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Cost and Small Business Analysis of 

Revisions to Minimum Risk Exemption

August 4, 2015

1 Background

Under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 25(b)(2), 

EPA may exempt from the requirements of FIFRA any pesticide that is “of a character 

unnecessary to be subject to [FIFRA]”. Pursuant to this authority, in March 1996, EPA 

promulgated 40 CFR 152.25(g), which exempted from FIFRA any pesticide products 

consisting solely of specified ingredients that EPA judged to pose minimum risk to 

humans and the environment (61 FR 8876, March 6, 1996). This provision was later 

redesignated as §152.25(f) (66 FR 64759, December 14, 2001). 

Unlike producers of registered pesticides, producers of products exempted under 

152.25(f) do not register their products with EPA, pay registration fees, or report 

production to EPA. Exempt products are required to provide certain information on their 

labels, including the names of both the active and inert ingredients. However, the names 

found on labels are often the technical names, which are not known to consumers, and 

may not be known to all inspectors, which can lead to confusion and delays in 

enforcement.

EPA is modifying the label requirements in the exemption to require the use of 

specific common chemical names in lists of ingredients on minimum risk pesticide 

product labels, which will facilitate enforcement, and to require producer contact 

information on the label. EPA is also revising the exemption to more clearly specify the 

active and inert ingredients permitted in products eligible for the exemption from 

regulation for minimum risk pesticides (40 CFR 152.25(f)). EPA is reorganizing these 

lists and adding specific chemical identifiers to make it clearer to manufacturers; the 

public; and Federal, state, and tribal inspectors the specific ingredients that are permitted 

in minimum risk pesticide products. 

The purpose of this analysis is to estimate the cost of label changes of this 

rulemaking, as separate and distinct from (i.e., incremental to) routine label changes that 

producers already undertake and assess the impacts on small entities. The document is 

organized as follows. In section 2, the profile of affected industry is described, including 

the total number of minimum risk pesticide products currently on the market and the 

firms that produce these products. In section 3, the anticipated costs of the final rule are

estimated for three implementation periods: immediate, two years, and three years. The 

cost per label change and the total number of label changes anticipated from the final rule 

are estimated, from which the industry cost is derived. Using the cost estimates of 

section 3, the impacts on small businesses are analyzed in section 4. Based on this 
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analysis, EPA concludes that there will not be a significant impact on substantial number 

of small entities.

2 Profile of Affected Industry

In this section, the minimum risk pesticide industry that would be affected by the

final rule is delineated. Minimum risk pesticide products are identified in subsection 2.1 

and the firms that produce these products are described in subsection 2.2.

2.1 Minimum Risk Pesticide Products

Table 1 shows the number and types of minimum risk pesticide products. The 

information in Table 1 is derived primarily from lists of products registered in 14 states

(EPA, 2010). Although minimum risk products are exempt from registration by EPA, 

approximately 37 states require registration of these pesticide products. Many of these 

states provide their pesticide registration lists (including for minimum risk pesticides) 

online, and available to the public. In addition to the states’ registration lists, the list of 

personal insect repellent products is also derived from the retail store scanner data 

(Nielsen, 2008) and on-line searches. 

Table 1. Minimum Risk Products

Type of Product Number

Antimicrobial 2

Deodorizer 1

Fungicide 9

Fungicide & Herbicide 2

Herbicide 62

Herbicide & Fertilizer 32

Rodenticide 6

Insecticide 149

Insecticide/Repellent 2

Repellent, Animals 141

Repellent, Insect for Animals 31

Repellent, Insect for Pets 20

Repellent, Insect 218

Repellent, Insect, Skin-applied 74

Unknown 8

Total 757

 Sources: State minimum risk product registrations (2010)

 and AC Nielsen (2008).

Only the products that comply with 40 CFR 152.25(f) would be subject to the 

rule. Based on the Agency’s enforcement experience and review of minimum risk insect 

repellent labels, some products marketed under the minimum risk exemption are not in 

full compliance. They may, for example, include inert ingredients that have not been 

approved for these products. When identified, these products must be registered with 

EPA or reformulated to comply with 40 CFR 152.25(f). 
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Since EPA may have incomplete information regarding the number of products 

out of compliance, we assume that all 757 products in Table 1 are subject to the rule, 

which would result in an overestimation of the cost of the rule. On the other hand, since 

exempt products are not registered, Table 1 may not include all of the minimum risk 

pesticide products on the market, leading to an underestimate of the cost of the rule. The 

net effect of these two opposing factors cannot be determined due to the lack of data.

 

2.2 Firms Producing Minimum Risk Products

Table 2 summarizes the number of firms producing the minimum risk pesticide 

products identified by EPA. A total of 216 firms were identified. Some of these firms 

(23) produce both skin-applied insect repellents and other minimum risk pesticide 

products.

Table 2. Number of Minimum Risk Pesticide Product Firms by Product Type

Firms Producing

Number of

Firms Products

Skin-Applied Insect Repellents 34 74

Other Products 205 683

Both of the Above 23

All Products 216 757

 Sources: State minimum risk product registrations (2010) and AC Nielsen (2008). 

For the purpose of cost analysis, the firm data is needed for the highest level of 

multi-layered corporate organizations, called the parent firm. EPA used the Dun & 

Bradstreet (D&B) Market Spectrum database to obtain firm size and financial data, and to 

determine the parent firms (Dun & Bradstreet, 2009). D&B is a comprehensive source of 

financial information on entities, including firm locations, sales, and primary business 

classifications under North American Industrial Classification System code (NAICS). 

Based on a review of this data, 192 parent companies were identified (Table 3). Not all 

parent companies could be determined from the D&B database. Together, the 192 parent 

companies account for 541 minimum risk products, or about 79 percent of those 

identified by EPA.

 

Table 3 shows the distribution of firms by NAICS code. Most firms in the 

minimum risk pesticide industry belong to Chemical Manufacturing (NAICS code 325) 

and Merchant Wholesalers, Nondurable Goods (NAICS code 424). Forty-two firms are 

divided among 31 NAICS codes, including NAICS codes 311, 332, and 333, each with 

four firms), NAICS codes 335 with 3 firms, NAICS codes 112, 115, 445, 453, 525, each 

with two firms, and 17 NAICS codes with one firm in each. 
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Table 3. Producers of Minimum Risk Pesticides

3-digit 

NAICS Code NAICS Code Description

Number of 

parent firms 

325 Chemical Manufacturing 72

339 Miscellaneous Manufacturing 8

423 Merchant Wholesalers, Durable Goods 11

424 Merchant Wholesalers, Nondurable Goods 32

444 Building Material and Garden Equipment and Supplies Dealers 7

541 Professional, Scientific, and Technical Services 7

561 Administrative and Support Services 13

Others 42

Total with classification 192

Sources: State product registrations (2010), AC Nielsen retail store scanner data (2008).

3 Cost of Label Changes

In this section, the cost of the final rule is estimated. The cost of the rule consists 

of a one-time change in the design of the label to comply with the labeling requirements. 

The incremental cost of the final rule depends on the extent to which the change is 

separate and distinct from the routine label changes firms undertake on regular basis. 

The section is organized as follows: the methodology for estimating the cost per label 

change is presented in subsection 3.1. In subsection 3.2, the total industry cost is 

estimated by multiplying the cost per label change by the total number of label changes 

that result from the final rule. 

3.1 Cost per Label Change Methodology

In general, the cost of a label change depends on the size and type of packages for 

products, which determine types of graphics and printing methods. Also, the firm size 

can influence the cost of labeling as smaller firms may choose setups that are less 

expensive (e.g., graphic designs with fewer colors). It is noted that firms change their 

labels on a routine basis to update or “refresh” their product labels even if not required by 

government regulation and this is an important factor that determines the magnitude of 

the cost of the rule. The final rule will impose some cost to redesign the label to 

accommodate new EPA requirements. The expected cost of the label change will depend 

on the duration of the rule implementation period, which will determine the extent to 

which the EPA’s requirements can be incorporated into firms’ routine relabeling 

operations. 

To estimate the cost of the rule, EPA uses the Food and Drug Administration’s 

(FDA) labeling cost model (FDA, 2003) developed for estimating the labeling cost for 

food products. This is a reasonable model for minimum risk pesticide products because 

the package sizes and shapes of exempt pesticide products are similar to the packaging 

for many food products. According to this model, firm’s labeling cost consists of:

1. Setup costs

a. Administrative costs
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b. Graphic design

c. Printing setup – prepress and engraving

2. Printing cost

Administrative costs include working with outside vendors to supply graphic 

design, prepress and engraving, market testing of redesigned graphics, and meeting EPA 

requirements (e.g., searching the common chemical names for the ingredients). Firms 

often work with a graphic design company to redesign their label graphics. Depending 

on the type of graphic designs (e.g., number of colors), costs vary. Prepress operations 

convert the design created by the designer into the film or files that are used to engrave or 

etch the printing plates or cylinders (FDA, 2003). Estimates for these setup costs are 

described in the next subsection (Table 4). 

Because firms have to print labels anyway, printing cost is not a cost of this rule 

unless firms would have to print labels before they used up their stock of printed labels. 

Because firms will be allowed three years to change labels and will know in advance of 

three years that label changes will be required, we assume that firms will be able to plan 

in advance and not have any unused packaged product and label stock.

The cost of a firm’s routine label change is considered as the baseline in estimating 

the incremental cost of the final rule, because the routine re-labeling cost is part of the 

normal business operations in the absence of the rule. 

In the next subsection the setup costs per label change are described.

3.1.1 Setup Costs per Label Change – Baseline

In order to successfully market their product, producers label their product with the 

information that they want the public to know about the product. Thus, producers create 

labels, and update labels as a routine cost of doing business. 

Table 4 below summarizes the setup costs per label change. Many products have 

more than one size or type of package. Each is referred to as a stock keeping unit (SKU) 

(FDA, 2003). Each SKU would have to be relabeled to comply with the new 

requirements. For each type of a label change (e.g. 1-color), FDA has a low, medium, 

and high estimate. Table 4 shows the low estimate for a 1-color change, the medium 

estimate for a 2-color change, and the high estimate for a full redesign with 6 colors, thus 

covering the range of cost estimates from the lowest to the highest. The last column 

shows the simple average of all nine of FDA’s estimates. EPA assumes that these

average costs will apply to the industry as whole (both large and small firms). The 

average setup costs to re-label range from $1,282 to $14,762.
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Table 4. Setup Cost to Re-label per SKU (Stock Keeping Unit): Baseline

1-color, 

low

2-color, 

medium

Full redesign, 

highb Averagec

Administrative $134 $504 $986 $504 

Graphic design $336 $1,512 $3,360 $1,512 

Prepress a $353 $765 $3,920 $1,389 

Engraving a $459 $1,374 $6,496 $2,229 

Total $1,282 $4,155 $14,762 $5,634 

Source: FDA Labeling Cost Model (FDA, 2003) adjusted for inflation using Producer Price Index for 

printing of 1.12

a Average of flexography, offset lithograph, and rotogravure

b With 6 colors

c Average of all 9 of FDA estimates: 3 each of 1-color, 2-color, and full redesign.

 Estimates in Table 4 represent the baseline costs of label change the firms 

routinely conduct as part of normal business operation. In the next subsection, the costs 

of the final rule under different compliance periods are estimated.

3.1.2 Cost of the Final Rule

The final rule will impose some cost to redesign the label to accommodate new 

EPA requirements. The expected cost of the label change will depend on the length of 

the rule implementation period, which determine the extent to which the new EPA 

requirements can be incorporated as part of firm’s routine relabeling operations. In a 

previous analysis (EPA, 2005), EPA determined that many pesticide labels routinely 

undergo changes every 1 to 3 years. Based on this information, for the current cost 

analysis, EPA assumes that firms will routinely re-label every three years, although some 

firms may re-label more or less frequently.

Also, the 2005 EPA analysis assumed that if the changes occurred during a 

routine label update, then one-third of the artwork cost would be due to EPA’s mandate. 

Applying the same assumption, EPA assumes that if the firm’s routine re-labeling 

operation falls within the rule compliance period (that is, if the rule requirements can be 

fully coordinated with the firm’s routine labeling change), the cost of the rule would 

amount to one-third of the baseline administrative and graphic design costs only. This 

incremental cost is associated with complying with EPA requirements (adding common 

chemical names and company contact information, etc). This is the only cost of the label 

change due to the rule because the rest of relabeling costs will be incurred as part of the 

firm’s normal business operations. In Table 5, the cost estimates for this scenario range

from $157 to $1,449.

If the firm’s routine relabeling cycle falls outside the rule compliance period (that 

is, if the rule requirements cannot be incorporated into the firm’s routine labeling 

change), then the firm must incur the full cost of label change estimated in the previous 

subsection (see Table 4) plus administrative and graphic design costs would be one-third 

larger due to EPA’s mandate. In the first row of Table 5, the cost estimates for this 

scenario range from $1,439 to $16,210. These costs are calculated by adding the one-
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third extra administrative and design costs to the baseline costs of a routine label change 

from Table 4. This extra cost is shown in the last row of Table 5 because EPA assumes 

that all labels would have been routinely changed within three years without the rule.

If the firm’s routine relabeling cycle overlaps with the rule implementation 

period, the cost of the rule would lie between the two cases described above. For 

example, if the rule implementation period is two years, two-thirds of the labels are likely 

to be relabeled during the rule implementation period, while one-third of the labels are 

likely to be relabeled ahead of their routine label change schedule because of the rule 

mandate (FDA, 2003). In this case, the average cost per label is estimated to range from 

$584 to $6,369 (Table 5). For example, the weighted average cost for a 1-color change is 

computed as $1,439*(1/3) + $157*(2/3) = $584. 

The estimated costs of the rule under different rule compliance periods are shown 

in Table 5. 

Table 5. Relabeling Cost per SKU (Stock Keeping Unit) under Three Rule 

Implementation Periods

1-color, 

low

2-color, 

medium

Full 

redesign, 

high Average1

Immediate relabeling2

$1,439 $4,827 $16,210 $6,306 

2-year implementation $584 $2,057 $6,369 $2,550 

3-year implementation3

$157 $672 $1,449 $672 

Source: EPA calculations.

1Average of all 9 of FDA estimates: 3 each of 1-color, 2-color, and full redesign.

2 Does not include additional printing costs due to discarding of label stocks.

3Since 3 years sufficient time for routine label changes, this row represents the cost attributable to rule if 

the firm would have relabeled anyway, which is 1/3 of administrative and design costs.

If firms are required to relabel their products, additional costs could be incurred in 

terms of unused packaged product and label stocks that have to be discarded requiring 

additional printing costs to replace discarded label stocks. However, EPA assumes that 

firms will be able to plan in advance and not have any unused inventory stocks, thus 

avoiding this cost with two or more years to comply with the label change requirements. 

While these costs would occur with immediate relabeling, we have no information to 

estimate additional printing costs due to discarding of label stocks. For the above

reasons, we did not include this cost in our estimates.

3.2 Industry Cost 

To estimate the cost to industry of the final rule, the average label setup cost per 

SKU is multiplied by the anticipated number of label changes (the total number of 

SKUs). For the industry consisting of large and small firms, we use the average re-label 

cost in the right hand column of Table 5. The total number of label changes is based on 

the number of exempt pesticide products in the industry and the average number of SKUs 
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per product, which depends on the number of package sizes and types per product. Since 

there is no data regarding the number of SKUs per product for the minimum risk 

pesticide industry, EPA uses 1.53 SKUs per product from the FDA’s sunscreen rule 

(FDA, 2011). EPA believes that skin-applied insect repellents (approximately 10% of the 

total number of minimum risk products identified in this study, see Table 1) are probably 

similar to sunscreen products in terms of multiple packaging since both are dermal 

application products for humans and thus, 1.53 SKUs per product may be a reasonable 

estimate for these products. However, for the other products affected by the rule there 

are no data regarding the number of SKUs per product, and this is a source of uncertainty

in the estimation of the cost of the final rule. Since EPA did not receive information 

during the public comment period on the number of SKUs per product, EPA has 

proceeded to use this estimate for all minimum risk pesticide products.

Using the average cost estimates from the last column of Table 5, EPA estimates 

the industry cost under three different rule implementation periods, assuming firms are on 

a three-year relabeling cycle: immediate relabeling, two years, and three years. To 

estimate the cost of the rule under each implementation period, the number of SKUs per 

product (1.53) is multiplied by the total number of minimum risk pesticide products (757 

from Table 1) to obtain the total number of SKUs (1,158), which is in turn multiplied by 

the average cost per SKU from the last column of Table 5. The results are displayed in 

Table 6. 

Table 6: Industry Cost Under Three Rule Implementation Periods

Immediate 2 years 3 years

Total number of SKUsa

1,158 1,158 1,158

Average cost per SKU label change 

(last column of Table 5)

$6,306 $2,550 $672

Total cost to industryb $7,300,282 $2,952,097 $778,005

Source: (FDA, 2003 and 2011)

a The total number of SKUs is equal to the SKUs per product (1.53) times the number of products (757).

b The total cost to industry is equal to the total number of SKUs times the average cost per SKU.

Under an implementation period of two years, the estimated industry cost is about $3

million. As shown in Table 6, with a three-year compliance period, the cost of the rule is

reduced to about $780,000. 

4 Small Firm Impact Analysis

The Regulatory Flexibility Act (RFA) of 1980, as amended by the Small Business 

Regulatory Enforcement Fairness Act (SBREFA) of 1996, requires regulators to assess 

the effects of regulations on small entities, including businesses, non-profit organizations, 

and governments. In some instances when significant economic impacts on a substantial 

number of small entities are expected, agencies are also required to examine regulatory 

alternatives that may reduce adverse economic effects on significantly impacted small 

entities.
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The RFA does not define the terms “significant” or “substantial” with regards to 

the extent of the economic impact and number of small entities affected. EPA has 

previously characterized annual incremental compliance costs of one percent of annual 

sales as not significant. If costs are likely to be greater than one percent of annual sales, 

EPA considers both the number of affected firms and their proportion of all small firms 

to determine if a substantially higher number of firms will be impacted. If costs are 

likely to be greater than three percent of annual sales, a smaller number and proportion of 

affected firms is considered substantial. 

4.1 Profile of Small Businesses

Firms are classified as small or large by the Small Business Administration 

(SBA). SBA uses either the number of employees or annual gross revenue as a threshold 

to classify a company as small or large. For example, the firms in the NAICS code 325: 

Chemical Manufacturing, the most common code for the firms producing minimum risk 

pesticide products are classified as small if the number of employees is less than 500, 

750, or 1,000, depending on the more refined classification scheme (that is, the 6-digit 

NAICS code) (see Table 3). The firms in the next most common NAICS code – 424: 

Merchant Wholesalers, Nondurable Goods – are classified as small if the number of 

employees is less than 100. The revenue threshold is used for only a few firms in the 

industry. Using such SBA thresholds, it is determined that for the minimum risk 

pesticide industry, there are 97 small firms (out of the total 192, see Table 3), accounting 

for approximately 51% of the industry. They employ on average approximately 30 

employees, with average annual revenue of approximately $2.8 million.1 Based on this 

information, EPA certifies that there will not be a significant impact on a substantial 

number of small entities (SISNOSE). This conclusion is based on our finding that the 

following criteria are met: Under a 3-year implementation period, fewer than 10 small 

businesses are likely to experience an economic impact of 1% or more of gross sales, and 

less than 10% of the small businesses are likely to experience an economic impact of 1% 

or more of gross sales. No small firms are expected to experience an economic impact 

greater than or equal to 3% of annual gross sales.

4.2 Estimation of Impacts on Small Businesses

As noted above, EPA evaluates the impact of a rule on a small firm by comparing 

the cost to the firm with the firm’s annual sales. We first examine the likely impact to 

small firms on average before refining the analysis to consider those firms that may face 

higher than average impacts.

The average cost to a small firm is simply the average cost of a label change 

multiplied by the number of labels the average firm would have to modify. The number 

of labels that must be changed is estimated as the average number of products a firm 

markets times the average number of SKU per product.

 

1 The average revenue is based on 85 small parent firms for which revenue information is available in Dun 

& Bradstreet (2009) database.
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The average relabeling cost per SKU was estimated in the previous section and 

presented in the last column of Table 5. The average cost may overestimate costs to 

small firms in the industry as smaller firms may be more likely than large firms to use 

simpler labels with one or two colors. The 97 small firms identified in Section 4.1 

market, on average, 3.8 products. The average number of products is multiplied by the 

estimate of 1.53 SKUs per product (see the discussion in Section 3.2 above) to obtain the 

expected number of labels that the average small firm would change as a result of the 

rule: 5.75 labels per firm. Table 7 presents the estimated impact, given average revenues 

of $2.8 million/year, under different rule implementation periods. The impacts of the 

final rule on small firms are measured as the cost of the rule as a percent of the average 

small business annual revenue ($2.8 million). Thus, the impacts are approximately 1.3%, 

0.5%, and 0.1% of the average gross revenue of small firms, under each rule 

implementation period. This means that under a three-year implementation period, for 

example, an average small firm is likely to experience the impact that is approximately

0.1% of average gross revenue. A similar interpretation is given for the other two 

implementation periods.

Table 7. Small Business Impacts

Rule implementation period

Average cost 

per SKU

Average cost 

per firma

Impact (% of 

gross revenue)b

Immediate $6,306 $36,189 1.3%

With 2 years to change labels $2,550 $14,634 0.5%

With 3 years to change labels $672 $3,857 0.1%

a Cost per SKU times 5.75 SKUs per firm (3.8 products per firm × 1.53 SKUs per product).

b Given average revenue per small firm of $2.8 million.

Thus, for the two-year and three-year implementation periods, EPA concludes 

that the average small firm would not face significant impacts, based on the criteria 

above. The immediate label change scenario might be a borderline case, but this scenario 

was not considered for the implementation period for the final rule. 

To better understand the distribution of impacts across firms, in the next section, 

the small business impacts are analyzed in more detail by further delineating the SBAdefined small firms into “small” and “very small” firms.

4.3 Refined Analysis

The size of the company may influence the cost of label changes. In general, 

small firms might choose setup costs that are less expensive, compared to the large 

companies with more resources. Thus, EPA assumes that small firms would choose 

either 1-color or 2-color label change schemes, and are unlikely to do a full color design 

of their labels. Inspection of firm revenue data indicates that there are several small firms 

with very small annual revenue. To investigate the impacts of the final rule on these 

firms more closely, EPA further classified the SBA-defined small firms into “small” and 

“very small” firms as follows. Since the medium cost for a 2-color label change is 

estimated to be $4,155 (see Table 4), which is approximately 1% of the gross revenue of 

a firm with gross revenue of $500,000, EPA assumes that small firms with annual 
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revenues of $500,000 or more would, on average, choose the medium 2-color setup for 

their labels. EPA also assumes that “very small” firms of less than $500,000 sales 

revenue would choose the low 1-color setup for their labels. 

Since the data on the number of products for each small firm is available, using 

the estimate of 1.53 SKUs per product for all small firms, EPA was able to estimate the 

total number of SKUs for each small firm. Then, EPA computed the cost of the rule for 

each small firm by multiplying the appropriate (i.e., the 1-color low estimate for “very 

“small” and 2-color medium estimate for “small” firms) average relabeling cost per SKU 

from Table 5 by the total number of SKUs for each firm. These firm-specific costs, as a 

percent of each firm’s annual revenue, are used as a measure of the impact of the final 

rule on small businesses. 

The impacts of the final rule on small businesses are reported in Table 8. With a 

three-year compliance period, 7 small firms (or 7% of all small firms) are likely to 

experience an economic impact of 1% or more of gross sales, while no small firms are 

expected to incur impacts greater than or equal to 3% of gross sales. Therefore, based on 

the criteria described above, EPA concludes that there will be no significant impact on a 

substantial number of small entities (SISNOSE) using the 3-year implementation period.

Because many of the firms are very small, even the modest setup cost (Table 4)

can result in a large impact on small firms. However, by allowing firms sufficient time to 

comply with the re-label requirements the impact on small firms can be reduced. For 

example, from Table 8, if given three years to comply over one or two years, the impact 

on small businesses can be greatly reduced.

Table 8. Small Business Impacts – Refined Analysis

Rule implementation period

Impact (% of annual gross revenue)a

≥ 1% ≥ 3%

Immediate 64% (62) 21% (21)

With 2 years to change labels 27% (26) 9% (9)

With 3 years to change labels 7% (7) 0% (0)

a The estimates are the percent of the small firms impacted out of 97 small firms and the 

numbers in parentheses represent the number of firms impacted. 

References 

Comments submitted by small businesses. Docket EPA-HQ-OPP-2010-0305

Dun and Bradstreet, 2009. Market Spectrum Analysis.

EPA, 2005. “Economic Analysis of the Bulk Pesticide Container Design and Residue 

Removal Standards.” Docket EPA-HQ-OPP-2005-0327. Document ID: EPA-HQ-OPP2005-0327-0024 
Page 12 of 12

EPA, 2010. State registration lists: AL, AK, AZ, CO, IO, LA, MS, NH, NC, OK, RI,

SC, SD, and WA. Docket EPA-HQ-OPP-2010-0305

FDA, 2003. FDA Labeling Cost Model. Research Triangle Institute.

FDA, 2011. Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-theCounter Human Use, Final Rule, June 17, 2011. Docket ID FDA-1978-N-0018 (formerly 

1978N-0038).

Nielsen Company. Scanner data on skin-applied insect repellent products. 2008. Docket 

EPA-HQ-OPP-2010-0305

EPA. State minimum risk product registrations. 2010. Docket EPA-HQ-OPP-2010-0305