EPA Registration Division contact: Samantha Hulkower<PHONE_NUMBER>
IR-4
PP# 1F7905

	EPA has received a pesticide petition PP # 1F7905 from Nichino America, Inc.  4550 New Linden Hill Road, Suite 501, Wilmington, DE  91808 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. 511 by establishing a tolerance for residues of buprofezin in or on the raw agricultural commodities: nut, tree group 14 (including pistachios) (0.05 ppm) 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. This summary has been prepared by Nichino America, Inc., Wilmington, DE 19808, the registrant.

A. Residue Chemistry
	1. Plant metabolism. The metabolic profile of buprofezin has been elucidated in a wide range of crops, including tomatoes, lettuce, cotton, and citrus.   In citrus, although buprofezin was a major component of the residue, a chromatographically well-defined region of radioactivity, clearly associated with polar conjugates, was observed. Mass spectrometry identified the principal polar residue as a hexose conjugate of BF4 (buprofezin hydroxylated in the t-butyl group). Although the conjugate was resistant to enzyme hydrolysis, acid hydrolysis of the polar fraction released predominantly BF26 with minor amounts of BF9 and BF12. The same compounds were observed following acid hydrolysis of a standard of BF4 clearly indicating that BF4 is the conjugated metabolite existing in citrus. Although only limited metabolism was observed in lettuce and cotton, trace levels of similar metabolites, including the conjugate BF4 were observed indicating that the metabolic pathway does not differ with plant species.

	2. Analytical method. The proposed analytical method involves extraction, partition, clean-up and detection of residues by liquid chromatography with tandem mass spectral detection (LC/MS/MS).

      3. Magnitude of residues. Field trials were conducted on pecans with buprofezin, the principal residue of concern, in the required geographic regions in the United States at the maximum rate and minimum application and the minimum pre-harvest interval.  Buprofezin residues for all samples in pecans were less than the limit of quantitation (LOQ) which was 0.01 mg/kg.   Based on these residue data and residue data previously submitted for almonds, a tolerance for the Tree Nut Crop Group 14 and Pistachios is being proposed at 0.05 ppm; the currently established tolerance for almonds (0.05 ppm) be revoked; and the currently established tolerance for Almond, hulls (2.0 ppm) remain as established. The requested proposed tolerance is adequately supported.

B. Toxicological Profile
	1. An extensive battery of toxicology studies has been conducted with buprofezin.  EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk  The nature of the toxic effects caused by buprofezin is discussed in Unit III.A. of the Final Rule on Buprofezin Pesticide Tolerance published in the Federal Register on September 5, 2001 (66 FR 46381) (FRL-6796-6).   An assessment of toxic effects caused by buprofezin including the toxicological endpoints of concern is also discussed in Unit III.A. and Unit III B. of the Federal Register dated June 25, 2003   (FRL-7310-7) (68 FR 37765).
      2. Animal metabolism. The metabolism of buprofezin has been extensively studied in various species of animals and fish. Buprofezin has several groups that can metabolize in a variety of ways thus potentially producing a very large number of metabolites. Extensive metabolism to many minor metabolites was observed in all the animal species. Metabolism in fish was, however, much more limited and clearly defined. Although not all metabolic intermediates have been detected in all the species, the major routes of metabolism have been identified in animals and fish and a consistent pattern is observed throughout these species. The proposed metabolic pathway was provided in the tolerance petition, PP 0F6087. For convenience, degradates are referred to by an internal code: BF 1 through 13. Corresponding chemical structures were provided in the tolerance petition, PP 0F6087.

	3. Metabolite toxicology.
	i. Metabolism in rats.  The major metabolite found in rat excreta was parent buprofezin in addition to several compounds formed after extensive metabolism. Whereas plant metabolism appeared restricted mainly to oxidation of the tertiary butyl group, oxidation of the butyl group and hydroxylation of the phenyl ring were both observed in rats. Oxidation of the t-butyl group proceeded beyond an alcohol to an acid and was accompanied by ring opening. The most extensively metabolized compound identified in rats was BF23 (acetylated p-aminophenol).
	ii. Metabolism in ruminants and hens. Residue levels were low (0.05 ppm) in all ruminant and poultry tissues and commodities, following treatment at exaggerated rates (approximately 20x and 7,500x the anticipated dietary burden, respectively). The only exceptions were cow liver (1.21 ppm), cow kidney (0.41 ppm), hen liver (0.15 ppm), and egg yolk (0.11 ppm). Extensive metabolism was observed in both species with a large number of minor metabolites being produced.  The principal metabolites identified in the cow were BF2 and BF23, indicating that the major pathway of degradation in ruminants is hydroxylation of the phenyl ring followed by opening and degradation of the heterocyclic ring. The identification of trace levels of BF13 confirms this pathway. As in rats, BF23 was the most extensively metabolized compound identified. Trace levels of BF12 were also detected. This indicates that the parallel pathway of heterocyclic ring opening without hydroxylation of the phenyl ring is also in operation. Similarly in hens, the identified metabolites were derived from degradation of the heterocyclic ring either with (BF13) or without (BF9 and BF12) phenyl ring hydroxylation.  No single unidentified compound accounted for more than 6% of the total residue in any animal tissue or commodity, with the exception of a component comprising 8.7% of egg white. The total residue in egg white was, however, only 0.02 ppm even at this highly exaggerated dose rate.
	 iii. Metabolism in fish. Analysis of fish tissues, following a bioaccumulation study, found a much simpler metabolic profile. Buprofezin was present in both edible and non-edible tissues, but the principle metabolites were polar conjugates of BF4. Trace levels of BF12 were also detected.

	4. Endocrine disruption. No special studies have been conducted to investigate the potential of buprofezin to induce estrogenic or other endocrine effects. The standard battery of required toxicity studies has been completed. These studies include an evaluation of the potential effects on reproduction and development and an evaluation of the pathology of the endocrine organs following repeated or long-term exposure. These studies are generally considered to be sufficient to detect any endocrine effects. The only effect noted on endocrine organs was an increased incidence of follicular cell hypertrophy and C-cell hyperplasia of the thyroid gland in rats administered buprofezin.  Buprofezin also caused mild to moderate hepatotoxic effects at this dietary concentration.  The effect on the thyroid is consistent with an increased turnover of T3/T4 in the liver with a resultant rise in TSH secretion (due to the hepatotoxicity). The rat is known to be much more susceptible than humans to these effects due to the very rapid turnover of thyroxine in the blood in rats (12 hours vs. about 5-9 days in humans). Therefore, the thyroid pathological  changes which have been noted following administration of high doses of buprofezin are considered to be of minimal relevance to human risk assessment, particularly considering the low levels of buprofezin to which humans are likely to be exposed.

C. Aggregate Exposure

1. Dietary exposure. Acute and chronic dietary risk analyses were conducted by the Agency to estimate to potential buprofezin residues in/on the following crops with established tolerances: almond, avocado, banana, bell and non-bell peppers, Brassica, head and stem, subgroup 5A [broccoli; broccoli, Chinese; Brussels sprouts; cabbage; cabbage, Chinese (napa); cabbage, Chinese mustard; cauliflower; cavalo broccoli; kohlrabi], canistel, celery, coffee, spinach, cotton, grape, grape raisin, longan, lychee, mamey sapote, mango, papaya, pecan, pomegranates, Spanish lime, head lettuce, leaf lettuce, snap bean, fruiting vegetables, cucurbit vegetables, citrus fruits, pome fruits, stone fruits, almond, pistachio, olive, and strawberry and meat and milk, using DEEM(TM) (ver. 7.76).   Residue estimates for water consumption were based on PRZM3/EXAMs and SCIGROW models and incremental exposure assessments for nuts  using LifeLine[TM] version 5.0.

	i. Food. The Hazard Identification Assessment Review Committee (HIARC) met on 15-February-2000 and determined the endpoint selection for buprofezin (HED Doc. No. 014093) and subsequently on 22-October-2002 to evaluate the potential for increased susceptibility of infants and children from exposure to buprofezin.  Based on toxicological considerations, the special FQPA safety factor was set at 1X when assessing acute and chronic dietary exposures.  The acute dietary aPAD (acute population adjusted dose) was set at 2.0 mg/kg/day for females aged 13-50 years old based on a developmental toxicity study in rats that had an oral NOEL of 200 mg/kg/day.  The chronic dietary cPAD (chronic Population Adjusted Dose) was determined to be 0.01 mg/kg/day for the general population based on a oral NOAEL of 1.0 mg/kg/day in the two-year rat chronic/oncogenicity study.  The uncertainty factor of 30 was used to account for interspecies and intraspecies variations.  An additional 10x database uncertainty factor was applied.  The resultant safety factor used to establish the cPAD was 300.  The cPAD was set at 0.0033 mg/kg/day.   Since the only evidence of carcinogenicity was `suggestive', this endpoint was not deemed relevant to this assessment.

The acute dietary exposure was based on the following assumptions: residues at tolerance levels, 100% crop treated, and DEEM(TM) (ver. 7.76) default processing factors for all registered/proposed commodities (Tier 1). For all currently registered crops and commodities, the acute risk was assessed as 7% of the aPAD for the population group females 13-49 years old.  No other population groups were identified based on the lack of adverse effects resulting from a single exposure  (Federal Register vol 74 No. 131 p 33157, July 19, 2009). An incremental exposure assessment for the petitioned tolerances was performed using LifeLine(TM) version 5.0.  Tolerance values were used for exposure and a default value of 100% crop treated. Expanded crops in the citrus and pome crop groupings were already modeled in the Agency's previous assessments.  The resulting incremental food exposure estimate for females 13-49 years old was approximately 0.0001% of the acute RfD bringing the total acute risk to 7% of the aPAD. No acute endpoint was identified for the remaining population subgroups.

The chronic dietary exposure assessment for all currently registered crops for food and water resulted in a risk estimate of  80% of the cPAD of 80% for the population groups receiving the greatest exposure (all infants <1 year old and children 1-2 years old) (Federal Register vol 74 No. 131 p 33157, July 19, 2009).
The incremental chronic dietary exposure used 100% crop treated for Nut, Tree Group 14. Proposed tolerance values were assumed for all crop residues. The food exposure estimates from residues of buprofezin for the U.S. population for the petitioned crops was 0.04% of the chronic population adjusted dose (cPAD) and 0.05% for children 3-5 years old. The total estimated risk from chronic exposure does not exceed 80% of the cPAD for the most sensitive population group, children 3-5 years old.  These can be considered conservative values.

Since the only evidence of carcinogenicity was `suggestive', EPA regards the carcinogenic potential as very low.  Therefore, an exposure assessment for evaluating cancer risk was not deemed relevant to this assessment and was not conducted.

	ii. Drinking water. The residue of concern in drinking water was determined to be buprofezin.  There are no established maximum contaminant levels or health advisory levels for residues of buprofezin in drinking water.  In the absence of comprehensive water monitoring data, the Agency uses the FQPA Index Reservoir Screening Tool or the Pesticide Root ZoneModel/Exposure Analysis Modeling System (PRZM/EXAMS) to produce estimates of pesticide concentrations in an index resevoir.   The SCI-GROW model is used to predict pesticide concentrations in shallow ground water. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate an index reservoir environment, and both models include a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.
	None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a screen for sorting out pesticides for which it is unlikely that drinking water concentrations would exceed human health levels of concern.
	The estimated drinking water concentrations (EDWCs) in surface water were determined using the Tier II PRZM (Pesticide Root Zone Model) and EXAMS (Exposure Analysis Modeling System (PE4-PL, version 01).  PRZM is used to simulate pesticide transport as a result of runoff and erosion and spray drift from an agricultural field and EXAMS estimates environmental fate and transport of pesticides in surface water.  The EPA estimated that based on the maximum use pattern of two applications to Florida citrus for the acute and long-term estimates. The acute EDWCs estimated for buprofezin acute exposure are 57.4 ppb for surface water and 0.09 ppb for ground water.  The chronic EECs are estimated to be 18.6 ppb for surface water and 0.09 ppb for ground water (Federal Register Vol. 74 No. 131 p 33157, July 19, 2009).

	2. Non-dietary exposure. The term residential exposure is used in this document to refer to non-occupational, non-dietary exposure (e.g. for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Buprofezin is not registered for use on any sites that would result in residential exposure.

D. Cumulative Effects
	A determination has not been made that buprofezin has a common mechanism of toxicity with other substances. Buprofezin does not appear to produce a common toxic metabolite with other substances. A cumulative risk assessment was, therefore, not performed for this analysis. Section 408(b)(2)(D)(v) of FFDCA 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 buprofezin and any other substances and buprofezin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that buprofezin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's OPP concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's web site at  http://www.epa.gov/ pesticides/cumulative/.

E. Safety Determination

	1. U.S. population.
i. Acute risk.  Using the conservative assumptions discussed above, based on the completeness and reliability of the toxicity data, it is concluded that aggregate exposure to the proposed uses of buprofezin are estimated to utilize at most
7% of the acute reference dose of females (13-49).  This estimate is likely to be much less, as more realistic data and models are developed.  Drinking water and other water consumption (EDWC of 57.4 ppb) scenarios were included in the dietary risk assessment modeling.

ii. Chronic Risk.  Based on the toxicology data base and available information on anticipated residues, the chronic dietary exposure to the U.S. Population (total) was estimated to utilize no more than 80.0 % of the estimated chronic population adjusted dose (cPAD). Drinking water and other potential water consumption scenarios (EDWC of 12.5 ppb) were included in the dietary risk assessment modeling. Based on these assessments, it can be concluded that there is reasonable certainty of no harm to the U.S. Population or any population subgroup from exposure to buprofezin.

	2. Infants and children. Chronic exposure to food and water to children ages 3-5, the highest exposed population subgroup, was 80.0 % of the cPAD).  EPA has determined that reliable data support the uncertainty factor (300 for combined interspecies and intraspecies variability and a data base uncertainty factor) for buprofezin.  EPA deemed an additional FQPA safety factor is not necessary to be protective of infants and children.  EPA generally has no concern for exposures below 100% of the cPAD. The Agency has considered the potential aggregate exposure from food, water and non-occupational exposure routes and has concluded aggregate exposure is not expected to exceed 100% of the chronic reference dose, and consequently, has determined there is a reasonable certainty that no harm will occur to infants and children from aggregate exposure to residues of buprofezin.

F. International Tolerances
Canada, Codex, and Mexico do not have maximum residue limits for residues of buprofezin in/on the proposed crops.  Therefore, harmonization is not an issue.


[Federal Register Volume 84, Number 250 (Tuesday, December 31, 2019)]
[Notices]
[Pages 72370-72377]
[FR Doc No: 2019-28269]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5955]

International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; World Health
Organization; Scheduling Recommendations; AB-FUBINACA; 5F-AMB-PINACA;
5F-MDMB-PICA; 4-F-MDMB-BINACA; 4-CMC; N-ethylhexedrone; alpha-PHP; DOC;
Crotonyl Fentanyl; Valeryl Fentanyl; Flualprazolam and Etizolam;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is providing interested
persons with the opportunity to submit written comments concerning
recommendations by the World Health Organization (WHO) to impose
international manufacturing and distributing restrictions, under
international treaties, on certain drug substances. The comments
received in response to this notice will be considered in preparing the
United States' position on these proposals for a meeting of the United
Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March
2020. This notice is issued under the Controlled Substances Act (CSA).

DATES: Submit either electronic or written comments by January 30,
2020. The short time period for the submission of comments is needed to
ensure that Health and Human Services (HHS) may, in a timely fashion,
carry out the required action and be responsive to the United Nations.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 30, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 30, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-5955 for ``International Drug Scheduling; Convention on
Psychotropic Substances; Single Convention on Narcotic Drugs; World
Health Organization; Scheduling Recommendations; AB-FUBINACA; 5F-AMB-
PINACA; 5F-MDMB-PICA; 4-F-MDMB-BINACA; 4-CMC; N-ethylhexedrone; alpha-
PHP; DOC; Crotonyl Fentanyl; Valeryl Fentanyl; Flualprazolam and
Etizolam; Request for Comments.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential

information that you do not wish to be made publicly available, submit
your comments only as a written/paper submission. You should submit two
copies total. One copy will include the information you claim to be
confidential with a heading or cover note that states ``THIS DOCUMENT
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy,
including the claimed confidential information, in its consideration of
comments. The second copy, which will have the claimed confidential
information redacted/blacked out, will be available for public viewing
and posted on https://www.regulations.gov. Submit both copies to the
Dockets Management Staff. If you do not wish your name and contact
information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug
Evaluation and Research, Controlled Substance Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver
Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The United States is a party to the 1971 Convention on Psychotropic
Substances (1971 Convention). Section 201(d)(2)(B) of the CSA (21
U.S.C. 811(d)(2)(B)) provides that when the United States is notified
under Article 2 of the 1971 Convention that the CND proposes to decide
whether to add a drug or other substance to one of the schedules of the
1971 Convention, transfer a drug or substance from one schedule to
another, or delete it from the schedules, the Secretary of State must
transmit notice of such information to the Secretary of Health and
Human Services (Secretary of HHS). The Secretary of HHS must then
publish a summary of such information in the Federal Register and
provide opportunity for interested persons to submit comments. The
Secretary of HHS must then evaluate the proposal and furnish a
recommendation to the Secretary of State that shall be binding on the
representative of the United States in discussions and negotiations
relating to the proposal.
    As detailed in the following paragraphs, the Secretary of State has
received notification from the Secretary-General of the United Nations
(the Secretary-General) regarding ten substances to be considered for
control under the 1971 Convention. This notification reflects the
recommendation from the 42nd WHO Expert Committee for Drug Dependence
(ECDD), which met in October 2019. In the Federal Register of September
10, 2019 (84 FR 47521), FDA announced the WHO ECDD review and invited
interested persons to submit information for WHO's consideration.
    The full text of the notification from the Secretary-General is
provided in section II. Section 201(d)(2)(B) of the CSA requires the
Secretary of HHS, after receiving a notification proposing scheduling,
to publish a notice in the Federal Register to provide the opportunity
for interested persons to submit information and comments on the
proposed scheduling action.
    The United States is also a party to the 1961 Single Convention on
Narcotic Drugs (1961 Convention). The Secretary of State has received a
notification from the Secretary-General regarding two substances to be
considered for control under this convention. The CSA does not require
HHS to publish a summary of such information in the Federal Register.
Nevertheless, to provide interested and affected persons an opportunity
to submit comments regarding the WHO recommendations for drugs under
the 1961 Convention, the notification regarding these substances is
also included in this Federal Register notice. The comments will be
shared with other relevant Agencies to assist the Secretary of State in
formulating the position of the United States on the control of these
substances. The HHS recommendations are not binding on the
representative of the United States in discussions and negotiations
relating to the proposal regarding control of substances under the 1961
Convention.

II. United Nations Notification

    The formal notification from the United Nations that identifies the
drug substances and explains the basis for the scheduling
recommendations is reproduced as follows (non-relevant text removed):

Reference: NAR/CL.10/2019
    WHO/ECDD42; 1961C-Art.3, 1971C-Art.2 CU 2019/462/DTA/SGB (A)

    The Secretary-General of the United Nations presents his
compliments to the Secretary of State of the United States of America
and has the honour to inform the Government that in a letter dated 15
November 2019 the Director-General of the World Health Organization
(WHO), pursuant to article 3, paragraphs 1 and 3 of the Single
Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol
(1961 Convention), and article 2, paragraphs 1 and 4 of the Convention
on Psychotropic Substances of 1971 (1971 Convention), notified the
Secretary-General of the following recommendations:
    Substances recommended to be added to Schedule I of the 1961
Convention:

Crotonyl fentanyl
    chemical name: (2E)-N-phenyl-N-[1-(2-phenylethyl)piperidin-4-
yl]but-2-enamide
Valeryl fentanyl
    chemical name: N-phenyl-N-[1-(2-phenylethyl)piperidin-4-
yl]pentanamide

    Substance recommended to be added to Schedule I of the 1971
Convention:

DOC
    chemical name: 1-(4-chloro-2,5-dimethoxyphenyl)propan-2-amine

    Substances recommended to be added to Schedule II of the 1971
Convention:

AB-FUBINACA
    chemical name: N-[1-amino-3-methyl-1-oxobutan-2-yl]-1-[(4-
fluorophenyl)methyl]-1H-indazole-3-carboxamide
5F-AMB-PINACA (5F-AMB, 5F-MMB-PINACA)
    chemical name: methyl 2-{[1-(5-fluoropentyl)-1H-indazole-3-
carbonyl]amino{time} -3-methylbutanoate
5F-MDMB-PICA (5F-MDMB-2201)
    chemical name: methyl 2-{[1-(5-fluoropentyl)-1H-indole-3-
carbonyl]amino{time} -3,3-dimethylbutanoate
4F-MDMB-BINACA
    chemical name: methyl 2-{[1-(4-fluorobutyl)-1H-indazole-3-
carbonyl]amino{time} -3,3-dimethylbutanoate
4-CMC (4-chloromethcathinone; clephedrone)
    chemical name: 1-(4-chlorophenyl)-2-(methylamino)propan-1-one

N-Ethylhexedrone
    chemical name: 2-(ethylamino)-1-phenylhexan-1-one
Alpha-PHP
    chemical name: 1-phenyl-2-(pyrrolidine-1-yl)hexan-1-one

    Substances recommended to be added to Schedule IV of the 1971
Convention:

Flualprazolam
    chemical name: 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-
benzo[f][1,2,4]triazolo[4,3-a][1,4] diazepine
Etizolam
    chemical name: 4-(2-chlorophenyl)-2-ethyl-9-methyl-6H-
thieno[3,2f][1,2,4]triazolo[4,3 a][1,4]diazepine

    In accordance with the provisions of article 3, paragraph 2 of the
1961 Convention and article 2, paragraph 2 of the 1971 Convention, the
Secretary-General hereby transmits the notification as annex I to the
present note. In connection with the notification, WHO also submitted a
summary of the rationale of the recommendations which is hereby
transmitted as annex II. For time reasons, this notification and its
annexes I and II are transmitted in English only. The notification and
its annexes will be transmitted in French and Spanish as soon as
available.
    Also in accordance with the same provisions, the notification from
WHO will be brought to the attention of the 63rd session of the
Commission on Narcotic Drugs (2-6 March 2020) in a pre-session document
that will be made available in the six official languages of the United
Nations on the website of the 63rd session of the CND: https://www.unodc.org/unodc/en/commissions/CND/session/63_Session_2020/session-63-of-the-commission-on-narcotic-drugs.html.
    In order to assist the Commission in reaching a decision, it would
be appreciated if the Government could communicate any comments it
considers relevant to the possible scheduling of substances recommended
by WHO to be placed under international control under the 1961
Convention, namely: Crotonyl fentanyl, Valeryl fentanyl, as well as any
economic, social, legal, administrative or other factors that it
considers relevant to the possible scheduling of substances recommended
by WHO to be placed under international control under the 1971
Convention, namely: DOC, AB-FUBINACA, 5F-AMB-PINACA (5F-AMB, 5F-MMB-
PINACA), 5F-MDMB-PICA (5F-MDMB-2201), 4F-MDMB-BINACA, 4-CMC (4-
chloromethcathinone; clephedrone), N-Ethylhexedrone, Alpha-PHP,
Flualprazolam, Etizolam.
    Communications should be sent to the Executive Director of the
United Nations Office on Drugs and Crime, c/o Secretary, Commission on
Narcotic Drugs, P.O. Box 500, 1400 Vienna, Austria, email<EMAIL_ADDRESS>(fax: +43-1-26060-5885), no later than by 31 January 2020.

2 December 2019

His Excellency,
Mr. Rex Tillerson,
Secretary of State of the United States of America

Annex I

Letter Addressed to the Secretary-General of the United Nations From
the Director-General of the World Health Organization

    ``The Forty-second meeting of the WHO Expert Committee on Drug
Dependence was convened from 21 to 25 October 2019 at WHO headquarters
in Geneva. The objective of this meeting was to carry out an in-depth
evaluation of psychoactive substances in order to determine whether WHO
should recommend these substances to be placed under international
control or if their level of control should be changed.
    The Forty-second Meeting reviewed thirteen psychoactive substances,
five of which are synthetic cannabinoids, four synthetic stimulants,
two fentanyl analogues, and two benzodiazepines. In addition, the
Meeting carried out a pre- review of preparations of
acetyldihydrocodeine, codeine, dihydrocodeine, ethylmorphine,
nicocodine, nicodicodine, norcodeine and pholcodine that are listed in
Schedule III of the 1961 Convention on Narcotic Drugs.
    With reference to Article 3, paragraphs 1 and 3 of the Single
Convention on Narcotic Drugs (1961), as amended by the 1972 Protocol,
and Article 2, paragraphs 1 and 4 of the Convention on Psychotropic
Substances (1971), I am pleased to submit recommendations of the Forty-
second Meeting of ECDD as follows:
    To be added to Schedule I of the Single Convention on Narcotic
Drugs (1961):

Crotonyl fentanyl
    chemical name: (2E)-N-phenyl-N-[1-(2-phenylethyl)piperidin-4-
yl]but-2-enamide
Valeryl fentanyl
    chemical name: N-phenyl-N-[1-(2-phenylethyl)piperidin-4-
yl]pentanamide

    To be added to Schedule I of the Convention on Psychotropic
Substances (1971):

DOC
    chemical name: 1-(4-chloro-2,5-dimethoxyphenyl)propan-2-amine

    To be added to Schedule II of the Convention on Psychotropic
Substances (1971):

AB-FUBINACA
    chemical name: N-[1-amino-3-methyl-1-oxobutan-2-yl]-1-[(4-
fluorophenyl)methyl]-1H-indazole-3-carboxamide
5F-AMB-PINACA (5F-AMB, 5F-MMB-PINACA)
    chemical name: methyl 2-{[1-(5-fluoropentyl)-1H-indazole-3-
carbonyl]amino{time} -3-methylbutanoate
5F-MDMB-PICA (5F-MDMB-2201)
    chemical name: methyl 2-{[1-(5-fluoropentyl)-1H-indole-3-
carbonyl]amino{time} -3,3-dimethylbutanoate
4-F-MDMB-BINACA
    chemical name: methyl 2-{[1-(4-fluorobutyl)-1H-indazole-3-
carbonyl]amino{time} -3,3-dimethylbutanoate
4-CMC (4-chloromethcathinone; clephedrone)
    chemical name: 1-(4-chlorophenyl)-2-(methylamino)propan-1-one
N-ethylhexedrone
    chemical name: 2-(ethylamino)-1-phenylhexan-1-one
Alpha-PHP
    chemical name: 1-phenyl-2-(pyrrolidine-1-yl)hexan-1-one

    To be added to Schedule IV of the Convention on Psychotropic
Substances (1971):

Flualprazolam
    chemical name: 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-
benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine
Etizolam
    chemical name: 4-(2-chlorophenyl)-2-ethyl-9-methyl-6H-
thieno[3,2f][1,2,4]triazolo [4,3-a][1,4]diazepine

    To be kept under surveillance:

APINACA (AKB-48)
    chemical name: N-(adamantan-1-yl)-1-pentyl-1H-indazole-3-
carboxamide
    To proceed to critical review:

--Preparations of acetyldihydrocodeine, codeine, dihydrocodeine,
ethylmorphine, nicocodine, nicodicodine, norcodeine and pholcodine
listed in Schedule III of the 1961 Single Convention on Narcotic Drugs

    The assessments and findings on which these recommendations are
based are set out in detail in the report of the Forty-second Meeting
of the WHO Expert Committee on Drug Dependence.

A summary of the rationale of these recommendations is attached in
Annex 1 of this letter.
    I am very pleased with the ongoing collaboration between WHO, the
United Nations Office on Drugs and Crime (UNODC) and the International
Narcotics Control Board (INCB) and in particular, how this
collaboration has benefited the work of the WHO Expert Committee on
Drug Dependence and more generally, the implementation of the
operational recommendations of the United Nations General Assembly
Special Session (UNGASS) 2016.''

Annex II

Summary of the Rationale for the Recommendations of the 42nd Expert
Committee on Drug Dependence

    Substances recommended to be added to Schedule I of the Single
Convention on Narcotic Drugs (1961), as amended by the 1972 Protocol:

Crotonyl fentanyl

    The chemical name for crotonyl fentanyl is (2E)-N-phenyl-N-[1-(2-
phenylethyl)piperidin-4-yl]but-2-enamide.
    Crotonyl fentanyl binds to mu opioid receptors and acts as an
opioid agonist. In animal models, crotonyl fentanyl produces
antinociception, actions predictive of oxycodone-like subjective
effects and both central nervous system stimulation and depression. The
opioid antagonist naltrexone blocks the effects of crotonyl fentanyl.
This pharmacological profile indicates that crotonyl fentanyl is an
opioid and comparative studies suggest that it has a potency
intermediate between oxycodone and fentanyl.
    Consistent with the results from animal studies, the effects of
crotonyl fentanyl were reversed by an opioid antagonist in a clinical
admission due to overdose. Due to its opioid mechanism of action,
crotonyl fentanyl has the potential to be associated with substantial
harm.
    Crotonyl fentanyl has been found in seized material from countries
across several regions. It has no veterinary or medical use.
    Based on its opioid mechanism of action and similarity to drugs
such as oxycodone and fentanyl that are controlled under Schedule I of
the Single Convention on Narcotic Drugs, it is recommended that
crotonyl fentanyl also be controlled under Schedule I of the Single
Convention on Narcotic Drugs (1961).

Valeryl fentanyl

    The chemical name for valeryl fentanyl is N-phenyl-N-[1-(2-
phenylethyl)piperidin-4-yl]pentanamide.
    Valeryl fentanyl binds to mu opioid receptors and acts as an opioid
agonist. In animal models, valeryl fentanyl suppresses opioid
withdrawal symptoms, produces antinociception and has actions
predictive of oxycodone-like subjective effects. The opioid antagonist
naltrexone blocks the effects of valeryl fentanyl. This pharmacological
profile indicates that valeryl fentanyl is an opioid and comparative
studies suggest that it has a potency less than that of fentanyl.
    Valeryl fentanyl has been detected in biological samples from a
small number of deaths and cases of driving under the influence of
drugs.
    Valeryl fentanyl has been detected in seizures from countries
across several regions. It has no veterinary or medical use.
    Based on the evidence of its opioid mechanism of action and
similarity to drugs such as fentanyl that are controlled under Schedule
I of the Single Convention on Narcotic Drugs, it is recommended that
valeryl fentanyl also be controlled under Schedule I of the Single
Convention on Narcotic Drugs (1961).
    Substance recommended to be added to Schedule I of the Convention
on Psychotropic Substances (1971):

DOC

    DOC is also known as 4-chloro-2,5-DMA or 2,5-dimethoxy-4-
chloroamphetamine. Its chemical name is 1-(4-chloro-2,5-
dimethoxyphenyl)propan-2-amine.
    DOC is an agonist at the serotonergic 5-HT2A receptor, a mechanism
it shares with hallucinogens such as LSD.
    In animal models, DOC has actions predictive of hallucinogenic
subjective effects (similar to LSD and DOM) and shows evidence of
rewarding effects. It can produce both central nervous system
stimulation and depression.
    Based on clinical admissions due to overdose, the adverse effects
associated with use of DOC include agitation, aggression,
hallucinations, tachycardia, hyperthermia and seizures.
    DOC has been detected in 40 countries. It has no veterinary or
medical use.
    Based on its similarity in mechanism of action and effects to
currently scheduled hallucinogens such as LSD and DOM, and the evidence
that it is abused so as to constitute a public health and social
problem, it is recommended that DOC be controlled under the 1971
Convention on Psychotropic Substances. As it has no medical use and its
use constitutes a serious risk to public health, it is recommended that
it be controlled under Schedule I of 1971 Convention on Psychotropic
Substances.
    Substances recommended to be scheduled in Schedule II of the
Convention on Psychotropic Substances (1971):

AB-FUBINACA

    The chemical name for AB-FUBINACA is N-[1-amino-3-methyl-1-
oxobutan-2-yl]-1-[(4-fluorophenyl)methyl]-1H-indazole-3-carboxamide.
    In common with other synthetic cannabinoids, AB-FUBINACA is a full
agonist at the cannabinoid CB1 receptor that mediates the psychoactive
effects of cannabinoids. In animal studies, it produced central nervous
system depression and other typical cannabinoid behavioural effects and
had actions predictive of cannabinoid subjective effects.
    AB-FUBINACA produces neurological signs in animals that are
indicative of toxicity, including seizures, hyperreflexia and
aggression. Based on its mechanism of action, it would be expected to
produce a range of adverse effects in human users that include
tachycardia, nausea, vomiting, confusion and hallucinations. There are
a large number of cases of intoxication resulting from AB-FUBINACA,
often in combination with other drugs, and at least one death has been
reported that is attributable to the effects of AB-FUBINACA.
    AB-FUBINACA use has been reported in over 30 countries across
different regions. It has no veterinary or medical use.
    Based on its capacity to produce a state of dependence, its ability
to produce central nervous system depression and the evidence that it
is abused so as to constitute a public health and social problem, it is
recommended that AB-FUBINACA be controlled under the 1971 Convention on
Psychotropic Substances. As it has no medical use and its use
constitutes a substantial risk to public health, it is recommended that
it be controlled under Schedule II of 1971 Convention on Psychotropic
Substances.

5F-AMB-PINACA

    5F-AMB-PINACA is also known as 5F-AMB and 5F-MMB-PINACA. Its
chemical name is methyl 2-{[1-(5-fluoropentyl)-1H-indazole-3-
carbonyl]amino{time} -3-methylbutanoate.
    In common with other synthetic cannabinoids, 5F-AMB-PINACA is a
full agonist at the cannabinoid CB1 receptor that mediates the
psychoactive effects of cannabinoids. In animal studies it

produced central nervous system depression and had actions predictive
of cannabinoid-like subjective effects. 5F-AMB-PINACA produces
impairment of memory and seizures in animals.
    5F-AMB-PINACA use has been associated with a number of cases of
fatal and non-fatal intoxication often in combination with other drugs.
In a case of non-fatal intoxication due to 5F-AMB-PINACA alone, the
effects included cognitive impairment, slowed movement, slurred speech
and poor coordination. Based on its mechanism of action, it would also
be expected to produce a range of other effects in human users that
include tachycardia, nausea, vomiting, confusion and hallucinations.
5F-AMB-PINACA has been identified as a causal factor in motor vehicle
accidents, some of which were fatal.
    5F-AMB-PINACA use has been reported in over 30 countries across
different regions. It has no veterinary or medical use.
    Based on its capacity to produce a state of dependence, its ability
to produce central nervous system depression and the evidence that it
is abused so as to constitute a public health and social problem, it is
recommended that 5F-AMB-PINACA be controlled under the 1971 Convention
on Psychotropic Substances. As it has no medical use and its use
constitutes a substantial risk to public health, it is recommended that
it be controlled under Schedule II of the 1971 Convention on
Psychotropic Substances.

5F-MDMB-PICA

    5F-MDMB-PICA is also known as 5F-MDMB-2201. Its chemical name is
methyl 2-{[1-(5-fluoropentyl)-1H-indole-3-carbonyl]amino{time} -3,3-
dimethylbutanoate.
    In common with other synthetic cannabinoids, 5F-MDMB-PICA is a full
agonist at the cannabinoid CB1 receptor that mediates the psychoactive
effects of cannabinoids.
    Its use has been associated with a number of fatal and non-fatal
intoxications that have been characterised by effects such as decreased
mental status, agitated delirium and seizures. While 5F-MDMB-PICA has
been present in biological samples mostly in combination with other
drugs, in at least some of these cases 5F-MDMB-PICA has been assessed
as having a high contribution to the effects produced. It has been used
by victims of three apparent mass overdose events, but at least one
other synthetic cannabinoid was also detected in biological fluids from
the victims.
    5F-MDMB-PICA has been detected in 20 countries. It has no
veterinary or medical use.
    Based on its mechanism of action, 5F-MDMB-PICA has the ability to
produce a state of dependence and central nervous system depression.
There is evidence that it is abused so as to constitute a public health
and social problem. It is therefore recommended that 5F-MDMB-PICA be
controlled under the 1971 Convention on Psychotropic Substances. As it
has no medical use and its use constitutes a substantial risk to public
health, it is recommended that it be controlled under Schedule II of
the 1971 Convention on Psychotropic Substances.

4F-MDMB-BINACA

    4F-MDMB-BINACA is also known as 4F-MDMB-BUTINACA. Its chemical name
is methyl 2-{[1-(4-fluorobutyl)-1H-indazole-3-carbonyl]amino{time} -
3,3-dimethylbutanoate.
    In common with other synthetic cannabinoids, 4F-MDMB-BINACA is a
full agonist at the CB1 receptor that mediates the psychoactive effects
of cannabinoids.
    Self-reported effects provided by individuals who had used
cannabinoid products that included 4F-MDMB-BINACA as the major
constituent, included auditory and visual hallucinations, vomiting,
paranoia, euphoria, relaxation, irregular heartbeat, agitation,
confusion, insomnia, and chest pain. These effects are consistent with
the cannabinoid full agonist mechanism of action of 4F-MDMB-BINACA. Its
use has been associated with a number of fatal and non-fatal
intoxications and of cases of driving under the influence of drugs.
However, other synthetic cannabinoids have been detected in most of
these cases.
    4F-MDMB-BINACA has been detected in a small number of countries to
date, but its use may be increasing. It has no veterinary or medical
use.
    Based on its mechanism of action, 4F-MDMB-BINACA has the ability to
produce a state of dependence and central nervous system depression.
There is evidence that it is abused so as to constitute a public health
and social problem. It is therefore recommended that 4F-MDMB-BINACA be
controlled under the 1971 Convention on Psychotropic Substances. As it
has no medical use and its use constitutes a substantial risk to public
health, it is recommended that it be controlled under Schedule II of
the 1971 Convention on Psychotropic Substances.

4-CMC
    4-CMC is also known as 4-chloromethcathinone and clephedrone. Its
chemical name is 1-(4-chlorophenyl)-2-(methylamino)propan-1-one.
    In common with other stimulants used non-medically, 4-CMC increases
neuronal concentrations of the neurotransmitter dopamine. It also has
effects on serotonin and, to a lesser extent, noradrenaline.
    In animal models, 4-CMC has effects predictive of abuse potential,
including actions predictive of MDMA-like subjective effects and
stimulation of brain reward centres. It also produces central nervous
system stimulation. Users of the drug report effects similar to other
stimulants, particularly MDMA-like effects, including increased energy,
mood elevation and increased sociability.
    4-CMC use has been associated with adverse effects typical of
stimulant drugs, including tachycardia, agitation and impaired
movement. Based on these effects and its mechanism of action, major
risks associated with use of this drug will include cardiac failure and
psychosis. In association with other drugs, 4-CMC has been involved in
fatalities due to overdose, suicide and traffic accidents. It has been
detected in used syringes, indicating the potential for injection
related health problems in association with its use.
    4-CMC has been detected in many countries across different regions.
It has no veterinary or medical use.
    Based on its mechanism of action and effects, 4-CMC has the ability
to produce a state of dependence and central nervous system
stimulation. There is evidence that it is abused so as to constitute a
public health and social problem. It is therefore recommended that 4-
CMC be controlled under the 1971 Convention on Psychotropic Substances.
As it has no medical use and its use constitutes a substantial risk to
public health, it is recommended that it be controlled under Schedule
II of the 1971 Convention on Psychotropic Substances.

N-Ethylhexedrone

    The chemical name for N-ethylhexedrone is 2-(ethylamino)-1-
phenylhexan-1-one.
    In common with other stimulants used non-medically, N-
ethylhexedrone increases neuronal concentrations of the
neurotransmitter dopamine. It also has effects on noradrenaline.
    In preclinical models, N-ethylhexedrone has actions predictive of
methamphetamine-like subjective effects and produces central nervous
system stimulation. Users of the drug

report effects similar to other stimulants, including increased energy,
mood elevation, perceptual changes and increased sociability.
    Information on the adverse effects is limited, but the effects
reported are consistent with the effects of stimulant drugs and include
tachycardia, tremor, seizures and hyperthermia. N-ethylhexedrone has
been implicated as the cause of at least one fatality and of cases of
impaired driving. It has been detected in used syringes, indicating the
potential for injection related health problems in association with its
use.
    N-ethylhexedrone has been detected in 30 countries across different
regions. It has no veterinary or medical use.
    Based on its mechanism of action and effects, N-ethylhexedrone has
the ability to produce a state of dependence and central nervous system
stimulation. There is evidence that it is abused so as to constitute a
public health and social problem. It is therefore recommended that N-
ethylhexedrone be controlled under the 1971 Convention on Psychotropic
Substances. As it has no medical use and its use constitutes a
substantial risk to public health, it is recommended that it be
controlled under Schedule II of the 1971 Convention on Psychotropic
Substances.

Alpha-PHP

    Alpha-PHP is also known as alpha-pyrrolidinohexanophenone. Its
chemical name is 1-phenyl-2-(pyrrolidine-1-yl)hexan-1-one.
    In common with other stimulants used non-medically, alpha-PHP
increases neuronal concentrations of the neurotransmitter dopamine. It
also has effects on noradrenaline.
    In animal models, alpha-PHP has effects predictive of abuse and
dependence potential, including actions predictive of methamphetamine-
like subjective effects and reinforcing properties. It produces central
nervous system stimulation in animals. Users of the drug report effects
similar to other stimulants, including increased energy, mood
elevation, perceptual changes and appetite suppression.
    The adverse effects of the drug include tachycardia, paranoia and
hallucinations. It has been identified as the cause of multiple deaths
and clinical admissions.
    Alpha-PHP has been detected in over 20 countries across different
regions. It has no veterinary or medical use.
    Based on its mechanism of action and effects, alpha-PHP has the
ability to produce a state of dependence and central nervous system
stimulation. There is evidence that it is abused so as to constitute a
public health and social problem. It is therefore recommended that
alpha-PHP be controlled under the 1971 Convention on Psychotropic
Substances. As it has no medical use and its use constitutes a
substantial risk to public health, it is recommended that it be
controlled under Schedule II of the 1971 Convention on Psychotropic
Substances.
    Substances recommended to be scheduled in Schedule IV of the
Convention on Psychotropic Substances (1971):

Flualprazolam

    The chemical name for flualprazolam is 8-chloro-6-(2-fluorophenyl)-
1-methyl-4H-benzo[f][1,2,4]triazolo[4,3-a][1,4] diazepine.
    Flualprazolam is chemically similar to the benzodiazepines
alprazolam and triazolam and in animal models it produces the typical
benzodiazepine effects of sedation, muscle relaxation and
anticonvulsant actions. Users have reported effects such as sedation,
disinhibition and memory impairment that are common with
benzodiazepines and have described it as similar to alprazolam and
clonazepam.
    In toxicology reports, flualprazolam has been documented as
contributing to forensic and clinical events, including fatal and non-
fatal intoxications and cases of driving under the influence. It has no
medical use.
    There is limited information on the extent of global use of
flualprazolam with most reported identifications coming from two
countries. There are numerous reports of its use on internet forums.
    Based on its capacity to produce a state of dependence and central
nervous system depression similar to the controlled benzodiazepine
alprazolam, which is controlled under Schedule IV of the1971 Convention
on Psychotropic Substances, as well as evidence that it is likely to be
abused so as to constitute a public health and social problem, it is
recommended that flualprazolam be controlled under Schedule IV of the
1971 Convention on Psychotropic Substances.

Etizolam

    The chemical name for etizolam is 4-(2-chlorophenyl)-2-ethyl-9-
methyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine. It has
been previously reviewed by the ECDD, most recently at its 39th meeting
in 2017.
    Etizolam is an agonist at the benzodiazepine site on the GABAA
receptor, inducing central nervous system depression. It has typical
benzodiazepine effects that include sedation and muscle relaxation as
well as anxiolytic and anticonvulsant actions. Adverse effects include
drowsiness, ataxia, slurred speech, cognitive impairment and loss of
consciousness.
    Etizolam use has been associated with a large number of deaths,
generally along with another drug or drugs. Benzodiazepines such as
etizolam pose a significant risk when combined with opioids as they can
potentiate the respiratory depressant effects of opioids.
    Etizolam has been used in a number of countries and in some of
these countries has been associated with reports of fatal and no-fatal
intoxication as well as cases of driving under the influence. It has
marketing authorization for medical use in three countries.
    Based on its capacity to produce a state of dependence and central
nervous system depression similar to other controlled benzodiazepines,
as well as evidence that it is abused so as to constitute a public
health and social problem, it is recommended that etizolam be
controlled under Schedule IV of the 1971 Convention on Psychotropic
Substances.
    Substance recommended for surveillance:

APINACA

    The chemical name for APINACA (also known as AKB-48) is N-
(adamantan-1-yl)-1-pentyl-1H-indazole-3-carboxamide. It was previously
reviewed at the 36th meeting of the WHO Expert Committee on Drug
Dependence in 2014 but was not recommended for control at that time.
    In common with other synthetic cannabinoids, APINACA is an agonist
at the CB1 receptor that mediates the psychoactive effects of
cannabinoids. In animal studies it produced central nervous system
depression and had actions predictive of cannabinoid-like subjective
effects.
    APINACA produces neurological signs in animals that include
seizures, hyperreflexia and aggression. However, there are no studies
of the adverse effects of APINACA in human users of the drug and no
available information regarding fatal or non-fatal intoxications.
    APINACA use has been reported in a number of countries but its use
has been declining since 2015 and it is now detected very infrequently
if at all.
    Owing to the lack of significantly more information since the
review conducted by the 36th ECDD in 2014, and considering the current
insufficiency of data regarding dependence, abuse and risks to public
health (including risks to the

individual), the Committee recommended that APINACA be kept under
surveillance.
    Preparations recommended for critical review:

--Preparations of acetyldihydrocodeine, codeine, dihydrocodeine,
ethylmorphine, nicocodine, nicodicodine, norcodeine and pholcodine
listed in Schedule III of the 1961 Single Convention on Narcotic Drugs

    The Committee considered a pre-review of the following preparations
listed in Schedule III of the 1961 Single Convention on Narcotic Drugs:
acetyldihydrocodeine, codeine, dihydrocodeine, ethylmorphine,
nicocodine, nicodicodine, norcodeine and pholcodine, when compounded
with one or more other ingredients and containing not more than 100
milligrams of the drug per dosage unit and with a concentration of not
more than 2.5 per cent in undivided preparations.
    These preparations have not been previously reviewed. The ECDD
Secretariat commissioned a pre-review of these preparations, on the
basis of concerns regarding abuse and harm of preparations of codeine
that were conveyed to the Secretariat. As many of the substances listed
in the first entry of Schedule III of the 1961 Single Convention are
chemically and pharmacologically similar to codeine, the eight
preparations were considered together.
    These preparations have been marketed and used as antitussive
medicines and analgesics for mild to moderate pain. In many countries
these preparations are available without medical prescription. The
active substances in the preparations are opioids and all substances
themselves are controlled under Schedule II of the 1961 Single
Convention on Narcotic Drugs. Misuse of and dependence on preparations
of codeine and dihydrocodeine have been well described. The pre-review
suggested that there may be less evidence regarding the other
preparations. The Committee also noted evidence of separation of the
opioid drug such as codeine from the other ingredients in these
preparations by people misusing these preparations.
    Based on the evidence available regarding dependence, abuse and
risks to public health, the Committee recommended a critical review of
the following preparations included in Schedule III of the 1961
Convention at a future meeting: acetyldihydrocodeine, codeine,
dihydrocodeine, ethylmorphine, nicocodine, nicodicodine, norcodeine,
and pholcodine when compounded with one or more other ingredients and
containing not more than 100 milligrams of the drug per dosage unit and
with a concentration of not more than 2.5 per cent in undivided
preparations.

III. Discussion

    Although WHO has made specific scheduling recommendations for each
of the drug substances, the CND is not obliged to follow the WHO
recommendations. Options available to the CND for substances considered
for control under the 1971 Convention include the following: (1) Accept
the WHO recommendations; (2) accept the recommendations to control but
control the drug substance in a schedule other than that recommended;
or (3) reject the recommendations entirely.
    Crotonyl fentanyl (chemical name: N-(1-phenethylpiperidin-4-yl)-N-
phenylbut-2-enamide) and valeryl fentanyl (chemical name: N-(1-
phenethylpiperidin-4-yl)-N-phenylpentanamide) are synthetic opioids
that have a pharmacological profile similar to other Schedule I and II
opioid substances controlled under the CSA such as cyclopropyl
fentanyl, fentanyl, and other related mu-opioid receptor agonist
substances. They are clandestinely produced and associated with adverse
events typically associated with opioid use such as respiratory
depression, anxiety, constipation, tiredness, hallucinations, and
withdrawal. Crotonyl fentanyl and valeryl fentanyl have been
encountered by law enforcement and/or reported in the scientific
literature by public health officials as being illicitly distributed
and abused. Crotonyl fentanyl and valeryl fentanyl have no commercial
or currently accepted medical uses in the United States. On February 1,
2018, valeryl fentanyl was temporarily placed into Schedule I of the
CSA. The chemical structure of crotonyl fentanyl defines it as a
fentanyl-related substance, as defined in 21 CFR 1308.11(h)(30);
therefore, crotonyl fentanyl was temporarily controlled as a Schedule I
controlled substance under the CSA as of February 6, 2018. As such,
additional controls will be necessary to fulfill United States
obligations if crotonyl fentanyl and valeryl fentanyl are placed in
Schedules I of the Single Convention on Narcotic Drugs (1961).
    DOC (chemical names: 2,5-Dimethoxy-4-chloroamfetamine; 2,5-
dimethoxy-4-chloroamphetamine; 1-(4-chloro-2,5-dimethoxyphenyl)propan-
2-amine) is a hallucinogenic substance with psychedelic effects. Law
enforcement has encountered DOC in tablet, capsule, powder, liquid, and
blotter paper forms. Its use has been associated with at least one
death. DOC has no currently accepted medical use in treatment in the
United States. DOC is not controlled under the CSA but is a Schedule I
controlled substance in the state of Florida. As such, additional
permanent controls will be necessary to fulfill United States
obligations if DOC is controlled under Schedule I of the 1971
Convention.
    AB-FUBINACA (chemical name: N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-
(4-fluorobenzyl)-1H-indazole-3-carboxamide) is a synthetic cannabinoid
that is a potent full agonist at CB1 receptors. This substance
functionally (biologically) mimics the effects of structurally
unrelated THC, a Schedule I substance under the CSA, and the main
psychoactive chemical constituent in cannabis. Synthetic cannabinoids
have been marketed under the guise of ``herbal incense,'' and promoted
by drug traffickers as legal alternatives to cannabis. AB-FUBINACA use
has been associated with serious adverse events including death in the
United States. There are no commercial or approved medical uses for AB-
FUBINACA. On September 6, 2016, AB-FUBINACA was permanently placed as a
Schedule I controlled substance under the CSA. As such, additional
permanent controls will not be necessary to fulfill United States
obligations if AB-FUBINACA is controlled under Schedule II of the 1971
Convention.
    5F-AMB (5F-AMB-PINACA, 5F-MMB-PINACA) (chemical name: methyl 2-(1-
(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) is a
synthetic cannabinoid that is a potent full agonist at CB1 receptors.
This substance functionally (biologically) mimics the effects of THC, a
Schedule I substance under the CSA, and the main psychoactive chemical
constituent in cannabis. Synthetic cannabinoids have been marketed
under the guise of ``herbal incense,'' and promoted by drug traffickers
as legal alternatives to cannabis. The use of synthetic cannabinoids,
including, 5F-AMB has been associated with nausea and vomiting,
shortness of breath or depressed breathing, hypertension, tachycardia,
chest pain, muscle twitching, acute renal failure, anxiety, agitation,
psychosis, suicidal ideation, and/or cognitive impairment. There are no
commercial or approved medical uses for 5F-AMB. On April 8, 2019, a
Drug Enforcement Administration Notice of Proposed Rulemaking proposed
permanently placing 5F-AMB

into Schedule I of the CSA. As such, additional permanent controls will
not be necessary to fulfill United States obligations if 5F-AMB is
controlled under Schedule II of the 1971 Convention.
    5F-MDMB-PICA (5F-MDMB-2201) (chemical name: methyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) is a
synthetic cannabinoid that has been sold online and used to mimic the
biological effects of THC, the main psychoactive chemical constituent
in cannabis. Research and clinical reports have demonstrated that
synthetic cannabinoids are applied onto plant material so that the
material may be smoked as users attempt to obtain a euphoric and
psychoactive ``high.'' Synthetic cannabinoids have been marketed under
the guise of ``herbal incense,'' and promoted by drug traffickers as
legal alternatives to cannabis. 5F-MDMB-PICA has been associated with
law enforcement seizures and overdoses requiring emergency medical
intervention. On April 16, 2019, 5F-MDMB-PICA was temporarily
controlled as a Schedule I substance under the CSA. As such, additional
permanent controls will be necessary to fulfill United States
obligations if 5F-MDMB-PICA is controlled under Schedule II of the 1971
Convention.
    4F-MDMB-BINACA (4F-ADB) (chemical name: methyl 2-(1-(4-
fluorobutyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) is a
synthetic cannabinoid that is a potent full agonist at CB1 receptors.
This substance functionally (biologically) mimics the effects of THC, a
Schedule I substance, and the main psychoactive constituent in
cannabis. 4F-MDMB-BINACA has been encountered in numerous synthetic
cannabinoid products that are smoked for their psychoactive effects.
Multiple law enforcement encounters of 4F-MDMB-BINACA have been
reported involving overdose deaths, illicit use, and seizures of drug
evidence between December 2018 and February 2019. There are no
commercial or approved medical uses for 4F-MDMB-BINACA. 4F-MDMB-BINACA
is a positional isomer of 5F-AMB (chemical name: methyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate), as defined
by 21 CFR 1300.01, and has been a Schedule I controlled substance under
the CSA since April 10, 2017. As such, additional permanent controls
will not be necessary to fulfill United States obligations if 4F-MDMB-
BINACA is controlled under Schedule II of the 1971 Convention.
    4-CMC (4-chloromethcathinone; clefedrone, clephedrone) (chemical
name: 1-(4-chlorophenyl)-2-(methylamino)propan-1-one) is a synthetic
cathinone. 4-CMC produces central nervous system stimulant effects and
is abused for its psychoactive properties. 4-CMC abuse has been
associated with adverse health effects. 4-CMC has no currently accepted
medical use in treatment in the United States. 4-CMC is not controlled
under the CSA, but it is considered a Schedule I controlled substance
by a number of states in the United States. As such, additional
permanent controls will be necessary to fulfill United States
obligations if 4-CMC is controlled under Schedule II of the 1971
Convention.
    N-Ethylhexedrone (chemical name: 2-(ethylamino)-1-phenylhexan-1-
one; NEH, hexen, Ethyl-Hex) and alpha-PHP (chemical name: 1-phenyl-2-
(pyrrolidin-1-yl)hexan-1-one; PV-7, [alpha]-pyrrolidinohexanophenone)
are synthetic cathinones. N-Ethylhexedrone and alpha-PHP produce
central nervous system stimulant effects and are abused for their
psychoactive properties. N-Ethylhexedrone and alpha-PHP have been
associated with adverse health effects leading to emergency department
admissions, and deaths. N-Ethylhexedrone and alpha-PHP have no
currently accepted medical use in treatment in the United States. On
July 18, 2019, N-Ethylhexedrone and alpha-PHP were temporarily
controlled as a Schedule I substance under the CSA. As such, additional
permanent controls will be necessary to fulfill United States
obligations if N-Ethylhexedrone and alpha-PHP are controlled under
Schedule II of the 1971 Convention.
    Flualprazolam and etizolam belong to a class of substances known as
benzodiazepines. Benzodiazepines produce central nervous system
depression and are commonly used to treat insomnia, anxiety, and
seizure disorders. Etizolam is currently prescribed in some countries;
however, neither drug substance is approved for medical use in the
United States. Currently, flualprazolam and etizolam are not controlled
under the CSA, but are controlled in a number of states in the United
States. As such, additional permanent controls will be necessary to
fulfill United States obligations if flualprazolam and etizolam are
controlled under Schedule IV of the 1971 Convention.
    FDA, on behalf of the Secretary of HHS, invites interested persons
to submit comments on the notifications from the United Nations
concerning these drug substances. FDA, in cooperation with the National
Institute on Drug Abuse, will consider the comments on behalf of HHS in
evaluating the WHO scheduling recommendations. Then, under section
201(d)(2)(B) of the CSA, HHS will recommend to the Secretary of State
what position the United States should take when voting on the
recommendations for control of substances under the 1971 Convention at
the CND meeting in March 2020.
    Comments regarding the WHO recommendations for control of crotonyl
fentanyl and valeryl fentanyl; under the 1961 Single Convention will
also be forwarded to the relevant Agencies for consideration in
developing the United States position regarding narcotic substances at
the CND meeting.

    Dated: December 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28269 Filed 12-30-19; 8:45 am]
 BILLING CODE 4164-01-P


CONTACT REPORT From: Dave Reeves Date of Contact: September 9, 2002 Company/ Agency: Quantegy Inc. 2230 Marvyn Parkway Opelika, AL 36801 Telephone Number: ( 334) 745  7643 Person Contacted: Bert Long, Environmental Manager [ blong@ quantegy. com]

CONTACT SUMMARY: I called Quantegy to inquire about reported emissions from the facility. Mr. Long verified that the facility only produces magnetic tape, so all of the reported TRI emissions are related to magnetic tape manufacturing operations. He also commented that the styrene emissions are an estimate ( 32 pounds in 1999) and that the styrene was associated with a small plastic injection molding process, which was closed down in July of 2000. Quantegy uses the bubble approach for emissions reporting under their Title V operating permit with the state of Alabama. The total ( purchased/ used) amount of VOC material is assumed to be emitted from the facility. Therefore, the reported fugitive emissions are always much higher than the calculated and reported stack emissions.

Quantegy's solvent recovery system has 6 carbon adsorbers, each with a separate stack. Mr. Long estimated the stacks to be 17' high and 32" in diameter. All solvent laden air ( SLA) from storage tanks, mix tanks, coating lines, and ovens is manifolded to the control system. Mr. Long provided room volumes for the 3 primary process areas involving solvents ( MEK and toluene) of each facility on site. The primary process areas include coating enclosures, oven rooms, and mix preparation areas.

There are 3 coating lines in Plant No. 1 considered to be a permanent total enclosure ( 4,312 cu. ft.) and the 3 ovens associated with the coating lines are also located in one room ( 33,750 cu. ft.). In addition, Plant No. 1 contains a mix prep area ( 171,110 cu. ft.) where solvents are processed.

Plant No. 2 contains two coating lines with each having individual enclosures of approximately 878 cu. ft. and 1,440 cu. ft. Plant No. 2 has a room approximately 165,835 cu. ft. that contains the ovens of both coating lines. The mix prep area for Plant No. 2 has approximately 415,538 cu. ft.

The Research and Development building contains two coating lines with each having individual enclosures of approximately 619 cu. ft. and 2,475 cu. ft. The oven rooms have approximately 14,850 cu. ft. and 7,475 cu. ft of area. The mix prep area for the Research and Development building has approximately 53,035 cu. ft. Mr. Long stated that the manufacturing operations are running 24 hours/ day and 5 days/ week. The mix room operates 7 days/ week preparing and filtering the various coatings ( batches) for the upcoming week of production runs.


9655 Federal Register / Vol. 68, No. 40 / Friday, February 28, 2003 / Notices products or taking `` other appropriate regulatory action.''

List of Subjects Environmental protection, Chemicals, Pesticides and pests.

Dated: February 21, 2003. Betty Shackleford, Acting Director, Special Review and Reregistration Division, Office of Pesticide Programs. [ FR Doc. 03   4778 Filed 2   27   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0028; FRL   7290   3]

EPTC; Receipt of Request For Amendments to Delete Uses AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In accordance with section 6( f)( 1) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended, EPA is issuing a notice of receipt of request for amendment by Syngenta Crop Protection Inc. ( formerly Zeneca Ag Products) to delete uses in certain registrations for products containing SEthyl di propyl thiocarbamate or EPTC. In addition, Drexel Chemical Company has asked EPA to cancel or amend their registrations for end use products containing EPTC. Pursuant to section 6( f)( 1) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), EPA is announcing the Agency's receipt of these requests. These requests for voluntary cancellation were submitted to EPA in March 2000 and February 2002. EPA also plans to issue a cancellation order for the deleted uses at the close of the comment period for this announcement. EPA will decide whether to approve the requests after consideration of public comment. DATES: Comments on the requested amendments to delete uses must be submitted to the address provided below by March 31, 2003. Withdrawal of request for deletion of use must be submitted in writing to the person listed under FOR FURTHER INFORMATION CONTACT, postmarked before March 31, 2003. FOR FURTHER INFORMATION CONTACT: Demson Fuller, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308   8062; email address: fuller. demson@ epamail. epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. You may be potentially affected by this action if you manufacture, sell, distribute, or use EPTC products. The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, does not apply because this action is not a rule, for purposes of 5 U. S. C. 804( 3). Since other entities may also 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 the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0028. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. To access RED documents and RED fact sheets electronically, go directly to the REDs table on the EPA Office of Pesticide Programs Home Page, at http:// www. epa. gov/ pesticides/ reregistration/ status. htm. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a VerDate Jan< 31> 2003 18: 05 Feb 27, 2003 Jkt 200001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 28FEN1. SGM 28FEN1 9656 Federal Register / Vol. 68, No. 40 / Friday, February 28, 2003 / Notices brief description written by the docket staff.

II. Request to Amend Registrations A. Background Information The Reregistration Eligibility Decision ( RED) for EPTC was completed in December 1999. At that time, EPA requested that Syngenta ( formerly Zeneca Ag Products) submit field trial data for citrus. On March 21, 2000, Syngenta submitted a written request to EPA seeking to amend the registrations for EPTC, specifically requesting that EPA amend registrations to terminate the use of EPTC on citrus. On August 27, 2000, the registrant further submitted labeling amendments deleting citrus from each label on which it appears. In addition, on February 15, 2002, Drexel Chemical Company requested a voluntary cancellation of citrus for its End Use products containing EPTC.

B. Requests for Voluntary Cancellation Under section 6( f)( 1)( A) of FIFRA, registrants may request, at any time, that their pesticide registrations be canceled or amended to terminate one or more pesticide uses. Section 6( f)( 1)( B) of FIFRA requires that before acting on a request for voluntary cancellation, EPA must provide a 30   day public comment period on the request for voluntary cancellation. In addition, section 6( f)( 1)( C) of FIFRA requires that EPA provide a 180   day comment period on a request for voluntary termination of any minor agricultural use before granting the request, unless ( 1) the registrants request a waiver of the comment period, or ( 2) the Administrator determines that continued use of the pesticide would pose an unreasonable adverse effect on the environment. The registrants have requested that EPA waive the 180   day comment period. EPA is granting the registrants' request to waive the 180   day comment period. Therefore, EPA will provide a 30   day comment period on the proposed requests. EPA anticipates granting the cancellation request shortly after the end of the 30   day comment period for this notice. The registrations that will be affected by the deletion of citrus are listed in the following Table 1.

TABLE 1.   END USE PRODUCT REGISTRATION AMENDMENT REQUEST Company Reg. No Product Use Syngenta Crop Protection, Inc. 100   1023 EPTAM Technical.

Syngenta Crop Protection, Inc. 100   1025 EPTAM 7   E Selective Herbicide.

Drexel Chemical Company. 19713   101 Drexel EPTC   7EC.

III. What is the Agency's Authority for Taking this Action? Section 6( f)( 1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled. FIFRA section 6( f)( 1) further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register, make reasonable efforts to inform persons who rely on the pesticide for minor agricultural uses, and provide a 30   day period in which the public may comment. Thereafter, the Administrator may approve such a request.

IV. Procedures for Withdrawal of Request Registrants who choose to withdraw a request for deletion of use must submit such withdrawal in writing to the person listed under FOR FURTHER INFORMATION CONTACT, postmarked before March 31, 2003. This written withdrawal of the request for deletion of use will apply only to the applicable FIFRA section 6( f)( 1) request listed in this notice. If the use( s) have been subject to a previous cancellation action, the effective date of cancellation and all other provisions of any earlier cancellation action are controlling. The withdrawal request must also include a commitment to pay any reregistration fees due, and to fulfill any applicable unsatisfied data requirements. V. Provisions for Disposition of Existing Stocks The registrants have submitted amendments to amend registrations to delete uses of EPTC identified in Table 1. Pursuant to section 6( f) of FIFRA, EPA expects to grant these requests for amendment upon the close of the comment period. The effective date of this amendment will be the date of the cancellation order. The orders effecting this requested amendment will generally permit a registrant to sell or distribute existing stocks for 1 year after the date the amendment request was received. This policy is in accordance with the Agency's statement of policy as prescribed in the Federal Register of June 26, 1991 ( 56 FR 29362) ( FRL   3846   4). Exceptions to this general rule will be made if a product poses a risk concern, or is in noncompliance with reregistration requirements, or is subject to a Data Call In. In all cases, productspecific disposition dates will be given in the cancellation orders.

VI. Future Tolerance Revocations EPA anticipates drafting a future Federal Register notice proposing revocation of this tolerance on commodities which no longer have registered uses of EPTC. In this notice, EPA seeks comment as to whether any individuals or groups want to support continuation of these tolerances. List of Subjects Environmental protection, Pesticides and pests.

Dated: February 6, 2003. Lois Rossi, Director, Special Review and Reregistration Division, Office of Pesticide Programs. [ FR Doc. 03   4774 Filed 2   27   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0040; FRL   7292   1]

Intent to Suspend Certain Pesticide Registrations AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice of issuance of notice of intent to suspend.

SUMMARY: This Notice, pursuant to section 6( f)( 2) of the Federal Insecticide, Fungicide and Rodenticide Act ( FIFRA), 7 U. S. C. 136 et seq., announces that EPA issued a Notice of Intent to Suspend pursuant to section 3( c)( 2)( B) of FIFRA and that the Notice of Intent to Suspend has since become an effective suspension order. The Notice of Intent to Suspend was issued following issuance of the 1991 Thiram Data Call In Notice ( DCI). The DCI required registrants of products containing thiram used as an active ingredient to VerDate Jan< 31> 2003 18: 05 Feb 27, 2003 Jkt 200001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 28FEN1. SGM 28FEN1


[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Page 30632]
[FR Doc No: 2014-12333]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2013-0043; OMB No. 1660-0002]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before June 27, 2014.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 500 C Street SW., Washington, DC 20472-
3100, facsimile number<PHONE_NUMBER>, or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Collection of Information

    Title: Disaster Assistance Registration.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0002.
    Form Titles and Numbers: FEMA Form 009-0-1T (English) Tele-
Registration, Disaster Assistance Registration; FEMA Form 009-0-1Int
(English) Internet, Disaster Assistance Registration; FEMA Form 009-0-
2Int (Spanish) Internet, Registro Para Asistencia De Desastre; FEMA
Form 009-0-1 (English) Paper Application/Disaster Assistance
Registration; FEMA Form 009-0-2 (Spanish), Solicitud en Papel/Registro
Para Asistencia De Desastre; FEMA Form 009-0-1S (English) Smartphone,
Disaster Assistance Registration; FEMA Form 009-0-2S (Spanish)
Smartphone, Registro Para Asistencia De Desastre; FEMA Form 009-0-3
(English), Declaration and Release; FEMA Form 009-0-4 (Spanish),
Declaraci[oacute]n Y Autorizaci[oacute]n; FEMA Form 009-0-5 (English),
Manufactured Housing Unit Revocable License and Receipt for Government
Property; FEMA Form 009-0-6 (Spanish), Las Casas Manufacturadas Unidad
Licencia Revocable y Recibo de la Propiedad del Gobierno.
    Abstract: The various forms in this collection are used to collect
pertinent information to provide financial assistance, and if
necessary, direct assistance to eligible individuals and households
who, as a direct result of a disaster or emergency, have uninsured or
under-insured, necessary expenses and serious needs that they are
unable to meet through other means.
    Affected Public: Individuals or Households.
    Estimated Number of Respondents: 3,264,753.
    Estimated Total Annual Burden Hours: 628,036 hours.
    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $19,255,579. There are no annual costs to respondents
operations and maintenance costs for technical services. There is no
annual start-up or capital costs. The cost to the Federal Government is
$15,618,762.

    Dated: May 21, 2014.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2014-12333 Filed 5-27-14; 8:45 am]
BILLING CODE 9111-23-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                 NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY                              2000 TRAVERWOOD ROAD                            ANN ARBOR, MI  48105-2498

									          	OFFICE OF 										AIR AND RADIATION

January 25, 2011

MEMORANDUM

SUBJECT:	Meeting with Honeywell

FROM:	Angela Cullen

TO:		Docket EPA-HQ-OAR-2010-0162

This memorandum documents a meeting held on Monday, January 24, 2011 between Honeywell, NHTSA, CARB, and EPA and included the following individuals:

      Honeywell: Nando Gomez, Ken Horen, Tony Shultz, Geoff Duff, Mark Rodrgues, Mike Guidry, Steve McKinley              EPA: Brian Nelson, Ed Nam, Bill Charmley, Angela Cullen, Tony Fernandez, Houshan Zhang, Ben Ellies, Allen Duncan, Byungho Lee        NHTSA: Lixin Zhao, Ryan Harrington              CARB: Paul Hughes, Steve Albu

The discussion focused on the turbocharger development and alternative refrigerants for light-duty and heavy-duty vehicles.