[Federal Register Volume 64, Number 169 (Wednesday, September 1, 1999)]
[Notices]
[Pages 47791-47795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22747]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-881; FRL-6090-8]


Ecolab Inc.; Notice of Filing a Pesticide Petition to Establish a 
Tolerance for Certain Pesticide Chemicals in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of 
certain pesticide chemicals in or on various food commodities.

DATES: Comments, identified by docket control number PF-881, must be 
received on or before October 1, 1999.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION'' section. To 
ensure proper receipt by EPA, it is imperative that you identify docket 
control number PF-881 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Amelia M. Acierto, 
Registration Support Branch, Registration Division (7505W), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460; telephone number: (703) 308-8375; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                               Examples of potentially
 Categories              NAICS                    affected entities
------------------------------------------------------------------------
   Industry  111                            Crop production
             112                            Animal production
             311                            Food manufacturing
             32532                          Pesticide manufacturing
------------------------------------------------------------------------


    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically.. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-881. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to

[[Page 47792]]

this action, including any information claimed as confidential business 
information (CBI). This official record includes the documents that are 
physically located in the docket, as well as the documents that are 
referenced in those documents. The public version of the official 
record does not include any information claimed as CBI. The public 
version of the official record, which includes printed, paper versions 
of any electronic comments submitted during an applicable comment 
period, is available for inspection in the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2 (CM #2), 1921 
Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The PIRIB telephone 
number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-881 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, CM #2, 1921 Jefferson Davis 
Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The PIRIB telephone 
number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
E-mail to: ``[email protected],'' or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 5.1/
6.1 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-881. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

     EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of certain 
pesticide chemicals in or on various food commodities under section 408 
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data supports granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: August 23, 1999.

James Jones,
Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

1. PP 9E5081

Summary of Petitions

    EPA has received a pesticide petition (PP 9E5081) from Ecolab Inc., 
370 N. Wabasha Street, St. Paul, MN 55102 proposing, pursuant to 
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from 
the requirement of a tolerance for hydroxyethylidene-1,1-diphosphonic 
acid (HEDP) in or on the raw agricultural commodities, in processed 
commodities, and in or on meat and meat byproducts of cattle, sheep, 
hogs, goats, horses, and poultry, milk, and dairy products, eggs, 
seafood and shellfish, and fruit and fruits and vegetables when such 
residues result from the use of HEDP as a component of a food contact 
surface sanitizing solution up to 34 parts per million (ppm) for use in 
food handling establishments. EPA has determined that the petition 
contains data or information regarding the elements set forth in 
section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated 
the sufficiency of the submitted data at this time or whether the data 
supports granting of the petition. Additional data may be needed before 
EPA rules on the petition.

A. Residue Chemistry

    1. Analytical method. Because Ecolab Inc. is petitioning for an 
exemption from the requirement of a tolerance, an enforcement method 
for HEDP is not needed.
    2. Magnitude of residues . The residues which transfer from the 
sanitized dish or utensil to food are not of toxicological 
significance.

B. Toxicological Profile

    1. Acute toxicity. This material has been reviewed by the EPA as an 
inert ingredient in antimicrobial pesticide

[[Page 47793]]

formulations used in or on raw agricultural commodities. The summary 
that follows is from the May 22, 1998 Federal Register Final Rule ((63 
FR 28253), (FRL-5790-1)). The rat acute oral lethal dose 
(LD)50 is 2,400 miligrams/kilograms (mg/kg).
    2. Genotoxicty. HEDP was reported to be non-mutagenic in a 
Salmonella/Mammalian microsome test or in a L5178Y TK mouse lymphoma 
cell point mutation assay, with and without mammalian microsomal 
activation.
    3. Reproductive and developmental toxicity. In a combined 2-
generation reproduction/developmental toxicity study, rats (22 rats/
sex/dose) were administered HEDP at doses of 0, 0.1, and 0.5% in the 
diet. The no obseverable adverse effect level (NOAEL) for developmental 
and reproductive findings was 50 mg/kg/day (0.1% in the diet) and the 
lowest observable adverse effect level (LOAEL) was 250 mg/kg/day (0.5% 
in the diet) based on reduced litter size in the first litter (F1a) and 
an increase in stillborn pups in the second litter (F1b). These effects 
occurred in the absence of maternal toxicity and were seen in both 
reproductive litters of the first generation. In a developmental 
toxicity study, rabbits were administered HEDP at doses of 0, 25, 50 
and 100 mg/kg/day, either incorporated into feed or by gavage with 
water. The NOAEL for both systemic and developmental effects was 50 mg/
kg/day and the LOAEL was 100 mg/kg/day by gavage based on decreased 
maternal weight gain/ food consumption and decreased fetal body 
weights.
    4. Subchronic toxicity. --i. Dogs. In a subchronic feeding study in 
beagle dogs (4 dogs/sex/dose), HEDP was administered via the diet at 0, 
1,881, 3,881, or 10,881 ppm for 90 days. The NOAEL was 10,881 ppm (250 
mg/kg/day).
    ii. Rats. In a subchronic feeding study in rats, Sprague-Dawley 
strain rats were fed HEDP at dietary concentrations of 0, 3,881, 10,881 
and 30,881 ppm for 90 days. The NOAEL was 10,881 ppm (approximately 500 
mg/kg/day) and the LOAEL was 30,881 ppm (approximately 1,500 mg/kg/day) 
based on decreased body weight decreased food consumption, slight 
anemia, and decreased heart, liver, and kidney weights.
    5. Chronic toxicity. Chronic exposure to HEDP is not expected to 
demonstrate any additional toxicity beyond what was noted in subchronic 
toxicity tests. Since this compound is not considered to be genotoxic 
and is not structurally similar to known carcinogens, it is not likely 
to be carcinogenic.
    6. Endocrine disruption. To the best of our knowledge, nothing in 
the literature suggests HEDP is an endocrine disruptor. HEDP does not 
act like hormones or inhibit hormonal activity.

C. Aggregate Exposure

    1. Dietary exposure. Acute: There are no acute toxicological 
concerns for HEDP, therefore, an acute dietary risk assessment is not 
required.
    i. Food. Chronic: Indirect using the worst case scenario of HEDP in 
a sanitizing solution at the maximum proposed level of 34 ppm, in a 
restaurant where all food consumed by an individual in a single day has 
contacted sanitized dishes and food preparation surfaces, and there is 
100% transference of the sanitizer from the surface to the food, the 
exposure would be 0.002 mg/kg/day for a 70 kg person (adult) and 0.0025 
mg/kg/day for a 28 kg person (child). Chronic: Direct Antimicrobial 
fruit and vegetable wash exposure calculated to be 0.88104 mg/kg/day 
for a 70 kg person and 0.8811 mg/kg/day for a 28 kg person (see Federal 
Register May 22, 1998 (63 FR 28253)).
    ii. Drinking water. Acute: Since there are no acute toxicological 
concerns for HEDP, an acute drinking water risk assessment should not 
be required. Chronic: Not expected to exceed 0.8817 mg/kg/day for 
adults and 0.0025 mg/kg/day for children (see Federal Register May 22, 
1998 (63 FR 28253)).
    2. Non-dietary exposure. Acute: Since there are no acute 
toxicological concerns for HEDP, an acute non-dietary risk assessment 
should not be required. Chronic: Not expected to exceed 0.0049 mg/kg/
day for adults and 0.0204 mg/kg/day for children (see Federal Register 
May 22, 1998 (63 FR 28253)).

D. Cumulative Effects

    Chronic drinking water: Not to exceed 0.8817 mg/kg/day adults and 
0.0025 mg/kg/day children (see Federal Register May 22, 1998 (63 FR 
28253)). Chronic dietary: Previous clearance as a component of an 
antimicrobial formulation for use on fruit and vegetables resulted in 
an overestimation of 0.88104 mg/kg/day for adults and 0.8811 mg/kg/day 
for children (see Federal Register May 22, 1998 (63 FR 28253)). The 
proposed use as a component of a food contact surface sanitizer is not 
to exceed 0.002 mg/kg/day for adults and 0.0025 mg/kg/day for children. 
Non-dietary exposure: Not to exceed 0.0049 mg/kg/day for adults and 
0.0204 mg/kg/day children.

E. Safety Determination

    1. U.S. population. Using the extremely conservative exposure 
assumptions described above, the aggregate exposure to HEDP from all 
uses, including the proposed use will not exceed 0.0076 mg/kg/day for 
adults and 0.0255 mg/kg/day for children.
    2. Infants and children. Nothing in the available literature 
indicates that infants or children are more sensitive to the effects of 
this compound. Exposure of this inert ingredient (from the use proposed 
in this petition) should not pose a health risk to the U.S. population 
subgroup of infants and children.

F. International Tolerances

    No Codex maximum residue levels have been established for HEDP.

2. PP 9E5086

Summary of Petition

    EPA has received a pesticide petition (PP 9E5086) from Ecolab Inc., 
370 N. Wabasha Street, St. Paul, MM 55102 proposing, pursuant to 
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from 
the requirement of a tolerance for acetic acid in or on the raw 
agricultural commodities, in processed commodities, and in or on meat 
and meat byproducts of cattle, sheep, hogs, goats, horses, and poultry, 
milk, and dairy products, eggs, seafood and shellfish, and fruit and 
fruits and vegetables when such residues result from the use of acetic 
acid as a component of a food contact surface sanitizing solution for 
use in food handling establishments. The request is for an unlimited 
clearance. EPA has determined that the petition contains data or 
information regarding the elements set forth in section 408(d)(2) of 
the FFDCA; however, EPA has not fully evaluated the sufficiency of the 
submitted data at this time or whether the data supports granting of 
the petition. Additional data may be needed before EPA rules on the 
petition.

A. Residue Chemistry

    1. Analytical method. Because Ecolab Inc. is petitioning for an 
exemption from the requirement of a tolerance, an enforcement method 
for acetic acid is not needed.
    2. Magnitude of residues. The residues which transfer from the 
sanitized dish or utensil to food are not of toxicological 
significance.

B. Toxicological Profile

    1. Acute toxicity. Acetic acid is a direct food additive. It is 
considered

[[Page 47794]]

generally recognized as safe by the Food and Drug Administration and is 
a normal constituent in the human diet. Acetic acid is allowed under 40 
CFR 180.1001(c) as an inert ingredient in pesticide formulation applied 
to growing crops or to raw agricultural commodities after harvest 
without limit in the formula. Acute oral lethel dose (LD50) 
(rat): 3310 3530 milligrams/kilograms (mg/kg); Acute oral 
LD50 (mouse): 4960 mg/kg; Inhalation LC50 
(mouse): 5620 parts per million (ppm)/l hour(s); Dermal LD50 
(rabbit): 1060 mg/kg.
    2. Genotoxicty. Nothing in the available literature indicates that 
acetic acid is a genotoxic or mutagenic compound. It is generally 
recognized as safe and is a normal constituent in the human diet.
    3. Reproductive and developmental toxicity. Nothing in the 
available literature indicates that acetic acid is a developmental or 
reproductive toxin. It is generally recognized as safe and is a normal 
constituent in the human diet.
    4. Subchronic toxicity. Nothing in the available literature 
indicates long term exposure to acetic acid produces any adverse 
toxicological effects unless it is ingested at a concentration where it 
produces corrosive or other effects on the gastric mucosa. There are no 
studies indicating that prolonged exposure to acetic acid produces 
cumulative toxicity since acetic acid is a normal constituent of 
cellular metabolism. Acetic acid is a catabolic breakdown product of 
fatty endogenous acid metabolism and is also used in the synthesis of 
lipids. Estimated daily intakes of acetic acid/acetate ion are in the 
range of 2 grams per day for an adult. As a normal constituent of the 
human diet, there are no toxicological concerns with acetic acid.
    5. Chronic toxicity. Chronic exposure would not produce any 
additional effect beyond what is noted in subchronic exposure, 
therefore, no additional concerns are warranted. Nothing in the 
literature indicates that acetic acid may be carcinogenic.
    6. Animal metabolism. Acetic acid and its derivatives are used in 
the metabolism fatty acids. It is a normal constituent of mammalian 
metabolism, therefore, a discussion of acetic acid metabolites is not 
relevant.
    7. Metabolite toxicology. ``Metabolites'' of acetic acid are used 
in several processes of cellular metabolism. These metabolites are 
normal constituents of the cell, therefore a discussion of metabolite 
toxicity of acetic acid is not relevant.
    8. Endocrine disruption. Acetic acid does not act like hormones or 
inhibit hormonal activity. It is not strucurally related to any known 
endocrine disruptor. Nothing in the literature suggests that it is an 
endocrine disruptor or possesses intrinsic hormonal activity.

C. Aggregate Exposure

    1. Dietary exposure. Acute: There are no acute toxicological 
concerns for acetic acid, an acute dietary risk assessment is not 
required. Chronic Indirect: Using a worst-case scenario, the additional 
exposure from food contact surface sanitizers would be 0.03 mg/kg/day 
for a 70 kg person (adult) and 0.04 mg/kg/day for a 28 kg person 
(child).
    i. Food. Chronic Direct: A typical adult ingests approximately 2 
grams (2000 mg) of acetic acid/acetate per day via the diet. The 
incremental increase in exposure as a result of the use in food contact 
surface sanitizing solutions is negligible.
    ii. Drinking water. Acute: Since there are no acute toxicological 
concerns for acetic acid, an acute drinking water risk assessment 
should not be required. Chronic: There is no concern about the 
potential for transfer of acetic acid residues to human drinking water. 
It is essentially impossible that residues from the proposed use will 
transfer acetic acid residues to any sources of human drinking water.
    2. Non-dietary exposure. The potential for significant additional 
non-occupational exposure under the use proposed to the general 
population (including children) is unlikely.

D. Cumulative Effects

    Well over 99% of the exposure to acetic acid will be via the diet. 
Most of this exposure will be through ingestion of ``vinegar'' in the 
diet. Small amounts of acetic acid exposure will be the result of non-
food uses. The amount of acetic acid exposure resulting from indirect 
exposure to sanitizing solutions will be virtually zero. Since acetic 
acid in the diet poses no toxicological risk, the cumulative toxicity 
resulting from this additional exposure is negligible.

E. Safety Determination

    1. U.S. population. Since there are not adverse toxicological 
effects resulting from normal dietary concentrations of acetic acid, 
there is no need to determine aggregate risks, or to conduct a safety 
determination. Acetic acid is generally recognized as safe and the 
incremental exposure due to its us as an inert in a food contact 
surface sanitizer is negligible.
    2. Infants and children. As in adults, infants and children use 
acetic acid as a basic constituent of cellular metabolism. Children are 
at no greater ``risk'' from exposure to acetic acid. Therefore, as with 
adults, a safety determination is not appropriate.

F. International Tolerances

     No Codex maximum residue levels have been established for acetic 
acid.

3. PP 9E6014

Summary of Petition

    EPA has received a pesticide petition (PP 9E6014) from Ecolab Inc., 
370 N. Wabasha Street, St. Paul, MN 55120 proposing, pursuant to 
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from 
the requirement of a tolerance for residues of phosphoric acid in or on 
raw agricultural commodities, in processed commodities, and in or on 
meat and meat byproducts of cattle, sheep, hogs, goats, horses, and 
poultry, milk, and dairy products, eggs, seafood and shellfish, and 
fruit and fruits and vegetables when such residues result from the use 
of phosphoric acid as a component of a food contact surface sanitizing 
solution for use in food handling establishments. The request is for an 
unlimited clearance. EPA has determined that the petition contains data 
or information regarding the elements set forth in section 408(d)(2) of 
the FFDCA; however, EPA has not fully evaluated the sufficiency of the 
submitted data at this time or whether the data supports granting of 
the petition. Additional data may be needed before EPA rules on the 
petition.

A. Residue Chemistry

    1. Analytical method. Because Ecolab Inc. is petitioning for an 
exemption from the requirement of a tolerance, an enforcement method 
for phosphoric acid is not needed.
    2. Magnitude of residues. The residues which transfer from the 
sanitized dish or utensil to food are not of toxicological 
significance.

B. Toxicological Profile

    1. Acute toxicity. Phosphoric acid is a direct food additive. It is 
considered generally recognized as safe by the Food and Drug 
Administration and is a normal constituent in the human diet. 
Phosphoric acid is allowed under 40 CFR 180.1001(c) as an inert 
ingredient in pesticide formulation applied to growing crops or to raw 
agricultural commodities after harvest without limit in the formula. 
From the Reregistration Eligibility Decision (RED) document for Mineral 
Acids: Acute oral lethal dose

[[Page 47795]]

(LD50): 1530 milligrams/kilograms (mg/kg); Dermal 
LD50: 2740 mg/kg.
    2. Genotoxicty. Nothing in the available literature indicates that 
phosphoric acid or phosphate ion are considered to be genotoxic or 
mutagenic.
    3. Reproductive and developmental toxicity. Nothing in the 
available literature indicates that phosphoric acid or phosphate ion 
are developmental or reproductive toxins. They are generally recognized 
as safe and are normal constituents in the human diet.
    4. Subchronic toxicity. Nothing in the available literature 
indicates long-term exposure of phosphoric acid/phosphate ion produces 
any adverse toxicological effects unless it is ingested at a 
concentration where it produces corrosive or other effects on the 
gastric mucosa. There are no studies that indicate that prolonged 
exposure to low concentrations of phosphoric acid/phosphate ion produce 
cumulative toxicity since they are normal constituents of cells.
    5. Chronic toxicity. Chronic exposure would not produce any 
additional effect over what is noted in subchronic exposure, therefore, 
no additional concerns are warranted. Nothing in the literature 
indicates that phosphoric acid may be carcinogenic.
    6. Animal metabolism. Phosphoric acid is a normal constituent of 
cells. It is used for many purposes including buffering of the blood, 
high energy bonds, DNA synthesis, etc. A discussion of the metabolism 
is not relevant.
    7. Metabolite toxicology. Phosphoric acid and phosphate are not 
metabolized by the body, but rather serve as major components in 
cellular structure and processes. A discussion of metabolite toxicity 
is not relevant.
    8. Endocrine disruption. A review of information from the Agency 
for Toxic Substances and Disease Registry indicates that potential 
endocrine effects from exposure to phosphoric acid or phosphate ion 
have not been studied. To the best of our knowledge, nothing in the 
available literature suggests that phosphoric acid acts as an endocrine 
disrupter or that it possesses intrinsic hormonal activity.

C. Aggregate Exposure

    1. Dietary exposure. Acute: There are no acute toxicological 
concerns for phosphoric acid, therefore, an acute dietary risk 
assessment is not required. Chronic Indirect: Using a worst-case 
scenario, the exposure would be 0.0065 mg/kg/day for a 70 kg person 
(adult) and 0.008 mg/kg/day for a 28 kg person (child).
    i. Food. Chronic Direct: A typical adult ingests approximately one 
to two grams of phosphoric acid/phosphate per day as phosphorus via the 
diet. Following ingestion, it is absorbed by the gastrointestinal 
tract. In the plasma and in intra and extracellular fluid, the pH is 
such that the phosphoric acid exists in its ionized form, phosphate. 
The approximate concentration of phosphate in the plasma is 4 mg/100 
milliliters (mls). Phosphate serves many biological purposes including 
buffering the blood, serving as a constituent of cell membranes, 
providing high energy phosphate bonds for cellular energy demands, 
maintaining DNA structure and many other functions. Phosphate is also a 
major constituent of the skeletal system. It is excreted in the urine 
and needs to be replenished on an ongoing basis. The normal human diet 
contains significant quantities of phosphate. Phosphate is also derived 
from phosphoric acid as a consequence of its direct addition to food, 
as approved under 21 CFR 582.1073. When used as a food contact surface 
sanitizer, the residue that would be introduced into food will be 
insignificant compared to the normal dietary intake of phosphoric acid/
phosphate ion. Based on this, there are no toxicological concerns 
resulting from exposures to residues of phosphoric acid resulting from 
the use of sanitizing solutions.
    ii. Drinking water. Acute: Since there are no acute toxicological 
concerns for phosphoric acid, an acute drinking water risk assessment 
should not be required. Chronic: There are no toxicological concerns 
about the exposure of low concentrations of phosphate ion in the 
drinking water. Although it is possible that trace amounts of 
phosphates used as a sanitizer may ultimately get into drinking water, 
no adverse health effects would result. The amount of ``naturally 
occurring phosphate'' in water will greatly exceed the amount derived 
from sanitizing solutions.
    2. Non-dietary exposure. The exposure phosphoric acid/phosphates in 
non-occupational settings is minimal. Phosphates may be present in some 
products including general purpose cleaners, soaps, etc. however, 
dermal absorption would be insignificant. Since phosphate is a 
relatively significant constituent of the diet, non-occupational 
exposure will be small by comparison.

D. Cumulative Effects

     Over 99% of the exposure to phosphoric acid/phosphates is expected 
to be via the diet. Small amounts of phosphoric acid/phosphate exposure 
will be the result of non-food uses. The amount of phosphoric acid/
phosphate exposure resulting from indirect exposure to sanitizing 
solutions will be virtually zero. Since phosphoric acid/phosphate in 
the diet poses no toxicological risk, the cumulative toxicity resulting 
from this additional exposure is negligible.

E. Safety Determination

    1. U.S. population. Since there are not adverse toxicological 
effects resulting from normal dietary concentrations of phosphoric 
acid/phosphate ion, there is no need to determine aggregate risks, or 
to conduct a safety determination. Phosphoric acid is generally 
recognized as safe and the incremental exposure due to its us as an 
inert in a food contact surface sanitizer is negligible.
    2. Infants and children. As in adults, infants and children use 
phosphoric acid as a basic constituent of cellular metabolism, energy 
production and cell structure. Children are at no greater ``risk'' from 
exposure to phosphoric acid. Therefore, as with adults, a safety 
determination is not appropriate.

F. International Tolerances

    No Codex maximum residue levels have been established for 
phosphoric acid.

[FR Doc. 99-22747 Filed 8-31-99; 8:45 am]
BILLING CODE 6560-50-F