62596 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 

WEST VIRGINIA—PM–10 

Designated area 

Designation Classification 

Date Type Date Type 

* * * * * * * 

Hancock and Brooke Counties (part): The City of Weirton .... 12/27/2004 Attainment.

* * * * * * * 

* * * * *

[FR Doc. 04–23945 Filed 10–26–04; 8:45 am] 

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0243; FRL–7371–6]

L-Glutamic Acid and Gamma 

Aminobutyric Acid: Order Denying 

Objections to Issuance of Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final Order.

SUMMARY: By this order, EPA denies the 

objections filed by the Truth In Labeling 

Campaign (TLC) and additional citizens 

to a final rule issued June 21, 2001. That 

rule exempts from the requirement of a 

tolerance under section 408 of the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA) use of L-glutamic acid (LGA) 

and gamma aminobutyric acid (GABA) 

on all food commodities when applied/

used in accordance with good 

agricultural practices. EPA is denying 

the objections because the Agency has 

evaluated these products and believes 

them to meet the statutory requirement 

of reasonable certainty of no harm.

DATES: This order is effective October 

27, 2004.

FOR FURTHER INFORMATION CONTACT:

Carol E. Frazer, Biopesticides and 

Pollution Prevention Division (7511C), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460; telephone number: (703) 

308–8810; fax number: (703) 308–7026; 

e-mail address: frazer.carol@epa.gov.

ADDRESSES: EPA has established a 

docket for this action under Docket 

identification number OPP–2004–0243. 

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, Monday through Friday, 

excluding legal holidays. The Docket 

telephone number is (703) 305–5805.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

This action is directed to the public 

in general. However, this action is of 

particular interest to TLC, the major 

objector to the use of LGA as a pesticide 

product and to Lucinda Larson, the only 

objector who specifically added GABA 

to her objection as well as LGA. Several 

other objectors expressed an objection to 

the Federal Register notice exempting 

the two chemicals from the requirement 

of a tolerance, without specifying either 

one. This action is also of interest to 

Emerald BioAgriculture Corporation, 

the manufacturer of AuxiGroTM, the 

only pesticide product that uses LGA 

and GABA as active ingredients, as well 

as users of AuxiGroTM products. Since 

various different entities may be 

interested in this action, the Agency has 

not attempted to describe all the specific 

entities that may be affected by this 

action. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the person 

listed in the FOR FURTHER INFORMATION

CONTACT section. 

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information? 

In addition to using EDOCKET (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

A. What Action Is the Agency Taking?

From June 28, 2001 through January 

14, 2002, TLC and others filed a series 

of objections to EPA’s issuance of an 

exemption from the requirement of a 

tolerance under section 408 of the 

FFDCA for use of LGA and GABA on all 

food commodities when applied/used in 

accordance with good agricultural 

practices. EPA is denying the objections 

because it has reviewed all available 

data on these pesticides and maintains 

its conclusion that the uses of these 

pesticides are safe. None of the objectors 

filed a hearing request.

B. What Is the Agency’s Authority for 

Taking This Action?

Section 408 of the FFDCA authorizes 

the establishment by regulation of 

maximum permissible levels of 

pesticides in foods. Such regulations are 

commonly referred to as ‘‘tolerances.’’

Without such a tolerance or an 

exemption from the requirement of a 

tolerance, a food containing a pesticide 

residue is ‘‘adulterated’’ under section 

402 of the FFDCA and may not be 

legally moved in interstate commerce. 

21 U.S.C. 331, 342. Monitoring and 

enforcement of pesticide tolerances are 

carried out by the U.S. Food and Drug 

Administration (FDA) and the U.S. 

Department of Agriculture (USDA).

Section 408(b)(2)(A)(i) of the FFDCA 

allows EPA to establish a tolerance only 

if EPA determines that the tolerance is 

‘‘safe.’’ Section 408(b)(2)(A)(ii) 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 

dietary exposure through food and 

drinking water and exposure other than 

dietary that occurs in non-occupational 

settings. In making safety 

determinations, EPA is required to 

consider, among other things, ‘‘available 

information concerning the cumulative 

effects of the pesticide chemical residue 

and other substances that have a 

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 62597

common mechanism of toxicity.’’ 21 

U.S.C. 346a(b)(2)(D)(v). Section 

408(b)(2)(C) 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. . . .’’ 21 U.S.C. 346a(b)(2)(C). 

For pesticides that pose a threshold 

effect, EPA is directed to apply ‘‘an 

additional tenfold margin of safety . . . 

to take into account potential pre- and 

post-natal toxicity and completeness of 

the data with respect to exposure and 

toxicity to infants and children.’’

[hereinafter referred to as ‘‘the 

children’s safety factor’’] Id. This 

provision additionally specifies that 

EPA ‘‘may use a different margin of 

safety for the pesticide chemical residue 

only if, on the basis of reliable data, 

such margin will be safe for infants and 

children.’’ Id. The procedure for 

establishing tolerance regulations is 

generally initiated by pesticide 

manufacturers through the filing with 

EPA of a petition requesting the 

establishment of a tolerance. See 21 

U.S.C. 346a(d). EPA is required to 

publish notice of this petition as well as 

a summary of the petition prepared by 

the petitioner. Id. 346a(d)(3). After 

evaluation of the petition, EPA may 

issue a final tolerance regulation, a 

proposed tolerance regulation, or an 

order denying the petition. Id. 

346a(d)(4). Once a final tolerance 

regulation is issued, any person may, 

within 60 days, file written objections to 

any aspect of this regulation and may 

also request a hearing on issues of fact 

raised by the objections. Id. 346a(g).

EPA regulations specify that if a 

hearing is requested, the objections 

must include a statement of the factual 

issues on which a hearing is requested, 

the requestor’s contentions on such 

issues, and a summary of any evidence 

relied upon by the requestor. 40 CFR 

178.27. A request for a hearing will be 

granted if the Administrator determines 

that the material submitted shows the 

following: There is 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 in the manner sought by the 

requestor would be adequate to justify 

the action requested. 40 CFR 178.32. 

EPA’s regulations specify that if no 

hearing is requested, or a requested 

hearing is denied, EPA will publish in 

the Federal Register its determination 

on each objection submitted. 40 CFR 

178.37(a). 

III. Regulatory and Procedural History 

LGA and GABA are pesticides 

produced by Emerald BioAgriculture 

(formerly Auxein) Corporation. They are 

currently registered under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA), 7 U.S.C. 136 et seq., for use 

on all food commodities (40 CFR 

180.1187 and 180.1188) and exemptions 

for the requirement of tolerances 

covering all uses have been established 

under the FFDCA.

In 1987, EPA approved use of LGA as 

a plant nutrient inert for seed treatment 

[40 CFR 180.1001(d)].

In August 1997, EPA published a 

notice of the first application for a new 

pesticide product containing both of 

these active ingredients (62 FR 42782, 

August 8, 1997) (FRL–5735–1). This 

notice announced receipt of an 

application to register a pesticide 

product, AuxiGro WP (EPA File Symbol 

70810–R) containing new active 

ingredients GABA: gamma aminobutyric 

acid at 29.2% and glutamic acid at 

36.5%, not included in any previously 

registered product pursuant to the 

provisions of section 3(c)(4) of the 

FIFRA, as amended. This product was a 

plant growth enhancer for use to 

increase yields and the quality of crop 

plants and early ripening in certain 

vegetables. EPA received no comments 

or objections to this application.

In September 1997, in response to a 

petition submitted by Auxein 

Corporation, EPA issued temporary 

tolerances for glutamic acid (62 FR 

46882, September 5, 1997) (FRL–5741–

3) and GABA (62 FR 46885, September 

5, 1997) (FRL–5741–4) on crops 

including: snap beans, peanuts, cotton, 

potatoes, tomatoes, lettuce, green 

peppers, spinach, broccoli, cauliflower 

and cabbage to enhance crop yields. 

These tolerances were scheduled to 

expire on October 1, 1999. Again, EPA 

received no comments or objections to 

the exemptions from the requirement for 

a tolerance.

Later that same year, EPA published 

a proposed permanent exemption from 

the requirement of a tolerance to cover 

use of both active ingredients (62 FR 

56168, October 29, 1997)(FRL–5751–3). 

Depending on the crop, the first 

application of AuxiGro was made at first 

bloom, first bud, at the 4 to 6 leaf stage, 

or other prescribed growth stage. A 

subsequent application, for a maximum 

of two applications, could be made 1 to 

3 weeks later. The rate range is 0.10 –

0.75 pounds of formulated product/acre 

per treatment, not to exceed a maximum 

of 1.5 lb/A per growing season. This 

equated to the application of 0.55 lb/A 

glutamic acid and 0.4 lb/A of GABA 

applied at the maximum use rate. EPA 

received no comments or objections to 

this proposal. EPA finalized this rule 

the following year (63 FR 679, January 

7, 1998)(FRL–5764–4).

On August 20, 1998, after the close of 

the objection period, Jack Samuels of 

the Truth in Labeling Campaign (TLC) 

wrote to EPA objecting to the approval 

of monosodium glutamate as a pesticide 

(Ref. 1). EPA responded to the letter on 

October 13, 1998 after Mr. Samuels’

objections were reviewed (Ref. 2).

In September 1998, EPA made a 

technical amendment to the 

nomenclature language of the tolerance 

exemption to change ‘‘glutamic acid’ to 

‘‘LGA’’ (63 FR 51302, September 25, 

1998)(FRL–6029–1).

In 2000, Auxein petitioned EPA to 

modify 40 CFR 180.1187 and 40 CFR 

180.1188 by deleting the wording 

‘‘when used as a plant growth 

enhancer’’ from the tolerance exemption 

then in place and, as a result broaden 

the scope of the tolerance exemption, 

and to correct the language of the 

tolerance exemption then in place by 

changing the term ‘‘raw agricultural 

commodities’’ to ‘‘food commodities’’

(65 FR 76241–76244, Dec. 06, 2000). 

EPA received no comments on the 

petition.

Auxein submitted efficacy studies to 

support the broadened use patterns and 

EPA evaluated the data and determined 

that the new claims were supported by 

the data. As a result, in June 2001, EPA 

finalized the changes proposed by 

Auxein by modifying 40 CFR 180.1187 

and 180.1188 accordingly (66 FR 33195, 

June 21, 2001)(FRL–6785–6).

On June 28, 2001, Dr. Adrienne 

Samuels of TLC submitted an Objection 

to the Exemption from the Requirement 

of a Tolerance and the group was joined 

individually by several of their members 

who also submitted objections.

IV. Response to Objections

A. Summary of Objections Received

There were 57 objectors to the revised 

tolerance exemption for LGA and 

GABA. All objections addressed the 

perception that an exemption for LGA 

was equivalent to treating crops with 

‘‘monosodium glutamate’’ or ‘‘processed 

free glutamic acid’’ or ‘‘processed free 

glutamic acid (MSG)’’ or to ‘‘what the 

Agency calls LGA.’’ None of the 

objections specifically address ‘‘LGA’’

or provided scientific evidence or 

information linking dietary 

62598 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 

consumption of LGA to adverse 

reactions. Similarly, none of the 

objections specifically cited 

consumption of GABA as the cause of 

adverse reactions or provided scientific 

evidence or information linking 

connection of dietary consumption of 

GABA to adverse reactions.

Rather, many objections reported the 

individual’s reactions or someone else’s 

reactions to dietary intake of MSG, and/

or to processed free glutamic acid 

(MSG). These included, with frequency 

of reaction cited, headache/migraine 

(12), nausea (5), abdominal cramps (5), 

allergy (5), shortness of breath (4), and 

accelerated pulse rate (3). Other 

symptoms mentioned once or twice 

included numbness, lethargy, stiffness, 

distorted vision, coughing, insomnia, 

and facial twitching. Eight objections 

noted individuals felt that ingestion of 

‘‘small’’ or ‘‘tiny’’ amounts of MSG 

elicited some reaction.

B. Agency Response to Summary 

Objections

As to the general objections on LGA, 

there is no evidence, and objectors 

provide no support for a claim, that 

dietary consumption of LGA causes 

adverse human health effects. This is 

the case regardless of whether the 

dietary consumption is of raw or 

processed food containing LGA or 

whether the LGA is produced 

environmentally by natural events or in 

the laboratory. In fact, because LGA is 

a defined chemical structure and a 

constituent of protein, there is 

significant exposure to LGA via the diet 

unrelated to the pesticide use and it is 

also synthesized endogenously (Ref. 3). 

Objectors provide no scientific evidence 

or information to distinguish natural 

LGA from what objectors refer to as 

‘‘processed’’ LGA. This is because there 

is no difference in chemical structure, 

for example, between LGA found in 

nature or the human body and LGA 

produced for pesticide purposes. Where 

the chemical structure of two chemicals 

is the same in all contexts, there is no 

scientific basis to distinguish between 

the chemicals.

With respect to the symptoms cited by 

objectors, these symptoms are 

representative of the ‘‘acute, temporary, 

and self-limited reactions’’ to oral 

ingestion of MSG, as delineated by an 

Expert Panel to the Food and Drug 

Administration (FDA) evaluating the 

safety of use of MSG (Ref. 3). There has 

been a long history of inquiry into the 

safety of MSG as a flavor enhancer in 

foods. The Expert Panel to FDA 

concluded that ‘‘...[b]ased on 

scientifically verifiable evidence, there 

is a subgroup of presumably healthy 

individuals within the population that 

responds generally within one hour of 

exposure with manifestations of the 

MSG Symptom Complex to an oral 

bolus of [greater than or equal to] 3 

grams in the absence of food.’’ However, 

the Expert Panel also concluded 

(emphasis theirs) that ‘‘...no evidence 

exists to support a role of ingested 

glutamate in the etiology or 

exacerbation of...any...long-term or 

chronic illness.’’ Moreover, there is no 

evidence that dietary consumption of 

LGA elicits, or has elicited, the ‘‘MSG 

Symptom Complex’’ of reactions. None 

of the objections identify foods 

containing LGA as the cause of the 

reactions cited.

C. Specific Objections and Agency 

Responses

1. First objection. TLC states that LGA 

naturally bound in protein or freed from 

protein via the natural human digestion 

process causes no adverse reactions (i.e., 

is safe). On the other hand, they state 

that foreign, unnatural substances are 

produced from protein containing 

glutamic acid stereoisomers (i.e., Lglutamic and D-glutamic acid) during 

natural fermentation, food preparation, 

and processing. Specifically mentioned 

are the production of D-glutamic acid 

and pyroglutamic acid when LGA is 

freed from protein via (microbial) 

fermentation, ‘‘high heat (but not acid) 

hydrolysis,’’ ‘‘enzymolysis/autolysis,’’

and ‘‘secretion.’’ In addition, they state 

carcinogenic propanols are produced 

from acid hydrolysis, and carcinogenic 

heterocyclic amines may be produced 

from heat but not acid. They state that 

LGA freed from protein via these 

mechanisms, and containing the above 

contaminants causes ‘‘adverse 

reactions.’’ They call these mixtures of 

chemicals ‘‘processed free glutamic 

acid’’ or ‘‘processed free glutamic acid 

(MSG).’’ No data were presented on the 

oral or dietary toxicity of any of the 

contaminants, nor on the doses required 

to produce toxicity, if any, to humans. 

Neither did they provide any evidence 

that the components of ‘‘processed free 

glutamic acid’’ can or do elicit reactions 

associated with ‘‘MSG Symptom 

Complex,’’ at any level of dietary 

exposure. Further, TLC states ‘‘...we 

have never stated these so called 

contaminants are the cause of adverse 

reactions.’’(Ref. 4)

EPA response. To the extent that 

objectors are concerned with 

contaminants that might be found in a 

pesticide product, EPA notes that its 

review of data/information submitted on 

the manufacturing process and on the 

chemical analyses of the technical grade 

of the active ingredient revealed none of 

the above mentioned contaminants. 

Thus, there is no scientific basis to 

support objectors’ statements regarding 

the presence of the above mentioned 

contaminants and, to the extent that 

objectors’ health-based statements are 

premised on the presence of these 

contaminants, there is no scientific basis 

to support objectors’ statements. Had 

the contaminants been present in a 

pesticide product, a separate tolerance 

or exemption would typically be 

necessary to cover residues of such 

chemicals in or on food.

In addition, as noted above, an 

apparent primary basis for objections by 

TLC (both at the EPA and FDA) appears 

to be derived from their belief that the 

LGA which is derived from a (or any) 

manufacturing process is somehow (and 

in an unspecified manner) different than 

if it were freed from protein via a 

mechanism of human digestion, and is 

somehow different from LGA that 

humans and other higher organisms 

synthesize in their bodies, and is 

somehow different from the LGA that is 

found in unadulterated, unprocessed, 

unfermented food. Further, according to 

TLC, the LGA in lower forms of life (like 

bacteria) is in some unspecified manner, 

not equivalent to the LGA found in 

higher organisms. Again, as noted 

above, there is no scientific basis to 

support such an argument. The 

chemical structure of LGA is the same 

regardless of the organism in which it is 

found or regardless of how it is freed 

from protein. To claim that people may 

react adversely to the same chemical 

structure solely on the basis of how it 

is produced is not a sound scientific 

proposition.

Specifically, and as an example, when 

a hydrogen ion becomes disassociated 

from LGA, the compound is called Lglutamate. When a sodium ion becomes 

associated with L-glutamate the 

compound is called monosodium 

glutamate (MSG). When a potassium or 

ammonium ion becomes associated with 

L-glutamate the compounds are called 

respectively, monopotassium and 

monoammonium glutamate. When the 

monosodium, or monopotassium, or 

monoammonium salts of L-glutamate 

are dissolved in water the sodium, or 

potassium, or ammonium ions become 

disassociated from the glutamate 

molecule. Thus, ‘‘...[G]lutamate entities 

from glutamic acid and glutamate 

entities from the three [ammonium, 

potassium, and sodium] salts are 

indistinguishable and, once added to 

food or water and eaten, glutamate from 

any source, whether naturally present in 

food or manufactured by bacteria, is 

metabolized in the same manner’’ (Ref. 

5). Likewise, upon release to the 

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 62599

environment (as in a pesticide product, 

for instance) glutamate entities from 

LGA or from the three salts would be 

metabolized in the same manner by 

organisms in the environment.

2. Second objection. In granting the 

tolerance exemption, the EPA has 

‘‘...violated Section 408(c)(2)(A)(i), 

Section 408(c)(2)(ii), Section 

(408)(c)(2)(b), and Section 408(b)(2)(D) 

of the Federal Food, Drug, and Cosmetic 

Act (FFDCA).’’

EPA response. EPA does not agree 

with TLC that use of LGA or GABA as 

permitted by the registration and 

tolerance exemptions violates the 

specified sections of FFDCA in granting 

the tolerance exemption for LGA. TLC 

states that LGA bound in protein and 

freed via human digestion causes no 

‘‘adverse reactions.’’ Since the chemical 

entity LGA is the same regardless of the 

source of protein or how it is freed from 

protein, it is the same as the ‘‘truly 

natural glutamic acid’’ referred to by 

TLC, and thus also would cause no 

adverse reactions. Further, none of the 

objectors registered any adverse 

reactions from dietary consumption of 

the chemical entity LGA as is normally 

found in foods. Finally, there is no 

evidence thus far submitted or thus far 

available to the Agency that dietary 

consumption of LGA has caused or will 

cause adverse effects in the U.S. 

population, and its subgroups. If such 

data/information became available, the 

Agency would then reassess its position 

with respect to the tolerance exemption 

for LGA (and also for GABA).

In establishing the tolerance 

exemption for LGA, the Agency has 

considered the validity, completeness, 

and reliability of the extensive scientific 

data base on LGA, including in its 

monosodium form (MSG), and 

concluded that based on that data there 

is reasonable certainty of no harm 

resulting from all anticipated dietary 

exposures to LGA. The Agency 

considered information on the dietary 

consumption patterns of humans, as 

well as the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children.

In addition, the strength and 

weakness of the existing data base, 

which includes the reports and 

conclusions of authors cited by TLC, 

previously has been reviewed and 

summarized in detail by the 1995 Expert 

Panel (Ref. 3). The Agency agrees with 

the conclusions of the subsequently 

issued summary report of Dr. Donald S. 

Stevenson (Ref. 6) that there is no 

scientific basis to support any argument 

that LGA, or glutamate, or MSG, plays 

any role in allergenicity including 

urticaria or anaphylaxis. ‘‘It is illogical 

to propose that the human immune 

systems would form antibodies against 

our own amino acids....All amino acids 

are too small to be an antigen (allergen)’’

(Ref. 6). EPA also agrees with the 

subsequent report conclusion of Dr. 

David G. Hattan (Ref. 7) that based on 

the scientific data ‘‘...we do not concur 

with the Expert Panel that asthma is a 

predisposing medical condition 

associated with the ingestion of MSG.’’

Finally, EPA agrees with the 

conclusions of the subsequently issued 

summary report of Dr. Roland N. Auer 

(Ref. 8) that ‘‘[n]o causal relationship 

has been established between...diseases 

and oral MSG [or glutamate] ingestion 

in humans...’’ There also is no evidence 

that ‘‘...retinal diseases are caused, 

related to or accelerated by MSG 

[glutamate].’’

3. Third objection. ‘‘The processed 

free glutamic acid (referred to in the 

1998 Final Rule as LGA) that was 

granted an exemption from the 

requirement of a tolerance, is a 

neurotoxic endocrine disruptor that 

causes brain lesions [and] endocrine 

disorders’’ which are manifested as 

growth disorders, learning/behavior/

memory deficits, MSG-associated 

responses, schizophrenia, multiple 

sclerosis (MS), Parkinson’s disease, 

amyotrophic lateral sclerosis (ALS), etc.

EPA response. The Agency does not 

agree with the objection that LGA is a 

neurotoxic endocrine disruptor, and 

when consumed in the diet will lead to 

the stated disorders and associated 

diseases, and to the MSG symptom 

complex of reactions. As concluded by 

the Expert Panel to FDA, ‘‘...no evidence 

exists to support a role of ingested 

glutamate in the etiology or 

exacerbation of...any...long-term or 

chronic illnesses...’’ including diseases 

such as Alzheimer’s disease, 

Huntington’s chorea, and amyotrophic 

lateral sclerosis (Ref. 3).

The Agency is aware of the studies in 

which LGA, when delivered at high 

doses to laboratory animals (mice, rats, 

infant primates) by appropriate route 

(injection, high-volume force feeding) 

induces neuronal death-associated 

lesions at the hypothalamus (and, in 

rodents, the medulla oblongata). The 

Agency also is aware of concerns 

presented by some (Ref. 9) that such 

findings, if extrapolatable to dietary 

intake of LGA by humans could have 

health implications. Such speculations, 

however, are not supported since there 

is no scientific evidence to indicate that 

LGA or MSG as consumed in foods 

disrupts the neuroendocrine axis. No 

such glutamate-induced lesions of the 

hypothalamus or medulla oblongata 

ever have been seen or described in 

humans upon autopsy of millions of 

people - including children - over the 

years. (Ref. 8). ‘‘Claims that orally 

ingested MSG [or glutamate] causes or 

contributes to Alzheimer’s disease, 

Parkinsonism, Huntington’s Chorea, 

amyotrophic lateral sclerosis, obesity, 

early or late puberty, stunting of growth, 

or infertility must be viewed with 

extreme skepticism until some evidence 

is provided.’’ (Ref. 8). 

4. Other specific objection issues 

raised by TLC.—a. TLC knows of ‘‘...no 

white, practically free-flowing 

crystalline powder that is ubiquitous in 

nature.’’

Agency response. When organic 

materials, like amino acids,are purified 

from nature they take on the physical 

and chemical characteristics of the 

purified molecule. Upon release of this 

purified material to the environment, as 

a pesticide active ingredient for 

example, it will dissolve in water and 

will be indistinguishable from the LGA 

already in the environment.

b. TLC states that EPA ‘‘...falsely 

asserted that processed free glutamic 

acid has a long history of food uses’’.

Agency response. EPA never has used 

the term ‘‘processed free glutamic acid.’’

This term is used by TLC, and is not 

used by members of the scientific 

community. The terms ‘‘LGA’’ and 

‘‘monosodium glutamate’’ define the 

chemical structures of specific organic 

molecules and are recognized terms.

c. TLC cites three publications by J. 

W. Olney to support their conclusion 

that ‘‘...there is growing recognition that 

the reactive component of monosodium 

glutamate is processed free glutamic 

acid...that causes adverse 

reactions...regardless of the names of the 

ingredients that contain it or the uses to 

which it is put.’’

Agency response. The scientific 

research results of J. W. Olney (e.g., Ref. 

10) showing neuronal lesions in certain 

laboratory animals have been 

considered by EPA in its finding of 

safety from dietary exposure in humans 

to LGA. EPA believes Olney’s research 

conclusions are based on effects due to 

the recognized molecules ‘‘monosodium 

glutamate’’ or ‘‘LGA’’ regardless of the 

source (e.g., natural or manufactured) 

and when delivered in highly purified 

form and at extreme dose levels.

d. TLC cites a report by Martinez (Ref. 

11) and concludes that the author 

‘‘...found a relationship between 

glutamate levels in the CSF 

[cerebrospinal fluid] of the central 

nervous system, not glutamate levels in 

the plasma, that were related to 

migraine headache.’’

Agency response. Martinez (Ref. 11) 

found that glutamic acid levels in CSF 

62600 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 

[obtained by lumbar puncture during 

migraine attack] were lower than in CSF 

of a ‘‘stress’’ control population (e.g., 

pre-operative surgery patients, acute 

stroke sufferers, cancer patient, multiple 

sclerosis sufferers). He also found that 

glutamic acid levels in plasma of 

migraine sufferers during attack were 

lower than in plasma of the ‘‘stress’’

control population. No conclusions on 

relationships between oral consumption 

of MSG and migraine can be drawn from 

the results, since the study was not 

designed to, or intended to, test such a 

relationship. The study results are best 

discussed with regard to possible 

physiological responses (e.g., glutamate 

release) to brain events (e.g., cortical 

blood flow, hypoxic ischemia) that 

occur during migraine.

e. TLC states ‘‘(i)ngestion of processed 

free glutamic acid causes adverse 

reactions in susceptible individuals - 

reactions known to occur as side effects 

of neurotropic drugs such as valium.’’

Agency response. The 

benzodiazepiene drug Valium 

(diazepam) is used to treat anxiety 

disorders, for skeletal muscle relaxation, 

and as a preoperative anesthetic. It 

interacts with part of the GABA 

receptor, in the presence of GABA to 

enhance GABA-induced changes in 

membrane potential, thereby 

augmenting inhibitory effects by 

stimulating various GABA-ergic 

pathways. Primary side effects are 

drowsiness and loss of balance. Thus 

Valium acts in concert with the 

neuroinhibitory physiological role of 

GABA, in apposition to the 

neuroexcitatory physiological role of Lglutamate.

f. EPA omitted data from the literature 

on toxic and endocrine-disrupting 

properties of processed free glutamic 

acid and its ability to cause adverse 

effects in humans. 

Agency response. TLC did not cite 

any studies done in humans that show 

adverse endocrine, neurological, 

learning, or locomotor effects from 

exposure to LGA, MSG, or to what TLC 

refers to as ‘‘processed free glutamic 

acid.’’ EPA believes it has considered all 

of the scientific literature.

g. TLC states that certain human 

studies done with placebos induced 

reactions in control groups and thereby 

obscured the results of such studies 

when the control population was 

compared to the treated group. TLC 

cites a study by Strong (Ref. 12) who 

concluded that placebo materials (e.g., 

capsules) in some earlier human studies 

may give headaches to ‘‘dietary 

migraine sufferers.’’

Agency response. Strong (Ref. 12) 

summarized results from six earlier 

published double-blind studies 

conducted to test patient sensitivity to 

tyramine and beta-phenylethylamine. 

His analysis of the results showed 18% 

of patients reported headaches from 

placebos which were concealed in 

gelatin capsules. In the current study by 

Strong (Ref. 12), the author was the sole 

subject in the study. The double-blind 

component of the study apparently was 

done with water containing 1 milligram/

milliliter (mg/ml) tyramine or with 

some unspecified amount of unspecified 

placebo in 20 ml of water. Gelatin 

capsules were not used. The author 

suffered headache after consuming 5 of 

6 of the tyramine samples, but not from 

placebo samples. The author selfreported headache from consuming 400 

mg of MSG in 15 grams (g) of cottage 

cheese, from 118 mg partially 

hydrolyzed vegetable protein in 15 g of 

ricotta cheese, and 123 g gelatin capsule 

in potato chips. This part of the study 

apparently was not double-blinded. The 

Agency believes the results from an 

extensive study done by Geha et al. (Ref. 

13) represent the best available data in 

a multicenter, multiphase, double-blind, 

placebo-controlled study with MSG 

using 130 self-reporting responders to 

MSG in the initial phase of the study. 

A citrus-based placebo beverage was 

used. The results suggested that ‘‘...large 

doses of MSG given without food may 

elicit more symptoms than a placebo in 

individuals who believe they react 

adversely to MSG. However, neither 

persistent nor serious effects from MSG 

ingestion are observed, and the 

responses were not consistent upon 

retesting.’’

h. TLC states ‘‘[t]here is no evidence 

that surface residue from processed free 

glutamic acid will be gone prior to 

harvesting crops...and the applicant 

failed to note there would be residue in 

and on food crops.’’ ‘‘To be effective as 

a plant growth enhancer...processed free 

glutamic acid would have to be taken up 

by the plants.’’ Also, all food crops 

‘‘[c]ould potentially be treated with 

processed free glutamic acid.’’

Agency response. The tolerance 

exemption for LGA is supported by a 

lack of dietary toxicity. Therefore, it is 

appropriate for the EPA to not require 

residue data for the pesticidal use of 

LGA.

i. TLC states they have demonstrated 

that the glutamic acid in monosodium 

glutamate or other processed foods is 

not chemically identical to the LGA 

found in unadulterated/unprocessed/

unfermented food. The glutamate 

industry has ‘‘failed to distinguish 

between free glutamic and processed 

free glutamic acid...and only processed 

free glutamic acid causes adverse 

reactions in MSG-sensitive people who 

ingest amounts that exceed their 

tolerance levels.’’

Agency response. TLC has not 

demonstrated that the chemical entity 

LGA is somehow different when it is 

manufactured. The chemical structure 

of LGA is the same no matter how it is 

produced, or from the source from 

which it is derived.

j. ‘‘...EPA had the audacity to state in 

1988 that ‘[t]he Agency has no 

information to suggest that glutamic 

acid will adversely affect the immune or 

endocrine systems’...and in 2001...EPA 

had the gall to ignore the subject of 

endocrine disruptors entirely.’’

Agency response. There is no 

evidence that dietary consumption of 

LGA or monosodium glutamate causes 

adverse effects to the immune or 

endocrine systems of humans including 

infants and children.

k. TLC states that ‘‘...monosodium 

glutamate and LGA are given hazard 

ratings of HR3 (most toxic) indicating an 

LD50 below 400 milligrams/kilogram 

(mg/kg)...in the sixth edition of 

‘Dangerous Properties of Industrial 

Materials.’’’

Agency response. The oral LD50

values for LGA are reported by the 

Registry of Toxic Effects of Chemical 

Substances (RTECS) as >30 g/kg in the 

rat and 2.3 g/kg in the rabbit. The oral 

LD50 values for MSG are reported at 16.6 

g/kg in the rat and 11.4 g/kg in the 

mouse. These values are consistent with 

the least toxic category for pesticides, 

and would not require any 

precautionary statements for human 

hazard on the pesticide label. More 

relevant, is the long history of human 

dietary exposure to the naturally 

occurring amino acid, LGA, with no 

adverse effects - including lethality - 

ever being attributed, linked, or even 

expected from such exposures.

l. TLC believes that EPA waived a 

requirement for a metabolism study 

with LGA because MSG has GRAS 

status.

Agency response. A laboratory animal 

metabolism study (i.e., OPPTS 

Harmonized Guideline No. 870.7485) is 

not an EPA requirement for registration 

of biochemical pesticides (LGA and 

GABA are classified as biochemical 

pesticides). Thus, there is no need to 

waive a requirement for a metabolism 

study. Yet, the EPA could require such 

a study for biochemical pesticides if 

considered warranted. However, such a 

study in laboratory animals is not 

warranted because there is extensive 

knowledge on dietary exposure to, and 

subsequent metabolism of, LGA in 

humans without findings of toxicity. 

Likewise, the GRAS status of MSG 

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 62601

supports, and is consistent with, the 

Agency’s finding for a tolerance 

exemption for LGA.

m. TLC cites a multigeneration 

reproduction study (Ref. 14) where mice 

were fed MSG to support their 

contention that ‘‘...failure to find 

differences in growth or adverse 

reactions of control and experimental 

groups may very well have been, in part, 

to the fact that control groups were 

receiving neurotoxic substances in their 

basal diets.’’ The cited potential 

component of the basal diet was ‘‘yeast 

food’’ which TLC states ‘‘...invariably 

contained either protease (which creates 

processed free glutamic acid during 

manufacture) or L-cysteine which 

produces neurotoxic effects...more 

extensive than the effects of processed 

free glutamic acid.’’

Agency response. In the above cited 

study, about 800 mice through the F0 to 

F3 generations were fed basal diet 

containing 1% MSG, and an additional 

800 mice were fed basal diet containing 

4% MSG. There were about 1800 mice 

in the control group, fed basal diet only. 

There were no observed adverse effects 

in animals from the control or treated 

groups. All parameters measured in the 

control and treated groups were within 

expected ranges for the mouse. No brain 

lesions or any other pathological 

changes were noted. Fertility index, 

gestation index, viability index, and 

lactation index were all high, in the 

MSG-treated animal and control groups. 

The hypothesis of TLC that neurotoxic 

components in the basal diet adversely 

affected the control group animals, and 

thus masked effects in the dosed group 

animals when the groups were 

compared is not supportable when no 

adverse effects were seen in any group, 

and all parameters were within 

expected ranges typical of the normal 

healthy mouse.

n. TLC states certain animal feeding 

studies submitted to the Agency were 

flawed because while they ‘‘...accounted 

for the amount of food consumed by 

experimental and control groups [they] 

did not account for the amount of 

processed free glutamic acid consumed 

as opposed to being left on the table.’’

‘‘Every animal owner knows that 

animals are quite adept at ferreting out 

and rejecting (not eating) pills or other 

goodies hidden in their food.’’

Agency response. In dietary studies 

with rodents, test materials are 

uniformly blended with, and thus 

uniformly distributed in the food. 

Therefore, rejection of the diet due to 

aversion to the test material mixed in 

the food would be readily determined 

by a measured decrease in food 

consumption. Food consumption was 

accounted for in experimental and 

control groups in the studies cited, and 

was comparable among the groups.

o. TLC states that the results from 

acute toxicity studies done with 

laboratory animals do not ‘‘...mimic the 

real life situation wherein animals could 

be sprayed or otherwise come in contact 

with Auxigro. 

Agency response. The acute toxicity 

battery of studies were done at doses 

sufficiently high to allow placement of 

the test material in the least toxic 

category for pesticides. Considering the 

acute inhalation toxicity study as an 

example, rats were exposed in a 

chamber to 2.58 mg/L for 4 hours. The 

only effects observed were piloerection, 

decreased activity, and red crust around 

the nose. These minor effects resolved 

by day 4 after exposure. Also, a very 

high dose of Auxigro (i.e., 5 g/kg) only 

caused slight and reversible redness to 

the animals’ skin, and the minor eye 

irritation effects observed also were 

reversible. It can be concluded that if 

animals were sprayed with Auxigro 

during pesticide application and use, 

they would not be adversely affected.

p. Agency summary response to 

objections by TLC on the tolerance 

exemption for LGA. TLC has not 

provided any scientific documentation 

that dietary consumption of LGA has 

caused harm, or will cause harm to 

humans, including to infants and 

children. They have not provided any 

evidence that LGA is allergenic, or 

when consumed by humans, adversely 

affects the endocrine system or the 

central and peripheral nervous system. 

They have provided no evidence that 

LGA is carcinogenic. They have not 

provided any scientific documentation 

that an oral bolus of MSG causes any 

adverse effects in humans beyond those 

typically associated with the MSG 

Symptom Complex. Even then, the 

pesticidal use of LGA represents an 

exposure scenario quite different than 

the food additive use of MSG as a flavor 

enhancer. Use of LGA as a pesticide is 

unlikely to contribute any significant 

addition of free glutamic acid already in 

the human diet, and even if use of LGA 

as a pesticide did significantly increase 

free glutamic acid in the diet there are 

no toxic endpoints that have been 

identified from dietary consumption of 

LGA. TLC has maintained that LGA is 

somehow different than the form found 

in nature when it is produced by 

microorganisms, or when it is released 

from protein by other than human 

digestive proteolytic enzymes. TLC calls 

this different material ‘‘processed free 

glutamic acid’’ and maintain that this is 

the material which causes numerous 

adverse effects. It mentions certain 

contaminants that may arise from 

certain processes that are used, or have 

been used, in deriving commercially 

available sources of LGA, but never 

states that it believes these 

contaminants are causing adverse 

effects, or provide any data on doseresponse studies to support adverse 

effects from these materials. In fact, it 

has ‘‘...never stated these so called 

contaminants are the cause of adverse 

reactions.’’ Nevertheless, the tolerance 

exemption set forth under 40 CFR 

180.1187 is for LGA, and is not for any 

other chemical.

D. Summary of Objections by Lucinda 

Larsen

One objector, Lucinda Larsen, 

objected to the tolerance exemption for 

LGA and GABA on the ground that it 

would allow use of unrestricted 

amounts of ‘‘potent neurotoxins’’ which 

would interfere with ‘‘...almost all 

bodily functions.’’ If supplemented in 

the diet, millions of consumers would 

suffer death or injury from ingestion of 

the slightest amount of ‘‘processed free 

glutamic acid’’ or ‘‘manufactured free 

glutamic acid.’’ ‘‘The glutamic acid 

found in nature is bound not freed and 

[is un]able to interfere with bodily 

functions.’’ The objector believes the 

EPA has not considered and 

‘‘...collect[ed] updated pertinent data 

from unbiased sources.’’

Agency response. The Agency has 

considered the strength and weakness of 

the existing scientific data base (e.g., see 

above) and has concluded that the 

tolerance exemptions for LGA and for 

GABA pose no unreasonable risk to 

human health. Free LGA is found in 

nature, in human bodies, and in the 

foods humans eat and it is the same 

glutamic acid as manufactured from 

microbial fermentation or by release 

from proteins. Likewise, free GABA, 

derived via enzymatic activity (i.e., 

decarboxylation reaction) from LGA, 

also is found in humans, plants, and 

microorganisms. LGA is the most 

important excitatory neurotransmitter in 

the central nervous system (CNS). 

GABA on the other hand is not an 

excitatory neurotransmitter, but rather is 

an important inhibitory 

neurotransmitter.

V. Order Responding to Objections

The exemptions for the requirement 

of a tolerance for LGA and GABA on all 

food commodities to which TLC and 

other objectors filed objections are in 

force and will remain so.

As detailed in Dr. Andersen’s October 

13, 1998 response to Mr. Jack Samuels 

and TLC’s first objection to the 

exemption for LGA in August 1998, EPA 

62602 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 

scientists critically appraised all the 

data at that time and came to the 

conclusion that Mr. Samuels’ objection 

was unwarranted (Ref. 2). However, 

EPA wishes to make sure all possible 

areas of disagreement are covered and 

has reviewed the latest information 

submitted by the objectors and believes 

nothing substantive has been added to 

the body of data known on these 

chemicals, and no change in the 

previous exemption is necessary.

VI. Regulatory Assessment 

Requirements

As indicated previously, this action 

announces the Agency’s final decision 

regarding an objection filed under 

section 408 of FFDCA. As such, this 

action is an adjudication and not a rule. 

The regulatory assessment requirements 

imposed on rulemakings do not, 

therefore, apply to this action.

VII. 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, does not apply 

because this action is not a rule for 

purposes of 5 U.S.C. 804(3). 

VIII. References

1. Letter from Jack L. Samuels to Sue 

Smith, The White House, Aug. 20, 1998.

2. Letter from J. Andersen to J. 

Samuels, Oct. 13, 1998.

3. Raiten, D.J. et al., Analysis of 

Adverse Reactions to Monosodium 

Glutamate (MSG), American Institute of 

Nutrition, MD, 1995.

4. e-Mail from J. Samuels to J. 

Andersen, 7/28/98.

5. Kuznesof, P.M., Expert Report, 

undated.

6. Stevenson, D.S. Expert Report, 

undated.

7. Hattan, D.G. Expert Report, 

undated.

8. Auer, R.N., Expert Report, undated. 

9. Olney, J. W. Excitotoxins in Foods. 

Neurotoxicology 15(3) 535–544, 1994.

10. Olney, J.W., et al., Cytotoxic 

effects of acidic and sulphur containing 

amino acids on the infant mouse central 

nervous system. Exp. Brain Res. 14:61–

76, 1971.

11. Martinez, F., et al. Neuroexcitatory 

amino acid levels in plasma and 

cerebrospinal fluid during migraine 

attacks. Cephalalgia. 13:89–93, 1993.

12. Strong, F.C., Why do some dietary 

migraine patients claim they get 

headaches from placebos? Clin. 

Experimental Allergy. 30:739–743, 

2000.

13. Geha R. S. et al., Multicenter, 

double-blind, placebo-controlled, 

multiple challenge evaluation of 

reported reactions to monosodium 

glutamate. J. Allergy Clin. Immunol. 

106:973–980, 2000.

14. Anantharaman, K., In utero and 

dietary administration of monosodium 

L-glutamate to mice: reproductive 

performance and development in a 

multigeneration study. In ‘‘Glutamic 

Acid: Advances in Biochemistry.’’ L. J. 

Filer, et al., eds. Raven Press, N.Y., 

1979.

List of Subjects in 40 CFR Part 180

Environmental protection, 

Administrative procedure, pesticides 

and pests.

Dated: October 18, 2004.

James Jones,

Director, Office of Pesticide Programs.

[FR Doc. 04–24041 Filed 10–26–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0331; FRL–7683–5]

Deltamethrin; Pesticide Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a 

tolerance for combined residues of 

deltamethrin, isomers transdeltamethrin and a-R-deltamethrin in or 

on almond hulls; apples, wet pomace; 

artichoke, globe; barley, bran; cattle, fat; 

cattle, meat; cattle, meat byproducts; 

corn, field, forage; corn, field, refined 

oil; corn, field, stover; corn, pop, stover; 

corn, sweet, forage; corn, sweet, kernel 

+ cob with husks removed; corn, sweet, 

stover; egg; fruit, pome, group 11; goat, 

fat; goat, meat; goat, meat byproducts; 

grain, aspirated fractions; grain, cereal, 

group 15, except sweet corn; hog, fat; 

horse, fat; horse, meat; horse, meat 

byproducts; lychee (import tolerance); 

milk, fat (reflecting 0.02 ppm in whole 

milk); nut, tree, group 14; onion, dry 

bulb; onion, green; poultry, fat; poultry, 

meat; poultry, meat byproducts; radish 

tops; rapeseed; rice, hulls; rye, bran; 

sheep, fat; sheep, meat; sheep, meat 

byproducts; sorghum, grain forage; 

sorghum, grain stover; soybean, seed; 

soybean, hulls; starfruit (import 

tolerance); sunflower seeds; vegetable, 

cucurbit, group 9; vegetable, fruiting, 

group 8; vegetable, root, except sugar 

beet, subgroup IB; vegetable, tuberous 

and corm, subgroup; IC; wheat, bran. 

Bayer Crop Science LP, formerly 

Aventis CropScience, requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA).

DATES: This regulation is effective 

October 27, 2004. Objections and 

requests for hearings must be received 

on or before December 27, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP –2004–

0331. 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:

George LaRocca, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW.,Washington, 

DC 20460–0001; telephone number: 

(703) 305–6100; e-mail address: 

larocca.george@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers.

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers.

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers;