[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52150-52152]
[FR Doc No: 2019-21242]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87109; File No. SR-Phlx-2019-36]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the
Exchange's Pricing Schedule, at Equity 7, Section 3

September 25, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''), \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 13, 2019, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I, II,
and III, below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's transaction fees at
Equity 7, Section 3, as described further below.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Presently, the Exchange has a pricing schedule, at Equity 7,
Section 3, which sets forth several different fees that it charges for
orders in securities priced at $1 or more per share that remove
liquidity from the Exchange and several different credits that it
providers for orders in such securities that add liquidity on the
Exchange. The Exchange recently amended this pricing schedule to
increase removal activity on the Exchange and to improve overall market
quality.\3\ Currently, the Exchange provides the following schedule of
credits for displayed orders/quotes that provide liquidity to the
Exchange:
---------------------------------------------------------------------------

    \3\ See SR-Phlx-2019-35.
---------------------------------------------------------------------------

     $0.0026 per share executed credit for quotes/orders
entered by member organizations that provide 0.15% or more of total
Consolidated Volume during a month;
     $0.0024 per share executed credit for quotes/orders
entered by member organizations that provide 0.07% or more of total
Consolidated Volume during a month; and
     $0.0023 per share executed credit for all other quotes/
orders.
    The Exchange now proposes to reduce its $0.0023 per share executed
credit for all other displayed quotes/orders to $0.0020 per share
executed. The Exchange proposes this change to further offset the costs
of its recent reductions to its transaction fees, as set forth in SR-
Phlx-2019-35, which the Exchange intends to incentivize increased
liquidity removal activity on the Exchange, and to further improve
overall market quality. Nasdaq [sic] notes that it mistakenly omitted
this change when it filed SR-Phlx-2019-35, and wishes to correct that
omission going forward.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\4\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\5\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

The Proposal Is Reasonable
    The Exchange's proposed change to its credit for all other
displayed orders/quotes is reasonable in several respects. As a
threshold matter, the Exchange is subject to significant competitive
forces in the market for equity securities transaction services that
constrain its pricing determinations in that market. The fact that this
market is competitive has long been recognized by the courts. In
NetCoalition v. Securities and Exchange Commission, the D.C. Circuit
stated as follows: ``[n]o one disputes that competition for order flow
is `fierce.' As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-dealers that
act as their order-routing agents, have a wide range of choices of
where to route orders for execution'; [and] `no exchange can afford to
take its market share percentages for granted' because `no exchange
possesses a monopoly, regulatory or otherwise, in the execution of
order flow from broker dealers'. . . .'' \6\
---------------------------------------------------------------------------

    \6\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-
21)).
---------------------------------------------------------------------------

    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. In Regulation
NMS, while adopting a series of steps to improve the current market
model, the Commission highlighted the importance of market forces in
determining prices and SRO revenues and, also, recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \7\
---------------------------------------------------------------------------

    \7\ Securities Exchange Act Release No. 51808 (June 9, 2005), 70
FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
---------------------------------------------------------------------------

    Numerous indicia demonstrate the competitive nature of this market.
For example, clear substitutes to the Exchange exist in the market for
equity security transaction services. The Exchange is only one of
several equity venues to which market participants may direct their
order flow. Competing equity exchanges offer similar tiered pricing
structures to that of the Exchange, including schedules of rebates and
fees that apply based upon members achieving certain volume
thresholds.\8\
---------------------------------------------------------------------------

    \8\ See Cboe EDGX U.S. Equities Exchange Fee Schedule, available
at https://markets.cboe.com/us/equities/membership/fee_schedule/edgx/.
---------------------------------------------------------------------------

    Within this environment, market participants can freely and often
do shift their order flow among the Exchange and competing venues in
response to changes in their respective pricing schedules.\9\ Within
the foregoing

context, the proposal represents a reasonable attempt by the Exchange
to further offset the costs of its recent action \10\ to improve market
quality and increase its market share relative to its competitors.
---------------------------------------------------------------------------

    \9\ The Exchange perceives no regulatory, structural, or cost
impediments to market participants shifting order flow away from it.
In particular, the Exchange notes that such shifts in liquidity and
market share occur within the context of market participants'
existing duties of Best Execution and obligations under the Order
Protection Rule under Regulation NMS.
    \10\ See SR-Phlx-2019-35.
---------------------------------------------------------------------------

    Generally, the Exchange's schedule of credits and charges in Equity
7, Section 3, as recently amended by SR-Phlx-2019-35, is intended to
provide strong incentives to member organizations to increase their
liquidity removal activity on the Exchange, and to do so broadly in
orders in securities in all Tapes. The Exchange believes that an
increase in overall liquidity removal activity on the Exchange will, in
turn, improve the quality of the Exchange's equity market and increase
its attractiveness to existing and prospective participants. The
proposal to reduce the Exchange's credit for all other displayed
orders/quotes is an effort to help offset the costs of its recent
reductions in transaction fees for removing liquidity from the
Exchange. Even as lowered, the proposed amended credit will be
comparable to, if not favorable to, those that its competitors
provide.\11\
---------------------------------------------------------------------------

    \11\ See n. 8, supra.
---------------------------------------------------------------------------

The Proposal Is an Equitable Allocation of Credits and Charges
    The Exchange believes its proposal will allocate its proposed
credits fairly among its market participants. The Exchange believes
that it is equitable to offset the costs of its recent proposal to
charge lower fees for liquidity removal \12\ by lowering its
corresponding credits for liquidity provision to the Exchange. Although
the proposed amended credit will be lower than the existing credit, the
Exchange believes that the proposed credit will continue to be
comparable to liquidity adding rebates provided by its competitors.\13\
That said, the Exchange again notes that those participants that do not
wish to receive the lower credit are free to shift their order flow to
competing venues that offer them higher credits.
---------------------------------------------------------------------------

    \12\ See SR-Phlx-2019-35.
    \13\ See n. 8, supra.
---------------------------------------------------------------------------

The Proposal Is Not Unfairly Discriminatory
    The Exchange believes that the proposal is not unfairly
discriminatory. As an initial matter, the Exchange believes that
nothing about its volume-based tiered pricing model is inherently
unfair; instead, it is a rational pricing model that is well-
established and ubiquitous in today's economy among firms in various
industries--from co-branded credit cards to grocery stores to cellular
telephone data plans--that use it to reward the loyalty of their best
customers that provide high levels of business activity and incent
other customers to increase the extent of their business activity. It
is also a pricing model that the Exchange and its competitors have long
employed with the assent of the Commission. It is fair because it
incentivizes customer activity that increases liquidity, enhances price
discovery, and improves the overall quality of the equity markets.
    The Exchange intends for the proposal to offset its costs of
improving market quality for all members on the Exchange. Although net
adders of liquidity will bear the burden of the lower credit, this
result is fair insofar as increased liquidity removal activity that the
lower credit facilitates will help to improve overall market quality
and the attractiveness of the Exchange's equity market to all existing
and prospective participants.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
Intramarket Competition
    The Exchange does not believe that its proposal will place any
category of Exchange participant at a competitive disadvantage. As
noted above, all members of the Exchange--and even those that receive
the lower proposed credit--will benefit from an increase in the removal
of liquidity by those that choose to meet the tier qualification
criteria. Moreover, members are free to trade on other venues to the
extent they believe that the credits provided are not attractive. As
one can observe by looking at any market share chart, price competition
between exchanges is fierce, with liquidity and market share moving
freely between exchanges in reaction to credit changes. The Exchange
notes that the tier structure is consistent with broker-dealer fee
practices as well as the other industries, as described above.
Intermarket Competition
    The Exchange believes that its proposed modification to its
schedule of credits will not impose a burden on competition because the
Exchange's execution services are completely voluntary and subject to
extensive competition both from the other 12 live exchanges and from
off-exchange venues, which include 32 alternative trading systems. The
Exchange notes that it operates in a highly competitive market in which
market participants can readily favor competing venues if they deem
rebate opportunities available at other venues to be more favorable. In
such an environment, the Exchange must continually adjust its fees and
credits to remain competitive with other exchanges and with alternative
trading systems that have been exempted from compliance with the
statutory standards applicable to exchanges. Because competitors are
free to modify their own credits in response, and because market
participants may readily adjust their order routing practices, the
Exchange believes that the degree to which credit changes in this
market may impose any burden on competition is extremely limited.
    The proposed amended credit is reflective of this competition
because, as a threshold issue, the Exchange is a relatively small
market so its ability to burden intermarket competition is limited. In
this regard, even the largest U.S. equities exchange by volume only has
17-18% market share, which in most markets could hardly be categorized
as having enough market power to burden competition. Moreover, as noted
above, price competition between exchanges is fierce, with liquidity
and market share moving freely between exchanges in reaction to fee and
credit changes. This is in addition to free flow of order flow to and
among off-exchange venues which comprised more than 37% of industry
volume for the month of July 2019.
    In sum, the Exchange intends for the proposed amended credit to
support increases in member incentives to remove liquidity from the
Exchange and to contribute to market quality, which is reflective of
fierce competition for order flow noted above; however, if the proposed
amended credit is unattractive to market participants, it is likely
that the Exchange will either fail to increase its market share or even
lose market share as a result. Accordingly, the Exchange does not
believe that the proposed amended credit will impair the ability of
members or competing order execution venues to maintain their
competitive standing in the financial markets.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\14\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2019-36 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2019-36. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2019-36 and should be submitted on
or before October 22, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-21242 Filed 9-30-19; 8:45 am]
BILLING CODE 8011-01-P


Page 1 of 23 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES May 18, 2004 MEMORANDUM SUBJECT: Tolerance Reassessment Decisions Completed by the Lower Risk Pesticide Chemical Focus Group FROM: Betty Shackleford, Associate Director Registration Division TO: Peter Caulkins, Associate Director Special Review and Reregistration Division Please find attached the Focus Group Decision Documents for glycerol and the glycerol esters of fatty acids. The three tolerance exemptions in 40 CFR 180.910 [ formerly 40 CFR180.1001( c)] and the two tolerance exemptions in 40 CFR 180.930 [ formerly 40 CFR180.1001( e)] for these chemicals are reassessed.

If you have any comments or questions, please contact Kathryn Boyle at 703 305 6304.

Attachment Page 2 of 23 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES May 18, 2004 MEMORANDUM FROM: Kathryn Boyle, Co Chair and Kerry Leifer, Co Chair Lower Risk Pesticide Chemical Focus Group Registration Division TO: Betty Shackleford, Associate Director Registration Division SUBJECT: Recommendation for Tolerance Reassessment The attached science assessment discusses the toxicity of glycerol, also known as glycerin, and various glycerol esters of various fatty acids. In the human body, these esters are hydrolyzed to the fatty acid and glycerol. Based on the available information on fatty acids ( including the previous Agency performed assessments) and on glycerol ( including reviews by FDA), and an understanding of the body's metabolism of the various glycerol esters of various fatty acids, a qualitative assessment was performed.

Based on its review and evaluation of the available information, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to residues of glycerol and the various glycerol esters of various fatty acids from their uses as inert ingredients in pesticide products. The following five exemptions from the requirement of a tolerance as established in 40 CFR 180 are reassessed:

glycerol 40 CFR180.910 [ formerly 40 CFR180.1001( c)]

glycerol ( glycerin) 40 CFR180.930 [ formerly 40 CFR180.1001( e)]

glycerol monooleate 40 CFR180.930 [ formerly 40 CFR180.1001( e)]

mono and diglycerides of C 8  C 18 fatty acids 40 CFR180.910 [ formerly 40 CFR180.1001( c)] Page 3 of 23 polyglycerol esters of fatty acids ( conforming to 21 CFR 172.854) 40 CFR180.910 [ formerly 40 CFR180.1001( c)]

The classification of glycerol is confirmed as List 4A. Based on the body's ready ability to metabolize the various glycerol esters of the C 8 to C 18 fatty acids, the following 23 chemical substances are classified as List 4A:

Octadecanoic acid, monoester with 1,2,3 propanetriol 31566 31 1 Octadecanoic acid, ester with 1,2,3 propanetriol 11099 07 3 9 Octadecenoic acid ( 9Z), monoester with 1,2,3 propanetriol 25496 72 4 9 Octadecenoic acid ( 9Z), 2,3 dihydroxypropyl ester 111 03 5 Hexadecanoic acid, monoester with 1,2,3 propanetriol 26657 96 5 Tetradecanoic acid, 2,3 dihydroxypropyl ester 589 68 4 Tetradecanoic acid, monoester with 1,2,3 propanetriol 27214 38 6 Dodecanoic acid, 2,3 dihydroxypropyl ester 142 18 7 Dodecanoic acid, monoester with 1,2,3 propanetriol 27215 38 9 Decanoic acid, monoester with 1,2,3 propanetriol 26402 22 2 Octanoic acid, monoester with 1,2,3 propanetriol 26402 26 6 9 Octadecanoic acid, monoester with oxybis ( propanediol) 12694 22 3 9 Octadecenoic acid, ester with 1,2,3 propanetriol 49553 76 6 Octadecanoic acid, diester with 1,2,3 propanetriol 1323 83 7 9 Octadecenoic acid ( 9Z), diester with 1,2,3 propanetriol 25637 84 7 Hexadecanoic acid, diester with 1,2,3 propanetriol 26657 95 4 Tetradecanoic acid, diester with 1,2,3 propanetriol 53563 63 6 Dodecanoic acid, diester with 1,2,3 propanetriol 27638 00 2 Decanoic acid, diester with 1,2,3 propanetriol 53988 07 1 Octanoic acid, diester with 1,2,3 propanetriol 36354 80 0 1,2,3 propanetriol, homopolymer ( 9Z) 9 octadecenoate 9007 48 1 9 Octadecenoic acid, monoester with tetraglycerol 71012 10 7 1,2,3 propanetriol, homopolymer, octadecanoate 9009 32 9 Page 4 of 23 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES May 12, 2004 Memorandum Subject: Glycerol, and Glycerol Esters of Fatty Acids: Antimicrobials Division Science Assessment Document for Tolerance Reassessment.

From: Deborah Smegal, Toxicologist/ Risk Assessor Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C)

Through: Norm Cook, Branch Chief Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C)

To: Lower Risk Pesticide Chemical Focus Group Kathryn Boyle, Co Chair Kerry Leifer, Co Chair Registration Division ( 7505C)

Background:

Attached is the Lower Risk Pesticide Chemical Focus Group's science assessment for glycerol and glycerol esters of fatty acids, which include: glycerol, glycerol monooleate, monoand diglycerides of C 8  C 18 fatty acids and polyglycerol esters of fatty acids. The purpose of this review is a reassessment of the exemption from the requirement of a tolerance. This assessment summarizes available information on the use, physical/ chemical properties, toxicological effects, exposure profile, and environmental fate and ecotoxicity of these compounds. In performing this assessment, EPA has utilized reviews previously performed by EPA and relied on peer reviewed evaluations performed by the Food and Drug Administration ( FDA), Food and Agriculture Organization of the World Health Organization ( FAO/ WHO), the Cosmetic Ingredient Review ( CIR) expert panel, and the Organization for Economic Cooperation and Development Screening 1 Calculated as total polyglycerol ester of palmitic acid.

Page 5 of 23 Information Data Set ( OECD SIDS) evaluation.

This assessment builds on the previous tolerance reassessment described in the following document:

a) The tolerance exemption for glycerol monostearate ( 40 CFR 180.1001 ( c) ( e)) was reassessed in the IIFG Decision Document " Butyl Stearate and Glycerol Monostearate", dated July 31, 2002.

I. Executive Summary:

The glycerol fatty acids evaluated in this report include: glycerol, glycerol monooleate, mono and diglycerides of C 8  C 18 fatty acids and polyglycerol esters of fatty acids. Exposure to glycerol and glycerol esters of fatty acids may come from a wide variety of sources, including ( but not limited to) FDA approved uses as food additives, in pharmaceuticals, or through its use in soaps, shampoos, toothpastes, baby lotions, and other cosmetic products. Glycerol, and monodi and triglycerides of fatty acids are present in common consumed fats and oils. Such fats and oils are a major source of calories in the human diet, accounting for between 30 and 40% of dietary intake in the U. S. Fatty acids normally are metabolized, forming simple compounds that serve as energy sources and structural components used in all living cells. The FDA has affirmed glycerol ( glycerin) and several glycerol esters of fatty acids as generally recognized as safe ( GRAS). The Joint FAO/ WHO Expert Committee on food additives ( 1974) has evaluated the polyglycerol esters of fatty acids and assigned an acceptable daily intake ( ADI) of 0.25 mg/ kg/ day. 1 This value is based on a no adverse effect level for rats of 2500 mg/ kg/ day ( 50,000 ppm or 5%) in the diet.

The physical, chemical and environmental behavior of glycerol fatty acids are dominated by the fatty acid groups. These compounds are insoluble in water, and exist primarily as dimers and complex arrays. In the human body, glycerol fatty acids are metabolized to free fatty acids and glycerol, both of which are available for resynthesis of triglycerides. These breakdown products are indistinguishable from the natural background of these same compounds in living systems.

The available ecotoxicity data for glycerol indicates that it is of low toxicity to fish and other aquatic organisms. Based on its low Log K ow , glycerol has a low potential for sorption to soil and is not expected to bioaccumulate. Glycerol fatty acid esters are immobile, bind tightly to sediment and soils and undergo rapid microbial degradation. Glycerol fatty acid esters are also a significant part of the normal daily diet of mammals, birds, and invertebrates. EPA believes that glycerol and the glycerol fatty acid esters will not cause unreasonable adverse effects on the environment.

Based on available information on glycerol and glycerol fatty acid esters, their presence in common dietary fats and oils, their expected use patterns, their safe history of use as food additives, their known metabolism, extensive use in commercially available cosmetics, 2A final rule was published in the Federal Register on January 3, 1974, in which some some revisions and additions to 40 CFR 180.1001( c), ( d) and ( e) were made. Included in the additions in that final rule was the Page 6 of 23 toothpastes, soaps, and baby lotions, and their low toxicity, the Lower Risk Pesticide Chemical Focus Group has determined that a quantitative risk assessment is not required for these compounds.

II. Use Information:

The exemption from the requirement of a tolerance being reassessed in this document, the location of the established tolerance exemption in 40 CFR, and the use pattern as an inert or active ingredient are listed in Table 1.

Table 1 Tolerance Exemptions Being Reassessed in this Document Tolerance Exemption Expression Cas No. PC Code 40 CFR

180. Use Pattern ( Pesticidal) List Classification glycerol ( glycerin) 56 81 5 063507 844502 910 and 930 thickener, solvent 4A glycerol monooleate 25496 72 4; 111 03 5 079096 900066 930 surfactant, related adjuvants of surfactants 4B mono and diglycerides of C8 C18 fatty acids ( various, see Table 2) 910 surfactants, related adjuvants of surfactants See Table 2 polyglycerol esters of fatty acids ( conforming to 21 CFR 172.854) ( a) ( various) 910 surfactants, related adjuvants of surfactants See Table 3 polyethylene esters of fatty acids ( conforming to 21 CFR 172.854) ( b) ( various) 910 surfactants, related adjuvants of surfactants See Table 3

Residues listed in 40 CFR 180.910 [ formerly 40 CFR180.1001 ( c)] are exempted from the requirement of a tolerance when used as inert ingredients in pesticide formulations when applied to growing crops or to raw agricultural commodities after harvest. Residues listed in 40 CFR 180.930 [ formerly 180.1001( e)] are exempted from the requirement of a tolerance when used as inert ingredients in pesticide formulations applied to animals. ( a) Based on 21 CFR 172.854, polyglycerol esters of fatty acids, up to and including the decaglycerol esters, may be safely used in food in accordance with the following prescribed conditions: ( a) They are prepared from corn oil, cottonseed oil, lard, palm oil from fruit, peanut oil, safflower oil, sesame oil, soybean oil, and tallow and the fatty acids derived from these substances ( hydrogenated and nonhydrogenated) meeting the requirements of Sec. 172.860( b) and/ or oleic acid derived from tall oil fatty acids meeting the requirements of Sec. 172.862. ( b) There is a typographical error in 40 CFR 180.930 [ formerly 180.1001 ( e)]. This listing should read " polyglycerol esters of fatty acids ( conforming to 21 CFR 172.854)" 2 establishment of a tolerance exemption for " Polyglycerol esters of fatty acids conforming to Title 21, [ section] 121.1120" under 40 CFR 180.1001( c) and " Polyglycerol esters of fatty acids, conforming to Title 21 [ section] 121.1120" under 40 CFR 180.1001( e). These listings were subsequently codified into the Code of Federal Regulations and appeared that way through the 1977 revision of the CFR ( 40 CFR Parts 100 to 399, Revised as of July 1, 1977). However, in the 1978 revision of the Code of Federal Regulations ( 40 CFR Parts 100 to 399, Revised as of July 1, 1978), the listing under 40 CFR 180.1001( c) remained the same but the listing under 40 CFR 180.1001( e) read " Polyethylene esters of fatty acids, conforming to Title 21 [ section] 121.1120." All subsequent versions of 40 CFR from 1979 to 2003 also then contained that same " polyethylene esters..." listing under 40 CFR 180.1001( e) [ Note: The 21 CFR 121.1120 reference was later recodified as 21 CFR 172.854]

Changes to a volume of CFR which were made by documents published in the Federal Register are enumerated in an index that is found in the individual volumes of the CFR entitled " List of CFR Sections Affected." The 1978 revision to 40 CFR Parts 100 to 399 lists only two Federal Register documents that revised or amended 40 CFR 180.1001( e) for that revision year ( 42 FR 40909; August 12, 1977, and 42 FR 63783; December 20, 1977). Neither of those two Final Rules revised or amended the 40 CFR 180.1001( e) entry of " Polyglycerol esters of fatty acids, conforming to Title 21 [ section] 121.1120." Based on this information, it can be concluded that the current listing of " Polyethylene esters of fatty acids conforming to 21 CFR 172.854" listed under 40 CFR 180.930 [ formerly 180.1001( e)] is in fact a typographical error in the Code of Federal Regulations that correctly should read exactly as the corresponding entry in 40 CFR 180.910 [ formerly 180.1001( c)], namely as " Polyglycerol esters of fatty acids conforming to 21 CFR 172.854."

Page 7 of 23 There are two types of glycerol ( or glycerin): natural glycerol derived from oils and fats from such sources as coconuts, and synthetic glycerol derived from petroleum. Glycerol is present in the form of its esters ( mono, di and triglycerides) in all animal and vegetable fats and oils. Dietary intake of glycerol comes mainly from these molecules in animal and plant products. ( http:// www. pdrhealth. com/ drug_ info/ nmdrugprofiles/ nutsupdrugs/ gly_ 0304. shtml, February 5, 2004).

Glyceryl monoesters are not pure monoesters, but are mostly mixtures with mono, diand triesters ( CIR 2001). The following Table describes the mono and diglycerides of C 8  C 18 ( caprylic to stearate) fatty acids evaluated in this document:

Table 2 Mono and Diglycerides of C8 C18 fatty acids ( a)

Chemical Substance ( Common Name) Nomenclature ( 9th CI name) CAS Reg. No. PC Code List Classification glyceryl monostearate Note: previously assessed in 2002 Octadecanoic acid, monoester with 1,2,3 propanetriol ( 9CI)

Octadecanoic acid, ester with 1,2,3 propanetriol ( 9CI) 31566 31 1 11099 07 3 900085 ( inert) 4A Table 2 Mono and Diglycerides of C8 C18 fatty acids ( a)

Chemical Substance ( Common Name) Nomenclature ( 9th CI name) CAS Reg. No. PC Code List Classification Page 8 of 23 glyceryl monooleate 9 Octadecenoic acid ( 9Z) , monoester with 1,2,3 propanetriol 9 Octadecenoic acid ( 9Z), 2,3 dihydroxypropyl ester ( 9CI) 25496 72 4;

111 03 5 079096 ( active)

900066 ( inert) 4B 4B glyceryl monopalmitate Hexadecanoic acid, monoester with 1,2,3 propanetriol 26657 96 5

glyceryl myristate Tetradecanoic acid, 2,3 dihydroxypropyl ester Tetradecanoic acid, monoester with 1,2,3 propanetriol ( 9CI) 589 68 4 27214 38 6

glyceryl monolaurate Dodecanoic acid, 2,3 dihydroxypropyl ester Dodecanoic acid, monoester with 1,2,3 propanetriol ( 9CI) 142 18 7 27215 38 9

011290 ( active)

glyceryl monocaprate Decanoic acid, monoester with 1,2,3 propanetriol 26402 22 2 011291( active) ( inert)

glyceryl monocaprylate Octanoic acid, monoester with 1,2,3 propanetriol 26402 26 6 011292 ( active) 911292 ( inert) 3 diglyceryl stearate 9 Octadecanoic acid, monoester with oxybis ( propanediol) 12694 22 3

diglyceryl monooleate 9 Octadecenoic acid, ester with 1,2,3 propanetriol 49553 76 6

glyceryl distearate Octadecanoic acid, diester with 1,2,3 propanetriol ( 9CI) 1323 83 7 911619 ( inert) 3 glyceryl dioleate 9 Octadecenoic acid ( 9Z), diester with 1,2,3 propanetriol ( 9CI) 25637 84 7 911285 ( inert) 3 glyceryl dipalmitate Hexadecanoic acid, diester with 1,2,3 propanetriol ( 9CI) 26657 95 4

glyceryl dimyristate Tetradecanoic acid, diester with 1,2,3 propanetriol ( 9CI) 53563 63 6

glyceryl dilaurate Dodecanoic acid, diester with 1,2,3 propanetriol ( 9CI) 27638 00 2   Table 2 Mono and Diglycerides of C8 C18 fatty acids ( a)

Chemical Substance ( Common Name) Nomenclature ( 9th CI name) CAS Reg. No. PC Code List Classification Page 9 of 23 glyceryl dicaprate Decanoic acid, diester with 1,2,3 propanetriol ( 9CI) 53988 07 1

glyceryl dicaprylate Octanoic acid, diester with 1,2,3 propanetriol ( 9CI) 36354 80 0

( a) Source: ChemIDplus, part of TOXNET, and OPPIN, where available.

Polyglycerol esters of fatty acids are mixtures of the esters of these fatty acids with the polyglycerol mixture. They include a large group of closely related compounds of complex composition. For tolerance reassessment purposes, this includes the identity of polyglycerol esters of fatty acids with the polyglycerol moiety range from diglycerol to the decaglycerol with not less than 70% being di, tri and tetraglycerols and not more than 10% being the hepta, octa, nona, and decaglycerol ester. Individual components of these fatty acid mixtures are found as normal constituents of the human diet, i. e., glycerol, glycerol mono, di and tri fatty acid esters and individual fatty acids, with the exceptions of the artificially produced polymers of glycerol, polymers of certain fatty acids and the actual separate esters between these polymers. These latter compounds represent the toxicologically important constituents ( WHO 1974). The following Table describes those polyglycerol esters of fatty acids that are found in EPA's listing of inert ingredients.

Table 3 Polyglycerol esters of Fatty Acids ( a)

Chemical Substance ( Common Name) Nomenclature ( 9th CI name) CAS Reg. No. PC Code List Classification decaglyceryl monooleate ( polyglycerol ester of oleic acid) 1,2,3 propanetriol, homopolymer ( 9Z) 9 octadecenoate 9007 48 1 900483 4B tetraglyceryl monooleate 9 Octadecenoic acid, monoester with tetraglycerol 71012 10 7 900068 4B polyglyceryl stearate 1,2,3 propanetriol, homopolymer, octadecanoate 9009 32 9 800438 3 ( a) Source: ChemIDplus, part of TOXNET, and OPPIN, where available.

Agricultural Uses of Glycerol Fatty Acid Monoesters:

Glycerol monocaprylate, glycerol monocaprate and glycerol monolaurate have agricultural uses as described in Table 3. They are pesticidal active ingredients recently registered by EPA in 2003 that act against bacteria, viruses, fungi and lipid coated yeasts to control spoilage of food and feed crops after harvest. They are generally applied at levels between 0.1% and 1% in the diluted formulation at a rate sufficient to wet thoroughly the commodity being treated. The end Page 10 of 23 use products are not intended for outdoor use ( EPA 2003).

Table 4 Use Pattern ( pesticidal  active ingredient)

Tolerance Exemption Expression Active PC Code Active Use Pattern ( Pesticidal) Use Sites glycerol monocaprylate 011292 bacteria, viruses, fungi, and lipid coated yeasts Post harvest fruits and vegetables glycerol monocaprate 011291 glycerol monolaurate 011290 FDA Uses:

Glycerol ( glycerin) is classified by FDA as a direct food additive affirmed as generally recognized as safe ( GRAS) ( 21 CFR 182.1320). It also has diverse uses in medicine. It has moisturizing and lubricating properties that can increase serum osmolality. It is given to reduce intraocular pressure and vitreous volume in eye surgery and is used as an adjunct in the management of acute glaucoma. Glycerol may also be used to reduce corneal edema during eye exams, as a laxative in suppositories, and in cough preparations. Glycerol is used by some athletes to improve thermoregulation and endurance during exercise or exposure to hot environments. ( http:// www. pdrhealth. com/ drug_ info/ nmdrugprofiles/ nutsupdrugs/ gly_ 0304. shtml, February 5, 2004).

Mono and diglycerides consisting of a mixture of glyceryl mono and diesters, and minor amounts of triesters, that are prepared from fats or oils or fat forming acids derived from edible sources are affirmed as generally recognized as safe ( GRAS) substances ( 21 CFR 182.1505) and indirect food additives ( 21 CFR 175.105, 176.210) for human consumption without restriction on their concentration ( at concentrations not to exceed good manufacturing practice, GMP).

Glycerol monostearate and glycerol monooleate are classified by FDA as direct food substances affirmed as GRAS with no limitation other than under current good manufacturing practices ( 21 CFR 184.1324 and 184.1323, respectively). Glycerol monooleate is a priorsanctioned food ingredient ( 21 CFR 181.27) and is an indirect food additive ( 21 CFR 175.300, 175.320). Glycerol monooleate is a synthetic flavor, and is also used in pharmaceuticals ( HSDB 2003).

Glyceryl tristearate is approved by the FDA as a direct food additive for human consumption when used as a crystallization accelerator in cocoa products, imitation chocolate, and in compound coatings ( not to exceed 1% of combined weight of formulation), as a formulation aid, lubricant and release agent, and surface finishing agent ( not to exceed 0.5%), as a formulation aid in confections ( not to exceed 3% of the combined weight of the formulation), as a formulation aid in fats and oils ( not to exceed 1% of the combined weight of the formulation), and Page 11 of 23 as a winterization and fractionation aid in fat and oil processing ( not to exceed 0.5% by weight of the processed fat or oil) ( 21 CFR 172.811).

Polyglycerol esters of fatty acids, up to and including decaglycerol esters are approved for use in food by the FDA ( 21 CFR 172.854). They are prepared from corn oil, cottonseed oil, lard, palm oil from fruit, peanut oil, safflower oil, sesame oil, soybean oil, and tallow and the fatty acids derived from these substances. They are used as emulsifiers in food, in amounts not greater than that required to produce the intended physical or technical effects. Polyglycerol esters of a mixture of stearic, oleic, and coconut fatty acids are used as a cloud inhibitor in vegetable and salad oils. Polyglycerol esters of butter oil fatty acids are used as emulsifiers ( 21 CFR 172.854).

Table 5: Use Pattern ( FDA GRAS)

Chemical GRAS Citation GRAS Uses glycerin 21 CFR 182.1320 Multiple purpose GRAS food substance when used in accordance with good manufacturing practice.

glyceryl monooleate 21 CFR 184.1323 flavoring agent, adjuvant, solvent, vehicle glyceryl monostearate 21 CFR 184.1324 emulsifier in baked goods and ice cream, food additive Mono and diglycerides 21 CFR 184.1505 dough strengthener, emulsifier and emulsifier salt, flavoring agent and adjuvant, formulation aid, lubricant, solvent and vehicle, stabilizer and thickener, surface active agent, texturizer Other Uses Glycerol is widely used as a solvent, as a sweetener in candy, syrup, liquor and some foods, in the manufacture of dynamite, cosmetics, liquid soaps, inks, and lubricants; to keep fabrics pliable; as a component of antifreeze mixtures; as a source of nutrients for fermentation cultures in the production of antibiotics and in medicine ( www. factmonster. com/ ce6/ sci, August 22, 2003). Glycerol is used in over 200 household products, including cosmetics, soaps, toothpaste, shampoos, baby lotions, and diaper rash cream. Concentrations generally range from 1 to 10% ( Household Products Database, http:// hpd. nlm. nih. gov/ cgi din/ household/, February 11, 2004).

Glycerol monooleate is an ingredient in over 700 cosmetic formulations, at concentrations ranging from # 0.1 to 5% in formulations that were predominantly lipsticks, eye shadows, makeup bases and skin care preparations ( CIR 1986). Caprylic/ capric triglyceride is derived from coconut oil, and is also used extensively in cosmetics, foods and pharmaceuticals. It is present in over 500 cosmetic formulations at concentrations ranging from > 0.1 to > 50% in bath oils, hair sprays and lipsticks ( CIR 1980).

The Agency notes that glycerol is included on the Agency's list of chemicals included in Page 12 of 23 the High Production Volume ( HPV) Challenge Program. HPV chemicals are those that are manufactured or imported into the United States in volumes greater than one million pounds per year. There are approximately 3,000 HPV chemicals that are produced or imported into the United States. The HPV Challenge Program is a voluntary partnership between industry, environmental groups, and the EPA which invites chemical manufacturers and importers to provide basic hazard data on the HPV chemicals they produce/ import. The goal of this program is to facilitate the public's right to know about the potential hazards of chemicals found in their environment, their homes, their workplace, and in consumer products. Glycerol is sponsored by the ICCA APAG Glycerol Group. In addition, a SIDS assessment is available for glycerol.

III. Physical/ Chemical Properties:

Glycerol is a liquid with a calculated vapor pressure of 0.000106 hPa ( at 25oC), is fully miscible in water and has a log K ow of  1.76 ( measured). It has a calculated half life for photooxidation of about 7 hours and is not susceptible to hydrolysis ( OECD SIDS 2002).

Glyceryl monoesters of fatty acids are primarily white to yellow oils or oily waxes with faint fatty odors. These substances are not pure substances, but are mixtures with mono, di and tri ester contents approximately 4: 4: 2. Glyceryl laurate and glyceryl caprylate are practically insoluble in water. Glyceryl monoesters have calculated Log K ow s in the range of 2.06 to 7 for glyceryl caprylate and glyceryl oleate, respectively ( CIR 2001).

The physical, chemical and environmental behavior of glyceryl fatty acid esters are dominated by the fatty acid groups ( EPA 2002, EFED memo from S. Termes to M. Perry). As a group the solubilities, vapor pressures, and Henry's Law Constants decrease with increasing chain length, but the n octanol water partition coefficients and strength of binding to soils increase with increasing chain length ( EPA 2002, EFED memo).

IV. Hazard Assessment:

The key toxicological data in the following sections were obtained from ToxNet ( www. toxnet. nlm. nih. gov) and other websites, such as FirstGov ( www. firstgov. gov), as well as from the Cosmetic Ingredient Review ( CIR) safety assessment, OECD SIDS assessments, and Food and Agriculture Organization of the World Health Organization ( FAO/ WHO) evaluations.

Glycerol and glyceryl fatty acid esters are natural constituents of dietary fats and oils ( e. g., coconut and palm oils) and natural breakdown products from fat metabolism in living organisms ( EPA 2003). Animal and vegetable fats contain about 10 percent by weight of glycerol ( FDA 1975). In vertebrate organisms ( e. g., humans), glyceryl fatty acid esters are formed as part of the metabolism of triglycerides. Glyceryl fatty acid esters are metabolized to free fatty acids and glycerol, both of which are available for the resynthesis of triglycerides ( CIR 2001). The EPA concluded that the breakdown products are indistinguishable from the natural background of these same compounds in living systems ( EPA 2003).

In general, fatty acids are a group of naturally occurring, monocarboxylic acids which are Page 13 of 23 present in common fats and oils ( such as corn oil, peanut oil, and butter) as triglycerides. The most common are palmitic, stearic, and oleic acids. A triglyceride is composed of three fatty acid molecules and a single molecule of glycerol and typically make up greater than 98% of most fats and refined oils. Fats and oils are a major source of calories in the human diet, commonly comprising between 30 and 40% of dietary intake in the United States. During the 1990s, average per capita fat consumption in the U. S. ranged from 60 to about 100 grams/ day. Once fats and oils are consumed, the triglycerides are rapidly hydrolyzed in the human body into glycerol and the free fatty acids ( such as stearic acid). Free fatty acids are then degraded to produce acetyl CoA ( one acetyl CoA for each 2 carbons in the chain) which is used in the Citric Acid Cycle or for ketone body synthesis.

In the sections below, are the available toxicological data for glycerol, and the glyceryl esters of fatty acids via the oral, dermal and/ or inhalation routes of exposure.

A. Toxicological data Glycerol:

Glycerol is one of the most common alcohols found in human metabolism. Following ingestion, glycerol is efficiently absorbed and rapidly metabolized. It is eliminated in the kidney by filtration. The elimination half life of glycerol is from 30 to 40 minutes. ( http:// www. pdrhealth. com/ drug_ info/ nmdrugprofiles/ nutsupdrugs/ gly_ 0304. shtml, February 5, 2004).

Glycerol is of low toxicity when ingested, inhaled or in contact with the skin ( OECD SIDS 2002). The acute oral LD 50 is 32 g/ kg in mice and 27 g/ kg in rats. ( http:// www. sykogyo co. jp/ english/ sei/ 1_ gly. html, August 20, 2003). At very high dose levels, the signs of toxicity include tremor, hyperaemia of the gastrointestinal tract, nausea, headache, and diarrhea. Skin and eye irritation studies indicate that glycerol has low potential to irritate the skin and eyes. The available human and animal data, together with the widespread potential for exposure and the absence of case reports of sensitization, indicate that glycerol is not a skin sensitizer ( OECD SIDS 2002). Due to its low vapor pressure, inhalation of vapors at room temperature is unlikely. Inhalation of mist may cause irritation of the respiratory tract. Persons with pre existing skin disorders or eye problems or impaired liver or kidney function may be more susceptible to the effects of glycerol. ( http:// www. jtbaker. com/ msds/ englishhtml. g4774. htm, February 5, 2004).

Repeated oral exposure to glycerol does not induce adverse effects other than local irritation of the gastrointestinal tract. In a two year rat study, no adverse systemic or local effects were observed at dietary concentrations up to 10,000 mg/ kg/ day. For inhalation exposure to aerosols, the no observed adverse effect concentration is 165 mg/ m3 for local irritant effects of the upper respiratory tract, and 662 mg/ m3 for systemic effects ( OECD SIDS 2002). In another chronic rat study, no adverse effects were noted in rats fed up to 20% of the diet for one year or 5 to 10% glycerin for 2 years ( approximately 5 and 10 g/ kg/ day, respectively) ( FDA 1975). Dogs fed balanced diets containing 5, 10 or 20% glycerin ( approximately 1.25, 2.5 and 5 g/ kg/ day, respectively) did not experience adverse effects ( FDA 1975). Page 14 of 23 Glycerol does not have structural alerts, which raise concern for mutagenicity. It is negative for gene mutations in bacterial strains, chromosomal effects in mammalian cells and primary DNA damage in vitro. In vivo tests with glycerol also did not result in significant effects, although study limitations prevent definitive conclusions. Overall, glycerol is not considered to possess genotoxic potential ( OECD SIDS 2002).

Data from studies designed to investigate tumor promotion activity in male mice suggest that oral administration of glycerol up to 20 weeks had a weak promotion effects on the incidence of tumor formation. However, there was no evidence of carcinogenicity in a 2 year rat study ( OECD SIDS 2002).

No effects on fertility, reproductive performance, growth or offspring development were observed in a two generation rat study with glycerol administered by gavage ( NOAEL 2000 mg/ kg) ( OECD SIDS 2002, FDA 1975). No maternal toxicity or teratogenic effects were seen in the rat, mouse, or rabbit at the highest dose levels tested in a guideline comparable teratogenicity study ( NOAEL 1180 mg/ kg/ day) ( OECD SIDS 2002). Developmental studies with mice and rats at doses up to 1.28 g/ kg/ day and 1.31 g/ kg/ day, respectively during gestational days 6 15 showed no clearly discernable effects on implantation, maternal or fetal survival or fetal development ( FDA 1975).

In humans, there are rare reports of cardiac dysrhythmias occurring with oral glycerol use and one report of hypertension occurring. Other adverse reactions include headaches, dizziness, confusion and amnesia ( in elderly subjects) and hyperglycemia. Hyperosmolarity, which occurs with oral glycerol, is usually clinically significant only in those with type 2 diabetes. The most frequent adverse reactions are gastrointestinal and include nausea and vomiting, bloating and diarrhea. ( http:// www. pdrhealth. com/ drug_ info/ nmdrugprofiles/ nutsupdrugs/ gly_ 0304. shtml, February 5, 2004).

Typical doses for exercise performance enhancement are 2 to 4 tablespoons ( approximately 60 mL or 75 grams) of glycerol in water, or other liquid. The ratio of fluids to glycerol is about 20 to 1 ( http:// www. pdrhealth. com/ drug_ info/ nmdrugprofiles/ nutsupdrugs/ gly_ 0304. shtml, February 5, 2004) .

For glycerin mist occupational exposures, the OSHA Permissible Exposure Limit ( PEL) is 15 mg/ m3 ( TWA) for total dust, and 5 mg/ m3 ( TWA) for respirable fraction. The ACGIH Threshold Limit Value ( TLV) is 10 mg/ m3. ( http:// www. jtbaker. com/ msds/ englishhtml. g4774. htm, February 5, 2004).

Mono, Di and Triglycerides of Fatty Acids:

In 1960, the Food Protection Committee of the National Academy of Sciences National Research Council Food and Nutrition Board ( National Academy of Sciences as cited in CIR 2001) concluded that there appears to be no reason to question the safety of mono, di, and Page 15 of 23 triglycerides of lauric acid ( i. e., Glyceryl Laurate, Glyceryl Dilaurate, or Glyceryl Trilaurate) as food additives. This conclusion was based on the following: ( 1) Lauric acid glycerides are used in important foods, such as human and cow's milk at concentrations of 3 6% and large quantities are present in coconut oil. The use of these foods has not been accompanied by recognized toxic effects. ( 2) Lauric acid glycerides undergo the usual metabolic changes of the higher fatty acids. ( 3) When lauric acid glycerides are fed in diets containing a variety of glycerides, there is no evidence of a specific toxic or harmful effect ( CIR 2001).

In 1975, the FDA reviewed the available toxicological data for the mono and diglycerides of edible fat forming fatty acids and concluded " there is no evidence in the available information on mono and diglycerides of fat forming fatty acids that demonstrates or suggests reasonable grounds to suspect a hazard to the public when they are used at levels that are now current or that might reasonably be expected in the future" ( FDA 1975).

EPA ( 2003) recently reviewed the C 8 , C 10 and C 12 straight chain fatty acid monoesters of glycerol: glycerol monocaprylate, glycerol monocaprate and glycerol monolaurate, and registered these compounds as new pesticidally active ingredients acting against bacteria, viruses, fungi and lipid coated yeasts. The Agency concluded that these compounds are non toxic on an acute basis ( except for eye irritation) and are rapidly metabolized in vertebrate systems to polyols and free fatty acids. These compounds are not known to be genotoxic, developmental/ reproductive toxicants, nor compounds that induce immune response. Breakdown products are indistinguishable from the natural background of these same compounds in living systems.

Acute toxicity data for glycerol monolaurate ( a C 8 monoester) indicate low acute toxicity via the oral ( LD 50 > 5000 mg/ kg), and dermal ( LD 50 > 5000 mg/ kg/ day) routes of exposure ( MRIDs 45405505, 45428503). Acute inhalation data are not available because all glycerol fatty acid monoesters are waxy solids at room temperature, which makes it impossible to generate respirable particles. In the rabbit primary eye irritation study, glycerol monolaurate caused slight conjunctivitis at 72 96 hours, which cleared by day 7 ( MRID 45405509). It also caused mild to slight erythema in the primary rabbit dermal irritation study ( MRID 45405511), and was not a dermal sensitizer ( MRID 45428504). The Agency granted requests for waivers from the data requirements for genotoxicity studies, teratogenicity studies and immune response studies based on studies/ data/ information submitted by the registrant ( EPA 2003).

An expert panel of the Cosmetic Ingredient Review ( CIR) conducted a safety assessment for 43 glyceryl monoesters in 2000, including glyceryl oleate, glyceryl palmitate, glyceryl myristate glyceryl laurate, glyceryl caprate, and glyceryl caprylate ( CIR 2001). This assessment considered numerous toxicological studies, including various acute, subchronic, and chronic/ carcinogenicity toxicity, and mutagenicity studies. This report also details extensive use of this glyceryl monoesters in numerous cosmetic products at concentrations ranging from 0.1 7 percent. Based on the available information, the panel concluded that " glyceryl monoesters are safe as cosmetic ingredients in the present practices of use and concentration" ( CIR 2001).

Glyceryl monoesters have little acute or short term toxicity in animals, and no toxicity was noted following chronic administration of a mixture consisting of mostly glyceryl di and mono 3 Irritation was noted in the following tests: acute test with undiluted or 50% glyceryl oleate in corn oil; acute test with 0.5 mL of a 5% glyceryl oleate formulation, 20 applications of 2 ml/ kg of a 25% corn oil solution; 4 week test with 5% glyceryl oleate formulation.

4 No irritation was noted in the following tests: single insult 15% and 30% concentrations of aqueous glycerol oleate; single insult fragrance preparation containing 19% glyceryl oleate; cumulative patch test with 5% glyceryl oleate sunscreen formulations; repeated insult patch test with 15% aqueous glyceryl oleate preparations or 5% sunscreen formulation.

Page 16 of 23 esters. Undiluted monoesters may produce minor skin irritation, especially in abraded skin, but in general these ingredients are not irritating at concentrations used in cosmetics. Glyceryl monoesters are not sensitizers, or photosensitizers ( CIR 2001).

Glyceryl Laurate: The acute oral LD 50 for glyceryl laurate is > 20,000 mg/ kg in rats ( CIR 2001). Glyceryl laurate is a mild irritant following inhalation exposure to an aerosol containing 10% glyceryl laurate in animals. It also had strong hemolytic activity in an in vitro assay using sheep erythrocytes. However, it was not an eye irritant in rabbits, nor a dermal sensitizer in guinea pigs ( CIR 2001). No adverse effects were reported for rats exposed to 14, one hour inhalation exposures at concentrations of 280 mg/ m3 ( Unichema International 1997b as cited in CIR 2001). Glyceryl citrate/ lactate/ linoleate/ oleate was not mutagenic in the Ames test system. glyceryl laurate exhibited antitumor activity and glyceryl stearate was negative in a tumor promotion assay. In a 2 year study, rats fed a mixture of Trilaurin ( 2%), glyceryl dilaurate ( 11%) and glyceryl laurate ( 10 to 11%) had no significant differences from basal diet controls, except for slight microscopic fatty liver changes. These effects were also in the control group fed hydrogenated cottonseed oil ( Fithugh et al. 1960 as cited in CIR 2001). At high concentrations, glyceryl laurate caused moderate erythema in human clinical studies, but the other glyceryl monoesters did not produce any adverse reactions ( CIR 2001).

Glyceryl Oleate: A 1986 safety assessment of glyceryl oleate ( Journal of the American College of Toxicology, 5[ 5]) was performed by an expert panel of the Cosmetic Ingredient Review ( CIR 1986). This assessment considered numerous toxicological studies, including various acute, subchronic, and chronic/ carcinogenicity toxicity studies. This report also details extensive use of this glyceryl fatty acid monester in numerous cosmetic products at concentrations ranging from # 0.1 5 percent. Based on the available information, the panel concluded that " glyceryl oleate is safe as a cosmetic ingredient in the present practices of use and concentration" ( CIR 1986).

Glyceryl oleate has low acute toxicity. No signs of toxicity were noted in rats given a single 13 ml/ kg oral dose of a sunscreen formulation containing 5% glyceryl oleate. Minimal to moderate eye irritation was produced by undiluted glyceryl oleate, 50% glyceryl oleate in corn oil, and a fragrance preparation containing 19% glyceryl oleate when administered to rabbits. In animals, dermal irritation was reported in acute and repeated dermal studies with glyceryl oleate3. However, in clinical human tests, no dermal irritation or sensitization was noted for glyceryl oleate preparations4 in single insult or cumulative occlusive patch tests. A few subjects exhibited 5 Calculated as total polyglycerol ester of palmitic acid.

Page 17 of 23 slight, transient erythematous responses in the photoallergy and phototoxicity tests ( CIR 1986).

In a two generation mouse study, a few brain tumors ( 3 tumors in 63 mice) were noted in mice fed 50 100 mg/ mouse glyceryl oleate. However, in the same study, mice fed 4 5 mg cholesterol developed a higher incidence of brain tumors ( 20 tumors in 80 mice). Digestive tract tumors were found in mice fed 200 mg/ mouse per day glyceryl oleate ( feed supplement) for fourseven generations and were considered due to free fatty acid impurities. The CIR Expert Panel found the results of these studies equivocal ( CIR 1986).

Caprylic/ Capric Triglyceride: An expert panel of CIR conducted a safety assessment for caprylic/ capric triglyceride ( CIR 1980) and concluded that it has very low toxicity to humans and animals based on acute, subchronic and chronic oral studies, dermal, skin sensitization, intraperitoneal, and intramuscular injection toxicity tests, skin and eye irritation tests, and a twogeneration reproductive study. The rat oral LD 50 is > 5 g/ kg ( CIR 1980). The expert panel concluded that the cosmetic product, Caprylic/ capric triglyceride is " safe when incorporated in amounts similar to those present on the market."

Polyglycerol esters of fatty acids The Joint FAO/ WHO Expert Committee on food additives ( 1974) has evaluated the polyglycerol esters of fatty acids and assigned an acceptable daily intake ( ADI) of 0.25 mg/ kg/ day. 5 This value is based on a no adverse effect level for rats of 2500 mg/ kg/ day ( 50,000 ppm or 5%) in the diet.

Acute toxicity data show no adverse effects in rats given a single oral dose up to 29 g/ kg polyglycerol ester, a single intraperitoneal ( i. p.) dose of up to 7 g/ kg or 5 daily oral doses of 10 g/ kg. A single i. p. dose of 10 g/ kg to rats caused some peritoneal reaction but no deaths ( WHO 1974). Rabbits dosed orally with 10 29 g/ kg showed no toxic effects.

The metabolic studies show hydrolysis of polyglycerol esters in the gastrointestinal tract and the utilization and digestibility studies justify the assumption that the fatty acid moiety is metabolized in the normal manner ( WHO 1974). There is no evidence of cumulation of the polyglycerol moiety in the body tissues. Human studies showed no adverse effects. A study in rats showed the percentage of dietary fatty acids absorbed, as measured by fecal fatty acids, decreased as the level of polyglycerol ester increased in the diet ( WHO 1974).

Rats fed 9% polyglycerol ester and 1% ground nut oil showed normal kidney function after 17 weeks, and no effects on the weight of the liver, kidney, adrenal, spleen and testes after 22 weeks. No gross or histological effects were noted in the liver ( WHO 1974). In another study, up to 10% polyglycerol ester ( deca glycerol deca oleate) fed to rats for 90 days had no Page 18 of 23 adverse effects on survival, growth, organ weights, body weight ratios, and hematologic parameters. Urinary nitrogen values for female rats was elevated at weeks three and nine. There were no compound related effects noted upon autopsy and microscopic evaluation ( WHO 1974). Another study reported no adverse effects in rats fed a diet containing 15% polyglycerol ester of fatty acids ( WHO 1974).

In two long term studies, mice and rats were fed either polyglycerol ester or ground nut oil at 5% in their diet for 80 weeks, and two years, respectively. No adverse effects were noted on body weight, food consumption, peripheral blood picture, or survival rate in either species. In rats, the liver and renal function tests were normal. In both mice and rats, there were no polyglycerol residues in the carcass fat, and levels of free fatty acids, unsaponifiable material, fatty acid composition of carcass fat and organ weights were the same in exposed and control groups, except for the liver and kidney weights of female mice, which were significantly higher. There were no remarkable microscopic findings in any major organ of either mice or rats. In rats, the tumor incidence and tumor distribution were similar between exposed and control animals ( WHO 1974).

In another long term study, mice were fed 1% polyglycerol ester emulsifier for 15.5 months. There were no significant differences between growth rate and longevity of test and control animals, nor was there any indication of carcinogenic activity ( WHO 1974).

In a human study, 37 volunteers were fed 2 20 g/ day polyglycerol ester in the diet for three weeks. No abnormalities were detected in plasma proteins, serum amino acids, thymol turbidity, serum bilirubin, total and free serum cholesterol, serum alkaline phosphatase, SGOT, SGPT, cholinesterase, cholesterol esterase, urine volume, urinary creatinine, urea output, total and split fecal fat or total fecal nitrogen ( WHO 1974).

In a reproductive study, rats were fed a diet of 1.5% polyglycerol ester for three generations. There were no significant effects on fertility or reproductive performance during the first year. There were no consistent compound related effects on the third generation ( WHO 1974).

B. Special Considerations for Infants and Children At this time, there is no concern for potential sensitivity to infants and children. Glycerol and glycerol fatty acid esters are used in many consumer products for children, including baby lotions and oils, diaper rash cream, and have a long history of safe use without incident. In animal studies with glycerol, no adverse development effects were noted at the highest dose tested in rats, mice or rabbits. A safety factor analysis has not been used to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

V. Exposure Assessment:

Exposure to glycerol, and glyceryl fatty acid esters may be through FDA approved uses as food additives, or through its use in soaps, baby lotions and oils, household cleaning products Page 19 of 23 and other cosmetic products. Cosmetic products containing glycerol or glyceryl monoesters are applied to most areas of the body, and could come in contact with the ocular and nasal mucosae. These products could be used safely on a daily basis, and could be applied frequently over a period of several years ( CIR 2001). Glycerol fatty acids are present in common fats and oils, which are a major source of calories in the human diet, accounting for between 30 and 40% of dietary intake in the U. S.

Residues from the pesticide uses of glycerol and glyceryl esters of fatty acids are not likely to exceed levels of naturally occurring fatty acids in commonly eaten foods. In addition, the use of these compounds in pesticide products is expected to result in much lower exposure than the FDA regulated use of these compounds, as well as lower exposure than the use in cosmetics. For example, cosmetic products containing glyceryl oleate may be used from once a week up to several times a day, and may remain in contact with body surfaces for a few minutes ( hair shampoos, cleansing creams) to as long as a few days ( moisturizing creams) ( CIR 1986). Glycerol and glyceryl esters of fatty acids are of low toxicity to humans, and there is no reason to expect that reasonable use will constitute any significant hazard. Therefore, a quantitative screeninglevel exposure assessment has not been conducted.

VI. Risk Characterization:

The glycerol fatty acids are a significant part of the normal daily diet, for they occur in dietary lipids which usually constitute about 90 grams in a day's diet. As previously discussed in this document, there are many FDA approved uses. Residues from the pesticide uses of fatty acid salts are not likely to exceed levels of naturally occurring fatty acids in commonly eaten foods.

Taking into consideration all available information on glycerol and glycerol fatty acid esters, including their low acute toxicity via oral and dermal routes, FDA's designation of glycerol and certain salts of glycerol fatty acid esters as GRAS, their presence in food products, food additives, cosmetics, and cleaning products, as well as the significant contribution of glycerol fatty acid esters in the diet, the uses of these compounds as inert and active ingredients in pesticide products are unlikely to pose a significant hazard to the general public or any population subgroup. Exposures from the aforementioned uses are expected to result in human exposure below any dose level that could possibly produce an adverse effect. As a result, OPP is conducting a qualitative approach to assessing human health risks from exposure to these compounds.

As noted previously, glycerol is included on the Agency's list of chemicals included in the High Production Volume ( HPV) Challenge Program. HPV chemicals are those that are manufactured or imported into the United States in volumes greater than one million pounds per year. Based on the available toxicity data for glycerol, and the OECD SIDS ( 2002) assessment that concluded glycerol is a low hazard potential, the Agency feels confident in proceeding with this tolerance reassessment decision. Any submission of data by sponsors of glycerol as part of the HPV Challenge Program may, in the future, be used by OPP to revise or update their tolerance reassessment decision for this compound as deemed necessary and appropriate. Page 20 of 23 VII. Environmental Fate/ Ecotoxicity/ Drinking Water Considerations:

Environmental Fate Characterization Glycerol is fully miscible in water. It has a calculated half life for photooxidation of about 7 hours and is not susceptible to hydrolysis. The experimental data indicate that glycerol is readily biodegradable under aerobic conditions. Fugacity modelling ( Mackay Level III) predicts that glycerol will partition to the aquatic compartment ( 100%). Based on the low Log Kow, it has a low potential for sorption to soil and is not expected to bioaccumulate ( OECD SIDS 2002). It is not expected to evaporate significantly from soil. In air, glycerol may be moderately degraded by reaction with photochemically produced hydroxyl radicals, and removed from the atmosphere to a moderate extent by wet deposition ( http:// www. jtbaker. com/ msds/ englishhtml. g4774. htm, February 5, 2004).

For the glycerol fatty acid esters, microbial degradation is the major route of transformation in the environment. Adsorption onto soil and sediment particulates is strong and, therefore, there is limited potential to reach surface water by dissolved runoff and/ or leach to ground water. Volatilization from soils and water is not likely to be a transport process in the environment. Although the potential to bioaccumulate is high, bioavailability is offset by the tendency to adsorb strongly to soil and sediment particulates, and to be biodegraded by microorganisms and be metabolized in animals. However, concentration at the water air interface is likely to be higher than in the water column, which results in lowering the surface tension of the aqueous system. The lowering of the surface tension and the hydrophobic layer at the water air interface has the potential to alter the physical and chemical characteristics of the aquatic environment. As a group, these compounds show the following trends with increasing chain length: decreasing water solubility, decreasing potential for volatilization, greater likelihood to partition and bind to soil and or sediment ( EPA 2002, EFED memo).

Ecotoxicity and Ecological Risk Characterization Glycerol: The weight of the evidence indicates that glycerol is of low toxicity to aquatic organisms and this conclusion is supported by QSAR predictions. The lowest LC 50 for fish is a 24 hr LC 50 of > 5000 mg/ L for Carassium auratus ( goldfish) and for aquatic invertebrates, a 24 hr EC 50 of > 10000 mg/ L for Daphnia magna is the lowest EC 50 . Several tests on algae are available, which suggest very low toxicity to a range of species, however their validity is uncertain. A QSAR prediction for the 96 hr EC 50 to algae was 78000 mg/ L. No toxicity towards the microorganism Pseudomonas putida was observed at 10000 mg/ L after exposure for 16 hours. No long term aquatic toxicity data are available. Screening studies are available on frog and carp embryos which indicate some effects on growth and hatching rates, respectively, at very high concentrations of glycerol > 7000 mg/ L. However, their ecological relevance is not clear ( OECD SIDS 2002). OECD SIDS ( 2002) estimated a tentative PNEC of 780 mg/ L for aquatic organisms using QSAR. There are no sediment or terrestrial effect data for glycerol, but partitioning to both soil and sediment is expected to be very low based on the low Log Kow of glycerol. OECD SIDS ( 2002) estimated tentative PNECs of 479 mg/ kg wwt and 92 mg/ kg wwt for soil and sediment, respectively. Page 21 of 23 Glycerol Fatty Acid Esters: EPA ( 2003) recently reviewed the C8, C10 and C12 straight chain fatty acid monoesters of glycerol: glycerol monocaprylate, glycerol monocaprate and glycerol monolaurate, and registered these compounds as new pesticidal active ingredients acting against bacteria, viruses, fungi and lipid coated yeasts. The Agency concluded that these compounds are non toxic on an acute basis ( except for eye irritation) and are rapidly metabolized in vertebrate systems to polyols and free fatty acids. Breakdown products are indistinguishable from the natural background of these same compounds in living systems. The Agency granted requests for waivers from the data requirements for avian acute oral toxicity studies, avian dietary studies, and freshwater fish studies. Based on the label use pattern anticipated for the end use product( s), there is little likelihood of exposure to non target birds, aquatic organisms or insects ( EPA 2003).

The ecotoxicity data for glyceryl monostearate indicate the reduced bioavailability and fairly rapid microbial degradation  approximately 4 days for primary degradation  these materials are not likely to result in a significant risk. Similarly these compounds are not expected to pose a risk to terrestrial vertebrates.

VIII. Aggregate Exposures In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings ( residential and other indoor uses). For the compounds ( glycerol and glycerol fatty acid esters) assessed in this document, a qualitative assessment for all pathways of human exposure ( food, drinking water, and residential) is appropriate given the their low toxicity and the body's ability to metabolize these compounds and their metabolites. As noted previously, a number of scientific bodies, in addition to EPA have concluded these compounds are of low concern, including the FDA, FAO/ WHO, OECD SIDS and CIR. Glycerol and many of the glycerol fatty acid esters are classified as GRAS substances.

IX. Cumulative Exposure:

Section 408( b)( 2)( D)( v) of the 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." The glycerol fatty acid esters are structurally related; however, all are low toxicity chemicals. Therefore, the resultant risks separately and/ or combined should also be low.

EPA does not have, at this time, available data to determine whether glycerol and glycerol fatty acid esters assessed in this document have a common mechanism of toxicity with other substances. 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 glycerol and glycerol fatty acid esters and any other substances and these compounds do not appear to produce a toxic metabolite produced by other substances. For the purposes of this Page 22 of 23 tolerance action, therefore, EPA has not assumed that glycerol and glycerol fatty acid esters have 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 Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative/.

References:

Cosmetic Ingredient Review ( CIR). 1980. Final Report of the Safety Assessment for Caprylic/ Capric Triglyceride. Journal of Environmental Pathology and Toxicology. 4( 4): 105 120. MRID 46200501.

Cosmetic Ingredient Review ( CIR). 1986. Final Report of the Safety Assessment of Glyceryl Oleate. Journal of the American College of Toxicology 5( 5): 391 413. MRID 46201401.

Cosmetic Ingredient Review ( CIR). 2001. Safety Assessment of Glyceryl Laurate, Glyceryl Laurate SE, Glyceryl Laurate/ Oleate, Glyceryl Adipate, Glyceryl Alginate, Glyceryl Arachidate, Glyceryl Arachidonate, Glyceryl Behenate, Glyceryl Caprate, Glyceryl Caprylate, Glyceryl Caprylate/ Caprate, Glyceryl Citrate/ Lactate/ Linoleate/ Oleate, Glyceryl Cocoate, Glyceryl Collagenate, Glyceryl Erucate, Glyceryl Hydrogenated Rosinate, Glyceryl Hydrogenated Soyate, Glyceryl Hydroxystearate, Glyceryl Isopalmitate, Glyceryl Isostearate, Glyceryl Isostearate// Myristate, Glyceryl Isostearates, Glyceryl Lanolate, Glyceryl Linoleate, Glyceryl Linolenate, Glyceryl Montanate, Glyceryl Myristate, Glyceryl Isotridecanoate/ Stearate/ Adipate, Glyceryl Oleate SE, Glyceryl Oleate/ Elaidate, Glyceryl Palmitate, .... Amended Final Report. February 13, 2001.

Food and Drug Administration ( FDA). 1975. Evaluation of the Health Aspects of Glycerin and Glycerides as Food Ingredients. Prepared for FDA by the The Life Sciences Research Office. Federation of American Societies for Experimental Biology under Contract No. FDA 223 75 2004. SCOGS 30. Bethesda, MD.

FAO/ WHO ( Food and Agriculture Organization of the United Nations/ World Health Organization). Joint FAO/ WHO Expert Committee on food additives. Summary and Conclusions. 17th Report, June 25 July 4, 1974. Geneva. ( http:// www. inchem. org/ documents/ jecfa/ jecmono/ v05je45. htm)( May 5, 2003)

OECD ( Organization for Economic Cooperation and Development) Screening Information Data Sets ( SIDS). Processed by United Nations Environment Programme ( UNEP) Chemicals as a contribution to the Inter Organization Programme for the Sound Management for Chemicals ( IOMC). ( http:// www. inchem. org/ documents/ sids/ sids/ sids5b01. htm. and http:// www. inchem. org/ documents/ sids/ sids/ sids5b06. htm. ) ( March 2002)

TOXNET 2003. Hazardous Substance Data Bank ( HSDB). On line Scientific Search Engine, Page 23 of 23 National Library of Medicine, National Institute of Health. Http:// www. toxnet. nlm. nih. gov. Search terms: glycerol monooleate ( May 14, 2003).

U. S. Environmental Protection Agency ( EPA) 2002. IIFG Decision Documents on Reassessment of Exemptions from the Requirement of a Tolerance for Butyl Stearate and Glyceryl Monostearate. Memorandum from K. Boyle and K. Leifer to R. Forrest. July 31, 2002.

U. S. Environmental Protection Agency ( EPA). 2002. " Tolerance Review of Compounds Known as Fatty Acids, Fatty Acid Salts, and Fatty Acid Esters, and Fatty Acid Derivatives Classified as Inert Ingredients in Terrestrial and/ or Aquatic Agricultural and Non Agricultural Uses". Memorandum from S. C. Termes/ H. Craven, Environmental Fate and Effects Division ( EFED) to M. Perry, Special Review and Reregistration Division ( SRRD). May 15, 2002.

U. S. Environmental Protection Agency ( EPA) 2003. Science Review in Support of the Registration of the Technical Grade Active Ingredient ( TGAI) Product, VMX 42 Technology Propylene Glycol Monocaprylate ( EPA File Symbol No. 10350 AN), Containing Two New Active Ingredients, 68.12% Propylene Glycol Monocaprylate ( Chemical No. 082704) and 0.15% Propylene Glycol Monocaprate ( Chemical No. 011289); and Science Review of Studies/ Data/ information to be used in Support of VMX Technology Chemicals, Consisting of Three Closely Related Propylene Glycol Monoesters [ Propylene Glycol Monocaprylate ( Chemical No. 082704); Propylene Glycol Monocaprate ( Chemical No. 011289); and Propylene Glycol Monolaurate ( Chemical No. 011288)]; and Three Closely Related Glycerol Monesters [ Glycerol Monocaprylate ( Chemical No. 011292); Glycerol Monocaprate ( Chemical No. 011297); and Glycerol Monolaurate ( Chemical No. 011290)]. Memo from R. Jones to C. Frazer, Biopesticide & Pollution Prevention Division. April.


[Federal Register Volume 84, Number 25 (Wednesday, February 6, 2019)]
[Notices]
[Pages 2334-2335]
[FR Doc No: 2019-01296]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Applications for Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications for special permits.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations, notice is hereby given
that the Office of Hazardous Materials Safety has received the
application described herein. Each mode of transportation for which a
particular special permit is requested is indicated by a number in the
``Nature of Application'' portion of the table below as follows: 1--
Motor vehicle, 2--Rail freight, 3--Cargo vessel, 4--Cargo aircraft
only, 5--Passenger-carrying aircraft.

DATES: Comments must be received on or before March 8, 2019.

ADDRESSES: Record Center, Pipeline and Hazardous Materials Safety
Administration, U.S. Department of Transportation Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Ryan Paquet, Director, Office of
Hazardous Materials Approvals and Permits Division, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, East Building, PHH-30, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Copies of the applications are available for
inspection in the Records Center, East Building, PHH-30, 1200 New
Jersey Avenue Southeast, Washington DC or at http://regulations.gov.
    This notice of receipt of applications for special permit is
published in accordance with part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on February 1, 2019.
Donald P. Burger,
Chief, General Approvals and Permits Branch.

                                              Special Permits Data
----------------------------------------------------------------------------------------------------------------
                                                                                Nature of the special
          Application No.                   Applicant        Regulation(s) Affected        permits thereof
----------------------------------------------------------------------------------------------------------------
20815-N............................  COLEP PORTUGAL, S.A...  178.33-7(a)...........  To authorize the
                                                                                manufacture, mark, sale,
                                                                                and use of non-DOT
                                                                                specification receptacles
                                                                                with a reduced wall
                                                                                thickness. (modes 1, 2, 3,
                                                                                4, 5).
20816-N............................  AIR PRODUCTS AND        178.274, 178.277......  To authorize the
                                      CHEMICALS, INC.                                 manufacture of portable
                                                                                tanks built to ASME
                                                                                Section XII
                                                                                specifications. (modes 1,
                                                                                2, 3).
20820-N............................  UNION TANK CAR COMPANY  180.509(e)(4).........  To authorize the inspection
                                                                                and testing of tank car
                                                                                tanks using ACFM (non-
                                                                                destructive test method)
                                                                                in lieu of the methods in
                                                                                49 CFR 180.509(e)(4).
                                                                                (mode 2).
20821-N............................  SPACEFLIGHT, INC......  173.185(a)............  To authorize the
                                                                                transportation in commerce
                                                                                of low production lithium
                                                                                ion batteries contained in
                                                                                equipment via air
                                                                                transportation. (mode 4).
20822-N............................  Return Solutions, Inc.  ......................  To authorize the
                                                                                manufacture, mark, sale,
                                                                                and use of non-DOT
                                                                                specification packaging
                                                                                for the transportation in
                                                                                commerce of certain
                                                                                materials authorized to be
                                                                                disposed of under 21 CFR
                                                                                Part 1317, Subpart B.
                                                                                (modes 1, 2).
20824-N............................  WORTHINGTON CYLINDER    178.65(f)(2)(iii).....  To authorize the
                                      CORPORATION.                                    manufacture, mark, sale,
                                                                                and use of non-DOT
                                                                                specification cylinders
                                                                                conforming to the DOT 39
                                                                                specification, except as
                                                                                provided herein. (modes 1,
                                                                                2, 3, 4).
20826-N............................  CHRIS' ROCKET           173.62................  To authorize the
                                      SUPPLIES, LLC.                                  transportation in commerce
                                                                                of Division 1.3 and 1.4
                                                                                rocket motors, reloading
                                                                                kits, and igniters in non-
                                                                                specification outer
                                                                                packaging as Division 1.4.
                                                                                (mode 1).
20828-N............................  BATTERIES PLUS, LLC...  173.159(e)(1).........  To authorize the
                                                                                transportation in commerce
                                                                                of batteries and
                                                                                lightbulbs containing
                                                                                mercury on the same
                                                                                transport vehicle without
                                                                                being subject to the
                                                                                requirements of the HMR.
                                                                                (mode 1).
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2019-01296 Filed 2-5-19; 8:45 am]
 BILLING CODE 4909-60-P