Federal Register / Vol. 81, No. 69 / Monday, April 11, 2016 / Notices 21335 

Dated: March 29, 2016. 

David Garcia, 

Deputy Director, Water Division, EPA Region 

6. 

Dated: March 29, 2016. 

Karen Flournoy, 

Director, Water, Wetlands, and Pesticides 

Division, EPA Region 7. 

Dated: March 29, 2016. 

Darcy O’Connor, 

Acting Assistant Regional Administrator, EPA 

Region 8. 

Dated: March 29, 2016. 

Mike Montgomery 

Assistant Director, Water Division, EPA 

Region 9. 

Dated: March 29, 2016. 

Daniel D. Opalski, 

Director, Office of Water and Watersheds, 

EPA Region 10. 

[FR Doc. 2016–08276 Filed 4–8–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2008–0316; FRL–9944–37] 

Tetrachlorvinphos (TCVP); EPA 

Proposal To Rely on Data From Human 

Research on TCVP Exposure From 

Flea Control Collars 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: In compliance with EPA’s 

rule for protection of human subjects, 

EPA is providing an opportunity for 

public comment on EPA’s proposal to 

rely on data from human research on 

tetrachlorvinphos (TCVP) exposure from 

flea control collars. 

DATES: Comments must be received on 

or before May 11, 2016. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2008–0316, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: For 

information on EPA’s Rule for 

Protection of Human Subjects contact: 

Maureen Lydon, Human Research 

Ethics Review Officer, Office of 

Pesticide Programs (7501P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–0440; email address: 

lydon.maureen@epa.gov. 

For information on the EPA risk 

assessment contact: James Parker, 

Chemical Review Manager, Pesticide 

Re-Evaluation Division (7508P), Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (703) 306–0469; 

email address: parker.james@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

This action is directed to the public 

in general, and may be of interest to a 

wide range of stakeholders including 

environmental, human health, farm 

worker, and agricultural advocates; the 

chemical industry; pesticide users; and 

members of the public interested in the 

sale, distribution, or use of pesticides. 

Since others also may be interested, the 

Agency has not attempted to describe all 

the specific entities that may be affected 

by this action. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult a contact 

listed under FOR FURTHER INFORMATION

CONTACT. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When preparing and submitting your 

comments, see the commenting tips at 

http://www.epa.gov/dockets/

comments.html. 

3. Environmental justice. EPA seeks to 

achieve environmental justice, the fair 

treatment and meaningful involvement 

of any group, including minority and/or 

low income populations, in the 

development, implementation, and 

enforcement of environmental laws, 

regulations, and policies. To help 

address potential environmental justice 

issues, the Agency seeks information on 

any groups or segments of the 

population who, as a result of their 

location, cultural practices, or other 

factors, may have atypical or 

disproportionately high and adverse 

human health impacts or environmental 

effects from exposure to the pesticides 

discussed in this document, compared 

to the general population. 

II. Authority 

EPA is conducting its registration 

review of TCVP pursuant to section 3(g) 

of the Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA), 7 U.S.C. 

136 et seq., and the Procedural 

Regulations for Registration Review at 

40 CFR part 155, subpart C. Section 3(g) 

of FIFRA provides, among other things, 

that the registrations of pesticides are to 

be reviewed every 15 years. Under 

FIFRA, a pesticide product may be 

registered or remain registered only if it 

meets the statutory standard for 

registration given in FIFRA section 

3(c)(5) (7 U.S.C. 136a(c)(5)). When used 

in accordance with widespread and 

commonly recognized practice, the 

pesticide product must perform its 

intended function without unreasonable 

adverse effects on the environment; that 

is, without any unreasonable risk to 

man or the environment, or a human 

dietary risk from residues that result 

from the use of a pesticide in or on food. 

III. EPA’s Proposal To Rely on 

Published TCVP Human Research 

During the public meeting of the 

Human Studies Review Board (HSRB) 

held on January 12–13, 2016, EPA’s 

Office of Pesticide Programs provided 

an overview and science and ethics 

review of the research discussed in the 

article ‘‘Assessing Intermittent Pesticide 

Exposure From Flea Control Collars 

Containing the Organophosphorus 

Insecticide Tetrachlorvinphos (TCVP).’’ 

This research article was authored by M. 

Keith Davis, J. Scott Boone, John E. 

Moran, John W. Tyler and Janice E. 

Chambers and published in 2008 in the 

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21336 Federal Register / Vol. 81, No. 69 / Monday, April 11, 2016 / Notices 

Journal of Exposure Science and 

Environmental Epidemiology (2008) 18, 

pages 564–570. EPA presented Davis et 

al. research to the HSRB for their 

review, along with a request for the 

HSRB to respond to questions posed by 

EPA. 

The Davis et al. research measured 

TCVP exposures in children and adults 

that could occur from contact with pet 

dogs wearing TCVP-containing flea 

control collars. The research was based 

on two studies conducted by the Center 

of Environmental Health Sciences, 

College of Veterinary Medicine, 

Mississippi State University (MSU). 

Although the families involved in the 

studies already used flea collars, the 

researchers provided specific flea 

collars to the participating families and 

asked that their dogs wear them during 

the studies. 

In study 1, conducted in 1998, TCVP 

residues were measured by rubbing/

petting dogs’ fur with a gloved hand. 

The sampling was conducted by 

volunteer technicians from MSU 

veterinary school who stroked the 

animals in a standardized, prescribed 

manner, in a marked 10 x 4 inch area 

with clean, white, cotton gloves for a 

continuous 5-minute period. The dogs 

were rubbed in three specific locations: 

Near the base of the tail, at the neck 

with the flea collar removed, and at the 

neck with the flea collar in place. Study 

1 also measured dog plasma 

cholinesterase. There were 23 pet dogs 

included in this study, one from each of 

the 23 participating households. 

Under study 2, conducted in 2002, 

volunteer technicians from MSU 

veterinary school collected TCVP 

residues by rubbing/petting dogs’ fur 

with a gloved hand, and used the same 

methods as those employed by study 1. 

The collection of the glove residue data 

did not involve children in either study 

1 or study 2. However, study 2 also 

quantified TCVP residues on tee shirts 

worn by children and included 

biomonitoring of the TCVP metabolite 

2,4,5-trichloromandelic acid (TCMA) in 

urine of participating children and 

adults. Study 2 included 1 child and 1 

adult from each of the 22 participating 

families and 22 pet dogs. 

EPA proposes to use only the glove 

residue data from the Davis et al. 

research in its risk assessment of TCVP 

because it is chemical-specific and 

results in the highest computed risks 

when compared to the other data in 

Davis et al. and all the approaches 

considered in the assessment; as a 

result, it supports the most protective 

risk characterization. The research 

complied with the ethical standards in 

place at the time the studies were 

conducted and meets the substantive 

acceptance standards. As described in 

the Davis et al. research, the data were 

derived in a manner that makes the 

research scientifically valid and are 

appropriate for use in EPA’s risk 

assessment. 

In the Federal Register of January 20, 

2016 (81 FR 3128, FRL–9940–81), EPA 

sought public comment on EPA’s draft 

human health and ecological risk 

assessment for the registration review of 

TCVP. The public can view the draft 

human health risk assessment and 

supporting documents, as well as 

comments received, in the docket 

established for the reregistration review 

of TCVP (see docket ID number EPA– 

HQ–OPP–2008–0316). EPA has 

determined that relying on the glove 

residue data from the Davis et al. 

research is crucial to a decision to 

potentially impose a more stringent 

regulatory restriction that would 

improve public health protection than 

could be justified without relying on the 

data. EPA currently does not have other 

pet collar glove residue data which are 

chemical-specific or that would lead to 

the same potential regulatory action to 

improve public health protection. For 

this reason, the glove residue data are 

crucial to EPA’s decision. 

IV. Reason for Review by the HSRB 

EPA chose, in this case, to obtain the 

views of the HSRB concerning EPA’s 

proposal to rely on the TCVP glove 

residue data from studies 1 and 2 for the 

following reasons. First, the proposal 

submitted to EPA’s Science to Achieve 

Results (STAR) grants program for 

funding of the research discussed 

correlating the residues from the 

rubbing procedure with the gloves, the 

residues from the tee shirts worn by 

children participating in the studies, 

and the urinary metabolites of the 

children and adults in the participating 

households and described these 

activities under the umbrella of one 

research project. Moreover, although 

EPA is relying only on the TCVP glove 

residue data from both studies, study 2 

further involved children wearing tee 

shirts and providing urine samples, and, 

at least for that portion of the study, is 

considered research involving 

intentional exposure to human subjects. 

Therefore, even though EPA does not 

wish to rely on the data involving 

children (namely the tee shirt and 

urinary data), EPA chose in this case to 

assume that the prohibition in 40 CFR 

26.1703 and the process in 40 CFR 

26.1706 apply, including submission of 

the research to the HSRB for review. 

40 CFR 26.1703 prohibits EPA 

reliance on data from any research 

involving intentional exposure of any 

human subject who is a pregnant 

woman (and therefore her fetus), 

nursing woman, or child, except as 

provided in 40 CFR 26.1706. 40 CFR 

26.1706 explains that EPA may rely on 

data that are unacceptable under the 

standards in 40 CFR 26.1703 through 

26.1705 only if EPA has: (a) Obtained 

the views of the HSRB; (b) provided an 

opportunity for public comment on the 

proposal to rely on the otherwise 

unacceptable data; (c) determined that 

relying on the data is crucial to a 

decision that would impose a more 

stringent regulatory restriction to protect 

public health than could be justified 

without the data; and (d) published a 

full explanation of the decision to rely 

on the data, including a thorough 

discussion of the ethical deficiencies of 

the underlying research and the full 

rationale for finding that the standard in 

item (c) was met. 

EPA sought and obtained the views of 

the HSRB during the public meeting of 

the HSRB on January 12–13, 2016. The 

HSRB documents their views in meeting 

minutes and a final report before EPA 

publishes the explanation required by 

40 CFR 26.1706(d). Pursuant to 40 CFR 

26.1706(b), EPA is hereby providing an 

opportunity for public comment on 

EPA’s proposal to rely on the TCVP 

glove residue data from the Davis et al. 

research. EPA proposes to rely on 

chemical-specific data from human 

research to potentially impose a more 

stringent regulatory restriction that 

would improve public health protection 

than could be justified without relying 

on the data. 

V. Background on Ethical Conduct of 

Research 

The research was funded by EPA’s 

STAR grants. EPA’s Office of Research 

and Development (ORD) reviewed the 

grant proposal, which involved human 

research and funding from EPA. EPA’s 

ethics review of the Davis et al. research 

presented at the January HSRB meeting 

relies in part on EPA’s ORD file because 

it contains draft consent forms used 

during study 2 and recruitment 

information. At the January 2016 HSRB 

meeting, EPA discussed the role of the 

veterinary students, the societal value of 

the Davis et al. research, and ethical 

considerations regarding recruitment of 

study participants, the independent 

ethics review, informed consent, respect 

for subjects and compensation for 

participation in the study. 

EPA reviewed with the HSRB the role 

of the veterinary students in rubbing the 

dogs. The technicians who rubbed the 

dogs in study 1 and study 2 were 

students enrolled at MSU’s College of 

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Federal Register / Vol. 81, No. 69 / Monday, April 11, 2016 / Notices 21337 

Veterinary Medicine. Both the 

researchers and the Institutional Review 

Board (IRB) viewed the veterinary 

students as technicians in the study, not 

as human subjects. The abstract for the 

research submitted to EPA for funding 

is included in the ORD file and states, 

on page 14, that ‘‘the samplers will be 

trained so that consistency in the 

sample collection is maintained among 

dogs and among samplers.’’ As 

discussed in the research article, the 

technicians wore gloves and stroked the 

animals in a standardized, prescribed 

manner: ‘‘in a marked 10 x 4 inch area 

with clean, white, cotton gloves for a 

continuous 5-min period.’’ The dogs 

were rubbed in specific locations (near 

the base of the tail, at the neck with 

collar removed, and at the neck with the 

collar in place). Under 40 CFR 

26.1102(e), the term ‘‘human subject’’ is 

defined, in part, as ‘‘a living individual 

about whom an investigator . . . 

conducting research obtains . . . 

data through intervention or 

interaction. . . .’’ The Primary 

Investigator for the research confirmed 

that she did not obtain data about the 

technicians, nor did she intend to do so. 

The pattern of rubbing does not 

resemble the typical human-pet 

interaction or provide information about 

how a person would normally interact 

with a pet. EPA noted during the HSRB 

meeting that the researchers were not 

collecting data about the technicians in 

this study and concluded that there is 

no indication from the research article, 

the ORD file or EPA’s interview with the 

Primary Investigator that the study 

collected data about the veterinary 

students who worked as technicians in 

the study. Instead, the researchers 

collected data only about the residues 

on the glove as an indication of how 

much residue was available for transfer 

from the pet. 

With regard to the societal value of 

the Davis et al. research, the objective 

was to assess the amount of exposure to 

TCVP that could occur in children and 

adults from the use of a TCVPcontaining collar on a pet dog. 

Regarding recruitment, the research 

article states that ‘‘the studies were 

conducted in Oktibbeha County, 

Mississippi (USA), with volunteer 

households having pet dogs’’ and that 

‘‘participating families were volunteers 

who routinely used flea control 

products on their pet dogs.’’ ‘‘One child 

and one adult were selected from each 

participating family’’ for study 2, which 

included 44 subjects. EPA’s file on the 

STAR grant, page 13, states that: ‘‘Dogs 

selected for this study will be owned by 

professional (DVM) or graduate students 

enrolled in the College of Veterinary 

Medicine, or staff/faculty members of 

Mississippi State University with a 

child aged 4–10 years in the household 

who routinely plays with this dog.’’ It 

goes on to state that ‘‘students or staff 

should be the most reliable group of 

owners (in contrast to the general 

public) in that they are accessible daily, 

their dogs can readily be treated and 

sampled when the students are in class 

or the staff members are at work, and as 

members of the academic community, 

the compliance and appreciation of the 

value of research should be high.’’ 

EPA’s file further states that ‘‘dogs 

participating in this study must be 

enrolled in the Small Animal 

Community Practice Health 

Maintenance Program, so that their 

health status and vaccination history are 

known.’’ 

Regarding the independent ethics 

review, the IRB for Research on Human 

Subjects at MSU reviewed and approved 

the sampling protocols and consent 

forms, and the EPA’s ORD, the National 

Center for Environmental Research and 

Quality Assurance (NCERQA) reviewed 

the STAR grant proposal focusing on 

this research. ORD supported the 

research dependent on the 

incorporation of NCERQA comments on 

the consent forms. The protocol was 

distributed to each participating 

household, informed consent was 

obtained from the adults, and children 

were informed verbally of the 

procedures and oral or written assent 

was obtained from them. The IRB for 

Research on Human Subjects at MSU 

approved all sampling protocols and 

informed consent forms. The ORD file 

contains a draft consent form for adults 

and a Minor’s Assent Form. The consent 

form states that the study involves 

research and identifies its purpose, 

expected duration, number of urine and 

tee shirt samples to be provided, states 

that research results will be coded, 

participants are free to withdraw, 

provides a contact for information, and 

specifies compensation of $150 for each 

participating household. The consent 

form, entitled ‘‘Authorization for 

Participation in Research Project,’’ also 

states that ‘‘no risks are anticipated to 

the participants.’’ The implication is 

that since families already used flea 

collars on their dogs, there was no 

added risk from participating in the 

study. In the abstract that the 

researchers submitted to ORD, however, 

page 4 states that ‘‘the residues of 

insecticides available for intermittent 

transfer to children from the fur of dogs 

treated by either a spot treatment or a 

collar for flea control will be 

appreciable and of a magnitude 

necessitating inclusion in cumulative 

risk assessments of pesticides to 

children; secondly, that the fur rubbing 

procedure developed to quantify 

dislodgeable residues provides a useful 

estimate of insecticide residues which 

could be transferred from the fur of dogs 

to children.’’ 

Although the families involved 

already used flea collars registered by 

EPA, in the interest of transparency, it 

would have been preferable for the 

researchers to have shared their 

hypothesis with the parents of the 

participating children and included it in 

the consent form. It is unknown 

whether the information was stated in 

the protocol provided to the families. 

The Minor’s Assent Form states that the 

researchers ‘‘will specifically obtain 

assent from the children recruited to our 

project . . . We will explain that the 

child’s parent or guardian has given us 

permission to request his/her help 

participation (sic) in the research 

project. We will then explain the urine 

collection protocol and the tee shirt 

protocol to the children in language 

appropriate to the age of the child and 

obtain his/her assent to participate. We 

will not explain the connection to the 

pesticide residues on the dog so as not 

to alter the behavior of the child with 

the dog. We will obtain the children’s 

assent orally because of the age range of 

the children involved.’’ 

The researchers demonstrated respect 

for subjects participating in the study in 

several ways. The researchers: Did not 

reveal subjects’ identities; obtained 

informed consent from participating 

subjects; provided light weight shortsleeve tee shirts to children for use 

during the study; gave written assurance 

that urine samples would only be used 

to quantify insecticide urinary 

metabolites; and provided 

compensation for participation in the 

study. Compensation included $100 

equivalent of veterinary care provided 

by the Animal Health Center of MSU 

College of Veterinary Medicine and 

$150 to participating households in 

Study 2. 

VI. Summary of Discussion on EthicsRelated Questions 

As documented on page 27 of the 

minutes of the January 2016 HSRB 

meeting, in response to EPA’s science 

charge question, the HSRB stated that, 

‘‘The research is scientifically sound 

and, if used appropriately, the pet fur 

transferable residue data from the 

rubbing protocol can provide useful 

information for evaluating potential 

exposures of adults and children from 

contact with dogs treated with 

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21338 Federal Register / Vol. 81, No. 69 / Monday, April 11, 2016 / Notices 

tetrachlorvinphos containing pet 

collars.’’ The HSRB noted that, ‘‘the 

limitations of the data would be 

discussed in the Board’s report.’’ The 

minutes of the January 12–13, 2016 

public HSRB meeting are available on 

the HSRB Web site at http://

www.epa.gov/osa/january-12-13-2016- 

meeting-human-studies-review-board. 

The EPA also asked the HSRB if they 

had any comments on the determination 

that the samplers (who petted/rubbed 

the dogs) were not human subjects. 

During the public meeting, as 

documented on pages 27–28 of the 

minutes, ‘‘Questions were raised by 

several committee members about the 

PI’s ([primary investigator’s) and the 

IRB’s (Institutional Review Board’s) 

determinations that the samplers were 

not human subjects in the study; rather 

they were viewed as study staff. Some 

members of the board asserted that the 

students/technicians, by virtue of being 

potentially exposed to the pesticide as 

part of the conduct of the study, should 

have been considered human subjects. 

Furthermore, if they had been treated as 

subjects, they might have been 

considered ‘vulnerable’ due to their 

status as students.’’ The HSRB noted 

that the flea control collars were 

‘‘commercially available at the time, and 

that the potential exposure to the 

pesticide residues through petting the 

dogs for 5 minute periods wearing 

cotton gloves was likely much less than 

average exposure of a pet owner. There 

is no information available about 

whether there was any ‘bleed through’ 

of pesticide from the cotton gloves to 

the skin of the samplers and therefore 

the actual exposure is unknown. 

Considering all of these factors, the 

committee felt that the risks of exposure 

were not greater than those experienced 

in everyday life. Thus, even if the 

determination regarding the status of the 

samplers as study staff rather than 

subjects was mistaken, the committee 

did not believe this resulted in any 

material harms and so this question 

should not prevent the EPA from using 

the pet fur transferable residue data 

derived from the study for making a 

decision to impose a more stringent 

regulatory restriction than could be 

justified without the data.’’ 

EPA asked the HSRB if they had any 

comments on the ethical conduct of the 

research. As noted on page 28 of the 

meeting minutes, ‘‘Committee members 

observed that the records from 

correspondence with EPA staff 

regarding the study suggest the consent 

form was amended to include disclosure 

to parents about the risks of pesticide 

exposure, although the final approved 

consent form was not available. A 

question was raised about the decision 

made to provide incomplete assent to 

the minor subjects following parental 

permission. Study documents suggest 

this was an intentional choice (‘We will 

not explain the connection to the 

pesticide residues on the dog . . .’), 

which was made, according to study 

documents, in order to avoid 

confounding the results by causing 

alterations in the children’s behavior 

around their dogs. Board members 

noted that the amount and type of 

information provided to children in an 

assent process will vary depending on 

the age of the child; the children 

enrolled in the study were between the 

ages of 3 and 11 years old and therefore 

would have had varying levels of 

capacity to process the information 

about the study. It was noted that 

FIFRA, which existed at the time of 

these studies, states that it’s unlawful to 

use any pesticide in tests on humans 

unless they are fully informed of the 

nature and purposes of the test. 

Although some board members viewed 

the assent as incomplete in this case, 

because parents are presumed to have 

given fully-informed permission,’’ and 

given that the flea control collars were 

‘‘commercially available at the time and 

already in use in the households 

recruited to the study, the committee 

felt that the risks of exposure were not 

greater than those experienced in 

everyday life. Thus, the committee did 

not believe this resulted in any material 

harms and so this question should not 

prevent the EPA from using the pet fur 

transferable residue data derived from 

the study for making a decision to 

impose a more stringent regulatory 

restriction than could be justified 

without the data.’’ 

VII. Standards Applicable to Ethical 

Conduct and Reliance on Data 

With regard to the standards 

applicable to the conduct of the 

research, study 1 was conducted in 1998 

and study 2 was conducted in 2002, 

both before EPA’s Rule for Protection of 

Human Subjects (40 CFR part 26, 

subparts B through Q) became effective 

in 2006. Thus, 40 CFR part 26, subparts 

B through Q, did not apply when this 

research was conducted. However, 

EPA’s codification of the Common Rule 

at 40 CFR part 26 subpart A was in 

place and applies to the underlying 

research that received EPA’s STAR grant 

funding. Key elements of the Common 

Rule include IRB oversight and prior 

approval, an acceptable informed 

consent process, risk minimization, a 

favorable risk-benefit balance, equitable 

subject selection, and fully informed 

and voluntary participation by subjects. 

In addition, FIFRA section 12(a)(2)(P), 

which states that it is unlawful to use 

any pesticide in tests on humans unless 

they are fully informed of the nature 

and purposes of the tests, as well as of 

any reasonably foreseeable physical and 

mental health consequences, and that 

participants freely volunteer, existed at 

the time of these studies. The Davis et 

al. research complied with the standards 

in place at the time the research was 

conducted. 

The substantive acceptance standards 

which apply to the research include: 40 

CFR 26.1703, which, except as provided 

in 40 CFR 26.1706, prohibits relying on 

data involving intentional exposure of 

pregnant or nursing women or of 

children; 40 CFR 26.1704, which, except 

as provided in 40 CFR 26.1706, 

prohibits reliance on data if research 

was fundamentally unethical or 

deficient relative to prevailing standards 

at the time; and FIFRA section 

12(a)(2)(P), which makes it unlawful to 

use a pesticide in human tests without 

fully informed, fully voluntary consent. 

40 CFR 26.1706 states that EPA may rely 

on data that are unacceptable under the 

standards in 40 CFR 26.1703 through 

26.1705 only if EPA has: (a) Obtained 

the views of the HSRB, (b) provided the 

opportunity for public comment on the 

proposal to rely on the otherwise 

unacceptable data, (c) determined that 

relying on the data is crucial to a 

decision that would impose a more 

stringent regulatory restriction to protect 

public health than could be justified 

without the data, and (d) published a 

full explanation of the decision to rely 

on the data, including a thorough 

discussion of the ethical deficiencies of 

the underlying research and the full 

rationale for finding that the standard in 

item (c) was met. Regarding 40 CFR 

26.1703, study 2 involved tee shirt and 

urine samples that came from children. 

As explained previously, even though 

EPA only intends to rely on the glove 

residue data from study 1 and study 2, 

which did not involve children, EPA 

chose in this case, out of an abundance 

of caution, to proceed under 40 CFR 

part 26, subpart Q. 

Regarding 40 CFR 26.1704, clear and 

convincing evidence that the pre-rule 

research was fundamentally unethical 

or deficient relative to prevailing ethics 

standards does not exist, and the 

research complied with FIFRA section 

12(a)(2)(P). In satisfaction of 40 CFR 

26.1706(a), EPA sought and obtained the 

views of the HSRB during the public 

HSRB meeting on January 12–13, 2016. 

The HSRB documents their views in 

meeting minutes and a final report 

before EPA publishes the explanation 

required by 40 CFR 26.1706(d). 

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Federal Register / Vol. 81, No. 69 / Monday, April 11, 2016 / Notices 21339 

Pursuant to 40 CFR 26.1706(b), EPA is 

providing an opportunity for public 

comment on EPA’s proposed decision to 

rely on the glove residue data. 

Regarding 40 CFR 26.1706(c), EPA has 

determined that relying on the glove 

residue data from the Davis et al. 

research is crucial to a decision to 

potentially impose a more stringent 

regulatory restriction that would 

improve public health protection than 

could be justified without relying on the 

data, as explained in EPA’s draft human 

health and ecological risk assessment 

for the registration review of TCVP. 

VIII. Availability of HSRB Meeting 

Materials 

In accordance with the requirements 

of the Federal Advisory Committee Act 

(FACA), 5 U.S.C. Appendix 2, the 

minutes of the HSRB public meeting 

held on January 12–13, 2016, including 

a description of the matters discussed 

and conclusions reached by the Board, 

must be certified by the HSRB meeting 

Chair and made public within 90 days 

of the meeting. The HSRB meeting Chair 

in fact certified those meeting minutes 

on February 24, 2016. The HSRB also 

will prepare a final report in response 

to questions posed by the EPA, which 

will include the Board’s review and 

analysis of materials presented. The 

approved minutes, final report and 

other materials from the January 12–13, 

2016 HSRB meeting are or will be 

available in docket ID number EPA– 

HQ–ORD–2015–0588 and on the HSRB 

Web site at http://www.epa.gov/osa/

human-studies-review-board. 

IX. Other Related Information on TCVP 

The public can view EPA’s draft 

human health and ecological risk 

assessment and supporting documents 

for the registration review of TCVP in 

the docket at http://www.regulations.gov 

(see docket ID number EPA–HQ–OPP– 

2008–0316). Information on the 

Agency’s registration review program 

and its implementing regulation is 

available at https://www.epa.gov/

pesticide-reevaluation/registrationreview-process. 

Authority: 7 U.S.C. 136 et seq. 

Dated: March 28, 2016. 

Jack E. Housenger, 

Director, Office of Pesticide Programs, Office 

of Chemical Safety and Pollution Prevention. 

[FR Doc. 2016–08281 Filed 4–8–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2015–0762; FRL–9943–48] 

Registration Review; Conventional, 

Biopesticide and Antimicrobial 

Dockets Opened for Review and 

Comment 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: With this document, EPA is 

opening the public comment period for 

several registration reviews. Registration 

review is EPA’s periodic review of 

pesticide registrations to ensure that 

each pesticide continues to satisfy the 

statutory standard for registration, that 

is, the pesticide can perform its 

intended function without unreasonable 

adverse effects on human health or the 

environment. Registration review 

dockets contain information that will 

assist the public in understanding the 

types of information and issues that the 

Agency may consider during the course 

of registration reviews. Through this 

program, EPA is ensuring that each 

pesticide’s registration is based on 

current scientific and other knowledge, 

including its effects on human health 

and the environment. 

DATES: Comments must be received on 

or before June 10, 2016. 

ADDRESSES: Submit your comments 

identified by the docket identification 

(ID) number for the specific pesticide of 

interest provided in the table in Unit III. 

A., by one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at http://www.epa.gov/

dockets. 

FOR FURTHER INFORMATION CONTACT: For 

pesticide specific information contact: 

The person identified as a contact in the 

table in Unit III.A. Also include the 

docket ID number listed in the table in 

Unit III.A. for the pesticide of interest. 

For general information contact: 

Richard Dumas, Pesticide Re-Evaluation 

Division (7508P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8015; fax number: 

(703) 308–8090; email address: 

dumas.richard@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

This action is directed to the public 

in general, and may be of interest to a 

wide range of stakeholders including 

environmental, human health, 

farmworker, and agricultural advocates; 

the chemical industry; pesticide users; 

and members of the public interested in 

the sale, distribution, or use of 

pesticides. Since others also may be 

interested, the Agency has not 

attempted to describe all the specific 

entities that may be affected by this 

action. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When preparing and submitting your 

comments, see the commenting tips at 

http://www.epa.gov/dockets/

comments.html. 

3. Environmental justice. EPA seeks to 

achieve environmental justice, the fair 

treatment and meaningful involvement 

of any group, including minority and/or 

low income populations, in the 

development, implementation, and 

enforcement of environmental laws, 

regulations, and policies. To help 

address potential environmental justice 

issues, the Agency seeks information on 

any groups or segments of the 

population who, as a result of their 

mstockstill on DSK4VPTVN1PROD with NOTICES