81 FR 21335 - Tetrachlorvinphos (TCVP); EPA Proposal To Rely on Data From Human Research on TCVP Exposure From Flea Control Collars

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 69 (April 11, 2016)

Page Range		21335-21339
FR Document		2016-08281
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.
Federal Register, Volume 81 Issue 69 (Monday, April 11, 2016)
[Federal Register Volume 81, Number 69 (Monday, April 11, 2016)]
[Notices]
[Pages 21335-21339]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08281]


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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.

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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: [email protected]
    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: [email protected].

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

[[Page 21336]]

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

[[Page 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 TCVP-containing 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 short-sleeve 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 Ethics-Related 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

[[Page 21338]]

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).

[[Page 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/registration-review-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
Federal Register / Vol. 81, No. 69 / Monday, April 11, 2016 / Notices 21335

Dated: March 29, 2016. follow the instructions at http:// accordance with procedures set forth in
David Garcia, www.epa.gov/dockets/contacts.html. 40 CFR part 2.
Deputy Director, Water Division, EPA Region Additional instructions on 2. Tips for preparing your comments.
6. commenting or visiting the docket, When preparing and submitting your
along with more information about comments, see the commenting tips at
Dated: March 29, 2016. http://www.epa.gov/dockets/
dockets generally, is available at
Karen Flournoy, http://www.epa.gov/dockets. comments.html.
Director, Water, Wetlands, and Pesticides FOR FURTHER INFORMATION CONTACT: For 3. Environmental justice. EPA seeks to
Division, EPA Region 7. achieve environmental justice, the fair
information on EPA’s Rule for
Dated: March 29, 2016. Protection of Human Subjects contact: treatment and meaningful involvement
Darcy O’Connor, Maureen Lydon, Human Research of any group, including minority and/or
Ethics Review Officer, Office of low income populations, in the
Acting Assistant Regional Administrator, EPA
Pesticide Programs (7501P), development, implementation, and
Region 8.
Environmental Protection Agency, 1200 enforcement of environmental laws,
Dated: March 29, 2016. Pennsylvania Ave. NW., Washington, regulations, and policies. To help
Mike Montgomery DC 20460–0001; telephone number: address potential environmental justice
Assistant Director, Water Division, EPA (703) 347–0440; email address: issues, the Agency seeks information on
Region 9. lydon.maureen@epa.gov. any groups or segments of the
For information on the EPA risk population who, as a result of their
Dated: March 29, 2016. location, cultural practices, or other
Daniel D. Opalski,
assessment contact: James Parker,
Chemical Review Manager, Pesticide factors, may have atypical or
Director, Office of Water and Watersheds, disproportionately high and adverse
EPA Region 10.
Re-Evaluation Division (7508P), Office
of Pesticide Programs, Environmental human health impacts or environmental
[FR Doc. 2016–08276 Filed 4–8–16; 8:45 am] Protection Agency, 1200 Pennsylvania effects from exposure to the pesticides
BILLING CODE 6560–50–P Ave. NW., Washington, DC 20460–0001; discussed in this document, compared
telephone number: (703) 306–0469; to the general population.
email address: parker.james@epa.gov. II. Authority
ENVIRONMENTAL PROTECTION SUPPLEMENTARY INFORMATION:
AGENCY EPA is conducting its registration
I. General Information review of TCVP pursuant to section 3(g)
[EPA–HQ–OPP–2008–0316; FRL–9944–37] of the Federal Insecticide, Fungicide,
A. Does this action apply to me? and Rodenticide Act (FIFRA), 7 U.S.C.
Tetrachlorvinphos (TCVP); EPA This action is directed to the public 136 et seq., and the Procedural
Proposal To Rely on Data From Human in general, and may be of interest to a Regulations for Registration Review at
Research on TCVP Exposure From wide range of stakeholders including 40 CFR part 155, subpart C. Section 3(g)
Flea Control Collars environmental, human health, farm of FIFRA provides, among other things,
worker, and agricultural advocates; the that the registrations of pesticides are to
AGENCY: Environmental Protection
chemical industry; pesticide users; and be reviewed every 15 years. Under
Agency (EPA).
members of the public interested in the FIFRA, a pesticide product may be
ACTION: Notice. sale, distribution, or use of pesticides. registered or remain registered only if it
SUMMARY: In compliance with EPA’s Since others also may be interested, the meets the statutory standard for
rule for protection of human subjects, Agency has not attempted to describe all registration given in FIFRA section
EPA is providing an opportunity for the specific entities that may be affected 3(c)(5) (7 U.S.C. 136a(c)(5)). When used
public comment on EPA’s proposal to by this action. If you have any questions in accordance with widespread and
rely on data from human research on regarding the applicability of this action commonly recognized practice, the
tetrachlorvinphos (TCVP) exposure from to a particular entity, consult a contact pesticide product must perform its
flea control collars. listed under FOR FURTHER INFORMATION intended function without unreasonable
CONTACT. adverse effects on the environment; that
DATES: Comments must be received on
is, without any unreasonable risk to
or before May 11, 2016. B. What should I consider as I prepare
man or the environment, or a human
ADDRESSES: Submit your comments, my comments for EPA?
dietary risk from residues that result
identified by docket identification (ID) 1. Submitting CBI. Do not submit this from the use of a pesticide in or on food.
number EPA–HQ–OPP–2008–0316, by information to EPA through
one of the following methods: regulations.gov or email. Clearly mark III. EPA’s Proposal To Rely on
• Federal eRulemaking Portal: http:// the part or all of the information that Published TCVP Human Research
www.regulations.gov. Follow the online you claim to be CBI. For CBI During the public meeting of the
instructions for submitting comments. information in a disk or CD–ROM that Human Studies Review Board (HSRB)
Do not submit electronically any you mail to EPA, mark the outside of the held on January 12–13, 2016, EPA’s
information you consider to be disk or CD–ROM as CBI and then Office of Pesticide Programs provided
Confidential Business Information (CBI) identify electronically within the disk or an overview and science and ethics
or other information whose disclosure is CD–ROM the specific information that review of the research discussed in the
mstockstill on DSK4VPTVN1PROD with NOTICES

restricted by statute. is claimed as CBI. In addition to one article ‘‘Assessing Intermittent Pesticide
• Mail: OPP Docket, Environmental complete version of the comment that Exposure From Flea Control Collars
Protection Agency Docket Center (EPA/ includes information claimed as CBI, a Containing the Organophosphorus
DC), (28221T), 1200 Pennsylvania Ave. copy of the comment that does not Insecticide Tetrachlorvinphos (TCVP).’’
NW., Washington, DC 20460–0001. contain the information claimed as CBI This research article was authored by M.
• Hand Delivery: To make special must be submitted for inclusion in the Keith Davis, J. Scott Boone, John E.
arrangements for hand delivery or public docket. Information so marked Moran, John W. Tyler and Janice E.
delivery of boxed information, please will not be disclosed except in Chambers and published in 2008 in the

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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 ENVIRONMENTAL PROTECTION docket ID number listed in the table in
providing an opportunity for public AGENCY Unit III.A. for the pesticide of interest.
comment on EPA’s proposed decision to For general information contact:
rely on the glove residue data. [EPA–HQ–OPP–2015–0762; FRL–9943–48] Richard Dumas, Pesticide Re-Evaluation
Division (7508P), Office of Pesticide
Regarding 40 CFR 26.1706(c), EPA has Registration Review; Conventional, Programs, Environmental Protection
determined that relying on the glove Biopesticide and Antimicrobial Agency, 1200 Pennsylvania Ave. NW.,
residue data from the Davis et al. Dockets Opened for Review and Washington, DC 20460–0001; telephone
research is crucial to a decision to Comment number: (703) 308–8015; fax number:
potentially impose a more stringent (703) 308–8090; email address:
regulatory restriction that would AGENCY: Environmental Protection
dumas.richard@epa.gov.
improve public health protection than Agency (EPA).
SUPPLEMENTARY INFORMATION:
could be justified without relying on the ACTION: Notice.
data, as explained in EPA’s draft human I. General Information
health and ecological risk assessment SUMMARY: With this document, EPA is
opening the public comment period for A. Does this action apply to me?
for the registration review of TCVP.
several registration reviews. Registration This action is directed to the public
VIII. Availability of HSRB Meeting review is EPA’s periodic review of in general, and may be of interest to a
Materials pesticide registrations to ensure that wide range of stakeholders including
each pesticide continues to satisfy the environmental, human health,
In accordance with the requirements statutory standard for registration, that farmworker, and agricultural advocates;
of the Federal Advisory Committee Act is, the pesticide can perform its the chemical industry; pesticide users;
(FACA), 5 U.S.C. Appendix 2, the intended function without unreasonable and members of the public interested in
minutes of the HSRB public meeting adverse effects on human health or the the sale, distribution, or use of
held on January 12–13, 2016, including environment. Registration review pesticides. Since others also may be
a description of the matters discussed dockets contain information that will interested, the Agency has not
and conclusions reached by the Board, assist the public in understanding the attempted to describe all the specific
must be certified by the HSRB meeting types of information and issues that the entities that may be affected by this
Chair and made public within 90 days Agency may consider during the course action.
of the meeting. The HSRB meeting Chair of registration reviews. Through this
program, EPA is ensuring that each B. What should I consider as I prepare
in fact certified those meeting minutes my comments for EPA?
on February 24, 2016. The HSRB also pesticide’s registration is based on
will prepare a final report in response current scientific and other knowledge, 1. Submitting CBI. Do not submit this
to questions posed by the EPA, which including its effects on human health information to EPA through
will include the Board’s review and and the environment. regulations.gov or email. Clearly mark
DATES: Comments must be received on the part or all of the information that
analysis of materials presented. The
or before June 10, 2016. you claim to be CBI. For CBI
approved minutes, final report and
information in a disk or CD–ROM that
other materials from the January 12–13, ADDRESSES: Submit your comments
you mail to EPA, mark the outside of the
2016 HSRB meeting are or will be identified by the docket identification
disk or CD–ROM as CBI and then
available in docket ID number EPA– (ID) number for the specific pesticide of
identify electronically within the disk or
HQ–ORD–2015–0588 and on the HSRB interest provided in the table in Unit III.
CD–ROM the specific information that
Web site at http://www.epa.gov/osa/ A., by one of the following methods:
is claimed as CBI. In addition to one
human-studies-review-board. • Federal eRulemaking Portal: http://
complete version of the comment that
www.regulations.gov. Follow the online
IX. Other Related Information on TCVP includes information claimed as CBI, a
instructions for submitting comments.
copy of the comment that does not
Do not submit electronically any
The public can view EPA’s draft contain the information claimed as CBI
information you consider to be
human health and ecological risk must be submitted for inclusion in the
Confidential Business Information (CBI)
assessment and supporting documents public docket. Information so marked
or other information whose disclosure is
for the registration review of TCVP in will not be disclosed except in
restricted by statute.
the docket at http://www.regulations.gov accordance with procedures set forth in
• Mail: OPP Docket, Environmental
(see docket ID number EPA–HQ–OPP– 40 CFR part 2.
Protection Agency Docket Center (EPA/ 2. Tips for preparing your comments.
2008–0316). Information on the DC), (28221T), 1200 Pennsylvania Ave.
Agency’s registration review program When preparing and submitting your
NW., Washington, DC 20460–0001. comments, see the commenting tips at
and its implementing regulation is • Hand Delivery: To make special http://www.epa.gov/dockets/
available at https://www.epa.gov/ arrangements for hand delivery or comments.html.
pesticide-reevaluation/registration- delivery of boxed information, please 3. Environmental justice. EPA seeks to
review-process. follow the instructions at http:// achieve environmental justice, the fair
Authority: 7 U.S.C. 136 et seq. www.epa.gov/dockets/contacts.html. treatment and meaningful involvement
Additional instructions on commenting of any group, including minority and/or
Dated: March 28, 2016. or visiting the docket, along with more
mstockstill on DSK4VPTVN1PROD with NOTICES

low income populations, in the
Jack E. Housenger, information about dockets generally, is development, implementation, and
Director, Office of Pesticide Programs, Office available at http://www.epa.gov/ enforcement of environmental laws,
of Chemical Safety and Pollution Prevention. dockets. regulations, and policies. To help
[FR Doc. 2016–08281 Filed 4–8–16; 8:45 am] FOR FURTHER INFORMATION CONTACT: For address potential environmental justice
BILLING CODE 6560–50–P pesticide specific information contact: issues, the Agency seeks information on
The person identified as a contact in the any groups or segments of the
table in Unit III.A. Also include the population who, as a result of their

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Document Created: 2016-04-09 00:11:37
Document Modified: 2016-04-09 00:11:37
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments must be received on or before May 11, 2016.
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
FR Citation		81 FR 21335