[Federal Register: December 29, 2008 (Volume 73, Number 249)]
[Rules and Regulations]
[Page 79314-79316]
[DOCID:fr29de08-7]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 155 and 156

[Docket No. USCG-2001-9046]
RIN 1625-AB12

Tank Level or Pressure Monitoring Devices on Single-Hull Tank
Ships and Single-Hull Tank Barges Carrying Oil or Oil Residue as Cargo

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is removing its regulations for tank level or
pressure monitoring (TLPM) devices because devices that satisfy
compliance requirements remain unavailable.

DATES: This final rule is effective January 28, 2009.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2001-9046 and are available for inspection or
copying at the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. You may also find this
docket on the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call Dolores Pyne-Mercier, Project Manager, Office of Standards
Evaluation and Development, Project Development Division (CG-5232),
Coast Guard, telephone<PHONE_NUMBER>, or e-mail address, Dolores.J.Pyne-
<EMAIL_ADDRESS>If you have questions on viewing the docket, call
Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-
9826.

SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

I. Abbreviations
II. Background
    A. Regulatory History
    B. Purpose
III. Discussion of Comments and Changes
IV. Regulatory Analyses
    A. Regulatory Planning and Review
    B. Small Entities
    C. Assistance for Small Entities
    D. Collection of Information
    E. Federalism
    F. Unfunded Mandates Reform Act
    G. Taking of Private Property
    H. Civil Justice Reform
    I. Protection of Children
    J. Indian Tribal Governments
    K. Energy Effects
    L. Technical Standards
    M. Environment

I. Abbreviations

FR Federal Register
NEPA National Environmental Policy Act of 1969
NPRM Notice of Proposed Rulemaking
NTTAA National Technology Transfer and Advancement Act
TLPM Tank Level or Pressure Monitoring

II. Background

A. Regulatory History

    In September 2002, the Coast Guard promulgated tank level or
pressure monitoring (TLPM) device regulations located in 33 CFR parts
155 and 156. (67 FR 58515). The Final Rule detailed TLPM performance
criteria and described the vessels required to install and use TLPM
devices by 2007.
    To date, we have identified no devices meeting the performance
criteria established in the final rule, and none have been submitted by
industry for our evaluation. As a result, in July 2005, we published a
Final Rule (70 FR 41614) suspending the regulations for TLPM devices
for three years until July 21, 2008. In the final rule, we also
solicited public comment on the status of TLPM technology development
and alternatives to TLPM devices. In response, we received two comments
supporting our suspension of the regulations for TLPM devices and no
new information on TLPM devices or alternatives. We published another
Final Rule (73 FR 23397) on May 5, 2008, extending the suspension for
three additional years until May 5, 2011, to allow time for the current
rulemaking process to be completed.
    On June 30, 2008, we published a notice of proposed rulemaking
entitled ``Tank Level or Pressure Monitoring Devices on Single-Hull
Tank Ships and Single-Hull Tank Barges Carrying Oil or Oil Residue as
Cargo'' in the Federal Register (73 FR 36825). We received 2 letters
commenting on the proposed rule. Both commenters supported the Coast
Guard's decision to remove the TLPM device regulations. No public
meeting was requested and none was held.

B. Purpose

    For a complete discussion of the background for this final rule,
see the NPRM published on June 30, 2008 (73 FR 36825, 36826).
    The Coast Guard is removing its regulations for TLPM devices
because

devices that satisfy compliance requirements remain unavailable. As
noted above in section II.A. ``Regulatory History,'' we published a
final rule suspending Coast Guard regulations for TLPM devices with a
request for public comments on the status of TLPM technology
development and other means of detecting leaks from oil cargo tanks
into the water. We received two comments supporting our suspension of
the regulations for TLPM devices. We received no new information on
TLPM devices or alternatives for detecting leaks into the water from
single-hull tank vessels carrying oil or oil residue as cargo.
    Based on the public response to the suspension, the absence of new
information regarding TLPM devices or alternatives, and the results of
a Congressionally-mandated study (available in the docket where
indicated under ADDRESSES), the Coast Guard revisited the feasibility
and practicality of retaining regulations for TLPM devices on single-
hull tank vessels and concluded that it is appropriate to remove these
regulations.

III. Discussion of Comments and Changes

    We received two comments on the NPRM; both were in favor of the
removal of the TLPM device requirement from the regulations. The Coast
Guard has made no changes from the NPRM, save a minor edit to the
authority citation for part 156.

IV. Regulatory Evaluation

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

A. Executive Order 12866

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    Public comments on the NPRM are summarized in Part IV of this
preamble. We received no public comments that would alter our
assessment of impacts in the NPRM. We have adopted the assessment in
the NPRM as final. See the ``Regulatory Evaluation'' section of the
NPRM for the complete analysis.
    This final rule removes the regulations for TLPM devices--a type of
shipboard equipment that does not currently exist in the marketplace
and which has no practical alternative. We conclude this rule will have
no impact on industry.

B. Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    We concluded that removing the performance standards for TLPM
devices and the requirements for their use will not have a significant
economic impact on a substantial number of small entities since
industry did not adopt or implement any TLPM provisions. Therefore, the
Coast Guard certifies under 5 U.S.C. 605(b) that this final rule will
not have a significant economic impact on a substantial number of small
entities.

C. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding the rule so that they could better evaluate
its effects on them and participate in the rulemaking.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions of the Coast Guard, call 1-888-REG-FAIR (1-888-734-
3247). The Coast Guard will not retaliate against small entities that
question or complain about this rule or any policy or action of the
Coast Guard.

D. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

E. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them.
    It is well settled that States may not regulate in categories
reserved for regulation by the Coast Guard. It is also well settled,
now, that all of the categories covered in 46 U.S.C. 3306, 3703, 7101,
and 8101 (design, construction, alteration, repair, maintenance,
operation, equipping, personnel qualification, and manning of vessels),
as well as the reporting of casualties and any other category in which
Congress intended the Coast Guard to be the sole source of a vessel's
obligations, are within the field foreclosed from regulation by the
States. (See the decision of the Supreme Court in the consolidated
cases of United States v. Locke and Intertanko v. Locke, 529 U.S. 89,
120 S.Ct. 1135 (March 6, 2000)). This rule removes previously published
rules on performance standards, and the use of TLPM devices falls into
the category of vessel equipment and operation. Because the States may
not regulate within these categories, preemption under Executive Order
13132 is not an issue.

F. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such expenditure, we do
discuss the effects of this rule elsewhere in the preamble.

G. Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

H. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

I. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

J. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

K. Energy Effects

    We analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a ``significant energy
action.'' Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

L. Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with the applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation: Test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

M. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 0023.1 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
that this action is one of a category of actions which do not
individually or cumulatively have a significant effect on the human
environment. Therefore, this rule is categorically excluded, under
section 2.B.2. Figure 2-1, paragraph 34(d), of the Instruction and
neither an environmental assessment nor an environmental impact
statement is required. This rule involves the equipping of vessels. An
environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects

33 CFR Part 155

    Alaska, Hazardous substances, Oil pollution, Reporting and
recordkeeping requirements.

33 CFR Part 156

    Hazardous substances, Oil pollution, Reporting and recordkeeping
requirements, Water pollution control.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR parts 155 and 156 as follows:

PART 155--OIL OR HAZARDOUS MATERIAL POLLUTION PREVENTION
REGULATIONS FOR VESSELS

0
1. The authority citation for 33 CFR Part 155 and the note following
citation continue to read as follows:

    Authority: 33 U.S.C. 1231, 1321(j); E.O. 11735, 3 CFR, 1971-1975
Comp., p. 793. Sections 155.100 through 155.130, 150.350 through
155.400, 155.430, 155.440, 155.470, 155.1030(j) and (k), and
155.1065(g) are also issued under 33 U.S.C. 1903(b). Sections
155.480, 155.490, 155.750(e), and 155.775 are also issued under 46
U.S.C. 3703. Section 155.490 also issued under section 4110(b) of
Pub. L. 101-380.

    Note to Part 155: Additional requirements for vessels carrying
oil or hazardous materials are contained in 46 CFR Parts 30 through
40, 150, 151, and 153.

Sec.  155.200  [Amended]

0
2. In Sec.  155.200, remove the definition for ``Sea State 5.''

Sec.  155.490  [Removed and Reserved]

0
3. Remove and reserve Sec.  155.490.

PART 156--OIL AND HAZARDOUS MATERIAL TRANSFER OPERATIONS

0
4. The authority citation for 33 CFR Part 156 is revised to read as
follows:

    Authority: 33 U.S.C. 1231, 1321(j); 46 U.S.C. 3703a, 3715; E.O.
11735, 3 CFR 1971-1975 Comp., p. 793. Section 156.120(bb) is also
issued under 46 U.S.C. 3703.

Sec.  156.120  [Amended]

0
5. In Sec.  156.120, remove paragraph (ee).

    Dated: December 17, 2008.
Brian M. Salerno,
Assistant Commandant for Marine Safety, Security and Stewardship, U.S.
Coast Guard.
 [FR Doc. E8-30803 Filed 12-24-08; 8:45 am]

BILLING CODE 4910-15-P


Page 1 of 17 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES September August 29, 2003 MEMORANDUM SUBJECT: Tolerance Reassessment Decisions Completed by the Lower Toxicity Pesticide Chemical Focus Group FROM: Peter Caulkins, Associate Director Registration Division TO: Richard Keigwin, Acting Associate Director Special Review and Reregistration Division Please find attached the Focus Group Decision Document for benzoic acid and its sodium salt. The four tolerance exemptions for these chemicals in 40 CFR 180.1001 are reassessed.

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

Attachments ( 1) Page 2 of 17 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES September 27, 2003 MEMORANDUM FROM: Kathryn Boyle, Chair Lower Toxicity Pesticide Chemical Focus Group Registration Division TO: Susan Lewis, Acting Chief Minor Use, Inerts, and Emergency Response Branch Registration Division SUBJECT: Recommendation for Tolerance Reassessment The attached science assessment discusses the toxicity of benzoic acid and its sodium, potassium, calcium, ammonium, and magnesium salts. Based on the rapid metabolism and excretion of these chemicals, and the existing assessments, 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 benzoic acid and its sodium, potassium, calcium, ammonium, and magnesium salts from their uses as inert ingredients in pesticide products. The benzoic acid exemptions from the requirement of a tolerance as established in 40 CFR 180.1001 ( c) and ( e) and the sodium benzoate exemptions from the requirement of a tolerance as established in 40 CFR 180.1001 ( c) and ( e) are reassessed. Based on their rapid metabolism and excretion and the available information on acute toxicity, sodium, potassium, calcium, ammonium, and magnesium benzoate are reclassified as List 4A. Benzoic acid is classified as List 4B based on severe eye irritation ( Toxicity Category I). Page 3 of 17 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES September 25, 2003 Memorandum Subject: Benzoic Acid and Benzoate salts: Health Effects Division Science Assessment Document for Tolerance Reassessment.

CAS No.: 65 85 0 ( benzoic acid) 532 32 1 ( sodium benzoate) 582 25 2 ( potassium benzoate) 2090 05 3 ( calcium benzoate) 1863 63 4 ( ammonium benzoate) 563 70 8 ( magnesium benzoate)

Chemical Class: benzoates From: Elissa Reaves, Toxicologist Reregistration Branch 2 Health Effects Division ( 7509C)

Through: Pauline Wagner, Branch Chief Reregistration Branch 2 Health Effects Division ( 7509C)

To: Lower Toxicity Pesticide Chemical Focus Group Kathryn Boyle, Chair Registration Division ( 7505C) Page 4 of 17 Background:

Attached is the Lower Toxicity Pesticide Chemicals Focus Group's science assessment for benzoic acid, sodium benzoate, and other salts of benzoic acid. This assessment summarizes available information on the use, physical/ chemical properties, toxicological effects, and exposure profile of these benzoate salts. In performing this assessment, EPA has utilized reviews previously performed by EPA and FDA and relied on peer reviewed evaluations performed by the Cosmetic Ingredient Review ( CIR) and FAO/ WHO.

I. Executive Summary:

Benzoic acid, also called benzenecarboxylic acid, occurs naturally in certain foods such as raspberries, cranberries, prunes, cinnamon, ripe cloves, plums, tea, anise, and oil of lovage; with most berries containing about 0.05 percent. Benzoic acid and sodium benzoate have been used for decades in pharmaceuticals, as a pH adjustor and/ or preservative in cosmetics, bath and beauty products, and as preservatives/ antimicrobial agents in foods and beverages. Less is known about the other salt forms of benzoic acid ( ammonium, calcium, magnesium, and potassium). However, it was considered that data gaps for one benzoate salt could be adequately addressed by the existing data for the other benzoate compounds. Benzoic acid and its salts are rapidly absorbed by mammals, conjugated with glycine, and rapidly excreted in the urine as hippuric acid. There is no reported accumulation of benzoate in the body. However, the ability to conjugate benzoic acid depends upon adequate liver function and nutritional supply of glycine.

Toxicological effects from exposure to benzoate solids documented in various websites and from open literature studies include irritation to the nose and throat, slight to moderate irritation to the skin, and irritation to the eyes. The benzoates were recognized to produce nonimmunologic contact reaction, but it was not determined whether the reactions were histamine or prostaglandin mediated. Dermal sensitization, photo toxicity, and photosensitization studies were negative.

The available ecotoxicity data for benzoic acid and the benzoate salts indicate that these compounds are expected to be readily biodegradable in the environment, are of low toxicity to fish and other aquatic organisms, mammals, and birds. EPA believes that benzoic and the benzoate salts will not cause unreasonable adverse effects on the environment.

Based on available information on benzoic acid and benzoate salts, their natural occurrence in berries, their expected use patterns, their safe history of use as food additives, their extensive use in cosmetics and bath products, and their low toxicity, the Health Effects Division ( HED) has determined that a quantitative risk assessment is not warranted for these compounds.

II. Use Information:

The tolerance exemptions being reassessed in this document, the 40 CFR location of the established tolerance exemption, and the use pattern as an inert or active ingredient are listed in Page 5 of 17 Table 1.

Table 1. Use Pattern ( pesticidal inert ingredient)

Chemical Name PC Code 40 CFR 180.1001

Inert Use Pattern ( Pesticidal) Current Inert List*

Benzoic Acid 809101 ( c) ( e) preservative for formulations 4B Sodium Benzoate 809103 ( c) ( e) anticaking agent, stabilizer, preservative 4B Potassium Benzoate 709103 non food only

Calcium Benzoate 900653 non food only 3 Ammonium Benzoate 809099 non food only 3 Magnesium Benzoate 900323 non food only 3

Residues listed in section ( c) of 40 CFR 180.1001 are exempted from 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 section ( e) of 40 CFR 180.1001 are exempted from a tolerance when used as inert ingredients in pesticide formulations applied to animals. * Inert ingredients are categorized into four lists as described in the 52 FR 13305, Inert Ingredients in Pesticide Products Policy Statement. List 3 includes inert ingredients of unknown toxicity. Inert ingredients on this list have not yet been determined to be of minimal concern. List 4 are inert ingredients of minimal concern and are subdivided into 4A ( minimal risk inert ingredients) and 4B ( inert ingredients with sufficient data to substantiate safe use in pesticide products). NA Not available According to the OPPIN database, both benzoic acid and sodium benzoate also have active ingredient PC Codes, 009101 and 009103, respectively. There are no active or pending registrations for benzoic acid as an active ingredient, and only one active registration for sodium benzoate.

Use Pattern ( non pesticidal):

Benzoic Acid: Benzoic acid is generally recognized as safe ( GRAS) by the U. S. FDA when used as an antimicrobial and flavoring agent and adjuvant ( 21 CFR 184.1021). The ingredient is used in food levels not to exceed good manufacturing practice with a maximum usage level of 0.1% in food. Benzoic acid and sodium benzoate are also used as a preservative in cosmetic formulations with the majority of both ingredients used at < 1% ( Anderson 2001). Benzoic acid and sodium benzoate are both also used as a pH adjustor and/ or preservative in bath and body products, and in pharmaceuticals. The major outlet ( 75%) for the production of benzoic acid is as a chemical intermediate in the production of phenol. Other uses of benzoic acid not specifically regulated includes the use in paints, varnishes, solvents, cleaning and washing agents, photo chemicals and antifreeze agents.

The Agency notes that benzoic acid is included on the Agency's list of chemicals included in the High Production Volume ( HPV) Challenge Program. HPV chemicals are those that are Page 6 of 17 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.

Sodium Benzoate: Sodium benzoate is generally recognized as safe by the U. S. FDA when used as an antimicrobial and flavoring agent and adjuvant ( 21 CFR 184.1733). The ingredient is used in food at levels not to exceed good manufacturing practice with a maximum usage level of 0.1% in food. The Cosmetic Ingredient Review ( CIR) Expert Panel concluded that benzoic acid and sodium benzoate could be used safely in cosmetic formulations at concentrations up to 5% ( Anderson 2001). Sodium benzoate is mainly produced for use as a preservative in food and beverages ( 60%) and is also important for use in cooling liquids ( 10%). The use of sodium benzoate in paint strippers is limited to uses in industrial settings. Other uses of sodium benzoate may include the use in paints, varnishes, solvents, cleaning and washing agents, photo chemicals, and antifreeze agents. The Agency notes that sodium benzoate is included on the HPV Challenge Program.

Ammonium Benzoate ( Benzoic Acid NH4+): Ammonium benzoate is regulated by the U. S. FDA as an indirect food additive for the limited use as a preservative component of adhesives ( 21 CFR 175.105). Ammonium benzoate is also reported as an industrial preservative for paper wrappers and as an agent for reducing curing time in vulcanization of rubber. Ammonium benzoate is not currently being sponsored; however, it is within the scope of the HPV Challenge Program and is currently available for sponsorship.

III. Physical/ Chemical Properties:

Table 2. Physical/ Chemical Properties.

Benzoic Acid Sodium Benzoate* Benzoic Acid NH4+

Physical State white solid white solid white solid Molecular Formula C 6 H 5 COOH C 6 H 5 COONa+ C 6 H 5 COONH 4+

Molecular Weight ( Da) 122.12 144.11 139.16 Melting Point ° C 122.4 330.6 198 Water Solubility insoluble soluble soluble Density ( g/ cm3) 1.2659 1.44 1.260 * Data for magnesium benzoate, potassium benzoate or calcium benzoate are expected to be similar to sodium Page 7 of 17 benzoate.

IV. Hazard Assessment Table 3. Summary of Acute Toxicity Data on Benzoic Acid and Sodium Benzoate.

Benzoic Acid Sodium Benzoate Test Species Results Category Species Results Category Oral LD50 rat 2565 mg/ kg III rat 3140 mg/ kg III Dermal LD50 rabbit > 2000 mg/ kg III no data Inhalation LC50 rat > 12.2 mg/ l/ 4h. IV no data Eye Irritation rabbit severe irritation I rabbit slightly irritating III Dermal Irritation rabbit non to slightly irritating III rabbit non irritating IV Dermal Sensitization guinea pig not sensitizing Not applicable human nonimmunologic contact urticaria Not applicable A. Toxicological Profile: The general effects of exposure to benzoic acid and sodium benzoate or its salts include nose and throat irritation if inhaled, as well as slight skin and severe eye irritation. Benzoic acid and the benzoate salts are rapidly metabolized and excreted, do not bioaccumulate, and have low toxicity after acute and repeated exposures. Early human consumption studies indicated no externally visible effects from ingesting 0.5 to 1.0 g/ day of benzoic acid for 44 consecutive days or for 82/ 86 or 88/ 92 days ( Gerlach 1909; as cited in USEPA IRIS). Assuming a human body weight of 70 kg, this corresponds to a dose of 14 mg/ kg/ day of benzoic acid. In another early study ( 1909), men who drank from 1 to 2.5 liters of apple juice containing 0.1 percent sodium benzoate complained of burning taste, headache, nausea and vomiting, itching of the skin, sweating, constipation and albuminuria. However, massive doses of sodium benzoate ( 25 60 g per day) were given to rheumatic patients Page 8 of 17 without producing any harmful effects ( FDA 1973). Adverse effects in humans given an oral bolus dose of less than or equal to 1.75 g/ day of benzoic acid over a 20 day period include observed irritation, discomfort, weakness, and malaise ( Wiley and Bigelow 1908; as cited in USEPA IRIS).

The oral LD50 for benzoic acid is 1,520 mg for the rabbit and 2,000 mg for the cat and dog. The lethal dose for benzoic acid in sheep is estimated to be 1,000 mg/ kg ( FDA 1973).

A chronic oral dose of 40 mg/ kg/ day of benzoic acid for 17 months was associated with decreased resistance to stress in mice and possibly with reduced food and water intake in rats after 18 months. However, another study reported by the same laboratory indicated 80 mg/ kg/ day in rats for 18 months was not associated with adverse effects on body weight, survival, or gross or microscopic pathology ( Shtenberg and Ignat'er 1970; Ignat'er 1965; as cited in USEPA IRIS). Other long term dietary studies showed decreased food intake and body weight in rats fed 1.5% benzoic acid ( 750 mg/ kg/ day). A reduced dose of 1.0% benzoic acid in the diet ( 50 mg/ kg/ day) did not produce signs of toxicity or adverse reproductive effects ( Marquardt 1960; as cited in USEPA IRIS).

No positive results have been reported for benzoic acid or sodium benzoate when tested for mutagenicity or genotoxicity in prokaryotes, eukaryotes, and several mammalian test systems ( McCann et al., 1975; Litton Bionetics, Inc., 1975 and 1975; Oikawa et al., 1980; as cited in USEPA IRIS).

B. Cations: Ammonium, Calcium, Magnesium, Potassium, and Sodium:

Calcium: The human body burden of calcium is approximately 1 kg for a 70 kg adult; thus, 1/ 70th of our weight is calcium. The calcium cation is necessary for bone and teeth formation. It is also important to the proper functioning of nerves, enzymes, and muscles, and plays a role in blood clotting and the maintenance of cell membranes. The recommended daily allowances ( RDAs) for calcium are 1000 mg/ day for adults aged 19 to 50 years, and 1200 mg/ day for individuals older than 50 years.

Magnesium: The human body burden of magnesium is approximately 20 g for a 70 kg adult. The magnesium cation is also used in building bones. It plays a role in releasing energy from muscles and regulating body temperature. The RDA is 310 to 320 mg/ day for adult females, and 400 to 420 mg/ day for adult males, with the RDA increasing with increasing age.

Potassium: The human body burden of potassium is approximately 140 g for a 70 kg adult. The potassium cation is important in regulating blood pressure, regulating cellular water content, maintaining proper pH balance, and transmission of nerve impulses. It helps to regulate the electrical activity of the heart and muscles. The potassium RDA is 900 mg/ day.

Sodium: The human body burden of sodium is approximately 20 g for a 70 kg adult. The sodium cation is necessary for the nerves and muscles to function properly. It is the principal Page 9 of 17 cation of extracellular fluid, and helps to maintain the body's water balance. These electrolytes, the electrically charged ions in the body fluids, consist to a great extent of sodium and potassium. There is no Recommended Daily Allowance ( RDA) for sodium.

C. Ammonium Salt:

Ammonium salts dissociate to the negatively charged anion and the positively charged ammonium cation ( NH 4 +). Humans cannot convert atmospheric nitrogen to any form that can be used as part of any of the various metabolic cycles. Therefore, reduced nitrogen ( NH 4 +) has to enter the body from an outside source. These sources are the nitrogen containing amino acids in protein which are consumed daily as part of the diet. Although the human body can produce some amino acids, ten amino acids are considered " essential" amino acids, i. e., they must be consumed in the diet.

Generally the body works to maintain a balance of nitrogen intake and nitrogen excretion. The estimated daily ammonia intake through food and drinking water is 18 mg. In contrast, 4000 mg of ammonia per day are produced endogenously in the human intestine.

Ammonia and the ammonium ion are integral components of normal human metabolic processes. Ammonia is released following deamination that occurs when protein is used by the body for energy production. The liver converts ammonia via the urea cycle into urea. According to FDA in the " Evaluation of the Health Aspects of Certain Ammonium Salts as Food Ingredients" ( 1974), " the normal liver so readily detoxifies ammonium ion from alimentary sources that blood concentrations of ammonium salts do not rise to the levels necessary to evoke toxic response." Approximately 80% of the body's excess nitrogen is eliminated through the kidneys as urea, approximately 25 to 30 grams per day.

D. Special Considerations for Infants and Children Given the wide spread occurrence of benzoates in the food supply, the amount of benzoates that can be applied to food as a result of its use in a pesticide product should not significantly increase the existing amounts in the food supply. Oral doses of sodium benzoate appeared to have no maternal toxicity, fetal toxicity, or teratogenicity in mice, rats, hamsters, or rabbits with the highest doses tested being 175.0 mg/ kg/ day in mice and rats, 300.0 mg/ kg/ day in hamsters, and 250.0 mg/ kg/ day in rabbits ( FDRL 1972; as cited in USEPA IRIS).

However, there is some concern that low birth weight or premature infants with immature livers can experience adverse effects when administered benzoic acid or benzoate salts. Infants with immature livers may not be capable of metabolizing benzoate. It was suggested that a combination of sodium benzoate and sodium phenylacetate not be administered to low birth weight infants unless the benefits outweigh the risks ( AMA 1991; USP DI 1992, as cited in TOXNET). Page 10 of 17 EPA believes there would be a very low exposure of premature or very young infants to benzoates. First, premature or very young infants ingest only formula or breast milk. ( It is generally recommended that infants not consume solid food until 4 to 6 months of age.) Regulation of infant formulas is under the purview of the FDA. ( www. fda. gov/ fdac/ features/ 596_ baby. html).

Benzoic acid and sodium benzoate are generally recognized as safe ( GRAS) under 21 CFR 184.1021 and 184.1733, respectively. Therefore, infants consuming only infant formula or breast milk would be exposed to very low amounts of benzoates. Second, even if a young infant were to be fed some solid food, given the characteristics of benzoic acid and benzoate salts, residues are not likely to be present above naturally occurring concentrations. As discussed below ( section 7) the benzoates are readily biodegradable. It is not likely to be taken up by plants.

Once past this several month time period, there is no longer a concern for potential sensitivity to infants and children. Older infants, like adults, process benzoates through well understood metabolic pathways. 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 Benzoic acid and sodium benzoate have been used for decades in pharmaceuticals, cosmetics and/ or in food as preservatives and flavoring/ fragrance agents. According to information in Product Registers the substances are also used in different kinds of products, such as in paints, varnishes, solvents, cleaning and washing agents, photo chemicals, and antifreeze agents. Benzoic acid and sodium benzoate both have the status " generally recognized as safe" ( GRAS) by the U. S. FDA. An estimated daily food input of benzoate by the U. S. EPA was 278 mg as sodium benzoate and 34 mg as benzoic acid. ( USEPA 1987; as cited in USEPA IRIS). In 1983, the Joint Expert Committee on Food Additives ( JEFCA) of the World Health Organization ( WHO) established a group acceptable daily intake ( ADI) for benzoic acid and its salt of 5 mg/ kg body weight. This group ADI is based on the structural similarity and common metabolic fate of these chemicals ( WHO 1997).

The National Research Council subcommittee also provided a possible daily human intake of benzoic acid and sodium benzoate in the total diet based on a comprehensive survey. The following table summarizes the possible daily intake for individuals in various age groups ( FDA 1973).

Table 4. Possible daily intake Total Intake mg mg/ kilogram of body weight*

Benzoic Acid Sodium Benzoate Benzoic Acid Sodium Benzoate Age group Avg. Max. Avg. Max Avg. Max. Avg. Max.

0 5 mos. 0.6 1 10 21 .1 .2 2 4 6 11 mos. 6 21 111 313 .8 2.6 14 39 Page 11 of 17 12 23 mos. 16 46 188 404 1.4 4.2 17 37 2 65+ yrs. 34 87 328 669 0.6 1.4 5.5 11 * Calculations based on an average weight of 60 kg for an adult and the following estimated weights of infants by age groups: 0 5 mos., 5 kg; 6 11 mos., 8 kg; and 12 23 mos., 11 kg.

It should also be noted that the NRC subcommittee stated the calculations of benzoate intakes are likely over stated, possibly by considerable margins. The Select Committee regarded the figures given in the table as levels that would unlikely be consumed by any of the age groups. Figures in the table were considered to be generous overestimates of the benzoic acid and sodium benzoate content of the human diet ( FDA 1973).

The worldwide production capacity for benzoic acid is estimated at 700 kt. The major outlet ( 75% or 525 kt) for benzoic acid is for the production of phenol, which in turn is mainly used to produce caprolactam. The next biggest outlet is as a feedstock for sodium benzoate ( 10% or 70 kt) and chemical synthesis of plasticizers ( 5% or 35 kt). So, benzoic acid is mainly used in controlled industrial settings.

The worldwide production of sodium benzoate is estimated at 100 kt. The major use for sodium benzoate is as a preservative in food and beverages ( 60% or 60 kt). The second most important market for sodium benzoate is for cooling liquids ( 10% or 10 kt). Like sodium benzoate, potassium benzoate is used mainly as a preservative in nonalcoholic beverages with an estimated worldwide production capacity of only 7 kt. Ammonium benzoate is approved only as an indirect food additive for use only as component of adhesives ( 21 CFR 175.105). No production estimates could be determined for ammonium benzoate or any of the other benzoate salts.

The use of benzoic acid and sodium benzoate in pesticide products as inert ingredients is expected to result in much lower exposure than the FDA regulated use of these compounds, as well as lower exposure than in the average daily intake of benzoates. Therefore, a quantitative screening level exposure assessment has not been conducted.

VI. Risk Characterization Benzoic acid is a naturally occurring compound found in berries and other foods. As previously discussed in this document, there are many FDA approved uses for benzoic acid and the benzoate salts. Residues from the pesticide uses of the benzoates are not likely to greatly contribute to the levels already approximated as the average daily intake.

As noted previously, three of the benzoates assessed in this document, benzoic acid, sodium benzoate, and ammonium benzoate, are 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. There are approximately 3,000 HPV chemicals that are produced or imported Page 12 of 17 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. Based on the available toxicity data for the benzoates, the Agency feels confident in proceeding with this tolerance reassessment decision. Any submission of data by sponsors of benzoic acid, sodium benzoate, and ammonium benzoate as part of the HPV Challenge Program may, in the future, be used by OPP to revise or update their tolerance reassessment decision for these benzoates as deemed necessary and appropriate.

Taking into consideration all available information on benzoic acid, sodium benzoate, and the other salts of benzoate, including the FDA's designation of GRAS for benzoic acid and sodium benzoate, as preservatives/ antimicrobial agents in foods and beverages, the historical use of benzoic acid and sodium benzoate in pharmaceuticals, cosmetics, as well as the natural presence of benzoic acid in berries, the use of ammonium benzoate as a preservative in adhesive components in foods, the use of benzoic acid and the benzoate salts as inert ingredients in pesticide formulations are unlikely to pose a significant hazard to the general public or any population subgroup. Therefore, HED is conducting a qualitative approach to assessing human health risks from exposure to benzoates.

VII. Environmental Fate/ Ecotoxicity/ Drinking Water Considerations:

The environmental fate and occurrence of benzoic acid has been well studied. The Hazardous Substances Database ( HSDB) ( www. toxnet. nlm. nih. gov) contains extensive summaries of the environmental fate of benzoic acid. In addition, HSDB information has been supplemented with predictive modeling based on structure activity relationships. For this analysis, sodium, potassium calcium, and magnesium salts were considered equivalent with respect to their environmental fate and ecotoxicity. Slight differences in physical chemical properties were observed, but are not expected to impact their behavior or toxicity in the environment. Benzoic acid and the ammonium salt of benzoic acid were addressed separately.

Table 1 provides key fate and chemical properties for benzoic acid and representative molecules of the salts. With a pKa of 4.204, benzoic acid will dissociate to form an anion at environmental pH up to the limits of its solubility. The benzoate salts are highly water soluble and readily dissociate into the anion ( benzoic acid) and cation ( sodium, potassium, calcium, magnesium and ammonium ion). Thus, the environmental fate and effects of the benzoic acid salts are closely related to that of benzoic acid, and the free cation.

Table 1. Properties and Environmental Fate of Benzoic Acid and Selected Salts Property Benzoic Acid Sodium Benzoate Benzoic Acid, Ammonium Salt Page 13 of 17 Water Solubility ( mg/ L) @ 25C 3400 ( M) 5.56E05 ( M) > 1.0E06 ( E)

Vapor Pressure mm Hg @ 25C 7E 04 ( M) 3.67E 09 ( E) 2.65E 07 ( E)

Henry's Law Coefficient ( atm m3/ mole) 3.8E 08 ( M) 1.09E 07 ( E) 5.2E 16 ( E)

Biodegradation Primary: hours days Ultimate: days weeks Primary: hours days Ultimate: days weeks Primary: hours days Ultimate: days weeks Log Kow 1.87 ( M)  2.27 ( E)  1.33 ( E)

Koc ( ml/ g) 14 ( E) 14 ( E) 99 Hydrolysis Half life @ pH 7 ( days) No hydrolizable functional groups No hydrolizable functional groups 52 days M: Measured; E: Estimated Based on low K oc s and log K ow s, benzoic acid and its salt are classified as highly mobile in soil ( McCall). Volatilization from water would be minimal, based on both benzoic acid and the salts' low Henry's Law constant. All compounds have a low potential to volatilize from soil surfaces, based on vapor pressures of less than 1 x 10 4 mm Hg.

The biodegradability of benzoic acid has been extensively studied and are expected to be readily biodegradable in the environment. Using both unacclimated and acclimated sludge inoculums, benzoic acid degraded with half lives of less than approximately 5 days. In most all cases, near complete mineralization occurred in under 10 days. In soil inoculums, benzoic acid exhibited a half life for mineralization of 4.5 hours. In a second study, complete mineralization occurred in one day. Benzoic acid degraded in a polluted river water in 0.85 days and in reservoir water in 3.6 days. Degradation appears to be concentration dependent, with low concentrations, less than 1 ppb, mineralizing in eutrophic and oligotrophic lake water in under 7 days. Overall half lives in unacclimated and acclimated systems ranges from hours to days for primary degradation and hours to weeks for ultimate ( mineralization) degradation.

In an acidic soil, benzoic acid mineralized up to 80 percent in less than 12 weeks. The same experiment in a neutral soil resulted in approximately 70 percent mineralized in 12 weeks. Anaerobically, more than 75 percent of benzoic acid mineralizes when incubated for 8 weeks using sludge from a secondary digester. In several other experiments using sewage sludge inoculums, benzoic acid mineralized > 90 percent in as little as 7 to 18 days. In a study using anoxic sediment from a hypereutrophic lake in Kalamazoo, MI, benzoic acid degraded completely ( methane and CO 2 ) in one week.

Due to the lack of hydrolyzable functional groups, abiotic degradation of benzoic acid and the salts of benzoate would not be expected to be an important fate process. However, the ammonium salt would hydrolyze in neutral to alkaline environments from 5 days at pH 8 to 52 Page 14 of 17 days at pH 7. Benzoic acid is expected to photolyze based on UV adsorption at 310nm. Available data indicate that 10.2 percent photolyzes in approximately 17 hours.

If any of these compounds were to enter the atmosphere, it is expected to exist solely as a vapor. Vapor phase benzoic acid would be readily degraded in the atmosphere by reaction with photochemically produced hydroxyl radicles with an estimated half life of 8 days.

Estimated toxicity ( Meylan, 1998) indicates benzoic acid is the most toxic of the substances reviewed in this assessment. Table 2 lists the estimated toxicity for several species. Green algae and fish are among the most sensitive species based on predictive modeling for acute and chronic endpoints for all compounds. Based on the environmental fate profile of benzoic acid and its salts, exposures from labels uses are unlikely to reach concentrations necessary to elicit effects in aquatic organisms. Using laboratory rat data as a surrogate for terrestrial wild mammals and birds, benzoic acid and its salts do not appear to be very toxic and adverse effects from labeled uses is not expected.

Table 2. Ecotoxicity of Benzoic Acid and Selected Salts Property Benzoic Acid Sodium Benzoate Benzoic Acid, Ammonium Salt Fish ( 96 h LC50; mg/ L) 1200 > 1.0E06 1.4E05 Daphnid ( 48 h LC50; mg/ L) 1274 8.8E05 1.2E05 Green Algae ( 96 h EC50; mg/ L) 790 4.3E05 61172 Fish ( 30 day Chronic; mg/ L) 151 71380 10486 Fish ( SW) ( 96 h LC50; mg/ L) 258 32047 6374 Mysid Shrimp ( 96 h LC50; mg/ L) 380 > 1.0E06 4.3E05 Green Algae ( 96 h Chronic; mg/ L) 73 3646 893 Earthworm ( 14 day LC50; mg/ Kg dry wt.) 8238 18317 9081 Detections of benzoic acid in surface water have been extensively reported, but not quantified. In ground water, concentrations of < 0.1 ppb have been reported for areas without known sources of potential contamination such as landfills, wood preserving facilities, and petroleum operations. Benzoic acid has been detected in the particulate fraction of rain and snow. In drinking water, concentrations of up to 15 ppm in the tap water of Otumwa, IA was reported, but was not detected in water from utilities in Seattle, Philadelphia, or Cincinnati. Benzoic acid has been detected, but not quantified, in other drinking water monitoring studies, domestically and internationally. Overall, and with few exceptions, concentrations of benzoic acid in ambient and drinking water is expected to be in the low ppb range. Page 15 of 17 VIII. 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."

EPA does not have, at this time, available data to determine whether benzoic acid or the benzoate salts 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 benzoic acid or the benzoate salts and any other substances and benzoic acid or the benzoate salts do no appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that benzoic acid or the benzoate salts 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:

( Note to the Reader: MRID ( Master Record Identification) Numbers were added to the references on October 17, 2003 and November 21, 2003. These numbers were not available at the time of document signature. No other changes were made to the document.)

AMA 1991. American Medical Association. AMA Drug Evaluations Annual 1991. Chicago, IL: American Medical Association, 1991. 2034 Anderson, F. Alan 2001. Forty Fourth Report of the Cosmetic Ingredient Review Expert Panel. Final Report on the Safety Assessment of Benzyl Alcohol, Benzoic Acid, and Sodium Benzoate. ( F. Alan Anderson). International Journal of Toxicology. Vol 20: Suppl 3: Pp 23 50. ( MRID No. 46067601)

Department of Health and Human Services, National Institutes of Health, U. S. National Library of Medicine. Benzoic Acid; CAS Registry Number 65 85 0, Sodium Benzoate; CAS Registry Number 532 32 1, and Ammonium Benzoate; CAS Registry Number 1863 63 4. Available at http:// www. toxnet. nlm. nih. gov.

FDA ( Food and Drug Administration). 1973. Evaluation of the Health Aspects of Benzoic Acid and Sodium Benzoate as Food Ingredients. DHEW, Washington, DC. Report No. SCOGS 7. NTIS PB 223837/ 6. ( MRID No. 46069301) Page 16 of 17 FDRL ( Food and Drug Research Labs., Inc.). 1972. Teratologic Evaluation of FDA 71 37 ( Sodium Benzoate). p.\ 75 79.

Gerlach, V. 1909. VII. Summary of the results. In: Physiological Activity of Benzoic Acid and Sodium Benzoate, V. Gerlach, Ed. Verlag von Heinrich Staadt, Wiesbaden. p.\ 90 92. ( Cited in Informatics, Inc., 1972)

HSDB 2003. Hazardous Substances Database in http:// www. toxnet. nlm. nih. gov Ignat'ev, A. D. 1965. Experimental information contributing to a hygienic characterization of the combined effect produced by some food presentations. Vop. Pitan. 24( 3): 61 68. ( Cited in Informatics, Inc., 1972)

Litton Bionetics, Inc. 1974. Mutagenic Evaluation of Compound FDA 71 37, Sodium Benzoate. Report No. LBI 2446 297, FDA, Washington, DC, PB 245 453/ 6.

Litton Bionetics, Inc. 1975. Mutagenic Evaluation of Compound FDA 73 70, Benzoic Acid Certified A. C. S. Report No. LBI 2468 376; FDABF GRAS 376 PB 245 500/ 4.

McCall. McCall, P. J., D. A. Laskowski, R. L. Swann, H. J. Dishburger, " Measurements of Sorption Coefficients of Organic Chemicals on their use in Environmental Fate Analysis, Agricultural Products Department, Dow AgroChemicals USA, Midland, MI. P104 ( 89 109).

McCann, J., E. Choi, E. Yamasaki and B. N. Ames. 1975. Detection of carcinogens as mutagens in the Salmonella/ microsome test: Assay of 300 chemicals. Proc. Natl. Acad. Sci. 72: 5135 5139.

Mylan, W. and P. Howard, 1998. ECOSAR Class Program, Version 0.99d. Syracuse Research Corporation, Syracuse, N. Y. For: U. S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, Washington, D. C.

Oikawa, A., H. Tohda, M. Kanai, M. Miwa and T. Sugimura. 1980. Inhibitors of poly( adenosine diphosphate ribose) induced sister chromatid exchanges. Biochem. Biophys. Res. Commun. 97( 4): 1311 1316.

Shtenberg, A. J. and A. D. Ignat'ev. 1970. Toxicological evaluation of some combinations of food preservatives. Food Cosmet. Toxicol. 8( 4): 369 380.

SIAR 2003. SIDS Initial Assessment Report. Benzoates Category. Pp1 34. ( MRID 46107301, 46107501, 46107401, and 46107201) Page 17 of 17 USP DI 1992. US Pharmacopeia Dispensing Information; Drug Information for the Health Care Professional 12th ed, V. I p. 2475.

U. S. EPA. 1987. Health and Environmental Effects Document for Benzoic Acid. Prepared by the Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office, Cincinnati, OH for the Office of Solid Waste and Emergency Response, Washington, DC.

U. S. EPA IRIS 2003. U. S. Environmental Protection Agency's Integrated Risk Information System ( IRIS) on Benzoic Acid ( 65 85 0). Available from: http:// www. epa. gov/ ngispgm3/ iris/ index. html WHO 1997. World Health Organization. Technical Report Series 868. Evaluation of Certain Food Additives and Contaminants. Forty sixth report of the Joint FAO/ WHO Expert Committee on Food Additives ( JECFA). Geneva. ( 1997)

Wiley, H. M. and W. D. Bigelow. 1908. Influence of benzoic acid and benzoates on digestion and health. Bulletin 84, pt. IV, Bureau of Chemistry, U. S. Dept. Agriculture. ( Cited in Informatics, Inc., 1972)


[Federal Register Volume 81, Number 188 (Wednesday, September 28, 2016)]
[Notices]
[Pages 66722-66724]
[FR Doc No: 2016-23359]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2016-0029]

Qualification of Drivers; Exemption Applications; Vision

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 23 individuals from the
vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs). They are unable to meet the vision requirement in one eye for
various reasons. The exemptions will enable these individuals to
operate commercial motor vehicles (CMVs) in interstate commerce without
meeting the prescribed vision requirement in one eye. The Agency has
concluded that granting these exemptions will provide a level of safety
that is equivalent to or greater than the level of safety maintained
without the exemptions for these CMV drivers.

DATES: The exemptions were granted July 29, 2016. The exemptions expire
on July 29, 2018.

FOR FURTHER INFORMATION CONTACT: Christine A. Hydock, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-113,
Washington, DC 20590-0001. Office hours are 8:30 a.m. to 5 p.m., e.t.,
Monday through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Docket
Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On June 28, 2016, FMCSA published a notice of receipt of exemption
applications from certain individuals, and requested comments from the
public (81 FR 42054). That notice listed 23 applicants' case histories.
The 23 individuals applied for exemptions from the vision requirement
in 49 CFR 391.41(b)(10), for drivers who operate CMVs in interstate
commerce.
    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for a 2-year period if it finds ``such exemption would likely achieve a
level of safety that is equivalent to or greater than the level that
would be achieved absent such exemption.'' The statute also allows the
Agency to renew exemptions at the end of the 2-year period.
Accordingly, FMCSA has evaluated the 23 applications on their merits
and

made a determination to grant exemptions to each of them.

III. Vision and Driving Experience of the Applicants

    The vision requirement in the FMCSRs provides:
    A person is physically qualified to drive a commercial motor
vehicle if that person has distant visual acuity of at least 20/40
(Snellen) in each eye without corrective lenses or visual acuity
separately corrected to 20/40 (Snellen) or better with corrective
lenses, distant binocular acuity of a least 20/40 (Snellen) in both
eyes with or without corrective lenses, field of vision of at least
70[deg] in the horizontal meridian in each eye, and the ability to
recognize the colors of traffic signals and devices showing red, green,
and amber (49 CFR 391.41(b)(10)).
    FMCSA recognizes that some drivers do not meet the vision
requirement but have adapted their driving to accommodate their
limitation and demonstrated their ability to drive safely. The 23
exemption applicants listed in this notice are in this category. They
are unable to meet the vision requirement in one eye for various
reasons, including amblyopia, aphakia, central chorioretinitis,
complete loss of vision, glaucoma, macular hole, macular pigment
epithelial detachment, macular scar, ocular histoplasmosis, optic nerve
hypoplasia, prosthetic eye, and refractive amblyopia. In most cases,
their eye conditions were not recently developed. Thirteen of the
applicants were either born with their vision impairments or have had
them since childhood.
    The 10 individuals that sustained their vision conditions as adults
have had them for a range of 5 to 40 years.
    Although each applicant has one eye which does not meet the vision
requirement in 49 CFR 391.41(b)(10), each has at least 20/40 corrected
vision in the other eye, and in a doctor's opinion, has sufficient
vision to perform all the tasks necessary to operate a CMV. Doctors'
opinions are supported by the applicants' possession of valid
commercial driver's licenses (CDLs) or non-CDLs to operate CMVs. Before
issuing CDLs, States subject drivers to knowledge and skills tests
designed to evaluate their qualifications to operate a CMV.
    All of these applicants satisfied the testing requirements for
their State of residence. By meeting State licensing requirements, the
applicants demonstrated their ability to operate a CMV, with their
limited vision, to the satisfaction of the State.
    While possessing a valid CDL or non-CDL, these 23 drivers have been
authorized to drive a CMV in intrastate commerce, even though their
vision disqualified them from driving in interstate commerce. They have
driven CMVs with their limited vision in careers ranging for 1.5 to 53
years. In the past three years, two drivers were involved in crashes
and no drivers were convicted of moving violations in a CMV.
    The qualifications, experience, and medical condition of each
applicant were stated and discussed in detail in the June 28, 2016,
notice (81 FR 42054).

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the vision requirement in 49 CFR 391.41(b)(10) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. Without the exemption, applicants
will continue to be restricted to intrastate driving. With the
exemption, applicants can drive in interstate commerce. Thus, our
analysis focuses on whether an equal or greater level of safety is
likely to be achieved by permitting each of these drivers to drive in
interstate commerce as opposed to restricting him or her to driving in
intrastate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered the medical reports about the applicants' vision as well as
their driving records and experience with the vision deficiency.
    To qualify for an exemption from the vision requirement, FMCSA
requires a person to present verifiable evidence that he/she has driven
a commercial vehicle safely with the vision deficiency for the past 3
years. Recent driving performance is especially important in evaluating
future safety, according to several research studies designed to
correlate past and future driving performance. Results of these studies
support the principle that the best predictor of future performance by
a driver is his/her past record of crashes and traffic violations.
Copies of the studies may be found at Docket Number FMCSA-1998-3637.
    FMCSA believes it can properly apply the principle to monocular
drivers, because data from the Federal Highway Administration's (FHWA)
former waiver study program clearly demonstrate the driving performance
of experienced monocular drivers in the program is better than that of
all CMV drivers collectively (See 61 FR 13338, 13345, March 26, 1996).
The fact that experienced monocular drivers demonstrated safe driving
records in the waiver program supports a conclusion that other
monocular drivers, meeting the same qualifying conditions as those
required by the waiver program, are also likely to have adapted to
their vision deficiency and will continue to operate safely.
    The first major research correlating past and future performance
was done in England by Greenwood and Yule in 1920. Subsequent studies,
building on that model, concluded that crash rates for the same
individual exposed to certain risks for two different time periods vary
only slightly (See Bates and Neyman, University of California
Publications in Statistics, April 1952). Other studies demonstrated
theories of predicting crash proneness from crash history coupled with
other factors. These factors--such as age, sex, geographic location,
mileage driven and conviction history--are used every day by insurance
companies and motor vehicle bureaus to predict the probability of an
individual experiencing future crashes (See Weber, Donald C.,
``Accident Rate Potential: An Application of Multiple Regression
Analysis of a Poisson Process,'' Journal of American Statistical
Association, June 1971). A 1964 California Driver Record Study prepared
by the California Department of Motor Vehicles concluded that the best
overall crash predictor for both concurrent and nonconcurrent events is
the number of single convictions. This study used 3 consecutive years
of data, comparing the experiences of drivers in the first 2 years with
their experiences in the final year.
    Applying principles from these studies to the past 3-year record of
the 23 applicants, two drivers were involved in crashes and no drivers
were convicted of moving violations in a CMV. All the applicants
achieved a record of safety while driving with their vision impairment,
demonstrating the likelihood that they have adapted their driving
skills to accommodate their condition. As the applicants' ample driving
histories with their vision deficiencies are good predictors of future
performance, FMCSA concludes their ability to drive safely can be
projected into the future.
    We believe that the applicants' intrastate driving experience and
history provide an adequate basis for predicting their ability to drive
safely in interstate commerce. Intrastate driving, like interstate
operations, involves substantial driving on highways on the interstate
system and on other roads built to interstate standards. Moreover,
driving in congested urban areas exposes the driver to more pedestrian

and vehicular traffic than exists on interstate highways. Faster
reaction to traffic and traffic signals is generally required because
distances between them are more compact. These conditions tax visual
capacity and driver response just as intensely as interstate driving
conditions. The veteran drivers in this proceeding have operated CMVs
safely under those conditions for at least 3 years, most for much
longer. Their experience and driving records lead us to believe that
each applicant is capable of operating in interstate commerce as safely
as he/she has been performing in intrastate commerce. Consequently,
FMCSA finds that exempting these applicants from the vision requirement
in 49 CFR 391.41(b)(10) is likely to achieve a level of safety equal to
that existing without the exemption. For this reason, the Agency is
granting the exemptions for the 2-year period allowed by 49 U.S.C.
31136(e) and 31315 to the 23 applicants listed in the notice of June
28, 2016 (81 FR 42054.
    We recognize that the vision of an applicant may change and affect
his/her ability to operate a CMV as safely as in the past. As a
condition of the exemption, therefore, FMCSA will impose requirements
on the 23 individuals consistent with the grandfathering provisions
applied to drivers who participated in the Agency's vision waiver
program.
    Those requirements are found at 49 CFR 391.64(b) and include the
following: (1) That each individual be physically examined every year
(a) by an ophthalmologist or optometrist who attests that the vision in
the better eye continues to meet the requirement in 49 CFR
391.41(b)(10) and (b) by a medical examiner who attests that the
individual is otherwise physically qualified under 49 CFR 391.41; (2)
that each individual provide a copy of the ophthalmologist's or
optometrist's report to the medical examiner at the time of the annual
medical examination; and (3) that each individual provide a copy of the
annual medical certification to the employer for retention in the
driver's qualification file, or keep a copy in his/her driver's
qualification file if he/she is self-employed. The driver must have a
copy of the certification when driving, for presentation to a duly
authorized Federal, State, or local enforcement official.

V. Discussion of Comments

    FMCSA received 2 comments in this proceeding. Deb Carlson states
that the state of Minnesota is in favor of granting David L. Evers the
exemption. The other comment submitted was not related to this notice.

IV. Conclusion

    Based upon its evaluation of the 23 exemption applications, FMCSA
exempts the following drivers from the vision requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above (49 CFR
391.64(b)):

Patrick R. Beallis (IL)
Gary A. Brown (PA)
Dudley G. Diebold (CT)
David L. Evers (MN)
John M. Harris (MS)
Raymond E. Hogue (PA)
Michael E. Jones (IL)
Robert L. Jones (FL)
Richard A. Kolodziejczyk (CT)
Dean A. Lardieri (NJ)
Darius R. Law (FL)
Robert C. Martin (WA)
Mark W. Mc Taggart (IL)
Hobie S. Morse (AR)
Noel Munoz (NM)
Frank C. Newberry (ID)
Peter J. O'Connell (PA)
James M. Paul (AL)
Ivan Romero (IL)
Richard M. Rosales (NM)
Jeffrey L. Tanner (WY)
Steve A. Taylor (NC)
Donald P. Winters (VA)
    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for 2 years unless revoked earlier by FMCSA. The
exemption will be revoked if: (1) The person fails to comply with the
terms and conditions of the exemption; (2) the exemption has resulted
in a lower level of safety than was maintained before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136 and 31315.
    If the exemption is still effective at the end of the 2-year
period, the person may apply to FMCSA for a renewal under procedures in
effect at that time.

    Issued on: September 15, 2016.
 Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2016-23359 Filed 9-27-16; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Notices]
[Page 14716]
[FR Doc No: 2017-05702]

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 ENVIRONMENTAL PROTECTION AGENCY

[FRL-9960-06-OA]

Notification of Two Public Teleconferences of the Science
Advisory Board Chemical Assessment Advisory Committee Augmented for the
Review of EPA's Draft Hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX)
Assessment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA or Agency) Science
Advisory Board (SAB) Staff Office announces two public teleconferences
of the SAB Chemical Assessment Advisory Committee Augmented for the
Review of the Draft Hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX)
Assessment (CAAC-RDX Panel) to peer review EPA's draft Integrated Risk
Information System (IRIS) Toxicological Review of Hexahydro-1,3,5-
trinitro-1,3,5-triazine (RDX) (External Review Draft--September 2016).

DATES: The public teleconferences will be held on Thursday April 13,
2017, and Monday April 17, 2017. The teleconferences will be held from
1:00 p.m. to 5:00 p.m. (Eastern Time) on both days.

ADDRESSES: Location: The public teleconference will be conducted by
telephone only.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing
further information concerning the teleconferences may contact Dr.
Diana Wong, Designated Federal Officer (DFO), SAB Staff Office, by
telephone at<PHONE_NUMBER>; or at<EMAIL_ADDRESS>General
information concerning the EPA Science Advisory Board can be found at
the EPA SAB Web site at http://www.epa.gov/sab.

SUPPLEMENTARY INFORMATION:
    Background: The SAB was established pursuant to the Environmental
Research, Development, and Demonstration Authorization Act (ERDAA)
codified at 42 U.S.C. 4365, to provide independent scientific and
technical advice to the Administrator on the technical basis for Agency
positions and regulations. The SAB is a Federal Advisory Committee
chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C.,
App. 2. The SAB will comply with the provisions of FACA and all
appropriate SAB Staff Office procedural policies. Pursuant to FACA and
EPA policy, notice is hereby given that the SAB CAAC--RDX Panel will
hold two public teleconferences to discuss its draft report regarding
the draft IRIS Toxicological Review of Hexahydro-1,3,5-trinitro-1,3,5-
triazine (External Review Draft--September 2016). The Panel will
provide advice to the Administrator through the chartered SAB regarding
this IRIS assessment.
    The SAB CAAC--RDX Panel held a public meeting on December 12-14,
2016. The purpose of that meeting was to develop responses to the peer
review charge on the agency's draft IRIS Toxicological Review of
Hexahydro-1,3,5-trinitro-1,3,5-triazine (External Review Draft--
September 2016). The purpose of these public teleconferences is for the
Panel to discuss these responses and draft report. The two public
teleconferences will be conducted as one complete meeting, beginning on
April 13, 2017, and if necessary, will continue on April 17, 2017.
    Availability of Meeting Materials: Additional background on this
SAB activity, the teleconference agenda, draft report, and other
materials for the teleconferences will be posted on the SAB Web site at
http://yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/IRIS%20RDX?OpenDocument.
    Procedures for Providing Public Input: Public comment for
consideration by EPA's federal advisory committees and panels has a
different purpose from public comment provided to EPA program offices.
Therefore, the process for submitting comments to a federal advisory
committee is different from the process used to submit comments to an
EPA program office. Federal advisory committees and panels, including
scientific advisory committees, provide independent advice to the EPA.
Members of the public can submit relevant comments pertaining to the
meeting materials or the group conducting this SAB activity. Input from
the public to the SAB will have the most impact if it consists of
comments that provide specific scientific or technical information or
analysis for SAB committees and panels to consider or if it relates to
the clarity or accuracy of the technical information. Members of the
public wishing to provide comment should contact the DFO directly.
    Oral Statements: In general, individuals or groups requesting an
oral presentation on a public teleconference will be limited to three
minutes per speaker. Interested parties wishing to provide comments
should contact Dr. Diana Wong, DFO (preferably via email), at the
contact information noted above, by April 6, 2017, to be placed on the
list of public speakers for the teleconference.
    Written Statements: Written statements will be accepted throughout
the advisory process; however, for timely consideration by Panel
members, statements should be should be supplied to the DFO (preferably
via email) at the contact information noted above by April 6, 2017. It
is the SAB Staff Office general policy to post written comments on the
Web page for the advisory meeting or teleconference. Submitters are
requested to provide an unsigned version of each document because the
SAB Staff Office does not publish documents with signatures on its Web
sites. Members of the public should be aware that their personal
contact information, if included in any written comments, may be posted
to the SAB Web site. Copyrighted material will not be posted without
explicit permission of the copyright holder.
    Accessibility: For information on access or services for
individuals with disabilities, please contact Dr. Diana Wong at (202)
564-2049 or<EMAIL_ADDRESS>To request accommodation of a
disability, please contact Dr. Wong preferably at least ten days prior
to the teleconferences, to give EPA as much time as possible to process
your request.

    Dated: March 8, 2017.
Khanna Johnston,
Acting Deputy Director, EPA Science Advisory Board Staff Office.
[FR Doc. 2017-05702 Filed 3-21-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Notices]
[Page 28411]
[FR Doc No: 2012-11701]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

Adrenalina, Affinity Technology Group, Inc., Braintech, Inc.,
Builders Transport, Incorporated, and Catuity, Inc.; Order of
Suspension of Trading

May 10, 2012.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Adrenalina because it has not filed any periodic reports since the
period ended September 30, 2008.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Affinity Technology Group, Inc. because it has not filed any periodic
reports since the period ended June 30, 2008.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Braintech, Inc. because it has not filed any periodic reports since the
period ended September 30, 2009.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Builders Transport, Incorporated because it has not filed any periodic
reports since the period ended March 31, 1998.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Catuity, Inc. because it has not filed any periodic reports since the
period ended March 31, 2007.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed companies is suspended
for the period from 9:30 a.m. EDT on May 10, 2012, through 11:59 p.m.
EDT on May 23, 2012.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2012-11701 Filed 5-10-12; 4:15 pm]
BILLING CODE 8011-01-P