[Federal Register Volume 70, Number 31 (Wednesday, February 16, 2005)]
[Rules and Regulations]
[Pages 7870-7876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2981]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0026; FRL-7697-9]


Syrups, Hydrolyzed Starch, Hydrogenated; Exemption from the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of syrups, hydrolyzed starch, hydrogenated 
(CAS Reg. No. 68425-17-2) when used as an inert ingredient in pesticide 
products. Grain Processing Corporation and SPI Polyols submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
as amended by the Food Quality Protection Act of 1996 (FQPA), 
requesting an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of syrups, hydrolyzed starch, hydrogenated.

DATES: This regulation is effective February 16, 2005. Objections and 
requests for hearings must be received on or before April 18, 2005.

ADDRESSES : To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit XI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a

[[Page 7871]]

docket for this action under docket identification (ID) number OPP-
2005-0026. All documents in the docket are listed in the EDOCKET index 
at http://www.epa.gov/edocket. Although listed in the index, some 
information is not publicly available, i.e., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available either electronically in EDOCKET or in hard 
copy at the Public Information and Records Integrity Branch (PIRIB), 
Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6304; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 32532)
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Electronic Documents and Other Related Information?

    In addition to using EDOCKET at http://www.epa.gov/edocket/, you 
may access this Federal Register document electronically through the 
EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 
CFR part 180 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

     In the Federal Register of October 23, 2002 (67 FR 65115) (FRL-
7276-8), EPA issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing 
the filing of a pesticide petition (PP 2E6503) by Grain Processing 
Corporation, 1600 Oregon St, Muscatine, Iowa 52761 and SPI Polyols, 321 
Cherry Lane, New Castle, Delaware 19720.
     The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of hydrogenated starch hydrolysate (CAS Reg. No. 68425-17-2). 
Hydrogenated starch hydrolysate is intended to be used as an inert 
ingredient in pesticide products. That notice included a summary of the 
petition prepared by the petitioner. One comment was submitted. The 
Agency's response to this comment is in Unit X.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of the FFDCA 
defines ``safe'' to mean that ``there is a reasonable certainty that no 
harm will result from aggregate exposure to the pesticide chemical 
residue, including all anticipated dietary exposures and all other 
exposures for which there is reliable information.'' This includes 
exposure through drinking water and in residential settings, but does 
not include occupational exposure. Section 408(b)(2)(C) of the FFDCA 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of the pesticide chemical. Second, EPA examines exposure to 
the pesticide through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Description of Syrups, Hydrolyzed Starch, Hydrogenated

    Syrups, hydrolyzed starch, hydrogenated (also known as hydrogenated 
starch hydrolyzate or HSH) is a generic term for various hydrogenated 
syrups. These are also known by the terms sugar alcohols, polyhydric 
alcohols, or polyols. According to the Food and Drug Administration 
(FDA), sugar alcohols are ``not technically considered artificial 
sweeteners, . . . are slightly lower in calories than sugar and do not 
promote tooth decay or cause a sudden increase in blood glucose. They 
include sorbitol, xylitol, lactitol, mannitol, and maltitol and are 
used mainly to sweeten sugar-free candies, cookies, and chewing gums.''
    Syrups, hydrolyzed starch, hydrogenated (CAS Reg. No. 68425-17-2) 
are typically prepared by hydrolyzing a starch (such as corn starch) 
and then hydrogenating the hydrolysis product. Starch is a polymer 
composed of repeating glucose units that are linked by glucosidic 
bonds. Hydrolysis is the process by which these bonds are broken. Given 
that starch is a complex polysaccharide, hydrolysis of a starch yields 
a complex mixture of various chemicals, that retain the basic 
configuration of saccharides, but can have different functional groups. 
This complex mixture is then hydrogenated. Both the starting material 
(the type of starch), and the method of hydrolysis (heat, acid and/or 
enzymatic) can impact the hydrolyzed starch product that would then be 
hydrogenated.
    Syrups, hydrolyzed starch, hydrogenated contain various amounts

[[Page 7872]]

of maltitol, sorbitol and higher order polyols or polysaccharides. 
Higher-order polyols can be considered to be somewhat polymerized. 
Syrups, hydrolyzed starch, hydrogenated do not contribute nutrition to 
the human diet, are often used in reduced-calorie products, and by many 
are considered useful in the diets of persons with diabetes.

V. Toxicological Profile

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action and considered its validity, completeness, and 
reliability and the relationship of this information to human risk. EPA 
has also considered available information concerning the variability of 
the sensitivities of major identifiable subgroups of consumers, 
including infants and children. The nature of the toxic effects caused 
by syrups, hydrolyzed starch, hydrogenated are discussed in this unit.

A. Review by JECFA

    The Joint Expert Committee on Food Additives (JECFA) is an 
international expert scientific committee that is administered jointly 
by the Food and Agriculture Organization of the United Nations (FAO) 
and the World Health Organization (WHO). In Food Additive Series 20, 
JECFA conducted a review of hydrogenated glucose syrups (see http://www.inchem.org/documents/jecfa/jecmono/v020je13.htm). JECFA defined 
these syrups as follows: ``Hydrogenated glucose syrups (HGS) are a 
mixture of polymers of glucose obtained from starch by hydrolysis 
which, upon hydrogenation, results in chemical reduction of the end-
group glucose molecule to sorbitol. HGS consists primarily of maltitol 
and sorbitol, with lower portions of hydrogenated oligo- and 
polysaccharides.'' The toxicity data base included metabolism studies; 
several mutagenicity studies; a multigeneration reproduction toxicity 
study; a developmental study; and various acute, short-term, and long-
term toxicity studies. JECFA's conclusions are extracted directly from 
that document:
     HGS or its major component maltitol produced significantly 
lower blood-glucose levels and more stable insulin levels than glucose 
or sucrose due to slow metabolism of maltitol.
     The results from the in vitro assays, with and without 
metabolic activation, suggest that HGS does not induce a mutagenic, 
clastogenic, genotoxic, or neoplastic transformation response. No in 
vivo clastogenic effects were observed.
     Acute and short-term animal studies indicate that HGS is 
not toxic after single or repeated oral administration of large doses. 
In rats, no evidence of toxic effects of prolonged feeding of up to 15-
20% of the diet was observed. A 90-day study in dogs showed no evidence 
of adverse effects, except for diarrhea, at a level of 4.95 grams/
kilogram body weight per day (g/kg bwt day).
     A multigeneration reproduction study in rats, in which HGS 
was administered in drinking water as an 18% aqueous solution, did not 
reveal any toxicologically significant effects.
    In humans, an effect of concern for all polyols is a laxative 
effect. Available information indicates that a laxative effect can 
occur at intake levels of 30-50 g/day.
    WHO/JECFA also reviewed an oral long-term toxicity/carcinogenic 
study in the rat conducted with a test substance that was approximately 
87% maltitol. No adverse effects were observed in the toxicity study. A 
slightly increased incidence of mammary gland adenocarcinomas was 
observed in female rats at the two highest dose levels. However, based 
on historical control data, these increases were not considered to be 
related to treatment (see http://www.inchem.org/documents/jecfa/jecmono/v32je08.htm).
    In 1998, JECFA conducted another review of Maltitol Syrup (see 
http://www.inchem.org/documents/jecfa/jecmono/v040je07.htm). This 
evaluation examined the metabolic fate of maltitol and higher-order 
polyols using both in vitro and in vivo studies. The results indicated 
that the higher-order polyols were readily hydrolyzed to glucose and 
maltitol. Glucose would be readily absorbed by the mammalian body; 
however, the rate of absorption is slower than that of directly 
ingested glucose. Maltitol would be further degraded through 
fermentation by intestinal flora. The amounts of maltitol that are 
absorbed are quickly excreted in the urine with little evidence of 
metabolism.
    JECFA's review of several animal toxicity studies indicated that no 
treatment-related toxicity was seen in rats or dogs fed a typical 
syrups, hydrolyzed starch, hydrogenated product at dose levels of 18 
and 43 g/kg bwt day, respectively, for 90 days.
    In 1999, JECFA conducted a review of the food additive polyglycitol 
syrup (see http://www.inchem.org/documents/jecfa/jecmono/v042je13.htm). 
In this review, JECFA stated that their previous evaluation of maltitol 
syrup was applicable to polyglycitol syrup. Maltitol syrup differs from 
polyglycitol syrup only in the relative proportions of sorbitol, 
maltitol and higher-order polyols. For this 1999 review, a short-term 
toxicity study in rats given material with a high-order polyol content 
of 78% was reviewed.
    Doses of a polyglycitol syrup, equal to 13 g/kg bwt per day, in the 
diets of rats for 13 weeks, ``was not associated with adverse effects. 
The only effects observed--increased weight of the empty caecum and 
increased urinary calcium excretion in the absence of elevated serum 
calcium--were considered to be the consequence of the accumulation of 
poorly absorbed material in the caecum and to be of no toxicological 
significance.''
    On the basis of the information reviewed at both the 1998 and the 
1999 meetings, JECFA allocated a group acceptable daily intake (ADI) of 
``not specified'' to materials conforming to the specifications for 
polyglycitol syrup and maltitol syrup. Thus, based on its review of the 
available data, polyglycitol syrups do not, in the opinion of JECFA, 
represent a hazard to health and the establishment of an acceptable 
daily intake (a specific limit on the average daily intake) expressed 
in numerical form is not needed.

B. Information Supplied by the Petitioner

    In an acute oral toxicity study, using a test substance described 
only as an hydrogenated starch hydrolyzate, the lethal dose 
(LD)50 was >2,500 mg/kg (Toxicity Category III).

C. Conclusion

    Syrups, hydrolyzed starch, hydrogenated is a generic term for a 
range of chemical substances that contain various sugar alcohols 
(sorbitol, maltitiol, and higher-order polyols) in varying proportions. 
WHO/JECFA has over a period of some years reviewed an extensive 
toxicity data base. The studies were conducted using similar mixtures 
of sugar alcohols. Generally, the studies did not reveal any 
toxicologically significant effects even at dose levels in the grams 
per kilogram body weight per day range. The human body has a 
demonstrated ability to metabolize this type of substance. The most 
noted effect in humans is a potential laxative effect.

VI. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA directs 
EPA to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including

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drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.

A. Dietary Exposure

    1. Food. To the best of the Agency's knowledge, products similar to 
syrups, hydrolyzed starch, hydrogenated have been used in food 
manufacture for approximately 20 years. In the food processing 
industry, these syrups are used as sweetening (flavoring) agents, 
humectants, texturizers, stabilizers, bulking agents and surface-
finishing agents. According to information on the internet, various 
syrups, hydrolyzed starch, hydrogenated products are used in the 
manufacture of sugar-free soft and hard candies, and chewing gum. The 
SPI Polyol website advocates for use of its products in hard candies at 
levels up to 40%.
    Given the widespread occurrence of all the various hydrogenated 
syrups or sugar alcohols in the existing food supply, the amount of 
syrups, hydrolyzed starch, hydrogenate in the food supply that could 
result from use in a pesticide product would not be expected to 
significantly increase the existing amounts in the food supply. The 
EPA-regulated uses as an inert ingredient in a pesticide product would 
be considerably less than all of the existing food additive non-
nutritive sweetener uses.
    2. Drinking water exposure. According to information on the 
internet, various syrups, hydrolyzed starch, hydrogenated products are 
soluble in water. It is expected that dissolving these chemicals in 
water would result in a thick syrupy solution depending on the percent 
of the syrups, hydrolyzed starch, hydrogenated in solution.
    The Agency has used a surrogate chemical, sorbitol, to model the 
behavior of syrups, hydrolyzed starch, hydrogenated in the environment. 
Degradation via chemical reactions without the participation of 
organisms, or abiotic degradation of these chemicals would not be 
expected to be an important fate process. Chemicals such as syrups, 
hydrolyzed starch, hydrogenated will tend to have very low sorption 
coefficients; thus, migration to ground water and surface water via 
dissolution in water is highly likely. Volatilization from water would 
be minimal. Biodegradation is expected to be rapid. Degradation will 
proceed to mineralization, the formation of carbon dioxide and water, 
in a matter of hours to days thus mitigating the likelihood of leaching 
and runoff in substantial quantities to sources of drinking water.

B. Other Non-Occupational Exposure

    Syrups, hydrolyzed starch, hydrogenated are also used in dental 
products since they do not contribute to tooth decay.

VII. Cumulative Effects

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance or tolerance 
exemption, the Agency consider ``available information'' concerning the 
cumulative effects of a particular chemical's residues and ``other 
substances that have a common mechanism of toxicity.''
    Unlike other pesticide chemicals 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 syrups, 
hydrolyzed starch, hydrogenated and any other substances, and syrups, 
hydrolyzed starch, hydrogenated does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that syrups, 
hydrolyzed starch, hydrogenated has a common mechanism of toxicity with 
other substances. For information regarding EPA's efforts to determine 
which chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the policy statements 
released by EPA's 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/.

VIII. Safety Factor for Infants and Children

    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the data base unless EPA concludes that a different 
margin of safety will be safe for infants and children. The JEFCA 
committee has evaluated a multigeneration reproductive toxicity study 
in rats in which HGS (hydrogenated glucose syrup), a substance very 
similar to syrups, hydrolyzed starch, hydrogenated was administered in 
drinking water as an 18% aqueous solution. JECFA's review and 
evaluation did not reveal any toxicologically significant effects, and 
found no indication of increased susceptibility. Based on the reviews 
and evaluations conducted by WHO/JECFA, EPA has not used a safety 
factor analysis to assess the risk of syrups, hydrolyzed starch, 
hydrogenated. For the same reasons the additional tenfold safety factor 
is unnecessary.

IX. Determination of Safety for U.S. Population and Infants and 
Children

    The JECFA Committee reviewed and evaluated over a period of some 
years toxicity studies performed on various sugar alcohol chemicals. As 
a result of their review and evaluation, JECFA determined an ADI 
(Acceptable Daily Intake) of ``not specified.'' The only concern was 
for the potential laxative effect at high intakes. Based on the 
available information, EPA finds that exempting syrups, hydrolyzed 
starch, hydrogenated (CAS Reg. No. 68425-17-2) from the requirement of 
a tolerance will be safe for the general population including infants 
and children.

X. Other Considerations

A. Endocrine Disruptors

    FQPA requires EPA to develop a screening program to determine 
whether certain substances, including all pesticide chemicals (both 
inert and active ingredients), ``may have an effect in humans that is 
similar to an effect produced by a naturally occurring estrogen, or 
such other endocrine effect. . . .'' EPA has been working with 
interested stakeholders to develop a screening and testing program as 
well as a priority setting scheme. As the Agency proceeds with 
implementation of this program, further testing of products containing 
syrups, hydrolyzed starch,

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hydrogenated for endocrine effects may be required.

B. Analytical Method(s)

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

C. Existing Exemptions

    There are no existing tolerances or tolerance exemptions for 
syrups, hydrolyzed starch, hydrogenated.

D. International Tolerances

    Various syrups, hydrolyzed starch, hydrogenated are used as food 
additives in several countries. The Agency is not aware of any country 
requiring a tolerance for syrups, hydrolyzed starch, hydrogenated nor 
have any CODEX Maximum Residue Levels (MRLs) been established for any 
food crops at this time.

E. List 4A (Minimal Risk) Classification

    The Agency established 40 CFR 180.950 (see the rationale in the 
proposed rule published January 15, 2002 (67 FR 1925) (FRL-6807-8)) to 
collect the tolerance exemptions for those substances classified as 
List 4A, i.e., minimal risk substances. As part of evaluating an inert 
ingredient and establishing the tolerance exemption, the Agency 
determines the chemical's list classification. The results of the 
reviews and evaluations performed by WHO/JECFA indicate a substance of 
lower toxicity. Therefore, syrups, hydrolyzed starch, hydrogenated (CAS 
Reg. No. 68425-17-2) is to be classified as a List 4A inert ingredient.

F. Public Comment

    One comment was received from the Corn Allergy Support Group 
requesting that the Agency not grant the tolerance exemption for 
syrups, hydrolyzed starch, hydrogenated. The commenter believes that 
syrups, hydrolyzed starch, hydrogenated can cause severe allergic 
reactions in those individuals who are allergic to corn. It is 
certainly possible for an individual to be allergic to any food. 
However, most food allergy experts agree that the most common food 
allergens are: Peanuts, tree nuts, milk, soybeans, eggs, fish, 
crustacea, and wheat. According to the Food Allergy and Anaphylaxis 
Network (see http://www.foodallergy.org/allergens.html) these eight 
allergens account for 90% of all food-allergic reactions.
    Generally, an allergic response occurs as a result of the body's 
reaction to protein. In 2001, the Agency evaluated in a White Paper the 
presence of protein in several of the processed foods derived from corn 
(see http://www.epa.gov/oscpmont/sap/2001/july/wetmilling.pdf). Corn 
can be milled by a dry milling or a wet milling process. The dry 
milling process produces flour, cornmeal, grits, corn bran and feed 
mixtures. The wet milling process uses a series of chemical reactions 
to produce corn syrup, corn oil and cornstarch. The steps that occur in 
the wet milling process are: Steeping, germ separation, fine grinding, 
starch separation, syrup conversion, and fermentation.
    Given that corn starch can be used as the starting material for 
syrups, hydrolyzed starch, hydrogenated, the following parts of the 
discussion of the starch separation process as extracted from the White 
Paper are relevant here: ``Mill starch is passed through a centrifuge 
which allows for the gluten to be spun out. . . . At this point, the 
starch has only approximately one to two percent of protein remaining. 
The starch is diluted 8 to 14 times, rediluted and washed again. . . to 
remove the last trace of protein and produce high quality starch 
(usually greater than 99.5% pure).'' The starch is then converted to 
corn syrup via various refinement steps that are similar to the heat, 
acid and/or enzymatic processes using in producing syrups, hydrolyzed 
starch, hydrogenated.
    Data in the White Paper demonstrate that while some very low levels 
of protein are present in the cornstarch, no detectable levels are 
present in corn syrup.

------------------------------------------------------------------------
  Fraction Derived from Corn Wet-Milling
                  Process                          Percent Protein
------------------------------------------------------------------------
Corn starch                                 0.3-0.35% (high amylose corn
                                             - up to 1%)
------------------------------------------------------------------------
Corn syrup (made from corn starch)          Not detectable
------------------------------------------------------------------------

    Given the similarities of the starting materials and the processes 
used, the Agency believes that the above data can be used to 
demonstrate the absence of protein in syrups, hydrolyzed starch, 
hydrogenated.
    In response to the comment received, Grain Processing Corporation, 
the petitioner, submitted an opinion paper prepared by Dr. Steve L. 
Taylor of the Food Allergy Research & Resource Program at the 
University of Nebraska. The opinion paper dated February 9, 2000, is 
titled, Allergenicity of Corn-Derived Maltodextrin and Corn Starch. The 
abstract of Dr. Taylor's opinion is as follows:
    No convincing evidence exists to support the existence of 
allergic reactions to corn-derived maltodextrin and corn starch. 
Corn, the primary source from which maltodextrins are derived, is 
rarely allergenic. The allergenicity of corn is likely due to 
specific protein allergens in corn, although these allergens have 
not been identified. Corn-derived maltodextrins and corn starch 
contain little, if any, protein. Reports of allergic reactions to 
corn-derived maltodextrins and corn starch in the medical literature 
are based upon controversial diagnostic approaches and/or anecdote. 
These reports have not been confirmed through double-blind, placebo-
controlled challenge trials. The few clinical studies that have been 
conducted on corn-allergic individuals using more rigorous clinical 
approaches have failed to document allergic reactions to corn 
starch, corn syrup, or corn-derived maltodextrins.

    Given the above data and an analysis of the information provided, 
EPA believes that there is a reasonable certainty that the tolerance 
exemption for syrups, hydrolyzed starch, hydrogenated would not 
contribute to allergic individuals' exposure to allergens. The protein 
that would provoke the allergic reaction is no longer present.

X. Conclusions

    Based on the reviews and evaluations performed by JECFA which 
included the establishment of an acceptable daily intake (ADI) of ``not 
specified'' for polyglycitol syrups, EPA concludes that there is a 
reasonable certainty of no harm from aggregate exposure to residues of 
syrups, hydrolyzed starch, hydrogenated. Accordingly, EPA finds that 
exempting syrups, hydrolyzed starch, hydrogenated (CAS Reg. No. 68425-
17-2) from the requirement of a tolerance will be safe.

XI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old FFDCA sections 408

[[Page 7875]]

and 409 of the FFDCA. However, the period for filing objections is now 
60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0026 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before April 18, 
2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential 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. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit XI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2005-0026, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

XII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under section 408(d) of the FFDCA in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the exemption in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers, and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal

[[Page 7876]]

Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, 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, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

XIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: February 7, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.950, the table in paragraph (e) is amended by adding 
alphabetically the following entry to read as follows:


Sec.  180.950  Tolerance exemptions for minimal risk active and inert 
ingredients.

* * * * *
    (e) * * *

------------------------------------------------------------------------
                    Chemical Name                           CAS No.
------------------------------------------------------------------------
                                * * * * *
Syrups, hydrolyzed starch, hydrogenated                     CAS Reg. No.
                                                              68425-17-2
                                * * * * *
------------------------------------------------------------------------


[FR Doc. 05-2981 Filed 2-15-05; 8:45 am]
BILLING CODE 6560-50-S