosate was 0.8% in the diet, corresponding to
400 mg/kg of body weight per day for glyphosate and 2.7 mg/kg of body
weight per day for AMPA.  No increase in tumour incidence was seen in
this study.  No multigeneration study of the reproductive toxicity of
AMPA has been reported, but in a recent two-generation study in rats
with technical-grade glyphosate at dietary levels of 0.2, 1 or 3%, the
test compound contained 0.61% AMPA. The NOAEL was 1% in the diet,
corresponding to 740 mg of glyphosate per kg of body weight per day, and
4.5 mg of AMPA per kg of body weight per day.

1 This section was taken and edited from FAO/WHO (1998).]

.  [The above studies  measure numerous endpoints with sufficient
sensitivity to detect potential endocrine-modulating activity.  No
effects have been identified in subchronic, chronic or developmental
toxicity or multi-generation reproduction studies to indicate any
endocrine-modulating activity by glyphosate.  In addition, adverse
effects were not  seen when glyphosate was tested in a dominant-lethal
mutation assay.  While this assay was designed as a genetic toxicity
test, agents that can affect male reproduction function will also cause
effects in this assay.]

.  [Food and feed uses:  Tolerances have been established (40CFR
180.364) for the residues in (N-phosphonomethyl) glycine resulting from
the application of the isopropylamine salt of glyphosate, the ammonium
salt of glyphosate and/or the ethanolamine salt of glyphosate  in or on
a variety of food commodities.  The petitioner proposes to add the
glyphosate dimethylammonium salt to this list of acceptable salt forms
to which the tolerances apply. This amendment will not change the
dietary exposure assessment because the magnitude of the tolerances are
unchanged, and present dietary exposure estimates have already included
the worst-case assumption of tolerance level residues and that 100% of
the crop has been treated.]

.  [Risk assessments were conducted by EPA to assess dietary exposure
from glyphosate in food as follows:

a.  Acute dietary exposure: Acute dietary risk assessments are performed
for the food-use pesticide if a toxicological study has indicated that
the possibility of an effect of concern occurring as a result of a 1 day
or single exposure. An acute dietary endpoint and dose were not
identified for glyphosate.  A review of the rat and rabbit developmental
studies did not provide a dose or endpoint that could be used for acute
dietary risk purposes.  Additionally, there are no data requirements for
acute and subchronic rat neurotoxicity studies, since there was no
evidence of neurotoxicity in any of the toxicology studies at very high
doses and glyphosate lacks a leaving group.

b.  Chronic dietary exposure.  In conducting this chronic dietary risk
assessment, the Dietary Exposure Evaluation Model (DEEM) analysis
evaluated the individual food consumption, as reported by respondents in
the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments:  The chronic dietary exposure analysis was conducted using
the reference dose (RfD) of 2.0 mg/kg/day.  The RfD is based on the
maternal NOAEL of 175 mg/kg/day from a developmental study and an
uncertainty factor of 100 (applicable to all population subgroups). The
DEEM analysis assumed tolerance level residues and 100% of the crop
treated in/on all commodities with an existing or proposed glyphosate
tolerance. These assumptions resulted in the following theoretical
maximum residue contributions (TMRC) and percentage RfDs for certain
population subgroups. The TMRC for the U.S. population (48 contiguous
States) was 0.033727 mg/kg/day or 1.7% of the RfD, 0.029752 mg/kg/day or
1.5% of the RfD for nursing infants (less than 1 year old);  0.094859
mg/kg/day or 4.7% of the RfD for non-nursing infants (less than 1 year
old);  0.072062 mg/kg/day or 3/6% of the RfD of children (1-6 years
old);  0.047815 mg/kg/day or 2.4% of the RfD for children (7-12 years
old);  0.034216 mg/kg/day or 1.7% of the RfD for females (13+/nursing);
0.033234 mg/kg/day or 1.6% of the RfD for non-Hispanic whites; and
0.035141 mg/kg/day or 1.7% of the RfD for non-Hispanic blacks.

.   The available field and laboratory data indicate that glyphosate
absorbs strongly to soil and would not be expected to move vertically
below the 6 inch soil layer.  Based on non-aged batch equilibrium
studies, glyphosate and glyphosate residues are expected to be immobile
with Kd (ads) values ranging from 62 to 175. The mechanism of absorption
is unclear; however, it is speculated that it may be associated with
vacant phosphate sorption sites or high levels of metallic soil cations.
 The data indicate that chemical and photochemical decomposition is not
a significant pathway of degradation of glyphosate in soil and water.
However, glyphosate is readily degraded by soil microbes to AMPA, which
is degraded to CO2, although at a slower rate than parent glyphosate.
Because the glyphosate anion and the potassium cation will be completely
dissociated in environmental media, the proposed use of potassium
glyphosate solutions will not change the environmental properties of
glyphosate.

The Agency lacks sufficient monitoring exposure data to complete a
comprehensive dietary exposure analysis and risk assessment for
glyphosate in drinking water. Because the Agency does not have
comprehensive monitoring data, drinking water concentration estimates
are made by reliance on simulation or modeling taking into account data
on the physical characteristics of glyphosate.

The Agency uses the Generic Expected Environmental Concentration
(GENEEC) or the Pesticide Rood Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water, and
the Screening Concentration and Ground Water (SCI-GROW) model, which
predicts pesticide concentrations in ground water.  In general,  EPA
will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2
model) for a screening-level assessment for surface water. The GENEEC
model is a subset of the PRZM/EXAMS model that uses a specific high-end
runoff scenario for pesticides. GENEEC incorporates a farm pond
scenario, while PRZM/EXAMS incorporate in index reservoir environment in
place of the previous pond scenario. The PRZM/EXAMS model includes a
percent crop area factor as an adjustment to account for the maximum
percent crop coverage with a watershed or drainage basin.

None of these models include consideration of the impact processing
(mixing, dilution or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water.  The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides, for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.

Since the models used are considered to be screening tools in the risk
assessment process, the Agency does not use estimated environmental
concentrations (EEC) from these models to quantify drinking water
exposure and risk as a %RfD or %PAD.  Instead, drinking water levels of
comparison (DWLOCs) are calculated and used as a point of comparison
against the model estimates of a pesticide’s concentration in water.
DWLOCs are theoretical upper limits on a pesticide’s concentration in
drinking water in light of total aggregate exposure to a pesticide in
food, and from residential uses. Since DWLOCs address total aggregate
exposure to glyphosate they are further discussed in the aggregate risk
sections below.

Using available environmental fate parameters and assuming two
applications with a

re-treatment interval of 90 days at a rate of 5 lbs. ai/A (3.75 lbs
ae/A), the ground water EEC from glyphosate using SCO-GROW was 0.0038
parts per billion (ppb). The current label allows multiple applications
of 0.37 - 5 lbs ai/A up to a maximum of 10.6 lbs ai/A/year. The ground
water EECs generated by SCI-GROW are based on the largest 90-day average
recorded during the sampling period. Since there is relatively little
temporal variation in ground water concentrations compared to surface
water, the concentrations can be considered as acute and chronic values.

The GENEEC model was used to estimate surface water concentrations for
glyphosate resulting from its maximum use rate on crops. GENEEC is a
single event model (one runoff event), but can account for spray drift
from multiple applications. GENEEC represents a 10 hectare field
immediately adjacent to a 1 hectare pond that is 2 meters deep with no
outlet. The pond receives a spray drift event from each application plus
one runoff event. The runoff event moves a maximum of 10% of the applied
pesticide into the pond. This amount can be reduced due to degradation
on the field and by soil sorption.  Spray drift is estimated as 5% of
the application rate. The GENEEC values represent upper-bound estimates
of the concentrations that might be found in the surface water due to
the glyphosate use. Thus, the GENEEC model predicts that glyphosate
surface water EECs range from a peak of 21 ppb to a 56-day average of
2.5 ppb.  For comparison purposes, EPA guidance suggests dividing the
56-day GENEEC EED value by 3 before comparison to the calculated
DWLOCchronic value (“Interim Guidance for Incorporating Drinking Water
Exposure into Aggregate Risk Assessments, 01-Aug-199, SOP 99.5).  Thus,
2.5 divided by 3 or 0.83 ppb is the predicted surface water EEC value
resulting from glyphosate treatment of crops.

To  estimate the possible concentration of glyphosate in surface water
resulting from direct application to water, EPA assumed application to a
water body 6 feet deep.  At an application rate of 3.75 lbs ae/A, the
estimated peak concentration is 230 ppb.  Using this peak value in a
first-order dissipation model with a half-life for glyphosate in water
of 7.5 days, the resulting 56-day average value divided by 3, or 15.4
ppb, is the predicted surface water EEC resulting from direct
application to water.  Because the glyphosate water-application estimate
is greater than the crop-application estimate, 15/4 ppb is the
appropriate chronic value to compare to the calculated DWLOCchronic
value for aggregate risk considerations.

Based on the GENEEC and SCI-GROW models the EECs of glyphosate for
chronic exposures are estimated to be 15.4 ppb for surface water and
0.004 ppb for ground water.]

. [Residential uses:  The term “residential exposure” is used in
this document to refer to non-occupational, non-dietary exposure (e.g.;
for lawn and garden pest control, indoor pest control, termiticides, and
flee and tick control on pets).

Glyphosate is currently registered for use on the following residential
non-dietary sites:  ornamentals, greenhouses, residential areas, lawns,
and industrial rights of way.  Glyphosate is formulated in liquid and
solid forms, and it is applied using ground or aerial equipment. Based
on the low acute toxicity and the lack of other toxicological concerns,
exposures from residential uses of glyphosate are not expected to pose
undue risks.]

[Cumulative exposure to substances with a common mechanism of toxicity.
Section 408(b) (2) (D) (v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide’s residues and “other substances that have a
common mechanism of toxicity”.

EPA does not, at this time, have available data to determine whether
glyphosate has a common mechanism of toxicity with other substances or
how to include this pesticide in a cumulative risk assessment. Unlike
other pesticides for which EPA has followed a cumulative risk approach
based on a common mechanism of toxicity, glyphosate does not appear to
produce a toxic metabolite produced by other substances.  For the
purpose of this tolerance action, therefore, EPA has not assumed that
glyphosate has a common mechanism of toxicity with other substances.
For information regarding EPA’s efforts to determine which chemicals
have a common mechanism of toxicity and to evaluate the cumulative
effects of such chemicals, see the final rule for Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997).]

.  [To estimate total aggregate exposure to a pesticide from food,
drinking water,and residential uses, the Agency calculates DWLOCs which
are used as a point of comparison against the model estimates of a
pesticide’s concentration in water (EECs).  DWLOC values are not
regulatory standards for drinking water.  DWLOCs are theoretical upper
limits on a pesticide’s concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the acceptable
exposure (i.e., the PAD) is available for exposure through drinking
water; e.g., allowable chronic water exposure (mg/kg/day) = cPAD -
(average food + residential exposure).  This allowable exposure through
drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water
consumption and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs:  2L/70 kg (adult male), 2L/60 kg (adult female), and

1L/10 kg (child).  Default body weights and drinking water consumption
values vary on an individual basis.  This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments.  Different populations will have different DWLOCs.
 Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic and cancer.

When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along with
other sources of exposure for which OPP has reliable data) would not
result in unacceptable levels of aggregate human health risk at this
time.  Because OPP considers the aggregate risk resulting from multiple
exposure pathways associated with a pesticide’s uses, levels of
comparison in drinking water may vary as those uses change. If new uses
are added in the future, OPP will reassess the potential impacts of
residues of the pesticide in drinking water as a part of the aggregate
risk assessment process.

a. Acute risk.  No appropriate toxicological endpoint for a single dose
exposure was identified in oral toxicity studies with glyphosate.
Therefore, an acute RfD was not established, and there is no expectation
of acute dietary risk from food and water.

b. Chronic Risk. Using the exposure assumptions described in this unit
for chronic exposure, EPA has concluded that exposure to glyphosate from
food using present tolerances and all proposed new tolerances will
utilize 1.7% of the cPAD for the U.S. population, 3.8% of the cPAD for
all infants less than 1 year old and 3.6% of the cPAD for children (1 to
6 years old).  These dietary exposure levels are unaffected by the
proposed tolerance regulation change.  Based on the use pattern, chronic
residential exposure to residues of glyphosate is not expected.  In
addition, there is potential for chronic dietary exposure to glyphosate
in drinking water.  After calculating DWLOCs and comparing them to the
EECs for surface and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the cPAD, as shown in the following

Table.

Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to
Glyphosate

Population

Subgroup	cPAD

mg/kg/day	%cPAD

(Food	Surface

Water EEC

(ppb)	Ground

Water EEC

(ppb)	DWLC

(ppb)

U.S.

Population		2.0	1.7	15.4	0.004	69,000

Non-nursing Infants, less Than 1 year Old	2.0	4.7	15.4	0.004	19,000

All infants, less than 1 Year old	2.0	3.8	15.4	0.004	19,000

Children, 1-6 Years old	2.0	3.6	15.4	0.004	19,000

------------------------------------------------------------------------
---------------------------------------------	c. Short- and
intermediate-term risk.  Short- and intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).  Though
residential exposure could occur with the use of glyphosate, no
toxicological effects have been identified for short- or
intermediate-term toxicity.  Therefore, the aggregate risk is the sum of
the risk from food and water, which do not exceed the Agency’s level
of concern.

d. Aggregate cancer risk for U.S. population.  Glyphosate has been
classified as a Group E chemical, with no evidence of carcinogenicity
for humans in two acceptable animal studies.  Glyphosate is not expected
to pose a cancer risk to humans.

e. Determination of safety.  Based on these risk assessments, Monsanto
concludes that there is reasonable certainty that no harm will result
from the aggregate exposure to glyphosate residues.]

. [i. In general, FFCDA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the case
of threshold effects to account for prenatal and postnatal toxicity, and
the completeness of the database on toxicity and exposure unless EPA
determines that a different margin of safety will be safe for infants
and children.  Margins of safety are incorporated into EPA risk
assessments either directly through use of a margin of exposure (MOE)
analysis or through using uncertainty (safety) factors in calculating a
dose level that poses no appreciable risk to humans.  EPA believes that
reliable data support using the standard uncertainty factor (usually 100
x for combined inter- and intra-species variability), and not the
additional tenfold MOE/uncertainty factor when EPA has a complete data
base under existing guidelines, and when the severity of the effects in
infants and children or the potency or unusual toxic properties of a
compound do not raise concerns regarding the adequacy of the standard
MOE/safety factor.

ii. Prenatal and postnatal sensitivity: There is no evidence of
increased susceptibility in rats and rabbits to in utero and/or
postnatal exposure to glyphosate.

iii. Conclusion:  There is a complete toxicity data base for glyphosate,
and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures.  EPA determined that the
10X safety factor to protect infants and children should be removed.
The FQPA factor is removed because: a) the toxicology data base is
complete;  b) there is no indication of increased susceptibility of rats
or rabbits to in utero and/or postnatal exposure to glyphosate (in the
prenatal developmental toxicity study in rats, effects in the offspring
were observed only at or above treatment levels which resulted in
evidence of appreciable prenatal toxicity).

The use of generally high quality data, conservative models and/or
assumptions in the exposure assessment, provide adequate protection of
infants and children.]

	[Several maximum residue limits (MRLs) for glyphosate have been
established by CODEX in or on various commodities.  These limits are
based on the residue definition of glyphosate per se, without reference
to the cation used in product formulation. Based on toxicological
considerations,  EPA has determined that AMPA no longer needs to be
regulated and with this regulation has deleted AMPA from the U.S.
tolerance expression, so that the U.S. residue definition is harmonized
with that of CODEX. The proposed regulation amendment to include
applications of potassium glyphosate into  existing  U.S. tolerances
does not propose numerical changes, and the agreement between U.S.
tolerances and CODEX international residue standards is unaffected by
this action.]

 PAGE  12

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