INCIDENT REPORTS ASSOCIATED WITH HALOHYDANTOINS ( PC CODE: 006315, 006317, 115501, 115502, 028501, and128826)

July 27, 2004 U. S. Environmental Protection Agency Office of Pesticide Programs Antimicrobials Division TABLE OF CONTENTS 0.0 INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1.0 INCIDENT REPORT DATA ASSOCIATED WITH HEALTH EFFECTS OF HYDANTOIN EXPOSURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1.1 OPP's Incident Data System ( IDS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1.2 Poison Control Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 1.3 California Data  1982 through 1996 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 1.4 National Pesticide Telecommunications Network ( NPTN) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1.5 Incident Reports Associated with Acute Toxic Effects of TEG Published in Scientific Literature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2.0 EPIDEMIOLOGICAL DATA ASSOCIATED WITH CHRONIC HEALTH EFFECTS OF HYDANTOIN EXPOSURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 3.0 SUMMARY AND CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 4.0 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Page 3 of 9 0.0 INTRODUCTION Hydantoins are antimicrobials used to control slime formation in water systems. Registered use sites include cooling water systems, paper and paperboard process water, wastewater treatment, use as an in tank toilet bowl sanitizer, and use in swimming pools. The dihalodialkylhydantoins are a group of chemicals composed of several halogenated compounds ( i. e. a central organic hydantoin ring moiety ( either dimethylhydantoin or ethylmethylhydantoin) to which halogen atoms ( bromine and/ or chlorine) can be attached at both the 1 and 3 positions on the hydantoin ring), as well as hydroxymethylhydantoin compounds ( 1,3 bis( hydroxymethyl) 5,5 dimethyl hydantoin and 1 hydroxymethyl) 5,5 dimethylhydantoin). The purpose of this chapter is to review the evidence of health effects in humans resulting from exposure to dihalodialkylhydantoins.

Two approaches are used in this section:

° The potential health effects of dihalodialkylhydantoins in humans, reported as incident reports from different sources, are summarized.

° A literature search of chronic health effects associated with dihalodialkylhydantoins exposure, including results of epidemiological studies, are summarized.

This reports summarized the potential health effects of hydantoins in humans, reported as incident reports from different sources.

1.0 INCIDENT REPORT DATA ASSOCIATED WITH HEALTH EFFECTS OF HYDANTOIN EXPOSURE The following databases have been consulted for the poisoning incident data on the active ingredient dihalodialkylhydantoins ( PC Code: 006315, 006317, 115501, 115502, 028501, and128826)

a. OPP Incident Data System ( IDS)  The Incident Data System of The Office of Pesticide Programs ( OPP) of the Environmental Protection Agency ( EPA) contains reports of incidents from various sources, including registrants, other federal and state health and environmental agencies and individual consumers, submitted to OPP since 1992. Reports submitted to the Incident Data System represent anecdotal reports or allegations only, unless otherwise stated. Typically no conclusions can be drawn implicating the pesticide as a cause of any of the reported health effects. Nevertheless, sometimes with enough cases and/ or enough documentation risk mitigation measures may be suggested.

b. Poison Control Centers  as the result of a data purchase by EPA, OPP received Page 4 of 9 Poison Control Center data covering the years 1993 through 1998 for all pesticides. Most of the national Poison Control Centers ( PCCs) participate in a national data collection system, the Toxic Exposure Surveillance System, which obtains data from about 65 70 centers at hospitals and universities. PCCs provide telephone consultation for individuals and health care providers on suspected poisonings, involving drugs, household products, pesticides, etc.

c. California Department of Pesticide Regulation  California has collected uniform data on suspected pesticide poisonings since 1982. Physicians are required, by statute, to report to their local health officer all occurrences of illness suspected of being related to exposure to pesticides. The majority of the incidents involve workers. Information on exposure ( worker activity), type of illness ( systemic, eye, skin, eye/ skin and respiratory), likelihood of a causal relationship, and number of days off work and in the hospital are provided.

d. National Pesticide Telecommunications Network ( NPTN)  NPTN is a toll free information service supported by OPP. A ranking of the top 200 active ingredients for which telephone calls were received during calendar years 1984 1991, inclusive, has been prepared. The total number of calls was tabulated for the categories human incidents, animal incidents, calls for information, and others.

e. Published Incident Reports  Some incident reports associated with hydantoins related human health hazard are published in the scientific literature.

1.1 OPP's Incident Data System ( IDS)

A total of 126 individual incident cases submitted to the EPA Office of Pesticide Programs involving the use of dihalodialkylhydantoin containing products were reviewed to determine the effects of exposure to dihalodialkylhydantoin. The reported routes of exposure for the 126 incident cases were dermal ( 44%), ocular ( 25%), ingestion ( 7%) and inhalation( 43%). In some cases more than one route of exposure applied for an individual incident case ( e. g., both dermal and ocular exposure).

The most common symptoms reported for cases of dermal exposure were skin irritation/ burning ( 91%), rash ( 36%), itching ( 14%), skin discoloration/ redness ( 11%), hives/ welts ( 9%), blistering ( 7%), allergic reaction ( 5%), and bleeding ( 2%). The most common symptoms reported for cases of ocular exposure were eye irritation/ burning ( 100%), eye pain ( 31%), and swelling of eyes ( 3%).

The most common symptoms reported for cases of inhalation exposure were respiratory irritation/ burning ( 70%), irritation to mouth/ throat/ nose ( 33%), coughing/ choking ( 24%), shortness of breath ( 9%), dizziness ( 4%), flu like symptoms ( 4%), headache ( 4%), seizure ( 2%), Page 5 of 9 and heart palpitation ( 2%).

The most common symptoms reported for cases of ingestion were irritation to mouth/ throat/ nose ( 67%), vomiting/ nausea/ abdominal pain ( 11%).

1.2 Poison Control Center All the incidences reported in the Poison Control Center data base were included in the OPP's IDS. No additional data were reported in the Poison Control Center database covering the years 1993 through 1996.

1.3 California Data  1982 through 1998 Detailed descriptions of 28 cases with a definite, probable or possible relationship cases submitted to the California Pesticide Illness Surveillance Program ( 1982 1998) were reviewed. All the reported cases are occupationally related. Table 4 1 presents the types of illnesses reported by year. Table 4 2 gives the total number of workers that took time off work as a result of their illness and how many were hospitalized and for how long.

Table 4 1. Cases Due to Dihalodialkylhydantoin Exposure in California Reported by Type of Illness and Year, 1982 1998 Year Illness Type Systemica Eye Skin Respiratory Combinationb Total 1990  1 1 1 1 1 1991 5 8 1 7 7 13 1992  3 1 2 1 5 1993   1   1 1994  2 2 1 1 3 1995   1   1 1996  1    1 1997    1  1 1998  1 1   2 Page 6 of 9 Year Illness Type Systemica Eye Skin Respiratory Combinationb Total Total 5 16 8 12 10 28 a Category include cases where skin, eye, or respiratory effects were also reported. b Category includes combined irritative effects to eye, skin, and respiratory system.

Table 4 2: Number of Persons Disabled ( taking time off work) or Hospitalized for Indicated Number of Days After Dihalodialkylhydantoin Exposure in California, 1982 1996.

Number of Persons Disabled Number of Persons Hospitalized One day 1

Two days

3 5 days

6 10 days 1

more than 10 days

Unknown 2

1.4 National Pesticide Telecommunications Network ( NPTN)

There are no incident reported in the NPTN database related to dihalodialkylhydantoin exposure.

1.5 Incident Reports Associated with Acute Toxic Effects of Hydantoins Published in Scientific Literature.

Several papers have been published outlining the problems associated with the use of dihalodialkylhydantoin. The chemical 1 bromo 3 chloro 5,5 dimethlyhydantoin ( BCDMH), one of four dihalodialkylhydantoins, is commonly used as an alternative to chlorine in the disinfection of swimming pools. Sodium bromide is one end product of BCDMH disinfection. Several case studies of exposure to BCDMH have been reported in the literature and some are briefly summarized here:

A survey performed in 1990 revealed that in chlorinated pools, rashes occurred in 2 out of 1.7 Page 7 of 9 million bathers ( 1.2 per million), while in BCDMH pools, rashes occurred in 43 out of 31,000 ( 1,387 per million) annual bathers ( Penny, 1991). The incidence of rashes appears to occur more often in the elderly population; approximately 20% in those over 70 years old and only about 0.2% in those under 20 years old. The reaction to BCDMH is considered to be an irritant contact dermatitis, rather than an allergic mechanism, since people who develop rashes do not test positive to patch tests of a 1% solution of DiHalo ® , a formulation of BCDMH.

Rycroft and Penny ( 1983) reported cases that happened in swimming pools in the United Kingdom. Nighteen brominated pools were visited. After visiting 19 swimming pools treated with BCDMH, 65 patients with rashes were seen. In one swimming pool, it was estimated that at least 5% of users of the pools had experienced itching after swimming and most had developed rashes. Penny ( 1999) summarized the typical features of a BCDMH. In most cases, exposure to BCDMH results in the development of an intensely itchy rash which starts within 12 hours of the exposure. Progression of the reaction leads to widespread dermatitis of varying distributions which occasionally include lesions and can be associated with fever and malaise. Re exposure can be considerably hazardous especially shortly after occurrence of the rash and many people find the symptoms so severe that they can no longer swim in pools treated with BCDMH . In some cases, people who develop rashes are unable to return to chlorinated pools, which suggests a cumulative trauma irritant dermatitis. It is believed that exposure causes the skin defenses to become damaged and that subsequent exposure to weaker irritants may then cause problems.

Morgan ( 1983) reported on a local swimming pool which had changed from using a chlorine disinfectant to Di Halo ( the active ingredient is BCDMH) . After the switch in disinfectant, 21 people developed a skin reaction. Seven of the 21 affected were children.

Malten et al. ( 1985) discussed the effects of exposure to Aquabrom, an antimicrobial agent containing dihalodialkylhydantoin used in indoor swimming pools. Children and elderly were observed to develop generalized dermatitis after frequent visits to the pools. One young girl exhibited deviations from normal resistance values after her forearm skin was exposed to the chemical on 4 consecutive days, for 1 hour per day at a 0.05% concentration. An elderly male exhibited both decreased resistance and water vapor loss after his skin was exposed. Clear deviations from normal were also exhibited by the elderly male subject after 5 consecutive days of 1 hour exposures at a 0.01% concentration of Aquabrom and after 10 days of 1 hour exposure at a 0.002% concentration of Aquabrom. The common usage concentration was reported to be between 0.0003% and 0.001%, which allows for a narrow safety margin between the concentration used here which produced effects and the concentrations normally used.

Loughney and Harrison. ( 1998) report a case on a 46 year old physiotherapist who did hydrotherapy work and developed an intense itching and redness of the skin after exposure to the swimming pool used at work. The itching and redness progressed into a persistent itching of the skin with a generalized dry condition. The patient's exposure was determined to be 3 sessions per week in the pool with each session lasting 3 hours. The pool was disinfected by a closed dosing Page 8 of 9 system with a bromine based disinfectant. Workplace visits and interviews with the staff revealed that 6 out of 15 pool users had mild symptoms of skin irritation and one had a severe case of eczema.

2.0 EPIDEMIOLOGICAL DATA ASSOCIATED WITH CHRONIC HEALTH EFFECTS OF HYDANTOIN EXPOSURE There is no epidemiological data that can be located associated with the chronic health effects of dihalodialkylhydantoins exposure.

3.0 SUMMARY AND CONCLUSION There are many incident reported associated with exposure to end use products containing dihalodialkylhydantoins. Dermal, ocular and inhalation are the primary routes of exposure. Most of the incidences are related to irritation and/ or allergic type reaction. The most common symptoms reported for cases of dermal exposure were skin irritation/ burning, rash, itching, skin discoloration/ redness and blistering. Allergic type reactions including hives/ welts, allergic contact dermatitis, and bleeding have also been reported.. The most common symptoms reported for cases of ocular exposure were eye irritation/ burning. Eye pain and swelling of eyes also have been reported in some incidents.

The most common symptoms reported for cases of inhalation exposure were respiratory irritation/ burning, irritation to mouth/ throat/ nose, coughing/ choking, shortness of breath, dizziness, flu like symptoms, and headache.

Although oral exposure is considered a minor route of exposure for dihalodialkylhydantoin use, irritation to mouth/ throat/ nose, vomiting/ nausea/ abdominal pain have been reported in the cases of ingestion.

There is no epidemiological data that can be located associated with chronic health effects of dihalodialkylhydantoins exposure. Page 9 of 9 4.0 REFERENCES Rycroft, R. J. and Penny, P. T. 1983. Dermatosis associated with brominated swimming pools. Br. Med. J. 287: 462.

Loughney, L. and Harrison, J. 1998. Irritant contact dermatitis due to 1, bromo 3 chloro 5,5 dimentylhydantoin in a hydrotherapy Pool. Risk assessment: the need for continuous evidence based assessment. Occup. Med. 48: 461 463 Morgan, J. M. 1983. Dermatoses associated with brominated swimming pools. Br. Med. J. 287: 913.

Gould, D. J. 1983. Dermatoses associated with brominated swimming pools. Br. Med. J. 287: 913.

Malten K. E. and den Arend J. A. 1985. Irritant contact dermatitis. Traumiterative and cumulative impairment by cosmetics, climate, and other daily loads. Derm Beruf Umwelt 33( 4): 125 32 Penny, P. T. 1991. Hydrotherapy pools of the future  the avoidance of health problems. J. Hosp. Infect. 18: 535 542.


[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Rules and Regulations]
[Pages 14143-14147]
[FR Doc No: 2017-05350]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 101, 112, 115, 117, 118, 507, and 800

[Docket No. FDA-2017-N-0011]

Presiding Officer for an Appeal and Informal Hearing; Technical
Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
making revisions to Chapter I of its regulations. These revisions are
necessary to reflect changes to the Agency's organizational structure,
including the dissolution of the Regional Food and Drug Director
position. The revisions replace references to the Regional Food and
Drug Director, who is designated to preside over administrative appeals
and at informal hearings on appeal, with references to Office of
Regulatory Affairs Program Directors. The rule does not impose any new
regulatory requirements on affected parties. This action is editorial
in nature and is intended to improve the accuracy of the Agency's
regulations.

DATES: This rule is effective March 17, 2017.

FOR FURTHER INFORMATION CONTACT: Peter Fox, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville,
MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA Office of Regulatory Affairs has dissolved the Regional
Food and Drug Director position. Certain duties related to
administrative appeals and informal hearings formerly held by Regional
Food and Drug Directors will transfer to Office of Regulatory Affairs
Program Directors. The revisions made by this rule pertain solely to
the designation of FDA officials and do not alter any substantive
standards.

II. Description of the Technical Amendments

    The regulations specified in this rule have been revised to replace
all references to the ``Regional Food and Drug Director'' with ``Office
of Regulatory Affairs Program Director,'' to reflect the change in
designation. In addition, the regulations have been revised to
authorize other FDA officials senior to an FDA District Director to
perform duties related to administrative appeals and informal hearings.
Finally, we have made minor conforming amendments and grammatical
changes as necessary to accommodate the new language.
    We are making these technical amendments to revise descriptions of
the FDA officials designated to preside over administrative appeals and
at informal hearings on appeal. The rule does not impose any new
regulatory requirements on affected parties. The amendments are
editorial in nature and should not be construed as modifying any
substantive standards or requirements.

III. Notice and Public Comment

    Publication of this document constitutes final action of these
changes under the Administrative Procedure Act (5 U.S.C. 553). Section
553 of the Administrative Procedure Act (APA) exempts ``rules of agency
organization, procedure, or practice'' from proposed rulemaking (i.e.,
notice and comment rulemaking). 5 U.S.C. 553(b)(3)(A). Rules are also
exempt when an agency finds ``good cause'' that notice and comment
rulemaking procedures would be ``impracticable, unnecessary, or
contrary to the public interest.'' 5 U.S.C. 553(b)(3)(B).
    FDA has determined that this rulemaking meets the notice and
comment exemption requirements in 5 U.S.C. 553(b)(3)(A) and (b)(3)(B).
FDA's revisions make technical or non-substantive changes that pertain
solely to the designation of FDA officials, and do not alter any
substantive standard. FDA does not believe public comment is necessary
for these minor revisions.
    The APA allows an effective date less than 30 days after
publication as ``provided by the agency for good cause found and
published with the rule'' (5 U.S.C. 553(d)(3)). A delayed effective
date is unnecessary in this case because the amendments do not impose
any new regulatory requirements on affected parties. As a result,
affected parties do not need time to prepare before the rule takes
effect. Therefore, FDA finds good cause for the amendments to become
effective on the date of publication of this action.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

21 CFR Part 112

    Dietary foods, Food grades and standards, Foods, Fruits, Packaging
and containers, Reporting and recordkeeping requirements, Safety,
Vegetables.

21 CFR Part 115

    Eggs and egg products, Foods.

21 CFR Part 117

    Food packaging, Foods.

21 CFR Part 118

    Eggs and egg products, Food grades and standards, Reporting and
recordkeeping requirements.

21 CFR Part 507

    Animal foods, Labeling, Packaging and containers, Reporting and
recordkeeping requirements.

21 CFR Part 800

    Administrative practice and procedure, Medical devices, Ophthalmic
goods and services, Packaging and containers, Reporting and
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
1, 101, 112, 115, 117, 118, 507, and 800 are amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 continues to read as follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c,
350d, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2,
362, 371, 373, 374, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a,
387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188,
116 Stat. 594, 668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.

0
2. Amend Sec.  1.403 by revising paragraph (f) to read as follows:

Sec.  1.403  What requirements apply to an informal hearing?

* * * * *
    (f) Section 1.404, rather than Sec.  16.42(a) of this chapter,
describes the FDA employees, i.e., Office of Regulatory Affairs Program
Directors or other officials senior to a District Director, who preside
at hearings under this subpart;
* * * * *

0
3. Revise Sec.  1.404 to read as follows:

Sec.  1.404  Who serves as the presiding officer for an appeal and for
an informal hearing?

    The presiding officer for an appeal, and for an informal hearing,
must be an Office of Regulatory Affairs Program Director or another FDA
official senior to an FDA District Director.

0
4. Amend Sec.  1.980 by revising paragraphs (g)(3)(iv) and (g)(4) to
read as follows:

Sec.  1.980  Administrative detention of drugs.

* * * * *
    (g) * * *
    (3) * * *
    (iv) Paragraph (g)(4) of this section, rather than Sec.  16.42(a)
of this chapter, describes the FDA employees, i.e., Office of
Regulatory Affairs Program Directors or other FDA officials senior to
an FDA District Director, who preside at hearings under this section.
    (4) The presiding officer of a regulatory hearing on an appeal of a
detention order, who also must decide the appeal, must be an Office of
Regulatory Affairs Program Director or another FDA official senior to
an FDA District Director who is permitted by Sec.  16.42(a) of this
chapter to preside over the hearing.
* * * * *

PART 101--FOOD LABELING

0
5. The authority citation for part 101 continues to read as follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.

0
6. Amend Sec.  101.17 by revising paragraphs (h)(7)(ii) introductory
text, (h)(7)(ii)(B), (h)(7)(ii)(C) introductory text, (h)(7)(ii)(C)(1),
(h)(7)(ii)(C)(4), (h)(7)(ii)(C)(5), (h)(7)(ii)(C)(6), (h)(7)(ii)(D),
(h)(7)(ii)(E), and (h)(7)(ii)(F) to read as follows:

Sec.  101.17  Food labeling warning, notice, and safe handling
statements.

* * * * *
    (h) * * *
    (7) * * *
    (ii) The person on whom the order for relabeling, diversion, or
destruction is served may either comply with the order or appeal the
order to an Office of Regulatory Affairs Program Director.
* * * * *
    (B) Summary decision. A request for a hearing may be denied, in
whole or in part and at any time after a request for a hearing has been
submitted, if the Office of Regulatory Affairs Program Director or
another FDA official senior to an FDA District Director determines that
no genuine and substantial issue of fact has been raised by the
material submitted in connection with the hearing or from matters
officially noticed. If the presiding FDA official determines that a
hearing is not justified, written notice of the determination will be
given to the parties explaining the reason for denial.
    (C) Informal hearing. Appearance by any appellant at the hearing
may be by mail or in person, with or without counsel. The informal
hearing shall be conducted by an Office of Regulatory Affairs Program
Director or another FDA official senior to an FDA District Director,
and a written summary of the proceedings shall be prepared by the
presiding FDA official.
    (1) The presiding FDA official may direct that the hearing be
conducted in any suitable manner permitted by law and this section. The
presiding FDA official has the power to take such actions and make such
rulings as are necessary or appropriate to maintain order and to
conduct an informal, fair, expeditious, and impartial hearing, and to
enforce the requirements concerning the conduct of hearings.
* * * * *
    (4) The party requesting the hearing may have the hearing
transcribed, at the party's expense, in which case a copy of the
transcript is to be furnished to FDA. Any transcript of the hearing
will be included with the presiding FDA official's report of the
hearing.
    (5) The presiding FDA official shall prepare a written report of
the hearing. All written material presented at the hearing will be
attached to the report. Whenever time permits, the presiding FDA
official may give the parties the opportunity to review and comment on
the report of the hearing.
    (6) The presiding FDA official shall include as part of the report
of the hearing a finding on the credibility of witnesses (other than
expert witnesses) whenever credibility is a material issue, and shall
include a recommended decision, with a statement of reasons.
    (D) Written appeal. If the appellant appeals the detention order
but does not request a hearing, the presiding FDA official shall render
a decision on the appeal affirming or revoking the detention within 5-
working days after the receipt of the appeal.
    (E) Presiding FDA official's decision. If, based on the evidence
presented at the hearing or by the appellant in a written appeal, the
presiding FDA official finds that the shell eggs were held in violation
of this section, he shall affirm the order that they be relabeled,
diverted under the supervision of an officer or employee of FDA for
processing under the EPIA, or destroyed by or under the supervision of
an officer or employee of FDA; otherwise, the presiding FDA official
shall issue a written notice that the prior order is withdrawn. If the
presiding FDA official affirms the order, he shall order that the
relabeling, diversion, or destruction be accomplished within 10-working
days from the date of the issuance of his decision. The presiding FDA
official's decision shall be accompanied by a statement of the reasons
for the decision. The decision of the presiding FDA official shall
constitute final agency action, reviewable in the courts.
    (F) No appeal. If there is no appeal of the order and the person in
possession of the shell eggs that are subject to the order fails to
relabel, divert, or destroy them within 10-working days, or if the
demand is affirmed by the presiding FDA official after an appeal and
the person in possession of such eggs fails to relabel, divert, or
destroy them within 10-working days, the FDA district office, or, if
applicable, the State or local agency may designate an officer or
employee to divert or destroy such eggs. It shall be unlawful to
prevent or to attempt to prevent such diversion or destruction of the
shell eggs by the designated officer or employee.
* * * * *

PART 112--STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND
HOLDING OF PRODUCE FOR HUMAN CONSUMPTION

0
7. The authority citation for part 112 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243,
264, 271.

0
8. Revise Sec.  112.209 to read as follows:

Sec.  112.209   Who is the presiding officer for an appeal and for an
informal hearing?

    The presiding officer for an appeal, and for an informal hearing,
must be an Office of Regulatory Affairs Program Director or another FDA
official senior to an FDA District Director.

PART 115--SHELL EGGS

0
9. The authority citation for part 115 continues to read as follows:

    Authority: 21 U.S.C. 342, 371; 42 U.S.C. 243, 264, 271.

0
10. Amend Sec.  115.50 by revising paragraphs (e)(2) introductory text,
(e)(2)(ii), (e)(2)(iii) introductory text, (e)(2)(iii)(A),
(e)(2)(iii)(D), (e)(2)(iii)(E), (e)(2)(iii)(F), (e)(2)(iv), (e)(2)(v),
and (e)(2)(vi) to read as follows:

Sec.  115.50   Refrigeration of shell eggs held for retail
distribution.

* * * * *
    (e) * * *
    (2) The person on whom the order for diversion or destruction is
served may either comply with the order or appeal the order to an
Office of Regulatory Affairs Program Director in accordance with the
following procedures:
* * * * *
    (ii) Summary decision. A request for a hearing may be denied, in
whole or in part and at any time after a request for a hearing has been
submitted, if the Office of Regulatory Affairs Program Director or
another FDA official senior to an FDA District Director determines that
no genuine and substantial issue of fact has been raised by the
material submitted in connection with the hearing or from matters
officially noticed. If the presiding FDA official determines that a
hearing is not justified, written notice of the determination will be
given to the parties explaining the reason for denial.
    (iii) Informal hearing. Appearance by any appellant at the hearing
may be by mail or in person, with or without counsel. The informal
hearing shall be conducted by the Office of Regulatory Affairs Program
Director or another FDA official senior to an FDA District Director,
and a written summary of the proceedings shall be prepared by the
presiding FDA official.
    (A) The presiding FDA official may direct that the hearing be
conducted in any suitable manner permitted by law and this section. The
presiding FDA official has the power to take such actions and make such
rulings as are necessary or appropriate to maintain order and to
conduct an informal, fair, expeditious, and impartial hearing, and to
enforce the requirements concerning the conduct of hearings.
* * * * *
    (D) The party requesting the hearing may have the hearing
transcribed, at the party's expense, in which case a copy of

the transcript is to be furnished to FDA. Any transcript of the hearing
will be included with the presiding FDA official's report of the
hearing.
    (E) The presiding FDA official shall prepare a written report of
the hearing. All written material presented at the hearing will be
attached to the report. Whenever time permits, the presiding FDA
official may give the parties the opportunity to review and comment on
the report of the hearing.
    (F) The presiding FDA official shall include as part of the report
of the hearing a finding on the credibility of witnesses (other than
expert witnesses) whenever credibility is a material issue, and shall
include a recommended decision, with a statement of reasons.
    (iv) Written appeal. If the appellant appeals the detention order
but does not request a hearing, the presiding FDA official shall render
a decision on the appeal affirming or revoking the detention within 5-
working days after the receipt of the appeal.
    (v) Presiding FDA official's decision. If, based on the evidence
presented at the hearing or by the appellant in a written appeal, the
presiding FDA official finds that the shell eggs were held in violation
of this section, he shall affirm the order that they be diverted, under
the supervision of an officer or employee of FDA for processing under
the EPIA or destroyed by or under the supervision of an officer or
employee of FDA; otherwise, the presiding FDA official shall issue a
written notice that the prior order is withdrawn. If the presiding FDA
official affirms the order, he shall order that the diversion or
destruction be accomplished within 10-working days from the date of the
issuance of his decision. The presiding FDA official's decision shall
be accompanied by a statement of the reasons for the decision. The
decision of the presiding FDA official shall constitute final agency
action, reviewable in the courts.
    (vi) No appeal. If there is no appeal of the order and the person
in possession of the shell eggs that are subject to the order fails to
divert or destroy them within 10-working days, or if the demand is
affirmed by the presiding FDA official after an appeal and the person
in possession of such eggs fails to divert or destroy them within 10-
working days, FDA's district office or appropriate State or local
agency may designate an officer or employee to divert or destroy such
eggs. It shall be unlawful to prevent or to attempt to prevent such
diversion or destruction of the shell eggs by the designated officer or
employee.
* * * * *

PART 117--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND
RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

0
11. The authority citation for part 117 continues to read as follows:

    Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note,
371, 374; 42 U.S.C. 243, 264, 271.

0
12. Revise Sec.  117.274 to read as follows:

Sec.  117.274  Presiding officer for an appeal and for an informal
hearing.

    The presiding officer for an appeal, and for an informal hearing,
must be an Office of Regulatory Affairs Program Director or another FDA
official senior to an FDA District Director.

PART 118--PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS

    13. The authority citation for part 118 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331- 334, 342, 371, 381, 393, 42
U.S.C. 243, 264, 271.

0
14. Amend Sec.  118.12 by revising paragraphs (a)(1)(i) introductory
text, (a)(2) introductory text, (a)(2)(ii), (a)(2)(iii) introductory
text, (a)(2)(iii)(A), (a)(2)(iii)(D), (a)(2)(iii)(E), (a)(2)(iii)(F),
(a)(2)(v), and (a)(2)(vi) to read as follows:

Sec.  118.12  Enforcement and compliance.

* * * * *
    (a) * * *
    (1) * * *
    (i) Order for diversion or destruction under the PHS Act. Any
district office of FDA or any State or locality acting under paragraph
(c) of this section, upon finding shell eggs that have been produced or
held in violation of this regulation, may serve a written order upon
the person in whose possession the eggs are found requiring that the
eggs be diverted, under the supervision of an officer or employee of
the issuing entity, for processing in accordance with the EPIA (21
U.S.C. 1031 et seq.) or by a treatment that achieves at least a 5-long
destruction of SE or destroyed by or under the supervision of the
issuing entity, within 10-working days from the date of receipt of the
order, unless under paragraph (a)(2)(iii) of this section, a hearing is
held, in which case the eggs must be diverted or destroyed consistent
with the decision of the Office of Regulatory Affairs Program Director
or another FDA official senior to an FDA District Director under
paragraph (a)(2)(v) of this section. The order must include the
following information:
* * * * *
    (2) The person on whom the order for diversion or destruction is
served may either comply with the order or appeal the order to an
Office of Regulatory Affairs Program Director in accordance with the
following procedures:
* * * * *
    (ii) Summary decision. A request for a hearing may be denied, in
whole or in part and at any time after a request for a hearing has been
submitted, if the Office of Regulatory Affairs Program Director or
another FDA official senior to an FDA District Director determines that
no genuine and substantial issue of fact has been raised by the
material submitted in connection with the hearing or from matters
officially noticed. If the presiding FDA official determines that a
hearing is not justified, written notice of the determination will be
given to the parties explaining the reason for denial.
    (iii) Informal hearing. Appearance by any appellant at the hearing
may be by mail or in person, with or without counsel. The informal
hearing must be conducted by the Office of Regulatory Affairs Program
Director or another FDA official senior to an FDA District Director,
and a written summary of the proceedings must be prepared by the
presiding FDA official.
    (A) The presiding FDA official may direct that the hearing be
conducted in any suitable manner permitted by law and by this section.
The presiding FDA official has the power to take such actions and make
such rulings as are necessary or appropriate to maintain order and to
conduct an informal, fair, expeditious, and impartial hearing, and to
enforce the requirements concerning the conduct of hearings.
* * * * *
    (D) The party requesting the hearing may have the hearing
transcribed, at the party's expense, in which case a copy of the
transcript is to be furnished to FDA. Any transcript of the hearing
will be included with the presiding FDA official's report of the
hearing.
    (E) The presiding FDA official must prepare a written report of the
hearing. All written material presented at the hearing will be attached
to the report. Whenever time permits, the presiding FDA official may
give the parties the opportunity to review and comment on the report of
the hearing.
    (F) The presiding FDA official must include as part of the report
of the hearing a finding on the credibility of witnesses (other than
expert witnesses) whenever credibility is a material issue,

and must include a recommended decision, with a statement of reasons.
    (iv) Written appeal. If the appellant appeals the detention order
but does not request a hearing, the presiding FDA official must render
a decision on the appeal affirming or revoking the detention order
within 5-working days after the receipt of the appeal.
    (v) Presiding FDA official's decision. If, based on the evidence
presented at the hearing or by the appellant in a written appeal, the
presiding FDA official finds that the shell eggs were produced or held
in violation of this section, he must affirm the order that they be
diverted, under the supervision of an officer or employee of FDA for
processing under the EPIA or by a treatment that achieves at least a 5-
log destruction of SE or destroyed by or under the supervision of an
officer or employee of FDA; otherwise, the presiding FDA official must
issue a written notice that the prior order is withdrawn. If the
presiding FDA official affirms the order, he must order that the
diversion or destruction be accomplished within 10-working days from
the date of the issuance of his decision. The presiding FDA official's
decision must be accompanied by a statement of the reasons for the
decision. The decision of the presiding FDA official constitutes final
agency action, subject to judicial review.
    (vi) No appeal. If there is no appeal of the order and the person
in possession of the shell eggs that are subject to the order fails to
divert or destroy them within 10-working days, or if the demand is
affirmed by the presiding FDA official after an appeal and the person
in possession of such eggs fails to divert or destroy them within 10-
working days, FDA's district office or, if applicable, the State or
local representative may designate an officer or employee to divert or
destroy such eggs. It shall be unlawful to prevent or to attempt to
prevent such diversion or destruction of the shell eggs by the
designated officer or employee.
* * * * *

PART 507--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND
RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS

0
15. The authority citation for part 507 continues to read as follows:

    Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note,
371, 374; 42 U.S.C. 243, 264, 271.

0
16. Revise Sec.  507.75 to read as follows:

Sec.  507.75  Residing officer for an appeal and for an informal
hearing.

    The presiding officer for an appeal, and for an informal hearing,
must be an Office of Regulatory Affairs Program Director or another FDA
official senior to an FDA District Director.

PART 800--GENERAL

0
17. The authority citation for part 800 continues to read as follows:

    Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k,
361, 362, 371.

0
18. Amend Sec.  800.55 by revising paragraphs (g)(3)(iv) and (g)(4) to
read as follows:

Sec.  800.55  Administrative detention.

* * * * *
    (g) * * *
    (3) * * *
    (iv) Paragraph (g)(4) of this section, rather than Sec.  16.42(a)
of this chapter, describes the FDA employees, i.e., Office of
Regulatory Affairs Program Directors or other FDA officials senior to
an FDA District Director, who preside at hearings under this section.
    (4) The presiding officer of a regulatory hearing on an appeal of a
detention order, who also shall decide the appeal, shall be an Office
of Regulatory Affairs Program Director or another FDA official senior
to an FDA District Director who is permitted by Sec.  16.42(a) of this
chapter to preside over the hearing.
* * * * *

    Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05350 Filed 3-16-17; 8:45 am]
 BILLING CODE 4164-01-P


  MacroButton macIb01 i

<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER  >

<EPA Registration Division contact: [Shaunta Hill, 703/347-8961]>

<INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.>

<TEMPLATE:>

<[BASF Corporation]>

<[0F7695]>

<	EPA has received a pesticide petition ([0F7695]) from [BASF
Corporation], [P.O Box 13528, Research Triangle Park, NC, 27709]
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by
establishing a tolerance for residues of [ametoctradin,
5-ethyl-6-octyl[1,2,4]triazolo[1,5-a]pyrimidin-7-amine] in or on the raw
agricultural commodities [brassica, head and stem, subgroup, at 12 parts
per million (ppm); brassica, leafy greens, subgroup, at 50 ppm; grape at
5 ppm; hop, dried cones, at 9 ppm; onion, bulb, subgroup, at 1.2 ppm;
onion, green, subgroup, at 16 ppm; raisin at 8 ppm; vegetable, fruiting,
group, at 2 ppm; vegetable, leafy, except brassica, group, at 70 ppm;
vegetable, cucurbit, group, at 4.5 ppm; vegetable, tuberous and corm,
subgroup, at 0.05 ppm ] and by establishing an exemption from the
requirement of a tolerance [for the metabolites M650F03,
(7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-y-l)acetic acid, and
M650F04, 7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic
acid in all food crops.]  EPA has determined that the petition contains
data or information regarding the elements set forth in section 408
(d)(2) of  FDDCA; 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.>

<A. Residue Chemistry>

>

<	2. Analytical method. [The proposed enforcement method for
ametoctradin was fully validated.  Ametoctradin is extracted with a
mixture of methanol/water. An aliquot of the extract is centrifuged and
partitioned against dichloromethane. The final determination of
ametoctradin is performed by HPLC-MS/MS.  This method has a limit of
quantitation of 0.01 mg/kg and is suitable for enforcement purposes. ]>

<	3. Magnitude of residues. [Supervised field trials were carried out to
determine the magnitude of the residue in/on brassica, head and stem,
subgroup; brassica, leafy greens, subgroup; grape; hop; dried cones;
onion, bulb, subgroup; onion, green, subgroup; raisin; vegetable,
fruiting, group; vegetable, leafy, except brassica; vegetable, cucurbit,
group; and vegetable, tuberous and corm, subgroup.  The number and
locations of field trials are in accordance with OPPTS Guideline
860.1500. Field trials were carried out using the maximum label rates,
the maximum number of applications, and the minimum pre-harvest interval
(PHI) for all the crops. Detected residues of BAS 650 F in all crops
support the proposed tolerances.]

<B. Toxicological Profile>

<	1. Acute toxicity.

[BAS 650 F and its formulated products have a favorable acute toxicity
profile.   The acute toxicity studies place technical BAS 650 F in the
toxicity category III for the acute oral and the acute dermal category
and category IV for the acute inhalation.  BAS 650 F is category IV for
both eye and skin irritation and is not a dermal sensitizer. ]

>

<	2. Genotoxicty. [BAS 650 F was tested for its genotoxic potential in a
battery of six in vitro or in vivo studies covering the required
endpoints of point mutations, chromosomal damage and DNA damage and
repair.  BAS 650 F did not demonstrate any genotoxic effects.>  BAS 650
F was negative for inducing mutations in both an in vitro Ames test and
an in vitro forward mutation assay in mammalian cells (HPRT test with
and without metabolic activation).  Both an in vitro and an in vivo
chromosome aberration assay (with and without metabolic activation)
showed no evidence of a clastogenic effect.  An in vivo micronucleus
test and an in vivo unscheduled DNA synthesis (UDS) test were also
negative. These studies demonstrate that BAS 650 F is not genotoxic.]

<	3. Reproductive and developmental toxicity. [The reproductive and
developmental toxicity of ametoctradin was investigated in a
2-generation rat reproduction study as well as in rat and rabbit
developmental toxicity studies. In the reproduction study, there were no
effects on fertility. There were no parental toxicity or pup effects at
any of the tested doses (up to and including the limit dose).  The
resulting parental systemic and developmental toxicity NOAEL’s are
1000 mg/kg bw.>

In the rat developmental toxicity study, the administration of
ametoctradin elicited no signs of maternal toxicity, had no influence on
gestational parameters and induced no signs of developmental toxicity at
the dose levels tested (up to and including the limit dose). Based on
these results, the no observed adverse effect level (NOAEL) in rat for
maternal and prenatal developmental toxicity is the limit dose level of
1000 mg/kg bw/d.

The administration of ametoctradin to rabbits elicited no signs of
maternal toxicity, had no influence on gestational parameters and
induced no signs of developmental toxicity at the dose levels tested (up
to and including the limit dose). Based on these results, the no
observed adverse effect level (NOAEL) in rabbit for maternal and
prenatal developmental toxicity is the limit dose level of 1000 mg/kg
bw/d.]

<	4. Subchronic toxicity. [The subchronic toxicity of ametoctradin was
investigated in 90-day feeding studies with rats, mice and dogs as well
as a dermal 28-day repeat dose study with rats.  Dosing at limit doses
(about 1000 mg/kg bw) in these studies caused no substance-related
adverse findings. Due to the lack of adverse findings, target organs
were not identified.  The lowest NOAEL in subchronic oral toxicity
studies was 912 mg/kg bw/day in the dog 90-day study.

The neurotoxic potential of ametoctradin was studied following both
acute and subchronic oral administration in the rat.  In the acute
neurotoxicity study there were no test-item related findings in the
clinical examinations, functional observational battery or the
measurement of motor activity at doses up to and including the limit
dose (2000 mg/kg bw).  Nor did neuropathology reveal any indications for
neurotoxicity at the limit dose. Therefore, ametoctradin did not cause
neurotoxicity up to the limit dose of 2000 mg/kg body weight in animals
of both sexes.

Ametoctradin was also tested in rats in a subchronic neurotoxicity study
at doses up to 15000 ppm in the diet (921.2 mg/kg bw, male and 1077.2
mg/kg bw, female) over a period of three months.  There were no
test-item related findings in the clinical examinations, functional
observational battery or the measurement of motor activity. The
neuropathological treatment-related findings (included brain weight
determination, necropsy and neuropathological examinations by light
microscopy) also showed no treatment-related findings. In summary,
ametoctradin did not show any neurotoxic potential up to the limit dose
of 15000 ppm (921.2 mg/kg bw, male and 1077.2 mg/kg bw, female).]

>

<	5. Chronic toxicity. [The results of long-term oral exposure studies
indicate that ametoctradin is not carcinogenic in mice or rats.  The
chronic toxicity/oncogenicity studies with ametoctradin included a
12-month feeding study with Beagle dogs, an 18-month C57BL/6 J Rj mouse
feeding study and a 24-month Wistar rat chronic/oncogenicity study.

At the limit dose in Beagle dogs, Wistar rats and C57BL/6 J Rj mice
there was no test substance-related adverse findings or evidence of
carcinogenicity.  The resulting NOAEL’s in the mouse oncogenicity
study were 6000 ppm for both sexes (1099 mg/kg bw for the male and 1543
mg/kg bw for the female).  In the rat chronic/oncogenicity study the
NOAEL’s were 15000 ppm for both sexes (870.7 mg/kg bw for the male and
979.3 mg/kg bw for the female).  In the chronic dog study, the NOAEL’s
were 30000 ppm for both sexes (848 mg/kg bw for the male and 936 mg/kg
bw for the female).]

>

<	6. Animal metabolism. [Rat, goat and hen metabolism studies were
conducted to determine the nature of ametoctradin residues in animals.
All studies were conducted with radio labeled ametoctradin.  In
ruminants and poultry ametoctradin is rapidly absorbed and excreted.
Ametoctradin is metabolized in goats and hens by oxidation of the
aliphatic side chain to the respective terminal carboxylic acid and
subsequent stepwise oxidative cleavage of the side chain (loss of
C2-units) analogous to the (-oxidation of fatty acids. The metabolic
pathways in rats, goats and hens were qualitatively similar.]>

	7. Metabolite toxicology. [No metabolites of toxicological concern were
identified.  M650F03 and M650F04, soil metabolites of BAS 650 F, were
evaluated for toxicological relevance.  These metabolites are
structurally similar to each other and to the parent ametoctradin.  To
further investigate the metabolites’ properties, genotoxicity studies
and sub-chronic dietary studies in the rat were conducted.  M650F03 was
not genotoxic in an Ames test (with and without S-9 activation) or in an
HPRT test in CHO cells (with and without S-9 activation). No sign of
chromosomal aberrations was present in vitro (V79 cells, with and
without S-9 activation) or in vivo (NMRI mice, micronucleus test). The
90-day dietary study demonstrated that as with the parent,
administration of M650F03 at dose levels up to and including the limit
dose resulted in no adverse substance-related findings.  M650F04 was not
genotoxic in an Ames test (with and without S-9 activation) or in an
HPRT test in CHO cells (with and without S-9 activation). M650F04 caused
no clastogenic effects in vitro (V79 cells, with and without S-9
activation). The 90-day dietary study demonstrated that as with the
parent, administration of M650F04 at dose levels up to and including the
limit dose resulted in no adverse substance-related findings. Studies
with the M650F03 and M650F04 metabolites confirmed that they are not
toxicologically relevant.]

	8. Endocrine disruption. [No specific tests have been conducted with
ametoctradin to determine whether the chemical may have an effect in
humans that is similar to an effect produced by a naturally occurring
estrogen or other endocrine effects.  However, there were no significant
findings in other relevant toxicity studies (e.g., sub-chronic and
chronic toxicity, developmental toxicity and multi-generation
reproductive studies) which would suggest that ametoctradin produces any
endocrine disruption.]

>

<

C. Aggregate Exposure>

<	1. Dietary exposure. [The dietary exposure assessment for ametoctradin
was conducted using tolerance level residues, 100% crop treated factors,
and default processing factors.  The crops and residue values used in
the assessment were: brassica, head and stem, subgroup, = 12 parts per
million (ppm); brassica, leafy greens, subgroup = 50 ppm; grape = 5 ppm;
hop, dried cones = 9 ppm; onion, bulb, subgroup = 1.2 ppm; onion, green,
subgroup = 16 ppm; raisin = 8 ppm; vegetable, fruiting, group = 2 ppm;
vegetable, leafy, except brassica, group = 70 ppm; vegetable, cucurbit,
group = 4.5 ppm; vegetable, tuberous and corm, subgroup = 0.05 ppm.  An
acute dietary endpoint was not determined because there was no
toxicological effect from a single exposure to ametoctradin.  The
chronic dietary endpoint is based on a NOAEL of 871 mg/kg bw – day
with a safety factor of 100 which resulted in a cPAD = 8.71 mg/kg bw
–day.  ]>

<Food. [

Acute Dietary Exposure Assessment

An acute assessment was not needed since there were no toxic effects
attributable to a single dose.  Therefore, a quantitative acute dietary
exposure and risk assessment were not required.

Acute Dietary Exposure Assessment

The chronic dietary exposure is shown in the table below.  The exposure
includes all food commodities and drinking water.  The dietary (food +
drinking water) utilized less than 1% of the cPAD for all populations.

Table 1.  Summary of Chronic Dietary Exposure Assessment

Considering All Proposed Tolerances for ametoctradin.  The assessment
includes food + drinking water.

Population

Subgroups	Exposure Estimate

(mg/kg b.w./day)	%cPAD

U.S. Population	0.037532	0.4

All Infants	0.022184	0.3

Children 1-2 years	0.054469	0.6

Children 3-5 years	0.050184	0.6

Children 6-12 years	0.037335	0.4

Youth 13-19 years	0.030329	0.3

Adults 20-49 years	0.036924	0.4

Adults 50+ years	0.037945	0.4

Females 13 - 49	0.037273	0.4

%cPAD = percent of chronic population adjusted dose

Exposure estimates based on tolerance values, default processing
factors, and 100% CT for all crops/commodities

 The results indicate that the exposure for ametoctradin is well below
the EPA level of concern.

The risk assessment was repeated with contribution from the metabolite
residues in rotational crops.  The highest total residue value of 0.8
ppm was observed in the field rotational crop study, derived from the
sum of the M650F03 and M650F04 residues in parent equivalents from a
118-day wheat straw sample.  For this assessment, this value of 0.8 ppm
was applied to all crops in the DEEM database that could possibly be
considered for crop rotation.  315 commodities were included.  In
addition, this value was also applied to potato commodities, since it is
higher than the proposed tolerance in potatoes.  The result of this
assessment is shown in Table 2.

Table 2.    Chronic Dietary Risk Assessment considering parent residue
on target crops and 0.8 ppm metabolite residue in rotational crops

	(315 commodities included)

Consumer Group	%ADI

US Population (total)	0.4

All infants (<1 yr)	0.4

Children 1-2 yrs	0.8

Children 3-5 yrs	0.7

Children 6-12 yrs	0.5

Youth 13-19 yrs	0.4

Adults 20-49 yrs	0.5

Adults 50+	0.5

Females 13-49 yrs	0.5

This assessment is overly conservative, especially considering the fact
that metabolite residues in rotational crops were relatively low in
consumer food items, compared to feed items.  When the results from the
two risk assessments are compared, it can be seen that there is no
significant difference in the consumer risk assessment when the two soil
metabolites are included.  All consumer groups are below 1% of the ADI
for both assessments.]

>

<ii. Drinking water.

[The drinking water exposure was modeled for all proposed uses using the
proposed label directions and the appropriate environmental fate data
for ametoctradin.  The highest drinking water values were obtained from
the PA tomato scenario.  Based on the PRZM/EXAMS model, the peak EDWCs
for chronic exposure are estimated to be 0.206 ug/L in surface water.

Acute Aggregate Exposure and Risk (Food and water)

Toxicology studies have shown that ametoctradin poses no acute dietary
risk.  Therefore an acute aggregate exposure assessment was not
required.

Short- and Intermediate Term Aggregate Exposure and Risk (food, water,
and residential)

Residential uses for ametoctradin are not being pursued, therefore a
short and intermediate term aggregate exposure and risk assessment was
not required.

 Chronic Aggregate Exposure and Risk (food and water)

The aggregate chronic risk includes residues of ametoctradin from food
and water (Table 1). The results demonstrate there are no safety
concerns for any subpopulation based on the proposed new uses, and that
the results clearly meet the FQPA standard of reasonable certainty of no
harm.]

>

<	2. Non-dietary exposure. [Residential uses for ametoctradin are not
being pursued, therefore, a non-dietary exposure and risk assessment was
not required. ]>

<D. Cumulative Effects>

<	["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." Unlike other pesticides for which EPA has
followed a cumulative risk approach based on a common mechanism of
toxicity, EPA has not made a common mechanism of toxicity finding as to
ametoctradin. In addition, ametoctradin does not produce a toxic
metabolite produced by other substances. Therefore, for the purposes of
this tolerance action, BASF assumes that ametoctradin does not have a
common mechanism of toxicity with other substances.]

>

<E. Safety Determination>

<	1. U.S. population. [Based on this risk assessment, BASF concludes
that there is a reasonable certainty that no harm will result to the
general population from the aggregate exposure to ametoctradin.]>

<	2. Infants and children. [Based on this risk assessment, BASF
concludes that there is a reasonable certainty that no harm will result
to infants or children from the aggregate exposure to ametoctradin.]>

<F. International Tolerances>

<	[A maximum residue level (MRL) has not been established for
ametoctradin in any crop by the Codex Alimentarius Commission.]>

 PAGE

 PAGE   2

{</P>}


[Federal Register Volume 86, Number 35 (Wednesday, February 24, 2021)]
[Notices]
[Pages 11289-11290]
[FR Doc No: 2021-03795]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-0482-0012; FRL-10020-76-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; SmartWay Transport Partnership (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), SmartWay Transport Partnership
(EPA ICR Number 2265.04, OMB Control Number 2060-0663) to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act. This is a proposed extension of the ICR,
which is currently approved through April 21, 2021. Public comments
were previously requested via the Federal Register filed on July 27,
2020 during a 60-day comment period. This notice allows for an
additional 30 days for public comments. A fuller description of the ICR
is given below, including its estimated burden and cost to the public.
An agency may not conduct or sponsor and a person is not required to
respond to a collection of information unless it displays a currently
valid OMB control number.

DATES: Additional comments may be submitted on or before March 26,
2021.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2007-0482-0012, online using www.regulations.gov (our preferred
method), by email to<EMAIL_ADDRESS>or by mail to: EPA Docket
Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all
comments received will be included in the public docket without change
including any personal information provided, unless the comment
includes profanity, threats, information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Erik Herzog, Office of Transportation
and Air Quality, Environmental Protection Agency, 2000 Traverwood
Drive, S-68, Ann Arbor, MI 48105; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: SmartWay is open to organizations that own, operate, or
contract with fleet operations, including truck, rail, barge, air and
multi-modal carriers, logistics companies, and shippers. Organizations
that do not operate fleets, but that are working to strengthen the
freight industry, such as industry trade associations, state and local
transportation agencies and environmental groups, also may join as
SmartWay affiliates. All organizations that join SmartWay are asked to
provide EPA with information as part of their SmartWay registration to
annually benchmark their transportation-related operations and improve
the environmental performance of their freight activities.
    A company joins SmartWay when it completes and submits a SmartWay
Excel-based tool (``reporting tool'') to EPA. The data outputs from the
submitted tool are used by partners and SmartWay in several ways.
First, the data provides confirmation that SmartWay partners are
meeting established objectives in their Partnership Agreement. The
reporting tool outputs enable EPA to assist SmartWay partners as
appropriate, and to update them with environmental performance and
technology information that empower them to improve their efficiency.
This information also improves EPA's knowledge and understanding of the
environmental and energy impacts associated with goods movement, and
the effectiveness of both proven and emerging strategies to lessen
those impacts.
    In addition to requesting annual freight transportation-related
data, EPA may ask its SmartWay partners for other kinds of information
which could include opinions and test data on the effectiveness of new
and emerging technology applications, sales volumes associated with
SmartWay-recommended vehicle equipment and technologies, the reach and
value of partnering with EPA through the SmartWay Partnership, and
awareness of the SmartWay brand. In some instances, EPA might query
other freight industry representatives (not just SmartWay partners),
including trade and professional associations, nonprofit environmental
groups, energy and community organizations, and universities, and a
small sampling of the general public.
    Form Numbers: Excellence Award Application: 5900-488, Smartway
Signature Page and Tractor Trailer Equipment Checklist: 5900-489,
Affiliate Agreement: 5900-490, Designated License Agreement: 5900-491.
    Respondents/affected entities: Private and public organizations;
freight industry representatives who engage in activities related to
the SmartWay Partnership; and the general public.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 4,925 (total).
    Frequency of response: Once for affiliates and generally annually
for partners.
    Total estimated burden: 12,830 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $861,881 (per year) for labor costs, includes
$0 annualized capital or operation & maintenance costs.
    Changes in the Estimates: Elimination of the Affiliate Challenge
and efficiencies gained through the use of the online reporting tool
have created burden reductions of 22 and 1,105 respectively for a total
reduction 1,127 hours. These reductions counteract a total burden
increase of 733 hours that results from increased participation in the
program and burden calculation adjustments. In this renewal ICR there
is an anticipated net reduction of 394 hours.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2021-03795 Filed 2-23-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 44 (Tuesday, March 6, 2018)]
[Notices]
[Page 9505]
[FR Doc No: 2018-04462]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL18-26-000; Docket No. AD18-8-000]

EDF Renewable Energy, Inc. v. Reform of Affected System
Coordination in the Generator Interconnection Process, v. Midcontinent
Independent System Operator, Inc., Southwest Power Pool, Inc., and PJM
Interconnection, L.L.C.; Supplemental Notice of Technical Conference

    As announced in the Notice of Technical Conference issued in this
proceeding on February 2, 2018, the Federal Energy Regulatory
Commission (Commission) will convene a staff-led technical conference
in the above-referenced proceeding on Tuesday and Wednesday, April 3-4,
2018 from 9:30 a.m. to 4:30 p.m. (ET). The conference will be held in
the Commission Meeting Room at Commission headquarters, 888 First
Street NE, Washington, DC 20426. Commissioners may attend and
participate. The purpose of this conference is to discuss issues
related to the coordination of affected systems that have been raised
in the complaint filed by EDF Renewable Energy, Inc. against
Midcontinent Independent System Operator, Inc., Southwest Power Pool,
Inc., and PJM Interconnection, L.L.C. in Docket No. EL18-26-000 and in
the Commission's Notice of Proposed Rulemaking (Generator
Interconnection NOPR) on the interconnection process in Docket No.
RM17-8-000. The first day of the conference will focus on questions
specific to issues raised in the complaint filed in Docket No. EL18-26-
000, while the second day of the conference will focus on the broader
affected systems issues raised in the Generator Interconnection NOPR in
Docket No. RM17-8-000.
    Attached to this Supplemental Notice is a preliminary agenda for
the technical conference. Additional information regarding the final
conference program and speakers will be provided in a subsequent
supplemental notice of technical conference.
    Those interested in speaking at the technical conference should
notify the Commission by March 2, 2018 by completing the online form at
the following web page: http://www.ferc.gov/whats-new/registration/04-03-18-speaker-form.asp. At this web page, please describe the topic(s)
you wish to address and provide biographical information. Due to time
constraints, we may not be able to accommodate all those interested in
speaking. We will notify selected speakers as soon as possible.
    The conference will be open for the public to attend. Information
on the technical conference will also be posted on the Calendar of
Events on the Commission's website, http://www.ferc.gov, prior to the
event. Advance registration is not required but is encouraged.
Attendees may register at the following web page: http://www.ferc.gov/whats-new/registration/04-03-18-form.asp.
    This event will be webcast and transcribed. Anyone with internet
access can navigate to the ``FERC Calendar'' at www.ferc.gov and locate
the technical conference in the Calendar of Events. Opening the
technical conference in the Calendar of Events will reveal a link to
its webcast. The Capitol Connection provides technical support for the
webcast and offers the option of listening to the meeting via phone-
bridge for a fee. If you have any questions, visit
www.capitolconnection.org or call<PHONE_NUMBER>. The webcast will be
available on the Calendar of Events at www.ferc.gov for three months
after the conference. Transcripts of the conference will be immediately
available for a fee from Ace-Federal Reporters, Inc.<PHONE_NUMBER>).
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to [email protected] or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER> with
the required accommodations.
    For more information about this technical conference, please
contact:

Sarah McKinley (Logistical Information), Office of External Affairs,
(202) 502-8004, [email protected].
Myra Sinnott (Technical Information), Office of Energy Policy and
Innovation,<PHONE_NUMBER>, [email protected].
Kathleen Ratcliff (Technical Information), Office of Energy Market
Regulation,<PHONE_NUMBER>, [email protected].
Lina Naik (Legal Information), Office of the General Counsel, (202)
502-8882 [email protected].

    Dated: February 27, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-04462 Filed 3-5-18; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Notices]
[Pages 29151-29152]
[FR Doc No: 2015-12199]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2015-0024]

Parts and Accessories Necessary for Safe Operation; Virginia Tech
Transportation Institute Exemption Application

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

ACTION: Notice of final disposition.

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

SUMMARY: The Federal Motor Carrier Safety Administration (FMCSA)
announces its decision to grant Virginia Tech Transportation
Institute's (VTTI) exemption application to allow the placement of
camera-based data acquisition systems (DAS) at the bottom of
windshields on commercial motor vehicles (CMVs). The Federal Motor
Carrier Safety Regulations (FMCSRs) require antennas, transponders, and
similar devices to be located not more than 6 inches below the upper
edge of the windshield, outside the area swept by the windshield
wipers, and outside the driver's sight lines to the road and highway
signs and signals. As part of a National Highway Traffic Safety
Administration (NHTSA) research program, VTTI is coordinating
development and installation of the DASs in up to 150 CMVs. The
exemption will enable VTTI and NHTSA to conduct research on the
reliability of collision avoidance systems for CMVs. FMCSA believes
that mounting the DASs at the bottom of the windshield would maintain a
level of safety that is equivalent to, or greater than, the level of
safety achieved without the exemption.

DATES: This exemption is effective May 20, 2015 and ends May 20, 2017.

FOR FURTHER INFORMATION CONTACT: Mr. Mike Huntley, Vehicle and Roadside
Operations Division, Office of Carrier, Driver, and Vehicle Safety, MC-
PSV,<PHONE_NUMBER>, Federal Motor Carrier Safety Administration, 1200
New Jersey Avenue SE., Washington, DC 20590-0001.

ADDRESSES: For access to the docket to read background documents,
including those referenced in this document, or to read comments
received, go to:
     Regulations.gov, http://www.regulations.gov, at any time
and insert FMCSA-2015-0024 in the ``Keyword'' box, and then click
``Search.''
     Docket Management Facility, Room W12-140, DOT Building,
1200 New Jersey Ave. SE., Washington, DC 20590. You may view the docket
online by visiting the facility between 9 a.m. and 5 p.m., Monday
through Friday except Federal holidays.

Viewing Comments and Documents

    To view comments filed in this docket, go to http://www.regulations.gov and click on the ``Read Comments'' box in the upper
right hand side of the screen. Then, in the ``Keyword'' box, insert
``FMCSA-2015-0024'' and click ``Search.'' Next, click ``Open Docket
Folder'' in the ``Actions'' column. Finally, in the ``Title'' column,
click on the document you would like to review. If you do not have
access to the Internet, you may view the docket by visiting the Docket
Management Facility at the address above.

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.

SUPPLEMENTARY INFORMATION:

Background

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain parts of the Federal Motor Carrier Safety
Regulations. FMCSA must publish a notice of each exemption request in
the Federal Register (49 CFR 381.315(a)). The Agency must provide the
public an opportunity to inspect the information relevant to the
application, including any safety analyses that have been conducted.
The Agency must also provide an opportunity for public comment on the
request.
    The Agency reviews safety analyses and public comments submitted,
and determines whether granting the exemption would likely achieve a
level of safety equivalent to, or greater than, the level that would be
achieved by compliance with the current regulation (49 CFR 381.305).
The decision of the Agency must be published in the Federal Register
(49 CFR 381.315(b)) with the reasons for denying or granting the
application and, if granted, the name of the person or class of persons
receiving the exemption, and the regulatory provision from which the
exemption is granted. The notice must also specify the effective period
and explain the terms and conditions of the exemption. The exemption
may be renewed (49 CFR 381.300(b)).

VTTI's Application for Exemption

    VTTI applied for an exemption from 49 CFR 393.60(e)(1) to allow the
installation of DASs at the bottom of the windshield on CMVs (80 FR
8750, Feb. 18, 2015). A copy of the application is included in the
docket referenced at the beginning of this notice.
    Section 393.60(e)(1) of the FMCSRs prohibits the obstruction of the
driver's field of view by devices mounted at the top of the windshield.
Antennas, transponders and similar devices (devices) must not be
mounted more than 152 mm (6 inches) below the upper edge of the
windshield. These devices must be located outside the area swept by the
windshield wipers and outside the driver's sight lines to the road and
highway signs and signals.
    VTTI applied for the exemption because it wants to install DASs in
up to 150 CMVs operating throughout the United States in support of
research being conducted on behalf of NHTSA. VTTI contends that it must
be able to mount the DASs lower than allowed under 49 CFR 393.60(e)(1)
``because the safety equipment must have a clear forward facing view of
the road, and low enough to accurately scan facial features for
detection of impaired driving.'' VTTI wants to mount the DASs and
necessary brackets at the bottom of the windshield, preferably 3 inches
or less above of the bottom of the wiper sweep and out of the driver's
sightlines to the road and highway signs and signals, to the extent
practicable.

FMCSA Grant of Waiver to VTTI

    Pursuant to 49 U.S.C. 31315(a) and 49 CFR part 381, subpart B, the
FMCSA granted VTTI a 90-day waiver on January 26, 2015 to allow the
placement of the DASs at the bottom of windshields on CMVs, outside of
the area permitted by section 393.60 of the FMCSRs. This waiver is
effective from January 26, 2015, through April 25, 2015. Up to 150 DASs
have been installed in CMVs operated by 7 carriers.
    During the waiver period, motor carriers participating in the NHTSA
research program must ensure that the DASs are mounted within three
inches of the bottom of the driver side windshield wiper sweep, and out
of the driver's sightlines to the road and highway signs and signals as
much as practicable. Vehicles participating in the study must carry a
copy of the waiver in the vehicle. A copy of the FMCSA waiver letter to
VTTI is included in the docket referenced at the beginning of this
notice.

Comments

    FMCSA published a notice of the exemption application in the
Federal Register on February 18, 2015, and asked for public comment (80
FR 8750). No comments were received.

FMCSA Decision

    The FMCSA has evaluated the VTTI exemption application. The Agency
believes that granting the temporary exemption to allow the placement
of the DASs and necessary mounting brackets at the bottom of the
windshield, within and/or below 3 inches of the bottom of the
windshield wiper sweep, will provide a level of safety that is
equivalent to, or greater than the level of safety achieved without the
exemption. FMCSA does not believe there will be any degradation in the
safety performance of motor carriers utilizing the exemption during the
2-year exemption period because (1) there is nothing in available
technical information to indicate that the DASs would obstruct drivers'
views of the roadway, highway signs and surrounding traffic; (2)
generally, trucks and buses have an elevated seating position which
greatly improves the forward visual field of the driver, making any
impairment of available sight lines minimal; and (3) the location three
inches or less above the bottom of the driver's-side windshield wiper
sweep, and out of the driver's sightline, is reasonable and enforceable
at roadside. Without the exemption, NHTSA would be unable to test this
innovative onboard safety monitoring system.

Terms and Conditions for the Exemption

    The Agency hereby grants the exemption for a two-year period,
beginning May 20, 2015 and ending May 20, 2017. During the temporary
exemption period, up to 150 DASs may be installed in CMVs operated by
the motor carriers listed below. These are the same carriers that have
operated under the waiver:
    1. USDOT #32052 Crosby Trucking Service Inc. in Mount Sydney. VA.
    2. USDOT #369138 Rush Trucking Corporation in Wayne, MI.
    3. USDOT #1977980 Kuperus Trucking Inc. in Jenison, MI.
    4. USDOT #282628 Stagecoach Cartage and Distribution, LP in El
Paso, TX.
    5. USDOT #184405 J & M Tank Lines Inc. in Birmingham, AL.
    6. USDOT #1243338 P&S Transportation LLC in Ensley, AL.
    7. USDOT #75827 Modular Transport Company in Wyoming, MI.
    These motor carriers must ensure that the DASs are mounted within
and/or below 3 inches of the bottom of the driver side windshield wiper
sweep, and out of the driver's sightlines to the road and highway signs
and signals as much as practicable.
    The exemption is valid for two years unless rescinded earlier by
FMCSA. The exemption will be rescinded if (1) motor carriers and/or
commercial motor vehicles fail to comply with the terms and conditions
of the exemption; (2) the exemption has resulted in a lower level of
safety than was maintained before it was granted; or (3) continuation
of the exemption would not be consistent with the goals and objectives
of 49 U.S.C. 31136(e) and 31315(b).
    Interested parties possessing information that would demonstrate
that motor carriers using the DASs are not achieving the requisite
statutory level of safety should immediately notify FMCSA. The Agency
will evaluate any such information and, if safety is being compromised
or if the continuation of the exemption is not consistent with 49
U.S.C. 31136(e) and 31315(b), will take immediate steps to revoke the
exemption.

Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with or is inconsistent
with this exemption with respect to a person operating under the
exemption.

    Issued on: May 5, 2015.
T.F. Scott Darling, III,
Chief Counsel.
[FR Doc. 2015-12199 Filed 5-19-15; 8:45 am]
BILLING CODE 4910-EX-P